Policy responses and statements
- Name of organisation:
- Department of Health
- Name of policy document:
(1) Healthcare professional regulation - Public consultation on proposals for change put forward by Chief Medical Officer in 'Good doctors, safer patients' [Donaldson report]
(2) The regulation of the non-medical healthcare professions: a review by the Department of Health [Foster Report]
- Deadline for response:
- 10 November 2006
Background: This consultation paper seeks views on the proposals put forward by the Chief Medical Officer in 'Good doctors, safer patients', and upon the options outlined in the parallel review of non-medical regulation.
Following the publication of The Shipman Inquiry: fifth report in December 2004, which was highly critical of the General Medical Council and the broader arrangements for medical regulation, Lord Warner commissioned a review of medical regulation. Shortly thereafter, the Department of Health elected to conduct a parallel review of the arrangements in place for the regulation of the other clinical professions in order to provide consistency of approach and in recognition of the blurring of traditional job roles in healthcare.
The review of medical regulation was conducted by Sir Liam Donaldson, Chief Medical Officer for England. His report, Good doctors, safer patients, along with the parallel departmental review of non-medical regulation, focuses upon the protection of the interests and safety of patients.
Among the key themes raised in the two reports are: changes to the governance and accountability of the professional regulators; the importance of operationalised standards against which to regulate; the appropriate legal standard of proof; the introduction of an independent adjudicator; a spectrum of revalidation across all clinical professions; and, devolution of some regulatory powers to the local level.
The Department of Health invited views and comments on the proposals put forward by the Chief Medical Officer in 'Good doctors, safer patients', and upon the options outlined in the parallel review of non-medical regulation.
DEPARTMENT OF HEALTH
HEALTHCARE PROFESSIONAL REGULATION:
PUBLIC CONSULTATION ON PROPOSALS FOR CHANGE PUT FORWARD BY CHIEF MEDICAL OFFICER IN 'GOOD DOCTORS, SAFER PATIENTS'
This paper includes the Royal College of Physicians of Edinburgh’s views on the principles and proposals within Good doctors, safer patients. The main principles are easily agreed, with the College being fully supportive of the need to protect patients and establish fair and effective fitness to practise procedures. The College is keen to contribute to the development of effective procedures, including the establishment of revalidation through re-licensing and re-certification.
Specific comments are referenced to the recommendation numbers.
EFFECTIVE AND FAIR FITNESS TO PRACTISE PROCEDURES
Standard of Proof (Recommendation 1)
The College believes that many doctors are legitimately concerned that the proposed reduction in standard of proof risks miscarriages of justice and too readily risks the destruction of doctors’ medical careers. If the regulator is to avoid significant appeals, then decisions must be made on the basis of strong evidence or the case will be continued through the judicial system, and this will benefit neither patient nor doctor. However, the College accepts that local, less serious cases could function effectively under civil standards of proof.
GMC Affiliates (Recommendations 2 – 7, 10 and 15)
The College is concerned that the proposals to create a locally devolved system of GMC affiliates could undermine the statutory responsibility of healthcare organisations for clinical quality. Improving the relationship between local clinical governance systems and national regulators is important, but the College believes there are significant problems with the affiliate solution as proposed, including:
- Lack of clarity over how local clinical governance systems would work with these local GMC appointed “affiliates”.
- Appointment procedures, by whom and how would these local doctors be selected.
- Who would seek appointment to this role and how they would be monitored?
- Objectivity if acting as judge and jury within their own area, and whether decisions would ever be taken by a single affiliate with no lay or expert medical input. Regional panels including lay representation and input from local clinical governance systems would be preferable. The definition of “local” requires further debate.
- The data collection and QA burdens of reviewing and holding all ‘recorded concerns’ centrally in the public domain would be significant.
- Consistency of referral and interpretation of cases where registrations status may be at stake.
- Concerns about costs and whether doctors would be expected to pay for this new network, largely targeted at resolving local service issues.
Separation of investigation and adjudication by GMC for serious cases (Recommendation 11 -12 and 15)
The College fully supports the independence of investigation and prosecution from adjudication. However, the Donaldson and Shipman recommendations do not reflect the recent reforms within the GMC which have resulted in independent fitness to practise panels with lay membership. The College recognises that public confidence is important, and understands the need for a tribunal completely independent of the GMC and offers the following specific comments:
- It would be important for the tribunal membership to represent the specialist expertise appropriate to the individual case, and that membership is by transparent (public) appointment procedures.
