A high standard of medical practice is a prerequisite of good medical care and clinical governance is the means for ensuring that a high standard is maintained. In February of this year the College issued the following report to its Fellows and Members. The report states unequivocally the College's position on clinical governance and self-regulation and what it expects of individual physicians and their employers in implementing them. Some of the proposals have already been acted upon and are set in train; others will require additional resources and the commitment of the Department of Health and the Trusts. |
Self-regulation has long been a central tenet of medical prac tice and with the passing of the first Medical Act of 1859, developed a legal framework. Hitherto, the responsibility for that self-regulation rested on central mechanisms of the Gen eral Medical Council, supported by the ethical responsibil ities of individual doctors. The public and the profession now have expectations of consistent very high standards of prac tice and behaviour, with less variability than has sometimes been the case. Towards meeting these expectations, the GMC has published Good Medical Practice' and Maintaining Good Medical Practice1, and the government has obliged hospital trusts to establish systems of clinical governance. The first annual report is due by 1 April 2000.The General Medical Council stresses that to maintain a good standard of professional work it is necessary to have in place the following:
- clear standards wherever possible - effective quality assurance, especially in clinical directorates - sound professional arrangements for dealing with concerns about particular doctors.
This approach to individual and team practice has already been encouraged by the Royal College of Physicians with its several initiatives in fostering and producing guidelines and audit materials, and with its supportive advice for physi cians contained in the publications Consultant Physicians Responding to Change* and Consultant Physicians Working for Patient^.Further action is demanded however as we are now required to demonstrate clearly good, effective practice not just assert it.
This report outlines the steps the College wishes to take over the next two years to ensure the maintenance of high standards of practice by physicians in England and Wales.

## Definition of clinical governance
Clinical Governance is the acceptance of the responsibility by individual physicians to work in a way which is consis tent with the values and strategic objectives of the organisa tion which employs them. Within this there is a responsibil ity to maintain good medical practice and achieve high standards. The responsibility of the organisation (Trust) is to provide appropriate facilities for medical work and to sup port the professional development of physicians and clinical teams on a continuing basis.

## The need for clinical governance
The Royal College of Physicians has always been involved in maintaining standards in clinical practice through many activities: more recently these have included the MRCP(UK) examination; educational initiatives; the approving of train ing posts in hospitals; representation on Advisory Appoint ment Committees, and many publications giving leadership in good medical practice. Physicians look to the College for advice about good practice and it is necessary and impor tant for the College to make public pronouncements about what consititues good medical practice and to criticise actions of government and other organisations when they adversely affect standards. Through its committees and administrative structure, both in London and in the regions, the College provides advice and support to physicians which enables them to be aware of the various require ments for their practice of medicine and the maintenance of high standards.
The College and its Members and Fellows must now discuss and introduce new ways whereby they not only improve the quality of their practice but demonstrate to the public, themselves and their colleagues that they can continue to maintain high standards.
In introducing and encouraging new methods of assess ment of clinical practice, and demonstrating maintenance of standards, the College is aware that such assessments create extra work on top of already heavy and onerous schedules. However, clinical governance and regulation by physicians working with management will identify inadequacies in facilities for good practice. This whole process should be seen as a dual responsibility: of the physician to maintain good standards; of management to provide adequate resources. The College will meanwhile continue to press for the additional consultant staff required to make clinical governance a feasible and useful proposition.
A few physicians perform below standard, and thus their patients are at risk. In the past, doctors who have recog nised failings of colleagues have not always taken effective action. Therefore, together with the concepts of clinical governance and self-regulation, must go a change of attitude and culture, in which colleagues who are not managing their work adequately can be helped. Physicians should be able to regard this is a helpful necessity rather than distasteful recrimination.

## Role of and action by the royal college of physicians towards implementing clinical governance

## Standards committee
A new committee, reporting to the Clinical Affairs Board, has been established to lead change and to oversee all matters concerning standards of practice, including the establishment of explicit standards, their measurement and methods of assessment. An urgent priority will be the publi cation of Good Medical Practice for Physicians,6 based on the GMC's Good Medical Practice.1

## Specialties
Appropriate standards (and methods of monitoring) will vary between specialties. The College will collaborate with specialist societies in developing standards for all 25 specialties represented by the College.

