Patient safety

Omissions: reading the Kennedy report on Ian Paterson

 

This imagined reflection by a doctor who worked with Ian Paterson is, of course, ill-informed. I was not there. But I have read Sir Ian Kennedy’s brilliantly written report (2013), and think that the messages it contains should be seen by the wider medical community. The report is 166 pages long, but perhaps this ‘story’ will help introduce people to it.

In the excerpts from the reports that follow the reflection, I have removed the names of clinicians. However, it is all in the public domain. The Kennedy report focuses on Mr Paterson’s unacceptable surgical technique, and the NHS Trust’s slow recognition and response. It does not examine the unjustified operations and investigations in the private sector, for which he was recently convicted.

This article sits with two other posts, ‘Why Michael didn’t blow the whistle: pub scene’ and ‘The eyes and the ears: why Adam blew the whistle’. Like those, it explores a doctor’s internal battle of the conscience, insecurities and the concept of moral bravery in the workplace.

 

***

 

“I wasn’t directly involved, but I was in a position to observe. When he was suspended I wasn’t surprised; it was high time. The criminal stuff, that did come as a surprise. I had no idea he was doing operations unnecessarily. But this is less about him than us, as a group. About me.

“We knew he was no good. His reputation preceded him, and as time went on a few people discovered firm evidence that he was an outlier. So your question is valid – why didn’t we act sooner? Why didn’t I?

Ian Kennedy

“When the weight of complaint was sufficient, action was taken. But before that, for years, we did what Kennedy said we did in his report, we worked around him. That’s what you do with difficult personalities. A jagged rock in the stream, which will not be eroded. The water goes around it. Decisions were made without him. He was excluded from the panel when the second surgeon was appointed. They couldn’t risk having him anywhere near the process.

“I watched him in the MDTs. He led from the front, made decisions quickly, and helped to ensure that the huge list of patients was dealt with. Snappy assessments and decisions were necessary. The referrals never let up. From time to time the oncologists pushed back, about the type of surgery, the need for revisions when you’d have expected a cure… but their searching tones changed to resignation after a while. They had done an audit on the resection margins, had proven he was an outlier, but nothing changed. What could they do? And anyway, they, the ones who were at the receiving end, who knew the outcomes were not right, didn’t actually work in the same Trust. You could see their faces, a bit fuzzy on the video link during the MDT… and they just looked neutral.

“The signal had been raised, the data had been forwarded… they say we are all managers, but we aren’t.  We are clinicians who rely on senior managers to tackle the problems while we get on with our jobs, which is seeing patients. That’s what they are for, to review the whole picture and make a judgment call.

“Okay, you say, what about your responsibility as a doctor to keep the pressure on, in the face of managerial inertia and an ongoing threat to patient safety. Well look at it… there was an external peer review around this time, and it concluded that apart from needing a few tweaks, the service was sound. In fact it was congratulatory. Once I heard that, I began to wonder if we, the doubters,  were the ones who had got it wrong.

“To keep the pressure on in this kind of situation you need to have absolute confidence in yourself. It’s got to be more than a suspicion or a sense of unease. So, if you hear that a review or an audit has been conducted, and that the people upstairs see no indication for urgent or fundamental change, you back off.

“Yes, even if you know, in your heart of hearts, that he’s probably doing harm. Because the risk in keeping your head above the parapet is substantial – not that it will be blown away, the NHS is not like that nowadays – but that your everyday professional life will become deeply unpleasant. There is enough sadness in cancer medicine, in the illness and grief we meet daily. If your interpersonal relationships breakdown, if you can’t look at your colleague in the eye or have a conversation, then coming to work becomes miserable. You might say that a little bit of discomfiture is nothing compared to protecting patients, but it’s all a balance. We go through our careers observing colleagues who may well under average, but we can’t act to remove all of them. Half of us are below average by definition, aren’t we? Quality lies on a spectrum. Who am I to say, not bring a surgeon, where one should lie on that spectrum?

“I did think about raising hell, once. This was when I met a patient who had a recurrence in breast tissue that should have been removed first time. She was living proof that his surgical method was wrong. There in front of me was the embodiment of disappointment and suffering, and also of dishonesty… because when she consented to her mastectomy she did not know that his particular method, to leave some fatty tissue behind, put her at a greater risk of recurrence. She, and her husband, assumed that the person in front of them knew best, that the expert was an expert, and would only suggest a treatment that was effective.

