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Investigation

Investigation into outbreaks of Clostridium difficile at Stoke Mandeville Hospital, Buckinghamshire Hospitals NHS Trust July 2006

Inspecting Informing Improving

2006 © Commission for Healthcare Audit and Inspection

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Contents

Foreword 2

The Healthcare Commission 3

Executive summary 4

Introduction 10

Clostridium difficile and healthcare acquired infections 12

The trust’s history and role 19

Outbreaks of Clostridium difficile 23

Factors that contributed to the outbreaks 32The environment at Stoke Mandeville Hospital 32 Arrangements for controlling infection 34Isolation of infected patients 40 Movement of patients from ward to ward 44Staffing levels and arrangements 45Arrangements to manage clinical risks 51

Strategic arrangements at the trust 59

Strategic priorities 64

Roles of external organisations 71

Events since the investigation was announced 77

Conclusions 82

Recommendations 91

Appendix A: The Healthcare Commission’s criteria for an NHS investigation 94

Appendix B: The investigation team 95

Appendix C: Interviews 96

Appendix D: Sources of information 98

Appendix E: Other work being undertaken by the Healthcare Commission onhealthcare associated infections 100

Appendix F: Clostridium difficile deaths 101

Appendix G: Letter of June 5th sent to the trust regarding observations 103

Appendix H: Photographs of sluices 107

Investigation into outbreaks of Clostridium difficile at Stoke Mandeville Hospital, Buckinghamshire Hospitals NHS Trust 1

Foreword

An awful tragedy occurred at Stoke Mandeville in 2004 and 2005. Over 30 people died as a consequence of two outbreaks of infection caused by the bacterium Clostridium difficile. On behalf of the Healthcare Commission, I extend my sincere condolences to the families of those who died.

The Healthcare Commission on its creation by Parliament in 2004 was given, as its principal function, the encouragement of improvement in the provision of healthcare by organisations in the NHS. It was created in part as a reflection of the Government’s intention that the events which gave rise to the public inquiry which I chaired into paediatric cardiac surgery at Bristol Royal Infirmary between 1984 and 1995 should not happen again. Patients, babies in the case of Bristol, died when their deaths were avoidable. The safety of patients was put at risk through a combination of factors, which together, constituted a failure in the system which provided healthcare.

I said in the immediate aftermath of the Bristol report that it was not possible to say with confidence that events such as those which took place in Bristol would not happen again. What happened at Stoke Mandeville demonstrates that they are still happening. Patients died when their deaths could have been avoided. It is a matter of the greatest regret that the lessons of Bristol have not been learned and incorporated into every corner of the NHS.

This report into what happened at Stoke Mandeville reflects many of the organisational failings identified in the Bristol report. There appears to have been what in the Bristol report was called a “club culture”; senior staff were unresponsive to and feared by other staff; senior managers concentrated too much on one responsibility (achieving financial balance in the case of Bristol, and meeting targets for waiting times in the case of Stoke Mandeville) and neglected others; the trust’s board was not actively engaged in the safety of patients; and, there was confusion as to which, of a number of organisations, was responsible for what, in dealing with the outbreaks of infection.

Through this investigation, the Healthcare Commission makes clear its commitment to the safety of patients. I pay tribute to the excellent work of the staff and our advisers. But, a report after the event, though it offers the opportunity to learn lessons for the future, necessarily arrives too late to avert the march of events. For this reason, we are also continuing to develop our capacity to identify when things are going wrong, before they end in tragedy. We intend to achieve this by using our techniques of surveillance, examining data on the performance of organisations providing healthcare on a regular basis, and by working with others. In this way, we intend to promote a safer system of healthcare for patients.

Moreover, by this report, we demonstrate again the need to place the safety of patients at the forefront of the agenda of healthcare. Safety cannot ever be allowed to play second fiddle to other objectives that may emerge from time to time. It is the first objective. For this reason, we expect action to be taken on our recommendations by all relevant parties. We will remain vigilant in the promotion of the pursuit of safe care for patients.

Professor Sir Ian Kennedy, Chairman.


The Healthcare Commission

The Healthcare Commission’s full name is the Commission for Healthcare Audit and Inspection. It exists to promote improvements in the quality of healthcare and public health in England. We are committed to making a real difference to the provision of healthcare and to promoting continuous improvement for the benefit of patients and the public.

The Healthcare Commission was created under the Health and Social Care (Community Health and Standards) Act 2003. The organisation has a range of new functions and has taken over some responsibilities from other Commissions. It:

• has replaced the Commission for Health Improvement (CHI), which ceased to exist on March 31st 2004

• has taken over responsibility for the independent healthcare sector from the National Care Standards Commission, which also ceased to exist on March 31st 2004

• carries out the elements of the Audit Commission’s work relating to the efficiency, effectiveness and economy of healthcare

We have a statutory duty to assess the performance of healthcare organisations, award annual ratings of performance for the NHS and coordinate reviews of healthcare with others.

We have created an entirely new approach to assessing and reporting on the performance of healthcare organisations. Our annual health check will examine a much broader range of issues than in the past, enabling us to report on what really matters to those who receive and provide healthcare.

Investigating serious failings in healthcare The Healthcare Commission is empowered by section 52 (1) of the Health and Social Care (Community Health and Standards) Act 2003 to conduct investigations into the provision of healthcare by, or for, an English NHS body.

We usually investigate when allegations of serious failings are made, particularly if there are concerns about the safety of patients. Our criteria for deciding to conduct an investigation are set out in Appendix A.

In investigating allegations of serious failings in healthcare, we aim to help organisations to improve the quality of care they provide, to build or restore public confidence in healthcare services, and to seek to ensure that the care provided to patients is safe throughout the NHS.


Executive summary

The Healthcare Commission carried out this investigation to look into outbreaks of Clostridium difficile (C. difficile) at Stoke Mandeville Hospital, part of Buckinghamshire Hospitals NHS Trust, and to consider the trust’s systems and procedures for the control of infection. The investigation was undertaken at the request of the Secretary of State. It followed two outbreaks of C. difficile at the hospital which resulted in a number of deaths and attracted national publicity.

Our particular focus was on the care of patients with C. difficile. We looked at the measures taken to control the spread of the bacterium and the current state of the systems to control this infection. More broadly, we sought to discover and disseminate information about how best to prevent and control healthcare acquired infections.

The investigation was carried out from September 2005 to April 2006. Staff from the Healthcare Commission worked with an external team of expert advisers. We interviewed more than 200 people including past and present staff at the trust, as well as patients who had been infected with C. difficile and their relatives. We reviewed case notes of patients who had been infected with C. difficile and examined more than a thousand documents including policies, reports, audits and records of meetings. We carried out scheduled and unannounced visits to wards and other parts of the hospital.

Synopsis of events During 2003, in the months before the first main outbreak, there had been a number of small outbreaks. The trust’s infection control team was concerned that patients with the infection were not being isolated and might

therefore be putting other patients at risk. The failure to isolate was in part due to the shortage of side rooms and in part due to other patients being given priority for these rooms.

The first hospital-wide outbreak of C. difficile occurred between October 2003 and June 2004. There were 174 new cases during this time and 19 deaths that were definitely or probably due to C. difficile. Sixteen of these patients had almost certainly acquired the infection at Stoke Mandeville Hospital. Many of the cases involved a new strain of C. difficile about which little was known. The infection control team asked for a dedicated area in which to care for patients with C. difficile but none was available. The infection control team followed recommended practice. However, senior managers did not focus clearly on, nor lend their full support to, the containment of the outbreak. What led to that outbreak, according to the Stoke Mandeville Hospital’s annual report on infection control in 2003-2004, was the failure to isolate patients with C. difficile. The report also mentioned deaths associated with the outbreak. However, we found that the non-executive members of the trust’s board did not see that report.

Some problems besides failure to isolate patients were identified and were addressed in the summer of 2004.

The second hospital-wide outbreak occurred between October 2004 and June 2005. There were 160 new cases and 19 further deaths among patients that were definitely or probably due to C. difficile. Seventeen of the 19 patients who died had almost certainly acquired the infection in Stoke Mandeville Hospital. Many of the cases involved the same unusual strain as in the first outbreak.

When the number of patients with infection


from C. difficile began to increase around the time of the second outbreak, the infection control team sought to implement further measures based on lessons learnt from the first outbreak. Again, they wanted to establish a ward dedicated to the care of patients with C. difficile, but the senior managers at the trust did not support this and continued to be reluctant to implement the advice of the infection control team and the local health protection unit. Although the number of cases fell, it is our view that it was only when the outbreak reached the attention of the Department of Health and then received national publicity, that the trust’s leaders gave urgent priority to its containment.

Our key findings and recommendations are summarised below and set out in full in the body of this report.

Overall conclusion We conclude that the first hospital-wide outbreak was a consequence of a poor environment for caring for patients, poor practice in the control of infection, lack of facilities to isolate patients and insufficient priority being given to the control of infection by senior managers.

Following the first major outbreak, the trust’s leaders chose to implement some changes but none that might compromise their strategic objectives. They failed to bring the second outbreak quickly under control because they were too focused on the reconfiguration of services and the meeting of the Government’s targets, and insufficiently focused on the management of clinical risk. It took the involvement of the Department of Health and national publicity to change their perspective.

There was a consensus amongst experts in the control of infection that the second outbreak should have been brought under control sooner. Although the number of new patients affected on any single day was lower than during the first outbreak, the total number of cases was similar, the number of deaths was virtually identical and the outbreak lasted longer.

The failure of the trust to implement the lessons from the first outbreak, combined with a dysfunctional system for governance which did not incorporate the assessment of risk into its decision making, nor make the board aware of the significance of the outbreaks, meant that it took longer than it should to control the second outbreak.

There was a serious failing at the highest levels of the trust to give priority to the management of the second major outbreak. The trust followed neither the advice of its own infection control team nor that of the Health Protection Agency. We find this to be a very significant failing. We are clear that this failing is on the part of the trust and its incorrect interpretation of national priorities.

Factors contributing to the outbreaks At the time of the outbreaks the buildings at Stoke Mandeville Hospital were widely dispersed and many of them were in a poor state of repair. The nature of the environment and the facilities meant that the control of infection was particularly difficult.

It was difficult to isolate patients because there were few side rooms, and some of these were not available for the isolation of patients with infections because of the reconfiguration of wards and ring-fencing of beds, thought necessary to ensure shorter waiting times for non-emergency patients undergoing surgery. The trust’s determination to meet the Government’s target for a maximum waiting time in A&E of four hours, led to some patients with diarrhoea being kept in or put on open wards rather than in isolation facilities.

Although clinical staff repeatedly raised concerns about moving patients to different wards because of the likely spread of infection, no effective action was taken to stop this happening.

Shortages of nurses probably contributed to the spread of infection because the staff on the wards told us they were too rushed to take basic precautions such as washing their hands,


wearing aprons and gloves consistently, emptying commodes promptly and cleaning mattresses and equipment properly.

The shortage was due to the relatively low number of nurses on some wards, nurses being moved to other wards, what was effectively a ban on the use of agency staff and the consequent failure to provide staff to cover vacancies and illness.

Other factors that contributed to problems were a lack of facilities for hand washing and antiquated bed pan washers. Nurses also had difficulties entering the utility rooms on wards and reaching the wash basins, because the rooms were cluttered with linen and waste bags that had not been collected. These rooms contained sluices, used for the dispersal of potentially contaminated waste such as the contents of bed pans.

Some extra facilities for hand-washing and partitions were added after the first outbreak, but the problems with the collection of linen and waste were not addressed until during the second outbreak, and continued to cause intermittent problems up to the time of completion of this report.

The infection control team, handling of the outbreaks, training and practice in the control of infection The members of the infection control team at Stoke Mandeville Hospital were held in high esteem by clinicians in the hospital and externally. In response to cases of C. difficile in 2003, the infection control team quickly changed the policy on the use of antibiotics. Restrictions were introduced before the first hospital-wide outbreak and these continued to be applied in an appropriate manner. The infection control team is to be commended for sending samples to the reference laboratory in the first outbreak to identify the type of bacterium present.

An unusual type of C. difficile was present about which little was known. This type of the bacterium appears to cause a more severe

infection than other types. However, the essential measures to control its spread should have been the same – cleanliness, isolation of patients and restricted movement of patients.

By the end of 2005 there had been an improvement in practice in respect of controlling infection, but it was still not an integral part of the daily routine of all clinical staff. Not all staff washed their hands correctly, or wore or changed protective clothing as often as they should.

Cleaning in some of the areas that we visited at the end of 2005 and in the beginning of 2006, and some of the practices that we observed, were of a completely unacceptable standard. A further outbreak of C. difficile in December 2005 demonstrated continuing problems with cleanliness and control of infection. However, this outbreak was rapidly brought under control.

The response of managers and the trust’s board The senior managers had had a challenging agenda and had made significant progress in many areas, but some of this progress was at the expense of infection control and the safety of patients.

Other managerial imperatives were given greater priority than the control of infection. At the most senior level of management, there was a lack of effective leadership, accountability and support for the control of infection. The director of infection prevention and control had not persuaded the board to give sufficient priority to the control of infection in general and to the control of C. difficile in particular.

The achievement of the Government’s targets was seen as more important than the management of the clinical risk inherent in the outbreaks of C. difficile. This was a significant failing.

This report includes many examples of the advice of the infection control team being overridden, even at the height of the second


outbreak. Some of the required changes were implemented after the first outbreak, while others of perhaps greater importance were not. The most significant lesson – the importance of rapid isolation – was not acted upon.

During the second hospital-wide outbreak the infection control team again asked for a dedicated isolation facility, as they had during the first outbreak. However, although the failure to isolate patients had been identified as the key factor in the first outbreak, this did not happen for two months.

In February 2005 the members of the board were informed about the pressures that the hospital was under, but decided to continue to pursue the achievement of the A&E target. In May 2005, against the advice of the infection control team and the health protection unit, the trust closed the ward that was acting as the isolation facility for patients with C. difficile, without providing an alternative dedicated area. Although there were only four patients in the ward on the day that it closed, the infection control team was very concerned at the loss of the facility.

Staff portrayed the executive team as a closely knit inner circle and considered their style of management to be oppressive and intolerant of failure. The executive team appeared unwilling or unable to hear adverse messages. Staff were frightened to speak openly. It was not an environment in which staff felt confident that the problems they experienced would be addressed, or in which they would be supported. The Healthcare Commission considered that the approach of the trust’s leadership to the investigation was defensive.

Informing the public There was no evidence of any discussion in public until after the outbreaks received national publicity. Although the non-executive staff insisted that they had been well informed about C. difficile, they were not knowledgeable about the outbreaks, nor the failure to implement lessons, nor did they seem aware of

the extent of related clinical concerns.

We have been unable to determine whether the board genuinely failed to discuss any aspect of such a fundamentally important matter, or whether discussions did in fact take place but that these discussions were not recorded. Either state of affairs, however, gives us considerable cause for concern.

Arrangements for governance The structure for governance and the management of risk should have drawn concerns about the safety of patients to the board’s attention. It failed to do so and, because of the structure’s complexity, tended to obscure those issues.

Incidents that had been reported consistently highlighted problems with the movement of patients, patients on inappropriate wards, low levels of nursing staff, problems associated with the delivery of the Government’s targets and the failure to isolate patients with infections. Although many of these required consideration and resolution at a strategic level, they were not discussed by the governance committee nor the board. The main purpose of the reporting of incidents had been missed, as the systemic and strategic issues were not identified and resolved at the highest levels of the trust.

The trust failed to demonstrate that it took the necessary steps to identify risks and implement changes to protect the interests of patients.

Listening to the concerns of staff about standards of care The trust failed to listen to its doctors and nurses. During the second outbreak the hospital was under severe pressure with many patients needing admission and nurses were extremely concerned that they could not look after patients properly.

The head nurses were so worried about standards of care and risks to patients that they


addressed their concerns directly to the chief executive. These concerns were not acted upon.

The nurses then contacted the Royal College of Nursing which raised a grievance against the trust. Even this did not lead to real or sustained improvement. Levels of nursing staff, particularly in areas opened when other wards were full, continued to be inadequate to provide acceptable care and to control infection. Staff were required to work in situations that compromised their professional standards. We believe that this constituted a significant failing.

Doctors were also concerned about the movement of patients between wards, failure to isolate patients with infections, the number of patients on inappropriate wards and the consequent degree of clinical risk. Many senior staff wrote to members of the executive team about these issues. They were not satisfied with the responses they received. They told us that nothing would be changed “unless a disaster occurred”.

Events since the start of the investigation The fact that there was a further outbreak in December 2005 indicated that there are continuing problems with cleanliness, infection control and levels of staffing. However, the way that the outbreak was handled demonstrated that the trust had learned significant lessons since the first outbreak.

We were pleased, during our visit in April 2006, to note improvements to the environment in which patients were cared for, particularly in the new part of the hospital, and improvements in the control of infection. However, we were not convinced that other aspects of the safety of patients were being given sufficient priority, even while our investigation was in progress.

The roles of external organisations Despite enduring national concerns over MRSA, there are still shortcomings in the structure and system to support and monitor the way in which trusts approach the control of infection and manage significant outbreaks of hospital-acquired infections.

The nurse consultant in health protection from the local Thames Valley health protection unit acted as an integral member of the infection control team, giving expert advice and support. The health protection unit generally saw its role as advisory and supportive, rather than to criticise the performance of a trust that was not following its advice. Although it was concerned that the senior managers at the trust did not give sufficient priority to controlling the outbreaks of C. difficile, it did not raise any concerns with the strategic health authority until April nor with the Department of Heath until May 2005, after the isolation ward was closed against its advice.

The strategic health authority focused its efforts on ensuring that trusts delivered the top national priorities. Reducing healthcare acquired infections as a consequence of MRSA was one such priority, but infection with C. difficile was not. The strategic health authority did not take any action after the first outbreak of C. difficile at the trust and did not intervene in the handling of the second outbreak until asked to do so by the health protection unit.

The Healthcare Commission recognises that complex issues are involved but is concerned that it is not clear which body has the principal responsibility to assess the implications of new strains of micro-organisms, and to disseminate relevant information to the NHS.


The national picture and lessons for other trusts Crucial amongst the lessons identified in handling outbreaks is the need for:

• rapid isolation of patients with diarrhoea

• restricting the movement of infected patients between wards

• rapid identification and notification of outbreaks

• establishment of a multidisciplinary outbreak committee which meets regularly

• rapid institution of recommended changes

• close monitoring of all components of the management of outbreaks including cleanliness, decontamination, the environment for patients, antibiotic regimes

• communication with patients, staff and outside agencies

To this the Healthcare Commission would add: ensuring that control of infection is given very high priority by trusts’ boards and senior managers.

In this investigation we found that the problems created for those attempting to reduce the incidence of hospital acquired infection were not just that the time and effort of managers were devoted to other priorities, but that the way the trust chose to pursue those other priorities compromised the controlof infection.

At Stoke Mandeville Hospital, the approach that the trust’s leadership took to meet the Government’s performance targets resulted in the movement of patients between wards, difficulties in isolating patients with infection and high occupancy of beds. Financial pressures led to less flexibility in the system and, in many cases, inadequate levels of staff.

The lack of suitable isolation facilities at Stoke Mandeville Hospital was exacerbated by changes to wards in order to achieve the Government’s targets. There had been an

increase in the frequency of patients being moved that increased the risk of transmitting infections. Higher occupancy of beds meant that there was less time for thorough cleaning.

Low levels of staffing made it particularly difficult for nurses to find time to practise good hand hygiene, to answer call bells and empty commodes promptly, to clean mattresses thoroughly, to use new or properly cleaned equipment for each patient, to wake patients to give them their antibiotics, to complete fluid balance charts and to supervise confused patients who wandered in and out of isolation areas.

These operational problems arose out of the need to juggle a number of ‘must do’ objectives, including the control of finance, the reconfiguration of services, and meeting targets for waiting times. It is our conclusion that the approach taken by the trust compromised the control of infection and hence the safety of patients. This was a significant failing, and we would re-iterate to NHS boards that the safety of patients is not to be compromised under any circumstances.

Because of the gravity of our findings, and our judgement that there were significant failings on the part of the leadership of the trust, we recommend that the leadership must change. We note that, at the time of publication, both the chief executive and the chairman had taken the decision to leave the trust. The full list of other recommendations is available in the body of this report.


Introduction

In June 2005, the Secretary of State wrote to the Healthcare Commission to request under section 52(4) of the Health and Social Care (Community Health and Standards) Act 2003, that we investigate and report on outbreaks of Clostridium difficile at Stoke Mandeville Hospital, part of Buckinghamshire Hospitals NHS Trust. This followed two outbreaks of C. difficile at the hospital in 2004/2005, associated with a number of deaths.

It was agreed that the investigation would not begin until the outbreak was under control, which meant the investigation formally began in September 2005. Our visits and interviews concluded in April 2006. A survey of acute trusts was carried out in conjunction with the Health Protection Agency in the autumn of 2005 and interim findings were produced in December 2005. This was to understand more generally the arrangements and challenges for the management of C. difficile.

Aim The investigation aimed to:

• establish whether the trust’s systems and processes for the prevention and control of infection were adequate during the first two hospital-wide outbreaks of C. difficile

• assess the current state of the trust’s systems and processes for the control of thisinfection

• help the trust and the wider NHS to learn how best to reduce the risk of C. difficile and control the spread of this infection

Terms of reference The Healthcare Commission’s investigation committee agreed the terms of reference for

the investigation in July 2005. The investigation set out to examine:

• all cases of infection with the toxigenic strains of Clostridium difficile bacterium which occurred at Stoke Mandeville Hospital from November 1st 2003, whether they were acquired at the hospital and factors contributing to the outbreaks

• actions to identify the presence of infection with the bacterium and to notify the relevant agencies

• actions taken to control and arrest the spread of the bacterium

• management actions in relation to the above

• roles, responsibilities and actions of the relevant NHS agencies

• the local and national context in which the trust is operating, including national guidance and policy

• any other matters which the Healthcare Commission considers arise out of, or are connected with, the matters above

The investigation focused primarily on the events from the inception of the trust in April 2003 until the announcement of the terms of reference of the investigation in July 2005. After the investigation commenced there was a smaller localised outbreak of C. difficile at Stoke Mandeville Hospital. This is covered in a section on events after the start of the investigation.

Key elements of the investigation Our investigation team worked with a team of expert advisers and sought additional advice from an expert in C. difficile. The membership is listed in Appendix B.

10 Investigation into outbreaks of Clostridium difficile at Stoke Mandeville Hospital, Buckinghamshire Hospitals NHS Trust

During the investigation, the investigation team:

• visited the trust a number of times, to interview staff in relation to the investigation, and to observe wards and clinical areas in the trust

• conducted more than 200 face-to-face and telephone interviews with past and present staff from the trust, representatives from local organisations representing patients, people who had used services at the trust, and members of the public (see Appendix C for further details)

• reviewed 20 sets of individual case notes of patients who had had C. difficile

• analysed more than 1,000 documents provided by the trust and other organisations (see Appendix D for a summary of sources of information and evidence)

This report This report concentrates on the systems and process in place at the trust at the time of the hospital-wide outbreaks, and associated issues and events up until the announcement of the investigation in July 2005. It also considers developments at the time of our visits, which took place from the autumn of 2005 to the spring of 2006.

This report makes a number of findings and recommendations in relation to the control of infection, particularly but not exclusively relating to C. difficile. Initially, the focus of the investigation was on the arrangements for the control of infection at Stoke Mandeville Hospital and the handling of the outbreaks.

However, based on our initial analysis of the evidence available, we considered it necessary to look more broadly at the arrangements at managerial and strategic level at the trust in relation to the spread of infection, and the priority given to the control of infection. We also considered the management of clinical risk across the hospitals. Lastly we considered the

role of other organisations and the lessons for the NHS.

In this report we summarise information on C. difficile and look at the guidance produced by the Department of Health in relation to the control of infection in general and specifically of C. difficile. We describe the context of the trust and the infection control teams. We consider the outbreaks and how they were handled by the trust. We look at the factors that were associated with controlling the outbreaks, at both ward and strategic levels. This includes a review of how the trust evaluated the risk posed to services by infection against the need to achieve other priorities. Lastly we looked at the role of other relevant agencies.

The Healthcare Commission is responsible for this report and for ensuring that Buckinghamshire Hospitals NHS Trust publishes an action plan in response to our investigation. The action plan will be available on the Healthcare Commission’s website. The South Central Strategic Health Authority and South Western Region of the Healthcare Commission will be responsible for monitoring the implementation of agreed actions.

Acknowledgements The Healthcare Commission wishes to thank the following people and organisations for their help and cooperation during the investigation at Buckinghamshire Hospitals NHS Trust:

• patients, their relatives and carers who contributed in person, by telephone or in writing

• staff interviewed by the investigation team

• those who contributed to the organisation and coordination of the investigation, particularly Liz Hollman, Patient Safety Manager at the trust

• the agencies and organisations that gave their views and submitted relevant information


Clostridium difficile and healthcare acquired infections

Clostridium difficile

What is Clostridium difficile? Clostridium difficile, (C. difficile) is the major infectious cause of diarrhoea that is acquired in hospitals in the UK.

C. difficile is a bacterium that can cause an infection of the gut. Only a minority of people, (perhaps 2 to 3% of healthy adults), carry C. difficile as part of their normal gut. Increasing proportions of older people can carry the bacterium without symptoms – around 20% of people over 65 in hospital. Risk of infection is significantly increased by exposure to antibiotics, though there are other contributory factors.

Unless controlled by other bacteria, C. difficile colonises the intestine, and certain strains then produce toxins that together cause extensive tissue damage to the walls of the intestine. This usually causes severe diarrhoea. Other symptoms include high white blood cell counts, lower abdominal pain and systemic symptoms such as fever, nausea and malaise. In severe cases of infection, diarrhoea may not be prominent. The symptoms in many cases are very debilitating, unpleasant and worrying for patients and their families.

In some cases there is a severe inflammation of the colon (known as pseudomembranous colitis) and C. difficile infection can cause death in some patients.

C. difficile cannot grow in the presence of air. Under certain conditions, such as exposure to oxygen in the atmosphere, C. difficile produces spores. These spores are resistant to drying, chemical disinfectants, alcohol and stomach acid. They can remain in the patient and the environment for lengthy periods, thereby

increasing the likelihood of cross infection. Spores transferred to other people can subsequently develop into bacteria that colonise the colon.

What is the importance of C. difficile? The risk that C. difficile poses to public health is regarded increasingly as important as methicillin resistant staphylococcus aureus (MRSA) and it is thought to have contributed to more deaths than MRSA in England, Wales and Northern Ireland in 2003.

In recent years there has been an increase in the number of deaths reported to be associated with C. difficile infection. It has been suggested that this increase is due to improved detection and reporting, together with a real increase in the incidence of infection. A report in May 2006 by the Office for National Statistics found that in England and Wales, the number of times C. difficile was mentioned on death certificates rose from 975 in 1999 to 2,247 in 2004. The main reasons for this are considered to be the increased number of reported cases of infection, the emergence of more virulent bacterial strains causing serious outbreaks, and mounting evidence that patients previously thought to be at lower risk of contracting the infection may be affected.

Why might infections with C. difficile be becoming more of a problem? Approximately 160 different types of C. difficile have now been identified by the typing method used at the Anaerobe Reference Laboratory. Recent years have seen the emergence of a strain, known in Europe as type 027, which appears to be associated with more severe infection. This may have contributed to the increased number of outbreaks of C. difficile recently.


Why does infection occur? For a patient to become infected, they must swallow C. difficile spores or bacteria. A patient could come into contact with C. difficile before they come into hospital, or encounter it in the hospital if the environment, equipment or clinicians’ hands or clothes are contaminated. Any factor that leads to the alteration of the normal bacterial flora of the colon can increase the risk of contracting C. difficile. Those particularly at risk of developing C. difficile infections include older people, people who have recently undergone surgery and people with serious underlying diseases.

Patients who have had recent exposure to antibiotics, possibly for the reasons described above, are at greatest risk of infection, especially those treated with broad spectrum antibiotics which are active against a wide range of bacteria. This is because these antibiotics eliminate many of the normal bacteria that inhabit the colon and their absence makes it easier for C. difficile to thrive. Classes of antibiotics that have been particularly implicated in the development of C. difficile infection are clindamycin, cephalosporins, aminopenicillins and fluoroquinolones. Diarrhoea typically starts within a few days of commencing a course of antibiotics, though those taken one or two months previously can predispose a person to infection.

Over 80% of cases reported are in patients who are over 65 years old. This may be due to lowered resistance, prolonged hospital stay, underlying disease or reduced capacity to produce antibodies to fight the toxins. There is evidence that the risk of infection is directly proportional to the length of stay in hospital, from 1% in patients admitted for less than a week to 50% among patients admitted for more than four weeks. On average, C. difficile infection causes an increase of 21 days in the length of the stay in hospital.

Diagnosis C. difficile infection can be reliably diagnosed by testing a sample of the patient’s diarrhoeal faeces for the presence of C. difficile toxins. Results can be obtained within a few hours, but a more accurate test gives results the next day.

In outbreaks the bacterium may be referred for “typing”. Typing involves assigning each sample of the bacterium to a recognised type, for example type 027, and takes a few days to complete. To do this, the bacterium has to be grown from the faecal sample and sent to the Anaerobe Reference Laboratory in Cardiff for typing, and testing for susceptibility to antibiotics.

Prevention and control The measures to control the spread of the bacterium are the same for all strains of C. difficile, including timely isolation of known and suspected cases, the application of high standards of hygiene and the restriction of the movement of patients between wards. Restriction of broad spectrum antibiotics is necessary to reduce the likelihood of infection in individual patients.

Hospital sites are contaminated by C. difficile spores to varying degrees, depending on the amount of faecal soiling and the level of cleaning. Commodes, bed frames, sluice rooms, toilet floors and ward floors are the areas most likely to be contaminated. Bleach based products (i.e. containing the chemical hypochlorite) should be used where there are patients with a C. difficile infection, rather than non bleach based agents, as the former are thought to be better at removing spores. The action of cleaning is the most effective method of removing spores from the environment. Deep cleaning, i.e. more frequent and extensive cleaning is needed where infected patients have been.

Spores can also be transported on the hands and clothing of staff and patients and on equipment. It is thus important to adhere to strict procedures, including washing hands with soap and water after seeing each patient;


cleaning equipment between patients; wearing new gloves and aprons for each patient; disposing of clinical waste effectively; and restricting the movement of patients around the hospital. People with the infection should be isolated from people who are unaffected to prevent the infection from spreading.