## Annual appraisal
This is a key component of clinical governance and is a Trust responsibility. It must include an annual review of the job plan to ensure that physicians are working appropri ately. The College, through its Standards Adviser, will give guidance on the detailed content of the job plan. The Appraisal based on the job plan is the single most important method of identifying the effectiveness of individual physicians, (see Working for Patients Part 2).5

## Guidelines and clinical audit
The College's Research Unit has been re-modelled and has become the Clinical Effectiveness and Evaluation Unit. In collaboration with the Standards Committee and specialist societies, it will continue the work of producing evidence based guidelines. It will also serve as a clearing house for guidelines relevant to medical specialties. The best objective test of clinical practice standards is appropriate audit, including outcome measures (with proper allowance for case mix and other potential confounding factors). The Clinical Effectiveness and Evaluation Unit will develop the necessary tools. It will also help to identify reliable outcome data, or process measures when outcome data are not avail able. In all this there will be close collaboration with the National Institute for Clinical Excellence (NICE).
Clinical audit cannot be carried out effectively without good data management to specified standards and appro priate information technology. Indeed, clinical audit should not be attempted if the basic data are not available in a suitable form. We wish to draw attention to the present inadequate provision of information technology in many hospital Trusts. While local audits are possible in many areas, participation in national audit through improved information management and IT systems is the ultimate goal.

## Peer assessment and service accreditation
Assessment of individual practitioners or clinical teams by other clinicians or groups (peer assessment) can be invalu able but is costly in resources and manpower. In addition, subjective value judgements may be misleading and, if adverse, might lead to complaints or even legal action. External peer assessment using explicit standards is time and resource-consuming, both for the assessors and the assessed. For example, if the aim was to assess each specialist unit at five-year intervals, a Trust with all 25 medical sub-specialties would have one medical visiting team every two months; add to that surgical and other specialties and the prospect is dauntingbut nonetheless may be essential. Some specialtiessuch as thoracic medicine, cardiology and nephrologyhave already intro duced peer assessment and the College is working closely with other Colleges and specialty societies to test different systems of team assessment. The College intends to pilot schemes involving multidisciplinary assessment and using explicit criteria to yield measurable outcomes which can serve as comparators with other similar services. Lay representation in the assessment process will be introduced.
Less rigorous assessment might be possible by extending the brief of existing visits related to training. If the teams were asked to make some observations about the adequacy of trainers' clinical practice, involvement in audit and CME, etc, it might give an early indication of weak practice. This might provide an interim measure whilst resources are identified to enable the introduction of the full system.

## Continuing professional development
Central to maintaining and improving standards is the concept of continuing professional development (CPD) and self-assessment. Most physicians in fact keep themselves up to date on medical practice but they are now expected also to demonstrate their state of knowledge. Whilst they have accepted the need for keeping records of their continuing medical education (CME) activities, it is generally accepted that filling in a diary of educational activities has limited value. Innovative and interactive CME programmes are therefore being developed, in which self-assessment will be built-in. These programmes will ultimately enable users to link to the College via the Internet, so providing evidence that self-assessment is being undertaken, sending an early warning when results are consistently poor and demonstrat ing the need to update in certain areas. Adequate funding for CME must be provided but this funding cannot be the responsibility of the College (although the College's CME Unit is actively developing such programmes and will publish details separately).
When adequate resources are available and structures are in place, CPD and CME will become mandatory for all career-grade physicians.

## Improving performance
Should physicians become aware that their knowledge or performance in some areas is below standard, it is their professional responsibility to remedy such deficiencies. They may not however, be able to do so unaided.
In these circumstances, their employer has a responsib ility to assist by providing time and resources for whatever educational processes are needed, and the College will always be prepared to give appropriate advice and, where necessary, help with any practical arrangements.
In the occasional instances where a physician's perfor mance is so defective that he/she has to stop practising either by suspension, or by a GMC decision to withold registration, there is no available method of resourcing the required professional rehabilitation. The College Standards Committee will seek ways to find methods to support this desirable process and, if funds are provided by the Depart ment of Health or Trusts, will establish relevant procedures and construct appropriate programmes.

