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Research report Continuing Fitness to Practise Towards an evidence- based approach to revalidation
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Page 1: Continuing Fitness to Practise - Health and Care ... · 5 Continuing fitness to practise –Towards an evidence-based approach to revalidation. The background to this work is the

Research report

ContinuingFitness toPractiseTowards an evidence-based approach to revalidation

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Foreword 3

Executive summary 4

1 Introduction 5

2 Trust, Assurance and Safety – The Regulation of Health Professionals in the 21st Century 6

3 Definitions, purpose and process 7

3.1 Definitions 7

3.2 Purpose 7

3.3 Process 8

4 Existing mechanisms forassuring continuing fitness to practise 9

4.1 HPC Mechanisms 9

4.1.1 Pre-registration mechanisms 9

4.1.2 Self-certification 9

4.1.3 CPD standards and audit 10

4.1.4 Returners to practice 10

4.1.5 Fitness to practise 11

4.1.6 Conclusions 11

4.2 National and local mechanisms 11

4.2.1 Recertification 12

4.2.2 Annual Development Review 13

4.2.3 Peer review and clinical supervision 13

4.2.4 Clinical governance 14

4.2.5 Public Services Ombudsman 14

4.2.6 Institutional inspection 15

4.2.7 Conclusions 15

4.3 International mechanisms forassuring continuing fitness to practise 15

4.3.1 College of Physiotherapists of Ontario Quality ManagementProgram 17

4.3.2 National Commission onCertification of Physician Assistants 17

4.3.3 Healthcare Providers Registrationand Information 17

4.3.4 Conclusions 17

4.4 UK revalidation 18

4.4.1 General Dental Council 18

4.4.2 General Medical Council 18

4.4.3 Conclusions 19

5 Risk 20

5.1 Fitness to practise 20

5.1.1 Data on overall trends 20

5.1.2 Complaints by profession 20

5.1.3 Complaints by route to registration 23

5.1 4 Complaints by gender 23

5.1.5 Complaints by age 25

5.1.6 Complaints by practiceenvironment 26

5.1.7 Conclusions 26

Contents

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5.2 Systemic risks 27

5.3 Professionalism 27

6 Costs and resources 29

6.1 Costs of other HPC assessmentprocesses 29

6.2 UK regulators 29

6.3 College of Physiotherapists of Ontario 29

6.4 Hypothetical costs 29

6.5 Wider costs 30

6.6 Conclusions 30

7 The public 31

7.1 Public awareness 31

7.2 Public expectations 32

7.3 Public involvement 32

7.4 Conclusions 32

8 Options for further work 33

8.1 Structured patient feedback 33

8.2 Understanding poor conduct and professionalism 33

8.3 Data analysis 34

9 Summary and overallconclusions 35

10 Recommendations 36

References 37

List of figures, tables andappendices 39

Appendix 1 –Membership of the Continuing Fitness to Practise ProfessionalLiaison Group (PLG) 40

Appendix 2 –Implementing the NHSKnowledge and Skills Framework (KSF) 41

Appendix 3 – Reproduced from Trust,Assurance and Safety – The Regulation of HealthProfessionals in the 21st Century 43

Notes 44

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I am delighted to welcome this monograph asthe second in a series of research reports onthe regulation of the heath professionsregistered with the HPC. This is a newdeparture, and reflects the HPC’s commitmentto building the evidence base of regulation. Weare planning further publications over thecoming years, each of which will exploredifferent aspects of the regulatory landscape.

We hope that over time these pieces of workwill contribute not only to our ownunderstanding of regulation in the health andsocial care sector, but also to a wider audienceof stakeholders with an interest in this area.

This monograph is based on a report to theCouncil about the work of the HPC’sContinuing Fitness to Practise ProfessionalLiaison Group. This Group, in consultation withthe professional bodies, educators, consumerrepresentatives, academics and otherstakeholders, researched the context forgovernment proposals to introduce revalidationfor the so called ‘non–medical’ professions.These proposals were outlined in the WhitePaper ‘Trust, Assurance and Safety – TheRegulation of Health Professionals in the 21stCentury’, published in 2007. The report makessome important observations of currentsystems for revalidation, discusses the costimplications and outlines the HPC’s ownprogramme of work in this area. It gives a clearmessage that further research is required inorder to formulate a constructive, costeffective, comprehensive plan for revalidation.

Anna van der GaagChair

Foreword

Continuing fitness to practise – Towards an evidence-based approach to revalidation3

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Continuing fitness to practise – Towards an evidence-based approach to revalidation 4

The HPC regards revalidation as one part of the process of assuring continuing fitness topractise. Continuing fitness to practiseencompasses all those steps taken byregulators, employers, health professionals andothers which support the maintenance of fitnessto practise beyond the point of initial registration.

The current evidence suggests that the riskposed by the professions regulated by theHPC overall is low. However, this is an areawhich merits further exploration. For example,our findings suggest that professional conductis a higher ‘risk’ area than competence.Research on the potential link between fitnessto practise outcomes and performance andconduct during pre-registration education andtraining is needed before implementation ofany further periodic checks on registrants.

Public trust in the health professionalsregulated by the HPC is high. However, furtherwork on ways to increase public involvement inregulation is merited. Service user feedbackmight be one way of achieving external inputinto the HPC’s existing processes.

The potential costs of additional regulatoryprocesses are likely to be significant and assuch must be clearly justified, balancing thecosts against demonstrable benefits.

In the light of these findings, existing regulatoryprocesses are currently appropriate andsufficient when considered in the context ofthe wider environment in which they operateand the risk of harm posed by the professionsregulated by the HPC.

A note on the text

This report was written by Michael Guthrie forthe Health Professions Council in October 2008.The referencing style broadly follows that of theModern Humanities Research Association.

Executive summary

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This is a report to the HPC Council (‘theCouncil’) of the Continuing Fitness to Practise Professional Liaison Group (PLG). The PLG consisted of members with a broadrange of backgrounds and expertise, includinglay and registrant members of the HPCCouncil and representatives from professional bodies, unions, regulatory bodies, the ScottishGovernment and employer organisations.Please see Appendix 1 for a full list of group members.

The group met five times between November2007 and September 2008. At its first meeting,the group benefited from the input ofrepresentatives from professional bodies.

The group was tasked with:

– defining continuing fitness to practise;

– identifying good practice in this area;

– reviewing the evidence base / literatureon continuing fitness to practise in anumber of key areas;

– exploring the issues raised by the WhitePaper; and

– making recommendations to the Councilfor next steps.

This report incorporates the group’sdiscussion, research undertaken before andafter PLG meetings and draws conclusionsand recommendations for next steps.

The group’s work was complementary to thatof the Department of Health Non-MedicalRevalidation working group, established totake forward the proposals outlined in theWhite Paper for the revalidation of non-medicalhealthcare professionals.

1 Introduction

Continuing fitness to practise – Towards an evidence-based approach to revalidation5

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The background to this work is therecommendations contained within the WhitePaper – Trust, Assurance and Safety – TheRegulation of Health Professionals in the 21stCentury, published in February 2007.

The recommendations in the White Paper aredetailed below.

‘Revalidation is necessary for all healthprofessionals, but its intensity and frequencyneeds to be proportionate to the risks inherentin the work in which each practitioner isinvolved.’ (paragraph 2.29)

‘…the regulatory body for each non-medicalprofession should be in charge of approvingstandards which registrants will need to meetto maintain their registration on a regularbasis.’ (paragraph 2.30)

There will be three groups for revalidation:

– Employees of an approved body –employers make recommendations tothe professional regulators.

– Self-employed contractors and othersperforming commissioned activities –commissioning organisations orregulators make recommendations.

– Others – regulator develops directrevalidation requirements. (paragraph 2.32)

‘Information gathered under the Knowledgeand Skills Framework should be used as far aspossible as the basis of revalidation, with anyadditional requirements justified by riskanalysis.’ (paragraph 2.34)

‘The Government will discuss with theDevolved Administrations and with publicprivate and voluntary sector employers thedevelopment of an affordable and manageabletimetable for the effective implementation ofrevalidation.’(paragraph 2.38)1

2 Trust, Assurance and Safety – The Regulation of Health Professionalsin the 21st Century

Continuing fitness to practise – Towards an evidence-based approach to revalidation 6

1 Department of Health, Trust, Assurance and Safety – The Regulation of Health Professions in the 21st Century (2007).

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A number of important preliminary issues wereidentified at an early stage of the PLG’s work.These included the need for clarity around thedefinition of revalidation and its purpose. Thereare also considerable challenges in finding ameaningful process for a revalidation systemwhich could be applicable to the thirteenprofessions regulated by the HPC. Some of theissues identified are briefly described below.

3.1 Definitions

The following definitions have been put forwardfor revalidation:

“The regular demonstration by registereddoctors that they remain fit to practise intheir chosen field(s).”

Ensuring standards, securing the future –consultation document (General MedicalCouncil, 2000)

“Revalidation is the process by which aregulated professional periodically has todemonstrate that he or she remains fit to practise.”

The regulation of the non-medicalhealthcare professionals (Department ofHealth, 2006)

“Revalidation is a mechanism that allowshealth professionals to demonstrate that they are up-to-date and fit to practise.”

Trust, Assurance and Safety – Theregulation of health professionals in the21st century, 2007(Department of Health, 2007)

There is a continued lack of clarity around theterm ‘revalidation’. Although there are commonfeatures in the definitions put forward aboutrevalidation above, there are also notabledifferences. In particular, the White Paper seemsto place Continuing Professional Development(CPD) within revalidation with reference topractitioners remaining ‘up to date’. In contrastCPD has often been viewed as a separate

process from revalidation, but one which mightgenerate some of the evidence upon which arevalidation decision is made.

Continuing fitness to practise is broadlydefined as encompassing all those steps takenby regulators, employers, health professionalsand others which support the maintenance offitness to practise beyond the point of initialregistration. This includes, but is not limited to,measures for ‘revalidation’.

3.2 Purpose

The purpose of revalidation is often unclear. Isrevalidation aimed at identifying poorlyperforming registrants who are not beingidentified as part of the fitness to practiseprocess? Or is it aimed at improving thestandard of practice for all practitioners?

There is a potential dichotomy in the aims ofrevalidation between ‘quality improvement’ and‘quality control’ mechanisms. Quality control isaimed at ensuring compliance throughthreshold standards; the focus is on theminority of practitioners who fail to meet thenecessary standards.

Quality improvement is aimed at improving thequality of the service delivered by practitionersat every level.