Carefully considered protocols for antibiotic prescribing are essential in reducing the risk of C. difficile infection. The protocols should restrict broad spectrum antibiotics and minimise use of multiple antibiotics and prolonged courses of antibiotics whenever possible. There should be periodic checks of the prescribing of antibiotics.

Treatment The first step is to stop, wherever possible, the course of antibiotics that has allowed C. difficile to proliferate. Antibiotics that do not increase the risk of precipitating C. difficile should be used where possible for patients whose condition requires continued antibiotic treatment. About 15% of patients improve spontaneously, but it is not possible to predict which patients will recover. If the patient continues to have symptoms after C. difficile has been diagnosed, which is usually 24 to 48 hours from the onset of diarrhoea, treatment is commenced. Either of the antibiotics metronidazole or vancomycin are usually prescribed. Where symptoms persist a second course of the same or a switch to the other antibiotic is recommended. In up to 30% of cases the patient experiences symptomatic recurrence after treatment, but this may be due to reinfection with a different strain.

As with all cases of diarrhoea, it is essential that the patient be monitored to ensure they are kept well hydrated and well nourished. Attempts to strengthen the response of the immune system remain popular yet unproven, although there have been reports of successful treatments of some cases with intravenous immunoglobin. Patients with pseudomembranous colitis often require surgical intervention as a life saving procedure.

Ascertaining cause of death As many patients who have C. difficile infection were already ill, it can be difficult to determine whether the C. difficile was the primary cause of death, or was one contributory factor amongst several, or was incidental.

Surveillance and incidence of disease In the UK since 1990 there has been voluntary reporting of C. difficile by trusts to the Public Health Laboratory Service, and latterly to the Health Protection Agency. The figures show a dramatic upward trend of reported cases of C. difficile, from 7,470 cases in 1994 to 43,682 cases in 2004. In January 2004, C. difficile became part of the mandatory surveillance scheme for hospital acquired infections. The first report, published in August 2005, allowed for a comparison of rates of C. difficile infection within the NHS. The mandatory surveillance scheme only requires reporting of cases occurring in people over 65 and therefore did not identify cases in younger people in England. Buckinghamshire Hospitals NHS Trust had figures that were in the middle range. The scheme produced figures for the whole trust and did not distinguish numbers at the different hospitals of the trust.

There is substantial evidence to show that the reported incidence of C. difficile has increased in many countries in the past decade. In Quebec, Canada, there was an approximate four fold increase in reported cases between 1997 and 2004. The greatest increases were seen in older patients. There have been reported outbreaks in at least six of the northern states of the United States of America since 2000.

Reporting of outbreaks Outbreaks need to be detected and reported as this allows recognition of changes in local and national disease pattern and alerts external organisations to the situation. Detection of new outbreaks of C. difficile can be difficult where high or continuously rising numbers of cases


are the normal, background rate. The National C. difficile Standards Group, (a review team established by the Department of Health and comprising 12 national experts,) took account of this in their recommendation that outbreaks should be defined as the “occurrence of two or more related cases over a defined period taking account of the background rate”.

At present trusts have to report ‘important or significant’ outbreaks to their local strategic health authority. There is an expectation they will also report outbreaks to the local health protection unit as part of the national process for monitoring such incidents. However, there is inconsistent reporting of outbreaks to both health protection units and strategic health authorities.

It may be the case that a trust with a low background rate has fewer cases of C. difficile during an outbreak than a trust with a high background rate not experiencing an outbreak. There is no routine published information identifying outbreaks and associated deaths.

Type 027 Reports from North America, where several outbreaks of C. difficile infection have occurred since 2000, have suggested that the C. difficile type known in the UK as 027, (which is known in elsewhere as type B1 or type NAP1), is more virulent and results in more deaths, illness and relapses than other strains. The highest number of cases and number of deaths is associated with increasing age, though there are suggestions that younger patients may also be affected. The factors that make the bacterium potentially virulent and the disease more severe have yet to be clearly established. Canadian research has indicated that C. difficile type 027 follows a seasonal pattern, with outbreaks peaking between December and March. However, it is unclear whether this is related to some aspect of the bacterium itself or, as seems more likely, it is due to external seasonal factors such as increased use of antibiotics or more admissions of older patients to hospital in winter.

Whereas the national guidelines promote the use of a type of antibiotic known as the quinolones as a control measure, type 027 is quinolone resistant. The use of quinolones therefore needs to be restricted as part of antibiotic control.

Type 027 is thought to have been circulating in Canada since 2002, and in 2005 was responsible for 109 deaths in Montreal alone. There is concern that the UK may experience a significant increase in deaths linked to C. difficile, similar to that seen in other countries.

Single isolates of type 027 were identified in Preston in 1999 and in Birmingham in 2002, but were not considered significant. Type 027 was first identified at Buckinghamshire Hospitals NHS Trust in April 2004, during their first major outbreak and was found intermittently thereafter throughout 2004 and 2005.

Mandatory sampling led to type 027 being detected in hospitals nationwide from June 2005 onwards. It is now the second most common strain identified by the national sampling surveillance programme led by the Health Protection Agency. However there are no data on deaths resulting from type 027 in the UK. The strain has also been found recently in Europe.

National guidance on the overall control of infection Since1999, the Department of Health has issued a series of guidance and initiatives that have emphasised the priority to be given to the control of healthcare acquired infection. This included Winning Ways: Working together to reduce Healthcare Associated Infection in England published in 2003, and Saving lives: a delivery programme to reduce healthcare associated infection including MRSA, published in 2005. In 2006, Going further, faster: implementing the saving lives delivery programme, was published. These documents concentrate on MRSA but the implications for practice have benefits for all for healthcare associated infections.


National guidance on Clostridium difficile In 1994 a joint working group of the Department of Health and Public Health Laboratory Service produced guidance on the prevention and management of C. difficile infection. This guidance was directed at trusts’ infection control teams, consultants in the control of communicable disease and clinical staff. The report covered four main areas: antibiotic policies, identification of outbreaks, prevention and control, and the laboratory investigation of infection with C. difficile.

Recommendations were made in relation to hand washing, the movement of patients and general measures such as the use of protective clothing and decontamination. These were part of more general infection control procedures that were required to prevent the transmission of C. difficile infection in clinical areas.

In February 2003 the Department of Health published a report by the National C. difficile Standards Group. This stated that treatment of a case of infection from C. difficile should include modified prescribing of antibiotics and isolation of people with the infection. It reported that the spread of infection could be prevented (but not completely eradicated) by reducing contamination of the environment through environmental cleaning and hand washing, and by restricting the inappropriate use of antibiotics.

In December 2005, the chief medical officer and chief nursing officer issued a letter to all NHS trust chief executives on infection caused by C. difficile. The letter was published in December 2005 at the same time as the results of the joint survey undertaken by the Healthcare Commission and Health Protection Agency. It reminded NHS trusts of the requirements of the mandatory surveillance scheme operated by the Health Protection Agency on behalf of the Department of Health. It outlined the recommendations for microbiological investigation of outbreaks, the need for policies and procedures to be in place

to minimise the risk of infection caused by C. difficile and the need to implement appropriate policies when cases occur.

The National Audit Office and the House of Commons Committee of Public Accounts The report of the National Audit Office in 2000 The management and control of hospital acquired infections in NHS acute trusts in England was critical of the priority given to the control of infection in the NHS. It noted that hospital acquired infections led to an estimated 5,000 deaths a year and cost the NHS about £1 billion annually.

The follow up report in July 2004 by the controller general, Improving patient care by reducing the risk of hospital acquired infection, indicated that there had been notable progress in putting systems in place at trust level, but the prevention of infections continued to be adversely affected by the pursuit of other NHS trust wide priorities and policies. In particular, the increased throughput to meet the Government’s performance targets resulted in considerable pressure towards higher occupancy of beds. Seventy one percent of trusts were still operating with levels of occupancy of beds that were higher than the 82% that the Department of Health reported it hoped to achieve by 2003-2004. More recent national data for 2004-2005 showed that under 15% of acute hospitals were achieving this figure. Higher occupancy of beds means that there is less time for thorough cleaning between patients and a higher probability of transmission of infection between patients. The lack of suitable isolation facilities remained a concern as did the increase in frequency of moving patients. Moving patients increases the risk of transmitting infections. The report noted that 12% of infection control teams reported that their request to close a ward to admissions had been refused or discouraged by their chief executive.

In April 2005 the House of Commons


Committee of Public Accounts (usually referred to as the Public Accounts Committee) followed this up by examining progress in reducing the risks of infection acquired in hospital. The report noted that compliance with good infection control such as hand hygiene was still patchy. It noted there were conflicts with other key targets and priorities and that these had continued to stand in the way of improving prevention and control. These included bed management policies and the need to meet waiting time targets that could compromise infection prevention and control. The report recommended that trusts needed to adopt more effective practices that avoided moving patients too frequently. The Public Accounts Committee considered that each strategic health authority should record incidents when there had been refusal to close a ward for the purposes of the control of infection. The Department of Health however, in their response to the findings of the Public Accounts Committee, did not consider the problem was sufficient for this to be necessary.

Health Protection Agency The Health Protection Agency was formed in 2003 by the merger of several bodies, including parts of the Public Health Laboratory Service. It was joined by the National Radiological Protection Board in April 2005. The Health Protection Agency is an executive non departmental public body responsible for protecting the health and wellbeing of people in England. Its role is to prevent and control the spread of infectious disease, reduce the adverse effect of chemical hazards, poisons and radiation, and prepare for potential or emerging threats to health. The Health Protection Agency is accountable to the Department of Health.

One of the main roles of the Health Protection Agency is supporting the Department of Health to reduce levels of healthcare associated infections. The Health Protection Agency develops new ways of preventing and controlling hospital acquired infections,

providing specialist expertise at local and national levels. The Health Protection Agency has extended the monitoring and surveillance of hospital acquired infections.

Another role of the Health Protection Agency is to provide advice to the NHS on managing and preventing cases and outbreaks of infectious disease, including those caused by C. difficile. The remit of the Centre for Infections, which is part of the Health Protection Agency, includes the provision of national expertise and of nationwide surveillance. It may coordinate the investigation of national or unusual outbreaks – but this may also be done within the local and regional services section of the Health Protection Agency. The two parts of the Health Protection Agency liaise to agree the best arrangement for the particular circumstances. Information on mandatory surveillance of C. difficile infection is sent to the Centre for Infections for national analysis.

The Health Protection Agency has nine regional teams that mirror the areas covered by the Government offices of the regions. Regional teams have a regional director, up to two regional epidemiologists and an information and surveillance team primarily composed of information officers and epidemiological scientists. Most regions have three or four health protection units. The 39 health protection units each cover an area broadly corresponding to a strategic health authority or police boundary. Each unit consists of a director, consultants, nurses and other staff with specialist health protection skills.

One of the tasks of each health protection unit is to work directly with the NHS primary care trusts, acute hospital trusts, strategic health authorities and local authorities in their area. Functions include surveillance of disease occurring locally, alert systems, and the investigation and management of the full range of health protection incidents and outbreaks. The health protection unit staff work closely with acute trusts, particularly their directors of infection prevention and control, and their infection control teams.


Joint survey by the Healthcare Commission and the Health Protection Agency In order to understand the national context for the investigation at Stoke Mandeville Hospital, the Healthcare Commission, in collaboration with the Health Protection Agency, undertook a survey of all NHS acute trusts in England in October 2005. The survey was intended to gain an understanding of the issues facing NHS hospitals in relation to the management, prevention and surveillance of infection caused by C. difficile.

An interim report was published in December 2005 to ensure that the important issues being raised could begin to be addressed by NHS trusts before the winter, as this is the time of year when the prevalence of infection caused by C. difficile tends to be at its highest. It was based on the results from the 118 respondents (68% of the 173 trusts) who had completed and returned the survey by then.

The main findings of the survey were as follows:

• two thirds of trusts stated that the incidence of reported cases of infection from C. difficile had increased during the past three years. This was thought to reflect increases in testing as well as increases in actual cases of the infection

• it was considered that the most effective measure in preventing and managing infection from C. difficile was the appropriate administration of antibiotics in hospital. Other important factors included the rapid isolation of patients, effective hygiene and clean environments

• forty per cent of trusts stated that they did not routinely isolate cases of the infection

• trusts were not working to an agreed definition of an outbreak, and were unclear to whom they should report an outbreak once it had been identified

• there was considerable variation in the use of culture and typing by different trusts and laboratories

• the reporting of positive specimens of C. difficile by laboratories under themandatory surveillance scheme wasinconsistent

As a result of our findings it was emphasised to trusts that they should ensure that their policies on the prescribing of antibiotics were informed by current guidelines on best practice, and that these policies should be properly monitored. Additionally trusts should review their procedures for, and capacity to, isolate patients with infection from C. difficile.

Other work that the Healthcare Commission is undertaking on healthcare acquired infections is summarised in Appendix E.


The trust’s history and role

Buckinghamshire Hospitals NHS Trust (the trust) was created on April 1st 2003 following the merger of South Buckinghamshire NHS Trust and Stoke Mandeville Hospital NHS Trust. It serves a population of approximately 500,000, covering Buckinghamshire, and parts of Oxfordshire, Hertfordshire and Bedfordshire. The trust employs approximately 4,700 staff in a range of specialties.

The trust’s board (the board), which consists of executive and non-executive directors, is responsible for the governance of the trust. The medical director, one director of operations and two non-executive directors had worked for one of the predecessor trusts. The trust has 14 clinical directorates and nine executive directors.

The trust has three hospitals and the administrative headquarters are at Amersham Hospital, which has 29 beds. Wycombe Hospital is a general hospital with around 450 beds providing a wide range of acute services and a specialist centre for urology. Both Amersham and Wycombe Hospitals had their premises significantly improved as a result of a Private Finance Initiative.

Stoke Mandeville Hospital is an acute hospital with around 460 beds, providing a range of acute services. It is also the base for ophthalmology services for the area. The trust provides sub regional services for patients with burns or requiring plastic surgery. It runs the National Spinal Injuries Centre (104 beds) providing diagnostic services, treatment and rehabilitation services for a population of 14 million people.

A new building funded by £40 million Private Finance Initiative opened during 2006, replacing many of the older wards at Stoke Mandeville Hospital.

The trust provides hospital services to Vale and Aylesbury Primary Care Trust (PCT), Chiltern and South Bucks PCT, and Wycombe PCT. The primary care trusts are responsible for organising primary care and community health services for the local population, and commissioning hospital care.

The trust was in the area of the Thames Valley strategic health authority from April 1st 2002 until the strategic health authority became part of the larger South Central Strategic Health Authority in July 2006. The role of the strategic health authority includes establishing and managing annual performance agreements with primary care trusts and NHS trusts.

In 2002 the Commission for Health Improvement (CHI) carried out clinical governance reviews of South Buckinghamshire NHS Trust and Stoke Mandeville NHS Trust. The Commission expressed concern that Stoke Mandeville NHS Trust did not have its full complement of infection control nurses nor the facilities to isolate all patients with MRSA or gastroenteritis. The Stoke Mandeville NHS Trust reported that it could not provide a comprehensive programme for the control of infection because of a lack of resources. Although information was available within the Stoke Mandeville NHS Trust about hospital acquired infections, this was not routinely reviewed by its board. An action plan was agreed for each trust but most of the work was to be taken forward by the newly formed trust as part of its clinical governance plan for 2003/2004.

In 2005, the Healthcare Commission carried out a joint inspection of Buckinghamshire’s health and social services community as part of a review of progress made by the against the National Service Framework for Older People.


The report noted progress in some areas but expressed concerns that the Department of Health core standards on safety, patient focus and the care environment might not be met.

In 2004/2005, the trust was awarded two stars by the Healthcare Commission in the annual performance (star) ratings. It had previously been awarded one star for performance in 2003/2004 and zero stars for 2002/2003, for the performance of the previous two trusts.

The trust is leading an extensive programme to reconfigure services, called Shaping Health Services. This involves the relocation of some services to one site in the trust, while emergency services are maintained on both main sites. This was in part to bring together a sufficient number of specialist clinicians to achieve effective sub-specialisation, in line with modern clinical practice. The main elements of the programme are the development of a treatment centre to provide planned surgery at Wycombe Hospital and the further development of sub-specialist surgical teams, with all emergency surgery undertaken at Stoke Mandeville Hospital. There are emergency services, including minor injuries, A&E doctors and nurses, ambulance and GP admissions, at both Wycombe Hospital and Stoke Mandeville Hospital. The changes include the development of specialist teams such as cardiology and trauma, with some patients being transferred by ambulance to a different hospital in the trust for specialist inpatient care.

These changes led to increased pressure at Stoke Mandeville Hospital with more patients being admitted as emergencies. On average, over 80 more patients were discharged in the first three months of 2006 compared to the three month period that began in April 2003, with increasing numbers of patients admitted as emergencies not being compensated for by a reduction in the numbers of routine patients. Moreover, generally, patients admitted as emergency cases require more resources and staff, and stay in hospital for longer, than those admitted for planned procedures.

The infection control teams There were two infection control teams in the trusts that merged – one based at Stoke Mandeville Hospital and the other at Wycombe Hospital, which also covered Amersham. This arrangement continued after the merger in 2003.

At Stoke Mandeville Hospital the complement of infection control nurses was 1.7 whole time equivalent (WTE) posts in 2003. This figure remained the same throughout the first outbreak until March 2005 when a part time surveillance nurse was appointed. This nurse did not undertake infection control duties. At the time of the first outbreak from late 2003 to June 2004 the complement of medical staff in the microbiology department at Stoke Mandeville Hospital was 1.8 WTE (one full-time consultant microbiologist and one working six sessions, plus on-call cover). This remained at this level until May 2005 when the full time consultant retired. From then until November 2005, the remaining consultant microbiologist continued to work the equivalent of four days a week. There was some locum support at various times but occasional periods where she had to work alone. As well as duties in the hospital, the team at Stoke Mandeville Hospital provided advice to Buckinghamshire Mental Health Trust and the Vale of Aylesbury PCT.

The composition of the infection control team at Wycombe Hospital was stable between December 2003 and March 2006. There were two whole time equivalent consultant microbiologists and their job plan allowed for approximately two half days for each consultant to be dedicated towards the control of infection. There were 2.34 whole time equivalent infection control nurses. In addition there was a further 0.53 WTE post for surveillance and other resources to provide advice and support to two PCTs, part of Buckinghamshire Mental Health Trust and Shelburne Hospital (a private hospital on the Wycombe site).

Each infection control team had its own infection control committee, and there was an over arching infection control management


Committee structure for reports on infection control

Wycombe Hospital infection control team (nurses,

microbiologist and administrative staff)

Trust board

Governance committee

Risk management committee

Infection control management forum

Stoke Mandeville Hospital infection control committee

Wycombe Hospital infection control committee

Clinical risk review panel

Stoke Mandeville Hospital infection control team

(nurses, microbiologist and administrative staff)

forum for the whole trust. A monthly report on infection control went to the clinical risk review panel, which reported to the risk management committee. In turn this reported to the governance committee, the minutes of which went to the board. This structure is set out in the diagram that follows.

Other important committees were the trust executive committee, consisting of the executive directors and the medical directors, and the trust management board, consisting of the executive directors, medical directors and clinical directors.


Each infection control team had a separate programme of work for 2003/2004. The programme became joint in 2004/2005 and included both trust wide tasks and some that were specific to each main hospital.

The medical director was the director of infection prevention and control at the trust. The director of infection prevention and control has overall responsibility for controlling infection in a trust, and reports directly to the chief executive and to the board.

Staff in the hospital found the infection control nurses to be professional, responsive, conscientious and efficient. They were thought to be quick to promote their work and disseminate learning. Staff also found the consultant microbiologists to be knowledgeable, supportive and approachable. The Health Protection Agency at local, regional and national levels perceived the teams to be professional, experienced and conscientious with a thorough grasp of issues related to the control of infection.

Staff on the wards said that the infection control nurses were readily available to provide help and advice. In an internal survey, 88% of staff said they knew where to find advice on the control of infection.


40

35

30

25

20

15

10

5

0 3 30 3 3 3000

40 0 40 40 40 0 4 04 50 0 0 5 50 0 50 5 50 60 0 0 0

2 02 -2 0 0- 2 -2 0 0 02 2 2 -2 0 0 0 0 0 0

- - - - 2 -2 2 2 2 2 0 2 02r n g t- c -b r n g -t- c b r n- g- -2 - -p eu uA A p u e t ce p u e bJ Oc D Fe A cJu A O D F A Ju A Oc D Fe

March 2 nd 2004: Outbreak committee

March 18 th 2005: Outbreak committee

July 20 th 2005: Terms of reference

Figure 1: C. difficile cases acquired at Stoke Mandeville Hospital from April 2003 to March 2006

The outbreaks of Clostridium difficile

The graph below shows the number of C. difficile cases from April 2003 to March 2006. The details are included in Appendix F.

The outbreak committee held their first meeting in March 2004 and reconvened in March 2005.

In the three years to March 2006 there were 498 patients with C. difficile infection at Stoke Mandeville Hospital that were almost certainly acquired at the hospital, since the infection developed 72 hours after the patients were admitted.

It can be seen there were two main outbreaks, one in the winter and spring of 2003/2004 and the other in the winter and spring of 2004/2005. In the first outbreak there were 174 new cases between October 2003 and June 2004 and in the second there were 160 new cases between the same months in 2004 and 2005.

Following the start of the investigation, there was a third small peak in November and December 2005, involving 28 new cases.


The first hospital-wide outbreak During 2003 there were several localised outbreaks of C. difficile at Stoke Mandeville Hospital. These were confined to specific wards.

There were 174 new cases between October 2003 and June 2004. There were 19 deaths during this period where C. difficile was the definite or probable cause of death. In 16 of these cases, the infection had almost certainly been acquired in Stoke Mandeville Hospital. Although the trust defined the outbreak as beginning in December, we consider that the rise from the baseline began in October. Using the months of October to June in the two successive years also gives useful comparative periods for this investigation.

The number of cases began to rise in the autumn of 2003. The infection control team became increasingly concerned about the numbers of patients with C. difficile and the numbers of wards involved. The wards affected were 1x, 3x, 6, 9, 11x, 12 and the emergency medical unit. Most of these were medical wards. Towards the end of February 2004 there were six new cases in one day. At this point the infection control team decided it was necessary to raise the profile of the outbreak in the trust so that more resources and support could be given to its control. The outbreak committee was set up to oversee the management of the outbreak and met for the first time on March 2nd

2004. The peak of the outbreak was in March when there were 35 new cases.

One of the consultant microbiologists chaired the committee. It included the other members of the infection control team, the director of infection prevention and control, a consultant in care of the elderly medicine, senior nurses, bed managers, pharmacists, representatives of estates and facilities, and the local nurse consultant in health protection. An action plan was developed and the committee met every three or four weeks until the end of July 2004, when the outbreak was considered to be over.

On March 10th the team reported the outbreak as an incident in infection control to the

regional epidemiologist at the south east region of the Health Protection Agency who was also the clinical director of the Thames Valley health protection unit. There is no record of managers at the trust reporting the outbreak as a serious untoward incident to the strategic health authority.

The restriction of the antibiotics to be prescribed is one of the established means of reducing the risk to patients of contracting C. difficile. In response to concerns about small pockets of C. difficile infection in 2003, such restrictions had already been introduced. Instructions had been sent in August 2003 and December 2003 on the prescription of antibiotics. These included a requirement to restrict broad spectrum antibiotics on the wards for patients with medical problems. In February 2004, high risk antibiotics were withdrawn from these wards for care of the elderly. There was a protocol for the use of alternative regimes. A new cleaning agent based on hypochlorite was also introduced.

In March 2004 isolates of C. difficile were sent to the Anaerobe Reference Laboratory in Cardiff. Analysis revealed a predominance of type 027, then thought to be rare in the United Kingdom. Its significance was not known at that stage. There was concern at Stoke Mandeville Hospital that the clinical picture was of more severe disease than usually associated with such outbreaks. The senior infection control nurse visited the Reference Laboratory in the autumn of 2004.

The infection control team was anxious to isolate patients with C. difficile or undiagnosed diarrhoea. However there were delays in isolating patients because, due to the age and style of the buildings, there were too few side rooms. At the first meeting of the outbreak committee the infection control team requested a dedicated area for the isolation of patients with C. difficile, but a suitable ward for isolation could not be identified, in part due to ‘ringfencing’ of the surgical wards. This ring-fencing meant that the beds in the surgical wards could only be used for surgical patients. This


arrangement was in place to avoid the cancellation of bookings for planned surgery. The trust did not lift the ‘ring-fencing’ restrictions of the side rooms on the surgical wards during the outbreak.

We noted that the ring-fencing was not absolute and that over two years from September 2003, around 250 medical patients had been admitted to surgical beds. Prior to this approximately 25 medical patients every week had been occupying surgical beds – which would have meant more than 2,500 in the same period.

Cohort nursing is an alternative way to reduce the risk of the spread of infection without having a dedicated isolation ward. The term is used to describe the nursing of a group or ‘cohort’ of patients that require physical separation from other patients within a hospital ward to prevent the spread of infection. A group of patients with the same infection is isolated in the same area. Nursing practice includes the wearing of personal protective equipment (gloves, aprons etc) and using dedicated equipment and staff where possible.

However it was difficult to use this system at Stoke Mandeville Hospital because there were few suitable areas on the wards, due to the scarcity of hand basins and the difficulty of separating patients physically. The layout of the wards and the absence of partitions contributed to this problem. In March 2004 the outbreak committee identified that new hand basins and partitions were required and those changes were made by July 2004. ‘Cohort nursing’ was particularly difficult when levels of staff were low, and especially at night.

It is normal practice for trusts to produce a formal report on a serious outbreak for the health protection unit. The report on the outbreak was produced by the consultant microbiologist who chaired the outbreak committee. It described the number and distribution of cases, the deaths, the contributory factors and the measures undertaken. The report covered the period from February to June 2004 although, with hindsight, it is clear that the cases started to

rise during the previous autumn. The outbreak at one stage involved six wards. Many of the patients had a prolonged course of illness, with frequent relapses.

Stoke Mandeville Hospital was compared by the infection control team with Wycombe Hospital where C. difficile levels were low, despite a similar level of use of the same antibiotics. Stoke Mandeville had half the number of side rooms available at Wycombe Hospital, making it more difficult to isolate patients. The infection control team and outbreak committee concluded that the hospital’s difficulty with isolating patients was the main cause of the spread of the infection. No areas suitable for ‘cohort nursing’ patients on wards could be found.

The report also found that nurses had difficulties entering “dirty utility-rooms” (sluices) and using the wash basin in these rooms, because linen and waste bags had not been collected. A sluice is used for the dispersal of potentially contaminated waste such as the contents of bed pans.

Several important points were made in the outbreak report. The first of these was that to control the spread of infection it is essential to isolate symptomatic patients immediately. The report also stressed the need to restrict broad spectrum antibiotics; it indicated the usefulness of hypochlorite for cleaning; it highlighted the value of identifying strains and it pointed out that delay in treatment led to unfavourable outcomes.

The outbreak report went to the risk management committee on September 7th

2004. The minutes of the risk management committee were received by the governance committee in October 2004. There was no record of the outbreak in the minutes of the governance committee, the finance, performance and information committee, or the board. The finance, performance and information committee is a sub committee of the board that meets monthly in private to discuss the main business of the trust.


Following the outbreak, and in response to the Department of Health’s guidance Winning Ways: Working together to reduce Healthcare Associated Infection in England, the trust set up the antibiotic review group in July 2004. This multidisciplinary group comprises the consultant microbiologists at both main hospitals, clinicians, senior nursing staff, the clinical audit and effectiveness manager and the antibiotic pharmacist. The group meets quarterly and is a subgroup of the drugs and therapeutics committee. The group’s responsibilities include producing and reviewing the guidelines for the staff of the trust on the use of antibiotics.

The infection control team gave a presentation to the trust executive committee on December 14th 2004 describing how the outbreak had been handled. The team emphasised the importance of isolating infected patients. It was agreed that C. difficile and other issues relating to infection control would be taken to the trust management board in two or three months. The trust management board consists of the executive team and the clinical directors. At the board’s February 2005 meeting, directorates were asked to identify their leads for clinical governance and infection control. This was during the second outbreak. The next mention of infection control was in June 2005, after the second outbreak had been publicised in the national media.

The infection control team kept the head nurses informed through regular reports to their monthly meetings. The head nurses are senior nurses with responsibilities for managing issues to do with nursing for a significant clinical area in the trust, for example medicine or planned surgery.

The second hospital-wide outbreak The number of cases began to rise again in November 2004 and climbed to a peak of 28 new cases in February 2005. There were 160 new cases between October 2004 and June 2005. There were 19 deaths that were definitely or probably due to C. difficile. In 17 of these

cases, the infection had almost certainly been acquired in Stoke Mandeville Hospital.

All the medical wards including the emergency medical unit and wards for the care of older patients were affected by the outbreak. The infection control team said they became increasingly anxious as the numbers escalated. There was a meeting involving the infection control team and the director of infection prevention and control in February, when the original action plan was re-activated. The infection control team requested that a ward for the isolation and care of patients with C. difficile should be established. This did not happen.

As the situation was not improving, and the cohort nursing approach did not work, the outbreak committee was reconvened on March 18th 2005. The committee met every three or four weeks until early June, when daily meetings were introduced until the beginning of July.

The outbreak was reported as an incident in healthcare associated infection to the regional epidemiologist in the Health Protection Agency on March 23rd 2005. The strategic health authority should have been alerted to this serious incident in early April as the trust used the national electronic system for reporting serious incidents, but a fault in the national system resulted in a delay in the strategic health authority being aware.

The incident report sent to the Health Protection Agency described the risk factors for the outbreak as:

• inadequate numbers of side rooms

• difficulty in accessing hand basins in sluices due to accumulation of rubbish

• four hour maximum wait for A&E leading to side rooms being given to A&E cases rather than patients on wards with diarrhoea

• excessive movement of patients

• inadequate cleaning of equipment

Action taken to control the outbreak included promoting good hand hygiene, improved waste


collection and increased cleaning, since there were concerns that the specification for cleaning was not being met. It was also recommended that staff should use equipment only for individual patients.

Guidance on antibiotic prescribing had been in place since the first outbreak but further actions involved an extension of the restrictions on the prescribing of antibiotics to include quinolone antibiotics. One of the consultant microbiologists, aware of outbreaks in Canada, contacted the author of several scientific papers in the Canadian Medical Association Journal. This led to the restriction of the use of quinolones.

