John Fry Fellowship Lecture

Revalidation of Doctors: The Credibility Challenge Professor Mike Pringle

Published by The Nuffield Trust 59 New Cavendish Street London W1G 7LP

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The John Fry Fellowship was established by the late Dr John Fry, for many years a trustee of the Nuffield Trust. It provides an opportunity for the Fellow to write and lecture on a subject in the field of general practice and primary health care.

This paper accompanies the lecture given by Professor Mike Pringle on 8th June 2005, at Cavendish Centre, London.

John Fry Fellows:

David Cameron Morrell John C Hasler Iona Heath Professor John Howie Professor Angela Coulter Professor Richard Saltman Professor Barbara Starfield Professor Mike Pringle

The Nuffield Trust 59 New Cavendish Street London W1G 7LP

1 Revalidation of Doctors: The Credibility Challenge

John Fry Fellowship Lecture

Professor Mike Pringle, CBE, MD, FRCGP, FMedSci, is Head of School and Professor of General Practice at the University of Nottingham. 2 Revalidation of Doctors: The Credibility Challenge

On the morning of the 15th launched. This was a profound event December 2004 two vital meetings in British medical history. were held in different parts of In the debate on the future of London. In its new premises on the revalidation the stakes are high. There Euston Road the General Medical are two powerful ideologies currently Council met in closed session to fighting for the soul of British discuss its response to the Fifth medicine. At issue is whether the new Report of the Shipman Inquiry1 led by Dame Janet Smith. Simultaneously,in culture of healthcare will be to refine the Department of Health in but essentially maintain our long Whitehall a summit was convened to tradition of medical paternalism; or discuss the department’s initial whether it will be to maximise patient response to the same report. care and choice, to protect patients That morning the General Medical from harm and to promote a patient- Council decided that the right policy centred, patient-led health care was to stick by its guns, including system3. reiterating its support for its model of In this paper I will look at the revalidation for doctors, only three background to the decisions on the months away from being introduced. 15th December 2004 and will try to Simultaneously, the Department of Health decided that revalidation could offer an analysis of the way forward not be allowed to proceed. Its formal for revalidation. I will be arguing announcement of the Chief Medical from the perspective of protecting Officer for England’s review was made and supporting patients. I will be two days later2. talking about all doctors, for an The effects of these concurrent effective system of quality assurance meetings cannot be under-estimated. has to apply across the profession, but Revalidation, that started with noble particularly referring to those doctors idealism in 1998, that had been in independent practice – consultants dramatically re-designed in 2001 – a and general practitioners. re-design found in Chapter 26 of the Before I start, however, I do need Fifth Shipman Report to be not fit for purpose – had been re-affirmed by to tell you a little about myself, and to the body that owned it, and had been offer a working definitions of the terminated, or at least deferred by term “revalidation” and “licence” that political power just before it was to be I will use in this paper. 3 Revalidation of Doctors: The Credibility Challenge

My background College of General Practitioners I became that College’s representative Before I can ask you to accept my on the General Medical Council and analysis, you do need to know then, in 2003, I was elected to the something about my credentials. I am, reformed General Medical Council, first and foremost, a general continuing my involvement in practitioner. For over 25 years I have revalidation. delivered care to my patients in Collingham, a medium size rural practice in Nottinghamshire. I have What are revalidation and a also been an academic for over two licence to practise? decades and one of my themes has Before I get too embroiled in this been the promotion, the quality narrative I need a working definition assurance and the recognition of of “revalidation” and “licence to excellence of clinical care, in order to practise” since it has become obvious enhance patient outcomes. I was the to me that semantics underlie some first ever Fellow by Assessment of the apparent disagreements surrounding Royal College of General this debate. Practitioners, I coined the term Since the General Medical Council “significant event auditing” and coined the term “revalidation” it can introduced it to primary care: it is claim, as it does, that it means exactly now embedded in the new General what the General Medical Council Medical Services contract’s quality wants it to mean. It says that “the and outcomes framework. I was co- purpose of revalidation is to ensure chair of the Diabetes National Service that patients have the confidence that Framework, which set out a patient licensed doctors are up to date and fit centric vision for diabetes care4. to practise”6, a positive endorsement In 1998, the year that revalidation of their performance. It goes on to say was first proposed by the General that revalidation identified for further Medical Council, I was elected to be review those whose fitness to practice chair of the Council of the Royal may be in doubt. College of General Practitioners, a It is not, they say, about post that was, over the next three identifying poor performance. Yet that years, to give me increasing insight is exactly what the legislation into policy development around introducing revalidation (which refers revalidation5. Soon after completion to revalidation as an “evaluation of a of my term as chairman of the Royal medical practitioner’s fitness to 4 Revalidation of Doctors: The Credibility Challenge