- There is some concern about other QA organisations having a direct right of referral to the adjudication tribunal following their own investigations and with no reference to the GMC.
- It is unclear who will fund the tribunal.
Links with the National Clinical Assessment Service (Recommendations 13 and 14)
The College would welcome further information about the plans to incorporate evidence from other organisations into GMC investigations, and how the system can be applied consistently across the UK (eg NCAS has no direct jurisdiction in Scotland)
Specifying remedial packages (Recommendation 15)
If the complaints system for doctors is to adopt a less judgemental and more remedial approach to investigations and adjudication, there will be a need for investment in mentorship support, pastoral care and effective retraining and remedial packages. The College applauds this move, but has concerns about how the NHS and other employers will deliver and fund this support.
ASSURE AND IMPROVE THE QUALITY OF MEDICAL PRACTICE
Unambiguous standards for generic medical practice (Recommendation 16)
The College supports the principle of doctors leading standard setting, but does not underestimate the challenges of agreeing unambiguous and measurable generic standards for “good doctors” and appropriate assessment instruments. Lay involvement is essential, although our own lay committee has voiced concern about continued hostility in regulatory matters, often fuelled by irresponsible press activity. The media is slow to change from an “off with their heads” approach, and this is unhelpful if the focus is to shift from removing the “unfit” to supporting all those registered to remain fit to practise.
Specialist Standards (Recommendations 17 and 18)
The College welcomes the opportunity for the Federation of the Royal Colleges of Physicians to work with specialist societies to take a lead in the development of specialist standards for physicians. Such standards must be evidence based, and should draw in the roles of other healthcare professionals participating in specialist care. However, there are significant concerns about the ability of NHS data systems to support clinical audit in a helpful way for physicians. The infrastructure for clinical audit is the responsibility of the NHS which should fund it adequately, and this includes ensuring sufficient clinician time within job plans. Colleges can contribute to the design of suitable systems but have neither the expertise nor resources to deliver them (see also Recommendation 33).
Transferring Undergraduate Education to PMETB (Recommendation 19)
The College does not consider that the case has been made for removing this responsibility from the GMC. Undergraduate medical education delivered by British medical schools is internationally important and should remain independent of the short term political imperatives of government. Academic standards within our medical schools must be protected and the GMC has the necessary expertise in quality assurance and, as regulator, sets the standards required of newly registered doctors.
However, there is a case for bringing the standards and QA of all medical education under a single body and, given the clear links between education, training and regulatory standards, it would seem more logical for this to become the responsibility of an independent and reformed GMC, reporting directly to Parliament.
Consistency of graduates and those registering for the first time (Recommendations 20- 22)
Communication skills (written and verbal) are fundamental to professional practice, and the College agrees that demonstration of this competence is essential for all doctors. The focus should be on communication rather than restricted to language proficiency.
Improving the consistency of medical graduates is an issue which could be addressed through the GMC at a national level and may need EC legislation. The College supports the development of national assessment to ensure the consistency of graduates from different medical schools, within and outwith the UK (assuming EC regulations permit).
The benefits of transferring PLAB to PMETB are unclear when PMETB has no particular expertise or resources to support the delivery of assessments.
Medical student registration (Recommendation 23)
The College agrees that medical students should understand the important ethical frameworks within medicine, and early exposure to a code of conduct is important. However, it is far from clear that student registration with the GMC will deliver more than the codes of practice and disciplinary procedures within individual medical schools. Also, Foundation trainees from European medical schools would not necessarily have been subjected to the same codes or level of scrutiny.
The GMC, through its external QA of medical schools will be in a position to require and assure robust national standards without having direct responsibility for individual student registration. In turn, medical schools have the opportunity to support students in difficulty and apply meaningful sanctions relating to their continued training. These must be applied consistently and fairly.
If it is determined that student registration with the GMC is important, such registration should be at no cost.
Registration for certification and licensure (Recommendations 24-27)
The College fully supports the principle of doctors demonstrating fitness to practise throughout their careers. All doctors employed in the NHS or in a quasi-contractual relationship would be captured appropriately by the plans for licensure and recertification, and the real challenge will be for doctors working in private practice and as self-employed locums. Private hospitals and locum agencies should run parallel systems to the NHS for their doctors, and all could participate in multi-source feedback. Regular knowledge based assessments would be useful. Practical concerns include:
- Flow of information to agencies following very short term locum appointments.