A chart was produced in April 2005 detailing antibiotic regimens for use during outbreaks of C. difficile. This applied to general medical wards, wards for care of the elderly patients and A&E from April 28th 2005, and to the National Spinal Injuries Centre from July 11th

2005. It suggested the use of particular antibiotics to treat respiratory, urinary tract, skin and soft tissue and systemic infection of unknown origin.

In mid April 2005 there were so many patients with C. difficile on ward 3x that it was decided to maintain it as a dedicated C. difficile ward. The infection control team and the health protection unit were concerned when ward 3x was closed on May 17th 2005, because the team had advised that it should not be closed unless alternative dedicated provision was made for the isolation of patients. The consequences of this decision were discussed at the outbreak meeting on May 25th and it was decided to reopen an isolation ward. At the end of May, another ward (ward 9) was opened for patients with C. difficile infection and later in the summer, this was changed to ward 8.

The team and the health protection unit were also concerned because a medical patient with a bowel disease and diarrhoea was transferred to the National Spinal Injuries Centre, against their advice. This patient was subsequently confirmed to have C. difficile. There was no spread to other patients in the centre.

Since the first outbreak, the infection control team had sent samples for typing and continued to do so as the numbers rose. As in the outbreak in 2003/2004, type 027 was discovered to be the dominant strain. The significance of this was unclear until the end of April 2005, when the Anaerobe Reference Laboratory confirmed in response to a query from the consultant microbiologists at Stoke Mandeville, that this strain was indistinguishable to that causing large outbreaks in Canada and the north eastern USA. The inspector of microbiology at Department of Health learnt this through his links with the reference laboratory. This led to a senior microbiology adviser at the Department of Health attending the special outbreak meeting of interested parties on May 24th 2005.

From the start of the second outbreak, the infection control team had advised the trust to restrict the movement of patients between wards to reduce the risk of the infection spreading. This was frequently discussed at the outbreak meetings. At the meeting on May 24th, the senior microbiology adviser at the Department of Health made recommendations including the use of buffer beds to restrict patients with diarrhoea to their own wards and reduce patient transfers. A buffer bed is an empty bed next to a patient with an infection. These restrictions were implemented and numbers of new cases declined further in June, accelerating the improvement that had begun in February but had slowed in May.

On May 26th 2005 an expert on decontamination from the Centre for Infections at the Health Protection Agency visited the trust and made recommendations about decontamination of the environment and equipment.

The trust instituted additional actions including the use of hydrogen peroxide vapour for decontamination in a number of areas, increased use of hypochlorite, audits of adherence to the protocol for antibiotics and the distribution of a protocol for the treatment of C. difficile.


At the end of May 2005, the Bucks Herald ran a story about the death of a patient at Stoke Mandeville Hospital due to C. difficile. On June 6th the outbreak made national headlines in the press and on the BBC, following a leak to the media. The chief executive then introduced and chaired daily meetings to ensure implementation of the action plan that incorporated advice from the Health Protection Agency and the Department of Health. Prior to that she had met with the leads for infection control, the director of infection prevention and control and director of estates on April 21st

2005. This was for an update and to discuss decontamination of wards using hydrogen peroxide.

On June 22nd the inspector of microbiology and the deputy chief medical officer responsible for governance visited the trust to give advice and support.

The senior infection control nurse, consultant microbiologist, director of estates and nurse consultant in health protection visited Montreal at the end of July to learn more about Type 027. The main additional lesson from North America was the importance of dedicated teams providing frequent and rigorous cleaning of the ward and isolation areas. The need for minimal movement of patients was stressed and the visit also confirmed that the drug vancomycin appeared to be more effective than metronidazole for treating type 027.

A report on the second outbreak was produced. This covered the period December 2004 to May 2005. The report noted 135 cases during this period and that there had been 17 deaths that were probably directly related to the infection.

As in the first outbreak, the major lesson identified in the report was that the immediate isolation of symptomatic patients was crucial to the control of outbreaks of C. difficile. The movement of patients between wards should be restricted as much as possible and patients who developed diarrhoea should be kept on their wards to avoid spreading the infection. Quinolone antibiotics should be restricted and

vancomycin appeared more effective in treating type 027. Daily testing for C. difficile and typing of strains were helpful.

There were several learning points relating to decontamination:

• the environment for patients should be clean

• the routine cleaning agents should contain hypochlorite

• it is vital to wash hands with soap and water

• hydrogen peroxide vapour can be useful in areas where spores persist

The close involvement of the chief executive in June 2005 ensured that required actions were taken.

The outbreak report was attached to the minutes of the clinical risk review panel in October 2005. The outbreak was discussed at subsequent meetings of the risk management committee and the governance committee although there was no record that the report had been considered.

The Health Protection Agency undertook a study of patients with C. difficile who were admitted to any of the hospitals in the trust between December 1st 2004 and May 31st 2005. This work will be completed later this year.

There was a further small outbreak of C. difficile in November and December 2005. This is covered in the section on events following the announcement of the investigation.

The care of patients with C. difficile In January 2006, the clinical experts on the Healthcare Commission’s investigation team carried out a review of the case notes of seven patients. This was to look at how the patients had been cared for by doctors and nurses. These patients had died between 2003 and 2005 with C. difficile recorded on their death certificate. This first sample was chosen by the trust on the basis of cases recommended by the consultant microbiologist where the medical records were readily available. As all of


these patients were aged 80 or older, we subsequently looked at sets of notes from three younger patients who had had C. difficile. None of the younger patients died. In April 2006 the Healthcare Commission chose at random a further set of 10 case notes from those patients with C. difficile who had died.

Most of the older patients had had a number of other medical conditions, which would have made them more susceptible to developing C. difficile. A number of these patients had moved wards several times, some late at night.

The notes of those patients treated in 2005 showed greater awareness by clinicians of potential C. difficile infection when patients developed diarrhoea.

The multidisciplinary notes showed both medical and nursing assessments. However, there was a general lack of clear planning for the management of both medical and nursing aspects of care. Reviews by junior doctors were a record of their findings but there was little evidence of conclusions reached and recommendations. When recommendations were made in the notes, they did not always appear to be implemented. For patients who were reviewed by the surgical teams, there was evidence of better, regular review and documentation within the records. For patients undergoing rehabilitation it appeared that medical decisions were only taken at the weekly multidisciplinary management team meetings.

Our review of case notes found that nursing assessment and care planning were poor. If this was the only documentation available to a bank or agency nurse, they would not have been able to determine what each individual patient was capable of doing or what care and management the patient required. The drug charts were missing for two patients.

For several patients the record of fluid balance was poor. This is important as patients with severe diarrhoea can become dehydrated. There was some evidence of inadequate fluid replacement, where the treatment was not as active as it could have been. Several patients had

consistently low blood pressure for a number of days but no action appeared to follow.

The notes for the younger patients showed better documentation, care planning and recording of fluid charts.

There were a number of ward transfers that seemed inappropriate. Two patients who were medically unstable were transferred to the gynaecology ward. Another patient with a medical condition, was transferred to a non medical ward and remained there for 13 days. During this time, from the records reviewed, we had concerns as to whether it was possible to provide the correct care for this patient on this ward. At one point the doctor on call suggested that the patient be moved back to a medical ward. The patient was transferred two days later. This patient was moved to four different wards during that admission.

Four hundred and ninety eight patients were thought to have acquired C. difficile at Stoke Mandeville Hospital between April 2003 and March 2006 (as symptoms related to the infection developed after they had been in the hospital for at least 72 hours); 127 of these patients died.

C. difficile was definitely or probably a factor that contributed to 41 of these deaths. For a further 24 patients, C difficile was thought to have possibly contributed to their deaths.

In summary, for 41 patients, the C. difficile infection was almost certainly acquired in Stoke Mandeville Hospital and it definitely or probably contributed to their deaths. It was a possible contributory factor in a further 24 deaths.

A further 45 patients died that were thought to have acquired C. difficile before they were admitted to Stoke Mandeville Hospital. Of these, C. difficile was thought to have definitely or probably contributed to the death of eight patients and to have been a possible contributory factor in 18.

During the two hospital-wide outbreaks, 33 patients became infected during their hospital stay and died from the infection.


Numbers of deaths

14

13

12

11

10

9

8

7

6

5

4

3

2

1

0 03 3 3 4 4 5 5

0 0 03 3 0 03 0 4 0 4 4 5

0 0 0 0 0 0 0 0 0 0 05 0 0 0 5 6 0 0 0 0 0 0 05 0 0

-2 -2 2 0 -2 0- 2 -2 -2 2 -2 2 -2 -2 -2 -2 2 0 0 0npr g 22-t- c b r n- g t- c b r n g t-2 c- -

A u u Oc De e pA u uA Oc De pF FJ e Ju u OA cA J A De bFe

All deathsStoke Mandeville Hospital acquired

s htaedf os reb

muN

This graph is based on the information in the tables in Appendix F

Figure 2: The number of deaths of patients with C. difficile in Stoke Mandeville Hospital from April 2003 to March 2006

Findings on the outbreaks and on the management of patients • Between April 2003 and March 2006 there

were 498 new cases of C. difficile at Stoke Mandeville Hospital. In the first winter outbreak there were 174 new cases and in the second, 160 cases.

• In total, 172 patients at Stoke Mandeville Hospital died who had C. difficile. In 127 of these cases, the infection was almost certainly acquired at the hospital. For 41 of this group, C. difficile was either definitely orprobably the cause of death. Thirty three of these deaths were during the major outbreaks.

• The conclusion of the trust’s reports on the hospital-wide outbreaks was that difficulty

with immediate isolation of symptomatic patients had been a crucial factor in the spread of C. difficile during both outbreaks.

• There was no written record that the reports on the outbreaks went to the governance committee or the board.

• Antibiotics were restricted before the first outbreak. The policy was reviewed and further restrictions subsequently introduced.

• New hand basins and partitions were installed after the first outbreak to facilitate cohort nursing. These were in place by July 2004.

• The outbreak committee was convened later than might have been expected, particularly in the second outbreak.


• The regional epidemiologist at the South East Health Protection Agency was informed promptly in both main outbreaks.

• There is no record of the strategic health authority being informed by the trust of the first outbreak, and a national fault in the electronic reporting system led to a delay in the strategic health authority being aware of the report of the second outbreak.

• Some lessons learnt during the first outbreak were only partially implemented during the second. In particular there was a delay in resolving problems of isolating patients, in restricting the movements of patients between wards and in ensuring unfettered access to utility rooms (sluices).

• The infection control team were proactive in sending strains for typing during both outbreaks. The senior infection control nurse visited the reference laboratory following the first outbreak.

• The advice given by the infection control team was in line with current guidance from the Department of Health and professional advice.

• An unusual type of C. difficile (027 strain) was found to predominate, the significance of which was not apparent nationally until the spring of 2005, and in early July a team was sent to Montreal to learn more about the strain.

• Medical and nursing assessments were recorded in the multidisciplinary notes, but nursing assessments and care planning were poor.

• For several patients the records of fluid balance were poor and little attention had been given to rehydration.

• There were some transfers of patients to wards that seemed inappropriate for their condition.


Factors that contributed to the outbreaks

The environment at Stoke Mandeville Hospital The new facilities at Stoke Mandeville Hospital opened in April 2006 and replaced many of the wards we visited, solving many of the environmental problems. This section relates to the hospital at the time of the outbreaks and when we visited between October 2005 and April 2006. We noted during our visits that the facilities at Wycombe Hospital were more modern and better maintained.

Stoke Mandeville Hospital is made up of buildings built at different times. Much of the accommodation was built during or after the Second World War and many of the medical wards were Nightingale wards. Nightingale wards are large open plan wards that offer dormitory style accommodation with most beds either side of a central area. The north and south corridors were built as temporary accommodation in 1941 with Nightingale wards of up to 20 beds. There were only one or two side rooms per block. A newer wing was added in the early 1970s and the new building was opened in April 2006, funded by a £40 million Private Finance Initiative.

In 1983 the National Spinal Injuries Centre was opened, replacing the original building. The centre is free standing but linked to the main hospital. It did not benefit from the Private Finance Initiative.

The blocks have been replaced over the years on a piecemeal basis. The wing built in the early 1970s contains outpatient services, A&E, and diagnostic imaging. There are four wards of a ‘racetrack’ design where bays with four to six beds surround a central office and reception area. There are several side rooms.

The hospital buildings are very spread out and corridors, up to 200 metres long, connect the different clinical areas. Some of the wards, such as the ward for patients with eye conditions (the eye ward), are isolated and remote. The nature of the site has implications for services. It makes transfers more difficult and can affect how quickly care can be provided in an emergency.

Plans had been in existence to replace the north and south corridor blocks for over twenty years but the contract for the Private Finance Initiative was only signed in May 2004. The initial impression gained of much of the hospital was of long corridors connecting dilapidated buildings. The signposting was poor.

Many staff reported that there had been a blight on improvement work since the announcement of the long awaited replacement of the current buildings. Renovations were only carried out if they were to remedy an immediate danger. Issues such as asbestos in the roof spaces made renovations difficult and expensive.

At the time of our visits many wards were at the end of their functional life. The general quality of furnishings, fittings and décor was poor. Wards had been repainted but this did not alter the state of the fabric of the building. All the water and drainage was at one end of the ward, which made it difficult to install extra basins, because of the long pipe runs required. The Nightingale wards did not have sufficient space in the “dirty utility rooms” (sluices) or enough hand basins for staff. A sluice is used for the dispersal of potentially contaminated waste such as the contents of bed pans.

Until the spring of 2005, nurses frequently found it difficult to enter the utility rooms as they were blocked by linen and waste bags.


Appendix H has photographs of the uncollected waste. There were delays in the collection of clinical waste - this problem and that of the linen collection were long standing and identified by Stoke Mandeville Hospital’s infection control team in 2003. Waste bins were not emptied regularly resulting in bags piling up and causing clutter.

Steps to resolve this problem were taken during the second outbreak in March 2005, following an assessment of the risk. To prevent access to utility rooms being blocked, waste was then stored outside in skips and cages. This meant that staff had to go outside to dispose of it. Situating the waste bins outside created further problems as the local environment was hazardous. On occasions staff had to walk through deep puddles to get to the waste trucks. In addition, we observed that some of the external waste bins were overflowing and unlocked. Some condemned items were waiting for collection for several days. We observed hazardous waste left in wards, posing a potential risk of contamination.

In the report produced by the national Patient Environment Action Team in 2004, the trust gained an acceptable score for environmental factors. However it scored two (poor) for waste handling in wards and one (unacceptable) for waste handling externally and in other public areas.

Some wards were cluttered and disorganised. There was inadequate storage on several wards and not enough space to keep the wards tidy. On some there were also large underused areas such as day rooms. In the wards for patients admitted as emergency cases, there were no lockers for their belongings. Ward staff improvised with boxes or bags. The trust said this helped to keep patients and their property together.

Many kitchens had poor layouts, with the hand basin in areas that were difficult for staff to reach. There was a poor flow of water in several hand basins. On wards 21, 22 and 23 there were too few toilets for the number of patients. In many shower rooms in the hospital the shower seats were not easy to clean.

There were intermittent problems with the machines for washing bed pans, particularly during the first outbreak. Fifteen new machines were fitted between May 2004 and December 2005. However on some of the wards that had washers, the weekly checks were intermittent. In some areas the housekeepers were responsible for checking, but if they were not on duty, it appeared that no one else took the responsibility or knew how to do these checks.

We observed in the National Spinal Injuries Centre that wards had had little upgrading since their commissioning over twenty years ago. Some had carpets reaching halfway up the walls. Storage space was badly managed with some areas overcrowded and other areas unused. The bathrooms were in a state of disrepair.

We noted that many wards had male and female patients next to each other and some had unisex toilet facilities. In some cases male and female toilets were next to each other in a toilet block, raising concerns about privacy and dignity. There were mixed male and female patients on general medical, respiratory and care of the elderly wards as well as the acute admission areas. It was particularly unfortunate for patients with a C. difficile infection to be in a mixed sex area since they often had diarrhoea many times a day. We noted that elimination of mixed sex areas was agreed in the action plan in April 2003, following the clinical governance review by CHI. However, no action appeared to have been taken and the trust told patients who complained about this issue, that it “did not have a single sex policy”.

The buildings did not lend themselves to the efficient isolation of patients. There were few side rooms because of the age of the buildings and since the start of the trust the number of rooms available for isolation had decreased at Stoke Mandeville Hospital. This was because of ward closures and the reconfiguration of wards. The existing side rooms had not been designed for the control of infection and few had en suite


facilities. The trust had to carry out work so that they would be more suitable for the isolation of patients.

The nature of the Nightingale wards made it difficult to nurse patients with infections together as a cohort, separate from other patients, because of the lack of space physically separated by partitions. Extra hand washing facilities and partitions were added in response to the first outbreak and completed in the summer of 2004.

As well as the scarcity of side rooms, there were problems for controlling infection because of the closeness of the beds, poor storage facilities and lack of hand washing facilities.

Staff commented that the environment at Stoke Mandeville Hospital made controlling C. difficile infection more difficult than in a modern purpose built facility.

Findings on the environment at Stoke Mandeville Hospital • The nature of the site made control of

infection particularly difficult.

• Many of the older wards which had environmental problems were replaced in April 2006.

• The National Spinal Injuries Centre was not replaced as it was in better condition than much of the rest of the hospital. However it had design flaws and environmental drawbacks.

• Many of the buildings on the Stoke Mandeville Hospital site at the time of the outbreaks and of our visits were in a poor state of repair.

• Many wards were at the end of their functional life and the general quality of fittings and furnishings and the décor were poor.

• Many wards did not have sufficient space in their utility rooms, hand basins or storage.

• There were problems for controlling infection

because of the closeness of the beds, poor storage facilities and lack of hand washing facilities.

• There was a lack of side rooms, and few had en suite facilities.

• Extra hand washing facilities and partitions were added in response to the first outbreak and completed in July 2004.

• It was not until the spring of 2005 that steps were taken to reduce the problems with the collection of linen and clinical waste.

• The storage of waste externally posed some health hazards.

• The hospital had many mixed sex wards and significant efforts to eliminate this problem did not appear to have been made.

Arrangements for controlling infection Following the merger of Stoke Mandeville NHS Trust and South Buckinghamshire NHS Trust, the trust had not merged the existing infection control teams to create a single team. The rationale for this was the distance between the hospitals and the different nature of the sites.

Accountability The senior infection control nurses were directly managed by the consultant microbiologists with responsibility for the control of infection. The infection control nurses were professionally accountable to the director of nursing. The budget for infection control was part of the pathology budget, and therefore came under the responsibility of one of the directors of operations. Additionally, the director of infection prevention and control had a responsibility for the teams. These arrangements meant that accountability was not always clear, and some nurses reported that at times they felt pulled in different directions.


Resources Since before the inception of the trust, the members of the infection control team at Stoke Mandeville felt that they did not have adequate resources to perform all of their functions. As described above, Stoke Mandeville Hospital consisted of many older and dilapidated buildings that were spread out. There were few single rooms that could be used to isolate patients with infections. It therefore posed particular challenges for the infection control team. This was also the view of the Healthcare Commission. We noted that the infection control team for Wycombe and Amersham had been slightly larger, although the environment was better and both teams had equivalent responsibilities for other providers and for surveillance. The budget for the training of the team members was also significantly larger at Wycombe. There was no transfer of staff or resources from the Wycombe team to Stoke Mandeville Hospital during the outbreaks. Other sources of funding were available for attendance at conferences.

The concerns of the team about being underresourced included secretarial support as well as nursing staff. These concerns were expressed in letters and e-mails during 20022005. Trust staff told us that business cases for extra infection control staff were developed but were not supported by the local primary care trusts. The primary care trusts told us they were not aware of these. In March 2005 a part time surveillance nurse was appointed and additional secretarial support was provided.

The minutes of the committees relating to infection control and the annual reports for infection control indicate that the infection control nurses had to decide which aspect of their work should come first. They decided that their main priority was to provide clinical advice and deal with urgent issues to do with infection in clinical areas. This meant, according to the team, that they were limited in their ability to contribute to education and training, audits of practice and the environment, and the revision and development of policies.

The control of infection at Stoke Mandeville Hospital Staff told us that, since the outbreaks, the control of infection was now a priority for the trust. They said that practice had improved over the last few years and especially since the second outbreak.

Nurses took the view that the importance of controlling infection on wards was less ingrained in medical staff than in other clinical staff. This was particularly the case with junior doctors who did not always follow appropriate procedures with regard to washing their hands. Most qualified nurses were happy to challenge doctors, and others had reported breaches of practice to the ward sister. However, most nurses thought doctors were more aware than previously and that they were getting better at washing their hands.

Staff told us that they still sometimes observed other members of staff breaching infection control, particularly temporary staff. Nurses reported that some of the domestic staff behaved as if they were unaware of the rules for controlling infection. Some nurses were happy to challenge them, others not.

The view of the infection control team was that the control of infection had improved with the greater provision of alcohol gels, greater emphasis on handwashing and the discarding of gloves. However the team considered that adherence to best practice was not thoroughly ingrained and not an integral part of clinical staff’s daily routine. The infection control team thought that some of the variation in practice on the wards was a consequence of the quality of leadership on the ward.

Patients and relatives who contacted us, raised concerns about the poor hygiene practice that they observed. Their comments mainly related to 2004 and the first six months of 2005. The concerns included a lack of isolation signs, or lack of enforcement where they were in place. Visitors told us they were not asked to wash their hands. Families and patients informed us that commodes were often not emptied for


considerable periods. They reported that some nurses and doctors followed infection control procedure and others did not, with particular inconsistency of hand washing and the movement of equipment between patients. They said that catering and cleaning staff acted no differently in isolation areas and main wards, with trolleys constantly being moved between the two.

The impact of levels of staff on good practice in controlling infection is covered in more detail later in the report.

The infection control team concluded that patients who moved frequently from ward to ward created additional risks of contamination. Items such as beds, belongings and equipment that could cross contaminate wards were being moved by staff and patients.

We observed a range of staff including doctors, nurses, phlebotomists and allied health professionals such as physiotherapists. Decontamination of hands and equipment did not always take place when staff were moving from patient to patient or from bays where patients with MRSA were being treated. A doctor was seen leaving such an area and going to examine two other patients without washing his hands. We observed staff handling dirty items and then going back into the ward without washing their hands. We saw staff contaminate the surrounding environment, and that disposable items of clinical clothing were not discarded when required. Some were wearing nail varnish and rings with stones, which could harbour micro organisms and contribute to the spread of infection. The trust subsequently sent us an interim policy for uniform that described the limited types of jewellery that could be worn, and prohibited the use of nail varnish.

We noticed that there was little consistency between and within wards on the style of isolation signs and notices on display. This was confusing for relatives and for staff, particularly those working on the ward on a temporary basis.

Cleanliness and hygiene at Stoke Mandeville Hospital Audits of infection control were mainly carried out by the infection control team. These involved checks on cleanliness of wards and equipment, and observing the practice of hygiene by staff. The team completed 11 environmental audits in 2004/2005. This was less than the original plan and much fewer than the 38 audits in the same period at Wycombe. The annual report of infection control for Stoke Mandeville Hospital for that year noted that this was due to work pressures. The team was able to embark on a more extensive programme of environmental audits in 2005/2006.

The average score for wards that had undergone an audit of the environment by the infection control team was less than 80%, with some wards scoring under 65%. Any scores under 70% give cause for concern, since that means the environment is not as clean and well maintained as it should be. Wards 22 and 1x, and the new wing and day surgery performed poorly on audits of the environment in 2003. In 2004 the areas with poor performance were wards 3x, 12, 22, the emergency medical unit, gynaecology, the delivery ward and A&E. Only a few environmental audits were completed in the first three months of 2005, because of the pressure on the team.

Wards generally scored badly on the section related to the risks of cross-infection.

We noted that audits led to recommendations either relating to practice or facilities, for example replacement of damaged hand basins. The audit report usually suggested that a further audit should take place to check if the necessary actions had been taken. However from interviews and documentary evidence it was clear such follow up audits did not take place in a regular and systematic way.

Staff on wards said that they did not always get feedback of the results of audits. Others said they were displayed in the sister’s office. Results from audits of wards went to the infection control committee but it was not clear


if concerns were always addressed or if senior managers were informed. Senior managers did not opt to attend the committee.

Many staff had noticed improvements in the cleanliness of the wards particularly since the second outbreak. Of the wards that we visited, it was not always the newer wards that were the cleanest. The infection control ward (ward 8) and the ward for plastic surgery were noticeably less cluttered, better organised and generally clean and tidy.

An external contractor provided cleaning services. Some domestic staff were not able to understand English. Clinical staff found it difficult to communicate with them, which affected both parties’ ability to perform their tasks properly.

Most staff reported that the standard of cleanliness on the wards was largely dependent on the conscientiousness of the individual cleaning staff. This meant that there were variations between wards, and between weekdays and weekends. Thorough cleaning of side rooms was sometimes delayed as the necessary cleaning equipment and domestic staff were not readily available out of hours. This in turn delayed the admission of other patients needing isolation.

Certain areas such as underneath beds, windowsills and some items of non medical equipment were not always cleaned properly. Nurses reported that toilets and shower rooms were often overlooked by domestic staff. Side rooms were not always cleaned to the same standard as the rest of the ward and surfaces such as shower floors were neglected.

We noticed unfilled soap dispensers and that alcohol gel dispensers were often empty. There was no bin in one bathroom, so used paper towels were piled on the sink. In the adjoining bathroom the paper towel dispenser was empty.

Most areas had toilet rolls that were not in holders in the wall or in any form of dispenser. This had the potential for cross contamination from handling of the rolls. In some areas where

there were toilet roll holders, they were located too far from the toilets and could not be reached.

Generally the domestic staff cleaned floors, walls, under beds, toilets and bathrooms. Nurses cleaned mattresses and the equipment used for patients. Either nurses or domestic staff cleaned lockers and tables. The trust had started to appoint ward housekeepers in part to fill the gap between the cleaning responsibilities of the nurses and the domestic staff. About half of the wards had a housekeeper at the time of our visits. There was no standard training for the housekeeper role. Staff told us that when housekeepers were away on leave or sick, some of their tasks were not covered by the other ward staff.

Patients and relatives who contacted us reported dirty wards, toilet areas and commodes. Their comments related to 2004 and the first six months of 2005.They gave examples of faeces on a bed rail, areas not cleaned under beds, the same mop used in side wards and on the main ward, urine and mop water emptied down a sink on the ward and urine spillages not cleaned up promptly or properly.

In the national survey of inpatients carried out by the Healthcare Commission in 2005, the trust came in the worst 20% of trusts for patients’ assessments of whether the toilets and bathrooms were clean.

Heavily soiled clothing was bagged up for relatives to wash, often with no explanation or advice given. A leaflet explaining that the wards do not have facilities for domestic laundry was produced in June 2005. On some wards, patients’ belongings were stored in bags on the floor due to the lack of lockers.

We observed bedding and equipment left lying on the floor and that the cleanliness or functioning of some items had not been checked daily as required. Defective furnishings had not been replaced. In several areas patients’ belongings including flannels were left drying on radiators.


In the National Spinal Injuries Centre we noted communal tubes of aqua gel and communal toiletries in many of the bathrooms. There was mould in shower rooms, cobwebs on the ceilings, grubby shower seats, hairs in several baths. On one ward the clinical waste bin was open with a glove covered in faeces hanging out.

As a consequence of our observations, we wrote to the trust on January 5th 2006, expressing concern about the risk to patients from lack of cleanliness and failure to follow good practice in the control of infection (see Appendix G). When we carried out further observations at the end of January 2006 we found that some issues had been resolved, but others had not. For example we saw soiled commodes that had not been adequately cleaned. The seal on a fridge in the National Spinal Injuries Centre had not been repaired and the fridge was still in use. We had informed the director of nursing about the fridge with a damaged seal during a visit in December 2005. This fridge contained food belonging to patients. In some cases, although a problem had been addressed in one part of the ward, it had cropped up elsewhere in the ward.

The trust told us that they monitored the cleanliness of the wards during the period of our visits and scored an average of 85%, using the national cleaning standards tool. This gave us some concerns about either the adequacy of the tool or the rigour of its application by the trust.

Training for staff on the control of infection The programme at the trust for the induction of new staff included a session on infection control, run by the infection control team. All staff had to attend the induction training programme. The session on control of infection was 25 minutes long and some nurses commented that this was insufficient time. Staff could be on the wards for some time before they attended induction. The trust told us that attendance at induction is monitored.

The trust’s training strategy for 2004-2005 did not give prominence to training on the control of

infection. It was not listed in the training brochure for September to December 2005. It is not mentioned at all in the Strategy for educational development and training for 20042006. The control of infection was not included in the programme of mandatory training.

There was a study day each year on the control of infection. Attendance was voluntary. There was no cohesive or integrated formal programme for ensuring that training on the control of infection was available to all clinical staff.

Most nurses told us that they had had informal training sessions on the wards. Staff often gained information about infection control through informal channels such as approaching senior staff or reading information packs on the wards rather than dedicated training sessions. As a result some staff had not received direct training on correct procedures for hand washing.

The uptake of training was determined by the availability of training opportunities, the awareness of staff and their determination to access these, and the degree of support from senior staff on the ward,

There were limited training opportunities for staff working at night as the infection control nurses did not operate out of hours. There was no formal arrangement for night staff to receive training on the control of infection and they only attended this training on their own initiative. NHS Professionals, who provided the trust with temporary staff, told us that training on the control of infection was mandatory for the nurses they recruited.

For nurses wishing to upgrade their knowledge and skills, infection control was not covered in the development programme for D grade nurses.

It was apparent from interviews and notes of meetings that it was difficult to release staff for training due to shortages of staff and pressures at work. There was confusion over recording who had attended, and who was responsible for ensuring that staff attended training.

Each ward at Stoke Mandeville Hospital had a manual containing information on infection


control. The manuals were organised in a folder into sections that were easy to follow and comprehensible. However, many folders were untidy and had information that was missing or outdated. Some papers were loose in the binder at the front without being hole-punched and filed in the relevant section.

Several sections of the manual were six or seven years old and had not been reviewed and updated. The who’s who list of the infection control team had last been updated in June 2004 and contained contact details for staff members who were no longer working at the trust. The general section containing procedures for laundry, estates, catering and pest control was several years out of date. The clinical guidelines for specific infectious diseases were up to date and there was a recent policy on hand washing. The policy for isolating patients contained a few guidelines for C. difficile but was mostly concerned with MRSA. This had been reviewed in September 2005. There was a specific policy on MRSA, which should have been reviewed in September 2004. The trust told us that the manuals had a specific policy on C. difficile. We found it in some but not all of the manuals that we looked at.