## The college network
The RCP now has a substantial network of physicians with specific responsibilities for implementing College policy in their own areas, and who are in regular communication with the College. These are:
- For each Deanery Regional Advisers; Deputy Regional Advisers; CME Advisers; 22 Regional Specialty Advisers - For each Trust or group of Trusts Trust Tutors; Assistant Trust Tutors; Standards Advisers are plarmed.
The Standards Adviser will be a new post designed specifically to assist colleagues in matters pertaining to clinical governance and, importantly, independent of the Trust clinical governance machinery, although inevitably in contact with the latter when required. The role of the Standards Adviser is to act as an independent adviser to individual physicians, and the Trust, on all matters affecting clinical governance. The postholder will encourage physicians in their approach to CPD, advise them about job plan preparation and career development as well as inform Trust Chief Executives and Medical Directors about RCP recommendations on clinical standards, CPD and career development.

## Election to frcp
Advancement to FRCP has always depended on evidence of a good professional reputation and performance, but this has customarily been obtained by subjective reports from a few senior colleagues. Work will proceed to ensure more direct evidence of adequate performance before admission to Fellowship, such as assessment of CME and an indication of involvement in clinical audit: for example, no-one will be elected to the Fellowship if they are not up to date with their CME. Maintenance of the Fellowship may also become dependent on continued participation in these programmes.

## Consultant advisory appointment committees
The College representatives on AACs have always been relied upon to indicate whether a candidate's experience and training was adequate for the post for which he/she has applied. The selection of these College representatives is being overhauled and instructions are being revised to ensure that this important task is performed well.

## Service review
The College has always been willing to respond to requests from managers, Trust Boards or physicians to send a suit able team to review a service and make recommendations when it seems that there may be some weakness or failure of service provision. This will continue under the direction of the Clinical Vice-President. The speed of response will be determined by the circumstances, but the College will always try to act quickly in the interest of patient safety.

## Local initiatives
Clinical governance, as currently formulated, is intended to operate at local level, and is a responsibility of the Chief Executive of NHS Trusts. The vast majority of physicians work in the National Health Service at local Trust hospitals but, of course, the principles formulated in this document apply also to those working in other areas such as private hospitals, prisons, hospices, etc. Discussions are therefore underway to introduce similar systems into the private sector.

## The job plan
This should be regarded as a two-way tool. A physician should have a detailed discussion annually about the job plan with the Clinical or Medical Director. This is an oppor tunity for the Clinical Director (and therefore the Trust) to identify any deficiencies in resources and facilities, as well as an opportunity for the Clinical Director to appraise the work of the physician, raising any points of criticism that may have been made in the course of the past year. Such appraisal of working ability and performance is now the norm in many occupations and should be accepted by physicians as an essential part of their professional life.
For the physician, this will be the opportunity for an annual discussion on continuing professional development and any plans for a change in working patterns; no longer is it accept able for all physicians to be appointed to a consultant post and then work to the same pattern for up to thirty years. The opportunity to discuss new patterns of practice, changing competencies and developing ambitions of physicians must be regarded as professionally desirable. Not all physicians will wish to alter their job plan, but they should have the oppor tunity to discuss the possibility of change.
The listed items in the job plan are:
- ward rounds - clinics - procedures (endoscopy, catheters, etc) - cover arrangements and post-take ward rounds - teaching (undergraduate and postgraduate) - CPD/CME - clinical governance and audit - administration - managerial work - national work - research (in some cases).
It is self-evident that to take on all the above duties is beyond the ability of a physician within his/her contracted hours. Unless an annual appraisal of physician's work and workload is carried out, management will never be under sufficient pressure to provide adequate facilities and the requisite personnel to allow the majority of these tasks to be carried out. Indeed, it will become apparent that since an individual physician cannot carry out all these tasks, more physicians will be necessary. So while the physician is openly accepting inspection and assessment of his work, he/she should require that there is adequate information technology for audit, good funding for CME and an allowance of time for teaching, research, learning and managerial duties.

## Clinical teams
All physicians in modern medical care work in teams, whether those teams are formally identified as such or not. Many aspects of governance and assessment are easier to achieve when the team is regarded as the unit of medical work. Quoting the GMC document Good Medical Practice1' .
Most doctors today practise in medical and clinical teams. As well as being responsible for their own perfor mance and conduct, they should share the responsibility for the quality of care provided by their team. Medical teams are usually organised around Clinical Direc torates in hospitals. Clinical teams include colleagues in other health professions.
The GMC goes on to state that medical and clinical teams must be well led and managed, and must:
- have a positive attitude to patients and listen to their wishes and needs - make themselves aware of what patients think about the quality of their services - have a clear understanding of their professional values, standards and purpose.
Team members must be:
- willing to learn - committed to providing good quality service and effective clinical practice - open and honest about professional performance, both together and separately.
To help maintain quality, clinical teams will normally use:
- an active and supportive approach to the professional development of each member - the standards set by a professional organisation - recommended clinical guidelines - detailed performance records - internal and external medical and clinical audit - regular review of individual members' performance - suitable procedures for looking into complaints, and avoiding unnecessary risk.
Mutual respect between team members is essential. Pro fessionals working in teams are skilled, highly qualified and as committed to good patient care as the medical profession and should be respected as such.
Finally, if a team is working wellor is to work wellno individual within it is likely to be performing badly, but if they are they should be identified and their performance discussed. This emphasises the value of assessment of teams rather than just individuals.