Such approaches are not necessarily mutuallyexclusive and both might be achievedsimultaneously. The HPC’s existing processesachieve quality control whilst also acting as adriver for quality improvement. Figure 1 overleafillustrates the comparison between qualitycontrol (ensuring safe, threshold practice) andquality improvement (practitioners at each levelhave increased competence).

This conclusion supports the perspectiveexpressed in the Foster review of non-medicalregulation:

3 Definitions, purpose and process

Continuing fitness to practise – Towards an evidence-based approach to revalidation7

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‘For regulation to motivate and engage with the majority who always aim to practise safely, it must aim for improvement, not mere compliance.’2

Figure 1 – Quality control and qualityimprovement

3.3 Process

A number of process related issues have alsobeen identified, many of which are about thepracticalities of additional periodic assessment.

These include:

– Standards and assessment

Against which standards should anyrevalidation assessment take place?

Is it possible to assess all aspects offitness to practise (i.e. competence,character, health)?

How frequently should any assessmentbe carried out?

– Context

Should or can registrants who do notwork in a clinical or patient / client facingenvironment be revalidated?

– Risk

Is it possible to identify those groups ofregistrants who pose the greatest ‘risk’of future harm to the public?

Quality control

Unsafe

Standards compliance

Num

ber

of re

gist

rant

s

Competent Excellent

Quality improvement

Continuing fitness to practise – Towards an evidence-based approach to revalidation 8

3 Definitions, purpose and process

2 Department of Health, The Regulation of the Non-medical Healthcare Professionals (2006), p. 11.

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A number of different mechanisms used inassuring or promoting continuing fitness topractise in the UK and worldwide have beenconsidered. This consideration focused onhow effective these mechanisms were, howthey worked and why they worked. Themechanisms were also judged against therecommendations of the White Paper to askwhether they could form a sufficient basis for revalidation.

The assessment of the effectiveness ofmechanisms which exist within and outside theprofessional regulatory environment isimportant in order to help assess whether anadditional layer of regulation is necessary atthe professional regulatory level.

The existing mechanisms examined anddiscussed in this section are divided into:

– HPC mechanisms (paragraphs 4 to 28);

– National and local mechanisms(paragraphs 29 to 62);

– International mechanisms (paragraphs63 to 75); and

– UK revalidation (paragraphs 76 to 82).

4.1 HPC mechanisms

The HPC sets standards, approves educationand training programmes that meet thosestandards, holds a register of individuals whopass those programmes and holds itsregistrants to its standards. Four processes aredescribed below which have a role incontinuing registration and continuing fitnessto practise.

4.1.1 Pre-registration mechanisms

Although in this report the focus is on continuingfitness to practise (i.e. fitness to practise beyondthe point of initial registration), the role thatregulators play at the pre-registration stage isalso important in helping to assure and enablecontinuing fitness to practise once anindividual is registered.

Such ‘pre-registration mechanisms’ include:

– Approval and monitoring of pre-registration education and trainingprogrammes against standards ofeducation and training and standards ofproficiency. This ensures that only thosewho have met the threshold standardsfor safe and effective practice are eligiblefor entry to the Register.

– Health and character checks onadmission to pre-registration educationand training programmes and onadmission to the Register.

4.1.2 Self-certification

Applicants for admission and readmission tothe Register make a declaration that they haveread and will comply with the standards ofproficiency, conduct, performance and ethicsand that they have read and will comply withthe standards for CPD. Applicants are alsorequired to declare any convictions, cautionsor determinations of other regulatorsresponsible for licensing a health or social careprofession as part of the application process.

Every two years when they renew theirregistration, registrants are required to sign adeclaration to confirm that they continue tomeet the standards of proficiency which applyto their practice; that there have been nochanges to their health or relating to their goodcharacter which they not advised the HPCabout and which would affect the safe andeffective practice of their profession; and thatthey continue to meet the standards for CPD.

The self-certification process is supported bythe health and character process. If aregistrant declares an issue relevant to theirgood character on application or renewal (eg acaution or conviction), a health reference raisespossible concern, or a registrant makes a self-referral during their registration cycle, thiswill be considered by a registration panel. Thepanel determines whether the applicant should

4 Existing mechanisms for assuringcontinuing fitness to practise

Continuing fitness to practise – Towards an evidence-based approach to revalidation9

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be admitted to the Register or permitted torenew their registration. Or, in the case of aself-referral, the panel decides whether thematter should be referred into the fitness topractise process.

Between June 2005 and December 2007, 560declarations on admission or renewal to theRegister were considered by the HPC andconcluded. In this same period, 239 self referralswere concluded. In 97 per cent of declarationcases, admission or renewal to the Register wasallowed; in 75 per cent of self-referral cases thematters were considered not to impact upon theregistrant’s fitness to practise.3

Self-certification and self-referral of importantinformation demonstrates the registrant’scommitment to maintain their fitness topractise. It also demonstrates behaviourscommensurate with professionalism.

It is acknowledged that as this is self-certification, there is a lack of externalverification as to the declaration made by theregistrant or applicant, unless a subsequentmatter is brought to the Council’s attention (orthe registrant is audited to demonstratecompliance with the CPD standards).

4.1.3 CPD standards and audit

The Council sets standards for CPD that areoutcomes based. Registrants are required toundertake CPD, record their CPD, ensure thattheir CPD contributes to the quality of theirpractice and service delivery, and ensure that itwill benefit service users.

CPD audits check registrant compliance withthe CPD standards. Random audits to checkcompliance with the CPD standards began inMay 2008 and are linked with renewal.

The sample size for the first two professions,chiropodists and podiatrists and operatingdepartment practitioners, is 5 per cent.

The CPD standards and audit are seen as bothquality control and quality improvementmechanisms. The audit is a quality controlmechanism in that registrants are sampled tocheck compliance with the standards. Thestandards are based on outcomes with afocus on benefits to service users andtherefore are a mechanism for qualityimprovement.

The outcome of a failure to meet the standardsis administrative removal from the Register.

Future analysis of the outcomes of the CPDaudits will help in the development of riskindicators for the regulated professions.

4.1.4 Returners to practice

Health professionals seeking readmission to theRegister who have been out of practice mustundertake an updating period of 30 days forbetween two and five years out of practice and60 days for five or more years out of practice.

The updating period can consist of privatestudy, formal study and supervised practice andhas to be countersigned by a registrant from thesame part of the Register who has been inregistered practice for three years or more.

The returners to practice requirements areprimarily a quality control mechanism aimed atmitigating the potential risks involved inreturning to practise after a break,demonstrating that the returner is up to dateand supporting fitness to practise. The returnersto practice requirements are thresholdrequirements which may be exceeded by therequirements of others, such as employers.

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4 Existing mechanisms for assuring continuing fitness to practise

3 HPC Education and Training Committee Meeting, 26 March 2008 [www.hpc-uk.org/assets/documents/10002168education _and_training_committee_20080326_enclosure09.pdf].

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4.1.5 Fitness to practise

The fitness to practise process is the way inwhich the HPC can consider complaintsagainst registrants. (Complaints via our fitnessto practise process are referred to in ourlegislation as ‘allegations’).

If a panel finds that a registrant’s fitness topractise is impaired, they have a range ofsanctions available in order to protectmembers of the public including cautioning aregistrant, making their registration subject toconditions, suspending their registration orstriking them off the Register.

The fitness to practise process is a qualitycontrol mechanism and relies on a system ofexception reporting. In 2007 – 08, 0.24 percent of registrants were subject to a complaint(see section 6.1).

4.1.6 Conclusions

The processes described above and on theprevious page should not be considered inisolation, and should be seen instead withinthe context of other activities undertaken bythe HPC which help to contribute towardscontinuing fitness to practise.

For example, the HPC’s role in approvingeducation and training programmes is focusedon ensuring that appropriate standards aremet, which will equip future registrants forlifelong continuing fitness to practise. Inaddition, the work of regulators (and otherorganisations) in providing guidance toregistrants can be seen as making a positivecontribution towards continuing fitness topractise and might be linked to improvedoutcomes. Philip Hampton concluded in‘Reducing Administrative Burdens: Effectiveinspection and enforcement’ that ‘betteradvice leads to better regulatory outcomes’.4

There is no evidence to suggest that theprocesses outlined above are ineffective in

achieving quality control and promoting qualityimprovement amongst registrants.

Considering each of these processes inisolation, we could conclude that whilst theydo contribute towards continuing fitness topractise, they do not represent a positiveaffirmation of fitness to practise in the sense ofa regular or periodic, external assessment ofeach registrant against standards of conductand competence at a given point in time. Forexample, the CPD and returners to practiceprocesses have no direct or explicit link tostandards of conduct or competence.

However, considering these processestogether, in light of the wider environment inwhich these processes operate and ourassessment of the risk profile for theprofessions regulated by the HPC, weconclude that these processes are appropriateand sufficient.

4.2 National and local mechanisms

A number of different mechanisms outside ofthe regulation of healthcare professionals thatmay be relevant to the continuing fitness topractise of registrants have been considered.

In this section, a small number of thosemechanisms are described in more detail. Thisis not intended as an exhaustive list or as acomprehensive exploration of the differentmechanisms considered by the group but isintended to summarise and illustrate theinterplay between such national and localmechanisms and regulation.

Where relevant, specific examples are givenwhich are relevant to the professions regulatedby the HPC. However, it is acknowledged thatmany of these mechanisms that exist also existfor other professions. Equally, some of themechanisms described may not be applicable tosome professions or indeed to all registrants.

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4 Existing mechanisms for assuring continuing fitness to practise

4 HM Treasury, Reducing Administrative Burdens: Effective inspection and enforcement, (2005), p.9.

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Table 1 lists and compares some of the models examined. This is not intended as an exhaustive list, but it does illustrate the wide range of mechanisms which contribute to practitioners’ continuing fitness to practice.

Table 1 – National and local mechanisms

Individual Employer Professional Institutional Regulatorybody

Clinical supervision Annual Accreditation Professional Ombudsman’sand peer review appraisal / KSF schemes indemnity offices

insurance

Re-certification Clinical CPD support National Patient Servicegovernance Safety Agency regulation

(NPSA)

CPD activity Risk management Mentoring Quality Assuranceschemes Agency (QAA)

Further training Mentoring Specific & research schemes Interest

Groups / professional networking schemes

Support for CPD activities

Six models are described in more detail as follows.

4.2.1 Recertification

Recertification is one mechanism used toassess continuing fitness to practise on anindividual level. The only profession regulatedby the HPC currently using recertification is theparamedic profession. Some National HealthService (NHS) Ambulance Trusts requireparamedics to undertake training andassessment in order to demonstrate theircontinuing competence. This model isemployer led without the involvement of thestatutory regulator.

