The professional regulation of doctors has assumed great prominence in recent years. The conviction of Dr Harold Shipman and the subsequent inquiry¹ and recommendations sparked major concerns about patient safety, the regulation of doctors and public confidence in the regulatory processes. A long period of consultation by government with representatives from various professional bodies and interested groups has followed culminating in the publication in 2010 of the General Medical Council (GMC) Consultation Document 'Revalidation: the way ahead'.²

The British Medical Association has, in turn, responded to the GMC Consultation Document raising a number of concerns about the proposals for revalidation.³ The new Health Minister, Andrew Lansley, has set out his views on revalidation in the context of a new coalition government and new spending restraints.⁴

The plans for revalidation have implications for doctors. However, the Shipman inquiry and public concern have also had wider implications for governance within the health service. It is important to consider the background to the changes in reaccreditation of doctors and the wider implications for clinical governance so that the 'current state of play' can be better understood. The relationship between clinical governance in healthcare organisations and revalidation is embodied in the role of the Responsible Officer in both.The Responsible Officer will have responsibility for evaluating the fitness to practise of doctors associated with that organisation and will also be responsible for ensuring that clinical governance (including appraisal) in their healthcare organisation is capable of supporting the process of doctors' revalidation (they will not have this additional role in Scotland where this area of responsibility is covered by existing legislation and organisations).²

It is appropriate to consider these implications and how to prepare for revalidation. At the moment, some consider the proposals for the revalidation of doctors to be 'threatening and disproportionate'.³

The governance challenge

Professor Scotland from the National Clinical Assessment Service (NCAS) summarises the 'governance challenge' posed by medical scandals such as that of Harold Shipman:⁵

• Was poor performance tolerated more than it should have been?
• Was the NHS able to learn from mistakes? It was apparent that there were common features in repeated service and individual failures and scandals.
• Were the systems for responding to these failures fit for purpose? These systems were considered outdated, unwieldy and bureaucratic. In addition, they worked in an excessively legalistic, adversarial and court-like manner.
• A culture of blame reflected or encouraged by the media response and reporting of incidents. In reality it can be difficult or impossible to distinguish individual failure and system failure from untoward incidents where no individual was at fault.

Professor Scotland summarises the wider response from government as:

• A statutory duty of quality placed on every healthcare organisation and underpinned by national quality standards (National Institute for Health and Clinical Excellence (NICE)/National Service Framework (NSF)) and support to local governance frameworks (Clinical Governance Support Teams (CGSTs)).
• A national regulatory framework for private and public sector services (the Healthcare Commission (HCC)).
• National initiative to build systems for learning lessons on patients' safety (the National Patient Safety Authority (NPSA)).⁶
• National service supporting the resolution of concern at practitioner performance (National Clinical Assessment Authority (NCAA)/National Clinical Assessment Service (NCAS)).

What are reaccreditation, revalidation and appraisal?

These processes are to form part of the means by which doctors are regulated. Essentially, all doctors now need a licence to practise and to be a GP (or other specialist); a doctor must also be on the appropriate GMC register for that specialty and, as such, will be 'certificated' for that specialty. Therefore, to continue as a GP the doctor must be both relicensed and recertificated through one process called revalidation. Revalidation will be achieved through annual appraisals and hence, after review of the 5 annual appraisals, 5-yearly relicensing and recertification of doctors.

The processes of recertification (or reaccreditation), revalidation and appraisal have been variously described in more detail:

• Reaccreditation is the process by which a doctor's continuing professional development, competence and fitness to practise is assessed, allowing revalidation of his or her registration status with the profession's regulatory body, which in the UK is the General Medical Council (GMC).⁷ The registration status details what specialist status the doctor has.
• Revalidation is a set of procedures operated by the GMC⁷ to secure the evaluation of a medical practitioner's fitness to practise as a condition of continuing to hold a licence to practise. Revalidation's purpose is to 'create public confidence that all licensed doctors are up to date and fit to practise'. Its aims, in the GMC's view, are:⁷
  • To encourage all doctors to reflect meaningfully on their practice, using evidence gathered through audit and in other ways.
  • To update what being registered and being qualified means, by shifting the emphasis away from qualifications alone, to being up to date and fit to practise.
  • To replace the 'management by exception' approach that has been in place since 1858, by introducing regular confirmation that there are no significant concerns about a doctor's practice and that the doctor is up to date and fit to practise.
• Appraisals according to ACAS 'regularly record an assessment of an employee's performance, potential and development needs. The appraisal is an opportunity to take an overall view of work content, loads and volume, to look back on what has been achieved during the reporting period and agree objectives for the next.' Appraisal by one's peers and clinical mentors is currently part of educational supervision and employer career monitoring but will, in an amended form, be part of a reaccreditation (or recertification) and revalidation process.