## Identifying poor performance
Failure to identify a poorly performing colleague is now regarded as a deficiency which could lead to disciplinary action. The public requires assurance that we have developed effective methods for identifying poor perform ance and that offending physicians are removed from practiceeither temporarily for retraining, or permanently. However, having accepted that such a change in culture and behaviour is now necessary, consideration must be given to how it could work sensitively and efficiently.
The Standards Committee will continue to give advice on behalf of the College about ways of dealing with matters of poor performance. Concern about possible poor perform ance should normally be addressed to the Trust's Medical Director, who has a clearly defined responsibility for clinical governance. If a clinician is uncertain about setting such a formal investigation in train, he/she may prefer first to discuss the matter with the College's Standards Adviser, who will have specific responsibility for advising on RCP recommendations and processes.

## Critical incident reporting
A highly effective method of identifying deficiencies in clinical management has been developed by the Royal College of Surgeons by means of the Confidential Enquiry into Perioperative Death. Such methods are more easily carried out in the surgical area than in medicine, particularly in relation to chronic conditions. However, we recommend that consideration be given to a system of critical incident reporting in medical wards; such a system is already in oper ation in some hospitals. Definition of a critical incident will have to be carefully considered. The possibility of a Confi dential Enquiry into deaths of emergency admissions under the age of 50 is under discussion with NICE.

# Conclusion
The long established mechanisms for regulating the medical profession are no longer good enough. The public, the profession and the government all expect a much greater degree of accountability, with less variation in standards of practice and behaviour. It is up to us to demonstrate as clearly as possible, through clinical governance and self-regulation, good and effective practice.
Clinical governance imposes a responsibility on physicians to maintain good medical practice and to strive for the highest standards. At the same time it places a responsibility on the employer to ensure that the appropri ate resources and facilities are in place to allow this. For many years the College has been involved in standard setting through a range of activities, including the MRCP(UK) examination, the approval of training posts and the publication of guidelines. However the College must now introduce new ways to improve the quality of practice and to demonstrate publicly its commitment to the maintenance of the highest possible standards. The College will do this in two ways: introducing a number of initiatives aimed at encouraging physicians to aspire realistically to the highest standards of clinical practice; persuading the Government and employing Trusts to put in place adequate resources and manpower to allow clinical governance to bring real benefits to patients.
Some of these initiatives can be put in place immediately, while others will inevitably require more time to enable sufficient resources to be identified. What is essential is widespread recognition of the key components of clinical governance: appraisal, CPD/CME, national audit, personal development plans and peer-led service review.
The following steps towards a system of clinical governance can be taken in the immediate future:
- Annual, thorough two-way job plan review and appraisal of performance with a Clinical or Medical Director. The RCP has prepared outline job plans for most specialties6 - Introduction of regular CME of an interactive nature, based on a personal development plan, with assessment programmes being followed as they develop - Involvement in local or national audit of clinical out come and process, with evidence of action resulting if required - Introduction of a Royal College of Physicians Standards Adviser for each Trust or group of Trusts to assist in all of the above - Piloting of multi-disciplinary peer assessment service reviews of clinical teams.
The following recommended initiatives require further exploration and will need to be costed: Special service reviews at the request of Trusts and Health Authorities.
[fig] : Development of standards in the clinical specialties in conjunction with specialist societies Establishment and introduction of evidence based clinical guidelines of effectiveness and management Provision of audit tool kits Identification of poor performance in colleagues Election to and maintenance of the FRCP, dependent on the satisfactory fulfillment of all components of clinical governance and self-regulation Critical incident reporting as a further component of clinical governance Development of processes for Continuing Professional Development Development of programmes for training in assessment, appraisal and educational supervision Development of retraining programmes. [/fig]