“When I saw the situation from the perspective of the patient, I shook myself out of my comfort zone, and I went to speak to someone. I won’t say who. And that conversation cooled my anger. Another perspective was provided. It was explained to me… that he carried the service, that he was industrious, not lazy… which you can’t say for everyone… that the patients trusted him and that didn’t happen accidentally, that there was actually an infrastructure in place for monitoring people like him, called appraisal, which he flew through each year. I walked away from the meeting with a new understanding. I didn’t have to sacrifice my professional quality of life, I didn’t have to go on a mission to get this guy out. Others were aware of the ‘problems’, and they were generally happy that although he was an outlier, he did not lie far enough outside the norm to be stopped.

“And of course, they were wrong. Perhaps they were all looking at each other, talking to each other, and hearing the same thing. Echo chamber. There is no real problem here… so many patients treated… targets met. Targets met… the echo.

“When, as a non-surgeon, you look at a surgeon, there is a certain awe. It sounds childish perhaps, and I’m no worshipper, but I know – we all know – that the job they do, cutting into others, is different. It takes confidence and skill to get through the training. There are technical factors that the non-surgeon cannot hope to understand. The interaction between tissue and metal is a mystery to people like me, I can’t judge it with confidence. The outcomes yes, but not the technique. That requires others to come in a make a judgement. The Trust did that… and we did not see the conclusions, not for years.

“These are not excuses. I am not proud of my inaction. I accept I played a part in the acquiescence. If I had made more of a fuss, perhaps fewer patients would have undergone bad operations. But for all of us to watch for 8 whole years between 2003, when the first concerns arose, and his exclusion from the Trust in 2011, it must have been something more than individual weakness… it must have been a permissive environment that prioritised surface efficiency over quality. Kennedy’s report focuses on the role of the non-executive directors, who incuriously accepted what they were fed by the executive, who had a rose-tinted view… on the secrecy of HR processes, on reports and audits being unsupported… organisational. Cultural. He does not put the blame on individuals like me, even though we were the ones of knew…

“And next time? That’s the problem you see. Although I can recognise my omissions in this case, I’m not sure I’ll act differently next time. Because you don’t know, until you’ve seen the proof, that the doctor you are worried about is a doing real harm, or is actually malign. You might have your suspicions, but the proof – which in this field is, ultimately, death – does not present itself.

“Unless we all agree that a certain degree of suspicion, a certain number of reports or complaints should result in suspension, we are not going to put these people on gardening leave just in case. Our clinical services could sustain it. There isn’t enough slack in the system. There wasn’t enough slack to give the two guys who were asked to write reports the time off from clinical duties to produce something quickly. It one of them took three months. We need the time and the space to work on these issues. We need to act on risk, not proven harm. In doing that, we might have to suspend five surgeons to confirm one case of unacceptable practise. ‘NNS, the number needed to suspend’ – do we buy into that? Perhaps we should, because when that risk is proven to be real, the time elapsed will have seen more patients come to harm while we vacillated.”

 

***

 

Excerpts from the Kennedy report on which this fictional reflection is based:

 

‘He came with something of a reputation as being a difficult person to work with. When he applied for the appointment, Dr _______, a senior manager at Good Hope Hospital, telephoned one of the Medical Directors at the Trust, Dr _______, to alert him to the fact that Mr Paterson had been the subject of an investigation and suspended in 1996 following an incident in which an operation on a patient had exposed the patient to a significant risk of harm. A review had been commissioned by the Royal College of Surgeons.’

 

‘That said, there was a level of informal knowledge. As one of the senior radiologists, told me, “To be honest, when we heard he was coming … it was, you know, ‘What’s gone on then?’ His reputation was well-known as being difficult and having open rows with a colleague at Good Hope. … it’s always a surprise to us why they took him on when they knew he was trouble”.’

