The Bristol Pathology Inquiry was triggered by my Private Eye column in June 2009 detailing allegations of significant errors in histopathology reporting at the Bristol Royal Infirmary, part of University Hospitals Bristol (UHB). Initially, allegations of error were made by four senior sources working at nearby North Bristol Trust (NBT) and covered the areas of respiratory, gynaecology, breast and skin pathology. A further source from within UHB then made serious allegations about long-standing errors in paediatric pathology, a shortage of paediatric pathologists and specific allegations about a named paediatric pathologist who was eventually reported to the General Medical Council but removed his name from the Medical Register and so was not investigated.
Incompetence can be extremely hard to define in a doctor, particularly a pathologist, given the complexity of some cases and the subtleties in interpretation of tissue samples. It was, and remains, unclear as to whether these alleged errors are as a result of general incompetence, or whether otherwise competent pathologists were working at the margins of their competence in dealing with particularly hard to interpret samples. In a grown-up safety culture, pathologists in the two hospitals would readily share samples and combine expertise and resources to give patients the best chance of the right diagnosis and the most appropriate treatment. The fact that this doesn’t appear to have happened in Bristol and that these allegations have been grumbling on for years without resolution (and without patients knowing about them) is a damning indictment of both of the inept management and secretive medical culture, and suggests that the lessons of the heart scandal have not been widely applied.
The heart and pathology inquiries differ in so far as the heart inquiry was in public, was easy to find out about and many patients and relatives were able to give evidence to it, whereas the pathology inquiry is being held in secret, in London rather than Bristol, and very few patients or even doctors are aware that it is happening. The Inquiry is due to report later this year. If you want to find out more or give evidence, contact:
David Jones
Inquiry Manager
Verita
53 Frith Street
London W1D 4SN
Tel: 020 7494 5670
www.verita.net
In the meantime, here’s Private Eye’s telling of the story so far…..
Private Eye: June 10, 2009
Pathological Sickness
On June 1, 2007 a letter was sent to Dr Martin Morse, Medical Director of North Bristol Trust (NBT), detailing eleven alleged serious diagnostic errors made by histopathologists at the Bristol Royal Infirmary, resulting in significant patient harm. These cases came to light when slides and samples were subsequently reviewed at NBT.
According to the allegations, one woman (now deceased) was told her breast biopsy was benign but later presented with metastatic cancer, and patients with malignant lymphoma, melanoma (twice) and vulval carcinoma were also initially told they did not have cancer. Conversely two other patients allegedly had treatment for cancer when review of their biopsies found no evidence of it.
Documented errors appeared most likely in patients with rare lung disease. Again, patients have allegedly been told they have cancer when they don’t, and vice versa. Another was allegedly told he had tuberculosis when subsequent review found that he didn’t.
Interpreting tissue slides is stressful and complex, and some mistakes inevitably happen. The Royal College of Pathologists (RCPath) clearly states that when discrepancies in reporting occur, prompt independent review is required but some of these errors date back to 2000, and when the college was invited to do such a review, it apparently declined as it did not want to get involved in an ‘internal matter.’
Bristol is blessed with some fine pathologists, including respiratory specialists based at NBT, and if they worked in teams, accepted the same quality control and shared difficult diagnoses, then doubtless some harm to patients could have been prevented or reduced.
Alas, the long-standing rivalry between Bristol hospitals has prevented this from happening. Until July 2008, NBT pathologists claim they were unable to access the slides for their patients who were treated at the BRI, though this has now been resolved. However, slides from other patients who might benefit from the specialist service at NBT are still not being shared. Dr Morse has raised concerns with the Medical Director of University Hospitals Bristol (UHB), Dr Jonathan Sheffield but – two years after the whistle was blown – an independent external review has not happened. Four additional cases of apparent lung misdiagnosis have now been documented, but Dr Sheffield has stated that there is ‘no evidence to confirm a significant error rate’ in the service.
As well as the RCPath, these concerns have been brought to the attention of the chief executives of both trusts, the medical director of the strategic health authority, the medical director of the Avon Somerset and Wiltshire Cancer Services and the National Clinical Assessment Authority, thus far without satisfactory investigation or resolution.
It seems extraordinary, given what happened previously in Bristol, that UHB staff would not accept they might have a problem in their pathology department and act quickly to get an outside assessment. An urgent external review and the assimilation of pathology services across Bristol into a network that encourages scrutiny and shared expertise is now vital for patient safety. Dr Sheffield and the RCPath have been sent a detailed summary of the alleged misdiagnoses and MD has asked Barbara Young at the Care Quality Commission to investigate.
