Foreword

In July 2006, the Healthcare Commission (HC) published a report into two outbreaks of Clostridium difficile infection at Stoke Mandeville hospital, part of the Buckinghamshire Hospitals NHS Trust. The HC reported that 334 patients were infected and 33 had died of C difficile infections acquired within the hospital. HC concluded that the hospital’s management had made serious mistakes in their handling of the outbreaks and that the standards at Stoke Mandeville had fallen significantly below those expected within the NHS. HC made a number of recommendations to improve infection control and patient care at the hospital.

In view of the issues raised in the HC’s report and the possibility that serious criminal offences had been committed at Stoke Mandeville hospital, HSE invited Thames Valley Police and the Crown Prosecution Service to consider the HC report under the terms of the Work-Related Deaths Protocol. Following meetings with the HC and HSE, the police and CPS concluded that: the report did not contain sufficient evidence of a causal link between the actions of any individual and the deaths of the patients involved; and therefore, a police-led investigation on the grounds of possible manslaughter should not be initiated. They did, however, make it clear that they would reconsider this matter further should additional evidence be uncovered. Consequently, HSE undertook an investigation to examine the extent to which the deaths due to C difficile at Stoke Mandeville could be linked to health and safety offences. In investigating these matters our review of the evidence has not revealed any matters requiring the re-involvement of Thames Valley Police.

Before investigating the outbreaks, HSE inspectors checked the trust’s (then) current level of compliance with health and safety law in relation to infection control and whether they had responded to the recommendations made to them by the HC. We found that infection control procedures and supporting governance arrangements were to a satisfactory standard as detailed in the Annex to this report.

This report concentrates on the extent to which the trust and its managers discharged their legal duties under health and safety legislation, prior to and during the outbreaks and whether anyone should be held to account before a criminal court as required by the Health and Safety Commission’s Enforcement Policy Statement. It does not consider evidence relating to clinical judgements about how individual patients were treated, or whether the NHS could have expected more of the trust and its managers as these issues were considered at length in the HC report.

The evidence we obtained was reviewed against the standard laid out in the Code for Crown Prosecutors, which requires that in order for HSE to prosecute for alleged health and safety offences there must be a realistic prospect of securing a conviction on each alleged breach. This included consideration of issues such as the applicability of qualifications such as reasonable practicability and the admissibility of evidence in a criminal court.

We concluded, on the basis of the evidence available in support of a prosecution and that pointing against, that there was not a realistic prospect of securing conviction on any charge where it could be alleged that the breach caused those deaths resulting from C difficile infection. Some purely regulatory breaches relating to the requirements to keep documents were found. However, we considered that as these were not directly linked to any of the deaths and were of a relatively minor nature they would not lead to more than a nominal penalty. We have therefore decided that it would not be in the public interest to bring legal proceedings against the trust and its managers in relation to these matters.

That said, the HSE investigation revealed a number of areas where more should have been done. For the most part these matters are addressed in detail in the HC report. HSE's key recommendations are made at the end of this report. Of particular concern to us was the fact that the trust did not have a contingency plan to help managers to respond to any outbreak. The consequence of this was that throughout the two C difficile outbreaks, managers were constantly having to respond to events rather than being able to implement and follow well thought -out solutions to foreseeable circumstances.

Sandra Caldwell,
Director of Field Operations,
HSE

• Full investigation report [164KB]