 

‘Mr Paterson was described as high-handed to the point of being dismissive of colleagues. Forewarnings of this pattern of behaviour were already evident when Mr Paterson worked in the vascular unit. This unit was run in a very collaborative way, but Mr Paterson did not participate and rarely attended the MDT. When Mr Paterson moved to breast surgery, he behaved in a similarly challenging way. The hope was, it appears, that the managerial and governance arrangements in place would deal with whatever had to be dealt with. It was a forlorn hope.’

 

‘He had been the subject of an investigation and suspension two years previously by his then employer, Good Hope Hospital and had been required to undergo a period of supervised practice before recommencing laparoscopic surgery. The Trust was advised of this prior to his appointment.’

 

‘He is described as charismatic and charming and was much-liked by his patients. He was not, however, a team-player in an area of care which is absolutely dependent on clinicians working efficiently and effectively as a team.’

 

‘They [his colleagues] were faced by an awful ethical dilemma: what to do about the patients whom they were seeing who were supposed to have had a mastectomy but had not, in fact, had one…’

 

‘The Report overlooked a crucial issue: the issue of consent. Women were giving their consent to a mastectomy. But, on occasions, a variation of a mastectomy was being carried out; what became known later as a “cleavage sparing mastectomy”. This was not a recognised procedure. Women did not consent to it in any properly informed way.’

 

‘Senior managers saw Mr Paterson at the time as a highly effective surgeon performing efficiently, enabling the Trust to meet its targets.’

 

‘The concerns over Mr Paterson’s clinical competence went unaddressed. Mr Paterson continued to operate as before for nearly four years. The oncologists who were based in another Trust felt ignored. They had expressed their concerns and supplied evidence. They felt that no-one at Mr Paterson’s Trust was listening.’

 

‘They were told the good news from the Report of the Peer Review in 2005. They were not told of Mr _____’s Report, nor the less favourable views expressed by the initial and follow-up QA Visits in 2004, and the recommendations which followed. Good news was preferred to true news.’

 

“…we did raise that we had some concerns and we were told not to worry about it, so for the next few years we didn’t say anything”

 

‘They took the view that because they were not surgeons, they were defined out of competence. As Dr _______ put it, “I had taken the trouble to go through 100 cases, two thirds of my case-load for a year basically, and anything other than the most rudimentary examination of that would have shown substantial problems and the Trust took not a blind bit of notice of it and, not only that, they swept it … under the carpet”.’

 

‘When the Trust decided to make a new appointment in 2007, Mr Paterson was excluded from the process of selection, despite his being the leading surgeon, for fear that he would again put off any applicant. This is just one example of how senior managers behaved, towards Mr Paterson. Rather than confront him, they preferred to work around him.’

 

‘The new surgeon appointed in 2007 soon began to raise concerns about Mr Paterson’s surgery after seeing some of Mr Paterson’s patients, under the newly introduced system of cross-cover. The senior managers decided to launch an investigation.’

 

‘… if the issue of consent had been identified, as it should have been, a reason to require Mr Paterson to cease operating had existed for several years earlier.’

 

‘He [a colleague] talked of “raising his head above the parapet”. This speaks volumes about the perception of the way that the Trust then worked: that raising concerns was to be characterised as putting your head above a parapet, with the implication that the head would be shot at rather than welcomed and invited over the battlements to talk further.’

 

‘He realised that what he lacked was proof that women were being put at risk. The only way that he would obtain that proof was if women presented with recurrences of their cancer. And given that it might be several years before recurrences occurred, there was nothing he could do in the meantime.’

 

‘Evidence of actual harm, except in the most obvious cases, is usually hard to come by. It takes careful documentation, proper sampling and statistical analysis. Without all these, the concerns will be at risk of being dismissed. Dr ______ provided evidence but it did not show harm. It showed a deviation from accepted practice and a risk of harm.’

 

‘They told me that by the time their own concerns were coming to the fore, “everybody was aware of this”. One replied, “… it’s like stating the bleedin’ obvious, they already knew. … the senior management had been informed by the rest of the team, the consultants, and I can see that us adding our voice to that may have had – well, I don’t believe it would have had any effect but I can see that there is an argument that you could say, well, you know, you didn’t raise concerns as well but they’d already been raised…”.

 

‘…once the HR procedures were invoked, everything was covered by a blanket of confidentiality. Like others, they were kept in the dark.’