- Challenges of multi-source feedback and peer review for single-handed private doctors, and the GMC may need a central registration service for such “unattached” doctors.
- Sensible arrangements will be required for doctors nearing retirement to avoid the risk of encouraging early retirement and loss of significant clinical experience.
An independent organisation to develop and deliver multi-source feedback (Recommendation 30)
The College agrees that multi-source feedback will provide valuable information on clinical skills and conduct. It makes good sense to adopt a standard tool, and for patient and doctor confidence this must be delivered by an independent body.
Specialist certification (Recommendation 31)
The College supports the proposed regular recertification, although the implementation challenges are considerable if the system is to be robust and reliable. The College welcomes the proposal that the Federation of the Royal Colleges of Physicians and specialist societies should take the lead in standard setting for physicians, supporting their members to prepare their submissions to the regulator. Further discussion is required to clarify the roles and responsibilities of key players, including the important issues of liability for recertification decisions, and indemnity for decision makers, but the College is keen to contribute to this valuable development.
The College notes and welcomes the emphasis within the parallel consultation for other health professionals on CPD, and seeks reassurance that training and development resources will be protected to permit adequate CPD for doctors along with the necessary assessment time and rehabilitation support. There are concerns that local study leave budgets are under pressure, particularly in England.
In addition to general CPD, the NHS and the regulator must support the concept of post- training “credentialing” to deliver training and assessment of trained doctors requiring new specialist skills and competences in response to changing service and career needs. The College believes that this will be an important part of re-certification in the future.
The College has major concerns about the reliance on current appraisal systems which are inconsistent and of variable quality across the UK, and would welcome efforts to address this issue in advance of the introduction of re-certification. There is still discomfort over appraisal being used as assessment within the wider context of re-certification, and this is reflected in the issues raised within the Foster Report about using the NHS appraisal system for other health professionals in a summative rather than formative way.
The IT requirements of a national re-certification system should not be underestimated, and it is important that early development work on cradle to grave recording and planning systems (electronic learning portfolios) is supported for the benefit of doctors, their employers and the regulator.
Clinical audit (Recommendation 33)
The College has been calling for greater investment in clinical audit systems for physicians for many years, and welcomes the opportunity for improvement. At present, it is extremely difficult for physicians to demonstrate the quality of their work due to time pressures and totally inadequate clinical information systems. The definition of “national” needs further thought, given devolution. The possible impact on direct patient contact if audit data is to be captured in advance of improved IT systems should not be underestimated.
BETTER INFORMATION FOR THE PUBLIC
Tiers of information in the public domain (Recommendations 38 and 39)
The College supports the need to ensure that information about the registration status of doctors is in the public domain and easily accessible, particularly the specialty registers, and sanctions or restrictions on practice. The College believes that access to health and other confidential information about doctors should not be widely available, assuming that some requests for information under the Freedom of Information Act could be restricted. Equally important is clear information on “acquittals” for doctors who have been under the strain of investigation, some of whom never fully recover from the experience.
STRUCTURE AND GOVERNANCE OF GMC
Role of Council (Recommendation 44)
The College believes that the GMC role, as regulator, in approving standards should be more prominent to support wider public understanding of the role of the GMC and deliver a more positive quality improvement image.
Membership (Recommendation 43)
The College supports the proposals to appoint rather than elect members to all regulatory bodies. However, it is important that the appointment process is open and wholly independent of government. The College believes that public and professional confidence will depend both on the perceived independence of the body and a balance of lay and medical members drawn from the general public, Royal Colleges, Universities and the NHS.
Accountable to Parliament (Recommendation 44)
The College fully supports the move to make the GMC directly accountable to Parliament. This will reinforce the independence of the GMC and increase public and clinical confidence after a difficult period for the regulator.
PRIORITIES FOR IMPLEMENTATION
For public confidence reasons and to support the independence of the GMC, it would be helpful to prioritise the restructuring of the Council and appoint new members quickly.
For professionals it would be helpful to quickly confirm the licensing and certification changes that will be required to continue to practise. This is particularly critical for re-licensing as plans are well developed, and it would be unfortunate to delay implementation pending decisions about re-certification.
DEPARTMENT OF HEALTH
THE REGULATION OF THE NON-MEDICAL HEALTHCARE PROFESSIONS: A REVIEW BY THE DEPARTMENT OF HEALTH [THE 'FOSTER REPORT']
The Royal College of Physicians of Edinburgh welcomes the opportunity to comment on the proposals and discussion within the Foster report.