During the course of our investigation, a new two page document dated November 8th 2005 on cleaning procedures required to prevent the spread of C. difficile had been put in the front of the binder. Wards were to adhere to these cleaning procedures until advised otherwise by the infection control team. Compliance with this was supposed to be monitored daily by checking the cleaning regime but this had not happened for some weeks on one ward that we visited.

There was no evidence of document control. For example, many old superseded policies had not been taken out of the binder, which meant there were two policy documents in the folder, which could lead to confusion. The section on special areas had some up to date policies. Extra papers had been added without updating the contents page.

Bug Busters was a magazine produced by the infection control teams every three months and was available for all trust staff. It aimed to impart up to date information about issues connected with the control of infection and to answer staff queries. Staff told us they liked the magazine.

The trust’s Clean Your Hands policy was implemented in response to the national guidance Winning Ways. It was launched in May 2005. The rolling out of this campaign included enlisting the support of key personnel for the campaign and organising meetings to educate staff. Bug Busters was used, along with the promotion of alcohol gel and of competency in hand hygiene.

In an internal survey carried out by the trust in September 2005, only 35% of staff had undertaken training on hand hygiene in the previous 12 months. It was noted that the campaign began in the summer of 2005.

The link practitioner programme at Stoke Mandeville Hospital started in February 2004. Link practitioners are found in many hospitals and are clinical staff, usually nurses, working within wards and departments who take on additional responsibilities in relation to infection control. Their responsibilities can include training of other staff, surveillance, implementation of policies and auditing. It was anticipated that the link practitioners would share knowledge, experience and initiatives with other team members in their ward or department. The programme was established to disseminate knowledge and good practice in the control of infection.

Not all wards in Stoke Mandeville Hospital had link nurses and, even when they were in place, not all staff were aware of them. The trust provided us with a written specification for the role of infection control link practitioners and guidance on how their role should be influence practice on the wards. However this information was not in place until September 2005 and amongst staff, and some of the practitioners, there was confusion over their responsibilities. They attended study days and


meetings, but not all were consistent in passing on information to their colleagues. Ward meetings provided a useful opportunity to cascade information, but not all wards had regular meetings. For many link nurses there were competing demands on their time. Their effectiveness was dependent on their commitment, their workload, and on the amount of continuing support they received from the infection control team.

The training on infection control was presented in a different manner for each hospital site although efforts had been made to standardise arrangements. No training was specified for healthcare assistants at Stoke Mandeville Hospital although the trust told us it had been offered since January 2005.

Findings on the arrangements to control infection at the trust • The accountability arrangements for the

control of infection and the infection control teams were complex.

• There were two infection control teams at the trust. The team at Wycombe and Amersham was slightly larger, although the environment at these hospitals was better.

• The infection control team at Stoke Mandeville Hospital had made giving clinical advice and support its top priority.

• The infection control team at Stoke Mandeville Hospital had not been able to complete the programme of audit and considered that more time to train staff would improve the control of infection.

• The infection control teams were highly regarded by staff in the hospital and externally.

• There had been an improvement in practice to control infection, but this was still not an integral part of the daily routine of all clinical staff.

• Compliance with hand hygiene procedures was variable among staff.

• Cleaning at the trust was of a variable standard. There were some serious deficiencies particularly at Stoke Mandeville Hospital.

• The style of notices about infection control and isolation was inconsistent and potentially confusing for staff and visitors.

• There were many examples of poor environment and defective furnishings and fittings at Stoke Mandeville Hospital.

• The new building replaced many of the wards at Stoke Mandeville Hospital; the National Spinal Injuries Centre was not part of the refurbishment.

• Some action was taken in response to specific concerns raised by the Healthcare Commission, other areas had not been addressed.

• There was informal training on the control of infection on the wards but no formal training programme.

• The educational, development & training strategy for 2004-2006 did not include infection control.

• It was often difficult for ward staff to attend training.

• A survey in September 2005 found only 35% of staff had undertaken training on hand hygiene in the previous 12 months.

• The infection control manuals contained useful information but also contained out of date policies and were not well organised.

• The link nurse/practitioner scheme at Stoke Mandeville Hospital was at an early stage and not all staff were clear about the role of the link nurse. Its effectiveness had not yet been established.

Isolation of infected patients

Ability to isolate patients The outbreak committee concluded that failure to isolate symptomatic patients quickly was a


major factor in the first two outbreaks. Reference has already been made to the shortage of facilities for isolation in Stoke Mandeville Hospital. In this section we consider isolation in more detail.

There were not enough side rooms at Stoke Mandeville Hospital for the isolation of patients with an infectious disease. The number of side rooms available for isolation was reduced further by a reconfiguration of wards during 2003, the establishment of the Medical Admissions Unit and the ring-fencing of surgical wards. Ring-fencing meant that these were wards could not routinely be used by medical or other patients, including those with C. difficile. In November 2003, the senior infection control nurse wrote to the director of operations about her concern that as a result of insufficient isolation facilities there was a risk of an increase in hospital acquired infection and potential ward closures.

Because of the lack of isolation facilities, the infection control team was keen there should be an updated trust-wide policy for isolating patients, to help decide the use of a scarce resource. This issue was first raised in the autumn of 2003. Prior to this the hospitals had their own policies dating back to before the merger. A policy was approved by the risk management committee in December 2003 but rejected by the trust’s executive committee the following month. This was because it was insufficiently flexible. Following further consultation, the revised policy on the isolation of patients was approved by the trust’s executive committee in July 2004 and launched in September 2004. The senior infection control nurse wrote to the director of infection prevention and control in August 2004 about the inappropriate admission of potentially infectious patients to open wards. She noted that the isolation policy had been under discussion for a year and was still not in operation.

Even after the policy was launched, the infection control team said there were problems putting it into operation and no mechanism for agreement based on risk assessment, when conflicts arose.

Stoke Mandeville Hospital’s annual report for infection control for 2003/2004 included the following information:

• ward changes and ring-fencing of surgical beds in 2003 had reduced the number of rooms available for isolation

• there was excessive movement of patients within the hospital

• there was a lack of hand washing facilities, antiquated bedpan washers and obstruction of facilities in sluices by clinical waste and used linen

• there had been a rise of 144% in the annual number of C. difficile isolates compared to the previous year

• the increase was a result of cross infection in the hospital

• there was a marked rise in the failure to isolate figures at the hospital, particularly in February and March 2004, at the peak of the outbreak

• the primary factor implicated in the spread of this infection was patients with diarrhoea who were not isolated, leading to contamination of the environment

The report stated that the failure to isolate patients “led directly to the C. difficile outbreak”. This report did not go to the board, as required by national guidance. The director of infection prevention and control admitted this was an error and could not explain it.

During 2003 there were numerous examples of patients requiring isolation who did not receive it. The consultant microbiologist in charge of infection control wrote to the medical director in July 2003 expressing concern that the failure to isolate patients had led to several outbreaks of infection including C. difficile, diarrhoea and MRSA. The letter said that on average there were five or six examples a month of patients who could not be isolated.

An e-mail message was sent in September 2003 from a bed manager to the director of nursing about the failure to isolate six patients.


In November 2003 one of the consultant microbiologists e-mailed one of the associate medical directors and the director of operations, highlighting concerns about 11 patients requiring isolation being nursed in six different open wards. He noted the increase in C. difficile figures at this time.

In April 2004, the consultant microbiologist again emphasised the need for a dedicated isolation area for major infectious disease. The figures for the number of patients requiring but not receiving isolation, remained high.

Shortly after this there was a steep decline in the numbers of new cases of C. difficile, but in July there was a further small outbreak, again identified by the infection control team as due to the failure to isolate symptomatic patients. In the autumn of 2004, the numbers began to rise.

In the two years to June 2005, there were 80 cases of failure to isolate patients in Stoke Mandeville Hospital that were reported as clinical incidents.

The issue of the failure to isolate symptomatic patients was raised at many meetings of the clinical risk review panel. At the meeting in January 2004, it was noted that 56 potentially infectious patients had not been isolated during the previous month. Concerns were further raised at the panel in 2004 in February, April, July, August, October and November. In 2005 problems of isolation were mentioned, alongside inappropriate transfers and concerns about safety, at virtually every meeting, according to the minutes of those meetings.

At a meeting of the trust executive committee in December 2004, the infection control team outlined the lessons they had identified from the first outbreak, and in particular, the importance of rapid isolation of patients.

The effect of other strategic objectives on the ability to isolate patients Every NHS trust has a number of strategic objectives. Central among these is the achievement of the Government’s targets. Targets are not optional for trusts and may be

accompanied by financial reward for achievement.

Many clinicians at Stoke Mandeville Hospital were concerned that the trust’s attempt to meet the Government’s key targets created barriers to the control of infection. One of these key targets is to ensure that no patient stays in A&E for over four hours. Clinicians were concerned that with the steady rise in emergency admissions (from around 1,650 per month in April 2003 to 1,850 in February 2006), reduction in beds (from 418 to 369, excluding maternity and SCBU) and shortages in nursing staff, this target would put other clinical areas in the trust under pressure. Their concerns were raised at meetings and expressed in letters and e-mail messages. They took the view that giving priority to the target would contribute to the movement of patients from ward to ward and potentially compromise the ability of the hospital to control infection.

Given the shortage of isolation facilities, the action taken by the trust to meet the target could have an effect in two ways. First, a patient waiting in A&E might be moved into a side room in preference to a patient with an infection who needed the room. Secondly, a patient in A&E with an actual or potentially infectious condition might be moved on to an open ward if a side room was not available, in order to avoid breaching the target. Managers told the infection control team that the team could not make decisions to isolate patients that led to a breach of the A&E target. We were told that this instruction had changed since the second outbreak.

The infection control team wrote to the members of the executive team on four occasions between April 2003 and April 2005, expressing concern that the advice of the infection control team had not been followed due to the need to accommodate the achievement of the A&E target, which was perceived to be more important. They also wrote to the regional epidemiologist at the Health Protection Agency with these concerns.

In the summer of 2003, letters from an orthopaedic surgeon and the clinical director of


medicine were sent to the chief executive stating their concern that the need to achieve targets was compromising patient safety. An incident in which patients with diarrhoea were transferred to an open ward in August 2003 was raised at an infection control meeting on the grounds that it could have led to an outbreak of gastroenteritis on ward 9. In September, one of the consultant microbiologists wrote to the chief executive about a patient with an infection who was moved out of a side room to avoid a breach of the A&E target. In the same month it was noted at the clinical risk review panel that there had been four incidents of patients with infections moved from side rooms on to open wards and the deputy director of nursing noted that there had been 17 reports of incidents of patients who had been moved inappropriately between wards. In November 2003 the acting chairman of the clinical risk review panel wrote to the chief executive expressing concerns that the focus on the A&E target was leading to infectious patients being transferred to open wards.

Between 2003 and 2005 there were several letters from other clinicians to either the chief executive or medical director about the impact of the A&E target on the safety of patients. These included consultants in ophthalmology, ear nose and throat, spinal injuries, medicine and surgery. Many of these specifically mentioned the risk of infection; others had different concerns (covered later).

Some specific examples included the admission of patients with infectious conditions to side rooms on the eye ward. This had been a recurrent issue from the beginning of the trust and criteria for admission had been developed. In April 2005, a patient with both MRSA and C. difficile was admitted to the eye ward. At the time the eye ward was closed to admissions because of an outbreak of Norovirus. The decision to admit to the eye ward was made against the advice of the infection control team and to avoid a breach of the A&E target for another patient. The consultant ophthalmologist and the consultant

microbiologist felt that this transfer placed the patient who was transferred, and the other patients on the ward, at unacceptable risk.

On March 17th 2005, two patients with diarrhoea who were in cubicles in A&E were moved, against the advice of the infection control team, onto an open ward area. This, which was reported as a clinical incident, was to avoid a breach of the A&E target.

Concerns about the effect of targets were consistently raised at meetings of the clinical risk review panel. These appear in the minutes throughout the second half of 2003, intermittently in 2004 and again in the first five months of 2005. At the meeting in February 2005 it was noted that staff considered that executives thought “everything was satisfactory as long as targets were met.”

In the summer of 2005, the clinical risk review panel recorded many incidents due to pressures in A&E and noted that 50% of reported incidents related to pressure to meet the four hour A&E target.

The approach to the target for the waiting time for planned surgery also had an impact, since the decision to ring-fence surgical beds caused a reduction in the side rooms available to patients with infection.

The trust’s reconfiguration programme, referred to as Shaping Health Services, affected the number and use of beds. Some staff reported that the need to change wards for the implementation of Shaping Health Services put further constraints on the trust, even in advance of the major change at the end of August 2005. They said this made it more difficult in the spring and summer of 2005 to identify, establish and maintain an isolation ward.

Findings on factors that contributed to the outbreaks - isolation • A major factor in the two hospital-wide

outbreaks was failure to isolate patients with infections.


• The number of side rooms that could routinely be used for isolation was reduced because of reconfiguration and ring-fencing of beds.

• It took a year to agree and launch a trust-wide policy for isolation.

• The annual report that identified the failure to isolate symptomatic patients as the key causeof the first outbreak did not go to the board.

• There were many instances of failure to isolate patients who should have been isolated.

• The approach to the target for A&E led to some patients with infections being admittedto, or moved to, open wards rather than isolation facilities.

• Despite many ways in which the infection control team and individual consultants drew attention to this issue, there was not an effective response by senior managers.

Movement of patients from ward to ward In addition to the isolation of patients with C. difficile or undiagnosed diarrhoea, an effective measure in the control of infection is restriction in the movement of patients between wards, particularly those patients with infections. Conversely, excessive movement of patients increases the risk of the transmission of infections.

In the 2003/2004 annual report for infection control, movement of patients was recorded as a contributory factor in the first outbreak of C. difficile. At the meetings of the outbreak committee in March and April 2005 it was noted to be contributing to the spread of the infection.

As in other hospitals, patients were moved because of their medical condition and the facilities and specialist staff available on other wards. However there were many instances when patients were moved for other reasons.

An analysis by the trust of bed moves showed that the proportion of patients moved because

of pressures on capacity, as opposed to for clinical reasons, was 38%, 45%, 50%, 47% and 41% in the months of May to September 2005 respectively.

Between January and March 2005, 84% of patients with a medical condition were moved during their stay. After their first move to the admissions unit, 40% were moved once, 21% (290 patients) were moved twice and 8% (112 patients) were moved at least three times.

Patients and relatives who contacted us reported their concern that patients with C. difficile were moved a number of times causing distress to them and their families. One of the upsetting aspects was that families were often not told about the move until they tried to visit. They also told us that on occasions patients were moved to wards where staff did not appear to be knowledgeable about their condition. Doctors similarly complained that on occasions they could not find their patients. This was not helped when their notes did not accompany the patient to the new ward.

The review we undertook of case notes of 20 patients with C. difficile confirmed that many were moved several times, often at night, and some of the moves did not appear appropriate for the condition of the patient.

The number of times patients were moved was a frequent theme in complaints. The director of nursing noted at the risk management committee in April 2005 that there had been a spate of complaints about this. Nurses confirmed that patients and families found moves worrying, especially when they happened at night.

It was noted at the meeting of the governance committee in June 2003 that one patient had moved five times in nine days. The clinical risk review panel in February 2004 received the results of an audit showing that older age medical patients at Stoke Mandeville Hospital had three or four moves after their initial move from A&E to the medical admissions unit, and averaged 3.7 wards per hospital stay. The trust told us that this was because these patients


had complex conditions and required rehabilitation. We were told by several members of staff about one patient who had been moved nine times, for non clinical reasons. The infection control team noted at its meeting in March 2005 that one patient with diarrhoea had been moved six times. This was in the middle of the second outbreak.

The frequency of moves of patients was raised as a concern at meetings of the hospital medical advisory committee, clinical risk review panel, risk management committee and the head nurses meeting. The Healthcare Commission in June 2005 mentioned it in the review of implementation of the National Service Framework for Older People. The report stated: “There are concerns around the movement of older people from ward to ward at Buckinghamshire Hospitals NHS Trust”.

Other aspects of the movement of patients will be considered in a subsequent section.

Findings on factors that contributed to the outbreaks – the movement of patients • Movement of patients was a contributory

factor in the outbreaks – during the second outbreak one patient with diarrhoea moved wards six times.

• Between 38% and 50% of moves were for reasons related to the capacity of wards, rather than for clinical reasons.

• Concerns about the movement of patients and inappropriate placements of patients had been raised consistently at the clinical risk review panel and other committees.

Staffing levels and arrangements Good practice in the control of infection should be embedded in the routine work of nurses. However, as with other aspects of nursing care, it may suffer when wards are short of staff.

Levels of nursing staff The Healthcare Commission’s acute hospitals

portfolio is a collection of reviews of key services, resources or issues that are of national concern and that are important to patients, managers of NHS trusts and clinicians. In the acute hospitals portfolio review of ward staffing in 2004/2005, we found that thirteen medical wards at the trust had establishments (funded numbers of nurses) that were between 1.6 and 12 whole time equivalents lower than at other comparable trusts in the review. The average shortfall was 16% or 3.9 WTE per ward.

Several nurses told us that in their view, based on working elsewhere, the staffing establishments were too low. Additionally on several wards they were not staffed at their establishment number. The trust told us that vacant posts were not frozen. However, ward managers reported that they “had to jump through hoops” to recruit to vacancies. Information showed that for March 2006, 97% of 2,500 requests for temporary staff were to fill vacancies. The trust informed us that “vacancy” might be indicated as the reason for requesting a shift to be covered, even if there was not a substantive vacancy.

The trust sent us figures showing that the percentage of qualified nurses as a proportion of all staff was similar to three other trusts, at 31%. However analysis of the same figures showed that the trust had the lowest ratio by some way of qualified nurses to beds at 1.21 (ie 1.21 qualified nurses to each bed), compared to 1.38, 1.54 and 1.95 in the three other trusts chosen by the trust for purposes of comparison.

In the autumn of 2003 the trust began discussions about reducing reliance on agency staff. We were told this was in part because of concerns about the quality of the care provided and in part to save money. At the meeting of the head nurses in November 2003 it was noted that staff from agencies could only be employed if an executive director agreed. From early 2004 the trust instituted a policy that there should be “no use of agency nurses”. At the finance performance and information committee in April 2004 it was noted that the restriction had


produced considerable savings, but that it had also put pressure on staff and had an adverse impact on morale.

In line with Department of Health policy, instead of using agency staff, wards were asked to use NHS Professionals. NHS Professionals was set up nationally in 2001 by the Department of Health on a local consortium basis to run banks of staff for the NHS. NHS Professionals took over the bank of staff at the trust in April 2003. There were problems with the service from NHS Professionals in the early days that had largely been resolved by 2004. NHS Professionals became a special health authority in April 2004. It works to meet requests from NHS trusts for temporary staff through using mainly NHS nurses from its own bank of staff. NHS Professionals told us that these nurses are normally familiar with local policies and practices. If NHS Professionals cannot provide staff from its own bank it will then use nurses from agencies.

At the time of the decision of the trust to stop the use of agency staff, 40% of all requests for temporary staff were being filled with nurses from commercial agencies, due to the small size of the bank inherited from the trust. NHS Professionals only resorted to agency nurses when it could not fill a shift from its own bank, and, as it had not had sufficient time to recruit more nurses, NHS Professionals frequently could not provide the number of temporary staff requested. By the time NHS Professionals had expanded its own bank in early 2005 to make up for the shortfall, demand for temporary nurses from the trust had increased by 25%.

A report from NHS Professionals showed that in February 2005, 37% of shifts for qualified staff were not filled and for unqualified nurses, 38% were unfilled. This was in the middle of the second outbreak. Overall there were more shifts for qualified staff that were unfilled in 2004/2005 than in 2003/2004 – 28.7% as compared to 10.1% – and the position deteriorated further in 2005/2006 to 31.4%. This was due to an increase in requests and the restriction on the use of staff from agencies.

The trust spent £2.0 million on bank nurses supplied by NHS Professionals in 2004/2005 and this expenditure rose to £2.9 million in 2005/2006.

When nurses thought they had no option but to ask for agency staff to cover a shortage, an executive director had to approve the request. The chief executive was notified of any approvals. In most instances in the early months of 2005 the requests were turned down. Alternatively, the request might be agreed but achieving agreement took a considerable time and the agency was then unable to cover the shift at short notice.

Nearly one in 10 reports of clinical incidents related to shortages of staff. In April 2005, the clinical risk review panel noted there had been several reports about shortages of nurses on the medical wards. In September 2005 the panel reviewed the most frequent incidents in the trust. Out of 1568 incidents reported between April and June 2005, 9% were reported to relate to staffing.

The trust conducted a survey in September 2005 asking staff about clinical governance and areas of risk. The two areas of highest risk identified by staff were hospital acquired infection and staffing shortages. Only 32% said their ward was adequately staffed.

Effect of levels of staff The acute hospitals portfolio review identified the trust as having a high number of complaints about nursing care, as did the other acute trusts in the comparative group. Nurses thought this was in large part due to having inadequate levels of staff. Patients and relatives who contacted us, said low levels of staff contributed to poor care. The subject of complaints is covered later in this report.

Over 50 members of staff told us about problems with the adequacy of the number of nursing staff. We were given examples of levels that were described by nurses as unsafe. There were often difficulties in staffing wards at night. We heard from one staff nurse who had been left on her own with six ill patients. On


another ward with nearly 30 beds there were often only two nurses on duty at night, with no healthcare assistants.

Nurses reported that they had little time to spend with patients, and frequently went home upset because they had not been able to do their job well. Senior nurses said they considered that the way junior nurses were treated was not good, and that the pressure they were under, was excessive. One used the phrase that it was “on the edge of abuse”. We were told staff had left because of the pressures they felt. The results of the Healthcare Commission staff surveys confirmed that the trust was in the worst 20% of trusts for the number of staff reporting that they wanted to leave.

Many examples were given of the adverse effect on patients of shortages of staff including them having accidents because they could wait no longer to go to the toilet, then having to wait to have their sheets changed. Nurses reported that it affected their ability to complete proper care plans. Other professionals confirmed the effect of a lack of nurses on their work. Dieticians said food supplements were not given, therapists told us they were not given information they needed about patients.

Nurses told us that they had completed incident forms to report the problems that shortages of staff caused, but that they had not received feedback, or that they had been discouraged from using forms for this purpose.

In response to an acute shortage of staff in one clinical area, nurses had often been moved from another ward. Several told us they had found it stressful to be moved from their ”home” ward to support another understaffed ward unfamiliar to them.

Having patients placed on wards that were not the most appropriate for their illness compounded the problems of shortage of staff. Thus for example nurses working on rehabilitation wards did not always have the appropriate skills to nurse acutely ill patients with medical problems.

Although not related specifically to shortages of staff, in the 2005 staff survey, in response to the statement “If I were a patient of this trust, I would be happy with the standard of care provided” a total of 35% of the trusts disagreed or strongly disagreed with the statement, compared with an average of 21% in all trusts and 24% in all acute trusts

‘Escalation’ areas Escalation or overflow areas were areas in the hospital that did not usually function as general admission wards but which were used as such when there were no suitable beds for admission available elsewhere in the hospital. We were told these had been opened more frequently as a consequence of increased admissions, reduced beds and the A&E target which required patients to spend no longer than four hours in A&E.

The use of escalation areas for patients needing admission was considered in this investigation both because of the opinion of clinical staff that it had contributed to the outbreaks, and because of wider issues about the quality and safety of care for patients.

The areas most commonly used for admitting patients when wards were full, included the pre-admission unit, which was part of A&E, day surgery and parts of other clinical areas and wards, including wards that were normally “five day” wards, closed at weekends. Clinical staff were concerned about the suitability of the areas in terms of their facilities and the ability of the trust to find enough nurses with the appropriate skills to look after the patients. Staff were unfamiliar with the wards. Other concerns were the problems arranging catering and cleaning. In some instances areas had been opened that lacked such basics as soap.

Members of the infection control team felt that the day surgery area was not suitable to function as a ward because of the lack of equipment, hand basins and bathroom, and the size of the “dirty utility-room” where the sluice was located. They were concerned about its use


for patients with an infection because of the proximity to operating theatres. Consultant surgeons were also concerned, and the chairman of the Medical Staff Committee wrote to the medical director in May 2004 about the inappropriate use of the day surgery facility for escalation. This did not result in any change.

Many nurses that we spoke to were worried that areas were opened for admission without adequate staff to look after patients safely. This was a combination of low levels of staff, the trust’s policy of not using staff from agencies, and hence difficulties with the provision of staff by NHS Professionals. Often staff were moved from other wards, leaving those wards understaffed.

A head nurse told us that she was instructed to open an escalation area for patients needing admission, even though she was concerned about low levels of staff. She found sufficient staff to provide care safely for nine patients but when she returned in the morning there were 15 patients on the ward. Other nurses told us that, because they were senior, they could resist pressure to open areas, but as soon as they went off duty, managers would pressurise more junior nurses who would be unable to resist this pressure.

We observed the pre-admission unit at the end of January 2006. The unit, initially a temporary overflow area for patients if beds on wards were not available, had recently been refurbished and had an air of permanence about it. There were six patients, four of whom had been there since the previous evening. One staff nurse had been there all day and while we were there a second staff nurse arrived to provide relief for an hour. She told us there could be a mixture of patients on the unit and it was possible that patients with diarrhoea would be placed there, although there were none on the day of our visit. However, one patient required observations every 15 minutes, which was impractical to sustain with only one member of staff when there were other patients to be looked after.

The nurses’ response to this issue Senior nurses attempted to raise their concerns about these levels of staff on many occasions. From December 2003 senior nurses had sent e-mail messages to the director and deputy director of nursing about low levels of staff. The low levels, which were sometimes described as unsafe, were due to low establishments, sickness, vacancies and shortfalls in provision by NHS Professionals. Concerns were expressed about a number of wards including wards 8,9,20,22 and the day surgery unit. These concerns often made specific reference to the problems of controlling infection when there were insufficient nurses on the wards.

The chair of the clinical governance committee in the surgical directorate wrote to the director of nursing in March 2005. This was about levels of staff and the skill mix at night on the surgical wards. He felt that the levels and skill mix were unsafe, and noted that it was the second time this issue had been raised in a formal letter.

The notes of the trust’s executive committee in May 2005 recorded that the night nurse practitioners working at night occasionally had to run wards due to the shortage of trained nursing staff.

At the meeting of head nurses in May 2003, it was noted that Stoke Mandeville Hospital was running at “dangerously low ” levels of staff, with agency staff in charge of wards. This issue frequently featured in these meetings over the next two years, culminating in a crucial meeting in February 2005.

The minutes of the meeting of the head nurses in February 2005 record that the nurses said that “morale on the medical wards was the lowest in 20 years.” (A survey of staff leaving at that time showed only 28 % thought that morale at the trust was good.) There had been insufficient staff on duty to provide care for patients. NHS Professionals were not able to fill shifts. Requests for agency staff had been turned down.

The minutes record that conditions were


intolerable. Patients had been left in wet beds and were not being fed. Patients with infections could not be isolated and staff reported they were under too much pressure to carry out the basics needed to control infection. These comments applied to the medical unit, day surgery unit and ward 9. Patients in A&E were on trolleys in the corridor. A member of NHS Professionals staff had been in tears, horrified at the lack of care of patients; she said she would not return to the ward.Senior nurses felt they could not face their own staff. On at least one occasion they had advised the executive director on call that the situation was unsafe.

These concerns were reinforced to us in interviews with the head nurses and other nurses and doctors who had been working at the time. The response to these concerns is considered later.

Involvement of the Royal College of Nursing Nurses contacted the Royal College of Nursing because they were concerned they could not provide acceptable care to patients. They felt the trust was not listening to their concerns. They considered they were professionally compromised in delivering care and that the care was unsafe.

The Royal College of Nursing was invited to become involved on at least three occasions. The first was in June 2003, before the director of nursing took up her post. It arose because nurses thought that there were not enough nurses available with the right skills, on the ward for patients requiring plastic surgery. This was particularly because the ward had many “outlying” medical patients on it who were acutely ill. This issue was resolved and the Royal College of Nursing was informed

The second time that nurses sought the help of the Royal College of Nursing was in February 2005. This was at a time when the hospital was under extreme pressure and escalation areas were being opened for patients needing admissions, with levels of staff that nurses felt were unsafe, as described earlier. As the Royal

College did not consider the initial response from the trust’s managers was satisfactory, in May 2005 they initiated a formal grievance against the trust. Following several meetings between the Royal College of Nursing and the senior managers of the trust, an action plan was drawn up in the summer of 2005.

The action plan included the development of a policy for escalation. This was not taken to the trust executive committee or the trust management board. There was no record that the board was informed about the involvement of the Royal College of Nursing. This matter had been discussed at meetings of the joint management and staff committee, which executive directors attended. Although non executives attended in rotation, only one of them had any recollection of this issue and this was not the non executive with close links to the profession of nursing and nursing issues. General managers reported that they had not been told to take steps to remove pressures on the wards.

The third time that nurses contacted the Royal College of Nursing with major concerns was in January 2006. Details of this are provided later.

The Royal College of Nursing told us that it was unusual for them to have this degree of involvement with a trust. They confirmed that nurses considered they were not being listened to, and felt helpless. They did not have confidence that senior managers took the concerns of nurses into account.

The effect of the levels of nursing staff on the control of infection In addition to the examples given already, staff provided us with other instances of shortages of nursing staff having an impact on the control of infection. Examples we were given included failure to:

• practise ‘cohort’ nursing effectively

• wake patients to give them their antibiotics

• complete fluid balance charts


• ensure patients took their nutritional supplement

• supervise confused patients who wandered in and out of isolation areas

• practice good hand hygiene

• clean mattresses thoroughly before being used by the next patient

• use new or cleaned equipment for each patient

• answer call bells and empty commodes promptly

We noted that in the Healthcare Commission’s survey of inpatients in 2005, the trust came in the worst 20% of trusts for how long it took to get help after inpatients used the call button.

The infection control team told us that low levels of nursing staff had been a cause of concern for some time, beginning with the localised outbreak of C. difficile on ward 11x in 2003. It was reported that moving nurses from one ward to another, to cover shortages, contributed to a lack of continuity of care and problems with completing fluid charts.