The exact format of recertification varies between NHS Trusts, however, it can include:

– a period of observed practice to identify personal development needs;

– a short period of CPD courses (around five days) including training in areas andcompetencies key to paramedicpractice; and

– assessment of those areas againstrelevant standards.

If recertification is failed, the practitioner maybe required to spend time in supervisedpractice, sometimes at a lower grade, andremedial training is offered.

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This model is noteworthy because it involvesperiodic assessment, usually against thresholdstandards. It is also the model amongst the HPCregulated professions which most closelyapproximates revalidation as defined in the WhitePaper, albeit employer-led. The outcome is apass or fail with remediation for those who fail.

In practice, this form of ‘revalidation’ has anumber of difficulties. First, it is not alwaysdelivered because of financial constraints;second, the standard varies betweenemployers; and third, the focus on previouslylearnt information may mean that there is not adirect relationship with fitness to practise.Despite having this system in place, HPCfitness to practise data indicates thatparamedics account for the largest proportionof complaints and that conduct is morefrequently a problem than competence (pleasesee section 6.1).

4.2.2 Annual Development Review

There are many well established annual reviewprocesses used by professionals working inthe NHS and the independent sector. In theNHS, annual development review is conductedusing the Knowledge and Skills Framework(KSF). The KSF is a tool which is focused ondefining and describing the knowledge andskills that NHS staff need to apply to deliverquality services within a defined role.

The KSF consists of 30 dimensions thatidentify the functions required by the NHS toprovide a good quality service. Six of thedimensions are core dimensions describingcore areas such as communication, with theremainder covering knowledge and skills whichare specific to some (though not all) jobs in theNHS. These core dimensions have beenmapped by the KSF Group of the NHS StaffCouncil against the HPC standards ofproficiency and standards of conduct,performance and ethics.

The KSF is used to develop an outline for eachpost (so that the skills and knowledge required

are clear) and is used as the basis of reviewingthe performance of staff. It is concerned withdeveloping staff within their role, andincorporates CPD.

The White Paper recommended that, for thoseregistrants working within the NHS, informationgained during the KSF performance reviewprocess should form the basis of revalidation,with employers providing evidence to regulators.

The following observations about the KSF canbe made:

– The KSF was developed in partnershipwith staff as a developmental tool and wasnot intended as a tool for revalidation.

– The KSF would apply to a significantnumber of registrants working within theNHS but not those who worked in othermanaged environments or who are inprivate practice.

– The KSF might potentially contributeevidence for revalidation.

– The KSF was still being implemented bysome organisations within the NHS andas such is not yet ready to contributetowards revalidation in some areas.

Appendix 2 gives an example of good practicein the implementation of the KSF.

The KSF Group of the NHS Staff Council hasbeen commissioned to undertake work withregulators, employers (both within and outsidethe NHS) and others to explore the potentialfor the use of the KSF in a revalidationprocess. This work is due to conclude inDecember 2008.

4.2.3 Peer review and clinicalsupervision

‘Peer review’ is an activity that supports thecontinuing fitness to practise of registrants byproviding an opportunity for the discussion andreview of practice by peers.

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Arrangements for peer review, includingmodels and approaches to this activity, mayvary between professions. How such activity isfunded, resourced or supported by employersmay additionally vary.

For many of the professions registered by theHPC supervision (sometimes referred to asclinical supervision) is seen as an importantpart of practice. Supervision, including peersupervision, mentoring, reflection-on-practiceand case review offers many opportunities forassessment of practice, learning anddevelopment by the practitioner or bycolleagues and managers. The process resultsin improved learning, practice delivery andcommunication and produces evidence tosupport the HPC’s CPD standards and audit.

In the arts therapy professions (art, music and drama therapy), as in the other therapyand psychotherapy professions, clinicalsupervision is embedded in the profession’sethos of good practice.

Such supervision provides a forum in whichthe therapeutic relationship between client andpractitioner can be monitored via discussionwith another colleague. Supervision in the artstherapies is profession led and supported byemployers but is not a specific regulatoryrequirement for ongoing registration.

In midwifery, there is a system of statutorysupervision which is similarly a peer-orientedprocess aimed at identifying any problems and acting quickly to remedy them in asupportive manner.

4.2.4 Clinical governance

Similar to annual development review, clinicalgovernance is a well established local

mechanism for assuring quality amongstteams of professionals. The principles of multi-disciplinary clinical audit have beendeveloped into a general framework for clinicalgovernance and accountability of NHS Trustsand strategic health authorities.5

The framework encompasses a range ofquality improvement initiatives, such as clinicalaudit, improving clinical effectiveness,supporting the implementation of evidencebased practice and improving record keeping.The focus is on locally driven initiatives withlocal ownership by individual practitioners,teams and managers.

In England, such local arrangements aresupported by clinical governance teams. The‘Standards for Better Health’, by which theHealthcare Commission in England assessesboth public and private sector facilities, requirethat ‘health care organisations work togetherto ensure that... the principles of clinicalgovernance are underpinning the work of everyclinical team and every clinical service’.6

Although the application of clinical governancemay vary across the UK, there is widespreadcommitment across the four NHS systems tothe principle of quality improvement and theneed for all staff to take responsibly for theirpart in its implementation at local level.

4.2.5 Public Services Ombudsman

Another example of an external control onquality is the Public Services Ombudsman. Ineach of the four UK countries, a Ombudsmanhas a role in reviewing complaints about publicbodies including the NHS.

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5 Scally G, and Donaldson L J, ‘Clinical governance and the drive for quality improvement in the new NHS in England,British Medical Journal, 317, (1998), 61 –65.Department of Health, Clinical governance reporting processes, November 2002.

6 Department of Health, National Standards, Local Action – Health and Social Care Standards and Planning Framework2005/06 – 2007/08, (2004), Annex 1.

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A complainant who is dissatisfied with theresponse of a public body to a complaint canask the Ombudsman to review their complaint.If the Ombudsman upholds a complaint, it canorder the public body to resolve the situation.

The Ombudsman therefore has a proactiverole in quality improvement. The Ombudsmanencourages public bodies to reviewprocedures regularly to ensure they areeffective, ask for feedback to improve servicesand learn lessons from complaints.7 TheOmbudsman often makes recommendationswhich lead to direct changes in the policies orprocedures of public bodies.

4.2.6 Institutional inspection

Inspection and assessment of organisationswhich deliver health or social care can be seenas both a quality control and qualityimprovement mechanism. A number oforganisations undertake this function includingthe Healthcare Commission in England,Healthcare Inspectorate Wales, NHS QualityImprovement Scotland and the Regulation andQuality Improvement Authority in NorthernIreland. A number of similar organisations alsocarry out an inspection role in the socialservices sector.

The role of these organisations is focused onthe quality of service delivery at anorganisational level. These organisations areinvolved in assessing the performance ofhealthcare providers against clear standardsand disseminating good practice to assurepatient safety.

4.2.7 Conclusions

The mechanisms outlined vary as to their focusand aims, but have overlapping purposes. Inmany cases HPC registrants will participate in,have contact with or will be influenced in someway by the mechanisms described.

However, it is acknowledged that some ofthese models may not apply to registrants whodo not work within managed environments.

In the existing professions regulated by theHPC, a number of the models outlined arevoluntary and dependent upon professionalbuy-in, or are required by an employer. Themodel is led by the profession and / oremployer and not by a professional regulator.

However, they collectively contribute to thecontinuing fitness to practise of registrants.Professional regulation is therefore but onepart of the whole; and quality improvementand quality control are subject to a number ofinterlocking checks and balances. Figure 2below illustrates this point.

Figure 2 – Professional regulation aspart of the quality and safety agenda

4.3 International mechanisms for assuring continuing fitness to practise

Regulatory mechanisms in place in Canada,the United States of America, Australia andEurope that are focused on continuedregistration were also considered as part ofthis work.

Table 2 overleaf provides a comparativesummary of some of the different models.Three models considered are described below.

Continuing fitness to practise – Towards an evidence-based approach to revalidation15

4 Existing mechanisms for assuring continuing fitness to practise

HPC Institutionalinspections

Clinicalgovernance

The patients’voice

Professionalism&

Values

7 Parliamentary and Health Service Ombudsman, Annual Report 2006/2007 – Putting principles into practice, (July2007). Parliamentary and Health Service Ombudsman, Principles for Remedy, (2007).

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Table 2 – Summary of features of different systems used worldwide

Self – Continuing Portfolio Periodic Remediationcertification Professional / tools assessment

Development

Physiotherapists ✔ ✔ ✔ ✔ ✔

(Ontario, Canada)

Occupational ✔ ✔ ✔ ✔ ✔

Therapists(Ontario, Canada)

Physical ✔ ✔ ✔ ✘ ✘

Therapists (Alberta, Canada)

Physicians and ✔ ✔ ✔ ✔ ✔

Surgeons(Ontario, Canada)

Doctors (Ohio, US) ✔ ✔ ✘ ✔ ✔

Physician Assistants ✘ ✔ ✘ ✘ ✘

(Certification, US)

Emergency ✔ ✔ ✘ ✘ ✘

Medical Technicians (Certification, US)

Occupational ✔ ✔ ✔ ✔ ✔

Therapists (New Zealand)

Nurses ✔ ✔ ✔ ✘ ✘

(Tasmania, Australia)

RIBIZ (Netherlands) ✘ ✘ ✘ ✘ ✔

Continuing fitness to practise – Towards an evidence-based approach to revalidation 16

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4.3.1 College of Physiotherapists ofOntario Quality Management Program

The College of Physiotherapists of Ontario(Canada), runs a ‘Quality ManagementProgram’ (QMP) which consists of three stages:

1. Competency reflection and integration

Registrants create and maintain aprofessional portfolio which containsinformation about their practice, CPD,and may include feedback from patientsor colleagues. Compliance with this isnot routinely checked; registrants haveto sign a declaration to confirm that theymeet the requirements when they renewtheir registration.

2. Competency assessment

Each registrant is subject to an onsiteassessment by a peer assessor everyfive to ten years. Registrants areexpected to demonstrate competencywithin the role that they perform.

If the College feels that there areconcerns about the registrant’s practice,they may set conditions for the registrantto bring their knowledge, skills andjudgement up to the required level.

3. Competency improvement

This is a remediation stage to assistregistrants with competency problems tomeet the required standards. Registrantsmay participate as a result ofcompetency assessment or as a resultof a separate disciplinary investigation.Between 1997 and 2001, 1 per cent ofregistrants who participated in theprogram were required to complete aperiod of remediation.

The QMP is ring-fenced from the College’sfitness to practise process.

