Trust, assurance and safety
April 2007
Suggested areas to consider
This briefing paper has been produced to highlight the key recommendations in the White Paper ‘Trust, Assurance and Safety – the Regulation of Health Professionals’ and proposes areas for consideration in relation to the potential impact on consultants.
The Central Consultants and Specialists Committee (CCSC) is keen to receive feedback from consultants outlining their views on the proposals outlined in the White Paper, and ways in which the CCSC can seek to influence the recommendations.
Please send comments to jalderman@bma.org.uk.
Overview
The recommendations, as they affect doctors, can be grouped into five categories roughly in order of how they will affect consultants directly:
- Revalidation
- The handling of concerns – local
- The handling of concerns - national
- Governance of the GMC
- Education
1. Revalidation
Relicensure
2.8 Medical revalidation will have two core components: relicensure and specialist recertification. All doctors wishing to practise in the UK will require a licence to practise. As a first stage, the General Medical Council (GMC) will issue these licences to practise as soon as it is practicable to do so.
2.12 The Department will consult with the GMC, the profession, the medical Royal Colleges, patient groups, NCAS and the Devolved Administrations, and develop proposals to commission and pilot appropriate national tools for 360-degree feedback to support this process. The Department will consider with stakeholders whether a single
generic national tool would be appropriate or whether elements will need to be tailored to the specific circumstances of different medical specialties and spheres of practice.
2.17 The Department will discuss with stakeholders the most effective means for the introduction of an appraisal process with summative components. The quality of the process will be regularly assured by the GMC. The appraisal arrangements will need to take account of the large numbers of doctors who work outside the NHS as well as in NHS Trusts, Foundation Trusts and primary care.
The White Paper makes a link between relicensure and a revised system of NHS appraisal for doctors. 2.10 suggests that the medical director would be responsible for collecting the information that comes out of appraisal that the GMC would need to assure itself of the integrity of the relicensing process.
There may be an opportunity here to ensure that the summative element of appraisal is improved and becomes the effective information gathering tool that could prevent relicensure becoming an excessive administrative burden for consultants.
Areas to consider
Do you agree with the principle of revalidation?
Do you agree with the principle of relicensure?
In the process of relicensure do you agree with adding a summative element to appraisal?
Alternatively do you believe a combination of appraisal (formative) and job planning (summative) can meet these requirements?
Priority: To influence appraisal in such a way as to ensure that relicensure does not create excessive new workload for consultants.
Can you provide suggestions for how this could work?
Specialist recertification
2.18 The second stage of revalidation for doctors will apply only to doctors who are on the specialist or general practice registers, requiring them to demonstrate that they continue to meet the particular standards that apply to their medical specialty, including general practice. Recertification, like relicensure, will be a positive affirmation of the doctor’s entitlement to practise, not simply an absence of concerns. Recertification will be carried out at regular intervals of no more than five years. Where possible, it will coincide with relicensure.
2.21 Both relicensure and recertification depend on an objective assessment of doctors against clear standards. To support relicensure, the Department will ask the GMC to consult with its key constituencies to translate its recent update of Good Medical Practice into an effective framework against which individual doctors’ practice can be appraised and objectively assessed. In addition, in England the Department will discuss with the profession, NHS employers and other stakeholders the best means of enshrining these standards in the contracts of those doctors who are directly employed and in the commissioning arrangements for those doctors who work within the terms of contracts with commissioners. Implementation in primary care will need to consider the impact on the wider contracting arrangements between the provider and the commissioner, and any unintentional impact on GPs’ partners. The Devolved Administrations will consider appropriate arrangements for doctors working in Scotland, Wales and Northern Ireland.
2.22 Standards will be drawn up for each area of specialist recertification by the appropriate medical Royal Colleges and specialist associations. These standards will be tested against the needs of patients and healthcare providers and based on wide consultation with all relevant stakeholders. The standards will be agreed with the GMC to ensure that they are sufficient to meet the requirements for remaining on the appropriate part of the medical register. This work will be led by the Academy of Medical Royal Colleges.