The College strongly supports:
- the commitment to “statutory regulation of professionals by bodies which are independent of government and with a leading role for members of the professions”
- the intention to build on systems already available to employers or under development
- the wish to create consistency of approach between the regulators
- the acknowledgement of a pragmatic risk-based approach to regulation to provide a system that protects patients but remains functional and affordable
The College also strongly supports the emphasis on the importance of continuing professional development and training within the regulatory framework. Demonstration of continued fitness to practice is, of course, of prime importance for patient safety, but creating a focus on continuous improvement will bring benefit to patients and professionals.
The development of new roles within the changing healthcare workforce presents clear CPD and regulatory challenges, and the College is in an ideal position to contribute to the CPD of those new healthcare professionals working in treatment and diagnostic areas relevant to physicians. Indeed, there may be a case for linking the regulation of some of these roles to the GMC and encouraging joint training.
The College understands the public anxiety over regulation and continuing fitness to practice of healthcare professionals and the importance of delivering new systems that improved confidence of the public and the professions.
The College applauds the recognition within the report of the challenge of delivering consistent regulation across the 4 devolved health administrations, particularly given the emphasis on linking regulation with local clinical governance systems and work-based assessment.
“Of Good Character” – Chapter 2
The College welcomes the plans to streamline the systems to confirm the “good character” of professionals, whether health or conduct related. Clearly, the development of an electronic staff record or equivalent will be of enormous benefit, particularly when staff change employment. However, the College remains concerned about assuring the status of those not employed by the NHS, whether as a result of functioning in a locum capacity or in private practice. A risk-based approach demands greater scrutiny of all professionals working outside “approved environments”.
Staying on the Registers – Chapter 3
The College agrees that the regulator should set the fitness-to-practice standards and that local (often employer based) information should form the core of revalidation evidence from “approved environments”. Those working as locums or in private practice may need to revalidate directly with the regulator.
All health professionals should participate in formative appraisal through their local systems of personal and career development and role review. The College understands that using appraisal as a summative tool is contentious and subject to on-going agreement through the NHS Human resources teams. Doctors have similar concerns about the use of appraisal for re-certification. The College has commented separately on the specific proposals for doctors involving GMC affiliates at local level. Concerns about the objectivity, bureaucracy and cost effectiveness of this approach apply equally to other health professions. Local complaints and appraisal systems must be fair and effective if patients are to be satisfied with a system that only refers to the regulator serious cases where registration status may be at stake. In practice, it may be difficult to set a sensible threshold for referral, but the principle is sound.
The College accepts that external bodies (eg Health Commission and NHS QIS) could quality assure local clinical governance systems and their role in revalidation. The costs of implementation would therefore be covered by the NHS and other independent providers. However, following the Shipman enquiry, this is not deemed sufficient for “high risk professionals” including doctors and a further layer of scrutiny is required. The College expects to have a significant role in specialist re-certification for physicians and could extend this to include the new extended role practitioners, particularly physician assistants.
Specialist registration for other health professionals is inevitable to satisfy the desire for easy public access to the level of competence and training achieved by specialist practitioners. The presentation style and format of this information will be critical.
The inclusion within the table of risk factors of “in current practice” as a criterion for more intensive revalidation is neither discriminatory nor helpful for patient safety. Also, excluding practitioners who do not have direct patient contact from less intensive revalidation may miss important risk areas eg cytology screening technicians.
Resolving Concerns about Fitness to Practise – Chapter 4
Investigation and Referral
The College understands the frustration for patients caused by multiple organisations involved in complaints, and unclear systems. However, it can be an equally anxious time for those health professionals subject to patient complaints and it is important that investigations are conducted quickly and thoroughly, particularly if evidence gathered by the initial investigation is to be used by the regulator in serious cases. The College agrees that a common portal for initial enquiries may improve patient understanding of the various elements of the complaints systems and ensure appropriate investigations are started quickly.
The College agrees that external scrutiny of decisions not to refer to the regulator will provide public reassurance about consistency. Local investigators will also require clear guidance on criteria for removal from the register to determine which cases should be referred to the regulator.
The College supports the principle of separating investigation and prosecution from adjudication. Indeed, the GMC, following its most recent batch of reforms, now has independent fitness to practice panels, often with a majority of lay members. However, public perception and confidence are important, and all regulators must adopt practices which persuade patients and doctors of the independence of the fitness to practice panels, however constituted. This would include the establishment of completely independent panels if necessary.
