Preparing for the Stafford Hospital Inquiry.

The Following Statement has been issued by Robert Francis QC on the terms of reference for the Stafford Hospital Inquiry.

Anyone who wishes to know more about the Inquiry may also wish to check out the website www.midstaffsinquiry.com where there will be regular updates.

INDEPENDENT INQUIRY INTO THE CARE PROVIDED BY THE MID STAFFORDSHIRE  NHS FOUNDATION TRUST

PROCEDURAL STATEMENT
Introduction
Thank you all for coming along this morning.  Before I launch into my statement I wanted to remind everyone of the context in which this inquiry was announced.  The Healthcare Commission produced a critical report into care at Mid Staffordshire Foundation Trust in March; the Department of Health then commissioned two reports from Professor Alberti and Dr Colin-Thomé looking at emergency services and the broader system respectively.  In his report, ‘High Quality of Care for All’, Lord Darzi highlighted the need for quality to be at the heart of all that the NHS does.  He pointed out that patients understand that not all outcomes of treatment are perfect but they do not accept that the organisation of their care should put them at risk. 
He reminded us that patient safety was central to quality and meant; “ensuring the environment is safe and clean, reducing avoidable harm such as excessive drug errors or rates of healthcare associated infections.”  He emphasised the importance of the patient experience, that; “quality of care includes quality of caring. This means what personal care is – the compassion, dignity and respect with which patients are treated.”
Sadly it is clear from these reports these aspirations, which many of us had thought to have been central to the provision of healthcare, seem to have been lacking in Stafford and it is the task of this inquiry to assist towards putting that right for the public who have the right to expect a consistently high standard of care in their local hospital. 
Department of Health Ministers felt that despite the inquiries that have taken place so far the experience and voice of patients had not been heard, and that patients and their families needed to be given such an opportunity.  The Secretary of State announced this inquiry as part of a package of measures in July, including legislation to amend the regulatory framework for Foundation Trusts.  He made it clear the inquiry should be swift and deliver key lessons.      
This inquiry’s primary objective is to listen to and learn from patients, users and carers who used services in mid-Staffordshire, and I am glad that there are patients and relatives in the audience today.   This inquiry needs to help re-build public confidence among local people in Stafford about the NHS.  With the participation of patients and staff I am confident we can learn lessons from what took place so that in the future care at the Mid Staffordshire Foundation Trust is of the same high standard that people expect elsewhere in the NHS.
I will now turn to the details of my inquiry.   
1. I have been appointed by the Secretary of State for Health to conduct an inquiry into the care provided at Mid Staffordshire Hospital.  The terms of reference were announced in the ministerial statement of 21st July 2009 and amended following a letter by the Secretary of State to me of 10th September.  They are now as follows:

• To investigate any individual case relating to the care provided by Mid Staffordshire NHS Foundation Trust between 2005 and March 2009 that, in its opinion, causes concern and to the extent that it considers appropriate.

• In the light of such investigation, to consider whether any additional lessons are to be learned beyond those identified by the inquiries conducted by the Healthcare Commission, Professor Alberti and Dr Colin-Thomé, and, if so;

• To consider what additional action is necessary for the new hospital management to ensure the Trust is delivering a sustainably good service to its local population.

•  To prepare and deliver to the Secretary of State a report of its findings.

The Secretary of State requires a report by the end of the year.  One of the reasons for this very tight timetable is that in his view it is very important not to distract staff and management at the hospital from the task of putting right the deficiencies already identified and to focus on the future.  I have told him that I will do my best to comply with this requirement.

2. The procedure to be adopted is a matter for me to decide.  I have consulted with a range of interested parties to obtain their views on how the inquiry should be conducted and have also considered the reports of the preceding inquiries and reviews, as well as reports of proceedings in Parliament in which the problems of this Trust have been discussed.

