HSE publishes investigation report into outbreaks of Clostridium Difficile at Stoke Mandeville Hospital

E043:07 15 November 2007

The Health and Safety Executive (HSE) is today publishing a report on its investigation into two outbreaks of Clostridium difficile (C. difficile) at Stoke Mandeville Hospital between 1 October 2003 and 30 June 2005.

Launching the report Sandra Caldwell, HSE Director of Field Operations, said:

" On the basis of the evidence available, HSE did not find sufficient admissible evidence to be able to bring criminal proceedings against the Trust, alleging a link between management failures and particular deaths. We did find some breaches relating to the requirements to keep documents. However, as these were not directly linked to any of the deaths and were of a relatively minor nature, HSE 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."

" The HSE investigation did reveal a number of areas where more should have been done. These recommendations have since been implemented by the Trust but are included as key learning points to ensure a robust approach to the prevention and control of C. difficile

" Of particular concern to HSE was the fact that the Trust did not have a contingency plan to help managers respond to any outbreak. The consequence 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."

The evidence HSE 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 any alleged breach .

Notes to editors

1. HSE became involved in July 2006 after the Healthcare Commission (HC) published a report into two outbreaks of Clostridium difficile infection at the 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.
2. 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. HSE found that infection control procedures and supporting governance arrangements were to a satisfactory standard.
3. 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. HSE's investigation concentrated 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. It was not the role of the investigation to consider evidence relating to clinical judgements about how individual patients were treated, nor whether the NHS could have expected more of the Trust and its managers, as these issues were considered at length in the HC report .
4. 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.
5. Further information on the Work Related Deaths Protocol can be found at http://www.hse.gov.uk/enforce/enforcementguide/wrdeaths/investigation.htm
6. Further information on HSE's work with the Health Services can be found at http://www.hse.gov.uk/healthservices/index.htm

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