Independent Inquiry Into Concerns About Histopathology Services at University Hospitals

INDEPENDENT INQUIRY INTO CONCERNS ABOUT HISTOPATHOLOGY SERVICES AT UNIVERSITY HOSPITALS BRISTOL NHS FOUNDATION TRUST

Introduction

University Hospitals Bristol NHS Foundation Trust (UH Bristol) commissioned an independent inquiry in August 2009 into allegations of serious misdiagnosis in histopathology services at the Trust between the years 2000 and 2008, which were published in Private Eye in June 2009.

The allegations related to cases of concern recorded by clinicians at North Bristol Trust between 2004 and 2008. 26 such cases were referred to the Inquiry panel for investigation. Other cases of concern have been brought to the panel’s attention during the course of the Inquiry.

The Board of University Hospitals Bristol NHS Foundation Trust received and accepted the final reportof the Inquiry panel in December 2010. The report was published in full on the Trust’s website on 8 December 2010. A press conference was held the same day and received significant local and some national coverage.

Method of inquiry

The independent inquiry panel consisted of:

Jane Mishcon (Chair), Counsel at Hailsham Chambers, London, a barrister with 30 years’ experience across a wide range of cases involving most clinical specialities;
Sir James Underwood, former Professor of Pathology at the University of Sheffield Medical School;
Ken Jarrold CBE, senior consultant at Dearden Consulting and former Chief Executive of County Durham and Tees Valley Strategic Health Authority;
Dr Margaret Spittle OBE MSc FRCP FRCR AKC, Consultant Clinical Oncologist and emeritus at University College London Hospitals NHS Foundation Trust and Guys & St Thomas’ Hospitals NHS Foundation Trust. (She replaced Dr Fergus Macbeth, consultant oncologist and Director of the Centre for Clinical Practice at the National Institute for Health and Clinical Excellence, on the panel in January 2010 following Dr Macbeth's decision to stand down due to his other work commitments);
Michael Summers, former vice chairman of the Patients Association.

Broad terms of reference asked the panel to consider not only the safety of histopathology services at UH Bristol but also the Trust’s response to the concerns raised.

The panel considered evidence from a variety of sources:

interviews in private with 58 witnesses;
reviews of the 26 original cases of concern both by Source BioScience and by the Royal College of Pathologists with commentary by Professor Peter Furness, President of the Royal College of Pathologists;
an audit by Source BioScience of 3,500 cases randomly selected from histopathology specimens reported in 2007, with a further review of the audit method and outcomes by the President of the Royal College of Pathologists;
expert advice from Dr Ray McMahon, Senior Lecturer in Pathology and Honorary Consultant Pathologist in Manchester.

Key findings

Thefollowing are headline findings from the Inquiry report. (Please see the Inquiry report for the full range of findings).

Overall there is no evidence to lead the Inquiry panel to believe that the department at UHBristol provides anything other than a safe service, although it has room and need for considerable improvement in some aspects.

Diagnostic mistakes have been made by the histopathologists at UH Bristol but only very few have been serious diagnostic errors with a serious adverse outcome for the patients concerned. Most errors were of lesser significance and are of a type that could have been — and frequently are — made by any histopathologist.

Any competent pathologist can make a serious error on rare occasions. The frequency of such errors therefore has to be considered. The number and frequency of the serious errors in the 26 cases identified for the purposes of this Inquiry do not in isolation justify serious concern about the overall competence of the pathologists in the histopathology department at UHBristol.
Professor Peter Furness, President of the Royal College of Pathologists, concluded that there was no systematic pattern of error in the sample audit of 3,500 cases, although he did identify areas of concern in the working practices of the department, particularly in relation to the sharing of difficult cases, the incorporation of second opinions into reports and the checking of particularly significant or unexpected diagnoses
The main area of concern relates to culture and attitude, both in the histopathology department itself and between the two Trusts. It is vital that there is an open and learning culture in which pathologists seek the advice of colleagues from within and outside their own department and in which mistakes are acknowledged and lessons learned. There is no place for arrogance or excessive confidence. The culture in the histopathology department at UHBristol veers towards the opposite of what is required. As for the culture and attitude between the two trusts: Professional competition is healthy. Professional rivalry which damages the sane and rational distribution of services is not.
The inappropriate and arguably unprofessional way of making serious allegations in 2004 about the competence of colleagues (in a letter copied to 14 separate individuals) in many ways set the tone for any subsequent response to and investigation of those allegations.
The concerns raised in 2004 and subsequently were not taken sufficiently seriously and were not properly investigated. The escalation of concern in 2008 was fuelled by a lack of appropriate response by management. Neither of the two medical directors at UHBristol and NBT appears to have taken action until 2008, by which time it was too late to deal with the issues ‘in-house’.
Failure to investigate the concerns promptly and thoroughly caused an already strained relationship between the two histopathology departments to become more deeply entrenched and led to publication of allegations by Private Eye.

Had the concerns of North Bristol Trust clinicians been thoroughly and promptly addressed when they were raised, it is likely that they would have been satisfied that there was no serious cause for concern about the diagnostic competency of the UH Bristol histopathology department.