7 practise” ), Dame Janet Smith and the CONTINUOUS PROCESS Internal: Shipman Inquiry, and the public at Professionalism 8 Peer Pressure large think it is about. Patient Expectations External: My view is as follows. We are Clinical Governance Audit/Quality Assurance embarking on a process that has two Annual Appraisal components – continuous monitoring Performance Management Complaints and episodic re-certification. Either of Litigation those processes can lead to concerns and these will result in either assessment or, if thought sufficiently EPISODIC SUBMISSION FURTHER severe, referral to the Fitness to OF EVIDENCE ASSESSMENT Practise Procedures of the GMC. The vast majority of doctors are up to date and fit to practice. The FITNESS TO continuous processes will raise no PRACTISE CONTINUING LICENCE PROCEDURES concerns; they will satisfy

revalidation’s first stage (the episodic Figure 1: The full system of continuous and episodic quality submission of evidence) and their assurance licensure will be continued (the left the Fitness to Practise Procedures of hand side in Figure 1). the GMC. Since the processes are an However, let us imagine a doctor integrated system of proactive who is slipping into under- scrutiny I refer to everything beneath performance. Perhaps the doctor has the dotted line in Figure 1 as developed a tremor that interferes “revalidation”.Thus for me with surgery, an alcohol problem or a revalidation both identifies those who depressive illness. Or the doctor hasn’t are up to date and fit to practise, and kept his clinical knowledge base up to those who are not – and deals with date. Or poor communication skills them appropriately. are being compounded by increasing The outcome of revalidation is a lack of insight. continuing licence to practise. Most In a perfect world such doctors would regard that as a licence to would always be detected and dealt undertake the work that they purport with by the continuous process; in the to undertake. So a licence to do renal real world many will not be. The transplants for a renal surgeon; a episodic submission of evidence will licence to undertake general practice be identified some for further for a general practitioner; a licence do assessment which may even lead to dermatology for a consultant 5 Revalidation of Doctors: The Credibility Challenge

dermatologist; and a licence to offer policy document of the year before supervised care for a junior doctor. (The New NHS: Modern and The essential outcome of revalidation, Dependable14) with A First-Class however defined, is that the public Service: Quality in the NHS15 in which and the profession can have it set out a new commitment to confidence in the licensure of doctors. ensuring all patients had better and This is the credibility challenge safer care; and the concept of regular referred to in the title – the public will re-certification of a doctor’s expect revalidation to protect them competency – now called revalidation from poor and under-performing – was seriously resurrected16. doctors. If it will do so, then let us say The 1998 revolution did not arise so. If it will not, then I would argue out of a void. While I regret that there that we are wasting our time. is insufficient time to explore the foundations of revalidation in full here, I believe that a summary will The background to help to develop my argument. revalidation

In 1975, the Merrison Committee9 The promotion and assessment recommended periodic tests of of quality in individual doctors competency for doctors. The Alment Committee then examined the First I will look at the attempts to concept in more detail and in 1976 promote and assess quality in declared it impractical. The idea was individuals. The very formation of the never fully discarded, but it had few General Medical Council in 1858 was friends or supporters for the next two the first codification of entry into the decades. profession and the General Medical 1998 was to be the pivotal year for Council through first its conduct revalidation. The General Medical procedures, then its health procedures Council’s hearing into paediatric and finally its performance cardio-thoracic surgery at Bristol procedures (now all wrapped together Royal Infirmary was concluded10,11; as the Fitness to Practise procedures) the second edition of Good Medical has taken a lead in examining Practice12 and the first edition of evidence concerning individual Maintaining Good Medical Practice13 doctors and acting to protect the were published by the General public when action was justified. By Medical Council; The Department of regulating medical education, the Health followed up its overarching General Medical Council has a major 6 Revalidation of Doctors: The Credibility Challenge

role in ensuring young doctors are fit then Membership by Assessment of to enter the medical register and by Performance19. setting standards of both ethics and In the post-1998 world, the NHS practice it sets the philosophical has become much more involved in framework in which competency and the quality assurance of individual fitness to practise can be assessed. doctors. The one that has most Individual doctors have always impact has been annual appraisal to been subject to the laws of the land which I shall return. Individual and complaints and litigation have doctors now have much greater been used by aggrieved patients. They direction in what care they should have been exposed to the opprobrium deliver through the National Institute or applause of their colleagues in of Clinical Excellence’s20 guidelines ward rounds, post-mortems, peri- and technology assessments, and natal mortality meetings and more National Service Frameworks. The recently in the “confidential inquiries”. other major change for individuals – In general practice I have been a and it applies to only a few – is the protagonist, as I said earlier, of National Clinical Assessment Service21 significant event auditing – a system (now part of the National Patient of peer review in which events leading Safety Authority) and its system for to good and adverse outcomes can be assessment. discussed in an atmosphere of quality improvement. The promotion and assessment The Royal Colleges have set entry of quality in healthcare teams examinations, usually taken well after registration, and these have acted as In more recent times there has been filters for doctors wishing to progress considerable activity to promote and to independent practice as a assess the quality of healthcare teams. consultant or general practitioner. As hospitals came to deliver care in They have traditionally concentrated firms and directorates and as care on knowledge and skills in preference became more complex – surgical to attitudes and behaviour although outcomes may depend as much on this is evolving. The Royal College of the quality of nursing in intensive care General Practitioners has, or of the anaesthetists as to the quality additionally, defined what it means by of the surgeons – so measuring excellence in clinical practice – outcomes of teams, units or whole starting with What Sort of Doctor?17 hospitals became important. Indeed, and Fellowship by Assessment18, and developing health informatics has 7 Revalidation of Doctors: The Credibility Challenge

