The Independent Inquiry into Histopathology Services A report for University Hospitals Bristol NHS Foundation Trust December 2010 PANEL MEMBERS Jane Mishcon was appointed as Chair of the Inquiry. She is a barrister at Hailsham Chambers in London. She has 30 years‘ experience and her main area of practice is clinical negligence. She has chaired nine other independent inquiries. She is ranked as a leading barrister in clinical negligence in both the Legal 500 and Chambers UK Directories. Professor Sir James Underwood is Emeritus Professor of Pathology at the University of Sheffield. He served as President of the Royal College of Pathologists from 2002 to 2005 and latterly was Dean of Sheffield University's Faculty of Medicine. He has had over 30 years‘ experience as a consultant histopathologist in Sheffield. Ken Jarrold CBE is Chair of Dearden Consulting, of the County Durham Economic Partnership and of the Partnership Committee of the Child Exploitation On Line Protection Centre [CEOP] and a member of the CEOP Board. Ken was a manager in the NHS for 36 years including three years as Director of Human Resources and Deputy to the Chief Executive of the NHS in England and 20 years as a Chief Executive of Health Authorities including the County Durham and Tees Valley Strategic Health Authority and the Wessex Regional Health Authority. Dr Margaret Spittle OBE MSc FRCP FRCR AKC is a consultant clinical oncologist and emeritus consultant at University College London Hospitals NHS Foundation Trust and Guys & St Thomas‘ Hospitals NHS Foundation Trust. She was Dean of the Royal College of Radiologists and is a Government adviser on radiation safety. In January 2010 she replaced Dr Fergus Macbeth, consultant oncologist and Director of the Centre for Clinical Practice at the National Institute for Health and Clinical Excellence, following Dr Macbeth's decision to stand down due to his other work commitments. Michael Summers was the Vice Chairman of the Patients Association, a registered charity, at the time of his appointment to the Panel. He retired from this position during the course of the Inquiry. ACKNOWLEDGEMENTS The administration and co-ordination of this Inquiry was undertaken by Ed Marsden and David Jones of Verita. We are extremely grateful to them both, but David, in particular, showed great patience and calm efficiency which made a complicated and lengthy process run so much more smoothly than it might have done otherwise. We would also like to thank Lesley Sargeant for her invaluable help. We are also grateful to the Fiona Shipley Transcribing Service, in particular Fiona and Lesley, for their indefatigable and good-humoured support in recording and transcribing the evidence for us. Their presence was unobtrusive but reassuring, and the accuracy of their transcribing was impressive. We also appreciated the frank and open way in which the many witnesses gave their evidence to us. This could not have been an easy process for anyone, particularly in the light of the media attention it has attracted, but everyone appeared to be trying to help us find workable and lasting solutions to the issues which we were investigating. CONTENTS Executive Summary 1 The Report 1. Introduction 37 2. Culture/Attitude 50 3. Management/Investigation of Concerns 69 4. Competence 156 5. Specialisation 166 6. Double Reporting 174 7. Paediatric Pathology 177 8. Patient Advocacy 191 9. Media Handling 192 10. Whistleblowing 193 11. Recommendations 195 Annexe 1: Terms of Reference 202 Annexe 2: Private Eye Article 10 June 2009 203 Annexe 3: Diagnostic Error in Histopathology (i) Sir James Underwood 204 (ii) Dr Ray McMahon 206 Annexe 4: Reviews of the 26 Cases (i) Review by the Royal College of Pathologists 210 (ii) Panel‘s Overview 229 Annexe 5: Statistical Analysis of the 3500 cases, Ian White 236 Annexe 6: Report on the Assessment of the Results of the Independent 240 Audit, Professor Peter Furness Annexe 7: UHBT Workload Graphs for 2007 and EQA Participation 250 EXECUTIVE SUMMARY Introduction 1 An Inquiry of this nature, scope and cost would never have been necessary or probably even contemplated had concerns been thoroughly and promptly investigated when and whenever they were raised and the results of those investigations made clear to those who had made the allegations. 2 The failure to carry out a thorough and prompt investigation of the concerns when raised meant that matters escalated out of all proportion and the already strained relationship between the histopathology services in the two Bristol Trusts became even more deeply entrenched. 