The infection control team in April 2005 was advised that an isolation ward could not be established because there were insufficient staff available to staff a new area.

In the context of the second C. difficile outbreak, the trust’s executive committee in May 2005 noted that a shortage of nurses was causing difficulties with aspects of the action plan and setting up an area where cohort nursing could be implemented.

The infection control team re-iterated their advice on the need for adequate levels of nursing staff during both of the hospital-wide outbreaks of C. difficile. It was emphasised during the outbreak of another micro organism (multi-resistant acinetobacter) on the National Spinal Injuries Centre in 2005. As the specific advice of the team could not be implemented due to low levels of staff, the risk of infection increased.

Findings on levels of nursing staff and the impact on control of infection and quality of care • The medical wards at the trust had nursing

establishments with fewer staff than other similar wards in comparable trusts.

• Agency staff could only be used with the permission of an executive director, requests were discouraged and frequently refused.

• There were many instances when NHSP could not fill shifts and in February 2005, 37% of shifts for qualified staff were unfilled. This was due to a large increase in demand for temporary staff by the trust and the restriction on the use of commercial agencies. This was at the peak of the second outbreak.

• Staff, patients and their families reported that the inadequate numbers of nurses had a negative impact on the quality of care and good practice in the control of infection.

• Nurses were put under pressure to open escalation areas for patients needing admission, even if there were insufficient staff.

• Nurses were taken from other wards to staff these escalation areas, often leaving these wards short of staff.

• Escalation areas to take patients needing admission, were open almost constantly throughout 2005 and up to the time of this report.

• We observed that there was an inadequate number of staff on the preadmission unit on the day of our visit.

• The concerns of senior nurses and other clinicians were regularly drawn to the attention of the executive team.

• Nurses felt they were professionally compromised.

• Nurses did not feel they were listened to within the trust.


• On three occasions nurses asked the Royal College of Nursing for help.

The action plan following the grievance raised by the Royal College of Nursing in 2005 had not been fully implemented and there had not been sustained change. The issues involved had not been drawn to the attention of the board in a timely manner.

From time to time nurses on the wards could not implement the advice of the infection control team because of low levels of staff.

Arrangements to manage clinical risks Although our main focus was on the control of infection, we also reviewed the trust’s systems for the management of clinical risk. Systems for the management of risk should allow trusts to identify trends and potential risks, and take timely action to minimise harm. Members of the trust’s board should be aware of key risks of a clinical nature and ensure that these risks are managed appropriately. One of the most important clinical risks for any hospital is that of infection.

We found that there were a number of groups within the trust with some responsibility for managing or monitoring risk, including the governance committee, risk management committee and clinical risk review panel. There was also a group involving executive directors established in August 2005 to take responsibility for responding to serious untoward incidents. However this group did not consider category red incidents, the next most serious group.

The monthly report on infection control went to the clinical risk review panel, which reported to the monthly risk management committee. In turn this reported to the governance committee. Non-executive directors participated in the governance committee which reported to the board.

In this section we consider how the trust

responded to concerns from staff and patients about the quality of care and risks to patients.

Systems to learn about and respond to the concerns of clinical staff An analysis of reports of incidents showed that, in the two years to June 2005, issues to do with failure to isolate patients at Stoke Mandeville Hospital were reported on 80 occasions. The most common reason given was lack of an available side room. Other relevant incidents included poor communication about patients with an infection, transfers of patients between wards and failure to collect clinical waste and rubbish. In one incident it took seven days for waste to be collected, and in another, there were more than 20 bags awaiting collection. Appendix 8 contains photographs of the obstruction in utility rooms.

We noted a decline in the number of reported incidents at Stoke Mandeville Hospital in 2004. Staff told us that they did not receive feedback on incidents and some said they had “lost faith” in the system. There was no trust-wide system for analysing the themes from incidents. The role of the clinical risk review panel in the review of incidents is considered below.

In the staff survey conducted by the Healthcare Commission in 2005, the trust was in the best (lowest) 20% of trusts for staff witnessing errors or incidents that could have hurt patients or staff. However, it was in the worst 20% of trusts in terms of staff views on the effectiveness of the reporting of incidents. This question asked staff if they felt reports of incidents were treated fairly and confidentially, and whether the trust took action to ensure such incidents did not happen again.

We noted with concern that the trust was unable to provide us with any information on serious untoward incidents for 2003.

Clinical staff were confused about the routes for reporting concerns, other than individual incidents, and the function of the different committees. The medical director told us that


there were a number of ways in which doctors could raise their concerns about clinical care and the experience of patients. These included taking the matter to the clinical director of their directorate, raising it with the medical director or an associate medical director, bringing it to the hospital medical advisory committee or writing to the chief executive. The trust had a policy for whistle-blowing which had been widely promoted. However, it did not appear to have been much used.

Clinical directors could bring concerns to their monthly meeting with the associate medical directors and the medical director. Minutes were not taken of this meeting so we could not identify what matters were raised. The trust explained that this was a learning and exchange forum. We were told that clinical directors could bring concerns to the trust’s management board. There was little evidence that this happened. A range of senior medical staff told us that some clinical directors were more active than others in raising the concerns of their colleagues.

There were differing views on the value of the hospital medical advisory committee, where senior doctors met with the executive team. Some thought it provided a useful opportunity to exchange information but others considered that it achieved little. It was evident that consultants raised more concerns at the medical staff committee, which was the same group but where the medical director was the only executive present.

The clinical risk review panel existed to analyse clinical risks. It did this through considering incident reports from directorates and regular reports about important clinical areas such as the control of infection. As described before, the clinical risk review panel reported to the risk management committee, which reported to the governance committee which reported to the board.

A significant number of issues had been raised in a consistent way at the clinical risk review panel over the three years that the trust had been in existence. The major issues relevant to this investigation were:

• the movement of patients between wards

• providing care on an appropriate ward

• the ability to isolate patients with a diagnosed or suspected infectious condition

• the effect of targets on the issues above

It was notable that although these concerns came from a number of directorates and generally could not be resolved at a local level within directorates, and that although they received some coverage at the risk management committee, they did not appear on the agenda or minutes of the governance committee or at the board. Although the minutes of the monthly risk management committee went to the governance committee, they were always late as the governance committee met quarterly. The trust say that members could comment on and question any of the documentation. However, we noted that the governance committee received a large number of reports and the minutes did not record any discussion of these issues.

The minutes of the trust’s executive committee noted in January 2005 that there had been an increase in the number of letters of concern from clinical staff. However, for the rest of 2005 we could find no evidence that the executive committee discussed these concerns.

Other than discussion at the clinical risk review panel, there was no system to analyse themes from clinical incidents by directorate or across the trust. Nor was there a system to link issues from significant untoward incidents with clinical incidents, legal claims and audit. It was not possible to identify discussion at the governance committee or board of the strategic issues identified by these reports.

We have considered the movement of patients, isolation and effect of targets previously. Below we consider the provision of care on an appropriate ward.


Providing care on an appropriate ward It is preferable for patients to be cared for on a ward that specialises in the care and treatment of their particular problem. For example, patients with heart problems should be cared for on a cardiac ward, while patients with lung disease should be admitted to a respiratory ward. This ensures that patients benefit from the experience of an appropriate specialist consultant and nurses with the right set of skills. However, existing national targets and current pressures on the availability of beds make this difficult to achieve in many hospitals.

Between April 2003 and March 2006 there was a reduction in medical beds at Stoke MandevilleHospital. In the medical directorate, occupancy of beds was routinely in excess of 90%, and was virtually 100% in 2003/2004 and 2004/2005 for wards 1x, 6, 9x and 10. Overall the trust reported an occupancy level of 90.2 % for 2004/2005.

The term “outlier” is used for a patient who is not on the most appropriate ward, for example a patient with a medical condition such as a stroke who is being cared for on a surgical ward. Many consultants at the trust were concerned that admission arrangements led to patients being admitted to inappropriate wards. Below are examples of concerns put in writing.

The eye ward In October 2003 an ophthalmic surgeon wrote to the medical director and director of operations expressing concerns about inappropriate admissions to the eye ward. He wrote because he was worried about the risk of infection and because some of the patients required high intensity nursing care.

In January 2004 the surgeon wrote to the chief executive expressing concern about inappropriate patients on the eye ward. The consultant noted that the ward was “continuously and extensively” used for such patients. The guidelines for transferring patients were not being followed and the staff on the eye ward were not qualified to look after the patients inappropriately placed there.

During April, May, June and July of 2005 there was a series of letters between an ophthalmic surgeon, the chief executive and the medical director about the issue of inappropriate transfers (medical outlier patients) to the eye ward.

Another ophthalmic surgeon wrote to the medical director in April 2005 expressing the same concerns. The guidelines for transfers to the ward had been overridden on numerous occasions. He requested that they review the guidance as the care of patients was being significantly compromised.

The National Spinal Injuries Centre In March 2005 the lead clinician and chair of the clinical governance committee for the National Spinal Injuries Centre wrote to the medical director to describe six incidents where patients were placed inappropriately in the National Spinal Injuries Centre without enough adequately skilled nurses to care for them. He said that this posed a risk to the patients, since the nurses had skills to care for patients with spinal injuries, not acutely ill medical patients. Although the guidelines for admission to the ward were reviewed, they were subsequently breached.

Surgery, gynaecology and ear, nose and throat Two consultant general surgeons wrote separate letters in March 2005 to the medical director, the general manager for surgery and the director of operations, expressing concern that due to extreme pressure on the availability of beds, patients were being “hot bedded” before going into theatre. This meant they were not allocated a bed prior to going to theatre. The surgeons indicated that patients were not receiving adequate preoperative assessment, which the surgeons noted contravened the recommendations of the Royal College of Surgeons. In one instance it was reported that a patient had to change into a theatre gown in the toilet.

A consultant anaesthetist wrote to the medical director and director of operations in February 2005 with similar concerns. He warned that whilst it had not happened so far, there was high chance of a serious clinical mishap.


Between May, June and July 2005 two ear, nose and throat surgeons raised concerns that the ear, nose and throat ward at Wycombe was full of medical patients and that ear, nose and throat inpatients were being admitted to various other wards without the equipment and appropriate staff to care for them. “Yet another incident” was described where a patient was suffering from a severe bleed in a ward without specialist ear, nose and throat nurses.

Medicine In May 2005, a consultant physician wrote to the medical director to express concerns about the capacity of the medical unit. There were constantly 20 more inpatients than the number of recognised medical beds, which he considered was an unsafe situation and led to what he called “safari” ward rounds, where doctors had to find their patients who were located on many different wards.

A number of doctors gave us examples of patients who were “lost”. A physician alleged that a patient was not included in a ward round for two weeks. Two other consultants reported they had “lost“a patient for over 48 hours. A junior doctor had reported an incident where he was not aware of a patient for four days and the patient had not been seen by a doctor during that time.

We noted that some of the doctors’ letters did not receive a response. In others, the concerns were noted and sympathised with, but it was exceptional for the replies to propose a solution.

There was a serious incident on the eye ward in March 2005, following a patient being admitted as an emergency case. The clinical diagnosis was pneumonia, and the patient was admitted initially to the pre assessment unit, adjacent to A&E, before being transferred to the eye ward. The patient was erroneously listed as being under the care of another consultant. The consultant who should have had responsibility for the care of this patient did not know for three days and saw the patient only shortly before they died, following a cardiac arrest. This was reported as a serious untoward incident.

The internal investigation conducted by the trust into the incident stated that the protected use of surgical beds, pressure of medical admissions and the target for patients to wait only four hours in A&E, all combined to produce an continuing problem of medical patients being cared for on non-medical wards. The investigation noted that there were agreed criteria for the admission of medical patients to the eye ward as part of the trust’s escalation policy. Additionally, the protocol stated that the transfer of patients should not occur after 9pm The investigation found that this transfer was in breach of both aspects of the protocol.

The investigation considered that from the records available it appeared that the patient had received satisfactory nursing and medical care. They were given appropriate treatment for pneumonia and seen by a doctor on a daily basis. The report of the investigation we received originally did not identify who had been involved in conducting the investigation. However the trust confirmed that the investigation was led by one of the associate medical directors who was not directly concerned with the management of this patient.

The investigation concluded that the issues raised by this incident were potentially a serious risk to the trust and to patients, and provision must be made to address the issues. However, as noted above, there have been subsequent letters from clinical staff about further inappropriate transfers. We were informed that nurses had completed 20 incident reports about patients being in inappropriate wards in 2005.

Also in March 2005, the clinical risk review panel noted an incident where a cancer patient had been admitted to the day surgery unit when it was operating as an escalation area. An incident form had been received from an external consultant, because pain relief had not been administered and the patient had become distressed. In day surgery, there were no facilities for administering controlled drugs for the relief of pain.

Several senior clinical staff reported in interviews that it was unlikely that things would be changed


unless there was a disaster. Even then, it was considered unlikely that the improvement would last. Generally their impression was that concerns they reported were not addressed. They said that consultants would like to follow safe and proper procedures but were not allowed to do so. They considered that managers knew the risks, but carried on regardless.

Our review of the case notes of 20 patients also raised concerns about the placement of some acutely ill patients on wards that appeared inappropriate for their condition.

Systems to investigate and learn from complaints from patients and relatives The trust provided us with copies of the quarterly reports of complaints from July 2004 to September 2005. Some of the reports include a summary of the key issues raised in complaints but since January 2005 the reports had only included numbers, with no analysis of issues.

There was a complaints committee that consisted of non executive directors. The trust reported it focused on the response to complaints. However this committee met infrequently and did not identify themes nor initiate change. The monitoring by the governance committee and in reviews of performance, focused principally on the time taken to respond. The themes or issues of substance identified in complaints were not considered at the committee.

When a complaint was received, the complaints manager sent it to the general manager of the directorate to collect statements from the staff concerned. The complaints manager then drafted a response which was checked by staff in the directorate before being finalised, and sent from the chief executive.

In November 2005, the board considered the report of an independent review of a complaint. This report made recommendations that the complaint be re-investigated, as there were concerns about the quality of the original investigation by the trust. The board however, declined to follow this recommendation, since they did not think that a full re-investigation

would add further information, but this decision was not made fully explicit in the minutes. The board approved an action plan. In January 2006 the board considered the report of another independent review of a different complaint. The report expressed concern that the process of responding to this complaint had not involved an investigation, but was essentially an opportunity for the staff complained about to advocate their position. There was no serious element of objective external analysis. The report concluded that there was failure by the members of the trust at the highest level to take complaints seriously. The minutes of the board do not record any comment on this conclusion.

In a review of a sample of complaints and responses we found much to support the conclusion of the independent review. There was little evidence of actual investigation of many complaints and replies were generally a collation of the views of staff, often dismissive, defensive, and sometimes hostile in tone. This view was expressed by some complainants who contacted the Healthcare Commission. We noted that letters to health professionals who raised complaints about care of a relative had a more conciliatory tone. Action was seldom taken when there were complaints about individual staff.

Staff in the complaints department told us that the responsibility for making changes was delegated to the directorates concerned. However neither the complaints department nor most of the nurses or general managers we interviewed seemed to know who was responsible. Some general managers openly acknowledged that they had no idea what happened as a consequence of complaints, and thought in any event that there were too many to follow up. Even in the directorates that seemed to have a system in place, it was not apparent that basic nursing care had improved. The message from the patient advice and liaison service was that time was spent “fire fighting”, rather than addressing underlying problems.

The acute hospitals portfolio survey found that the trust had a high number of complaints about nursing care. The level of complaints was


similar to other hospital trusts in the area of the Thames Valley Strategic Health Authority. None of the trust’s non executive directors we talked to about this finding, was aware of it.

In the sample of complaints we analysed, the two most common subjects of complaints were poor standards of basic nursing care and lack of information and communication. Other common concerns were unhelpful staff, inappropriate ward moves, hospital acquired infection and lack of cleanliness on wards.

We noted that in the Healthcare Commission’s survey of inpatients in 2005, the trust came in the worst 20% of trusts for patients having confidence and trust in the nurses treating them. Additionally it was in the worst category for sharing a room or bay with patients of the opposite sex. The issue of being cared for on a mixed sex ward was also identified from patients and relatives, complaints and the Patient Advice and Liaison Service.

Views of patients and families who contacted the Healthcare Commission Relatives and patients who contacted us complained that medical staff had not communicated well with them about C. difficile, except for those who had talked to a microbiologist. Patients, relatives and members of the public interviewed did not consider that C. difficile had been adequately explained to them on the wards. They suspected that the trust was reluctant to admit to patients that they had a C. difficile infection. They told us that sometimes diarrhoea was not even recorded in patient notes. The trust produced an information leaflet for patients on C. difficile but not until July 2005.

We noted that in the 2005 inpatient survey, the trust came in the lowest (worst) 20% for the amount of information given to patients about their condition or treatment, and for the opportunity for patients and relatives to talk to a doctor.

One relative sent us a detailed record of their perceptions of the lack of action to control infection during the second outbreak.

Risk register A risk register is a way for trusts to record and grade risks in terms of their severity. It should be used to influence planning, investment and management. We heard differing opinions on the adequacy and usefulness of the risk register at the trust. Some senior clinicians, including clinical directors, were unaware of its existence.

The register consisted of two levels. One level related to risks specific to directorates and was at an early stage of its development. The other included all risks regarded as sufficiently serious to be considered relevant to the trust as a whole. The risk of an outbreak of a healthcare acquired infection was included in the latter category from February 2005.

It was generally acknowledged that the register did not as yet sufficiently influence operational planning and management.

Clinical negligence scheme for trusts The NHS Litigation Authority, under the clinical negligence scheme for trusts, sets general standards for the management of clinical risks. These standards apply to all trusts and cover factors such as procedures for obtaining consent from patients, management of health records, infection control and staff induction and training. A higher level from CNST reflects better management of risk, and the range of levels is from zero to three.

The trust obtained CNST level one, the lowest score, in March 2004. Because the board had not formally reviewed the arrangements for infection control on an annual basis (despite this having been raised previously) it was rated as zero for infection control. It also failed on its preparedness to respond to major clinical incidents.

Mandatory training Statutory training is that required by law for all staff and includes, for example, training on what to do in the event of a fire. Mandatory training is determined by trusts. Managers decide which


training staff must undertake and this varies for different categories of staff. Mandatory training includes topics such as manual handling and cardio pulmonary resuscitation. We have already noted that training on infection control was not mandatory at the trust.

There was a low uptake of mandatory training in the trust. Staff found it hard to take time off for training for example because of understaffing of wards. This was a continuing problem in the trust and had been noted regularly at the risk management committee. In July 2005, the committee was concerned that only 10% of staff had attended mandatory training in that year. There was a question about who had responsibility for enforcing the take-up of mandatory training. The HR committee had discussed poor performance on attendance at mandatory training in the context of the trust’s declaration for Better standards for health, but we could not find any record that the board was aware of this issue or had discussed it.

Fndings on arrangements to manage clinical risk • Concerns were raised consistently at the

clinical risk review panel about the movement of patients, patients placed on inappropriate wards, failure to isolate patients with infections and the effect of targets.

• There was no evidence from the minutes that these concerns were discussed at the governance committee, finance, performance and information committee or the board.

• Systemic and strategic issues identified in complaints and incidents were not addressed.

• Many patients were admitted to wards that were not the most appropriate for their care.

• Many consultants had put their concerns in writing about the inappropriate placement of patients. Replies generally noted and sympathised with the problems. There was little change.

• There had been serious untoward incidents involving patients on inappropriate wards.

• Criteria for admission to wards were developed but then overridden.

• Doctors reported that patients were sometimes “lost” to the system for days at a time.

• Clinicians thought that the trust ignored their concerns and only took action if there was a serious incident.

• The trust received information on the numbers of complaints, and the time taken to respond, but not on themes.

• Complaints were not adequately investigated. The recommendation of an independent review that a complaint should be investigated again, had been declined by the board, although an action plan was developed.

• Failure to investigate complaints properly meant lessons were unlikely to be learnt. There was no mechanism to follow up complaints and no mechanism for sharing any learning which resulted.

• An independent review of one complaint concluded that the members of the trust at the highest level failed to take complaints seriously.

• Action to improve practice following complaints or incidents was meant to be delegated to directorates, but in most directorates there was confusion over who was responsible.

• The risk of an outbreak of a healthcare acquired infection was not included on the risk register as a risk for the trust as a whole until the peak of the second outbreak.

• Training on infection control was not mandatory.

• There was poor attendance at mandatory training.


Strategic arrangements at the trust

Clinical governance The medical director was the executive leader for clinical governance. He was also the director of infection prevention and control. He chaired the governance committee and was seen by colleagues to be supportive and sympathetic, but not effective at championing the management of clinical risk or solving problems.

The governance committee encompassed both corporate and clinical governance. It asked to oversee the development and implementation of the strategy for governance. Since the formation of the trust much of the time of the committee had been used to agree policies and strategies relating to clinical governance.

Various presentations on topics relating to infection control were made to the committee. There was no evidence in the minutes of any discussion of the outbreaks of C. difficile until July 22nd 2005, after the publicity in the national media. If the members of the committee were aware before this, there is no record that they drew the outbreak to the attention of the board.

The associate medical director with responsibility for governance and risk was not a member of the governance committee. Neither was the risk manager. They both attended the risk management committee, which did not include non-executive directors. There was no evidence in the minutes of the governance committee of any discussion of the risks identified in the clinical risk review panel and risk management committee, particularly the number of times patient had been moved, the placement of patients on inappropriate wards or the failure to isolate patients. Nor was there

any reference to the poor attendance at mandatory training.

Although in 2005 the trust had commissioned work on outcomes from Dr Foster (a commercial company that provides comparative information for trusts on their performance in relation to other trusts), death rates were not included in the reports from the directorates and were not discussed at the governance committee, although some executive directors told us they were. We could not find evidence of any committee where there was routine discussion of the outcomes of care, as would be indicated by death or complication rates.

A report on serious untoward incidents went regularly to the governance committee and was discussed here and at the private session of the board. However there was no overview of lessons learnt or identification of wider issues.

Although it was noted in the early meetings of this committee that there would need to be a strong framework and guidelines for teams within directorates with responsibility for clinical governance, this had not happened. The committee appeared, on paper, to function adequately, receiving regular reports from each directorate. However, in reality, the minutes of meetings and the views of staff interviewed showed that the committee rarely discussed the reports it received.

There was little infrastructure below the committee to deliver change and issues delegated to the directorates were not policed or monitored. There was little central collation of information relating to clinical governance or learning across directorates. Issues got lost in the system. Although there were reports every


quarter on governance, it was not possible to identify discussion at the governance committee or the board of the strategic issues identified by incident reports, claims and complaints.

We could not determine whether the governance committee failed to discuss the key issues, or failed to minute the discussion.

Findings on governance • Much of the time of the governance

committee had been used to agree policies and strategies.

• Information on outcomes did not go to the governance committee.

• Information on patients on inappropriate wards, the movement of patients and the failure to isolate patients with infections, was not considered by the governance committee.

• The structure was complex and did not succeed in ensuring that serious operational problems and risks were identified and assessed at the higher levels of the trust.

• The governance committee provided little leadership to directorates.

• The first record of the outbreaks in the minutes of the governance committee was on July 22nd 2005.

The role of the director of infection prevention and control The report of the chief medical officer in December 2003 Winning Ways: Working together to reduce Healthcare Associated Infection in England required each organisation providing NHS services to designate a director of infection prevention and control (DIPC). The guidance on the competencies required was produced in May 2004. This guidance said that the director of infection prevention and control would have overall responsibility for creating a culture in which effective hygiene is the norm and infection control is everyone’s

business. If the director of infection prevention and control did not have expertise and experience in infection control, management of the infected patient, decontamination protocols and antibiotic usage, they would need to have access to expert professional guidance. The role of the director of infection prevention and control is to:

• oversee infection control policies and their implementation

• be responsible for the infection control team

• report directly to the chief executive and board

• challenge inappropriate clinical hygiene practice and antibiotic prescribing decisions

• assess the impact of all existing and new plans and policies on infection control and make recommendations for change

• be an integral member of the clinical governance and patient safety teams and structures

• produce an annual report on the state of healthcare acquired infection in the organisation and release it publicly

The National Audit Office report in 2004 Improving patient care by reducing the risk of hospital acquired infection stated that 37% of directors of infection prevention and control were microbiologists, and 48% were medical or nursing directors.

The medical director became the director of infection prevention and control in December 2003, before the publication of the more detailed guidance in the following May. He was a consultant in rheumatology and did not have a background or any further qualifications in infection control. The chief executive said she nominated him because of his involvement with the executive team, the board and governance. There was no formal appointment process. We noted that the two infection control teams in existence at the time of the merger had not


been amalgamated, as might have been expected. The trust and the infection control teams explained that this was because the teams identified strongly with their hospitals, which had quite different challenges. The existence of two teams did not facilitate the support of one team by the other. We noted there had been some collaborative working on protocols and that one microbiologist covered the whole trust when they were on call.

The director of infection prevention and control attended the meetings of the outbreak committee and chaired the Infection Control Management Forum, which was the overarching committee for the whole trust. He did not attend the Stoke Mandeville infection control committee during either of the first two outbreaks, or routinely visit the wards affected at that time. He sent a report on one occasion to the infection control committee. His lack of attendance was a cause for concern to the infection control team and they brought this concern to his attention. He acknowledged to us that he now regrets his absence. He has attended meetings of both Wycombe and Stoke Mandeville infection control committees from July 2005 onwards and chaired the Stoke Mandeville meetings. The trust provided evidence of extensive exchange of e-mail correspondence between the director and the team.

The members of the infection control team at Stoke Mandeville did not consider that the director of infection prevention and control had raised the profile of infection control or that he had supported them adequately. They did not think he had been a strong advocate for the cause of preventing and controlling infection. They were concerned that it took nearly a year to get agreement on the trust-wide isolation policy. Although they looked to him for support on staffing in the team, it took a long time to get agreement for additional posts. The perspective of the Thames Valley health protection unit was that the director of infection

prevention and control did not exert enough influence on the senior managers at the trust to change the priority they gave to controlling infection. We were told that medical directors in some other acute trusts had had their priorities changed when they became director of infection prevention and control, because they realised the importance and benefits of controlling infection. The view of the Health Protection Agency was that this had not happened at the trust. Although he did not see any major tensions with his wider corporate responsibilities as medical director, others clinicians and those working in infection control viewed it differently. Most took the view that he had not demonstrated leadership in promoting the control of infection.

One of the designated functions of the director of infection prevention and control is to produce an annual report on the state of healthcare associated infection in the organisation. The annual report must be a public document. The usual practice is for annual reports to be taken to and noted at a public meeting of the board.

In 2003/2004, the two infection control teams at the trust produced separate annual reports. The Stoke Mandeville report described a significant rise in cases of C. difficile. The primary factor implicated in the spread of this infection was failure to isolate patients with diarrhoea. The report noted the impact of the ward changes and ‘ring-fencing’ of surgical beds. It stated that the failure to isolate patients led directly to the C. difficile outbreak.

This report was not released as a public document and did not go to the board. The clinical negligence scheme for trusts had previously criticised the trust because the board had not approved the arrangements for infection control. There was no evidence that the non-executive directors knew about this criticism.

In April 2005, the infection control team gave a presentation on healthcare acquired infection to


the public meeting of the board. The main focus was on MRSA, which was better known to the public, and was part of the emphasis of the Cleanyourhands campaign. The members of the team told us the director of infection prevention and control discouraged them from presenting information on the C. difficile outbreak at this meeting, even though it had been reported a few days earlier as a serious untoward event to the strategic health authority and as an outbreak to the Health Protection Agency. The trust has responded that there was no intention to suppress information.

Involvement of the board in the control of infection The chief executive of a trust carries legal responsibility for the quality of care provided by the trust and for taking the necessary steps to control infection. The board has collective corporate responsibility for the management of the trust. We wanted to discover the extent to which the board had discussed the outbreaks of C. difficile, the risks to patients and the actions being taken.

Because we could not find any record of discussion of the outbreaks of C. difficile in the minutes of key committees until the matter became public knowledge, we wrote to the trust to ask for details of when the outbreaks had been discussed and an explanation of why the discussions were not minuted. The paragraphs below outline the relevant discussions at formal meetings involving members of the board. There were several meetings that involved board members including the public and private sessions of the board. There was also the finance performance and information committee (the FPI) which all members attended, and the governance committee of which two non-executives were members. Neither of these two meetings were held in public, but their minutes went to the board.

There was a presentation by the director of infection prevention and control at the public part of the board in April 2004 on Winning Ways: Working together to reduce Healthcare Associated Infection. However there was no record that the board knew about, or discussed, the C. difficile outbreak that was happening at that time, and which had been reported to the Health Protection Agency as an incident in healthcare acquired infection. Figures on MRSA were noted in the private part of the July 2004 meeting of the board.

In the autumn of 2004, the infection control team suggested a presentation to the board on the first outbreak of C. difficile. However the director of infection prevention and control thought it would be more appropriate to do the presentation to the trust’s executive committee. The trust explained to us this was because of the operational implications of the report. Non-executives did not attend this meeting. The presentation, highlighting the importance of rapid isolation of patients with C. difficile and undiagnosed diarrhoea, happened in December 2004.

The Cleanyourhands strategy was approved by the board at the public meeting in April 2005. There was a presentation by members of the infection control team on health care acquired infection, looking particularly at the trust’s performance on reducing MRSA. C. difficile was highlighted as a specific challenge on the Stoke Mandeville Hospital site, but no mention was made of the outbreak. The handwritten notes of the secretary to the board recorded that in the private part of the same meeting the medical director gave an update on the latest cases of C. difficile, although this was not recorded in the minutes. The hand written notes indicate that he reported that the outbreak had been reported to the Health Protection Agency and that work was in hand to deal with it.

The outbreak was publicised in the Independent on June 6th 2005. This followed a leak to the newspaper.


On July 29th 2005 the medical director reported the outbreak of C. difficile to the public meeting of the board. He said that the trust was working closely with the Health Protection Agency, and controlling the outbreak was “continuing to receive top priority.” This was the first time that the outbreak was acknowledged in public at the board. The medical director reported that members of staff had visited Montreal to learn more about the 027 strain. He commended staffwho had been working under pressure.

Although the minutes of the risk management committee and the quarterly clinical governancereports went to the Governance Committee, of which non-executive directors were members, there was no record of any discussion of these issues by that group before July 2005.

The only discussion recorded in the minutes of the finance, performance and information committee prior to June 2005 was in February 2005 and related to pressures that been experienced in the first few weeks of the year. This is considered further later.