made it easier to monitor the clinical Foster27, are in the private sector and outcomes of whole hospitals or use NHS data to inform the NHS and general practices than to monitor the public. Mainly though such individuals within those institutions. scrutiny comes from the NHS itself, 22 Medical audit (promoted heavily in with monitoring of performance the 1990s) has been renamed clinical targets, Star Ratings, the NHS audit and then often as quality Litigation Authority, Healthcare improvement. It primarily looks at the 28 outcomes of team care. Commission reviews, and the like. General practice contracts have The new concept of “patient rewarded some “quality” activities safety” has been promulgated by the since the 1965 General Practice National Patient Safety Agency29. The Charter23 and especially since recognition of the importance of immunisation and cervical cytology system failures was led by the Chief uptake rates – quintessentially team Medical Officer for England with An activities – were rewarded with target Organisation with a Memory30 and will 24 payments in the 1990 contract . The hopefully, in time, change the culture New General Medical Services of the health service. The responsibility Contract25 is the first to be explicitly a of individuals will then be “team contract” but this was merely an acknowledgement of the prevailing appropriately placed alongside the reality. responsibility for systems that those Most of the changes of the last few individuals use in order to effective years, since the watershed year of protect patients from harm. 1998, have been targeted at quality However the most significant assuring teams. The most dramatic of change from 1998 has been the these is clinical governance26 which erosion of the old assumption that combines some aspects of individual leaving individuals and teams to “get doctors’ care, such as complaints or on with it” was sufficient. The real satisfaction surveys, with a catalyst was the Bristol hearings at the predominant emphasis on data from General Medical Council and then the clinical teams such as practices, clinical directorates or whole Kennedy Inquiry. The chain-reaction hospitals. was reinforced by a roll-call of shame: There are now many assessments Shipman, Ayling, Neale, and and comparisons between teams and Ledwood. The system was clearly not whole institutions. Some, such as Dr working to protect patients. 8 Revalidation of Doctors: The Credibility Challenge

International perspectives been considerably strengthened since 2001 with each doctor expected to Developments in the UK need to spend at least 50 hours per year on re- be seen in an international context. certification activities including Our concerns about protecting external audit, peer review of cases, patients have their echoes elsewhere analysis of outcomes and reflective in the world as other examples of practice32. Doctors can supply their long-term unacceptable performance evidence through their College (see 31 have come to light . Further,as below). doctors migrate throughout the world The Federation of Medical there needs to be international Licensing Authorities in Canada is coherence in how we train, register proposing a system of re-certification and continually quality assure based on demonstrable performance doctors. using a three stage process: screening Most other countries, including of all doctors; assessment of doctors those in the European Union, do not at risk or in need; and then a detailed see the need for re-certification of needs assessment. Finally registration doctors. Perhaps I should add the would be at risk. However there is, as word “yet”.The move to re- yet, no date for its launch33. certification is, so far, mainly a feature Also in the design stage are of Anglophone countries – the United proposals from the Irish Medical States, Canada, New Zealand, Council in which a doctor will need Australia and Ireland – with to demonstrate 250 hours in each five Singapore also leading the way. years cycle of approved continuing In some of these countries re- medical education, a peer review of certification is undertaken or is competence and a performance proposed to be undertaken by the review34. registration body, the equivalent of In some other countries our General Medical Council. professional bodies – Boards or From 1995, New Zealand doctors Colleges – require continuing or in independent practice have had to episodic evidence in order to retain obtain an Annual Practising membership in good standing, which Certificate from the Medical Council in itself holds rights to practise. In of New Zealand and for this they some countries, such as New Zealand must demonstrate that they were where failure to meet the standards of taking part in continuing medical the College results in removal from education and clinical audit. This has the Medical Council of New Zealand’s 9 Revalidation of Doctors: The Credibility Challenge

register, the College is in fact re- of Obstetricians and Gynaecologists37, certificating the licence to practice; the Royal New Zealand College of while in others failure of re- General Practitioners38, the Royal certification by a College results in Australian College of General withdrawal of membership of that Practitioners39, The Royal College of College with no direct effect on Physicians and Surgeons of registration. Canada40,The College of Family Let me start with the United States Physicians of Canada41 – have a long of America where the situation is, track record of 3 to 5 year cycles of re- perhaps inevitably, complex. The certification based on points for American Board of Medical taking part in audit, continuing Specialities, through its member education and other professional boards, must certify a doctor if that activities such as teaching and doctor is to be a specialist or sub- research. The College of Family specialist. So failure of re-certification Physicians of Canada’s evolving does not remove registration per se, programme requires evidence of but can remove the doctor’s main reflective practice – audit and source of livelihood. The American education linked in a quality Board of Medical Specialities started improvement cycle and the Royal with re-certification solely by College of Physicians and Surgeons of examination. However It is moving to Canada additionally requires a system called Maintenance of accredited self-assessment, and Certification involving evidence of structured learning with outcomes professional standing (peer achieved; these latter two appear assessment), self-assessment, lifelong particularly innovative and credible. learning (typically 300 hours of Another approach is that of the approved continuing education over 7 College of Physicians and Surgeons of years), an examination of knowledge Ontario which introduced in 1980 a and attitudes (including ethics and system for peer assessment of both a professionalism), and auditing of random sample of their members, performance including of anyone thought to be at risk, any communication and doctor requesting an assessment and professionalism35,36. This is clearly the all doctors reaching 70 years of age. most comprehensive approach and The assessment includes the physical stands in a category of its own. environment, the medical records Some Colleges – the Royal and, through case review, the quality Australian and New Zealand College of patient care42. 10 Revalidation of Doctors: The Credibility Challenge