4.3.2 National Commission onCertification of Physician Assistants

The National Commission on Certification ofPhysician Assistants (NCCPA) runs a system ofcertification in the United States. Certificationwith NCCPA is one of the criteria to become alicensed physician assistant in each of thestates. Graduates from accredited coursesundertake an exam, and, if successful, achieve certification.

Recertification happens in six yearly cycles.Every two years, 100 hours of continuingmedical education must be undertaken, loggedand a renewal fee paid. By the end of the sixthyear, a recertification exam must also be passedwhich covers general medical and surgicalknowledge. However, not all state boardsrequire recertification for licence renewal.

4.3.3 Healthcare Providers Registrationand Information

In the Netherlands, ‘Healthcare ProvidersRegistration and Information’ or ‘RIBIZ’ holds aregister of over 350,000 health professionals.

In 2009, RIBIZ plans to introduce re-registration requirements for nurses, midwivesand physiotherapists. At present, a registrantcan remain on the Dutch Register indefinitely.

Registrants in these professions will have todemonstrate that they have practised theequivalent of one working day a week duringthe last four to five year period, or elseundergo additional training which RIBIZ willprescribe. RIBIZ believes that these changeswill ensure that their Register is a measure ofthe competence of healthcare professionals inthe Netherlands but this has yet to be pilotedand evaluated.

4.3.4 Conclusions

There are a number of features commonbetween some, if not all, of the differentinternational models studied. These includeself-certification against standards, compulsory

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CPD, the structured identification of learningneeds, periodic assessment of competencyand remediation.

The approach in Ontario around periodicassessment of practitioners is noteworthy interms of its approach to risk. The Ontariomodel is characterised by a ‘funnel’, in that theproportion of registrants involved decreasesgreatly at each stage, as the thoroughness ofthe check increases. This approach targetsmost resources (i.e. in the remediation stage)at those registrants where performancedifficulties have been identified. The OntartioModel is in line with the approach taken by theNational Clinical Assessment Service (NCAS) inthe UK, and other medical programmes forpoorly performing doctors worldwide.8

Many of the models studied use a ‘structured’or ‘enhanced’ CPD approach. CompulsoryCPD requirements are supported by toolsregistrants can use to identify and reflect ontheir learning needs and structure CPD tomeet those needs.

The costs and resources involved in developingand administering many of the models are likelyto be substantial. Many of these models exist ina uni-professional regulatory environment andthere are differences between the physical andfinancial environment in which the professionsinvolved practise compared with the UK. Thoseregulators who use a regular performanceassessment approach are also far smaller interms of registrant numbers compared to the HPC.

4.4. UK revalidation

The revalidation systems currently indevelopment by the General Dental Council(GDC) and General Medical Council (GMC) arebriefly summarised as follows.

4.4.1 General Dental Council

The GDC has concluded that there isinsufficient evidence at this time in order toestablish groups of registrants for revalidationwho carry more risk than others – ‘static grouprisks’. Instead, the GDC propose to approachrevalidation in terms of ‘static individual risk’ –i.e. the risk the individual registrant may poseowing to previous fitness to practise action orfuture non-compliance with revalidation.

The GDC have developed a three step model.Step one is an all registrant sift where allregistrants submit information. Step two ispeer assessment in practice of those aboutwhom potential problems have been identified.Step three is an in depth assessment of thoseregistrants about whom concern still remains.The assessment would take place againststandards and information drawn fromappraisal might form one of the pieces ofevidence submitted by a registrant. The finedetail of each stage is currently underdevelopment. It is intended that the outcomefor those who fail to participate in or who failthe stages of the revalidation process will beadministrative erasure.

4.4.2 General Medical Council

The GMC’s proposals are currently undergoingfurther development and piloting. They consistof two stages.

1. Relicensing of basic medicalregistration

This would require a portfolio of evidence(e.g. clinical audit, prescribing data, multi-source feedback and appraisal) collectedagainst standards from the GMC’s GoodMedical Practice.

Continuing fitness to practise – Towards an evidence-based approach to revalidation 18

4 Existing mechanisms for assuring continuing fitness to practise

8 Knight JR., Sanchez, LT., Sherritt L., Bresnahan LR., Fromson JA., ‘Outcomes of a Monitoring Program for Physicianswith Mental and Behavioral Health Problems’, Journal of Psychiatric Practice, 13(1), (2007), 25–32. Cohen D., Rhydderch M., ‘Measuring a doctor's performance: personality, health and well-being’, OccupationalMedicine (London) 56(7), (2006), 438–40.

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Responsible officers in the local area wouldbe asked to review the portfolio and affirmthe Doctor’s fitness to practise.

2. Recertification of specialism

Standards would be set by the relevantRoyal Colleges and specialistassociations and approved by the GMC.Evidence for recertification would includeappraisal, audit and patient feedback.

4.4.3 Conclusions

The proposed General Dental Council modelapplies the principle of risk and proportionalityto the process itself – the thoroughness of thecheck increases as registrants progressthrough the stages (please see section 6).

The proposed General Medical Council modelis noteworthy in incorporating multi-sourcefeedback into the process and it is useful toconsider whether such an approach would bemeaningful and add benefit in the context ofthe professions regulated by the HPC (pleasesee section 9).

The costs of these proposed models have notyet been fully assessed but have the potentialto be significant. Any HPC approach torevalidation would need to be based on athorough cost analysis, compared to ananalysis of the demonstrable benefits ofadditional regulation (please see section 7).

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The White Paper states that: ‘Revalidation isnecessary for all health professionals, but itsintensity and frequency needs to beproportionate to the risks inherent in the workin which each practitioner is involved.’(paragraph 2.29)

We have considered whether there is evidenceof risks of harm to public safety amongst theprofessions regulated by the HPC that are notsufficiently mitigated by existing mechanismsand which therefore might indicate some kindof additional regulation is necessary.

The White Paper included a table whichhighlighted some areas which might indicatewhether a registrant was higher or lower risk(Appendix 3). The following observations canbe made:

– The areas have some intuitive basis butsuch assumptions would need to besupported by clear evidence related tothe professions regulated by the HPC;

– The table suggests a homogeneity ofpractice environment which may notalways exist within some settings;

– The table is not exhaustive – otherfactors such as age and gender are alsoknown to be important; and

– There are potentially a number oflogistical obstacles to any risk basedapproach – particularly around thelogistical difficulty of capturing reliableinformation about the practice ofregistrants and the possible impact uponareas of practice considered ‘high risk’.

Furthermore, risk in the context of health carearises not only from risks associated with poorperformance (i.e. harm resulting fromshortcomings in competence). It also arises

from human errors (i.e. wrong diagnosis ofserious diseases) and organisational dysfunction or error to leading system failures in care (i.e.deaths due to infection in hospital).9

Taking a risk based approach is both complexand challenging without evidence to guide theparameters that might be used to calculate riskof harm to service users.

This section is sub-divided into three areas:

– Fitness to practise;

– System risks; and

– Professionalism.

5.1. Fitness to practise

The group considered data from the fitness topractise process as evidence of risk indicatorsamongst the professions regulated by the HPC(as well as evidence which might support arationale for revalidation).

This section compares the proportion ofcomplaints received in particular areas, againstother information available from the Register. In2007–08, 422 complaints were received aboutregistrants. As the number of complaints isstatistically small relative to the HPC Register asa whole, the numbers involved in theproportions described is correspondingly small.

5.1.1 Data on overall trends

In 2007 – 08, 0.24 per cent of registrants weresubject to a complaint via our fitness topractise process. This figure was 0.18 per centin 2006 – 07.10

In 2006 – 07, 10 per cent of complaintsconsidered were purely about lack ofcompetence, compared with 88 per centwhich had a conduct element. (Of these, 13per cent were about convictions and cautions.)

5 Risk

Continuing fitness to practise – Towards an evidence-based approach to revalidation 20

9 Department of Health, Good Doctors, Safer Patients, (2006).

10 Health Professions Council, Fitness to Practise Annual Report 2006 – 07 and Fitness to Practise Annual Report 2007 – 08, (2007 and 2008).

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In 2007–08 misconduct cases consideredincluding making false statements on a CV; drugmisuse; inappropriate relationships with patients;and fraudulent use of employer property.

Lack of competence cases often concerned aprolonged failure to meet the requiredstandards of proficiency. Issues consideredincluded failures in assessment, treatment andfollow–up care.

In 2007 – 08, less than 1 per cent ofcomplaints were about the physical or mentalhealth of the registrant.

Taken together, these trends indicate thatconduct more than competence is thepredominant ‘risk’ in terms of public protection and safety for the professionsregulated by the HPC.

The number of complaints as a proportion ofregistrants considered by the HPC seems lowercompared to those of other regulators. In2006–07, the HPC received 1.8 complaints per1000 registrants, the lowest of the nineregulators of healthcare professionals.11 Whilstthese figures could partly be accounted for bydifferences in the processes of the regulators,and in public awareness of their role and theprofessions they regulate, they potentiallysuggest that the professions regulated by theHPC are of ‘lower risk’ than others.

This is supported by other evidence. A recentreport from the Information Centre for Healthand Social Care (2007) revealed that 60 percent of complaints in the National HealthService (NHS) related to nursing and medicalstaff, compared to 5 per cent for ‘professionsallied to medicine’.12

The HPC’s fitness to practise process does notexist in isolation but exists in an environment

which includes complaints mechanismsoperated by employers and other organisations.These mechanisms often have a differentpurpose, for example, focusing on mattersmore related to service delivery or handlingcomplaints at a local level which would notnormally justify regulatory action.

We are unable to quantify the extent to which,if at all, matters that should be dealt with at aprofessional regulatory level fail to be broughtto the attention of the regulator. However, thisis a common potential issue across all theregulators of health professionals and theavailable data does still indicate that theprofessions regulated by the HPC are overall of‘lower risk’ compared to others.

5.1.2 Complaints by profession

Analysis of fitness to practise data byprofession reveals that there is some variationin the proportion of complaints received byprofession (please see figure three overleaf).

In 2007 – 08, the rate of complaints was higherfor arts therapists, chiropodists / podiatrists,operating department practitioners,paramedics and prosthetists and orthotiststhan would be expected by the proportion ofthese professions on the Register. In 2006–07,this trend was the same for chiropodists /podiatrists, operating department practitionersand paramedics.

In 2006–07 and 2007 – 08, paramedicsaccounted for the largest proportion ofcomplaints. In 2007 – 08, paramedicsaccounted for 22 per cent of complaints butmade up 8 per cent of the total number ofregistrants. This was consistent with trends inprevious years.

This trend may be due to a number of factors.

