regulatory developments in clinical science and technology

The Health Professions Council

Regulatory Developments in Clinical Science and Technology

Dr. Christopher H. Green

UK elected hpc member for Clinical Scientists

What could this mean?

I. Review and possible changes to Regulators themselves – Foster Report

II. Possible changes in registration procedures for Clinical Scientists

III. Possible registration of aspirant groups, particularly emerging technologies

IV. Regulatory Developments in the hpc itself:- possible changes in elections / appointments to Council

Topics...

Ref:HPC/MJS/HPC/June 2005

Possible Regulatory Developments

I. Review and possible changes to Regulators themselves – Foster Report




Topics...


Reminder of the Principles of Professional Regulation

• Self regulation

• Professionally led

• Statutory regulation

• UK model

Introduction – Principles...


HPC is an independent regulator of healthcare professionals

• Reports to Privy Council– Not part of Department of Health– Not part of NHS, (E,NI, S & W)

• Body Corporate

Introduction...Introduction – Independent...


Primary, Secondary & Tertiary legislation

• Health Act 1999– Chapter 8

• Health Professions Order 20011st April 2002– Statutory Instrument No. 254– Recall the Old CPSM & 12 Boards 1961

• Rules– 9th July 2003

• Standards & Guidance

Introduction – PS&T Legislation...


Introduction – OIC ...

HPO 2001 Rules


Nine UK Regulators of Healthcare Professionals

• General Chiropractic Council

• General Dental Council

• General Medical Council

• General Optical Council

• General Osteopathic Council

• Health Professions Council

• Nursing and Midwifery Council

• Pharmaceutical Society of NI (NB Foster)

• Royal Pharmaceutical Society of GB (NB Foster)

Introduction – Nine Regulators...


Other related Regulators

• General Social Care Council

– England, NI, Scotland & Wales

• Council for Healthcare Regulatory Excellence (CHRE)

– 1st April 2003

– Appeals against “Lenient” decisions

– Coordination & best practice

– The president of each of the nine regulators sits on CHRE

– Foster Report suggests enhanced role for CHRE

Introduction – Other Regulators...


Complementary Roles

• Professional Body IPEM– Body of knowledge/ Learned Society– Promotion of profession– Curriculum framework

• Trade Association HPA– Terms & conditions

• Regulator HPC– Sets and maintains standards

» Approves programmes» Keeps a Register» Fitness to Practise» Continuing Professional Development (CPD)

Introduction – Complementary Roles...


Regulator must be separate

TradeAssociation

HPA

ProfessionalBodyIPEM

RegulatorHPC

Introduction – Separation...


(but pharmacistists aren’t separate, see comment in

Foster Report)

Further Separations

• In Investigative and Disciplinary cases, the Regulator should not be judge and jury (e.g., public perceives doctors on GMC looking after their own).

• Currently done by Investigative panels reporting to Council through Investigative committee.

• This function may move to the Council for Healthcare Regulatory Excellence (CHRE) under Foster Report.

HPC main objective

“To safeguard the health and well-being of persons using or needing the services of registrants”

Health Professions Order 2001

Article 3 (4)

Recall how the HPC meets this Objective

Objective...


There is an Integrated process of setting & maintaining standards

StandardsStandards

RegisterRegisterProgrammeApproval

ProgrammeApproval

ContinuingProfession

Development

ContinuingProfession

Development

Fitnessto

Practice

Fitnessto

Practice

ConductPerformance

Ethics

ConductPerformance

Ethics

CPDStandards

CPDStandards

StandardsProficiencyStandardsProficiency

StandardsEducationTraining

StandardsEducationTraining

4 Standards – 5 Processes...


The Council has Statutory & Non-Statutory Committees

HealthHealth

Registration –Now disbandedRegistration –

Now disbanded

CouncilCouncil

Approvals –Now disbanded

Approvals –Now disbanded

InvestigatingInvestigating

Conduct&

Competence

Conduct&

Competence

Finance & ResourcesFinance & Resources CommunicationsCommunications

Education & TrainingEducation & Training

S&O – Committees...