My conclusions from this an unacceptable doctor as well as an summary of the international position excellent doctor. This was a vital first will be included in my discussions of stage in defining the standard ways forward. Suffice it to say here expected for revalidation. that the UK is at or near the leading Then, again with a broadly edge in re-certification but that we do representative group including two not appear to have taken the lessons senior officers of the General Medical from abroad fully to heart in our Council, we wrote a document discussions of policy options. describing a system for revalidation in general practice44 – well received on consultation – and a core document A partial history of revalidation called Criteria, Standards and Evidence in the UK for Revalidation of General I will not attempt to provide a Practitioners45. Although first written blow by blow account of the in 2000, we have kept this document development of revalidation. For that up to date. The Royal College of I can recommend Chapter 26 of the General Practitioners consulted on it Fifth Report of the Shipman Inquiry. I in the autumn of 2004 with wide can however give a personal support from the profession and perspective. interested parties. In 1998 the Royal College of By 2000 we had achieved, I General Practitioners was asked by the believe, a high level of consensus on General Medical Council, as were the both the general methodology and the other Royal Colleges, to lead on filling standards for revalidation in half the in the gaps in revalidation for general profession. The process is outlined in practice. We worked on this with the Figure 2: General Practitioners’ Committee of In essence every doctor, in hospital the British Medical Association, the or primary care, would submit a General Medical Council itself, and folder of evidence, much of the lay people. We first took Good Medical evidence gathered for appraisals and Practice and in a team led by Professor through clinical governance, to be Martin Roland we wrote and assessed against the Criteria, consulted on Good Medical Practice Standards and Evidence (based on for General Practitioners43. This Good Medical Practice) for their expanded on Good Medical Practice discipline. The folder would be and crucially defined a range of assessed by at least three people characteristics that we felt described including a clinical peer and a lay 11 Revalidation of Doctors: The Credibility Challenge

CONTINUOUS PROCESS which became General Medical Internal: Professionalism Council policy in May 2003 and is still Peer Pressure Patient Expectations the General Medical Council’s External: preferred option for most doctors. In Clinical Governance Audit/Quality Assurance essence it is as shown in Figure 3. Annual Appraisal Performance Management Complaints CONTINUOUS PROCESS Internal: Litigation Professionalism Peer Pressure Patient Expectations External: Clinical Governance EPISODIC SUBMISSION Audit/Quality Assurance OF FOLDER OF Annual Appraisal FURTHER Performance Management EVIDENCE, ASSESSED ASSESSMENT BY LOCAL Complaints Litigation REVALIDATION GROUP

FITNESS TO EPISODIC SUBMISSION PRACTISE OF EVIDENCE OF FIVE FURTHER CONTINUING LICENCE PROCEDURES APPRAISALS AND ASSESSMENT CLINICAL GOVERNANCE SIGN OFF Figure 2: The original model of revalidation pre-1998

person. If they recommended FITNESS TO PRACTISE revalidation the General Medical CONTINUING LICENCE PROCEDURES Council would normally continue that doctor’s licence for a further five Figure 3: The appraisal and clinical governance system of revalidation for doctors in GMC approved organisations years. Everything started to change, What changed? Well, the routine however, in April 2001 when the submission of folders was jettisoned, Royal College of General with only a small sample being Practitioners’ group was stood down examined. The lay input to assessing on the recommendation of the evidence went too. Criteria, Standards representatives from the General and Evidence disappeared for most Medical Council. It was at this time doctors, only to be used in the that the “five appraisals” route was “further assessment”.The essence of first adopted46 for doctors working in revalidation became the ability to General Medical Council approved satisfactorily manage five appraisals managed organisations (code for the and to avoid coming to the attention NHS and large private providers). of the clinical governance team. This became the “appraisal and There is no doubt that there was a clinical governance” methodology shift in policy in the spring of 2001. 12 Revalidation of Doctors: The Credibility Challenge