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5 Risk

11 Council for Healthcare Regulatory Excellence (CHRE), Annual Report 2006/2007, (2007).

12 Information Centre for Health and Social Care, Data on written complaints in the NHS 2006–07, (2007).

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It may reflect the nature of paramedic practice in that paramedics have direct contact with members of the public and are therefore more likely to be subject to complaint, compared to some of the other professions, such as biomedicalscientists, who typically have little or no direct contact. It might also be linked to the invasive nature of some procedures undertaken by paramedics and a practice environment which typically includes working outside of the hospital environment, dealing with situations which may be unpredictable and may involve some lone working.

As with all cases overall, most cases about paramedics concerned conduct rather than competence issues.

Figure 3 – Allegations by profession, compared to the proportion of registrants on the Register

% Allegations% Register

Arts therapists

Biomedical scientists

Clinical scientists

Chiropodists / podiatrists

Dietitians

Operating department practitioners

Orthoptists

Paramedics

Physiotherapists

Prosthetists / orthotists

Radiographers

Speech and language therapists

0 5 10 15 20 25 30

Occupational therapists

Pro

fess

ion

%

Continuing fitness to practise – Towards an evidence-based approach to revalidation 22

5 Risk

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5.1.3 Complaints by route to registration

Figure 4 – Allegations by route toregistration, compared to theproportion of registrants on the Register

An analysis of complaints by route toregistration indicates that there is a correlationbetween the percentage of registrants whoentered the Register via a particular route andthe route to registration of those subject to a complaint.

There are three ways of gaining registration,which we refer to as ‘routes to registration’:

1. UK approved course

This refers to individuals who registerhaving successfully completed aprogramme delivered in the UK that we approve.

2. International

This refers to individuals who havecompleted education and trainingoutside of the UK who apply forregistration via the international route to registration.

3. Grandparenting

Normally, when the HPC regulates a newprofession there will be a time–limited‘Grandparenting’ period.

The Grandparenting period allowspeople who have previously beenpractising the profession but who couldnot become voluntarily registered toapply for registration, provided that theycan meet certain criteria.

There is no significant difference betweencomplaints compared to the way in whichthose individuals complained about wereregistered. For example, 89 per cent of ourRegister is made up of individuals whoregistered having completed an approvedcourse, and 88 per cent of complaintsreceived in 2007 – 08 were about registrantsfrom this route to registration.

We can conclude therefore that there is nosignificant difference in risk between registrantson the basis of their registration background.

5.1.4 Complaints by gender

In contrast, the data suggests that gender is afactor in any assessment of the risk ofregistrants. Male registrants are more likely thantheir female counterparts to be subject to acomplaint (please see figures 5 and 6 overleaf).

In 2007–08, women accounted for 76 per centof the total number of registrants and men 24per cent. However, 57 per cent of complaintswere about men and in every profession theproportion of complaints about men was higherthan the proportion of males in that profession.

% Allegations% Register

0

10

20

30

40

50

60

70

80

90

100

Route to registration

%

UK International Grandparenting

Continuing fitness to practise – Towards an evidence-based approach to revalidation23

5 Risk

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This trend is particularly marked amongstoperating department practitioners, where 79per cent of complaints were about maleregistrants, compared to 38 per cent of maleregistrants in this profession.

Evidence from the medical profession has alsoindicated that gender might be an importantfactor in fitness to practice. One US studyfound that male doctors were three times morelikely to be subject to malpractice claims thantheir female counterparts.13

In the UK, Firth-Cozens observed that conductand drug dependency concerns about doctorsare also predominantly about male doctors.She suggests that women’s communicationskills and emotional intelligence ‘may makethem forge better relationships with patientsand make them less likely to be the subject of complaints’.14

Continuing fitness to practise – Towards an evidence-based approach to revalidation 24

5 Risk

Figure 5 – Proportion of allegations against female registrants, compared to the proportion of females on the Register

% Allegations% RegistrantsArts therapists

Biomedical scientists

Chiropodists / podiatrists

Clinical scientists

Dietitians

Operating department practitioners

Orthoptists

Paramedics

Physiotherapists

Prosthetists / orthotists

Radiographers

Speech and language therapists

0 10 20 30 40 50 60 70 80 90 100

Occupational therapists

Total

Pro

fess

ion

%

13 Taragin, M., Wilczek, A., Karns, M., Trout, R., Carson, J., ‘Physician demographics and the risk of medicalmalpractice’, American Medical Journal, 93, (1992), 535–42.

14 Firth-Cozens, Jenny, ‘Effects of gender on performance in medicines’, British Medical Journal, 336, (2008), 731–2.

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Figure 6 – Proportion of allegations against male registrants, compared to the proportion of males on the Register

% Allegations% RegistrantsArts therapists

Biomedical scientists

Chiropodists / podiatrists

Clinical scientists

Dietitians

Operating department practitioners

Orthoptists

Paramedics

Physiotherapists

Prosthetists / orthotists

Radiographers

Speech and language therapists

0 10 20 30 40 50 60 70 80 90 100

Occupational therapists

Total

%

Pro

fess

ion

5.1.5 Complaints by age

An analysis of data against age range revealsthat certain age groups are more likely to besubject to a complaint than might be expectedby the proportion of registrants in that agegroup (Please see Figure 7 overleaf).

In 2007 – 08, registrants between the ages of40 and 59 were disproportionately subject tomore complaints. This trend was most markedin the 45-49 age group, which accounted for20 per cent of complaints but only 14 per centof the whole Register.

Registrants between 20 and 39 wereproportionately subject to fewer complaintsand no complaints were received aboutregistrants aged 65 or over.

This data seems to suggest that there may besome correlation between the age of aregistrant and their risk of complaint. This issupported by evidence in the medicalprofession. For example, an analysis of datafrom referrals to the National ClinicalAssessment Service (NCAS) revealed that therate of referral to NCAS increases with age.15

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15 National Clinical Assessment Service, Analysis of the first four years referral data, (July 2006).

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Figure 7 – Proportion of allegations by age group, compared to the proportion of each age group on the Register

5.1.6 Complaints by practiceenvironment

Collection of data relating to the practiceenvironment of registrants subject to acomplaint has recently begun. The HPCFitness to Practise Department now classifiescomplaints by where the matters allegedoccurred under the following headings:

– NHS Hospital;

– Other public sector place ofemployment;

– Patient home;

– Private clinic;

– Private hospital;

– Not during work; and

– Other

Therefore, at this time, there is a lack ofavailable quantitative evidence in order toassess whether different environments (ieindependent practice compared to managedenvironments) pose more risk than others.

It is worth noting here that the biggestcomplainant group remains employers,accounting for 50 per cent of complaints in 2006 – 07 and 40 per cent of complaints in 2007 – 08.

5.1.7 Conclusions

The vast majority of registrants never have anycontact with the fitness to practise processand hence the numbers involved are smallrelative to numbers on the Register. However,analysis of the data does identify someinteresting trends.

The majority of cases concern conduct or havea conduct element to them, suggesting thatconduct is a higher area of risk or morefrequently a ‘problem’ than competence.Conduct is associated with the attitudes andvalues which influence future behaviour –intangible aspects of practice which are difficultto identify and measure. Therefore, it may bedifficult to revalidate conduct in any meaningfulway and it is unlikely that a revalidation processwould prevent poor conduct occurring.

% Allegations% Register

65+

60-64

55-59

50-54

45-49

40-44

30-34

25-29

20-24

0 5 10 15 20 25

35-39

%

Age

ran

ge

Continuing fitness to practise – Towards an evidence-based approach to revalidation 26

5 Risk

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This poses the question whether additionalregulation focused on competence (which isfar easier to identify and measure in concreteterms) would be properly focused on the areaof greatest risk.

Given the limited information available, it is notbe possible at this time to revalidate on thebasis of risk – in the sense of treatingregistrants differently dependent upon using apre-determined assessment of the risk thattheir practice attracts.

The data indicates that the professionsregulated by the HPC overall are of lower riskcompared to other regulators. However, thedata did reveal that some professions may beof ‘higher risk’ than others and further work inthis area is warranted.

5.2 Systemic risks

The group also explored the risks arising frommechanisms and environments which have animpact upon patient safety.

The National Patient Safety Agency (NPSA)has examined studies into patient safetyincidents and concluded that: ‘…the best wayof reducing error rates is to target theunderlying mechanisms failures, rather thantake action against individual members ofstaff.’ The NPSA’s ‘seven steps to patientsafety’ reveal risks which occur at anorganisational or system level and which canbe tackled and mitigated at that level.16 Theserisks are often cultural in nature and concerncommunication, leadership and theempowerment of staff to identify, report andtackle safety problems.

The work of the organisations involved ininstitutional inspection are similarly focused onservice / mechanisms and quality improvement.

The clinical governance agenda within the NHSis also about mitigating risk and ensuring patientsafety (please see section 5.2, paragraphs 58and 59).

The risks associated with individualpractitioners are only one part of a picturewhich includes risks associated withmechanisms and organisational culture. Thisraises the question of whether revalidating theindividual practitioner is properly focused onthe area of greatest risk.

5.3 Professionalism

The HPC’s own fitness to practise data indicatesthat conduct or professional behaviour is morefrequently a problem than competence. Thisraises questions about the nature of anyproposed new system for revalidation.

The definitions of revalidation put forward sofar often refer to ‘fitness to practise’. Fitness topractise is more than just technical ability andis defined as the combination of conduct,competence, health and character necessaryto practise safely and effectively.17 This raisesthe question of the ability of any revalidationprocess to positively revalidate ‘conduct’,‘character’ or ‘professionalism’, despite ourassessment of risk.

Work undertaken in the medical profession onthe issue of professionalism may provide uswith a way forward. The Royal College ofPhysicians and the King’s Fund have definedthis more intangible aspect of practice as ‘aset of values, behaviours, and relationshipsthat underpins the trust the public has indoctors.’18 Such a definition might beextended to other health professionals.Professionalism is clearly linked to public trust,and this is consistent with research undertakeninto the views and expectations of members of

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5 Risk

16 National Patient Safety Agency, Seven steps to patient safety, (2004).

17 Health Professions Council, Managing Fitness to Practise: a guide for registrants and employers, (2008), p.2.

18 King’s Fund and Royal College of Physicians, Understanding Doctors – Harnessing Professionalism, (2008).

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the public (please see section eight).

Research undertaken in the United States hasrevealed that doctors who had identifiedconcerns about their professionalism whilststudents were more likely to be subsequentlydisciplined by their state medical board oncequalified than those without any such concerns.