RemunerationRemuneration AuditAudit


Standards of Education & Training

• “Light Touch” regulation (really?)• Six components

– Level of qualification for entry to the register MSc– Programme admissions procedures IPEM– Programme management & resources ,,– Curriculum ,,– Practice placements ,,– Assessment ,,

• Seems a very long process to me

Standards – E&T...


Standards of Proficiency

• Threshold standards for entry to Register• Two components

– Shared– Profession specific

• Three standards– Expectations of a Health Professional– Skills required for application of practice– Knowledge

Standards – Proficiency...


Standards of Conduct, Performance & Ethics

• Apply to registrants & prospective registrants

• Conduct, (4)– 3. Maintain high standards of personal conduct

• Performance, (8)– 10. Keep accurate patient, client and user records

• Ethics, (4)– 14.Behave with integrity & honesty

• HPC booklet available – currently under review

Standards – CPE...


Standards – Brochure...


Standards of CPD

• HPC will require registrants to undertake CPD before renewal of registration, current done by a declaration.

• Implementation July 2006 already done• Auditing profiles July 2008 July 2009 for us

Will implementation mean more that just a declaration?Yes, a sample, probably initially 5% dropping to 2½ % will

be taken of all registrants in group to be audited.

Standards – CPD...



I. Review and possible changes to Regulators themselves – Foster Report - done




Topics...


Clinical ScientistsA clinical scientist is an appropriately qualified and trained scientist working in health care who:

• gives scientific and clinical advice which has a direct bearing on the management of patients

• applies scientific methods to maintain the efficacy, quality and safety of investigative or therapeutic techniques

• introduces and advances new scientific and clinical procedures for patient benefit

• is registered with the Health Professions Council (HPC).• “Clinical Scientist” is a title protected under law and

anyone not registered using it fraudulently will be prosecuted.

How do we compare with others on the Register?

162,000 registrants,13 Professions

Process – Number of Registrants...

0

5,000

10,000

15,000

20,000

25,000

30,000

35,000

40,000


Clinical Scientists• There are only about 5000 clinical scientists as opposed

to 35000 or so physiotherapists. Whereas the latter have their own protected title, Medical Physicists join in with Biochemists, Clinical Geneticists, etc., and are collectively known by the protected title ‘Clinical Scientist’. Each professional group has banded together to form the Association of Clinical Scientists, which has the task of awarding the ‘Certificate of Attainment’, which permits entry to the HPC Register.

• Compare with other Groups:-– Physiotherapist - 3 year degree, straight onto hpc Register

– Clinical Scientist - 3 year degree, 1 year MSc, training Scheme placement, portfolio etc, Certificate of Attainment by ACS which permits entry to hpc Register. Currently 4 years reducing to 3.

Compare with Doctors

• 5 year degree to get MBBS• 1 year’s pre-registration (as House Officer)• Thereafter, post-registration as Senior House Officer,

then Special Registrars, etc. Working to obtain MRCP, FRCS, MRCR, MRCPath, etc, regarded as qualification for Consultant status. NB, biochemists, Clinical microbiologists, etc. can also study for MRCPath.

• Specialist (higher) registration, however is through the Joint Committee on Higher Medical Training (JCHMT), and the Postgraduate Medical Education and Training Board (PMETB) – Not connected with GMC.

• That may all change, too (Donaldson Report)

Clinical Scientists

• My own view for Clinical Scientists has always been that it should be:-– 3 year degree,

– 1 year MSc,

– 1 year Training Scheme placement (pre-registration year)

– Straight on to HPC register.

• Thereafter, ‘doctor equivalent’ pathway could be:-– Studying for Membership of IPEM – ticket for later consultant post.

– ‘Higher registration’ in specialist modalities such as Radiotherapy or Nuclear Medicine (equivalent of registration with JCHMT or PMETB)

– Ditch portfolio etc, and Certificate of Attainment!

Clinical ScientistsThe Association of Clinical Scientists has recognised twelve

different modalities of practice for registration, being:-

1. audiology 2. cellular science 3. clinical biochemistry 4. clinical genetics 5. clinical embryology 6. clinical immunology 7. clinical microbiology 8. clinical physiology 9. haematology 10. histocompatibility and immunogenetics 11. medical physics and clinical engineering 12. developing sciences.