Recommendations

The Inquiry report contains a range of recommendationsunder 12 separate headings (shown at Annex 1).

The main recommendation is that a unified histopathology service should be established in Bristol. This will allow greater specialisation and ease of double reporting and, as indicated in the Report, should have the potential to make it one of the leading service and academic histopathologycentres in the country.

Trust response

The Trust Board has accepted the findings of the Inquiry in full.

UH Bristol has made a public apology for the harm caused to patients as a result of diagnostic errors. The Chief Executive’s statement on behalf of the Board is attached for information at Annex 2.

UH Bristoland North Bristol NHS Trustare committed to greater co-operation in the interests of patients, as reflected in a formal Partnership Agreementapproved by both Boards in November 2010, enshrining principles of co-operation in the patient interest and outlining a number of areas for joint working.

The two Trusts have agreed to advertise for a joint clinical director of histopathology services as the first step in unifying the two departments in Bristol. A job description has been agreed and has been submitted to the Royal College of Pathologists for their view.

Communication and personal support is in place for the UH Bristol Histopathologists in the light of the Inquiry outcome.

The Trust’s consideration of the individual recommendations is reported in Annex 3.

The Trust Board has accepted the recommendations that apply to UH Bristol. The Board should note strong clinical advice internally and from North Bristol Trust, however, that recommendation I3 should only be partially agreed. This is because a delay in informing patients about the results of histopathology tests until full multi-disciplinary team discussion has taken place interferes with the one-stop clinic model in place in some services and may contribute to patient anxiety. Instead, the Trust proposes to follow the spirit of the recommendation in establishing the principle that patients should be given the full context for any early communication of unvalidated diagnostic results.

In addition to the actions planned in response to the specific recommendations in the Inquiry report, UH Bristol has implemented a protocol and process for the mandatory central logging of any formal concern about clinical services or patient safety so that such concerns cannot remain under the sole supervision of one director.

The Trust has submitted the report to the Department of Health via the Strategic Health Authority and formally notified the Royal College of Pathologists about the recommendations applying to them.

Regulatory response

The Care Quality Commission and Monitor were informed about the Inquiry at its inception and have been briefed about subsequent progress.

Both regulators have received copies of the Inquiry report and will make their own determination in due course about the appropriate regulatory response. The Trust’s action plan responding to the recommendations in the Inquiry Report will be material to that deliberation.

Action plan

The Trust’s action plan in response to the Inquiry Report is set out at Annex 4.

Those plan elements that apply jointly to UH Bristol and North Bristol Trust will be extracted and formally agreed between the organisations. It will be seen that a number of principles underpinning this joint action plan have already been agreed.

Performance management

It is proposed that progress against the action plan will be monitored at a fortnightly project group chaired by the Chief Nurse and involving the Acting Medical Director. This will report in turn to the Clinical Risk and Assurance Committee on a monthly basis, which reports quarterly to the Governance and Risk Management Committee (which is a sub-committee of the Board) and thence to the Trust Board.

Recommendations

The Trust Board is asked to:

note the steps taken in response to the Inquiry Report
approve the action plan
approve the proposed performance management and reporting framework.

Robert Woolley

Chief Executive

17 December 2010

ANNEX 1

RECOMMENDATIONS

Recommendation / Action
A / A single Histopathology Service should be established for Bristol with the potential to be one of the leading service and academic centres.

Consultant staffing levels should be reviewed in accordance with the Royal College of Pathologists' "Guidelines on staffing and workload for histopathology and cytopathology departments"(2nd edition)June 2005, and, if necessary, adjusted to ensure they are sufficient for a safe, timely and reliable service.
The service should for the time being remain on two sites.
The unified service should be managed by a lead Trust unless the two Trusts have been merged.
The unified service should have strong management and effective clinical leadership.
A Job Description for the post of Head of the new integrated department should be prepared with adequate sessional provision for their managerial responsibilities.
All future consultant appointments should be joint appointments between the two Trusts unless they have merged. The appropriate clinicians should be involved depending on the specialist interest[s]of the post.
Consultants should work across both sites when necessary to provide the optimum service to patients.
Specialisation should be developed with full participation in appropriate EQA schemes and attendance at relevant CPD events.
The MDTs in both Trusts should be reviewed to promote collaboration.
An audit programme should be established for all specialties.
The BRI histopathology department should be upgraded.
Implementation of a unified histopathology service for Bristol should be carefully planned and should include direct involvement of all consultants and other staff, facilitation by an experienced external facilitator and the involvement of patient representatives.
The histopathology service should place the provision of excellent services to patients at the centre of everything it does. Personal and organisational rivalries should not be allowed to stand in the way of the provision of excellent services.

/ UHBT
NBT
B / Management Structure
If the current management structure for the Histopathology Department is to remain, there should be clarification of the roles and responsibilities of Head of Division, Clinical Lead and Head of Department. / UHBT
C / Relocation of Services
Whenever services are re-located, careful consideration must be given to the consequences for histopathology. The histopathologists with the appropriate expertise should transfer with the services to the new location where suitable facilities for them should be provided. / UHBT
NBT
D / Double Reporting
The term ‘double reporting’ is often used loosely.