2.25 In addition, as Good doctors, safer patients pointed out, valid up-to-date information on the quality of care is also vital for patient choice and identifying opportunities for service improvement. Local clinical audit, within the framework of clinical governance, needs to be revitalised. The Government therefore agrees with the CMO that a wide and inclusive clinical audit advisory group should be established in England to drive the further development of local and national clinical audit programmes and to establish how best the ‘Connecting for Health’ programme can support this work. The work will yield publicly available information to accelerate improvement in practice and service delivery. The Department will make additional funding available to support this work in England and will discuss with the Devolved Administrations how they will take this work forward.
2.34 The Government agrees that the appraisal process within the NHS, which will be a central component of revalidation, should be both formative and summative, to ensure objectively that required standards are met. Information gathered under the Knowledge and Skills Framework should be used as far as possible as the basis of revalidation, with any additional requirements justified by risk analysis. As these measures will require the introduction of summative elements to assessment, the Department will discuss these proposals with the Devolved Administrations, the relevant regulators, NHS employers, trades unions and others with an interest to ensure this is proportionate, fair and appropriate.
The White Paper envisages specialist recertification being carried out by the relevant Royal College. It will be a “comprehensive assessment against the standards drawn up by that College”. The Academy will be funded to lead the development of the recertification processes. A working group will be set up to develop and pilot it.
The main concerns here are likely to be costs, the work associated with demonstrating achievement of the standards to the College and the incorporation of the standards into doctors contracts (as per 2.21).
Areas to consider
Do you agree with the principle of recertification?
Do you agree that the Royal colleges should set these standards?
Do you agree that the royal colleges should assess these standards?
Who should pay for this process?
Can you provide positive suggestions about how the work, costs and contractual burden could be kept to a minimum?
2. The handling of concerns - local
Recorded concerns
3.45 The Department agrees with the proposals set out in Good doctors, safer patients for recorded concerns. There are important legal issues to be addressed to ensure that they work effectively and fairly and further discussion will be needed to ensure that they mesh appropriately with employers’ existing disciplinary arrangements.
3.46 The Department will discuss with key stakeholders from across the UK how to frame detailed proposals on the practical implementation of the new system of GMC Affiliates and recorded concerns, through a piloted approach in England, with Devolved Administrations considering local arrangements in the light of learning from these pilots. The Department will invite stakeholders covering appropriate UK interests to participate
The proposal to introduce a system of recording concerns locally will create concerns that the smallest complaint against a doctor, justified or otherwise, will appear on their GMC record and highlight them as “potential problems”.
Areas to consider
Do you believe in the concept of recorded concerns?
How could it be made to work?
GMC affiliates
3.31 As a first stage, the Government will seek parliamentary approval to establish a UK network of GMC Affiliates at regional level in England and at a national level in Scotland, Wales and Northern Ireland. In England, the Affiliates will cover areas that are coterminous with strategic health authority (SHA) boundaries. The Government will pilot these approaches at different levels of engagement within this prior to full-scale rollout. The Government will seek parliamentary approval at the earliest opportunity to enable the implementation of a system of GMC Affiliates, informed by piloting and local or national considerations.
3.35 These changes mean that medical directors, and others in similar roles, will generally take on the roles originally envisaged for more local GMC Affiliates in Good doctors, safer patients. In England, all practising doctors on the medical register will relate formally to a responsible officer who will either be the organisation’s medical director or a responsible officer designated by the organisation for which they work or provide services. In other cases the GMC Affiliate will assign a responsible officer in the region to carry out the role for doctors.
3.37 The Department will lead a project to establish more explicit competencies for the role of medical directors in England as well as measures to enhance their direct accountability to boards for actions that relate to their new responsibilities and powers for regulation and revalidation. This will include consideration of whether responsible officers should have a personal statutory accountability for handling performance issues. It is envisaged that in order to be approved as the responsible officer by the regional GMC Affiliate, they will need to demonstrate that they are able to meet a set of agreed competencies; are registered doctors; are properly resourced to carry out their functions; and have appropriate accountability to their boards for the exercise of their regulatory responsibilities. Responsible officers, including those who are medical directors, will be able to require doctors to attend meetings to resolve patient complaints.