Background

The Medical Act 1983

This recognised the need for revalidation and a clear public expectation that medical regulation should include measures to assure patients that consultants, and GPs, continue to perform effectively throughout their working lives. 'We and patients are interested in performance, demonstrated day by day, not simply knowledge and skills displayed periodically under conditions removed from the doctor's place of work.' GMC, 30 June 1998.

The Shipman Inquiry

The GMC's initial plans for the revalidation process were not introduced as anticipated in 2005, due to the reporting of The Shipman Inquiry. The report called into question the GMC's proposed mechanisms for ongoing revalidation of medical practitioners, reasoning that the arrangements as proposed would not have been sufficient to detect a problem in a case like Dr Shipman's.

Dame Janet Smith in the Fifth Report of the Shipman Inquiry further stated that:
'Local systems … if properly developed and well resourced, clinical governance could provide the most effective means of achieving two important aims. First, it could enable PCTs to detect poorly performing or dysfunctional GPs on their lists. It could also help practices to discover any problems or weaknesses among their own number. Second, it could have the beneficial effect of helping doctors who are performing satisfactorily to do even better. At the moment, I do not think it is achieving these ends.'

The subsequent White Paper

On 21st February 2007 the Government published two documents:

• A White Paper: 'Trust, Assurance and Safety - The Regulation of Health Professionals in the 21st Century', and
• 'Safeguarding Patients' - the Government's response to the recommendations of the Shipman Inquiry's fifth report and to the recommendations of the Ayling, Neale and Kerr/Haslam Inquiries.

The White Paper: Trust, Assurance and Safety - The Regulation of Health Professionals in the 21st Century (February 2007) set out the following recommendations:

• Medical Revalidation will have two components: relicensure and specialist recertification. All doctors wishing to practise in the UK will require a licence.
• The Department will consult with the General Medical Council (GMC), the profession, the medical Royal Colleges, patient groups, National Clinical Assessment Service (NCAS) and the Devolved Administrations, and develop proposals to commission and pilot appropriate national tools for multi-source (360°) feedback to support this process.
• The Department will discuss with stakeholders the most effective means for the introduction of an appraisal process with summative components. The quality of the process will be regularly assured by the GMC.⁷ The appraisal arrangements will need to take account of the large number of doctors who work outside the NHS as well as in NHS Trusts, Foundation Trusts and Primary Care.
• There are some non-medical professional staff, such as clinical scientists, who undertake higher specialist training and practise for most of their careers at a specialist autonomous level. The Department will work with the Devolved Administrations to establish a short-term working party to consider how regulation and revalidation should reflect this.
• The Government agrees with the proposal for a three-board model covering undergraduate education, postgraduate education and continuing professional development.

The Medical Revalidation Working Group

The Chief Medical Officer, Sir Liam Donaldson, was asked to lead a consultation exercise involving the GMC, the profession and other interested parties.
As part of the implementation planning, the Department of Health (DH) held a stakeholder conference in London on 5th June 2007 to discuss the membership, terms of reference and work programmes of the various working groups. A national working group was established to pursue these recommendations. The Medical Revalidation Working Group is tasked with the development of a strengthened appraisal system for doctors and a new relicensing system for doctors.

Terms of Reference for the Working Group

'To consider the proposals in Trust, Assurance and Safety on revalidation and to make recommendations on the timely, effective and affordable introduction of a revalidation system - comprising relicensure and recertification of doctors. Further, to consider the impact of the introduction of such a system on medical education, training and continuing professional development.'

