The Scottish Government's Response to the Vale of Leven Hospital Inquiry Report

Chapter 1 Introduction

1.1 The Inquiry

On 21 August 2009, the Rt Hon Lord MacLean was appointed by the then Cabinet Secretary for Health and Wellbeing to hold a public inquiry into the occurrence of Clostridium difficile (C. diff) infection at the Vale of Leven Hospital (VOLH) from 1 January 2007 onwards, in particular between 1 December 2007 and 1 June 2008, and to investigate the deaths associated with that infection.

• The Terms of Reference for the Inquiry were wide-ranging and included investigation of:
• the circumstances contributing to the occurrence and rates of C. diff infection at the VOLH
• management of, and clinical responses to, C. diff rates at the hospital
• systems in place at hospital and NHS board levels to identify and respond to increased rates of outbreaks and deaths associated with C. diff infection, including action taken to inform patients, relatives and the public
• governance arrangements in NHS Greater Glasgow & Clyde and the priority given to the prevention and control of the infection
• lessons to be learned.

1.2 The report

The Vale of Leven Hospital Inquiry Report (hereafter referred to as "the report") was published on 24 November 2014, presenting 75 recommendations (the recommendations and where they are reflected in this Scottish Government response are shown in Appendix 1).

The report and its recommendations are based on the Inquiry Team's extensive scrutiny of collected documents, written statements and oral hearings with witnesses, and testimony from experts engaged to assist the Inquiry. Lessons to be learned feature throughout the report and are reflected in the recommendations.

C. diff infection can be very serious, even fatal, particularly in older people or those who are frail. It is also a distressing illness with deeply unpleasant and humiliating symptoms that impact not only on affected people's physical health and mental wellbeing, but also their sense of dignity. It requires skilled nursing and medical care to ensure patients with C. diff are cared for and treated appropriately and that they, their families, the public and healthcare workers are protected from spread of infection.

Tragically, the report identifies serious shortcomings at the VOLH that put infected patients in great jeopardy and unnecessarily exposed others to the risk of cross-infection. The failings in care were compounded by inadequate structures and scrutiny systems at national and NHS board levels, unclear responsibilities and reporting lines, and a lack of effective management and leadership.

The report identifies 34 deaths in the period from 1 January 2007 to 31 December 2008 in which C. diff infection was implicated, but this is likely to be an under-estimate as medical records were not available to the Inquiry Team for all patients during this period. Each of these deaths is a personal tragedy for the victims and their families.

Among the report's many findings, it identifies:

• governance and management failures that resulted in an environment in which patient care was compromised
• significant deficiencies in infection prevention and control practices and systems, with no national inspection regime in place
• deficiencies in prudent antibiotic prescribing practices and scrutiny
• a physical environment at the VOLH that was not conducive to safety and cleanliness
• inadequate standards of nursing care, compounded by issues such as pressures of work, lack of training, inadequate support and poor leadership
• deficiencies in relation to medical staffing and inadequate medical review of patients with C. diff infection.

These factors (and others highlighted by the report) contributed to what the report considers to be a culture that had lost sight of what is the very essence of a hospital - "a caring and compassionate environment dedicated to the provision of the highest possible level of care".

1.3 Scottish Government response

The Scottish Government accepts its responsibility for the failings identified in the report and we apologise unreservedly for the suffering and loss caused. We accept in full all of the report's recommendations.

While we sadly cannot reverse the individual tragedies that befell the patients in the VOLH and their loved ones, we can ensure structures and mechanisms are in place to make sure that what happened at the VOLH does not happen anywhere else in future. This response provides the foundation from which we will achieve this for the people of Scotland.

The report recognises that some of the issues raised in 2007/08 and which are highlighted in recommendations have been overtaken by events and actions in subsequent years: the report's identification of a lack of independent and rigorous scrutiny and assurance of NHSScotland hospitals in 2007/08, for example, has been addressed through the creation of the Healthcare Environment Inspectorate in April 2009. While we recognise that much remains to be done, our response aims to show how actions such as this have been taken to protect the people of Scotland and enhance the services they receive.

This response

The Cabinet Secretary for Health, Wellbeing and Sport announced in the Scottish Parliament on 25 November 2014 that following full consideration of the report and its recommendations, the Scottish Government would publish its response in spring 2015. This response presents evidence of activity in Scotland since 2007/08 that is relevant to the broad areas of interest to the Inquiry and the recommendations it produced and sets out what more we intend to do.

The response should be considered in tandem with the implementation plan that is being developed by the Vale of Leven Hospital Inquiry Implementation Group, working in partnership with the Vale of Leven Hospital Inquiry Reference Group. The plan will set out in detail how, and by when, the recommendations will be enacted fully in Scotland.

Vale of Leven Hospital Inquiry Implementation Group and Vale of Leven Hospital Inquiry Reference Group

The Vale of Leven Hospital Inquiry Implementation Group has been set up to oversee and facilitate implementation of the 75 recommendations from the report. The group is chaired by the Chief Nursing Officer and includes a range of stakeholders. The implementation group is working with the Scottish Government to: review an analysis of NHS board responses to a self-assessment of the recommendations advise on the feasibility, prioritisation and timescales for implementing the recommendations provide strategic oversight for the development and monitoring of an implementation plan, including a risk register ensure that the reference group's views are taken into account by the implementation group and the recommendations are implemented appropriately require individual group members to ensure effective two-way communication with their constituencies. The implementation group works alongside the Vale of Leven Hospital Inquiry Reference Group to ensure that patients and families affected by the outbreak are involved and have a voice in implementation of the recommendations. The reference group provides advice and support to the implementation group and will act as a sounding board for the implementation plan.

This response is presented over five chapters. Following the introduction, core issues identified in the report are addressed under three themes:

• oversight and leadership (Chapter 2)
• preventing and controlling infection (Chapter 3)
• professional practice (Chapter 4).

These chapters identify report recommendations relevant to each of the themes - all 75 recommendations are covered across the chapters, some more than once - before setting out brief details of legislation, policy and other initiatives put in place since 2007 (and, in some cases, prior to 2007) that address core elements of the themes. Boxed text is used throughout to highlight polices and initiatives that may be of particular interest, address specific areas of concern and provide additional information.

We fully acknowledge and accept the failings that led to the tragic events at the VOLH and recognise that more needs to be done, but believe that significant progress has been made to ensure that such events do not happen again in Scotland. We hope the information in Chapters 2-4 will provide some reassurance to the people of Scotland, particularly those whose lives have been directly affected by the VOLH outbreak, that we have learned, and will continue to learn, from the lessons of the tragedy.

The final chapter of the response (Chapter 5) sets out our next steps. Precise detail on implementation of the recommendations will be presented in the plan being developed by the implementation and reference groups, which will be published in due course.

1.4 Learning lessons

At the launch of the report on 24 November 2014, Lord MacLean said: "The major single lesson to be learned is that what happened at the Vale of Leven Hospital to cause such personal suffering should never be allowed to happen again."

He concluded his remarks by noting: "I want to emphasise that my recommendations are designed to encapsulate a concept of patient care that includes skilled and considerate medical and nursing care, transparency, candour, effective systems of infection prevention and control, and strong and dedicated leadership."

We heartily concur with Lord MacLean. We will now devote our efforts to learning the lessons from his report and ensuring the realisation of his aspirations for NHSScotland.