The secretary to the finance performance and information committee provided her handwritten notes of two meetings in April 2005. This was because the outbreak was not recorded in the minutes and the trust wished to provide evidence of discussion. The hand written notes of the first meeting recorded that the committee was told beds had been closed for reasons of infection control. At the second meeting the handwritten notes record that the medical director said:

• there was an outbreak of C. difficile at Stoke Mandeville Hospital that was more toxic and potent than average in the UK and Europe

• fifteen patients had died since September from this infection and there were another fifteen deaths where C. difficile had been a contributory factor

• the Health Protection Agency were helping with guidance on how to contain the problem including a new way of cleaning wards

• there was a group working on developing an action plan to handle it

• the public relations aspects were being addressed

• statements would be prepared for board members

In interviews and in the written response to the Healthcare Commission, members of the board were unable to explain why the second outbreak was not discussed in public or recorded in minutes before it appeared in the national media. We were concerned that many of the board members appeared to have little or no recollection of events and discussions. Although they reported that there had been such discussions, most of the issues they recalled, such as the visit of staff to Canada, related to events after national publicity. Several board members stated that they felt that the board had been completely open about the outbreaks, but acknowledged that they did not mean they were open with the public. There was no record of the outbreaks being mentioned at the trust’s management board or the hospital medical advisory committee until after the publicity. A substantial number of nurses and other staff told us they found out about the outbreak from the media.

As the board members were unable to recall details, and the minutes did not provide a record, we could not determine whether the board failed to discuss the key issues or failed to minute the discussions.

Comments from local voluntary and statutory organisations included the view that whilst the trust had been open since the second C. difficile outbreak was made public, they did not feel that this had previously been the case and the trust was not active in providing information to relevant organisations.


When the outbreak became public, the chief executive joined the team to assist the ongoing management of the outbreak and instituted daily “outbreak” meetings, which she chaired.

Findings on the role of the director of infection prevention and control and the involvement of the board in the prevention and control of infection • The medical director became the director of

infection prevention and control in December 2003. He did not have a background in the control of infection.

• The director of infection prevention and control attended the outbreak committee meetings. He did not attend meetings of the Stoke Mandeville infection control committee for two years, including the period covering the two major outbreaks.

• The infection control team did not feel adequately supported by the director of infection prevention and control during the two major outbreaks.

• The annual report of infection control at Stoke Mandeville Hospital for 2003/2004 was not taken to the board, although there was a formal requirement to do so. The director of infection prevention and control could not provide an explanation for this.

• Although the second major outbreak was reported as an incident in March 2005, it was not included in a presentation on infection control to the board in April 2005.

• At the finance performance information committee meeting at the end of April 2005, the outbreak was discussed including the public relations aspects, but none of the discussion was minuted.

• The outbreak was publicised in the Independent on June 6, 2005.

• When the outbreak became public, the chief executive joined the team to help manage the outbreak and instituted daily meetings.

• The C. difficile outbreak was not reported to a public meeting of the board until July 29th 2005.

• Members of the board were unable to explain why the second outbreak was not discussed in public at the board before it appeared in the national media, nor why earlier discussions in other meetings had not been minuted.

• Members of the board had poor recollections of the events and discussions concerning the outbreaks of C. difficile.


Strategic priorities

The strategic focus of the trust The trust had faced a challenging agenda since the merger in April 2003. As well as bringing together two disparate organisations, the leadership had to deliver a major reconfiguration of services and a new hospital building, funded by a Private Finance Initiative. In the meantime, services at Stoke Mandeville had to be delivered from poor and in part dilapidated buildings. This was against a background of demanding Government targets and a health economy with significant financial problems. In their last year, the two trusts that merged to form the trust each had zero stars. The new trust acquired one star in its first year and two in its second year. It clearly placed emphasis on the achievement of national targets and was effective at delivering them.

There was a shared perception internally and externally that the trust was strongly driven by the achievement of targets. Some credited the senior managers with having achieved immense change very quickly. Others saw the leadership as overbearing, confrontational and intolerant of failure.

Many clinicians had concerns that on occasions the targets were being achieved at the expense of the control of infection and the safety of patients. The meetings of the clinical risk review panel frequently reflected these concerns; for example at the meeting in January 2005 the deputy director of nursing emphasised the pressure the hospital was under to reach targets and asked that the board acknowledge the risks. However, there was no evidence that they were ever discussed at the governance committee or the board. As the person in charge of clinical governance, the medical director bore part of the responsibility for this.

It was noted at a meeting of the trust’s executive committee in January 2005 that a greater than usual number of letters had been received from clinicians expressing concerns at the risks being run. There is no record that non-executives were informed about this, although they were informed the trust was under pressure. Although related concerns were documented at the HR committee and joint management and staff committee, neither did it appear that non-executives knew that the Royal College of Nursing had raised a grievance about the shortage of nurses and about the effect of this on the care of patients.

There was no record that in the first six months of 2005, nor at any other time, that the board was told about the serious worries of the head nurses. It was at the February 2005 meeting of the head nurses that they reported patients going without food and medication, sitting in wet beds, and nurses going home in tears. The minutes had been sent to the chief executive and director of nursing.

The minutes of the meeting of the finance, performance and information committee on February 28th 2005, noted that both A&E and ward staff had been under pressure to ensure that patients waited no longer than four hours in A&E. The situation had been compounded by staff sickness, leavers and problems related to the control of infection. The minutes recorded that a number of risks were outlined but the committee thought that these were being addressed and “the view was taken that the trust should continue to pursue the target” i.e. the four hour maximum wait in A&E.

This decision was taken at the height of the second C. difficile outbreak and it was at this


time that the request of the infection control team, supported by the health protection unit, for a dedicated isolation ward, was not supported.

At a meeting of the infection control operational group on March 24th 2005, the consultant microbiologist present expressed concern about the effect of performance targets on the spread of C. difficile. The director of operations responded that it was critical for the trust to meet targets. The consultant enquired about the cost of meeting these targets if it was at the expense of failing to prevent the spread of infection. The response of the director of operations was minuted as “whatever the cost”. The members of the infection control team present have confirmed the minutes as being a verbatim record. The director in question has since denied that it was intended as recorded, but was meant to indicate no cost should be spared. The others present strongly refute this interpretation.

At various meetings the executives informed staff that the trust would lose £500,000 that they would receive only if the A&E target was achieved. In response to concerns expressed by clinicians at meetings of the trust’s management board and hospital medical advisory committee, the chief executive highlighted the importance of the A&E target and stressed that it was “non-negotiable.” At the meeting of the trust management board in November 2004, the chief executive confirmed that the four hour maximum wait in A&E was “the number one target nationally and the trust would be severely penalised should it fail.”

The senior adviser in microbiology at the Department of Health attended the special outbreak meeting of interested parties on May 24th 2005 on behalf of the inspector of microbiology. His impression gained was that the trust was mainly concerned about the programme of change planned between Stoke Mandeville and Wycombe hospitals (Shaping

Health Services) and did not want to use beds or wards for isolating patients if that would interfere with the programme. His report stated “There was a perceived reluctance to accept the need for urgent and sustained action to prevent further escalation of the outbreak. It was apparent the infection control team will need support from both the Health Protection Agency and the strategic health authority in ensuring that the action points are carried through as rapidly as possible”. The director of infection prevention and control responded in writing to contest that view, and give an assurance that action was being taken.

The inspector of microbiology visited the trust a month later on June 22nd , by which time there had been national publicity and daily meetings had been instituted. He gave a more positive report.

We asked the chief executive if at any point the trust had considered closure of the hospital to emergency admissions. We were told that this had been discussed with the chief executive of the strategic health authority. It was considered that, overall, patients served by the trust would be “subject to unpalatable and unacceptable” experience if the trust were to close to admissions. The option of cancelling planned surgery was apparently not considered a viable alternative. The advice of the infection control team was not sought in making this decision.

Priority given to advice from the infection control team We were told of many cases in which the advice of the infection control team had been overridden. Some of these have been referred to earlier.

There was a meeting involving the infection control team and the director of infection prevention and control in February 2005, during the second outbreak when the original action plan was re-activated. The infection control team requested that a ward for the isolation and care of patients with C. difficile should be


established. This request was supported by the nurse consultant at the health protection unit, but did not happen.

In March 2005, during the second outbreak, two patients with diarrhoea were moved out of cubicles onto the open ward area of the pre admission unit. In April 2005 a patient with C. difficile was moved to the eye ward which was closed to admissions because of an outbreak of Norovirus. Also on that occasion, patients were moved against the advice of the consultant microbiologist into ward 12 in the middle of the night. The isolation bay on ward 12 had been decommissioned and had not been adequately cleaned before these new patients were moved into it. Managers did not act to resolve the situation of the patient on the eye ward, despite advice to them and the director of infection prevention and control from the consultant microbiologist. Although the consultant wrote to the chief executive, she did not reply. The medical director sent a memo saying he understood the pressures that those responsible for the control of infection were under and concluded that there was an ongoing tension where an appropriate balance needed to be drawn between governance and clinical practice. He explained to us that the tension to which he referred, was between targets and clinical practice.

At the meeting of the outbreak committee in March 2005, the minutes record the view of the infection control team that there was a lack of support from senior managers for the measures that needed to be taken to control the outbreak. It was noted that no member of the executive team had attended the infection control committee since July 2003.

During the second outbreak, in the second half of April 2005, a number of patients with C. difficile had been admitted or transferred to ward 3x. It then became established as the C. difficile ward. It was at this time that the significance of type 027 became known. The

Health Protection Agency and the infection control team were concerned that a ward should remain dedicated to the care of patients with C. difficile. Despite direct advice from the clinical director of the health protection unit, who was also the regional epidemiologist, and the infection control doctor, to the director of infection prevention and control, this ward was closed prematurely on May 17th 2005. The four remaining patients who had C. difficile were accommodated in single rooms. The trust told us this was because of the need for inpatient beds for other patients. The trust did not immediately designate an alternative ward for isolation, although a ward was identified when it became apparent that the decision was premature.

At this time, a medical patient with diarrhoea was transferred to the National Spinal Injuries Centre, against the advice of the infection control team. This patient was later discovered to have type 027 C. difficile. Although the transfer did not lead to spread of the infection in the National Spinal Injuries Centre, this action was described to us by an external expert on the control of infection as being in breach of “the most elementary of risk assessments”, given the vulnerability of patients in the centre.

As described earlier, there was a special meeting following the outbreak committee on May 24th 2005. The external participants from the centre for infections, the health protection unit and the Department of Health reported that the chief executive appeared to be opposed to the implementation of advice from infection control. Trust representatives have responded to us that this advice had to be placed in the context of the overall requirements of the trust.

There was a consensus among the external participants that we interviewed, that the second outbreak could have been brought under control earlier, if greater priority had


been given to the advice from the infection control team and Health Protection Agency. We were told by some clinicians in the trust and external experts that, until it received national publicity, the outbreak was not treated by the leadership of the trust with the seriousness it deserved.

The infection control team did not think that they had had adequate support from trust managers before, during or after the outbreaks.

We noted that when there was conflict between infection control and other priorities, there was no mechanism to negotiate agreed action based on risk assessments.

Findings on strategic focus and the priority given to infection control • The trust’s senior managers had a huge

agenda and had made significant progress in many areas. The trust had gone from zero stars to two stars in two years. The long awaited new facilities at Stoke Mandeville Hospital were commissioned and built.

• The trust did not establish an isolation ward in February 2005, although advised to do so by the infection control team and the Health Protection Agency.

• The trust did not consistently follow the advice of the infection control team, even at the height of the second outbreak, and there was no mechanism to reconcile the advice from the infection control team and the options preferred by managers.

• The trust closed ward 3x as an isolation facility against the advice of the infection control team and the Health Protection Agency.

• At the height of the second outbreak, in February 2005, the board members, sitting as the FPI group, took the decision to continue to pursue targets, despite the outbreak.

• External organisations did not feel that those responsible for the management of

the trust took the outbreaks sufficiently seriously.

• Other management imperatives took greater priority than the control of infection.

• When the possibility of closing the trust to new admissions was considered, the advice of the infection control team was not sought.

Leadership and managerial culture The picture given to the investigation team about the culture and style of management at the trust was that it was focused, controlling and oppressive and driven by the pursuit of targets and the reconfiguration of services. Staff acknowledged the scale of challenges faced and the achievements that had been made. Several senior clinicians felt that the number of the Government’s targets and local priorities made such an approach almost inevitable.

However, the unrelenting “can do” approach was seen by many staff as high risk, representing a sweeping aside of the concerns of doctors and nurses, disregarding the pressure on front line staff and the effect on patients. Others referred to a relentless “good news” culture, where the top team only talked about, and wanted to hear about, success. This appeared to include the information that was given to the trust’s non-executive directors, although they did not view it in this way. They were largely unaware of issues such as the concerns of the Royal College of Nursing and head nurses, the missing annual reports of infection control, and concerns expressed by consultants and other clinical staff.

The results of the Healthcare Commission staff survey in 2003 and 2004 found that the trust was in the worst 20% of trusts for staff perception of the quality of the leadership of senior managers and positive feeling in the organisation. The position deteriorated in the 2004 survey with regard to job satisfaction and the proportion that intended to leave. The


response rate of 66% was reported to be one of the highest in the country. The trust reports that this was in part because managers encouraged staff to complete the survey. In 2005 the trust was in the worst 20% for positive feeling in the organisation, including about the care being provided to patients. The trust had a relatively high proportion of staff members who did not feel they would like to be a patient at the trust.

In interviews, many staff described the leadership as dictatorial, and “verging on bullying”. The Royal College of Nursing reported that staff were frightened to speak openly. They were fearful of raising issues within the trust and relied on external organisations to express their concern. The Healthcare Commission also encountered staff who were scared to describe the situation on the wards, for fear the trust might identify them as the source of such comments. Local organisations told us that staff described low morale at the trust and felt pressurised rather than supported.

Members of the board were keen to stress that clinicians led the organisation. However, this was not the view of the majority of clinical staff nor was it supported by our evidence. Several consultants told us that they felt increasingly disenfranchised. They saw the trust as driven by targets and management priorities. It was recorded in the minutes of the Medical Staff Committee that senior managers “coerced” staff to ensure that targets were met and staff confirmed this at interview. The serious concerns of the head nurses about the safety of patients were not discussed at executive team meetings or the board. The trust’s management board, which involved clinical directors and executives, had no written record of the outbreaks until they were publicised nationally.

Members described the board as open, but this was not apparent from the minutes and members conceded that transparency to the public about the outbreaks was not an early goal.

The Healthcare Commission found it impossible to deduce from the minutes how the trust had approached the outbreak, to what extent information was shared with the board and to ascertain the degree and depth of discussion. The board members were unable to recollect the discussions in any detail and we could not determine whether the board failed to discuss the key issues or whether it was an organisation which was not open and, for whatever reason, did not record details of important discussions. Local organisations did not think the trust had been open about the outbreaks until the outbreaks were publicised nationally.

The executive team were a closely knit group, some of whom had worked together previously. A number of staff reported to us that there was a serious disconnection between the executive team and the rest of the organisation, particularly middle managers. A picture was presented of an inner circle with a limited focus on the needs of the wider staff group.

The non-executive directors appeared to be committed to the trust and supportive of the executive team. They also seemed defensive. There was little evidence that they had challenged the executives at crucial times on matters to do with clinical risk and the safety of patients. The committee structure also resulted in the important business of the board effectively taking place behind closed doors at the finance performance and information committee rather than at board meetings.

Staff did not perceive non-executive directors as a conduit for concerns even where they had a formal role. The non-executive directors did not appear to be aware of the concerns clinicians had about the degree of risk being run by the trust.

The chairman was not involved in early meetings with the Healthcare Commission about the investigation. Unusually, there was no other non-executive involvement either.


Moreover when the Healthcare Commission wrote to the trust on January 5th 2006 with our concerns about the environment and clinical practice, the non-executive with responsibility for these issues was not aware of this when we spoke to them three or four weeks later.

Senior nurses considered that the director of nursing did not listen to her professional colleagues, that she did not represent the concerns of nurses to the board and did not have a focus on the care of patients. Their concerns about the poor care of patients had been expressed regularly at meetings and in letters and e-mails sent to the director. The nurses reported that she did not appear interested in the quality of nursing care and did not take action in the face of clear evidence of poor care, or concerns about the safety of patients, despite her role as safety champion on the board. The minutes of the board also confirmed their view, since there was little discussion of issues related to nursing, and no mention of the concerns of the head nurses or the involvement of the Royal College of Nursing.

Although following the meeting of the head nurses in February 2005, she invited senior nurses to contact her, they considered that such contact did not lead to solutions. When interviewed by the investigation team, she also appeared unconcerned about the frequency with which patients of both sexes were mixed together on wards, reporting on some occasions that it was impossible to avoid, and on others that some patients preferred it.

The structure for clinical leadership of doctors consisted of a medical director, four associate medical director posts and a number of clinical directors and lead clinicians. The associate medical directors and the clinical directors were confused as to whether they had job descriptions. There was little clarity over their roles. Although the associate medical director with responsibility for medical education was under the impression that consultants who

were clinical directors or lead clinicians were appraised on both roles, this was not the experience of any of those we interviewed. None had their role as clinical director discussed as part of their clinical appraisal. However, the trust told us that after the first year in post the medical director informally met with each clinical director and in the second year the chief executive and medical director jointly met with individual clinical directors to discuss their role.

The structure with two and then three directors of operations created confusing accountability arrangements for the general managers, particularly since the directors of operations were focused on the delivery of their specific agendas. This on occasions led to conflicting messages and general managers being pulled in different directions. Many of them described the trust as working in silos.

There was no forum in which general managers could meet. They felt isolated, inadequately informed and unsupported. Some felt the executives acted as a barrier between them and the chief executive and chairman. They and others felt that the executive directors avoided giving the chief executive information she did not want to hear.

Partly because of the reconfiguration programme, many managerial staff had had a number of significant changes in their roles and responsibilities. Clinicians found this confusing and frustrating.

The general manager on-call system involved service managers as well as general managers. Staff were called so frequently during the night that it had become a duty manager rather than on-call system. Often they would only get one or two hours sleep and had to work the next day. The general managers reported they were managing a group of stressed and distressed managers. Everything was “top priority”. The message was said to be


“failure is not an option” and managers were in fear of losing their jobs. It was reported that failure to achieve targets led to threats and humiliation. Senior managers told us that middle managers were at breaking point some were regularly in tears, others on medication. Senior staff told us some directorates had fostered a supportive “microculture” to shield and sustain staff.

General managers confirmed that their performance was assessed solely against targets – both financial targets and access times.

The Healthcare Commission’s own experience of the trust’s approach to the investigation underlined some of the concerns expressed by staff about a lack of openness in the trust. We were told by senior nurses that senior managers informed them that the information they gave at interview could be directly attributed to them in the report. At the time this was drawn to our attention, we asked for any misunderstanding to be corrected, but this did not appear to have happened, and the trust later denied that the inaccurate information had originally been given to staff.

The trust sent us a timeline, describing the order of events relating to the outbreaks. We found this to be deficient: information was omitted, incomplete or incorrect. We found that relevant information collected by the trust from members of staff for the purpose of the investigation, had not been sent to us, and other information that was provided to us, was incomplete.

We were concerned that neither the chairman nor four of the non-executives were initially available for interview at the end of January 2006 although we had provided the dates some months earlier. There were also problems with the availability of the executive directors. Uniquely the trust had offered mock interviews to some senior staff and members of the infection control team. These interviews were

conducted in the presence of the trust’s legal representatives and a manager took notes. The trust told us that these interviews were intended to support staff.

This combination of factors raised concerns about the extent to which the trust was prepared to cooperate in a full and open examination of the terms of reference.

Findings on leadership and management • The leadership was seen by many as

discounting clinical risk in pursuit of the Government’s targets.

• Senior managers were seen as overbearing and intolerant of failure.

• The executive team were a closely knit inner circle, disconnected from the rest of the organisation and with limited appreciation of the needs of the wider staff group.

• The culture within the trust was not seen by staff as open or valuing the importance of learning.

• The committee structure led to some important business of the board being conducted “behind closed doors” at the finance performance and information committee.

• The non-executives did not appear to be fully informed about the organisation and its challenges, particularly in relation to clinical risk.

• There was a lack of evidence of discussion by the board of key issues relating to clinical risk, particularly the outbreaks of C. difficile.

• Having two and then three directors of operations caused confusion for the next tier of managers.

• Middle managers were under considerable stress and many felt isolated and unsupported.

• The trust’s preparation for, and approach to, our investigation did not appear designed to facilitate full and balanced scrutiny.


The role of external organisations

The strategic health authority Strategic health authorities were created in 2002 to manage the local NHS on behalf of the Secretary of State. Each strategic health authority is responsible for developing a strategic framework for the health and social care community and managing the performance of all providers of healthcare in the NHS within its geographic boundaries. This includes putting and keeping in place arrangements for monitoring and improving the quality of health care provided to individuals in the area. Strategic health authorities are responsible for assuring the quality of services for everyone.

Although the trust officially notified the Health Protection Agency about the first hospital-wide outbreak on March 10th, 2004, there was no record that the trust had notified the Thames Valley strategic health authority. However the nurse consultant in health protection at the health protection unit e-mailed the medical director of the strategic health authority on March 9th to inform him of the outbreak, including the risks and the actions agreed at the meeting of the outbreak committee. The strategic health authority was informed that the trust had been advised to report the outbreak as a serious untoward incident. The nurse consultant in health protection sent further information on April 8th 2004 with an update of the situation and the advice the Health Protection Unit had given to the trust. The medical director at the strategic health authority recalled the communication on April 8th but not the earlier e-mail message

The strategic health authority did not take any action to follow up the outbreak or check whether there had been any changes to procedures or practice as a consequence. The

strategic health authority considered this was the role of the Health Protection Agency. There was a draft memorandum of understanding between the strategic health authority and Health Protection Agency dated August 2004. This stated that the Health Protection Agency had to provide advice and support to the strategic health authority on actions needed for performance monitoring, but did not clarify at whose initiative. The memorandum also stated that the two organisations should collaborate to ensure efficient handling of all incidents notified through the system of either.

The trust notified the Health Protection Agency about the second hospital-wide outbreak on March 23rd 2005. We were unable to determine exactly when the trust reported the outbreak as a significant untoward incident to the strategic health authority, although on April 5th 2005 the trust’s risk manager reported to the Health Protection Agency that it had been put on the strategic executive information system. This is a system using e-mail to report management information including all serious untoward incidents. The system should send an alert to the strategic health authority of a new serious incident, but on this occasion the alert system did not work. Consequently the strategic health authority initially did not know about the outbreak. The problem with the strategic executive information system was a national one, but the strategic health authority was not informed about it. It was identified retrospectively after concerns were raised.

The health protection unit was surprised that it was not contacted by the strategic health authority in early April and saw no evidence from the behaviour of senior managers at the trust that the strategic health authority had been in contact, since they could not detect any increased priority given to the control of the


outbreak. They checked with the strategic health authority if the serious incident report had been received.

The medical director at the strategic health authority said that he knew about the outbreak following a phone call from the regional epidemiologist on April 25th, followed by an e-mail on April 26th 2005.

The medical director of the strategic health authority with responsibility for public health, discussed the outbreak with the medical director of the trust at a pre-arranged meeting on April 27th. The medical director of the strategic health authority told us that he used this opportunity to stress that the trust should follow the guidance that they had been given. Furthermore the trust should not let finances stand in the way of doing so. This was with particular reference to the potential cost of special cleaning and decontamination procedures.

The associate director of nursing at the strategic health authority with responsibility for MRSA and healthcare associated infections, did not learn about the second outbreak and the number of cases until May 17th 2005. This was when she came to chair an infection control conference and was approached by the senior infection control nurse. The nurse raised the issue of the closure of ward 3X, which had been used for patients with C. difficile. It was immediately following that, on May 18th, that the health protection unit contacted the strategic health authority with their concerns about how the trust’s managers were handling the outbreak. It was then realised that the national strategic executive information system e-mail alert system had not been working properly.

The incident had also been wrongly categorised. On June 27th 2005 the strategic health authority pointed out to the trust that the serious untoward incident was still filed under the category of ‘other’ and had not been filed properly under ‘communicable diseases’. On August 3rd 2005, the strategic health authority noted that the trust had updated the form and provided an update on events.

In terms of general performance management, the action plans relating to Healthcare acquired infections and saving lives formed part of a performance report that went to the strategic health authority board. The main focus was on infections with MRSA. As far as C. difficile was concerned, the Department of Health had established the surveillance programme but there were no targets. The strategic health authority did not do any monitoring of C. difficile and told us they did not have additional resources to do more detailed monitoring.

In September 2005 the strategic health authority launched a network to share good practice and knowledge on infection acquired in a healthcare setting. This involved the healthcare organisations in Thames Valley and the first meeting of the steering group took place in December 2005.

There was agreement that the position remained confused as which outbreaks should be reported, when and to which organisation. The strategic health authority did not inform the Department of Health of the second outbreak because they presumed the Health Protection Agency had done this. However the Health Protection Agency told us that routine notification was not the role of the Health Protection Agency.

Findings on the strategic health authority • No action was taken by the strategic health

authority after the first outbreak at the trust.

• A draft memoranda of understanding was agreed in August 2004 which described the roles of the strategic health authority and the health protection unit, and how they should work together.

• The medical director of the strategic health authority had a scheduled meeting with the medical director of the trust in April 2005, at which the second outbreak was discussed.

• The nurse at the strategic health authority with responsibility for MRSA and healthcare


associated infections did not learn about the second outbreak until May 17th 2005, when she attended a conference.

• The strategic health authority did not intervene in the second outbreak until asked to do so by the Health Protection Agency. Although there was a draft memorandum of understanding in place from August 2004, there was still confusion as to how this should work in practice.

• The strategic health authority did not monitor the performance of the trust in respect of the management of C. difficile.

The role of the Health Protection Agency and Anaerobe Reference Laboratory A key role of the Health Protection Agency is to provide advice to trusts and clinicians in managing and preventing cases and outbreaks of infectious disease, including those caused by C. difficile.

The remit of the Health Protection Agency’s Centre for Infections (CfI) includes the provision of national expertise and surveillance of infectious diseases. It may coordinate the investigation of national and uncommon outbreaks.

Most regions have three or four health protection units. Each unit consists of a director, consultants, nurses and other staff with specialist health protection skills.

The unit staff work closely with acute trusts, particularly their directors of infection prevention and control and the infection control teams.

The Thames Valley health protection unit, part of the South East Region Health Protection Agency, worked with the trust during the outbreaks at Stoke Mandeville Hospital.

The Anaerobe Reference Laboratory The Anaerobe Reference Laboratory is not part

of the Health Protection Agency. It is located in the University Hospital of Wales and became part of the National Public Health Service Wales in 2003. The Anaerobe Reference Laboratory provides expert support to the NHS and health protection and public health services.

It also has a role in the investigation of outbreaks of infection involving species of clostridium. Trusts send cultures of C. difficile to the laboratory so that the specific type can be identified and sensitivity to antibiotics determined.

The involvement of the Health Protection Agency in the outbreaks of C. difficile at Stoke Mandeville Hospital During both outbreaks the nurse consultant in health protection, working for the Thames Valley health protection unit , provided support to the trust’s infection control team. The nurse consultant in health protection was a member of the Infection Control Committee and of the Outbreak Committees. She provided expert advice on the control of infection and liaised with others at the Health Protection Agency and other specialists as appropriate. The infection control team was appreciative of this help and support.

The nurse consultant in health protection advised the trust to report both hospital-wide outbreaks as serious untoward incidents to the strategic health authority.

The nurse consultant in health protection was concerned that senior managers at the trust had given insufficient priority to the control of infection during the first outbreak. Staff at the health protection unit did not think senior managers appreciated the importance of isolating patients or the risk posed by the scale of the movement of patients between wards, even after the experience of the first outbreak.

When the second outbreak began, the nurse consultant in health protection and the trust’s infection control team argued for a dedicated


ward for C. difficile. Concerns escalated at the Health Protection Agency once the significance of type 027 was known.

On April 5th 2005, the nurse consultant in health protection requested confirmation from the trust that they had reported the outbreak as a serious untoward incident to the strategic health authority, as there had been no contact from the strategic health authority to the health protection unit or the outbreak committee. The risk manager at the trust confirmed it had been put on the strategic executive information system.

The health protection unit was not confident that managers at the trust were taking the issue seriously. The nurse consultant in health protection at the health protection unit had concerns about a potential conflict of roles if she was to inform the strategic health authority. There was also concern about the effect of criticism on the relationship with the trust. Following discussion with the regional epidemiologist and the regional director of the south east Health Protection Agency, it was agreed the strategic health authority should be informed. On April 25th the regional epidemiologist telephoned the medical director of the strategic health authority.

In mid May 2005, the ward that had been established as a dedicated ward for patients with C. difficile infection, was closed. This happened, despite the advice to the trust, through the director of infection prevention and control, that this be retained. This advice came from the infection control team, health protection unit and the regional epidemiologist. The regional epidemiologist was sufficiently concerned that this ward should remain dedicated to C. difficile that she contacted the medical director personally about it. Although the remaining patients were isolated in single rooms, the health protection unit and the regional epidemiologist felt that the decision to close the ward was premature.

When the director of infection prevention and control ignored the advice of the infection control team and health protection unit not to close the isolation ward (3x) in May 2005, the

health protection unit formally reported its concerns to the strategic health authority and the Department of Health. When the ward was closed the regional epidemiologist contacted the medical director in the strategic health authority to discuss the problem and check on the strategic health authority’s response to the serious incident report. She also reported the unusual type of C. difficile involved directly to the Department of Health. The inspector of microbiology was already aware of an unusual strain of C. difficile because of his contacts with the Anaerobe Reference Laboratory. He requested that a special fact finding meeting be held at Stoke Mandeville Hospital.

This special outbreak meeting was held on May 24th 2005 and attended by a senior microbiologist from the department of health, deputising for the inspector of microbiology, and by the deputy director of the healthcare associated infection and antimicrobial resistance department of the centre for infections. Both formed the view that the trust had not given adequate priority to controlling the outbreak of C. difficile.

On May 26th 2005 an expert on decontamination from the centre for infections at the Health Protection Agency visited the trust and made recommendations about decontamination of the environment and equipment.