Private Eye: June 20, 2009
Has Bristol learned from Bristol?
How much has the safety culture at University Hospitals Bristol (UHB) changed since the public inquiry into cardiac surgery? On the plus side, when the Eye broke the heart scandal in 1992, it took seven years to announce an external inquiry. When allegations of serious histopathology errors were published last month (Eye 1238), it took seven days. There’s even a web page dedicated to the histopathology review.
http://www.uhbristol.nhs.uk/histopathology-review-june-2009
But there’s still plenty of ‘old’ Bristol. Too much power concentrated in too few hands, very serious allegations not shared with the trust board, arrogance and bullying, a shortage of specialist staff, an ineffectual royal college and a brave consultant who raised concerns but felt compelled to leave Bristol when they were not taken seriously. And once again, many doctors, managers and establishment figures have been well aware of the problems for some years, but virtually no patients.
The UHB website says the review was ordered after ‘15 potential cases of histopathology misdiagnosis’ were published in ‘the satirical magazine, Private Eye.’ But the trust knows that there are far more than 15 alleged errors dating back from 2000. These are a sample of the errors collated by a single consultant where significant harm to patients had occurred. There are other examples where harm was fortuitously averted. Other consultants have also raised concerns specifically in four areas (respiratory, breast, skin and gynaecology), some as far back as 2004.
Other allegations that have been explicitly made to the UHB medical director Dr Jonathan Sheffield or the chief executive Dr Graham Rich since 2007 include:
UHB pathologists not routinely sending difficult slides for an outside opinion
Diagnostic errors and omissions in gynaecology reporting picked up by a specialist pathologist over a 2 year period with ‘serious implications for patient safety.’ The more serious errors were confirmed by an external expert.
Attitudes of hostility and denial when the above concerns were raised, a smearing of the specialist and a consequent abandonment of the specialist scrutiny of gynaecology reporting
Formal and informal complaints against a lead UHB pathologist.
Coroners reports performed to a substandard level by UHB pathologists but no action taken.
Deficiencies in UHB pathology audit
Dr Sheffield, himself a histopathologist, has frequently met and exchanged correspondence, with those raising concerns but to no satisfactory resolution In July 2008, the minutes of the Medical Advisory Committee at North Bristol Trust (NBT), state that there ‘continued to be serious cases of respiratory misdiagnosis by UHB histopathologists of specimens from NBT patients, despite there having been assurances by UHB that the problems had been overcome’ and ‘UHB continued to refuse to allow slides to be looked at by NBT histopathologists.’ Dr Morse, then medical director, said that unless an external review was arranged, he would report the matter to the Healthcare Commission. In August 2008, Graham Rich gave a written assurance that an external review had been requested. It never happened. The Royal College of Pathologists was contacted but claim they never received the formal agreement of both trusts to do the review. And without an invitation, the royal college is powerless to intervene even if serious misdiagnosis is occurring.
Forced into action by the Eye, UHB has organised its own external review using a private company called Medical Solutions, which already does the trust’s breast cancer receptor testing, and so has a financial stake in one of the four areas of concern. Hardly independent. 3,500 slides across the entire pathology service are going to be chosen at random for one year (2007) to see if there is a significant error rate. If UHB had proper prospective audit, it would already know what it’s error rate is for subspecialties and pathologists. The random selection will not include any errors prior to 2007 and, according to one statistician, ‘is fraught with methodological problems and extremely unlikely to get to the heart of the problem.’
Specialist pathology is not simply making a diagnosis of, say, benign or malignant but recognising other features of the tissue that should guide very complex treatment in discussion with the entire team. There is a national shortage of specialist pathologists, and Bristol can only provide a safe service by merging the expertise of its two trusts. As one senior consultant at NHS Bristol put it: ‘We’ve been trying to do this ever since I arrived in Bristol 25 years ago.’ The external review is looking for the wrong problem in the wrong place. It’s changing the culture and service afterwards that matters. Time to grow up and get on with it.
Private Eye: September 11, 2009
The histopathology review at University Hospitals Bristol prompted by the Eye’s exposure of allegations of serious errors in reporting of skin, breast, lung and gynaecology specimens between 2000 and 2008 (Eyes passim) may have to cast its net still wider. A senior specialist with many years experience working at UHB has now demanded that paediatric pathology be investigated too.
The paediatric pathology department was recognised as one of the best in the world prior to the Bristol heart inquiry in 2001, with three specialists including a professor and a senior lecturer. The samples they kept were instrumental in proving that the standard of complex paediatric heart surgery prior to 1995 had been so poor. When it emerged that most of the samples had been kept without parental consent, the pathologists were hung out to dry in the press and, unsupported by management, they left.