Particular considerations are:

• The role of appraisal in supporting revalidation.
• The appropriate balance between summative and formative components in appraisal.
• The scope, structure, standards and process for recertification of specialists, GPs.
• The introduction of a multi-source feedback (MSF) element to appraisal.
• The role of GMC affiliates in appraisal and revalidation (liaising closely with the working group developing the role of affiliates).⁷
• Scope, structure and process for re-licensing all doctors.
• The relationship between appraisal and assessment for doctors in training.
• Links between recertification of specialists and any appropriate measures for career grade doctors.
• Necessary measures for doctors who are not in substantive NHS posts or whose practice extends to more than one setting.
• Arrangements for doctors who are retired from practice.
• The timetable for the introduction of new processes.
• Embedding the principles of Good Medical Practice within curricula.
• Developing and enhancing the concept of professionalism.
• The assessment of educational progress as evidence for revalidation.
• The effect on medical education at all its stages of the introduction of revalidation.

Aims and timing for the Working Group

Revalidation:
The key task of this group was to develop, oversee and evaluate pilot projects (from across the specialities) that support a revalidation programme (jointly with the nonmedical revalidation Working Group). This task was set to be completed by the end of 2008.

The aims were to:

• Establish standards to support summative appraisal.
• Set standards for specialist and GP recertification (to be developed by Royal Colleges).
• Establish methods of testing against the agreed standards for specialities.
• Develop a system of multi-source feedback (360° appraisal).
• Advise on a management information system that supports the process of relicensure and recertification
• Ensure that an effective appraisal and revalidation system for all doctors is practical and affordable for the NHS and others.
• Establish a remediation strategy for those not meeting the relevant standards.
• To provide advice and support to the GMC during the implementation phase of the new arrangements for relicensure and recertification (by October 2009).

• To provide options and advice on the establishment of a three-board education model for undergraduate, postgraduate and continuing professional development (CPD) between the GMC and Postgraduate Medical Education Training Board (PMETB).

'The White Paper sets out the key principles for a lasting settlement for professional regulation, but putting those principles into practice effectively will require the advice and participation of a wide range of stakeholders to ensure effective delivery.' The Working Group will continue to meet on a regular basis throughout 2008/09. Further information on the progress of the Working Groups will be published on the Department of Health website.

There are some clues in the White paper as to what the contentious areas might be:

• 'Appraisal In the absence of standards or standardisation of approach, the pattern of appraisal around the country is reported as variable. … Such practice, apart from having no value, undermines a process intended to benefit the quality of care.' Sir Liam Donaldson 'Good Doctors, Safer Patients', chapter 5.
• 'Patients in the United Kingdom rightly have great confidence in their health professionals … The danger is that … we risk highlighting too much the poor practice or unacceptable behaviour of a very small number … … professionalism is an unquantifiable asset … which rules, regulations and systems must support not inhibit.' Secretary of State for Health, Foreword, White Paper.
• 'The core principles of proportionality, accountability, consistency, transparency and targeting are bringing a more common-sense approach to regulation.' Sir Liam Donaldson in the 'Introduction to White Paper', paragraph 23.

General Medical Council role^2,7

The GMC has now issued licences to practise and published the Consultation Document setting out how revalidation will work and when it will be introduced.²

Medical revalidation

Medical revalidation will have two core components:

• Relicensure
• Specialist recertification:

• All doctors will have a licence to practise.
• The licence to practise will have to be renewed every five years.
• It aims to bring objective assurance of continuing fitness to practise.
• The appraisal process will include summative elements which confirm that a doctor has objectively met the standards expected.
• The relicensing process will generally be based on agreed generic standards of practice set by the GMC.
• The license will be renewed on the basis that:
  • The doctor has engaged in an annual appraisal.⁸
  • The doctor has participated in an independent 360° feedback.
  • Any issues arising have been resolved.

• Will apply only to doctors who are on the specialist or general practice registers.
• Will demonstrate that they continue to meet the particular standards that apply to their medical speciality, including general practice.
• Will be a positive affirmation of the doctor's entitlement to practise.
• Occur at regular intervals of no more than five years.
• Where possible, it will coincide with relicensure.
• The process will be carried out by the relevant medical Royal College.
• Based upon a comprehensive assessment against the standards drawn up by the college.
• Will be contingent upon a positive statement of assurance by that college to the GMC.⁷
• The evidence will vary between specialities.