The potential economies of scale of a shared pool of panellists may be negated by the need for experienced experts for factual interpretation and to retain the confidence of the professions. The College considers that, on balance, individual adjudication panels would be more effective and would minimise the number of appeals. However, there could be some shared working eg generic training or encouraging cross panel observers to ensure consistency of approach across the professional groups.
On balance, the College supports Option B – to retain a separate adjudicator for doctors, whilst maintaining current arrangements for other professions and bringing the standard of all up to that of the best.
Regulating New Professional Roles – Chapter 6
The College agrees that these new roles should be regulated, but considers that this should fall to one of the existing regulators. Staff fulfilling these new roles will come from varied backgrounds, and many will already be subject to an existing regulator. However, the College considers that the regulator of these new roles should have a complete understanding of the patient safety issues and clinical standards expected of health professionals with diagnostic and treatment responsibilities.
This is a critical new area of regulation and, in terms of a risk-based approach, may present one of the major regulatory challenges in the short term. These new roles will take time to bed in, and practitioners will often be working independently with patients (albeit within clearly defined limits). The College feels it would be worth exploring the benefits of a partnership between the GMC and the Health Professions Council.
The College is concerned about the proposals for “distributed regulation” by which professionals moving into an extended role from an existing regulated role could continue to be regulated by their original regulator. The College believes that it is important for each professional to be regulated by a body which understands the competencies and sets the standards for the role in question, and that dual regulation may be inevitable if a professional is functioning in several roles eg working as a physician assistant, but continuing to fulfil some nursing responsibilities.
The College considers that for the “grandparent” clause to be acceptable, all those coming from different disciplines or health systems and who may seek to register without completing the UK training programmes must have a reliable and robust method of assessment, in line with equivalence arrangements for doctors.
The College supports strongly the need for a common approach to the regulation of these new roles across the devolved administrations.
Role and Structure and Functions of Regulatory Bodies – Chapter 7
The College agrees that there will be some consistent and common standards between regulatory bodies eg conduct.
Proposals for the structure of the GMC include the replacement of elected council members with appointed members. The College supports this principle, with transparent appointment processes which must be independent of government and have significant professional input.
Membership of the Council for Regulatory Excellence, as the umbrella body, requires expert advice from each regulator at Council level. If there is opportunity to rationalise the regulatory bodies in the future, this will bring the additional benefit of a more manageable Council.
Issues mentioned in the Donaldson Report but missing from the Foster proposals - Chapter 8
The Donaldson proposals for the retention of information and public disclosure are important to encourage full and open reporting of problems, and to protect doctors with health difficulties. Similar safeguards should be incorporated by all regulators to ensure that details of investigations, outcomes and sanctions are in the public domain, but that qualitative and confidential information is restricted. Data protection and Freedom of Information issues will require careful consideration.
Language test proposals need further discussion to agree the standards expected of verbal and written communication in English, and how aspiring registrants might demonstrate them. However, the critical issue is communication rather than language alone, and appropriate communication assessments should be mandatory for all health professionals.
Donaldson proposes that medical students should be registered with the GMC, although exactly when is open to further discussion. The College agrees that students should understand the ethical code and standards expected of all people participating in the treatment of patients (whether qualified or as a student). However, medical schools have their own codes of conduct and disciplinary processes for students and can apply real sanctions that limit or terminate undergraduate education. Prior to registration, regulators have limited influence on individual students but should impose a robust system of external quality control on universities to ensure consistency. The principles of signing up to a code of conduct and professional standards should be applied to all healthcare professionals through their education institution.
Doctors have an unenviable record of substance abuse and addiction and other health related causes of performance and conduct problems. The College supports strongly treatment and support services for doctors in difficulty, and recommends that such services are available to all health professionals who may be at risk.
One of the more worrying aspects for doctors is the proposal to reduce the standard of proof in fitness to practice cases from criminal (beyond reasonable doubt) to civil (on the balance of probabilities). Whilst accepting the patient safety issues, the College is concerned that serious cases may be misjudged and outcomes prolonged by appeals through the judicial system. It is important for public and professional confidence that significant decisions made by all regulators are based on the best possible evidence, and not open to subsequent challenge through the courts.
Copies of these responses are available from:
Royal College of Physicians of Edinburgh,
9 Queen Street,
Tel: 0131 225 7324 ext 608
Fax: 0131 220 3939
[2 October 2006]