3 It was the cumulative effect of repeated allegations being allowed to linger or be unsatisfactorily answered which led to the perceived necessity to ‗blow the whistle‘ by going to Private Eye. 4 It is essential that lessons are learned as a result of our Inquiry by both Trusts, and, most importantly, are acted upon in a spirit of co-operation and with the determination to take any necessary steps towards achieving workable and cohesive solutions to the concerns highlighted in the Report. ------------------------------------------ 5 The earliest concerns about histopathology in University Hospitals Bristol NHS Foundation Trust (UHBT) were raised in 2001 regarding paediatric histopathology and were about the lack of sufficient staff and adequate cover. This followed the disintegration of a highly regarded service. 6 Then in August 2004 a letter was written by five respiratory physicians from North Bristol NHS Trust (NBT) to a thoracic surgeon at the Bristol Royal Infirmary (BRI) but copied to 14 other individuals including the Medical Directors of both UHBT and NBT and all of the UHBT consultant histopathologists. The letter expressed the physicians‘ concern about the reporting of surgical lung biopsy and resection specimens from NBT patients which had been 1 referred to the histopathology service at UHBT. The concerns were based on the perception that the reporting was being carried out by ‗general pathologists‘ at UHBT who were not ‗specialist‘ lung pathologists. The letter also stated that ―This has led to a number of incorrect diagnoses and in 2 recent cases serious adverse clinical effects for our patients” and requested that lung pathology from NBT patients should be transferred back to the NBT histopathologists. 7 Between September 2004 and January 2007 the only other concern raised by the NBT respiratory physicians was in March 2005 when one of them wrote to the Medical Director at NBT, describing a recent case of alleged misdiagnosis at UHBT and again asking for surgical lung pathology specimens to be sent back to NBT. 8 In January 2007 the Lead Clinician for respiratory medicine at NBT raised further concerns with Dr Jonathan Sheffield, the Medical Director of UHBT, relating to the difficulties experienced by the NBT respiratory physicians in obtaining from the UHBT histopathology department the histology slides of NBT patients for review at their lung cancer MDT meetings. Similar concerns were expressed in July 2008. 9 In early July 2007 Dr Nassif Ibrahim, one of the consultant histopathologists at NBT, wrote to Dr Sheffield detailing 11 cases in which he alleged errors in diagnosis had been made by the histopathologists at UHBT. 10 Also in 2007 Dr Lynn Hirschowitz, one of the NBT pathologists who was a nationally acclaimed gynaecological histopathologist, raised concerns about the reporting of several gynaecological cases by the UHBT histopathologists. 11 In October 2008 Dr Sheffield submitted a formal application to the Royal College of Pathologists (RCPath) to carry out an external review of UHBT‘s histopathology service. It was intended that this should be a joint review with NBT and a letter was sent by Dr Martin Morse, Medical Director of NBT, confirming this. 12 The College requested more information and stated that the apparent difference of emphasis between the application from Dr Sheffield and the letter from Dr Morse would need to be reconciled in a revised and joint application by both Trusts with agreed terms of reference. No further application appears to have been made to the College. 2 13 It was not until the publication of the Private Eye article on 10 June 2009 that any kind of independent investigation into the concerns which had been raised over the years was actually instigated. 14 Within days of the Private Eye article, the Trust announced that it was to set up an independent review of histopathology specimens reported by the UHBT pathologists. The Trust commissioned Medical Solutions (since 1 January 2010 known as Source BioScience Healthcare), a company providing diagnostic and screening services to NHS and private healthcare, to carry out this review and also to review 26 specific cases of alleged diagnostic errors by the UHBT histopathologists. Source BioScience subsequently audited 3,500 cases randomly selected from histopathology specimens reported at UHBT in 2007 in addition to the 26 cases. 15 In July 2009 the Trust announced that it was to commission an Independent Inquiry to draw conclusions from the results of the independent review, to scrutinise the performance of the histopathology service at UHBT, and to consider whether appropriate action was taken by the Trust to address any concerns which had been raised about the performance of the UHBT histopathology service. 16 As stated above, a total of 26 cases had been identified by the clinicians and histopathologists at NBT as being cases in which they felt that the diagnosis given by the original reporting histopathologist at UHBT was questionable. The cases covered an eight-year period between 2000 and 2008. 17 As part of the Inquiry process, these 26 cases were reviewed both by Source BioScience and by the Royal College of Pathologists, and we have prepared our own ‗overview‘ of these reviews [See Annexe 4]. It is these 26 cases which are at the heart of this Inquiry, rather than the 3,500 cases reviewed by Source BioScience.