One study considered whether disciplinaryaction taken against licensees by the StateMedical Board could be predicted in thebehaviour of these doctors whilst medicalstudents. A professionalism measure identifiedthat poor reliability and responsibility, lack ofself improvement and adaptability and poorinitiative and motivation were the domainswhich predicted future disciplinary action. Ofthe disciplinary actions subsequently taken bythe State Medical Board, 95 per cent were fordeficiencies in professionalism.19

Another study found that admissions materialdid not predict professional behaviour in lateryears, only academic achievement. Instead, thisstudy suggested that it was possible to identify‘context bound’ and ‘concrete’ areas whichcould predict future behaviour, and which weremore helpful than more generic expressions ofwhat is meant by professionalism andprofessional behaviour. For example, the studyfound that medical students’ failures tocomplete evaluations and failures to complywith immunisation requirements were specificpredictors of later poor performance.20 In theUK, there is a broad consensus that attentionneeds to be given to both selecting applicantswho demonstrate professional behaviours andteaching and assessing professionalism duringmedical training.

In some US medical schools, these measuresof professionalism are now used as part of theoverall monitoring of student development.

The findings from these studies are helpful inthat they suggest that it might be possible tospecifically identify the areas which predictfuture professional behaviour. We havepreviously identified the difficultly of‘revalidating’ conduct; instead such anapproach would seek to measure aspects ofprofessional behaviour and ongoing conductfrom an early stage.

If such findings were extended to theprofessions regulated by the HPC, they mightsuggest that more regulatory effort should befocused on promoting understanding ofprofessionalism in pre-registration educationand training, as this is the area which is mostlikely to predict future professional behaviour.

However, no such research exists in theprofessions regulated by the HPC. We foundno comparable studies of our professions anda recent independent literature review found alack of evidence generally about complaintsagainst non-medical healthcareprofessionals.21 This is an area where furtherinvestigation would be beneficial.

Continuing fitness to practise – Towards an evidence-based approach to revalidation 28

5 Risk

19 Papadakis, M., Hodgson C., Teherani, A., Kohatsu N., ‘Unprofessional behaviour in medical school is associated withsubsequent disciplinary action by a state medical board’, Academic Medicine, 79(3), (2004), 244–249.

20 Stern, David, ‘The Prediction of Professional Behaviour’, Medical Education, 39(1), (2005) 75–82.

21 Gulland, Jackie, Scoping report on existing research on complaints mechanisms, (January 2008) [http://www.hpc-uk.org/assets/documents/ 100021EB230408-enclosure4-Complaintsreview.pdf].

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An analysis of the likely cost and resourceimplications of any form of additional regulationis important in our discussion of revalidation.

The assessment of the likely costs ofrevalidation is hampered by limited informationaround the costs of existing models.

However, the limited available information does help us develop a picture of the likelycosts involved.

6.1 Costs of other HPCassessment processes

The group considered the costs of two existingHPC processes.

1. International registrationassessment

Applicants for registration who qualifiedoutside of the United Kingdom areassessed via a paper based process bytwo registration assessors.

In 2006, an external auditing exerciseput the costs of international applicationprocess, including assessment,administration costs and overheads at£354 per applicant.

2. Continuing ProfessionalDevelopment

Registrants’ CPD profiles are assessedby two CPD assessors and a decisionreached. The current audit is of 5 percent of the Register but it is anticipatedthat this will drop to 2.5%. The estimatedcost of assessing CPD profiles is £77.27per profile – this figure includes fees,administrative costs and overheads butdoes not include development costs (iestandards development, literature,assessor training).

6.2 UK regulators

There was a lack of information about thecosting of revalidation undertaken by other UKregulators of healthcare professionals. Thecosting of the models developed by the GeneralMedical Council and General Dental Council isongoing or is to be commenced shortly.

For reference, in 2001 the General MedicalCouncil estimated the cost of their revalidationproposals (which have subsequently changedand are currently under development) as£7.85m per annum.22

6.3 College of Physiotherapists of Ontario Quality ManagementProgram

The College of Physiotherapists of Ontarioprovided a breakdown of the costs involved intheir ‘Quality Management Program’ whichincluded marketing, development and legalexpenses as well as the direct costs ofassessment (see section 5.3).

The direct costs of individual registrantassessment in the competency assessmentstage, including assessor travel costs, werearound CA$400 per assessment (around £200).

6.4 Hypothetical costs

Any costing of a revalidation process inevitablyrelies on key assumptions about the number ofregistrants, the frequency of revalidation andthe mechanism of the revalidation process.

6 Costs and resources

Continuing fitness to practise – Towards an evidence-based approach to revalidation29

22 General Medical Council, Council papers and minutes, (May 2001), [www.gmc-uk.org/about/council/papers/2001_05.asp].

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We considered whether a costing model couldbe developed to produce an indication of thehypothetical costs of various forms ofrevalidation. However, there are potentially ahuge number of possible options for howrevalidation might be delivered – ranging frommaking small changes to existing processesup to comprehensive individual assessment.The non-assessment related costs involved arealso likely to be extensive includingcommunications activity, standardsdevelopment and evaluation. As such, it wouldbe difficult to produce an estimate ofhypothetical costs which would be meaningfuland account for all these possibilities.

6.5 Wider costs

The White Paper indicated that thegovernment would consider the impactrevalidation would have on ‘diverting frontlinestaff from direct patient care’ and the ‘capacityof regulators and employers for each group’(paragraph 2.38).

This highlights the wider costs in implementingany revalidation system. These wider costsinclude the question about whether regulatorytime, finances and resources might be betterfocused on other areas, such as bringing newprofessions into statutory regulation, where thisis warranted.

6.6 Conclusions

The costs of revalidation are potentiallysignificant and would increase pressure on thelevel of the registration fee. However, there is alack of information on which to quantify thisconclusion in absolute terms.

However, any assessment of whetheradditional regulation was necessary wouldneed to include a cost-benefit analysis and theoutcome of this may vary enormously with thenature of any approach taken.

For example, a tokenistic approach torevalidation may well carry with it little cost butmay achieve few demonstrable benefits andwould do little to prevent risk.

The evaluation of any future piloting of arevalidation approach would need to include acomprehensive impact assessment including athorough understanding of cost.

Continuing fitness to practise – Towards an evidence-based approach to revalidation 30

6 Costs and resources

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The role that patients and members of thepublic play in the revalidation debate was also considered.

Potential issues include differences in publicawareness, public expectations and publicinvolvement. These are explored below.

7.1 Public awareness

Research was undertaken as part of the reviewof the regulation of non-medical healthprofessionals to gauge attitudes of membersof the public to the regulation of professionalsother than doctors.23 The research concludedthat there was very little public understandingof the existing system of health regulation.

Ipsos MORI research commissioned by theHPC found that around one in seven UKresidents had heard of the HPC. Awareness ofthe functions and purpose of professionalregulation was also low, with 32 per cent of thegeneral public unable to identify what the roleof a regulator of health professionals might beat all.24

7.2 Public expectations

The work on public expectations is less clearcut. On the one hand, the Department ofHealth commissioned research concluded thatthere was ‘strong public support for regularchecks being carried out on the non-medical

healthcare professionals’.

In contrast, the Department of Health researchalso concluded that there was a high level ofsatisfaction with non-medical healthcareprofessionals – 88 per cent of researchparticipants reported that they were satisfiedwith their last contact with a non-medicalhealthcare professional. Recent surveys ofpatient satisfaction by the Picker Institute andby the Healthcare Commission show thatlevels of satisfaction are rising, with a higherproportion of patients expressing satisfactionwith their care than in previous years. Onerecent report revealed that non-medicalprimary care staff have consistently had thehighest levels of trust and confidence amongstpatients surveyed.25

There is also a body of work exploring in moredepth what the public expect from healthprofessionals. Technical competence iscertainly one expectation, but patients also saythey want to be treated with respect, to belistened to and to have a clear explanation oftheir diagnosis and treatment options.26

The characteristics highlighted as important fortrust and confidence in non-medical healthcareprofessions in the Department of Health researchwere listening skills; giving the impression ofcaring / showing concern; taking the time tospeak to patients; and giving personal treatment/ treating patients as ‘humans’.

7 The public

Continuing fitness to practise – Towards an evidence-based approach to revalidation31

23 MORI (Commissioned by the Department of Health), Attitudes to Regulation of Non-medical Healthcare Professionals, (2005).

24 MORI (Commissioned by the Health Professions Council), Health Professions Council – Public, Registrant andStakeholder Views, (2007).

25 Healthcare commission, National survey of local health services, (2008). Richards, N and Coulter, A, Is the NHS becoming more patient centred? Trends from the national surveys of NHSPatients in England 2002–2007 (2007), p.10.

26 Elwyn, G., Edwards, A., Kinnersley, P, ‘Shared decision making in primary care: the neglected second half of theconsultation’ British Journal of General Practice, 49 (1999), 477–482. Donaldson, L, ‘Expert patients usher in a new era of opportunity in the NHS’ British Medical Journal, 329 (2003), 1279–1280. Coulter, A, ‘Paternalism or Partnership?’, British Medical Journal, 319 (1999), 719–720.Gott, M., Stevens, T., Small, A., Ahmedzai, S, ‘Involving users, improving services; the example of cancer’, BritishJournal of Clinical Governance, 7;(2), (2002), 81–85.

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7.3 Public involvement

Public involvement in developing andmonitoring professional practice in healthcareis also a key influence on the current regulatoryprocess, although public awareness of this isalso likely to be limited.

At the HPC, lay council and committeemembers, lay panel members and patientgroups as well as voluntary sectororganisations are involved not only in thegovernance of the regulatory body itself, butalso in the development and revision ofstandards, fitness to practise panels and inspecific projects. The HPC also participates inthe work of the Joint Regulators’ Patient PublicInvolvement (PPI) Group, which aims topromote patient involvement in the regulatoryprocess. In some areas of education there hasbeen a move toward service user involvement inthe development and delivery of pre-registrationeducation. These are all examples of publicinvolvement which are less well known but arenevertheless a crucial aspect of quality controland quality improvement in regulation.

7.4 Conclusions

Research has shown that public awareness ofthe function of regulators is low and publicexpectations of the existing system differ fromthe reality. This, however, needs to be seen inthe overall context of high levels of trust ofhealth professionals and low levels ofcomplaints against the professionals regulatedby the HPC.

Any additional regulation must be meaningfuland easy to communicate with members ofthe public. An approach which was tokenisticmight have the effect of providing falsereassurance to the public which would becounter-productive in terms of public safetyand maintaining public trust and confidence.

It could further be argued that the currentmechanisms are appropriate given the low riskprofile of the professions regulated by the HPC(in light of the available information) and, if thepublic had more knowledge of the existingsystem and the rationale behind it, they wouldbe reassured by it. The areas identified by theDepartment of Health are around so called‘soft skills’ – the more intangible aspects ofpractice that are inevitably more difficult toassess and which would be much morechallenging to revalidate.