Why it occurred is for others to say; the episodic submission of evidence but I believe that this was when (Figure 1). If it can identify with principles gave way to pragmatism reasonable accuracy and precision and the seeds of the current debacle those doctors who are under- were sown47. Right from my first performing then the affirmation of a opportunities, I have argued that this doctor as fit to practise will have some was an error of judgement, and I will meaning to doctors, employers and, continue to do so in this monograph. most importantly, patients and the My reasons for doing so will become public. This was, of course, one of the more apparent in my discussion of foundation principles of revalidation the ways forward. as set out by the General Medical Council in 2000 – it must be effective Options for the future of in sorting out those who are fit to revalidation practise from those who are not48. I have heard the argument, as you In this section I will look at each will have, that the continuous process of the tension points, as I see them, will be so efficient that no under- phrased as a series of ten questions performing doctors should need to be and, based on the account given so far identified at the five-yearly in this monograph, offer ways revalidation. That, by inference, forward. means that revalidation need not be an effective detector of under- Question 1: What is the purpose of performing doctors since none will revalidation? It might seem bizarre that this get there. In that case I would argue question would need asking. If there that there is no function for is no clear consensus answer by now, revalidation and we should scrap it. It then what have we been doing for the will add nothing to the identification past seven years? of fitness to practise. The sad reality is that there are So the credibility of revalidation two clear cut answers to this seminal depends on whether it can detect, question. The prevailing answer is with reasonable accuracy (no system that it is to affirm that the vast will be 100%) under-performing majority of doctors are up to date and doctors who have slipped through the fit to practice. continuous system net. As I will The credibility of this position lies argue, the current “clinical governance on the specificity and sensitivity of and appraisal” method of revalidation 13 Revalidation of Doctors: The Credibility Challenge

will definitely not achieve that role appraisal by a GP colleague and, in with any degree of credibility. my capacity as an academic, I have Before I make that case, I wish to been appraised by more senior return to this question: what is the academics. As Head of School I am purpose of revalidation? I believe it is also asked to be an appraiser, with an primarily to protect the public from NHS colleague, of clinical academics, under-performing doctors. In doing including consultants, on behalf of so, revalidation will reassure the the university. public, employers and the profession For my appraisals, I have found that those with a licence to practise the preparation for appraisal and the are fit to practise. To achieve this all reflection involved useful. I have, the aspects of the overall system however, not found the appraisal itself (Figure 1) must work effectively; and rigorous or searching and was I a in particular revalidation must be fit poorly performing doctor I would not for purpose. find it a difficult hurdle. The formative nature of general Question 2: Is annual appraisal a good practitioner appraisal – a principle I foundation for revalidation? whole-heartedly support – may In the current proposals from the account for this. General Medical Council a key However when attending element of revalidation is evidence appraisals of consultants on behalf of that appraisal has been undertaken the university I have seen no evidence effectively; in other words, that the there that performance was being doctor has had annual appraisals and assessed. No clinical audit has taken part in the process information was disclosed, no positively. These appraisals are usually outcomes measured. Almost all the a one-to-one discussion between a discussion concerned the content of doctor and a peer, in hospitals this “programmed activities”.The NHS peer is often the head of the clinical manager wants to ensure productivity directorate. There is usually no third and flexibility and I am concerned party present and certainly not lay that the academic activities of the input. consultant are maximised. My experience of appraisal is as The most concerning follows. I have been trained as an characteristic of appraisal in this appraiser and I have trained doctors debate is that it is completely free of in how to be appraisers and how to be any explicit standards. There is no appraised. I have experienced attempt to define minimum standards 14 Revalidation of Doctors: The Credibility Challenge

other than the taking part in the Question 3: Is clinical governance, process. Even the idea that if an alone or with appraisal, an appropriate appraiser finds unacceptable practise tool for revalidation? he or she should stop the appraisal I was pleased when the “appraisal has never been associated with any route” to revalidation became the definitions. “appraisal and clinical governance The only report on the working of route”,mainly on the grounds that anything was an improvement. I annual appraisals in the UK that I believe that clinical governance will, have been able to find was published in time, become a very useful in Wales and covers General keystone in revalidation. But either Practitioner appraisals in 2003/449. alone or with annual appraisal, There were no reported cases of an clinical governance is not, and will appraisal revealing under- never be, a revalidation methodology performance. This might, of course, that is fit for purpose. be because there are no under- My reasons are as follows. The performing general practitioners in application of clinical governance in Wales. Or it might be that appraisal is the NHS is still variable and its the wrong tool to use to detect under- presence outside the NHS is even performance unless volunteered by more erratic. To rely on a system that the doctor in a moment of catharsis. is in early development and has not While I believe that appraisal can bedded-in would be, in my view, be a useful formative process that can unreasonable. This is compounded by be used to generate evidence for the variation between Trusts – revalidation, it could not be and primary care and acute – in how clinical governance is managed. probably never will be a robust As I explained earlier, the focus of foundation for a system of clinical governance is partly on revalidation that commands the individual doctors through respect of the profession and the complaints, patient surveys and public. The idea that five appraisals significant events. But its main focus alone, as conceived in 2001, would is on teams, often large teams or offer a reasonable method for whole organisations. revalidation is patently absurd, yet it Since revalidation is about quality still permeates the thinking of those assuring individual doctors, we need who support the current General to be certain of the robustness of Medical Council proposals. those parts of clinical governance as 15 Revalidation of Doctors: The Credibility Challenge