Key issues

• The overwhelming majority of doctors will meet and exceed the standards required.
• Where doctors fail to satisfy the requirements of either element they should spend a period in supervised practice in order that a tailored plan of remediation and rehabilitation may be put in place.
• In the majority of cases, remediation is expected to result in revalidation and return to practice.
• Regulation will be risk-based. If regulators operate effectively this will target resources where they are most needed.
• Risk assessment is an essential means of directing regulatory resources where they can have the maximum impact on outcomes.
• Regulators should use the resources released through risk-based assessment to provide improved advice, because better advice leads to better regulatory outcome.
• The revised system of NHS appraisal is an important part of the process. Key factors are likely to be:
  • The development of generic and specialist standards.
  • Translation of 'Good Medical Practice'⁹ into a framework for appraisal and objective assessment with a summative element rather than the current formative nature of appraisal.
  • The introduction of multi-source feedback (or 360° appraisal).
  • Development of roles to oversee and co-ordinate the process (role of Responsible Officer and a GMC affiliate) centrally and locally.
  • The relicensing process is expected to follow agreed generic standards of practice set by the GMC, a revised system of NHS appraisal and any concerns known to the medical director (or Responsible Officer).
  • The Responsible Officer will submit a formal list of recommendations to the GMC affiliate.
  • License renewal will then be on the basis that the doctor has engaged in an annual appraisal (incorporating participation in independent 360° feedback) and that any issues have been resolved.
  • Development of approaches to assessment for recertification in the timeframes outlined.

British Medical Association (BMA) response and concerns about the GMC proposal³

The BMA represents doctors across different specialties in the UK. They report feedback suggesting that proposed mechanisms of revalidation 'appear both threatening and disproportionate'. The BMA response considers that the current proposals:

• Appear to set standards described as 'excellence' rather than those needed to maintain registration.
• Put a burden on individual doctors who may be unable to provide the level and extent of detail required.
• Appear to support strengthened appraisal before ordinary appraisal has been implemented.
• Support untested and unproven methods such as multi-source feedback and all the associated 'industry' and expense.
• Will be expensive and in the current climate this will mean that the expense will fall on doctors.
• May involve conflict of interest in some organisations where Responsible Officers hold appointments.
• Appear to make revalidation 'an all-or-nothing assessment' of doctors' fitness to practise rather than a continual process of improvement in performance.

They uphold that their 'concerns must be taken seriously, and addressed satisfactorily, for revalidation to be implemented successfully, for patients to be assured of the quality of care offered by their doctor and for the BMA to support the introduction of revalidation.'

The timetable for introduction of revalidation

• It is anticipated that revalidation will be phased in from April 2011 with completion of the introductory phase by 2016. Some sites will be involved in Pathfinder pilots started in January 2010.
• It is anticipated that the first revalidation recommendations will be made to the GMC in autumn 2011 and soon after that GPs should know when they are expected to submit their portfolio of supporting information.
• The Appraisal Toolkit website has been undergoing changes which reflect these unfolding developments.
• Information and opportunities to feed back on the proposals can be found on the websites of the RCGP and BMA.

National Clinical Assessment Authority (NCAA) and National Clinical Assessment Service (NCAS)⁵

It is worth also considering NCAA and how it will work alongside professional regulatory processes. The NCAA supports a service to health authorities, primary care trusts and hospital and community trusts who are faced with concerns over the performance of an individual doctor or dentist. This relatively new organisation will work alongside but independently of the professional regulatory process described.

The NCAS promotes patient safety by providing confidential advice and support to the NHS in situations where the performance of doctors and dentists is giving cause for concern. Employing organisations, managers or practitioners themselves can contact NCAS for advice to help the practitioner to deliver a safe and useful service to patients. The NCAS Handbook explains the services in detail.

The NCAS describes a performance triangle of health, clinical capability and behaviour in the work context. Problems in any of these areas may give rise to concerns that have evaded the process of professional regulation.

What should you do?

It seems likely that in the near future a clearly defined structured set of procedures will be introduced involving local NHS appraisal mechanisms and a new local and national system of monitoring and reporting. It is likely to involve examining supportive evidence, collected by medical practitioners, of their continuing professional and personal development, reflective practice and any issues such as health that may impact on their fitness to practise. To this end, it would be prudent for all doctors to collate and organise information that would support them in this process. The emphasis, on the basis of the tone of previous GMC opinion on the subject, should be on work-based information. Useful details to begin collecting might include:

• All information assembled for each and every appraisal.^{8,10,11,12,13}
• Nature of work and working patterns.
• Evidence of reflective practice (for example, audit projects, research, risk management initiatives, incident reporting and action to correct errors).¹⁴
• Peer and mentor support and supervision (including the NHS appraisal process).
• Clinical governance experience.^13,15,16
• Educational details (including meetings, online learning, journal time, reading around cases/current medical issues, use of Webmentor).^16,17,18,19
• Membership of and involvement with medical societies.
• Proof of having examined and complied with professional development advice from specialty college.²⁰
• Information concerning any personal health issues that may affect fitness to practise.
• Maintain personal development plan (PDP).^21,22
• Collect some information on a practice basis (to share between clinicians and save time).