The role of the Anaerobe reference laboratory in the outbreaks In March 2004 during the first outbreak, the consultant microbiologist sent isolates of C. difficile to the Anaerobe Reference Laboratory. Later that year the senior infection control nurse visited the laboratory. The analysis revealed a predominance of type 027, which was at that time thought to be rare in the United Kingdom. Its significance was not known at that stage. This did not apparently trigger any enquiry into its similarity to other types in other countries. The director of the laboratory reported that they have limited resources and that these have been stretched by the mandatory sampling programme.


When cultures were sent during the second outbreak, type 027 was again discovered to be the dominant strain. The significance of this was unclear until the end of April 2005, when the Anaerobe Reference Laboratory confirmed in response to a query from the consultant microbiologists at Stoke Mandeville, that this strain was indistinguishable to that causing large outbreaks in Canada and the north eastern USA. The reference laboratory informed the inspector of microbiology.

The role of organisations in respect of new strains We were told by the Health Protection Agency that, at a conference in Atlanta in March 2004, the new, apparently virulent strain of C. difficile was discussed. However, it was over a year later before it was identified as the same strain as type 027.

In our enquiry we asked a number of people, including the head of the anaerobe reference laboratory and the deputy director of the healthcare associated infection and antimicrobial resistance department of Centre for Infections, whose responsibility it was to recognise the implications of a new strain of C. difficile. We did not get a clear answer. The Health Protection Agency have told us this is because it is a shared responsibility. They reported that “the laboratory types and identifies new strains, the trust has the information on the local clinical picture and the Health Protection Agency will know the public health picture.” The deputy director of the healthcare associated infection and microbial resistance department of the centre for infections, reported that understanding the significance of new strains inevitably involves a collaboration.

The head of the reference laboratory told us that the surveillance programme for C. difficile and the work of the reference laboratory in identifying new strains, represent greater progress than in most of Europe.

Members of the trust’s board told us that they were not happy with the degree of support and

specific advice they received from the Health Protection Agency, particularly in the context of the 027 strain. The trust felt that the Health Protection Agency should have identified earlier that it was the same as the North American strain and advised the trust accordingly. The Health Protection Agency responded, and we concur, that the strain should not have made any difference to the essential measures of isolating patients, restricting the movement of patients and improved hygiene and cleaning, necessary to control the outbreak. The trust contend that earlier restriction of quinolones could have prevented some cases.

Findings on the role of the Health Protection Agency and the Anaerobe reference lab • The nurse consultant in health protection

provided advice and support to the infection control team during the outbreak.

• The trust did not react to the advice from the health protection unit and South East Health Protection Agency in the way they expected, and the Health Protection Agency was concerned that the senior managers at the trust did not give sufficient priority to the control of infection.

• On April 25th 2005 the South East region of the Health Protection Agency checked that the strategic health authority was aware of the outbreak and raised their concerns. These concerns were raised again on May 18th with the strategic health authority and the Department of Health.

• The health protection unit also contacted the Centre for Infections and inspector of microbiology.

• The health protection unit considers in retrospect it should have checked earlier that the strategic health authority understood the complexities of the outbreak, and raised its concerns at an earlier stage.

• The Centre for Infections considered the trust had not given sufficient priority to controlling the outbreak.


• Staff in healthcare associated infection and antimicrobial resistance department at the centre for infections knew in March 2004 that there was a new strain in North America, but staff at the anaerobe reference laboratory did not discover that this was indistinguishable from 027 until April 2005.

• The Healthcare Commission was unable to determine who had the main responsibility for identifying the significance of new strains of C. difficile.

The commissioners – the primary care trusts The trust provides hospital services to Vale and Aylesbury PCT, Chiltern and South Bucks PCT and Wycombe PCT. The PCT’s are responsible for organising primary care and community health services for the local population, and commissioning hospital care.

We were interested in whether those responsible for commissioning services for patients from the trust had made the control of infection a priority in their contractual agreements with the trust. For the two years 2003/2004 and 2004/2005, service standards that formed part of the agreement between the primary care trusts and the trust, were the same as those in the previous year. Other than a general reference to standards set out in Your guide to the NHS (which replaced the Patients' charter standards) which were to be seen as a priority, there was no mention of infection control in the service level agreements for these two years.

More detailed quality standards were included in the service level agreement for 2005/2006. None of the10 key quality standards in the agreement related specifically to infection control. Seven quality performance standards were also detailed in the 2005/2006 service level agreement, one mentioned reducing complications (experienced by patients) caused by healthcare acquired infection. In August 2005 information about numbers of C. difficile

and MRSA cases was requested at a regular meeting on performance attended by the trust and the PCTs. Wycombe primary care trust informed us that the information requested was not available to the commissioners until February 2006. From that time the primary care trust’s board considered the report on performance that went to the trust’s board. This included a section that monitored the numbers of MRSA cases against a target.

The primary care trusts told us that the countywide committee for infection control, which was established in May 2003, undertook developmental work with the trust to monitor and improve performance in relation to the control of infection. The minutes of this committee went to the risk management committee of each primary care trust. We noted that the outbreaks had been recorded at the committee but could not see any evidence of the management of performance in relation to the outbreaks of C. difficile at the trust. There had not been any follow up after the outbreaks.

Findings on the role of the primary care trusts • The commissioners had not made the

control of infection a priority in their service level agreements with the trust for 20032004 and 2004-2005.

• Information that could have been used for monitoring and performance management of hospital acquired infections in the trust was not made available to commissioners until nearly the end of the 2005-2006 contractual year, and after the outbreaks had occurred.


Events since the investigation was announced

This section looks at what has happened since the investigation was announced. It covers the period from July 2005 to April 2006.

Infection control team A locum infection control nurse was appointed at Stoke Mandeville from June 2005 to March 2006 to assist the work of the team. She worked three to four days a week and her contract expired in March 2006. An additional infection control nurse was appointed to meet the needs of the local Vale of Aylesbury PCT in August 2005. As from April 2006, there was the equivalent of 2.25 nurses working in the infection control team at Stoke Mandeville, plus some additional support for surveillance (0.6 WTE) and work for the primary care trusts (0.8 WTE).

At the end of November 2005 the trust decided to divide the budget for training equally between the infection control teams. Previously the budget for the training of the team members had been significantly larger at Wycombe.

Additional guidance on the prescribing of antibiotics was produced in September 2005, ahead of national guidance. This recommended antibiotic regimens for common infectious diseases under normal conditions and during an outbreak of C. difficile.

The ‘who’s who’ list for infection control was updated in October 2005.

From July 2005, the director of infection prevention and control attended the meetings of the infection control committee.

Training for staff We were pleased to note that the trust has decided to make the training on the prevention

and control of infections mandatory. Members of the infection control team have agreed a statement for inclusion in the training brochure.

The trust has begun to monitor attendance at mandatory training as well as at induction.

The infection control committee noted in October 2005 that some wards had not received the packs relating to the Cleanyourhands campaign. It was reported at the November 2005 meeting of the infection control management forum that there were difficulties in maintaining the momentum of the campaign.

The environment and practice in the control of infection As described earlier in the report, we had a number of serious concerns both about the environment and the practice of infection control when we carried out observations in late 2005 and January 2006. These were particularly troubling given the earlier outbreaks and the fact that there was an investigation involving the control of infection underway at the trust.

We were concerned to learn that, in February 2006, empty beds were moved from the infection control ward to ward 1x, which was acting as an admission area. The beds were moved without the knowledge of the senior nurse or the infection control team. The trust informed us that this issue was dealt with quickly and there was no spread of C. difficile. The trust recognised this had created the risk of exposure of recently admitted patients on 1x to beds contaminated by C. difficile.

New wards were commissioned and occupied during April and May 2006. The new building


houses 10 new wards, two new day case theatres, and an endoscopy suite. It replaced the wards of the north and south corridors and some in the “newer” wing of the old hospital. The new wards have 369 beds, replacing 403 in the original wards.

During an unannounced visit in late April 2006 we were pleased to note that the new hospital building provided a much better environment for patients and had trebled the number of side rooms. We noted that the trust intends to use the side rooms as its resource for isolating patients with infections, rather than designating a ward for such patients. In the event of an outbreak which could not be contained within side rooms, the trust told us it would open an isolation ward.

We felt that some opportunities had been missed, such as the failure to promote consistently the hand hygiene message to both staff and patients and the lack of closed toilet roll dispensers.

We were also pleased that the National Spinal Injuries Centre appeared cleaner and less dilapidated than on previous visits and that generally, staff were paying more attention to hand hygiene and good practice in the control of infection. The fridge had been replaced and the trust has said it will refurbish the bathrooms. However, in wards elsewhere we noted bags piled up in one utility room and access to sinks blocked in several areas.

Further outbreaks at the trust

Outbreak on the “receive, assess and treat unit” in November and December 2005 There was an outbreak of C. difficile on the “receive, assess and treat” unit in the last two months of 2005. The aim of the unit is to assess and treat patients quickly by increasing the level of medical, nursing, therapeutic, rehabilitation and primary care support. Following assessment, patients may move to a specialist unit, for example cardiology or respiratory units for more specialist care. In

addition, physiotherapy and occupational health assessment areas will be provided. The trust reports that the aim is to see more patients sooner, and reduce the time spent in hospital by providing tailored care.

From August 2005 there were fewer than five new cases of C. difficile infection per month in the hospital. From this low baseline the numbers began to rise during the autumn and fifteen patients became infected with C. difficile on the “receive, assess and treat unit“ in November and December 2005. There was a small secondary spread to another ward where a patient had been transferred from the unit.

The outbreak committee was reconvened on December 8th 2005. The outbreak was reported to the Health Protection Agency on December 9th.

The conclusion of the trust’s investigation into this outbreak was that inadequate cleaning was the main factor that facilitated spread of the infection, since there was contamination of the ward by spores from infected patients. Another factor was considered to be poor hand washing. The report noted that a shortage of nurses at that time resulted in lack of consistent adherence to guidelines for the control of infection. An epidemiological study showed that 13 patients with C. difficile were moved frequently between the wards on the unit.

Actions taken during this outbreak included enhanced cleaning, withdrawing the antibiotic cefuroxime from surgical wards and theatres, and re-iterating the need for good hand hygiene.

The outbreak was under control by early January 2006. Lessons to be learnt included the need for better cleaning of the wards especially following contamination, and the importance of maintaining optimal levels of nursing staff to ensure consistent adherence to good procedures in controlling infection.

In addition to the lessons learned and actions taken as set out in the outbreak report, it was evident the trust had learned significant lessons in the management of outbreaks. Key


amongst these were the rapid identification and notification of an outbreak, establishment of a multidisciplinary outbreak committee, regular meetings, rapid institution of recommended changes, and close monitoring of all components of outbreak management including cleanliness, decontamination, the patient environment, rapid isolation of patients with diarrhoea, antibiotic regimes and communication with patients, staff and outside agencies. Rapid intervention in this outbreak proved successful.

We noted and commend the trust that, before and after this third outbreak, the background levels of C. difficile at Stoke Mandeville Hospital had reduced considerably.

Outbreak at Wycombe in February and March 2005 This outbreak occurred over an eight week period and affected 36 individuals in 14 wards. There were four clusters of cases. A mixture of strains was found.

The trust reported that prompt action by a multidisciplinary team helped bring the outbreak under control. The trust identified the key actions as increased cleaning, restricted antibiotic regimes and increasing the number of side rooms available for isolation of affected patients.

We acknowledge that the outbreak was brought rapidly under control but we are concerned that the outbreak spread to involve so many wards, and note that the baseline level was nine new cases in April.

Changes to services There was a major change to services at the end of the summer 2005, as part of the Shaping Health Services programme. The principal change was that all emergency surgery was undertaken at Stoke Mandeville Hospital. This led to increased pressure on services at that hospital which may have contributed in part to the outbreak on the “receive, assess and treat

unit”. Many members of staff told us that the increased workload generated by increased admissions of emergency patients had not been matched by increased resources, particularly staff.

Staffing We noted continuing concerns from nurses about levels of staff on wards and particularly on those escalation areas opened to take patients who needed to be admitted when the other, established wards were full.

We analysed clinical incident forms across the trust that were completed between December 2005 and March 2006. We found over 50 related to shortages of nursing staff that impacted on the care of patients or were considered to be potentially unsafe.

We saw further correspondence from nurses expressing concern about levels of staff.

Following a review of the numbers of nurses on the receive, assess and treat unit during October 2005, the infection control team had contacted the nurse at the strategic health authority with responsibility for healthcare acquired infection, with their concerns. These concerns were also raised at the clinical risk review panel meeting in November where it was noted there had been four “category red” clinical incidents related to shortages of staff. These had included errors in the administration of drugs and an intravenous needle left in situ in a patient.

The unit was nine staff below its establishment number. This was because of staff sickness and staff being moved to escalation areas opened to take patients needing admission. These levels of staff were considered to be a contributory factor to the outbreak of C. difficile on the unit mentioned above, together with inconsistency in following good practice. This was linked to the contamination of the environment that was a critical event for the spread of C. difficile within the unit.

We were informed that due to staffing restrictions, nurses could not comply fully with


the advice of the infection control team during the outbreak of Norovirus on wards 22 and 9x in February 2006. The team’s advice concerned limiting the movement of staff who had been in contact with Norovirus.

Nurses told us about their dissatisfaction with action taken following the expressions of concern by the Royal College of Nursing in the spring of 2005. An action plan had been produced that included the development of a policy for opening escalation areas to take patients needing admission when the wards were full. However, although a checklist had been agreed in August 2005, it was not backed up by a written policy. Nurses were concerned in March 2006 that they were still being asked to open areas without sufficient staff. Other elements of the action plan, such as an internal pool of nurses to provide staffing cover, had not been put into place.

Nurses contacted the Royal College of Nursing again with major concerns in January 2006. On this occasion nurses at Wycombe Hospital expressed concern about staffing and financial pressures. Their concerns were that the strict control on recruitment and the use of agency staff had led to patients not being safe, particularly in escalation areas. For example, a redundant clinical area was opened at a weekend and, as there was no equipment, they had to take it from another clinical area. However, that clinical area then needed to be used as well for patients.

We noted during an unannounced visit to the hospital in April 2006 that the nurse in charge of ward 1x, the overflow admission area for patients on that day, was unable to find the cardiac arrest pack on the ward. After we reported this, the pack was located in a store on the ward. However, this could have had serious consequences if a patient had had a cardiac arrest. There was no piped oxygen on the ward. The arrangements to decontaminate urine bottles were also unsatisfactory on this ward.

Care of patients We noted that many patients continued to be cared for on mixed sex wards, even for those with longer stays and in the new part of the hospital.

We analysed complaints that had been received between January and March 2006 to identify if there were continuing concerns about the issues most relevant to this investigation. In that time there had been 21 complaints about poor basic care such as poor hygiene or lack of help with feeding, 12 about dirty wards, 10 about inappropriate ward transfers, five about failure to follow infection control procedures and four about hospital acquired infection. We were particularly concerned about two incidents where patients reported they had had to intervene to help other patients. We considered that the majority of responses were unsympathetic in tone.

We were told by a number of clinical staff that there were still large numbers of patients on wards that were not the most appropriate for their care.

Arrangements for governance, risk and the culture of the organisation

Operational In April 2006 we noted with concern the significant backlog of incidents that had not been entered on the trust’s system. The trust has told us that the backlog has since been cleared. We noted that incident reports continued to demonstrate problems with capacity, transfers and moves of patients, poor cleanliness, lack of isolation and uncollected clinical waste and rubbish. We had some concerns that the rating of severity was inconsistent.

In December 2005 the risk manager pointed out at the clinical risk review panel that the register for the whole trust did not capture the range of clinical risks being run by the trust.


Because of this the trust has said that additional efforts are being made to develop risk registers for directorates.

The trust has established a post of ‘patient safety manager’. The responsibilities include enhancing learning from incidents and other areas of the management of risk.

The trust failed its assessment for level two in the clinical negligence scheme for trusts in January 2006 but retained level one. The trust did not perform well on attendance by staff at training and the monitoring of attendance.

The infection control team at Stoke Mandeville Hospital was concerned that the assessment in 2006 took place without the involvement or knowledge of the team there. Several members of staff told us that the trust approached assessments such as that of the clinical negligence scheme for trusts in a way that meant that they complied with the formal requirements, but did not absorb or embed the underlying principles.

In December 2005 a forum was established in which general managers could meet. There was still no forum for them to meet with the clinical directors. The general managers continued to feel isolated, inadequately informed and unsupported.

Strategic Since the outbreaks had become public knowledge the board minutes recorded regular information about the investigation and the situation in respect of C. difficile. It was noted that the figures from the mandatory surveillance of patients aged over 65 with C. difficile indicated that the trust was in the mid range of numbers nationally.

At the board meeting in November 2005, members were told they could have access to the infection control annual reports of 20032004. There was no record of any query about why they had not been available 18 months earlier.

Although there was an increased focus on the control of infection, we could not ascertain any change in the arrangements for governance or the priority given to reducing clinical risk. It still appeared that the concerns of clinical staff were not always heard.

The trust told us that the way the various committees and individuals link and interact is currently being reviewed by the trust.

We note that at the time of publication, there have been changes to the leadership of the trust.


Conclusions

This report describes a newly merged trust having to make major changes to services, provide new buildings, achieve the Government’s targets, resolve serious financial pressures and manage major outbreaks of C. difficile. The Healthcare Commission’s overall conclusion is that the pursuit of the first four of these objectives compromised the fifth.

It is set against a background of an infectious disease that is becoming more common nationally.

The trust has expressed the view that some of our findings, such as non-compliance with good hand hygiene, are not peculiar to them but national problems. The Healthcare Commission accepts that is the case, but considers such non-compliance is still unacceptable.

The story of the hospital-wide outbreaks During 2003 the trust’s infection control team was worried about the increasing number of cases and the difficulties that they had in obtaining isolation facilities for patients with symptoms of infection with C. difficile. One of the main reasons for these difficulties was that the buildings were old and had few single rooms. However, this situation was compounded by the decision to change the configuration of beds and services in order to ensure that targets for waiting times were achieved. This led to managers ring-fencing surgical beds and as a result the single rooms on those wards could no longer routinely be used for other patients with infections. The creation of the emergency medical unit led to a further loss of potential capacity for isolation. The infection control team advised senior managers of the risks inherent in these changes.

To reduce the risk of patients developing infection with C. difficile, the infection control team strongly encouraged a change in the use of those antibiotics known to increase the risk of infection.

When the rising number of cases in the winter of 2003-2004 indicated that the trust was experiencing a significant outbreak, the members of the infection control team followed the guidance available to them, within the constraints created by the buildings and competing priorities of the trust. When they were not able to have a ward dedicated to patients with C. difficile, they tried to introduce physical separation of those patients considered likely to spread the infection. However, the physical nature of the wards made this difficult and unsatisfactory. The team put as much emphasis as they could on the importance of isolating infected or potentially infected patients. They expressed concerns that patients being moved was creating further risk of spreading the infection and that nurses were unable to get access to utility rooms containing sluices because of accumulations of uncollected linen and clinical waste.

The infection control team is to be commended for sending strains of C. difficile for typing in the first outbreak and for visiting the reference laboratory. An unusual strain was detected but its significance was not appreciated initially, because at that time there was little knowledge nationally about this strain.

There were 174 new cases of patients with C. difficile infection between October 2003 and June 2004, and 19 deaths of patients during that time that were definitely or probably caused by the infection, 16 of whom were almost certainly infected at the hospital.


A report written by the infection control team after the first outbreak and the trust’s annual report for infection control that year, itemised the factors thought to have contributed to the outbreak. The annual report noted that the failure to isolate patients led directly to the outbreak.

There was a small outbreak on one ward in the summer of 2004 that was attributed to the failure to isolate patients. In the late autumn, the numbers began to rise again and several wards were involved. During the winter it became apparent that there was another major outbreak. In early 2005, the infection control team had a meeting with the director of infection prevention and control and asked for a ward dedicated to the patients with C. difficile infection to be established. This did not happen until much later, and then largely by default.

Between October 2004 and June 2005, there were 160 patients with C. difficile infection and a further 19 deaths definitely or probably due to the infection, with 17 of these patients almost certainly acquiring the infection in the hospital.

Did the trust learn and implement lessons after the first outbreak? The conclusion of the Healthcare Commission is that the infection control team identified the issues that had led to the spread of C. difficile in the first outbreak, but that the trust only implemented some changes and did not choose to implement others. We noted there was no increase in resources available to the infection control team at Stoke Mandeville Hospital.

After the first major outbreak subsided in June 2004, the trust installed partitions and hand basins on some of the wards, in order to make physical separation, partial isolation and nursing care more effective.

The major factor in the spread of the infection was failure to isolate patients with C. difficile or undiagnosed diarrhoea. The most important lesson – the importance of rapid isolation, was not acted upon.

The difficulty of isolating patients was caused by a number of factors. Because of the old buildings there were few side rooms, and some of these became unavailable to be used for the isolation of patients with infections because of the reconfiguration of wards and ring-fencing of surgical beds. It took nearly a year to agree and launch a trust wide policy for isolation. The trust’s uncompromising approach to the national four hour target for people waiting in A&E led to some patients with diarrhoea being kept in or put on open wards rather than in isolation facilities.

The problem of access to utility rooms containing sluices being obstructed by clinical waste and used linen, was not addressed, which meant that nurses could not follow the rules of good practice.

The movement of patients within the hospital had been identified as a further contributor to the spread of infection, but this was not reduced either. Doctors had expressed concerns about the movement of patients, failure to isolate patients with infections, the number of patients on inappropriate wards and the degree of clinical risk. Many senior staff wrote to members of the executive team and were not satisfied with the responses they received.

The infection control team and the health protection unit were concerned when a medical patient with a bowel disease and diarrhoea was transferred to the National Spinal Injuries Centre, against their advice. This patient was subsequently confirmed to have C. difficile. There was no spread to other patients in the centre, but this was a risk that should not have been run, particularly since the consequences of an outbreak in the centre could have been very serious.

Information from nurses, patients and families suggested that shortages of nurses contributed to the spread of infection because they were too rushed to undertake activities such as washing their hands, donning aprons and gloves consistently, emptying commodes promptly and cleaning mattresses and equipment properly.


At the time of the second outbreak, the hospital was finding it very difficult to cope with patients needing admission and nurses were extremely concerned that they could not look after patients properly. The number of nurses on many wards was comparatively low to begin with, they were often moved to other areas, and there was effectively a ban on the use of agency staff.

The head nurses were so worried about standards of care and risk to patients that they ensured their concerns went directly to the chief executive, since they did not have confidence that the director of nursing would take any action. This was because raising these issues with the director of nursing at meetings, and through correspondence and e-mail messages, had not led to change. Our evidence supports their view. Despite the minutes going to the chief executive, the leadership did not act on these concerns. This further contributed to the likelihood of poor infection control and the spread of the infection.

Levels of nursing staff, particularly on ‘escalation’ areas opened to take patients needing admission when the hospital was full, were often inadequate to provide acceptable care and to control infection. Staff were required to work in circumstances that compromised their professional standards. This was a significant failing.

Could the second outbreak have been managed more effectively? The judgement of the Healthcare Commission is that the second outbreak could and should have been managed more effectively.

The infection control team was frequently frustrated by the failure of senior managers to implement the lessons that had been learnt in earlier outbreaks. Our report includes many examples of the advice of the infection control team being overridden, even at the height of the second outbreak.

If greater attention had been given to the advice from their own infection control team and the

local health protection unit in terms of isolating patients, restricting the movement of patients to other wards, and adequately staffing wards, then it is likely that there would have been less extensive spread and fewer cases of infection, and that the outbreak would have been brought under control sooner.

There was a consensus among experts in the control of infection (both externally and internally) that the second outbreak should have been brought under control sooner. Although the number of new patients on any single day was lower than the first outbreak, the total number of cases was similar, the number of deaths was virtually identical and the outbreak lasted longer. We believe that this constituted a significant failing.

The effect of national publicity Once the story appeared in the national media, there was an immediate and obvious change in the priority given by the leadership to controlling the outbreak. This was in stark contrast to the priority given before this time. Daily meetings chaired by the chief executive were introduced and the actions recommended by the infection control team and external experts were implemented. Following the publicity, an information leaflet for patients was produced, based on work by the Health Protection Agency.

Arrangements for the control of infection from our visits The infection control team in Stoke Mandeville Hospital was held in high esteem by clinicians in the hospital and externally. The infection control nurses were not generously funded and had to make worrying decisions about their priorities. There was no redistribution of resources or staff from the team in Wycombe Hospital. The Stoke Mandeville team made giving clinical advice and support on the wards its top priority. This had an impact on the time the nurses were able to devote to training, audit and the development of policy.


Despite the serious nature of the C. difficile outbreaks, training on infection control was still not satisfactory at the time of our visits. A short session was included in the induction course for new staff but infection control was not part of mandatory training for all staff. In any event mandatory training was poorly attended. There was informal training on the wards for staff but no formal training programme. It was often difficult for staff to attend training because of shortage of staff on the wards. Even in September 2005, after two major outbreaks, only a third of staff had received training about hand hygiene.

Each ward had an infection control manual that contained useful information. However, the material in the manuals was poorly organised. Some of the policies and other information were out of date.

At the time of the outbreaks, many of the buildings in Stoke Mandeville Hospital were in a poor state of repair. The general quality of furnishing and décor were poor. Many of the wards did not have sufficient storage, space in utility rooms, or hand basins. These factors made the control of infection particularly difficult. Although there had been improvements since the outbreaks, there were still serious concerns about cleanliness and hygiene. There were still intermittent problems with the collection of dirty linen and clinical waste.

When we visited we observed some areas of potential contamination that were completely unacceptable and practices that created risks of generating and spreading further infection in the hospital. This was despite the fact there had been two major outbreaks. Even when we drew these to the attention of the trust, not all of them were resolved.

There had been an improvement in practice in respect of controlling infection, but it was still not an integral part of the daily routine of all clinical staff.

Although the new hospital buildings should solve many of the environmental problems, these do not include new facilities for the National Spinal Injuries Centre. This is a

concern as the environment in the centre was unsatisfactory in several respects, including dilapidated bathrooms and carpeted walls.

The management of clinical risk at the trust The Healthcare Commission’s conclusion is that the structure established to bring clinical risk to the attention of the board actually obstructed the flow of appropriate information to the board. For example, incidents that had been reported consistently highlighted problems relating to the movement of patients in the hospital, patients being on inappropriate wards, and failure to isolate patients who had infections. Complaints about the same problems were not adequately investigated, so it was unlikely that appropriate improvements would be made. Although many of these issues required consideration and resolution at a strategic level, they were not discussed at the governance committee or by the board. The main purpose of the reporting of incidents had been missed, as weaknesses in the underlying systems and broader strategic issues were not identified and resolved at the highest levels of the trust. This was a significant failing.

There was no mechanism across the trust to follow up any actions required or to share lessons. A risk register was established but it did not refer to risks that should have been recognised at the corporate level, and was not actively managed or reviewed for much of the time under investigation.

The trust did not act as though a key part of its responsibility was the management of risk.


Decisions by the board In the context of the first and second outbreaks of C. difficile, the trust did not appear to act on the principle that risks should be identified and appropriate changes implemented to protect the interests of patients.

For example, in late February 2005 the members of the board, sitting as the finance performance and information committee, heard about the pressures that the hospital was under, but decided to continue to pursue the Government’s target for a maximum wait of four hours in A&E.

There was no evidence of any discussion of the outbreaks by the board in public until after the outbreaks had been reported in the national press. We are unable to determine whether the board genuinely failed to discuss any aspect of such a fundamentally important matter, or whether discussions did in fact take place but that these discussions were not recorded. Either state of affairs however, gives us considerable cause for concern.

Leadership and the priority given to the control of infection. The senior managers had a challenging agenda and had made significant progress in many aspects, but some was at the expense of infection control. We found that the leadership did not give sufficient priority to the control of infection in general and of C. difficile in particular. The director of infection prevention and control did not provide appropriate direction and leadership for the control of infection, as demonstrated by his lack of attendance at key meetings in Stoke Mandeville Hospital during the outbreaks, and his failure to take the 2003/2004 annual reports on infection control to the board.

Our report documents examples where the achievement of targets for admitting patients from A&E was seen as more important than the management of the clinical risk inherent in the C. difficile outbreaks.

In May 2005 the trust closed the ward that was acting as the isolation facility for patients with C. difficile, against the advice given to the director of infection prevention and control by the infection control team and Health Protection Agency. Although there were only four patients involved, this decision was premature.

The executive team was portrayed by staff as being a closely knit inner circle. They described their management style as oppressive and intolerant of failure. We found that it was not an environment in which staff felt confident that the problems they experienced would be addressed, or that they would be supported.

The Healthcare Commission was concerned by the degree of stress shown by many staff in managerial positions, both clinical and non-clinical. Staff were frightened to speak openly. The trust was not an open, learning organisation.

The Healthcare Commission was concerned that the approach of the trust’s leadership to the investigation was defensive. The leadership appeared reluctant to accept that there were short-comings in their response to the second outbreak.

Events since the start of the investigation The fact that there was an outbreak on the ‘receive treat and assess’ unit in December 2005 indicated that there were continuing problems with cleanliness, infection control and levels of staff. However, the handling of the outbreak demonstrated the trust had learned significant lessons since the first outbreak.

Crucial among these were the rapid identification and notification of an outbreak, establishment of a multidisciplinary outbreak committee; regular meetings; rapid institution of recommended changes; and close monitoring of all components of the management of outbreaks including cleanliness, decontamination, the environment


in which patients were cared for, rapid isolation of patients with diarrhoea, antibiotic regimes; and communication with patients, staff and outside agencies. Rapid intervention in the case of this outbreak proved successful.

We note that before and after this third outbreak the background levels of C. difficile had fallen considerably at Stoke Mandeville Hospital.

We were pleased to note in April 2006 that the new building in the hospital provided a much better environment for patients and had many more side rooms. The National Spinal Injuries Centre appeared cleaner and less dilapidated than on previous visits and the trust has said that it intends to refurbish the bathrooms. Generally, staff were paying more attention to hand hygiene and good practice in the control of infection.

Summary The first outbreak was a consequence of a poor environment in which to care for patients, poor practice in the control of infection, lack of isolation facilities and insufficient priority being given to the control of infection by senior managers.

The trust implemented some changes but none that might compromise their strategic objectives and not enough to reduce significantly the likelihood of a further outbreak. They failed to bring the second outbreak under control quickly because they were focused on the reconfiguration of services and the achievement of the Government’s targets. It took the involvement of the Department of Health and, more particularly, national publicity to change their perspective on the importance of controlling infectious conditions. We noted that the outbreak in December 2005 was brought rapidly under control.