According to the allegations: ‘Over the next 2 years paediatric work was done by adult pathologists… from a highly dysfunctional department, some of whose competence in their own fields was in doubt. The results were disastrous, particularly in the fields of children’s cancers and Hirschsprung’s disease. In 2002-2003, the Trust appointed a non-UK trained paediatric pathologist, Dr S, who had not been short-listed for posts elsewhere. He should never have been appointed and within a few months it was apparent that he was incompetent. Serious errors in children with cancer and Hirschsprung’s disease continued (one of the latter died as a direct result of this). His post-mortems were of a very poor standard. This caused particular problems in children dying of heart disease. After clinical staff reported numerous incidents to managers they were eventually forced to take action and he left to work in Europe.’
‘In 2004, two new paediatric pathologists (PP) were appointed but one found the environment so hostile that she left in 2005. Since 2005 a single-handed PP has soldiered on valiantly despite hostility from adult pathologists and little help from managers. The standards are very high when she is there but there are still major problems when she’s away. She does all the biopsy work but not post mortems. £450,000 comes to the Trust for regional perinatal work and the adult pathologists have tried to keep this for their own use. They have also used devious tactics to try to block appointments to the 2 vacant PP posts. It is hoped that one post will shortly be filled but meanwhile there are serious deficiencies affecting oncology, cardiac, genetic and surgical services.’
In response, UHB has referred all these new allegations to the pathology review team, to be chaired by Jane Mischon. In addition, ‘the incident alleged in the letter was fully investigated at the time. As a result, the Trust reported an individual to the General Medical Council, whose name was removed from the medical register at the end of 2004.’ Meanwhile, in the draft minutes of a June 12 2009 meeting, UHB gynaecologist John Murdoch refers to the Eye’s reporting of Trust’s pathology problems as ‘sensationalist’ and referring to ‘a few lung cancer cases’. In fact, many of the allegations are in his own area and the Trust has confirmed that ‘Mr Murdoch was aware of the serious allegations about gynaecology reporting in June 2008.’ Odd that he should not minute them a year later.
Private Eye September 25, 2009
Irregulation
The GMC has issued a puzzling statement about Dr S, a paediatric pathologist employed by United Hospitals Bristol (UHB). According to the GMC: ‘We received information from UHB in 2004 regarding Dr S. It became clear that conducting our normal investigations was going to take longer than was in the public interest. We therefore decided to remove the doctor from the register with his agreement. The doctor was removed from the register in December 2004 and has not been registered with the GMC since that date. This means that he has not been able to practise as a doctor in the UK since 2004.”
MD has asked the GMC to clarify how it can be in the public interest not to investigate serious concerns about patient safety, but without reply. One argument used locally to silence dissenters is ‘the last thing Bristol needs is another scandal.’ In fact, the last thing Bristol needs is another cover up. Jane Mishcon, chair of the UHB pathology review, has a lot of digging to do. Meanwhile Dr S is now a Professor in Canada, citing ‘Clinical Reader at the Bristol University’ as one of his achievements.
Private Eye: January 20, 2010
Bristol Update
‘Failure to reconfigure child heart surgery will be a stain on the soul of the specialty and will compromise the treatment of the most vulnerable members of the next generation.’ So says NHS Medical Director and cardiac surgeon Sir Bruce Keogh, just 18 years after the Bristol heart scandal was exposed in Private Eye. The Public Inquiry a decade ago found that as many as 35 babies had died unnecessarily, and a review in 2003 recommended the concentration of scarce expertise and equipment in fewer centres. Alas, Labour ignored it for fear of the political ramifications. Keogh admits there has ‘frankly been little progress’ since the inquiry and he can’t at present guarantee that ‘another Bristol’ won’t happen.
The job of fixing it has now been handed to the National Specialised Commissioning Group (NSCG), which since 2007 has been responsible for making sure the treatment for all rare and complex conditions is ‘safe and sustainable.’ As Keogh puts it: ‘The NSCG has to flex its muscles. Politicians have to accept their recommendations and clinicians have to put aside personal conflict and institutional self interest.’ And patients and parents have to accept they may have to travel further to get the best treatment. We shall see.
The battle to safely reconfigure specialist services is also at the heart of the current Bristol pathology inquiry, which MD is due to give evidence to next month. The Royal College of Pathologists (RCPath) describes pathology as ‘the hidden science at the heart of modern medicine’ but it’s high time it was flushed out into the open. As medicine becomes increasingly technical and individualised, there is an urgent demand for specialist pathologists with the experience to spot the complex nuances in tissue samples and advise on treatment. Alas, specialist pathologists are in short supply and the temptation, to save money and hold onto business, is to let those with insufficient expertise report on complex slides.