The Royal College of Pathologists should agree a national definition of double reporting which we suggest should be:

“For a case to be regarded as double reported, two histopathologists should examine and discuss the case and then issue a diagnostic report in their joint names.”
We suggest that the normal process should be as follows;
(a)The pathologist examines the case. If the case is straightforward, and not involving the specialties where double reporting is mandatory, the pathologist should prepare the report.
(b)If the case involves the specialties where double reporting is mandatory that should be arranged.
(c)If the pathologist feels that it would be helpful to have the views of a colleague informally that should be arranged. Informal consultation of this kind should be encouraged in order to promote a learning culture.
(d)If the case is doubtful or difficult, double reporting should be arranged.
(e)If a second opinion is required from outside the department that should be arranged. An interim report should be prepared which should make it clear that a second opinion is being arranged.
(f)Until the new integrated department is established second opinions from the ‘other’ Bristol department should be regarded as from ‘outside’ the department.
(g)Until the new integrated department is established, histopathologists should be encouraged to ask colleagues in the other Bristol department for a second opinion where appropriate.

The histological slides should be available for review and presentation at the MDT meeting for any case involving histopathological interpretation.

/ RCPath
UHBT
NBT
E / Raising Concerns

Any concerns about the standard of pathology reporting should be thoroughly, rapidly and, where appropriate, independently investigated and the results made available to all those involved.
Concerns should be dealt with at the lowest possible level and not escalated unnecessarily.
The pathologist(s) involved should be consulted directly.

We suggest that the process should be as follows:
a)If a pathologist, or any other clinician, is concerned about a pathology opinion the first step should be informal discussion with the pathologist who prepared the report. The spirit of the discussion should be one of enquiry and learning.
b)If the matter is not resolved the concern should be raised with the Head of Department of the person raising the concern who should discuss the matter with the Head of Department of the pathologist who prepared the report.
c)If the concern is not resolved by the Heads of Department the issue should be raised with the Head of Division of the person raising the concern who should discuss the matter with the Head of Division of the pathologist who prepared the report.
d) If the concern is not resolved by the Heads of Division the matter should be raised with the Medical Director of the person raising the concern who should discuss the matter with the Medical Director of the pathologist who prepared the report.
e)If the concern is not resolved by the Medical Directors the matter should be raised with the Chief Executive of the person raising the concern who should discuss the matter with the Chief Executive of the pathologist who prepared the report.
f)The person raising the concern and the pathologist who prepared the report should be appropriately supported at all stages.
Where appropriate, an audit of relevant specimens should be conducted. / UHBT
NBT
F / Whistleblowing
The Department of Health should review advice on whistleblowing to ensure that local policies include clear guidance on raising concerns about the work of a pathologist or any other clinician who works for a different Trust from the Trust employing the person raising the concern. / Department of Health
G / Relationships with the Media
Proactive media relations are even more important in Bristol because of the legacy of the Kennedy Report.

Relationships with the media should be proactive with an emphasis on openness, honesty and the involvement of senior managers and clinicians including the Chief Executive.
Relationships with the media should reinforce positive relationships with patients.
Service change should be explained.
The Trust website should be kept up to date.
The handling of our Report will be the first challenge of the new approach to relationships with the media.

/ UHBT
H / Paediatric and Perinatal Pathology

Paediatric and perinatal pathology should be valued and supported by managers, pathologists and other clinicians.
The minimum level of staffing should be one paediatric pathologist, one perinatal pathologist and one pathologist trained in both paediatric and perinatal pathology.
Joint working between the paediatric and perinatal pathologists in Bristol, Southampton and Oxford should be strongly encouraged.

/ UHBT
I / Patients and Histopathology

The Department of Health and the Royal College of Pathologists should work together to improve further patients’ understanding of the role of histopathology.
The Trust should develop proactive and constructive relationships with patients and patient advocates.
Where a patient’s care is going to be discussed at a multidisciplinary team meeting, patients should not be given information contained in histopathology reports until the reports have been considered by the multidisciplinary team.
Where errors of diagnosis are identified, patients should be promptly informed.

/ Department of Health
RCPath
UHBT
NBT
J / Specialist Pathology

The Royal College of Pathologists should review its guidance on ‘specialist’ histopathology with the intention of making it more explicit where possible.
There should be at least two specialist histopathologists in each subspecialist area to allow proper review and to provide cover for meetings and periods of leave.

/ RCPath
UHBT
NBT
K / Trainees
Trainees should have supervised involvement in the full range of specimens, including the most complex cases, in accordance with their seniority and experience. / UHBT
L / The Aftermath of this Inquiry

The histopathologists should be given whatever support they need to face the aftermath of this Inquiry including skilled facilitation.
Consideration should be given to inviting the Inquiry Panel to return within the next 12 months to review what steps are being taken to address these Recommendations .

/ UHBT
NBT