Although we were pleased during our visit in April 2006 to note improvements to the environment and to practice in the control of

infection, we were not convinced that other aspects of the safety of patients had sufficient priority, even while our investigation was in progress.

The roles of external organisations The creation of the Health Protection Agency in 2003 led to some confusion over the respective roles of the Health Protection Agency and strategic health authorities in the control of infection, and particularly the oversight of the management of outbreaks in acute trusts.

Consultants in communicable disease control, who are experts in the control of infection, originally worked in health authorities and then primary care trusts. They subsequently moved to the local health protection units of the Health Protection Agency. Many had a long history of working closely with their colleagues in the control of infection in acute trusts.

The local Thames Valley health protection unit saw its role as largely advisory and supportive, and the infection control team at the trust valued this support. The nurse consultant in health protection saw herself as part of the infection control team and gave advice within the team. The health protection unit did not see itself as having a role in criticising and managing the performance of trusts who failed to follow its advice. The clinical director of the health protection unit raised concerns with the strategic health authority in April but, although the director of the unit was of the view that the senior managers at the trust did not give sufficient priority to controlling the outbreak of C. difficile, she did not raise any formal concerns with the Department of Health until May 2005, when the isolation ward was closed against advice.

The strategic health authority focused its efforts on ensuring that trusts delivered the top national priorities. Reducing healthcareacquired infection as a consequence of MRSA was one such priority, but control and prevention of infection with C. difficile was not.


The strategic health authority did not take any action after the first outbreak of C. difficile at the trust. Although the medical director at the strategic health authority was aware of the second outbreak in April 2005, the senior nurse at the strategic health authority with responsibility for the control of infection did not learn about it until the middle of following month. The strategic health authority did not intervene in the handling of this outbreak until asked to do so by the Health Protection Agency.

The strategic health authority believed that strategic health authorities generally did not have the resource or expertise to monitor closely how individual trusts managed outbreaks of infectious diseases. In Thames Valley Strategic Health Authority, the medical director assumed that the Health Protection Agency would advise him of any concerns. The draft memorandum of understanding did not provide sufficient clarity on roles and joint working.

The Healthcare Commission concludes that there was no clarity as to which body had the major responsibility to assess the implications of new strains of bacteria and other microorganisms and to disseminate the information to ensure that bodies such as strategic health authorities and trusts were informed of these threats. We would consider that this role should be led by the Health Protection Agency.

We also judge that, despite enduring national concerns over MRSA, there are still shortcomings in the structure and system to support and monitor the way in which trusts approach the control of infection, or manage significant outbreaks more broadly. This includes continuing confusion over the definition of outbreaks and the arrangements to report them.

The national picture and lessons for the NHS The background to this investigation is mounting evidence of an increase in the incidence of C. difficile infection in many

countries. It is a concern that many trusts do not report outbreaks and one of the obstacles is the difficulty of agreeing a clear definition of what constitutes a C. difficile outbreak.

Crucial among the lessons identified in handling outbreaks are the need for:

• rapid isolation of patients with diarrhoea

• restricting the movement of infected patients between wards

• rapid identification and notification of outbreaks

• establishment of a multidisciplinary outbreak committee which meets regularly

• rapid institution of recommended changes

• close monitoring of all components of the management of outbreaks including cleanliness, decontamination, the environment for patients, antibiotic regimes

• communication with patients, staff and outside agencies

To this the Healthcare Commission would add: ensuring that control of infection is given very high priority by trusts’ boards and senior managers.

There also needs to be clarification of the roles of external organisations, including the role of health protection units in both supporting trusts and alerting others of problems.

There is much in this report to suggest that there may be continuing tensions between the control of infection in hospitals and other national priorities. Whereas the trust had a particularly strong focus on the achievement of the Government’s targets, there is no doubt that the potential conflict between these targets and the control of infection is an issue that faces all acute trusts. This observation is in line with previous publications including the report of the National Audit Office (NAO) in 2000, The management and control of hospital acquired infections in NHS acute trusts in England, which was critical of the low level of priority given to the control of infection in the NHS.


The report from the NAO in July 2004 Improving patient care by reducing the risk of hospital acquired infection, which followed up the earlier report, indicated that there had been notable progress in putting systems in place at trust level, but that the prevention of infections continued to be adversely affected by the pursuit of other priorities.

In April 2005, the Public Accounts Committee examined progress in reducing the risks of hospital acquired infection. The committee’s report noted that compliance with good infection control such as hand hygiene was still patchy. It found that there were conflicts with other key targets and priorities and that these had continued to stand in the way of improving prevention and control.

The Healthcare Commission’s survey in 2005, conducted jointly with the Health Protection Agency, found that nearly 40% of trusts did not isolate cases of C. difficile routinely and only 11% had a ward that could be used for isolating patients with C. difficile.

A key lesson from this investigation is the importance of the rapid isolation of patients and of not moving patients with infections to other areas, which increases the likelihood of further contamination, unless their movement is vital for other clinical reasons.

In this investigation we found that the problems created for those attempting to reduce the incidence of hospital acquired infection was not just that the time and effort of managers were devoted to other priorities, but that the approach to achieving those other priorities can itself compromise the control of infection.

At Stoke Mandeville Hospital, the increased throughput of patients needed to meet performance targets resulted in patients being moved, difficulties in isolating patients with infection and high occupancy of beds. Financial pressures meant less flexibility in the system and in many cases, inadequate levels of staff.

The lack of suitable isolation facilities at Stoke Mandeville Hospital was exacerbated by

changes to wards such as ‘ring-fencing’ surgical beds in order to deliver Government’s targets. There had been an increase in the frequency of patients being moved that increased the risk of infections being transmitted. Higher occupancy of beds meant that there was less time for thorough cleaning. In general, the cleaning services were not of consistently high quality.

Another key lesson for the NHS is that hospitals need to be meticulous about cleanliness, hygiene and good practice in the control of infection.

There was insufficient focus on training on infection control and there were some concerns about the quality of basic nursing care. The levels of staff made it particularly difficult for nurses to find the time to practise control of infection effectively. They were constrained in their ability to practise good hand hygiene, answer call bells and empty commodes promptly, clean mattresses thoroughly, use new or cleaned equipment for each patient, wake patients to give them their antibiotics, complete fluid balance charts or supervise confused patients who wandered in and out of isolation areas.

Our report considers that many of the operational problems described above arose out of the need to juggle a number of ‘must do’ objectives including the control of finance, reconfiguration of services, and targets for access times, in particular the admission of patients from A&E.

It is the role of every NHS trust board to balance competing priorities and take difficult decisions. To do this the board must ensure that it has systems of governance and structures for accountability to support it in its role in understanding and managing risk and protecting patients. Where the executive team is focused on day-to-day operational issues, the non-executive directors have a duty to bring a balanced judgement to all the issues and choices faced by the organisation. They can only contribute effectively if they are sufficiently well informed


and prepared to challenge other perspectives. Crucial to this is the participation of non-executives in the audit or risk management committees of the trust where they should monitor and oversee systems and processes for internal control and risk management.

It is also essential that the full board should be made aware of major issues affecting the safety of patients and give them due consideration. It is hard to identify an issue that would better justify such consideration than both of the major outbreaks of C. difficile infection at Stoke Mandeville Hospital.

It is our judgement that the approach taken by this trust compromised the control of infection and hence the safety of patients. This was a significant failing. We would re-iterate to NHS boards and advisory organisations such as the Health Protection Agency, that the safety of patients is not to be compromised in any circumstances.

This is particularly important given the mounting evidence that the incidence of infection with C. difficile has increased substantially during the last decade, the possibility that it increasingly affects people previously considered at lower risk, and the likelihood that its severity has increased.


Recommendations

The Healthcare Commission expects the trust to consider all aspects of this report. Here, we highlight areas where action is particularly important.

The Healthcare Commission considers the findings of this investigation to be extremely grave and that the trust has failed to protect the interests of patients, particularly in their management of the second outbreak of C. difficile. In the light of this significant failing we recommend that the leadership of the trust must change. Other key recommendations are detailed below.

Action by managers to control the risk of infection 1 The trust needs to ensure acceptable

standards of cleanliness throughout its hospitals and resolve permanently the problem of uncollected clinical waste and dirty linen.

2 The trust needs to assess and continually improve practice in respect of controlling infection and ensure that it is an integral part of the daily routine of all clinical staff. The responsibility for this should be in the job descriptions of all relevant managers, including ward managers, rather than being seen primarily as the role of the infection control team.

3 The trust should make training in the control and prevention of infection mandatory for clinical staff and ensure that there are adequate resources to provide that training.

Standards of care 4 In the clinical management of patients with

C. difficile, greater attention must be given to ensuring that patients do not become

dehydrated and that good records are kept of their intake and loss of fluid.

5 Within 60 days of publishing this report the criteria for transfer between wards should be reviewed to ensure that clinical advice is taken fully into account and that acutely ill patients are not placed on inappropriate wards without adequate medical and nursing support.

6 The trust must ensure it is treating all patients with dignity and respect and pay particular attention to providing single-sex accommodation.

7 The trust must review, and where necessary improve, the standard of documenting and implementing decisions about clinical management.

Staffing 8 The trust must work with the strategic

health authority and PCT to agree appropriate levels of nursing staff and then ensure that the trust has sufficient nurses to provide acceptable and safe care, including on escalation (overflow) areas. Within 60 days of publishing this report, the trust needs to develop and publish criteria for the opening of escalation areas. Adherence to these criteria must be audited and reported to the board.

Clinical governance and the management of risk 9 Within 60 days of the publication of this

report, the trust must review its arrangements for governance to ensure that the board is aware of clinical risks and that consideration of risk is an integral part of all major decisions. The views of clinical staff


and particularly any concerns about the safety of patients must be heard at the level of the board.

10 Control of infection needs to be an integral part and focal concern of clinical governance and, with this in mind, the role of the director of infection prevention and control must be reviewed. The post holder must have relevant experience and competency, as set out in the Department of Health’s publication, Winning Ways.

11 The trust needs to ensure that the safety of patients is not compromised in the pursuit of other strategic objectives. In this judgement, the board and senior managers need to give sufficient importance to the control of infection and the advice of the director of infection prevention and control.

12 The trust must improve the arrangements to manage risk, ensuring that:

• structures and lines of accountability are clear

• there is analysis of the risks raised by clinical incidents which is drawn to the attention of the board

• the board undergoes training in the management of risk

• the board plays a stronger role in examining and, if necessary, challenging assessments by trust managers

• the risk register contains the key clinical risks and is used to inform decisions about investment

• a system is in place to ensure that lessons from incidents are learnt across the trust

13 The trust must have an effective process to assess the risk of failing to isolate patients with diagnosed or suspected transmissible infections and ensure the appropriate isolation of patients who pose a potential or actual high risk of infection to others. This process must involve the infection control team.

Handling and learning from complaints 14 The trust needs to improve its systems to

ensure that appropriate action is taken in response to complaints. In particular it should ensure that:

• complaints are investigated in an objective manner

• complaints are analysed, themes identified, links made to claims and incidents, and audit triggered where appropriate

• where appropriate, action is taken if staff are found to have provided poor care

• the board fully considers the recommendations of external reviews and follows their recommendations unless there are compelling reasons not to. When not complying, the principles involved should be considered in a full and public meeting of the board

• action plans are generated in response to serious complaints, and then implemented and monitored

• lessons are disseminated across the trust

For those recommendations above that are to be completed within 60 days, the Healthcare Commission will assess the situation within 90 days of publication, to ensure compliance.

National recommendations 15 The NHS and the Health Protection Agency

need to work together to ensure that there is clarity about their respective roles and responsibilities, in relation to the management of outbreaks of communicable diseases in acute trusts. This work should include a review of the definition of outbreaks and of arrangements to report them. The development of operational protocols and clear channels of communication may be helpful.

16 The Health Protection Agency should ensure that the system for disseminating relevant information to the NHS about the emergence of new strains of micro


organisms is robust. This will require collaboration with the reference laboratories and the NHS.

17 The Health Protection Agency should ensure that it provides regular, up-to-date advice to health professionals, in an electronic form, on the management of C. difficile.

18 In the light of the recently reported increase in cases of C. difficile and associated deaths, and the findings from the Healthcare Commission’s and HPA’s survey that 40% of trusts are not isolating patients with C. difficile, the Department of Health should re-emphasise to all trusts, including those responsible for commissioning, the importance of controlling this infection.

19 The Department of Health should re-emphasise to NHS managers and non-executive directors that assuring the safety of patients is a responsibility that cannot be compromised.


Appendix A: Healthcare Commission’s criteriafor an NHS investigation

The Healthcare Commission works to improve the quality of healthcare provided by the NHS and the independent (private and voluntary) sector. One of its functions is to investigate serious failures in NHS services.

What will the Healthcare Commission investigate? The Healthcare Commission will investigate allegations of serious failings that have a negative impact on the safety of patients, clinical effectiveness or responsiveness to patients. This may include:

• a higher number than anticipated, or unexplained, deaths, serious injury or permanent harm, whether physical, psychological or emotional

• events that put at risk public confidence in the healthcare provided, or in the NHS more generally

• a pattern of adverse effects or other evidence of high risk activity

• a pattern of failures in service(s) or team(s) or concerns about these

• allegations of abuse, neglect or discrimination against patients

Other failings with less serious effects on patients’ safety may be subject to a review. In determining whether to investigate, the Healthcare Commission will consider the extent to which local resolution, referral to an alternative body, or other action might offer a more effective solution.

The Healthcare Commission does not investigate:

• a complaint that has not been pursued through the NHS complaints procedure or the Healthcare Commission’s independent stage, unless it raises an immediate concern

• individual complaints about professional misconduct

• changes to service configurations

• matters being considered by legal process

• specific matters already determined by legal process

This does not preclude the Healthcare Commission from investigating circumstances surrounding such matters, particularly if there are general concerns about patient safety or suggestions that organisational systems are flawed.


Appendix B: The investigation team

Dr Heather Wood Investigation Manager Healthcare Commission

Dr John Gray Consultant Microbiologist University Hospital of North Staffordshire NHS Trust

Mr Alan Turner Retired Medical Director Peterborough and Stamford Hospitals NHS Foundation Trust

Mr Mark Taylor Retired Chief Executive Royal Brompton and Harefield NHS Trust

Christine Perry Nurse Consultant and Director of Infection Prevention and Control United Bristol Healthcare NHS Trust

Judy Worthington Vice Chair University of Leicester Hospitals NHS Trust

Phillipa Marszall Senior Analyst Healthcare Commission

Abigail Knight Investigation Coordinator Healthcare Commission

David Harvey Team Leader, investigation analyst team Healthcare Commission

Paula Palmer Investigation Officer Healthcare Commission

Benjamin Young Analyst Healthcare Commission

Expert advice on C. dificile was sought from:

Professor Mark Wilcox Consultant/Clinical Director of Microbiology,Director of Infection Prevention and Control,Reader in Medical MicrobiologyThe Leeds Teaching Hospitals NHS Trust,University of Leeds


Appendix C: Interviews

The investigation team conducted a total of 207 interviews. 170 interviews involved 163 former or current trust staff (some people were interviewed more than once). 49 stakeholders (members of the public or members of external organisations associated with the trust) were interviewed over 37 interviews, as some were

seen in small groups. Four people were seen or interviewed more than once. They were interviewed face to face or by telephone either as a result of contacting the investigation team or in response to an invitation from the investigation team. The following shows a breakdown of those interviewed:

Chief executive and executive/associate directors, including associate medical and nursing directors 14

Chairman and non-executive directors 6

General managers 5

Non-clinical senior and middle managers 14

Clinical directors and deputy clinical directors 7

Microbiologists 5

Infection control nurses 5

Head nurses 9

Consultants 14

Junior and other doctors 6

Ward nurses and health care assistants 48

Pharmacy staff 2

Staff side and union representatives 4

Allied health professionals 4

Coordinators/administrative staff 10

Domestic staff and housekeepers 7

Portering staff 2

Trust staff and former trust staff interviewed


Patients and relatives 11

Department of Health 2

Thames Valley Strategic Health Authority 5

Wycombe Primary Care Trust 5

Vale of Aylesbury Primary Care Trust 4

Health Protection Agency 4

Royal College of Nursing 3

Anaerobe Reference Unit 1

NHS Professionals 3

National Patient Safety Agency 1

Voluntary organisations 3

Local government 5

Auditors 1

Stakeholders interviewed


Appendix D: Sources of information

• interviews and correspondence with patients, relatives and carers

• interviews and correspondence with past and present trust staff

• interviews with organisations in the health community, including local PCT’s, Thames Valley Strategic Health Authority and the Health Protection Unit

• interviews and information provided by the Health Protection Agency, the Anaerobe Reference Laboratory, the Royal College of Nursing and NHS Professionals

• interviews and information from the Department of Health

• interviews and correspondence with MPs

• interviews with external stakeholders such as the overview and scrutiny committee and the Brain Rehabilitation Trust

• observations on the wards

• selection of case notes of patients who contracted or died with C. difficile

• minutes of trust meetings, including meetings of the trust board, the clinical governance committee, the risk management committee, the clinical risk review panel, the finance, performance and information committee, the trust’s executive committee, the trust management board, the head nurses meeting, the older people’s directorate meetings, as well as minutes of the infection control directorate meetings, including the outbreak committee, daily C. difficile meetings and the community-wide infection control meetings

• relevant trust policies and procedures with particular reference to infection control and the management of C. difficile, including policies on isolation, escalation, bed management and ward transfers

• the trust’s annual reports 2003/2004 and 2004/2005

• information from the Thames Valley Strategic Health Authority and local PCT’s

• commission for Health Improvement clinical governance reviews into South Buckinghamshire Hospitals NHS Trust, November 2002, and Stoke Mandeville Hospital NHS Trust, December 2002

• information on relevant complaints, including reports by independent review panels

• information on relevant incidents (including reports of serious untoward incidents)

• clinical governance documentation, such as the risk register

• self assessments, audits and position statements by the trust

• analysis by the acute hospital portfolio team at the Healthcare Commission

• findings from the Healthcare Commission’s 2004 and 2005 national surveys of inpatients and staff in the NHS

• routine and bespoke information provided by the trust

• documentation and correspondence provided by the trust relating to staffing numbers, use of bank and agency staff, appraisal, induction, mandatory training and sickness levels


• information for patients, for example, leaflets

• National Service Framework for Older People and the Healthcare Commission’s review of progress against it

• analysis of trust data on bed moves, medical outliers and occupancy figures

• the Healthcare Commission’s analysis of hospital episode statistics from 2003 to 2005

• reports of visits by Department of Health representatives, May – June 2005, and Health Protection Agency representatives, May 2005

• reports and information on Shaping Health Services

• reports and information on the Private Finance Initiative

• patient environment action team 2004 report and patient environment action team 2005 information

• correspondence, including emails, relating to clinicians’ concerns

• leavers survey January-March 2003

• auditors reports 2003/2004 and 2004/2005 from KPMG

• C. difficile outbreak reports February-June 2004, December 2004-May 2005, November-December 2005

• report on research visit to Montreal, June 2005

• audits, guidance and information relating to antimicrobial prescribing

• analysis of trust data on death certificates and mortality figures

• infection control annual reports 2003/2004 and 2004/2005

• documents and guidance relating to domestic services and training

• documents and information relating to decontamination

• documents and information relating to planned preventative maintenance

• environmental audits 2003-2005

• infection control action plan for SHA 2004/2005

• summary and information from laboratories, including a summary of C. difficile positives and care programme approach reports

• spreadsheet provided by trust of anonymised patient with C. difficile acquired at Stoke Mandeville Hospital

• clinical negligence scheme for trusts and risk pooling scheme for trusts reports 2004 and sections of the clinical negligence scheme for trusts report 2006

• national Spinal Injuries Centre annual report 2004/2005

• information and correspondence relating to Royal College of Nursing grievance

• analysis of the Healthcare Commission’s and Health Protection Agency’s joint C. difficile survey, December 2005

Where appropriate, we also took account of the absence of relevant information and the trust’s inability to provide us with information or evidence in particular areas.


Appendix E: Other work being undertaken by the Healthcare Commission on healthcare aquired infections The Healthcare Commission is undertaking a national study on healthcare acquired infections. This will be the second part of the response to a request by the Chief Medical Officer that the Healthcare Commission carries out a review of hospital cleanliness and infection control. The first part of the response was covered in the Snapshot of hospital cleanliness in England report that was published in December 2005.

In April 2006 a comprehensive questionnaire was sent to all acute trusts in England probing the various processes that trusts have put in place relating to the prevention and control of infection. The answers provided by trusts are being analysed alongside their infection outcomes to investigate what combination of factors may help drive improvement. A national report is scheduled for publication later in 2006.

The conclusions of the study will also inform the development of the Healthcare Commission's framework to assess healthcare organisations compliance with the hygiene code of practice, which is part of the Health Bill currently passing through Parliament. In addition, it is anticipated that the national study will contribute to the Department of Health’s Improvement Programme on healthcare acquired infections and its guidance to trusts on how to prioritise resources in order to meet the new national target to halve the number of MRSA bacteraemias by March 2008.


Appendix F: Clostridium difficile deaths

Methodology The microbiology department at Stoke Mandeville Hospital has kept a database of patients with C. difficile who died. Medical and clinical notes have been studied as well as post mortem reports in order to glean information about the patients symptoms, diagnoses and treatment. An assessment has been made for each patient to classify the contribution of C. difficile to the death of the patient as either:

• definite

• probable

• possible

• unlikely

• none

C. difficile was thought not to have been acquired in the hospital if the patient showed symptoms of having the infection within 72 hours of being admitted.

Table 1 overleaf shows the number of patients who were thought to have acquired C. difficile in the hospital for each of the months from April 2003 to March 2006. Numbers of patients who died each month are also shown as well as the results of the assessment of the contribution of the infection to death, as detailed above.


Table 1: Number of C. difficile deaths

Apr-03 7 9 0 1 1 4 2 1 May-03 10 2 1 1 1 (1) Jun-03 17 5 1 3 (1) 2 Jul-03 17 4 2 1 (2) 2 1

Number of Number of C. difficile deaths,

C. difficile deaths, NOT SMH e

ed SMH acquirNumber of acquired

ee l yt b l li b ea e

C. difficile (by month (by month n i ki b s if o s l n

cases of onset) of onset)

e r o n o

D P P U N

Aug-03 20 4 1 1 2 1 (1) Sep-03 9 0 1 (1) Oct-03 17 1 0 1 Nov-03 16 0 0 Dec-03 25 2 4 1 (1) 1 (2) (1) Jan-04 20 3 3 2 (1) (1) 1 (1) Feb-04 26 4 1 1 2 1 (1) Mar-04 35 5 1 2 (1) 2 1 Apr-04 16 3 1 1 2 (1) May-04 12 1 1 1 (1) Jun-04 7 3 1 1 1 (1) 1 Jul-04 17 3 0 2 1 Aug-04 9 3 2 1 (1) 1 (1) 1 Sep-04 13 4 0 1 2 1 Oct-04 8 2 1 1 1 (1) Nov-04 8 4 2 1 1 1 (1) 1 (1) Dec-04 19 8 1 1 2 3 2 (1) Jan-05 24 9 3 1 2 2 (1) 2 (1) 2 (1) Feb-05 28 9 2 2 2 (1) 1 (1) 4 Mar-05 25 5 3 1 2 (1) (2) 2 Apr-05 20 7 3 4 (1) 1 (1) 1 (1) 1 May-05 19 7 1 1 2 (1) 2 2 Jun-05 9 0 0 Jul-05 6 1 0 1 Aug-05 4 2 1 (1) 1 1 Sep-05 1 0 1 (1) Oct-05 3 2 4 1 (2) (1) 1 (1) Nov-05 8 5 0 1 2 2 Dec-05 12 7 0 1 1 3 2 Jan-06 5 2 1 1 (1) 1 Feb-06 2 1 0 1 Mar-06 4 0 2 (2)

TOTAL 498 127 45 23 (5) 18 (3) 24 (18) 35 (10) 27 (9)

Classification of contribution of C. difficile to death, Stoke Mandeville Hospital acquired, (numbers in brackets are for cases NOT acquired at Stoke Mandeville Hospital)


Appendix G: Letter of January 5th 2006 sent to the trust regarding observations

By e-mail and post Private and confidential

Ruth Harrison, Chief Executive

Buckingham Hospitals NHS Trust Amersham Hospital

Whieldon Street Amersham

Buckinghamshire HP7 0JD

5th January 2006

Dear Ruth,

Re: Healthcare Commission investigation – Concerns identified during observations at the trust.

As you know, our visits have involved observations by the clinicians on our team on a number of wards in the trust. I know that you have been keen to have feedback, and we have already raised a couple of specific concerns with Maureen Davies.

We have now collated information from the observations we have conducted to date and there are a number of issues which we consider pose a significant risk of infection. I am writing to draw your attention to these in the attached summary, and to ask that action is taken to reduce the risk.

Clearly we would like an assurance that this will be forthcoming.

Yours sincerely

Dr Heather Wood

Investigation Manager


Introduction During site visits at both Stoke Mandeville and Wycombe Hospitals observations of care and practice on wards was undertaken by various members of the investigation team. Whilst in a number of areas the environment and cleanliness could be improved, this report highlights only those practices considered to pose a significant risk of infection.

Stoke Mandeville Hospital

General findings • checks of washer/disinfectors were not

being consistently carried out daily

• toilet rolls were not located in closed dispensers and were often contaminated

• there was evidence of faecal matter on several commodes inspected

St George’s Ward • many of the shower chairs were mouldy. In

particular a red shower seat was in a disgusting condition

• there were numerous rolls of toilet paper open and not in holders. Several of these appeared to be dirty

• an occupational therapist was observed to walk around the ward wearing the same gloves and apron. At one point she had contact with an MRSA patient and then did not remove them before continuing her work

• a nurse was observed to walk out of the MRSA bay whilst continuing to wear gloves and aprons

• a hoist was used in the MRSA bay and then returned to general use without it being decontaminated

• a locker at an empty bed space was dusty and the bed still had urine bag leg straps tied around the foot plate

• a staff nurse was observed to come out from behind curtains of one patient and then assist with the care of another patient without hand hygiene or changing gloves and apron

• pillows were observed to be on the floor at the bottom of one patient’s bed and these were then picked up and returned to use without changing of the pillowcases being observed

• on completion of a bed bath, a nurse was noted to put dirty towel and gloves on the floor

St Patrick’s Ward • the washer-disinfector in the sluice was not

being checked daily

• a nurse was observed to handle a dirty laundry bag and then leave the sluice without removing gloves and apron or washing hands

• one of the baths was severely damaged

• there were pubic hairs in the base of the bath

• twice daily cleaning check lists for some isolated patients were not being completed

St Andrew’s ward • a member of medical staff was noted to be in

the MRSA bay without wearing gloves and aprons. This member of medical staff then also had direct contact with two other patients and did not decontaminate his hands

Ward 22 • a phlebotomist was observed to be wearing

the same glove for more than one patient, although she did put alcohol on her hand and glove before moving from patient to patient

Ward 9 • the sinks on this ward are not well located

and the water flow is very poor. One of the hand washing sinks was blocked during a visit


• a phlebotomist was observed to be wearing one glove when taking blood from a patient and then moving to other patients still wearing the same glove. She was also observed to contaminate lots of inanimate objects in the environment with this glove

• the sharps bin used by the phlebotomist was contaminated on the outside with blood

Ward 10 • a nurse was observed to carry linen through

the ward to discard into a linen bag on a number of occasions

• the clinical waste bin lid in the sluice touches paper towels when raised leading to contamination

• a member of staff was observed to leave the bay housing MRSA patients without performing hand hygiene

• the lower end of the ward was a cohort bay but there was no sign to indicate this

• there was patient laundry soaking in a bowl in the sluice

Ward 12 • a reusable slipper bedpan was in use,

despite the ward having a macerator, therefore there is no adequate way to clean and disinfect this piece of equipment

Emergency Medical Unit • a nurse was observed to use a domestic

waste bin lid as a surface on which to place a tray of drugs before taking these to the patient to administer

• a discontinued intravenous infusion was left hanging over a drip stand

• another infusion line was draped over a drip stand with a removed venflon cannula still attached posing a risk from blood contamination

Ward 3X • one of the toilet rolls on a commode was

visibly soiled with faeces

Ward 8 • the bed on the right hand side as you enter

the ward blocks access to the only hand wash basin in this part of the ward. From a number of observations it was evident that this basin is inaccessible when the curtains are closed around the bed. Serious consideration should be given to taking this bed out of use

Ward 20 • a nurse was observed to wear one apron and

go to three different patients with the same apron on. It is also possible that the nurse did not wash hands before leaving an isolation room due to the time that was spent in there and no evidence of hearing water running

• despite infection control advice to use a chlorine based disinfectant for commode cleaning during the latest outbreak, a nurse was observed to bring a commode in, look at the tub of Chlor-clean tablets and then proceed to clean the commode with alcohol wipes

Eye Ward • the bed spacing in the male and female bays

is extremely close and the only hand wash basin in this area is behind the curtain of bed eight; therefore, if the curtains were pulled around it would not be possible for staff to access the hand washing facilities

Pre-admission Unit • there are three hand wash basins in the area

but two of the basins are behind curtains; therefore, if curtains are pulled around it would not be possible to access them

• patient wipes were located on top of a domestic waste bin


• a nurse who was attending to patients was observed to be wearing very obvious nail varnish

Wycombe Hospital

General findings • checks of washer/disinfectors were not

being consistently carried out daily

Stroke Unit • apron dispensers are positioned so they are

touching waste bins leading to potential contamination

• the sluice does not have a dedicated hand wash basin

Medical Admission Unit • all the single rooms were in use, therefore,

one patient was being ‘isolated’ in a bay. There did not appear to be a ‘buffer’ bed in use as recommended in the Trust’s infection control procedures

• in one of the single rooms a nurse was observed to drop linen on the floor, pick this up and put it back on the bed to use later

Ward 12A • curtains were draped across the clinical

waste bin, potentially contaminating them

Ward 3A • the only hand wash basin in the female bay

was completely blocked by a bed adjacent to it and the door being open

• two patients that were in isolation had no isolation signs on their beds

Ward 4A • plastic apron holders were situated at a very

low level above a domestic waste bin. These were actually touching the lift lid of the domestic waste bin leading to risk of contamination


Appendix H: Photographs of sluices

These photographs show the obstruction caused by bags of uncollected linen, clinical and other waste in utility rooms.


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