3. The themes of this inquiry - The principal theme of this inquiry will be to supplement the inquiries and reviews that have already taken place by allowing patients, their families and others affected by poor standards of care and service in Mid Stafford Hospital to tell their stories and ensure that they are listened to. The Secretary of State said in announcing the setting up of this inquiry that; “the full impact of what happened at Mid Staffordshire is revealed through the personal stories of those affected and it is clear to me that people want a chance to tell these,” and that; “the focus of the inquiry will be on ensuring that patients and their families have an opportunity to raise their concerns.”  The lessons to be learned from those stories – and I am already confident that there are such lessons - will be reported so that they can be taken on board by the new management of the Trust.  A central criticism of the previous management has been the failure to engage with and listen to service users and to give first priority to the quality and safety of care.  It is intended that this inquiry should contribute to filling this gap.  I take the view that this does not entail making determinations in each case raised whether outcomes were avoidable: this is a matter for the independent clinical review.  It does mean that the adverse experiences of all those affected must be had regard to.
 
A second theme will be to allow the hospital staff to offer their experiences of working conditions and the culture that is said to have developed and show the context in which the cases of concern occurred.  The staff can contribute significantly to the rebuilding of public confidence in the hospital by explaining why patients had such bad experiences, and how concerns about matters affecting the quality and safety of care were communicated, received and dealt with. 

A third theme will be to consider the role of those who were responsible for the management of the hospital at the time.  There should be an opportunity for them to offer their side of the story in relation to the criticisms that have been made.

A fourth theme will be to review the processes of accountability that have been undertaken.

A fifth theme will be to offer an opportunity for engagement between the hospital and the community it serves to enable them to plan together to mend the fractured confidence.

4. Scope of inquiry - The inquiry was limited by its original terms of reference to cases arising in the period 2005 to 2008.  I received some representations urging me to look further back than that.  I am not persuaded that it would be fruitful to do so, even if the terms of reference permitted this.  It is clear from the HCC report that there was a long standing problem but I believe sufficient indications of what were the problem areas will emerge from examination of cases starting in 2005 and that there is no value in examining detailed cases before.

On the other hand it was suggested that I should ask the Secretary of State to extend the remit to permit me to look at cases occurring up to the date of the publication of the Healthcare Commission report in March 2009.  He has agreed with that suggestion and my terms of reference have been extended accordingly.

5. There are a number of things which this inquiry is not:
a. It is not a public inquiry.  It is intended to be informal, flexible and designed to obtain the maximum amount of information on events, views and impressions, in a short time scale.  Much of the information I will have to consider concerns confidential medical information and other private matters of a sensitive nature.  I do not have the statutory powers of an inquiry under the Inquiries Act 2005, for instance to compel witnesses to attend, and I hope that will be unnecessary.  Any healthcare worker or NHS manager who was involved in relevant events between 2005 and March 2009 should feel it part of their duty to assist this inquiry and contribute to the learning and healing process of which it is part.   Should I consider it necessary to seek such powers the Secretary of State has made it clear that I am free to ask for them.

b. This inquiry is not tasked with reviewing the findings of the Healthcare Commission, Alberti, or Colin-Thomé reports.

c. It is not a forum for a debate on how regulators and other statutory bodies could better work to ensure that poor delivery of services is detected and remedied at an earlier stage, or on how safety and quality criteria should be better worked into the application for and status of a Foundation Trust.  This is not part of my terms of reference.  An interested party asked me to relay to the Secretary of State a request that my remit be extended to allow for an investigation into the question of why regulators and other external bodies did not detect that things were going wrong earlier.  He has declined to do so.  The time frame for this inquiry simply does not permit that sort of investigation.  However, should information relevant to such issues emerge in the course of my inquiry I shall consider what, if any, recommendations I should make for further work in this area. 

d. The inquiry is not a tribunal before which individuals are to be held to account.  In other words it is not for me to make findings of civil liability or to take disciplinary action.  There are other bodies charged with such responsibilities.  I intend to conduct this inquiry in a way which shies away from the so-called “culture of blame” and focuses on hearing and reporting on the experiences of individuals.  It is not for me to make judgments on individual cases as would be done by a court hearing a clinical negligence or other action.  However the terms of reference require me to consider whether additional lessons other than those identified in those reports need to be learned.  As already indicated, as part of my inquiry I will be looking at the process of accountability adopted.