Association Of Clinical Scientists

The Association Of Clinical Scientists would still have a role in advising the HPC on which MSc courses and placement schemes were suitable, and could moderate and advise on the higher registration modalities, but I suggest that the gatekeeper role for HPC registration could be given back to the HPC

The Register

• Skill levels & modalities of care

• Renew registration every two years

• Standards of Practice & health self-certification

• Public vs. Private

Process – The Register...


162,000 UK & International Registrants

England77%

Scotland10%

Wales6%

NI3%

International4%

Process – Register – Registrants – Home Countries...




II. Possible changes in registration procedures for Clinical Scientists - done



Topics...


Emergence of aspirant groups or new professions

ASET & SP

ASET & SP

BSET & SP

Time

Process – Register – New Professions...


Aspirant groups

• Number of professions not restricted• Dozens of Aspirant Groups – examples below

– Operating Department Practitioners 7,500 (10/04)– Applied Psychologists 15,000 (12/05)?– Dance Movement Therapists 300 – Medical Illustrators 400– Clinical Perfusionists 300– Clinical Physiologists 5,000– Clinical Technologists 5,000– Max Fax 400– Health Care Scientists 17,500 Est.

Process – Register – Aspirant Groups...


Two stage assessment process

• HPC– Assess aspirant group by reference to ten criteria,

described in next two slides.

• DoH– Public consultation process.– Amends legislation.

• HPC can recommend regulation even though no application received.

Process – Register – Aspirant Groups...


Ten reference criteria to assess aspirant group by

At least 1 criterion of invasive procedures, clinical intervention with potential for harm, exercise of judgement by unsupervised professionals.

Ten reference criteria to assess aspirant group by

1. Discrete area of activity displaying some homogeneity.2. Defined body of knowledge.3. Evidence of efficacy.4. At lease 1 established professional body a/c for

significant proportion of occupation.5. Voluntary register(s)6. Defined routes of entry to the profession.7. Independently assessed entry qualifications.8. Conduct performance and ethics standards.9. Disciplinary procedures to enforce those standards.10. Commitment to CPD.

Closure of Title

• Closure of function - GOC– “Eye test”– Definition and job demarcation

• Closure of Title – HPC– No limit to scope of practice

• Titles– Limited number of protected titles aids public

recognition– Market Research indicates that the public requires

specific titles to be protected

Process – Register – Titles...


“Grandparenting”

• Process starts as new titles are protected• Sets aside existing educational

requirements• Applicants must demonstrate lawful, safe

& effective practice • Two or three year window • £200 fee at present – will go up.

Process – Register – Grandparenting...


Aspirant Groups• At a recent presentation by the HPC aspirant

group manager, there were 52 new aspirant groups, including 9 different Psychotherapy groups, ye gods!

• What they need to do is to get their act together, and form an Association of Clinical Psychotherapists, and have one protected title and seat on council.

• When Dance Therapists come on board, it has already been agreed that they will be subsumed into the Arts Therapists Group.

Aspirant Groups• AND HERE THEY ALL ARE, THE ALPHABETICAL LIST OF APPLICANT GROUPS/SPECIAL

INTEREST GROUP – YE GODS!• OrganisationProfession/Practitioners1Acupuncture Regulatory Working