they pertain to individuals before we So clinical governance offers trust it as a main element for promise, as yet unfulfilled, but cannot revalidation. And again there are no alone or in combination with explicit standards for the clinical appraisal be relied on for revalidation. governance sign off: the implicit However it can, as with appraisal, be understanding is that clinical used as a way of gathering governance leads can recognise the information that can be used in the threshold of under-performance revalidation assessment. without guidance or training. The most powerful argument Question 4: Is more than appraisal and against relying on clinical governance clinical governance required for and appraisal is that there is a logical revalidation? inconsistency in doing so. Since these My answer is, of course, unequivocally two systems are the cornerstone of the “yes”. continuous processes of the NHS, any But what? I am very struck by the under-performing doctor not detected approach of the College of Physicians by these continuous processes will not and Surgeons of Ontario which uses be detected through revalidation. In peer assessment of the performance of this model, revalidation is no more a sample of their members. However I rigorous or effective than local would only support such a system processes and the outcome will be, here if it applied to every doctor and naturally, that no doctor will be found it included lay input; that would be to be under-performing by impractical. revalidation. I return therefore to the In the early years of revalidation requirement for clinical audits of the this will be a vindication of the use of care delivered by that doctor; the continuous processes; in later adequate standards of care shown by years the illogicality would be exposed those audits; and continuing and the whole charade of this method education, linked where appropriate of revalidation exposed. Again I ask: to the evidence from the audits. This why put in place a methodology for is both similar to the approach of the revalidation that offers no more College of Family Physicians of assurance to the public than current Canada and to our own Criteria, continuous processes. Not only would Standards and Evidence. it be a waste of time and effort, but it I use the term “clinical audit”to would further erode the public’s include both case-based audits – confidence in medical regulation. significant event auditing in primary 16 Revalidation of Doctors: The Credibility Challenge

care – and audits of cohorts of Then, Criteria, Standards and patients looked after by that doctor. Evidence contains: These data can be used to Criterion 9: The doctor in clinical demonstrate a range of skills and practice maintains skills in cardio- standards of care, and the doctor’s pulmonary resuscitation. reflection on them. Standard 9: The doctor can It is my expectation that each demonstrate continuing doctor would develop a folder of proficiency in cardio-pulmonary evidence through their appraisals and resuscitation. involvement in clinical governance. Evidence 9: Evidence of proficiency But the folder itself would be assessed in cardiopulmonary resuscitation, – all folders would be assessed – for example a certification of against clearly defined standards, competence issued at an criteria and evidence. For the appropriate course annually over avoidance of doubt I will illustrate the last five years. this last point. There is a statement in Good This approach allows for Medical Practice that says: “you must objectivity and transparency in keep your knowledge and skills up to assessment and it allows lay input. In date throughout your working life”. my view a revalidation folder should Good Medical Practice for General include: Practitioners elaborates on this, • A statement of what the doctors offering a number of definitions of an does unacceptable general practitioner • Evidence that the doctor is fit to including that such a doctor has little practise those activities, including: knowledge of developments in clinical • Certification of having practice; has limited insight into the effectively taken part in current state of his or her knowledge appraisal, or performance; rarely attends • Certification of meeting local educational events or chooses ones standards for clinical which do not reflect his or her governance and that there are learning needs; reads little and is no local concerns, heavily reliant on trade press for • The results from case-based information; and does not audit care and conventional audits, in his or her practice, or does not feed • The doctor’s reflective the results back into practice. continuing professional 17 Revalidation of Doctors: The Credibility Challenge

development within an annual actually does in this imperfect world. personal development plan, “Performance could be thought of as • The views of patients and being competence minus colleagues (360 degree distraction”50. Knowledge is, therefore, assessment) including one dimension to competency and complaints and their outcome, competency is a requirement for • Certification of technical skills required for the doctor’s role performance. (such as communication skills, If we assess performance we are medical record keeping and assessing knowledge, which is an cardio-pulmonary essential pre-requisite, but we are also resuscitation), assessing the doctor’s application of • Self-certification of health and that knowledge. However, there is probity, another argument. Since many under- • Other speciality specific performing doctors have poor evidence as required If there are concerns that this knowledge and it is relatively cheap sounds onerous, I can reassure you. and simple to measure, inclusion of a This material is available for doctors knowledge test within a multi- whenever required in most general dimensional assessment would practices with the exception of the strengthen revalidation. A knowledge views of colleagues – and that is test is a key element of the GMC’s because the General Medical Council Fitness to Practise procedures where still has not published its performance is in doubt. questionnaire. I cannot speak for hospital doctors, but I see no reason My view is that over-reliance on why they cannot meet these knowledge tests would be a serious requirements as well. error; using them as one element of revalidation might be reasonable. Question 5: What is the role of a However, I would need evidence on knowledge test? its effectiveness, and I know of no Competency is the potential ability to such evidence at present. And any case apply appropriately – through the use for direct assessment of knowledge of judgement and communication – knowledge, skills, and attitudes. This might equally apply to technical skills, is what a doctor can do in a perfect such as surgical or communication world. Performance is what the doctor skills, and attitudes. 18 Revalidation of Doctors: The Credibility Challenge