6. Stages of inquiry
a. There will be five stages to this inquiry:
i. Collection of documentary information.
ii. Hearings relating to selected service users’ experiences.
iii. Hearings relating to selected staff members’ and management experiences.
iv. Discussion forums for invited service users and other interested parties, and for members of staff.
v. Consideration of all the evidence and preparation of the report.

Some of these stages will be conducted in parallel.  I will appoint a group of expert advisers, covering clinical management, nursing, Board governance, patient experience and patient representation, who I will call on during the inquiry.

7. Collection of information - There are a number of sources of information which have already been identified.  These include:
a. The independent clinical review: this review led by Dr Laker, is considering the cases of any service user who has requested such review.  The inquiry will, subject to appropriate consent, consider the cases reviewed.  The inquiry will generally accept the conclusion of the review where this has been completed unless there appears to be a compelling reason not to. However it is understood that the review will take until next year to be substantially complete. In order to report within the timeframe I have been given this inquiry will have to assess the significance of cases from its own resources, but leave the review to come to later conclusions on the detail of individual cases. 
b. Cases submitted by representative bodies such as Cure the NHS.
c. Cases considered by the Healthcare Commission.
d. Cases subject to complaints made to the hospital and/or other statutory agencies.
e. Trust serious untoward incident records.
f. The Trust and other statutory agencies have agreed to make available to me such of the materials in their possession which will assist my inquiry.
g. In addition I invite and encourage members of the public and hospital staff to bring to the attention of the inquiry any information about the quality and safety of care delivered at the hospital from 2005 to March 2009 that they believe is of sufficient concern to be considered by me.  All information received in this way will be dealt with confidentially, and if requested by the informant no disclosure will be made to any third party of his or her identity.
h. It is important that all information of this nature is obtained by the inquiry at the earliest opportunity. It is envisaged that the bulk of such material will be obtained  by the end of September. I do not propose to set a specific deadline beyond which I will not receive further evidence or materials, but I am unlikely to take into account materials received which cannot be processed in time for me to deliver my report within the required timescale.

8. Oral hearings in relation to service user complaints and experiences
a. It will not be practicable to hear oral evidence in relation to all the cases and complaints arising from events between 2005 and March 2009.  I intend to identify from the material available common themes of concern and then select a representative sample of cases:
i. Which appear to be illustrative of each of the themes, or
ii. Which appear to require clarification or resolution of disputed facts and are of sufficient significance to the objectives of the inquiry to warrant an oral hearing
iii. I will also consider particular requests to give oral evidence on their individual merits.  The fact that a particular case or complaint is not selected for consideration at an oral hearing does not mean it will not be taken into account.  All written material will be taken into account.  

b. Where a case is selected for consideration at an oral hearing, the inquiry will identify the required witnesses and invite them to attend such a hearing.  The witnesses required may include patients, family members or others who witnessed the events in question and also staff who may be able to assist explain what happened and why. 

c. Witnesses will be invited to make written statements and may be given an indication of the areas and particular questions the inquiry would appreciate receiving information on.  In the case of any staff invited to give evidence any particular areas of apparent concern or potential criticism will be drawn to their attention where this is possible, and their comments invited. 