 

‘Organisations can tend to become closed, to exclude others and become disinclined to listen to the voice of “outsiders”. This is usually a bad sign in terms of the performance of the organisation… The “outsider” may see himself in such terms, feel he has done his bit and retreat to familiar territory.’

 

‘It is impossible to overstate the emotional burden that he and others shouldered for years. As Mr _______, who carried out an investigation in 2007, put it to me, while he did not want to emphasise the element of emotion in what he heard as he gathered evidence for his Report, “to see someone virtually in tears was an eye opener”.’

 

‘He realised that what he lacked was proof that women were being put at risk. The only way that he would obtain that proof was if women presented with recurrences of their cancer. And given that it might be several years before recurrences occurred, there was nothing he could do in the meantime.’

 

‘A concern about the practice of a clinician is raised. It is perceived as a criticism of the clinician rather than a concern about patients. The perspective is that of the clinician. The response of managers to the person expressing concerns is to demand evidence: to “put up or shut up”’.

 

‘The call for proof, in a situation such as the one under review, was based on two flaws. First, it proceeded on the basis that the issues at stake were scientific and technical and could and should only be addressed scientifically and technically. This is the way that clinicians tend to think. It is their comfort zone. And, it allows arguments about data and its interpretation to go on for years. The flaw is that, while there may be technical issues to address, the primary issue is that concerns are being expressed about the care of patients [   ] the proper response is to stop and look.’

 

‘Peer Review Visits do not have sufficient rigour to be regarded as a reliable guide to performance. They should either acquire the necessary rigour or be regarded as a useful exercise in bringing people together but not a serious examination. Currently, organisations may present the results of a Peer Review Visit in self-congratulatory terms, even though, on occasions, self-congratulation, on a more careful analysis, may be unwarranted. Patients and the public, therefore, should be alert to this when forming a view on the performance of a service or unit.’

 

‘Further light is cast on the failure to grasp the importance of consent by the practice, which I still encountered in 2013, of clinicians talking of “consenting” patients. The objections to this awful phrase are not merely linguistic. They go to the heart of a proper understanding of the relationship between patients and clinicians.’

 

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The corrections

 

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I can number on the fingers of one hand the times I have been explicitly corrected during my medical career. There was the time I treated a patient all night for septic shock when in fact he had cardiogenic shock – the fluid nearly drowned him. There was the time I performed a lumbar puncture on an obese patient, and put the needle three inches away from the correct inter-spinous space. There was the time I failed to check a gentamicin level before the weekend, and came back on Monday to find the patient in renal failure. And during higher training, the course where my endoscopic technique was picked apart against a list of errors that the assessor held in his hand; he described three issues, but I glimpsed the piece of paper and the list was at least ten items long. There are others, some of which are littered across this blog.

Each time I felt embarrassed and defensive. I reacted by rationalizing. The reasons, or excuses, were various, and included the way I had been trained, the pressure of time, the load of patients, the need to balance speed and vigilance, and plain bad luck. But each time the fact that I had been criticised ate away at me. I was not used to it. Few of us are.

Medical students tend to come from the highest strata of achievement in secondary education, where their performance requires very little correction. Most float through training in the middle of the pack, periodically struggling to stay above the flood of knowledge, neither excelling nor failing. They require little in the way of feedback, just the odd nudge back on track. They become competent in the early years on the job and deliver medicine safely. Errors occur, many due to weaknesses in the system rather than personal fallibility. Corrections happen, but they are infrequent. And then, before you know it… they are practising more or less independently. They are part of a team, but they are essentially ‘complete’. They habituate to many forms of stress, but one that they are not accustomed to is ‘constructive’ feedback. When it comes, if it comes, it hurts.

How else do we improve once we have arrived at our natural ceiling of seniority? Continuing professional education is mandatory, we do it, and our knowledge is augmented, but weaknesses are not identified by passive absorption. Appraisal? Somewhat routine, and focused more on our perception of ourselves than feedback. Revalidation – mmmm… we’ll see. So how do our weaknesses get identified? The answer is, by our peers – those whom we work with day in and day out. The difficulty with this is that they are the last people who wish to engage us on our deficiencies. They are colleagues and friends.