It is worth considering that appraisal in future is likely to incorporate:

• 360° appraisal. This implies feedback from everyone who works with you, including staff, colleagues and patients.
• More summative information. This means incorporating 'measurable' or 'measured' elements. In theory any data currently being measured which can be ascribed to your own professional activity could be looked at more closely. It seems logical that, with a risk-based approach, those who stand out from the crowd will attract closer scrutiny!

Appraisal in general practice appears often to have developed as a personal and quite 'closed' process. Opportunities to develop and improve practice performance may be overlooked. It is perhaps worth trying to derive benefit to the practice by:

• Sharing some of the information collected where practicable.
• Sharing where possible appraisal outcomes, personal development plans and other aspects of individual appraisal which may benefit or affect practice development, practice management or partnership planning.

Document references

1. The Shipman Inquiry; The Shipman Inquiry official site
2. Revalidation: the way ahead 2010, General Medical Council (GMC); GMC Consultation Document
3. The BMA response to the GMC Consultation Document, June 2010, British Medical Association (BMA)
4. Letter to the General Medical Council from Health Minister Andrew Lansley, Dept of Health, June 2010
5. National Clinical Assessment Service (NCAS); NHS National Patient Safety Agency
6. National Patient Safety Agency (NPSA); Home page
7. Guidance on Continuing Professional Development (2010) General Medical Council (GMC)
8. NHS Appraisal Toolkit
9. Good Medical Practice (2009), General Medical Council (GMC)
10. British Medical Association (BMA), Appraisal: a guide for medical practitioners, Oct 2003
11. Appraisal for GPs; Dept of Health, Feb 2007
12. ABC of GP appraisal; National Association of Primary Care Educators
13. Evidence for Medical Appraisal; Statement of the National Association of Primary Care Educators (NAPCE)/Clinical Governance Support Team (CGST) conference, Feb 2007
14. Principles for Best Practice in Clinical Audit, NICE (2002)
15. Clinicians, services and commissioning in chronic disease management in the NHS. The need for coordinated management programmes; Report of a joint working party of the Royal College of Physicians of London, the Royal College of General Practitioners and the NHS Alliance (2004)
16. The Wisdom Centre: offers courses to health professionals on clinical governance, risk management and medical informatics
17. PUNS and DENS; North Thames Deanery website: PUNs and DENs as developed by Dr Richard Eve, UK GP from Taunton
18. BMJ Learning; Learning home page
19. Learning styles; Richard Felder and Barbara Soloman; Index of Learning Styles Questionnaire. Online version. North Carolina State University
20. Learning Guide to Professional Development, Royal College of General Practitioners (RCGP)
21. gp-training.net; Website by Dr Brad Cheek, UK general practicitioner and trainer. Continuing medical eductation page with many useful links for appraisal and PDPs
22. PDP Toolkit; NHS Eastern Deanery, updated 2005: website with collected resorces and links about PDPs, appraisal and good medical practice. The 'guide to PDP' link has useful examples showing how to write a PDP in relation to your learning needs

Internet and further reading

• National Association of Sessional GPs; Home page
• Edwards A, Elwyn G, Gwyn R; General practice registrar responses to the use of different risk communication tools in simulated consultations: a focus group study. BMJ. 1999 Sep 18;319(7212):749-52. [abstract]
• National Patient Safety Agency (NPSA); Home page
• Skills for Health; Developing Skills in Healthcare
• Hutton J - Speech by Rt Hon John Hutton MP, Minister of State (Health), 15 June 2004: British Association of Medical Managers AGM
• Campbell SM, Roland MO, Middleton E, et al; Improvements in quality of clinical care in English general practice 1998-2003: longitudinal observational study. BMJ. 2005 Nov 12;331(7525):1121. Epub 2005 Oct 28. [abstract]
• Assuring the Quality of Medical Appraisal; Clinical Governance Support team; NHS; July 2005.
• Guide to the Revalidation of General Practitioners, version 4.0. Royal College of General Practitioners (RCGP), June 2010

Acknowledgements