Question 6: What should the role of lay in the end, especially since the Fitness people be in revalidation? to Practise test is regarded by the I regard this as crucial. If revalidation President of the General Medical is to have credibility with the public, Council himself to be “remarkably and even in time to earn the trust and low”51. support of the public, there must be An alternative is for revalidation effective lay input at all levels. The to be set at the level of a newly first part of revalidation, which I registered doctor. This would, in my argue here should include the view, be very similar to the notional examination of a folder from every level of the Fitness to Practise doctor, should include lay people, procedures. suitably trained. It is important that The third option is to expect a they retain a non-medical perspective, doctor to be performing at the level of and therefore we may need to use entry into their current post. For a each of them for limited periods – say consultant or general practitioner this five years at a time. would be the level of their College’s The further assessment of those examination; for a second-year who do not satisfy the revalidation foundation-scheme doctor it would group’s assessment of their folder be at the level required for should include lay input. The Fitness registration. to Practise procedures already include This would be what most lay people. The changes in April 2001 members of the public would expect. effectively excluded lay involvement in If they consult a dermatologist in out the process of revalidation for the vast majority of doctors. This must be patients they would expect corrected. revalidation to have assessed that doctor’s fitness to practise as a Question 7: At what level should dermatologist. It is entirely revalidation be set? appropriate, therefore, that the level of There are several possible answers. revalidation should be at the level of Currently revalidation is “set”,in the the specialist qualification. final outcome, at the level of the The prime objection to this is that Fitness to Practise processes. If setting such standards would be too revalidation is set higher than the complex for a single national Fitness to Practise level many doctors organisation such as the General who initially appear to be under- Medical Council. It is therefore easier performing will not be found to be so to re-license all doctors who do not 19 Revalidation of Doctors: The Credibility Challenge

fall foul of the very low levels of the credible form of revalidation was fitness to practise procedures. shaken when its revalidation steering However, I will shortly offer a way group and its programme of pilot to achieve this through the Colleges. studies was abandoned three years Meantime, let me reiterate the ago. It has been further eroded by the principle: the need to protect the continuing support for a system of public and have a credible system for revalidation that would not protect revalidation requires that we the public and the lack of clarity revalidate doctors for what they do at around the content of the assessments the level required for that role. that follow on from the initial stage of The logic would then be that revalidation. revalidation maintains a licence for Recently a number of folders of the role and the Fitness to Practise evidence from senior doctors were procedures maintain or remove the examined by the General Medical basic medical licence required for Council. There have been no recent supervised practice. pilots on folders from “real” doctors. We have been promised a report on Question 8: Should the General 360 degree peer assessment but by 1st Medical Council be the body to oversee April 2005 – the date when revalidation? revalidation would have come in – no My preference has always been for the report has been presented to the General Medical Council to be, as the Council. guardian of the register, the body to Now the General Medical Council, administer revalidation. It has never after the date on which they intended intended to do so alone. The Colleges, to introduce revalidation, is proposing by writing their versions of Good a larger pilot study52. This conversion Medical Practice and Criteria, back to basing revalidation on pilots Standards and Evidence for their and evidence is, in my view, too little disciplines have a key role in deciding too late. standards for revalidation; the local We are now seven years after the employers and peers have key roles in 1998 watershed and there are the continuous processes locally. But I numerous un-resolved questions of have always seen the General Medical principle, substance and detail on Council as the conductor of the revalidation. In an atmosphere in revalidation orchestra. which expectations have been raised, My confidence in the General regulation is under the microscope, Medical Council’s ability to deliver a patients are at risk and medical 20 Revalidation of Doctors: The Credibility Challenge

careers are at stake, it seems to me that discipline. At every stage there unacceptable that revalidation is being would need to be real and effective lay pursued so unsatisfactorily. input. A College-based system would, If the General Medical Council of course, require legislation, but I continues to promulgate a system of cannot see any other practical revalidation that is not fit for purpose impediment. and which lacks credibility, and if it Could we trust the Colleges? My continues to fail to manage the response is, and I am of course heavily process effectively, then other bodies biased, that I would prefer to trust the should conduct revalidation. Colleges, with their long tradition of standards setting and examinations, Question 9: What should be the role of rather than the General Medical the Colleges in revalidation? Council. But trust would not be What other bodies could credibly enough. I would propose that the conduct revalidation? Building on the General Medical Council would hold New Zealand and USA experience, the the key function of quality assuring only other obvious route would be the Colleges’ processes. The through the Royal Colleges. In this management of the re-accreditation model the Colleges would set the of membership in good standing and, criteria, standards and evidence through sampling of folders, the required for revalidation (as most quality of decision making would be already have); the Colleges would signed off by the General Medical organise the local examination of Council. folders including lay input; the Clearly this solution would not Colleges would undertake further deal with doctors in training or long assessment if required; and each term supervised practice. There are College would decide if a doctor also a few doctors, health continued in membership of that informaticians for example, who do College. not fit within the conventional If membership in good standing College system. of a College were a requirement for Finding a suitable solution for practising as an unsupervised doctor these doctors seems to me to be well – a consultant or a general within our capacity. I would not want practitioner – then a College’s failure to pre-judge what solution might be to certify a doctor as a member in best, but the General Medical Council good standing would mean might revalidate these doctors, or the withdrawal of the right to practise in College’s might run schemes for 21 Revalidation of Doctors: The Credibility Challenge