This is the allegation made against pathologists at University Hospitals Bristol, with evidence submitted of serious reporting errors for complex gynaecology, respiratory, dermatology, breast and paediatric tissue samples. There is also evidence that, as with the heart scandal, a lot of senior NHS managers, consultants and the royal college have known concerns about UHB’s pathology department for some time. So there are powerful vested interests in not having another scandal.
UHB ordered the external inquiry, chaired by Jane Mishcon, but only after the Eye went public with the allegations. The Trust was initially overseeing the inquiry, but this clearly lacked independence and it has now transferred to London under the management of Verita. However, the inquiry panel has no control over the analysis of samples. The alleged errors reported to MD have occurred between 2000 and 2009, and all in specialist areas. Whereas the inquiry is looking at a random sample of 3,500 adult slides taken across a single year and including all the ‘bread and butter’ reporting, so complex mistakes can be buried and the overall error rate will look small. This is precisely the tactic used in defence of the heart surgeons. The inquiry needs to focus its attention on specialist areas and specific cases.
Against this background, local cancer services are in the process of being reconfigured to make them ‘safe and sustainable’. All are highly dependent on co-operation between hospitals and developing specialist pathology services but whether Bristol’s clinicians and managers can work together and share expertise remains to be seen. Oh, and UHBs chief executive Graham Rich has just resigned.
Private Eye: January 26, 2010
Very human errors
Last year, MD met an Australian surgeon who tells his junior staff: ‘Your job is to stop me killing anyone.’ Nurses, receptionists, patients and relatives are all encouraged to speak up if they think something isn’t right, and it’s looked into promptly without knee-jerk blame. As a result, his cock-ups and complaints are commendably sparse and he has no shortage of applicants for his training posts.
The NHS has been trying to develop a grown-up safety culture for over a decade, but there is still a huge reluctance for staff to comment on each other’s work. A senior nurse who helped developed the national guidelines for the safe and sterile insertion of central venous lines recently observed a junior doctor putting a central line with a clearly dirty technique. The drapes weren’t in place and there was a danger he would introduce infection directly into the patient’s blood stream. But because it wasn’t her patient and she didn’t know the doctor, she didn’t feel in a position to comment.
The reticence of some NHS staff to offer constructive criticism and the unwillingness of others to accept it is at the heart of many clinical errors. When serious errors are analysed in detail, staff have often spotted something wrong but not said anything, or tried to raise concerns and not been taken seriously. In the infamous ‘wrong kidney’ disaster, both the medical and nursing students tried to point out the surgeon was operating on the wrong side. And in the death of Elaine Bromiley (Eye 8.5.08 ), nurses recognised that she needed an emergency tracheotomy after a failed anaesthetic, and even brought the kit into the operating theatre, but didn’t feel able to interrupt the consultants.
Elaine’s husband Martin, a pilot, founded the Clinical Human Factors Group (CHFG) to help the NHS learn that guidelines and checklists are pointless without behavioural and cultural change. Under pressure, even the most senior doctor can panic, develop tunnel vision and go badly off piste, and without a team ethos that allows someone more junior to point this out, a disaster inevitably happens. The CHFG has now joined forces with the Patient Safety First campaign for a series of webcasts on the importance of addressing human factors in preventing medical error. One relatively simple idea is to encourage anyone performing a procedure to say: ‘If you think I’m going to make a mistake, please tell me.’ This also applies to patients and relatives. A change of pill colour or site of infusion is always worth querying. And given that 1 in 10 patients are harmed by their treatment, even a modest reduction in medical error could pay huge dividends.
Picking up errors after the event is also important. Pathologists are particularly vulnerable because tissue patterns are complex and subtle, and samples reported under stress are then stored for others to analyse at leisure. Specialists are also in short supply and this makes it imperative that pathologists work in teams and networks across regions, double checking difficult samples and seeking expert opinions. In Bristol, where pathologists in one hospital have tried to raise concerns about errors at another, the culture appears to be stuck in ‘how dare you question my reporting?’, rather than ‘let’s work together to make sure this patient gets the correct diagnosis and best treatment.’ Whether the current inquiry sorts it remains to be seen, but the pathology departments of both hospitals could do worse than sitting down together for the Truth and reconciliation following serious harm webcast (Thu 4 Feb, 10.30-11.30)1
1www.patientsafetyfirst.nhs.uk/Content.aspx?path=/Campaign-support/humanfactorsweek/.