GroupAcupuncture2The Alliance of Private Sector Chiropody & Podiatry PractitionersFoot Health Practitioners3Artists in Mental HealthArtists in Mental Health4Association of Child PsychotherapistsChild Psychotherapists5Association of Dance Movement TherapistsDance Movement Therapy6Association of Operating Department PractitionersOperating Department Practitioners7Association of OsteomyologistsOsteomyologists8Association of Professional Ambulance PersonnelAmbulance Practitioners, Advanced Ambulance Practitioners and Ambulance Technicians9British Academy of AudiologistsAudiology10British Association for Counselling & PsychotherapyCounselling & Psychotherapy11British Association for Nutritional TherapyNutritional Therapy12British Association of Play TherapistsPlay Therapists13British Association for Psychoanalytic & Psychodynamic SupervisionPsychotherapists & Counsellors14British Association of Sports Rehabilitators & TrainersSports rehabilitators & trainers15British Confederation of PsychotherapistsPsychotherapists16British Orthopaedic AssociationOrthopaedic Technicians17The British Psychological SocietyApplied Psychologists18British Society of Clinical HypnosisHypnotherapy/Clinical Hypnotherapy19British Society of EchocardiographersEchocardiography20British Association of Tissue BankingTissue Banking21Cambridge Society for PsychotherapyPsychotherapists & Counsellors22College of Health Care ChaplainsHealth Care Chaplains23The College of Psychoanalysts UKPsychotherapists & Counsellors24The Commission for Healthcare Regulatory ExcellenceHealthcare Assistants in the Prison Service25Confederation of Analytical PsychologistsPsychotherapists & Counsellors26Craniosacral Therapy Association of the UKCraniosacral Therapists27Diabetic RetinopathyDiabetic Retinopathy28Hospital Play Staff Education TrustHospital Play Staff

• There’s another24, but I don’t think we’ll bother with those!

HPC committed to the protection of professional titles

• Article 39 Criminal offence• Communicate sanctions for misuse• “State Registration” or SR

– The use of the phrase or abbreviation to be actively discouraged once Grandparenting completed

• HPC will prosecute

Process – Protected Titles...




II. Possible changes in registration procedures for Clinical Scientists - done

III. Possible registration of aspirant groups, particularly emerging technologies - done


Topics...


Structure of Council

• One Registrant member of Council from each profession– Each Registrant has an Alternate– Elected by Registrants from July 2005

• One less Lay member c.f. RegistrantR=L-1– Public appointment

• If President is a Registrant– Add a Lay & a Registrant Council member

S&O – Council...


UK Wide remit

• Four Home countries– At least one Registrant

member from each of the four Home Countries

– At least one Lay member from each of the four Home Countries

S&O – UK Remit...


Restructuring of the Health Professions Council

The Government’s position and priorities

Government principles

• Patient safety is the guiding reason for regulation, not professional interest.

• The regulator should contain some members elected by the regulated professions to provide professional buy-in.

• As the HPC is a UK-wide body, there must be minimum representation from all four home countries guaranteed.

Government principles

• The chosen election scheme should be as democratic as possible, once four country representation has been guaranteed.

• The election scheme should provide the most efficient model possible, achieving the best balance of continuity and introduction of new members.

• The election scheme should be as open and transparent as possible.

BUT…• At a recent Council meeting it was noted that Council

had already agreed to discontinue elections, and have wholly appointed registrant members.

• When I expressed surprise, a member informed me that it had all been agreed at a Council Away Day.

• I then informed him be email that this ‘agreement’ to abolish elected representatives had therefore been taken by un-elected members before the first elections in July 2005 had even taken place.

• The government’s position on the previous two slides had been given after July 2005, and after the above Council Away Day.

• I think the re-structuring of Council is not finalised, and the debate continues.

Stakeholders

• Carers• Clients:Patients:Users• Consumer

Associations• Employers• Government• Higher Education

Institutions

• Members of the Public• Professional Bodies• Registrants• Regulators• SIPGs• Trade Unions

Communications – Stakeholders...


Current Issues

• Structure of the Register & size of Council• Health & Disabilities• Returners to practice

– Less than two years– Between two & five years– More than five years

• Review standards• Post registration qualifications

Issues – Current...


Current Issues (contd)

• Extending Regulation– Supervised Assistants– Non-professional healthcare workers

• Mitigating the necessity to register with two UK regulators of healthcare professions

Issues – Current...


Future Issues

• Post Shipman – Foster review – NOW OUT• Revalidation• Regulation of Teams• Regulation of Complementary Medicine• Flexible workforce = Flexible regulation• The desirability for reducing the number of

UK Regulators of health professionals– Unitary regulator– Communications, Energy, Financial

Issues – Future...


regulatory developments in clinical science and technology

Technology

council topics

standards expectations

standards et

privy council

rules ref

possible changes

chre introduction

scotland wales council