This certainly accords with evidence from theNational Clinical Assessment Service whichseems to indicate that the areas of concernand, we might conclude, risk, are aroundissues with communication, patientinvolvement and information exchange.Information about complaints made about theNHS also show that these are the prevalentareas of patient complaint.27 These ‘soft skills’are, however, also some of the skillsassociated with ‘professionalism’ (please seesection 6.2).

The CPD standards and audit process is partlyfocused on the benefits of registrants’ learningto those who use or are affected by theirpractice. However, service user feedback,which might be helpful in terms of providingfeedback on ‘soft skills’, is not specificallyintegrated within the CPD standards or CPDprocess. Such tools are also a potential,structured way of achieving further publicinvolvement in the regulatory processes.

This is an area where further investigationis indicated.

Continuing fitness to practise – Towards an evidence-based approach to revalidation 32

7 The public

27 Scottish Public Services Ombudsman, Annual Report 2006/07, (2007). Public Services Ombudsman for Wales, Annual Report 2007/08, (2008).

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In this section, possible options for furtherwork or enhancements to the HPC’sprocesses are discussed in the light of theanalysis included in this report.

8.1 Structured patient feedback

A feedback tool or feedback tools could beuseful in promoting the integration of feedbackfrom service users and colleagues into thework of registrants and in achieving higherlevels of public involvement in regulation.

This section refers to ‘structured patientfeedback’ as a potential starting point for ourexploration of the usefulness of such tools.However, it is acknowledged that manyregistrants do not work in roles with directcontact with patients and that accordingly,further ongoing work would be necessary.

Multi-source feedback from patients andcolleagues is part of the General MedicalCouncil’s revalidation proposals, and researchand piloting has been undertaken to test thereliability and validity of assessment tools.

In 2006, a Picker Institute study concludedthat patient questionnaires could be aneffective way of testing the core qualities of adoctor’s performance, but that the quality ofquestionnaires could be variable and thatfurther research was necessary.28

Research commissioned by the GeneralMedical Council to validate a patient andcolleague assessment concluded that theproposed patient and colleague questionnairesdo offer a ‘reliable basis for the assessment ofprofessionalism’. The research furtherconcluded: ‘If used in the revalidation ofdoctors’ registration, the questionnaires wouldbe capable of discriminating a range ofprofessional performance among doctors, and

potentially identifying a minority whose practiceshould be subjected to further scrutiny.’29

The self-certification and CPD processeslargely rely on the trust placed in healthprofessionals in assessing their owncompliance with standards. A patient feedbackmeasure could have the potential to providestructured, regular, external input andverification, which is currently missing from theexisting HPC processes.

Research would be needed to validate thereliability of any tool in the context of thepractice of the professions regulated by theHPC and the variety of different workingcontexts of registrants. Depending on theoutcome of this research, further work wouldbe necessary to consider how such a toolmight be integrated within the HPC’sprocesses. For example, whether such a toolmight provide a helpful way for registrants toreflect on their practice and identify their CPDneeds as a result.

8.2 Understanding poor conductand professionalism

The evidence of the models examinedsuggests that competence or performance istackled directly by other mechanisms (e.g.clinical governance, supervision, accreditation)in a way that aspects of conduct may not be.

Our analysis has highlighted that conductrepresents the main risk amongst theprofessions regulated by the HPC. As such,we need to explore this further and look atways in which we can measure and monitor itmore effectively.

In particular, a clearer understanding of thepotential link between poor conduct duringpre-registration education and training and

8 Options for further work

Continuing fitness to practise – Towards an evidence-based approach to revalidation33

28 Chisholm, A and Askham, J, A review of questionnaires for gathering patients’ feedback on their doctor, (2006).

29 Campbell, J., Richard, S., Dickens, A., Greco, M., Narayanan, A., Brearley, S., ‘Assessing the professionalperformance of UK doctors: an evaluation of the utility of the General Medical Council patient and colleaguequestionnaires’, Quality and Safety in Health Care, 17, (2008), 187–193.

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subsequent fitness to practise action would behelpful here in directing our efforts to the areaof greatest risk.

A greater understanding of this area may alsobe useful when considering future work aroundthe standards of conduct, performance andethics (and any future guidance) and their rolein the continued professionalism of registrants.

8.3 Data analysis

Analysis of fitness to practise data has beenhelpful in developing an assessment of the riskposed by the professions regulated by the HPC,and further analysis of data, particularly relatingto practice environment, would be helpful.

Ongoing analysis of data will be helpful interms of identifying trends, assessing theongoing effectiveness of HPC’s processes andfurther developing our assessment of risk. Inparticular, analysis of the outcomes of theongoing CPD audits is likely to be helpful inthis regard.

Further consideration of data availableelsewhere may also be helpful.

Continuing fitness to practise – Towards an evidence-based approach to revalidation 34

8 Options for further work

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In line with the White Paper proposal thatrevalidation must be risk–based andproportionate, the HPC has taken an evidence–based approach to exploring what revalidationmight mean for the professions it regulates.

Based on the evidence considered, weconclude that revalidation as described in theWhite Paper is not necessary at this time forthe professions regulated by the HPC.

The existing system operated by the HPC is asuccessful one and overall there is a lack ofevidence to suggest that the existing system isnot working, The HPC system does not exist ina vacuum but is one part of an interlockingprocess of checks and balances which help toassure continuing fitness to practise. Thissystem is not limited to service regulation butincludes many other initiatives which areemployer, profession or individual led and whichexist without compulsion. This interlockingprocess involves the individual registrant, peers,employers, regulators, professional bodies,service users and others as a collective driverfor continued fitness to practise.

All of these contribute to promoting a culture ofaccountability – where accountability to theregulator is just one aspect of goodprofessional practice.

Any additional regulation must be clearlyjustified, balancing the costs of regulationagainst clear benefits. The costs of revalidationhave the potential to be significant. The needfor additional regulation and the benefits topublic protection and public confidence areunclear at this time and it is important that we avoid an approach which is tokenistic innature and fails to add value to the HPC’sexisting processes.

Public awareness and understanding of therole of regulation is low, but trust in the non-medical healthcare professions is high. Theresearch indicates that the areas of practicelinked to trust and confidence are those thatare linked to professionalism and which may

be more difficult to directly and meaningfullyrevalidate. Any additional regulation must bemeaningful and focused in the areas ofgreatest risk if it is to maintain already highlevels of public trust and confidence.

The models of revalidation examined, in the UKand elsewhere, are not appropriate for use bythe HPC at this time as they could not bejustified by the available evidence. They couldalso not be easily applied across theprofessions regulated by the HPC and thediverse settings in which registrants work.However, the integration of patient feedbacksuggested in one of the developing models isidentified as an area which merits furtherexploration and has the potential to achievemeaningful external input.

Analysis of fitness to practise data indicates alow overall risk profile for the professionsregulated by the HPC and that conduct ismuch more frequently a concern thancompetence. We should therefore focus ourefforts on professionalism and its constituentsrather than on competence which is alreadybeing monitored through other means.

The HPC remains committed to an ongoingprocess of review in order to adapt to meetchanging needs and challenges and toconstantly improve the efficiency of itsperformance. A number of avenues for furtherwork have been identified.

In light of the evidence presented, werecommend that further work should beundertaken before any additional layer ofregulation is introduced for the professionsregulated by the HPC.

A number of pieces of further work areindicated, to further develop our understandingof risk (see section 10).

9 Summary and overall conclusions

Continuing fitness to practise – Towards an evidence-based approach to revalidation35

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At this stage we have concluded that furtherregulation in this area is not necessary for theprofessions regulated by the HPC. However, anumber of areas for further exploration havebeen identified.

We recommend further investigation via aseries of pilot projects.

– Analysis of fitness to practice data toexplore correlations between age,location of practice and fitness topractice.

– Analysis of the outcomes of the CPDaudits currently being conducted.

– A retrospective study to explore whetherregistrants from a particular professionwho have undergone fitness to practiseaction are more likely to have beeninvolved in disciplinary procedures or todemonstrate a poor record inprofessional behaviour during training.

– A prospective study piloting the use of aprofessionalism tool with education andtraining providers for two differentprofessions and track the progress ofstudents over five years.

– Depending on the outcome from thesestudies, a wider use of this tool ineducation and training programmes forother professions may be recommended.

– In parallel to the above recommendation,further explore the teaching of‘professionalism’ on pre-registrationprogrammes across the 13 professionsand look at ways of promoting thisfurther, for example, via the standards ofeducation and training.

– A prospective study looking at theapplication of a patient feedback toolwith a random sample of registrantsand students.

10 Recommendations

Continuing fitness to practise – Towards an evidence-based approach to revalidation 36

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Campbell, J., Richards, S., Dickens, A., Greco, M., Narayanan, A., Brearley, S., ‘Assessing theprofessional performance of UK doctors: an evaluation of the utility of the General Medical Councilpatient and colleague questionnaires’, Quality and Safety in Health Care, 17, (2008), 187–193.

Chisholm, A, and Askham, J, A review of questionnaires for gathering patients’ feedback on theirdoctor, (2006).

Council for Healthcare Regulatory Excellence, Annual Report 2006–07, (2007).

Cohen, D and Rhydderch, M, ‘Measuring a doctor’s performance: personality, health and well-being’, Occupational Medicine (London), 56(7) (2006), 438–40.

Coulter, A, ‘Paternalism or Partnership?’, British Medical Journal, 319 (1999), 719–720.

Department of Health, Good Doctors, Safer Patients, (2006).

Department of Health, National Standards, Local Action – Health and Social Care Standards andPlanning Framework 2005 – 06 – 2007 – 08, (2004).

Department of Health, The Regulation of the Non-medical Healthcare Professionals, (2006).

Department of Health, Trust, Assurance and Safety – The Regulation of Health Professions in theCentury, (2007).

Donaldson, L, ‘Expert patients usher in a new era of opportunity in the NHS’, British MedicalJournal, 326 (2003), 1279–1280.

Elwyn, G., Edwards, A., Kinnersley, P, ‘Shared decision making in primary care: the neglectedsecond half of the consultation’, British Journal of General Practice, 49 (1999), 477 –482.

Firth-Cozens, J, ‘Effects of gender on performance in medicines’, British Medical Journal 336(2008), 731–732.

General Medical Council, Ensuring Standards, securing the future – consultation document, (2000).

Gulland, J, (commissioned by the Health Professions Council) Scoping report on existing researchon complaints mechanisms, (January 2008).