d. Oral hearings will be in private and only persons authorised by me will be permitted to attend. I intend that the hearings will be inquisitorial, not adversarial. I am prepared to consider applications by persons or organisations who can demonstrate a legitimate interest to be present to assist the inquiry at oral hearings generally or particular hearings.  Where such permission is granted such interested parties may be legally represented or may attend in person or by a senior officer as appropriate.  My permission may be withdrawn at any time, and individual witnesses may ask to give evidence in the absence of all or some of such interested parties.  Where such a request is granted, such parties will not receive a transcript of any proceedings from which they have been excluded.

e. Any witness may be accompanied to the hearing by a friend or professional representative, including a legal adviser.

f. Witnesses will be asked to confirm that they will tell the truth and that any written statement submitted by them as evidence is true.  Witnesses will be questioned by counsel to the inquiry and where required by me and any expert assessor sitting with me.  Any interested parties present who have questions they wish the witness to be asked must request counsel to the inquiry to consider putting them.  Counsel will have an absolute discretion to decide whether or not to do so.  Exceptionally third parties will be able to apply to me to allow them to ask questions directly, but I will require very compelling reasons to allow this.  At the completion of questioning by counsel to the inquiry, myself, the assessor and any third party permitted to ask direct questions, the witness may make a closing statement addressing issues raised by the questioning or if so advised and accompanied by a friend or professional  representative may be asked questions by the friend or representative, but limited to points raised in the preceding questioning and to within such time limit as I specify.

g. A transcript of all oral evidence will be prepared, and witnesses will receive a copy of this and be given an opportunity to correct or add to it.  The proceedings and the transcript will be confidential.  Copies of transcripts will at my discretion be made available to interested parties I have permitted to be present on condition that they provide an undertaking in a form I will specify to preserve its confidentiality. Copies may only be shared with third parties with my permission and on receipt of an express written undertaking that they will be used only for the purpose of this inquiry and not disclosed to any other person without my express permission. 

h. It is for the Department of Health to decide on the funding of legal representatives for patients but I hope that support will be made available so that people are able to make representations effectively, and in a way that causes them least distress.   
9. Oral hearings in relation to staff experiences
a. A selection will be made of members of staff who appear to be able to offer information relevant to the general failures in the quality and safety of care from their own experiences.

b. The procedure for such hearings will be the same as for the service user hearings, but the following points should be noted:

i. I will consider sympathetically any request for evidence to be given in the absence of third parties or for evidence to be recorded anonymously.

ii. It is not my intention to identify individual members of staff in my report except for members of senior and accountable management, whose identities are likely to be widely known in any event.

iii. The Trust, through its Chief Executive will be writing to all staff assuring them that there will be no adverse employment consequences for any member of staff in relation to any evidence they may give to this inquiry.

10. Oral hearings for managers - The procedure will be as for staff hearings.

11. Communications
a. There is a web site www.midstaffsinquiry.com, which is going live at noon today, with information about the Inquiry. People can also email the Inquiry – info@midstaffsinquiry.com. I am also keen that there are regular reports and summaries of proceedings available to all those who wish to read them, on the website.

12. This procedure may be amended at my discretion at any time, and I am willing to receive representations about the procedure from any person or body affected.  I do want to emphasise how important it is that members of the public get in touch with the inquiry and make representations.  The more views we can gather, the better the report will be and, critically, the lessons to be learned.

13.  I hope my statement explains how I intend to go about my inquiry.  The inquiry will be held in Stafford, and we are looking at locations at the moment. Obviously we need somewhere that is large enough for the inquiry and accessible to patients. I am very open to suggestions that any of you may have.  As I have indicated , it is not my style to be adversarial, and it would obviously do no good in the circumstances we are dealing with here to act in that way.  However I shall be inquisitorial.  I shall not shrink from looking into matters which may be uncomfortable and difficult.  This, allied to private hearings and regular reports of proceedings, is, I am sure, the best way of receiving constructive evidence from individuals and achieving the objectives of the inquiry.  I do sincerely hope that everyone will co-operate with the inquiry.  That way we can learn lessons that will allow the patients, the local community and the hospital to move on from this unfortunate period.