Most error is self detected and self corrected. Although I listed only a handful of occasions where mistakes were fed back to me, there are hundreds (well, let’s say ‘tens’) of similarly significant mistakes which I identified myself, and reflected on. Nobody came to tell me that such and such happened because I missed a clinical clue or performed a procedure incorrectly – there is no ubiquitous or all-seeing observer to perform this function. The continuous feedback loop of self-improvement requires attention to consequence, and the ability to accept that something bad has happened because of what you did or omitted to do. Without a willingness to seek the consequences of our decisions we will blunder on regardless. However, a safe culture cannot be expected to rely solely on such of subjective system.

Receiving  feedback as a junior doctor in training is hard enough, but it is standard and expected. You rely on it. The discomfort that comes with receiving negative feedback from a colleague of equal seniority, at consultant or GP level, is even more acute. The same rationalisations occur, recourse to the same ‘excuses’ – the pressures, the pace, the reaction to diffuse responsibility that appears to have unjustly landed on your head just because your name was over the patient’s bed. So much for receiving; how about giving? It’s even worse. But becoming comfortable with discomfort seems an absolute requirement for a safe medical culture. It is easily described, but not so easily undertaken.

Soon after becoming a consultant I took on the task of reviewing the notes of patients who had suffered ‘hospital acquired’ venous thromboembolism (ie. DVT or PE). It sounded easy, and quite interesting. I flicked through the charts, identified possible lapses in prescriptions of anti-coagulant, and marked them as avoidable or unavoidable. The catch was… I had to interview the consultant in charge of patients deemed to have suffered avoidable events. I sent out emails, arranged convenient times to meet, and found myself addressing equally experienced or more established consultants. It was not easy. The key to converting it from a repeatedly painful and nerve-wracking exercise was this – I too had been called up to justify a similar lapse, months earlier. The discomfort, the access of humility, the acceptance that yes, it could have been done better, we (I) should have been more vigilant, served as a brief lesson in correction. That was the angle when it came to phrasing my own feedback:

‘It happens to all of us at some point, it’s bound to. Happened to me last year. And it worked. If I hadn’t been asked to attend the meeting I wouldn’t have known that so and so had a big PE three weeks after they went home from my ward. It worked. It made be think twice about checking it on ward rounds, brought it home. It’s not about criticism, it’s about focusing minds on the things that are easy to let slip through your fingers…’

You get the gist. Correction shouldn’t be exceptional; it’s inevitable.

If hospitals and surgeries are to witness more of those ‘difficult conversations’ we keep hearing about, in order to promote a safe culture, each of us has to find a way to get comfortable with starting those conversations. The best way – in my limited experience – is to bracket them in the context of our own fallibility, for none of us are perfect, and we are all bouncing from error to error as we move forward in our careers. That’s medicine.

___

There do not seem to be many articles on how to deal with the discomfort of giving negative feedback, but I did find these two in the BMJ and the Hospitalist (US).

 

New booklet, click picture to explore…

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The place of blame

The importance of a ‘no blame’ culture in the NHS has become axiomatic. It is accepted that the chain of learning that connects adverse healthcare events to improvements in safety is fatally interrupted when incidents are not reported. If people fear blame and censure, they will not report. Berwick focussed on this in his 2013 post-Francis report, ‘A promise to learn – a commitment to act Improving the Safety of Patients in England’. It says,

Patient safety problems exist throughout the NHS as with every other health care system in the world.

NHS staff are not to blame – in the vast majority of cases it is the systems, procedures, conditions, environment and constraints they face that lead to patient safety problems.

Fear is toxic to both safety and improvement.

 and recommends,

To address these issues the system must: 

– Recognise with clarity and courage the need for wide systemic change.

– Abandon blame as a tool and trust the goodwill and good intentions of the staff.

 blameberwreportfront

 

As a doctor who is involved in mortality and morbidity meetings, I often think about the role of blame in learning lessons. At my level medicine consists of numerous interactions between just two or three kinds of people; patients and doctors/nurses. If a mistake is reported an assessment is undertaken as to whether that mistake was due to a fault in the system (eg. poor process, unclear guidelines, bad IT, poor labelling) or a restricted error on behalf of the health care worker. The latter might include mistakes due to a lack of knowledge, or due to a lack of concentration.  But what if the lack of concentration is the result of unintelligent rota design, or distraction due to an over-burdened system? The spectrum of potential accountability is wide, but whenever an error is identified it is necessary to see at what point on that spectrum the underlying cause lies. Or the blame.