Gott, M., Stevens, T., Small, A., Ahmedzai, S., ‘Involving users, improving services; the example ofcancer’, British Journal of Clinical Governance, 7 (2), (2002), 81–85.

Healthcare Commission, National survey of local health services, (2008).

The Health Professions Council, Managing Fitness to Practise: a guide for registrants andemployers, (2006).

The Health Professions Council, Fitness to Practise Annual Report 2006 – 07, (2007).

The Health Professions Council, Fitness to Practise Annual Report 2007 – 08, (2008).

HM Treasury, Reducing Administrative Burdens: Effective inspection and enforcement, (2005).

Information Centre for Health and Social Care, Data on written complaints in the NHS 2006 – 07, (2007).

References

Continuing fitness to practise – Towards an evidence-based approach to revalidation37

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King’s Fund and Royal College of Physicians, Understanding Doctors – HarnessingProfessionalism, (2008).

Knight J., Sanchez, L., Sherritt, L., Bresnahan, L., Fromson, J., ‘Outcomes of a MonitoringProgram for Physicians with Mental and Behavioral Health Problems’, Journal of PsychiatricPractice, 13(1), (2007), 25–32.

MORI (Commissioned by the Department of Health), Attitudes to Regulation of Non-medicalHealthcare Professionals, (2005)

MORI (Commissioned by the Health Professions Council), Health Professions Council – Public,Registrant and Stakeholder Views, (2007).

National Clinical Assessment Service, Analysis of the first four years referral data, (July 2006).

National Patient Safety Agency, Seven steps to patient safety, (2004).

Papadakis, M., Hodgson, C., Teherani, A., Kohatsu, N., ‘Unprofessional behaviour in medicalschool is associated with subsequent disciplinary action by a state medical board’, AcademicMedicine, 79(3), (2004), 244–9.

Parliamentary and Health Service Ombudsman, Annual Report 2006 – 07 – Putting principles intopractice, (July 2007).

Parliamentary and Health Service Ombudsman, Principles for Remedy, (2007).

Public Services Ombudsman for Wales, Annual Report 2007 – 08, (2008).

Richards, N and Coulter, A, Is the NHS becoming more patient centred? Trends from the nationalsurveys of NHS Patients in England 2002–07, (2007).

Scally G and Donaldson L, ‘Clinical governance and the drive for quality improvement in the newNHS in England’, British Medical Journal, 317 (1998), 61–65.

Scottish Public Services Ombudsman, Annual Report 2006 – 07, (2007).

Stern, D, ‘The Prediction of Professional Behaviour’, Medical Education, 39(1) (2005), 75–82.

Taragin, M., Wilczek, A., Karns, M., Trout, R., Carson, J., ‘Physician demographics and the risk ofmedical malpractice’, American Medical Journal, 93, (1992), 535–42.

Continuing fitness to practise – Towards an evidence-based approach to revalidation 38

References

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Figures

Figure 1 Quality control and quality improvement 8

Figure 2 Professional regulation as part of the quality and safety agenda 15

Figure 3 Allegations by profession, compared to the proportion of registrants on the Register 22

Figure 4 Allegations by route to registration, compared to the proportion of registrants on the Register 23

Figure 5 Proportion of allegations against female registrants, compared to the proportion of femaleson the Register 24

Figure 6 Proportion of allegations against male registrants, compared to the proportion of males onthe Register 25

Figure 7 Proportion of allegations by age group, compared to the proportion of each age group onthe Register 26

Tables

Table 1 National and local mechanisms 12

Table 2 International mechanisms 16

Appendices

Appendix 1 Membership of the Continuing Fitness to Practise Professional Liaison Group (PLG) 40

Appendix 2 Implementing the NHS Knowledge and Skills Framework (KSF) 41

Appendix 3 Reproduced from Trust, Assurance and Safety – The Regulation of HealthProfessionals in the 21st Century 43

List of figures, tables and appendices

Continuing fitness to practise – Towards an evidence-based approach to revalidation39

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Mary Clark-Glass Lay member of the HPC Council

Audrey Cowie Scottish Government Health Directorate

Ruth Crowder Allied Health Professions Federation

Vince Cullen General Osteopathic Council

Christine Farrell Lay member of the HPC Council

Thelma Harvey KSF Group of the NHS Staff Council

Morag Mackellar Dietitian member of the HPC Council

Sharon Prout Unison

Keith Ross Lay member of the HPC Council

Charles Shaw Attended in a personal capacity

Lynne Smith Federation for Healthcare Science

Eileen Thornton Alternate physiotherapist member of the HPC Council

Anna van der Gaag Chair of the HPC Council and Chair of the PLG

Mark Woolcock Alternate paramedic member of the HPC Council

Appendix 1 –Membership of the Continuing Fitness to Practise Professional LiaisonGroup (PLG)

Continuing fitness to practise – Towards an evidence-based approach to revalidation 40

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Working Smarter, not harder;bedding the Knowledge SkillsFramework into practice

The Government’s proposals for the regulationof health professionals in the White Paper,Trust, Assurance and Safety (DoH 2007) weresummarised in OT News (OTN June 2007 pg27). Since then these have been taken forwardand have been included within the QueensSpeech. Representatives of NHS employers,professionals and unions are now looking atsystems to implement this although details areas far as we understand not yet available. Oneof the proposals is that within the NHS inEngland, the Knowledge and Skills Framework(KSF) (DoH 2004) will form the basis ofrevalidation within Trusts. The implications ifthis becomes law are far-reaching and haveshaped our approach to implementing the KSFlocally within South West London & St.Georges Mental Health Trust. This articlediscusses our work so far and invites debateon the revalidation proposals and howoccupational therapists are responding.

As an early implementer for Agenda forChange, the occupational therapy service hasbuilt up considerable experience linking theKSF with the College of OccupationalTherapists and the Health Professions Council(HPC) requirements for continuing professionaldevelopment (CPD). With the advent of theproposals in the White Paper, we decided toconduct a local audit of occupationaltherapists to monitor exactly how evidence oflearning was currently being recorded.

In late 2006, the audit showed that althoughstaff were aware of the expectations there wasno consistency in the way in which they wereevidencing their learning. They had developedportfolios containing either insufficient evidenceor duplication of work, the majority of whichhad not been mapped, that is to say linked toeither the KSF or HPC standards. There was alot of anxiety and staff clearly identified the

barriers to creating adequate portfolios astime, competing priorities and struggling withthe language of the KSF.

To address these issues we developed anintegrated, flexible and time efficient system tosupport staff in this process which was rolledout throughout the Trust through a series oflocal, practical workshops. Staff were givenguidance on the logging and mapping ofevidence against standards and were shownhow to get the most out of individual pieces ofwork. The process of cross referencingevidence into a KSF record of progress wasalso included which facilitated the auditing ofportfolios and formulation of personaldevelopment plans at development review.Everyone received a practical example of anintegrated portfolio, the ‘Jigsaw Book’illustrating a completed KSF record HPC and aCPD profile. The profile uses Agenda forChange language and fully acknowledges andintegrates the KSF within it. We have alsointegrated preceptorship into the process thatstaff at all stages of their career use the samesystem. In parallel to this reflective practiceand supervision skills training werecommissioned for those staff who identifiedthese as development needs. The time issuewas highlighted by a joint statement from thenursing and the allied health professionalbodies, including the COT (RCN 2007) and thishas been integrated into our local supervisionand CPD policies.

We shared our ideas with colleagues throughthe ‘Working Smarter Not Harder’ workshop atthe 2007 COT Conference in Manchester andfollowing this we have provided workshops foroccupational therapists, allied healthprofessionals and to a lesser extent nursingstaff throughout the UK. As we have met withother staff it is clear that everyone is facingsimilar challenges to those we describedlocally. Individuals have KSF outlines butstruggle to integrate CPD with KSF and

Appendix 2 –Implementing the NHS Knowledgeand Skills Framework (KSF)

Continuing fitness to practise – Towards an evidence-based approach to revalidation41

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therefore we thought it would be helpful toshare the results of our follow up audit. Thissuggested the use of the ‘Jigsaw Book’ andthe ‘Working Smarter’ workshops is bothappealing and achievable for staff. Althoughwe have not obtained perfection, the graphillustrates the growth that has been achievedsince the implementation of the new process.Most significant and positive has been theincrease in the inclusion of evidence producedas part of people’s everyday practice inportfolios and the rise in the amount ofevidence that is being mapped against KSFand HPC standards.

The learning that has been achieved since thebeginning of our journey is the result of thewillingness of therapy staff to pilot new ideasand work together to design systems that are‘user friendly’. We feel that the evolution of thisprocess has been timely as staff now feelbetter prepared for the CPD audit by the HPCin October 2009 but are aware that we mustcontinue to invest time and support if we are tobed this into day to day practice.

Department of Health 2007 Trust, Assuranceand Safety – The Regulation of HealthProfessionals in the 21st Century Departmentof Health London

Royal College of Nursing 2007 A JointStatement on Continuing ProfessionalDevelopment for Health and Social CarePractitioners Royal College of Nursing London

Department of Health 2004 The NHSKnowledge and Skills Framework and theDevelopment Review Process Department ofHealth London

Jane Smith, OT training coordinator

Dr. Mary Morley, Director of Therapies

South West London & St. Georges MentalHealth NHS Trust

[email protected]

Continuing fitness to practise – Towards an evidence-based approach to revalidation 42

Appendix 2 –Implementing the NHS Knowledge and Skills Framework (KSF)

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Appendix 3 – Reproduced from Trust, Assuranceand Safety – The Regulation of HealthProfessionals in the 21st Century

Continuing fitness to practise – Towards an evidence-based approach to revalidation43

Higher Lower

High level of responsibility for patient safetyinherent in scope of practise

Low level of responsibility for patient safetyinherent in scope of practice

Leaders of clinical teams Team members

People who practise outside managedenvironments such as a hospital or clinic

People who practise within such environments

People whose working environment is not subject to NHS standards of clinical governance

People whose working environment is subject toNHS standards of clinical governance

Practitioners who are frequently alone withpatients / clients (including in their homes)

Practitioners who do not work face to face withpatients / clients

Unsupervised practitioners / posts Supervised practitioners / posts

People in their first few years of registration (and possibly also their last few, according tosome evidence)

Registrants in mid (or late?) career

Recent adverse finding by a regulator Clean regulatory record

Recent appraisals show concern about performance

Good performance record

People who are in current practice People who are not practising (some regulatorshave proposed a scheme where non-practisingregistrants need not revalidate at all). Those whoare not practising should not be required torevalidate as there is no risk to the public. Thisdoes however have implications for re-entry tothe register.

People using invasive, high-risk interventions People using lower-risk interventions

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Notes

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Notes

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