associate membership in good as a specialist, and is looking for an standing. appointment as a Consultant Gastroenterologist. He submits his Question 10: So what does my final folder to a panel at the Royal College model look like? of Physicians who confirm he is fit to The best way that I can draw this continue to be a member in good together is to describe one theoretical standing. doctor’s journey through a future The next two revalidation career in British medicine. assessments are satisfactory. But the At 19 years of age, this doctor time he is aged 50, this doctor is a enters medical school where the consultant in a major district hospital, curriculum and assessment processes attends a community hospital and has are periodically reviewed and a moderate private practice in a local approved by the General Medical private hospital. There have been Council. The university tests him and some complaints about his attitude the General Medical Council gives and communication skills in the provisional registration. After the first district hospital but then complaints foundation year the university are common anyway. One episode of certifies the young doctor as not attending his clinic has been competent for that stage in their explained as an administrative mix- career, and the General Medical up. Colleagues see him as “coasting” Council grants a full licence to but no red flags have been raised by practise. clinical governance. Five years later the first In the community hospital they revalidation point arrives. The young are much less sanguine. He is doctor – he is now aged 30 – is in unpleasant to team members and training to be a gastroenterologist. He doesn’t inform them of his clinical is an associate member of the Royal decisions. There have been a number College of Physicians. His folder is of informal patient complaints about assessed by a panel from the Royal his attitude but only two full College of Physicians that includes complaints. Even when clearly in the one or more lay people. He passes wrong, he was unwilling to apologise. with flying colours and continues to The Community Hospital fears that if be an associate member of the Royal he leaves he might not be replaced College of Physicians. and the service will disappear. By the age of 35, he has passed the The private hospital has had only MRCP examination, been registered one significant problem with this 22 Revalidation of Doctors: The Credibility Challenge

doctor’s performance. He recently In this case it can be seen that I missed a cancer when doing a visualise revalidation as a partnership gastroscopy – the cancer was picked between the General Medical Council, up a few days later when a colleague the Royal Colleges, the NHS, had to repeat the procedure. Nobody employing organisations and lay was surprised. Our doctor was known interests, with the key objective of to be a bit slap-dash. protecting the public and ensuring However, the doctor’s revalidation that a revalidated doctor is fit to folder which included all informal practise the work they undertake. and formal complaints, patient surveys, the views of colleagues and Conclusions reports from the clinical governance leaders in all three settings, In this paper I have agreed with Dame demonstrated a likely pattern of Janet Smith, as she set out in her increasing poor performance. Further findings in the Fifth Report from the assessment by the Royal College of Shipman Inquiry, that the current Physicians confirmed this and he was system for revalidation, as proposed offered a period of support and re- by the General Medical Council, is training. not credible because it is not fit for However, at the end of this period purpose. I have described what I The Royal College of Physicians finds believe needs to be put in place in it cannot issue a certificate of order to develop a methodology for membership in good standing. This revalidation that is credible and has three consequences. The first is would adequately protect the public. that the doctor can no longer practise To continue with a system that was unsupervised. The second is that a full not credible with the public would assessment maps out what needs to merely reinforce the commonly held occur for him to return to view that the General Medical membership in good standing. And Council exists to protect doctors at third the General Medical Council the expense of patient interests53. reviews him with a view to deciding The system for revalidation that I whether fitness to practise procedures have described here is based on each is required. Any return to doctor in whatever branch of unsupervised practice would require medicine submitting folders that are the approval of the General Medical assessed against clear criteria, Council and might require standards and evidence. That revalidation in a reduced interval. assessment must include lay people 23 Revalidation of Doctors: The Credibility Challenge

and it must be externally quality the emperor’s clothes were the finest assured. Continuous local processes they had seen. This façade would must be used to identify and deal with collapse when the first under- under- and poor performance; but performing, but revalidated, doctor revalidation cannot rely on those was identified. The public’s reaction is alone to achieve a credible outcome. easy to imagine. I have concluded that if the General Medical Council is not The alternative is a system of prepared to instigate a credible system revalidation that is fit for purpose. It for revalidation, then the Colleges will be painful. If it isn’t identifying should be given the task. I have poor performance then there is either described how such a system might no poor performance – a hardly work. It relies on independent credible proposition – or all poor practice requiring “membership in performance is being dealt with good standing” with the medical locally, or some doctors will have their licence as a lower test of fitness to practise as a supervised doctor. licence to practise curtailed. If I must return to the challenge I set revalidation is transparent to the at the beginning. I said that there are public, objective, fair but firm, and two powerful ideologies currently designed to protect patients, the fighting for the soul of British public and all of us will benefit. medicine. This may have sounded We have a once in a generation over-dramatic. But I hope I have chance to do something that will illustrated the nature and importance transform the quality of patient care, of that fight. The expedient outcome is to agree protecting them from unacceptable a system of revalidation which will doctors. It is in our gift to create a not threaten the livelihood of doctors, new culture of healthcare that will will not therefore identify poor- maximise patient care and choice, performance and will pass the buck to protect patients from harm and local clinical governance systems to promote a patient-centred, patient-led “sort the problem out”.The public’s health care system. If we fail this confidence in such a system would be challenge, public trust in doctors will gained through a united face, with the General Medical Council, the British be significantly eroded and we will Medical Association and the lose the right to professional Department of Health all saying that involvement in medical regulation. 24 Revalidation of Doctors: The Credibility Challenge

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