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Example: a junior doctor gives a patient an antibiotic that she is allergic to, the doctor having failed to recognise that the trade name (let’s say Tazocin) disguises the fact that it contains penicillin. The patient has an anaphylactic reaction and spends a week on intensive care.

The focus of accountability could reasonably fall on one of several points. It could be the doctor not being aware that the antibiotic contained penicillin, or for not checking that the patient was allergic. For not bloody thinking, his exasperated supervising consultant might say to herself, immediately succumbing to the emotional retort that is ‘blame’.  Or, could it be the doctor’s educators who have not emphasised that fact in his training? Or the drug firm for releasing a medication which does not make its crucial ingredient plain? Or the Trust for not being responsive to the fact that this doctor is routinely over-pressurised at night, and making decisions in a hurried way. Or the Department of Health for capping central funding, or David Cameron for supporting a policy of austerity…  or mortgage lenders in America for contributing to the 2007 financial crisis.

This begins to sound sounds absurd, but the point I’m trying to make is that the chain of blame could be a long one. And when you make a mistake, it is natural to look up and around for mitigating circumstances.

Now imagine that the junior doctor is brought into his educational supervisor’s office. It is explained that the patient came to harm because the doctor prescribed the drug to which the patient was known to be allergic. It’s my fault, is how the doctor will feel. But the educational supervisor will be quick to soften the criticism by explaining that there will be a review of systems, more nurse education so that injections are not actually  given if it says penicillin allergy on a drug chart, and the Trust will arrange some extra pharmacology teaching for House Officers. Use of the misleading trade name will be banned. The system has learned. It’s not your fault.

Immediately the sense of blame rises from the shoulders of the junior doctor and it becomes clear to him that it is not just his problem. Should that doctor walk out of the room with no sense to blame? Well, I can recall most of the mistakes that I have made in my career, and the intense sense of blame and guilt that accompanied them. Whether it was mismanaging Gentamicin and causing renal failure, missing a cord compression or making a late diagnosis on data that I should have interpreted correctly. It is blame, the sense of personal responsibility, that nagged at my mind and made sure I never made the same mistake again. For this reason I think individual blame does have a role. And I am not alone. A National Patient Safety Agency presentation from 2004 includes these slides:

blamejustculture

blamegraph1

 

At least 90% of error can be attributed to system problems or ‘honest’ errors, while only a small percentage are deemed ‘culpable’. This data is largely derived from the aviation industry, where many parallels with healthcare have been identified. But even this presents problems. The ‘honest error’ is still an error. Just because it is honest (ie. not intentional or negligent, an error that quite would probably have been committed by a peer in the same combination of circumstances) there is still something to be learned by the individual.

The psychologist James Reason describes person and system approaches. The former attributes unsafe acts to,

aberrant mental processes such as forgetfulness, inattention, poor motivation, carelessness, negligence, and recklessness.

 Whereas a system approach accepts that,

 humans are fallible and errors are to be expected, even in the best organisations. Errors are seen as consequences rather than causes, having their origins not so much in the perversity of human nature as in “upstream” systemic factors.

 

For those of us dealing with error on a day to day basis, an approach that tackles individual blame while paying heed to system-wide lessons must be taken. For reporting to be encouraged, blame must not apportioned in public… for that is where shame develops, and its lethal consequence – inhibition. But in private, as we look at near misses and significant errors, we will sometimes accept that it really was a silly thing to do. And we will not hide our concern, nor conceal our disappointment if the error appears to indicate a worrying gap in knowledge, method or attitude. If this is the case a way must be found to lighten the sense of personal blame by looking up at systemic factors (if present), but without allaying personal discomfort entirely. In this way we (for it will happen to all of us at some point) will remain alert, and perhaps even a little paranoid, when we enter a similar clinical scenario in the future.

 

oOo

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