Donaldson proposed the creation of GMC affiliates in workplaces to act as the first port of call for concerns about doctors.
Because of the numbers of doctors that would have to be involved, the White Paper proposes having GMC affiliates at SHA level only. In England, they will lead regional medical regulation support teams.
The White Paper envisages medical directors taking on the roles originally envisaged for more local GMC affiliates. All doctors will have to relate formally to the “responsible officer” who will be the medical director or another doctor designated by the employer or by the GMC affiliate.
Areas to consider
Do you believe an augmented role for the Medical director can deliver the roles envisaged?
Do you agree with the regional role proposed?
3. The handling of concerns - national
The standard of proof
4.8 The Government agrees with Dame Janet Smith and the CMO that the civil standard of proof, with its sliding scale, should be the common standard of proof for all the regulatory bodies in fitness to practise proceedings.
The White Paper makes an effort to explain the proposed change in the standards of proof, pointing out that the civil standard is a sliding scale and a very flexible system which is often close to the criminal standard. It also points that all healthcare regulatory bodies apart from the GMD, GOC (general optical council) and NWC (general nursing and midwifery council), now use the civil standard of proof and that the NWC has welcomed the recommendation to move to the civil.
Areas to consider
Do you accept the move towards a sliding scale civil standard of proof?
Rehabilitation and health
4.22 For doctors, the Government will ensure that the GMC can deliver this new emphasis on support and rehabilitation for doctors by requiring NCAS and the GMC to work together with employers to agree specific packages of rehabilitation and conditions on practice, following a comprehensive assessment, where fitness to practise has been called into question. This may take place during the investigation stage, where agreement is reached between the GMC and the doctor concerned as part of consensual disposal’, or following the determination of a fitness to practise hearing. In both cases, a comprehensive assessment of the practitioner will be required. In cases of consensual disposal, doctors will be referred to a fitness to practise panel where they are unco-operative or do not comply with the agreed conditions on practice.
4.28 To ensure an integrated, affordable and cost-effective approach to the health of health professionals, the Department will establish a wide ranging and inclusive national advisory group to inform the development of a national strategy for health covering all health professionals. Including a wide range of UK stakeholders, the group will advise on measures to ensure appropriate prevention and early intervention for health professionals; the role of health in revalidation arrangements; enabling easier and confidential uptake services; the roles and responsibilities of employers, regulators, professionals themselves and others in ensuring the health of professionals; and more effective arrangements for the rehabilitation of health professionals whose actions have led to regulatory involvement.
Do you agree with developing the role of NCAS?
Do you agree with the formation of the national advisory group to ensure appropriate and early intervention in health and related matters?
Adjudication
4.36 For doctors, the Government agrees with Dame Janet Smith and with the CMO that the separation of investigation and prosecution from adjudication is essential to ensure complete public and professional confidence in the independence of the decisions made by the adjudicator. Working closely with the GMC, the Government will seek legislative agreement to establish an independent body to adjudicate on fitness to practise cases involving the medical profession. Doctors and the GMC (which is responsible for the integrity of the Register) will have the right of appeal against the decision of the independent body to the High Court or the Court of Session. As part of its scrutiny function, CHRE will review the application of this new GMC right of appeal, reporting to Parliament on an annual basis.
The White Paper recommends the complete separation of adjudication on fitness to practice from investigation and prosecution. This function will therefore be removed completely from the GMC and handed to an independent body.
This is one of the recommendations that have led commentators to say that the White Paper amounts to “the loss of professional self-regulation”.
Areas to consider
Do you agree with the separation of the adjudication function from the GMC?
4. Governance of the GMC
The White Paper seeks to ensure that all regulatory bodies of parity of lay/professional membership as a minimum. Those that seek parity rather than majority of lay membership will be subject to greater accountability requirements and will be subject to review in 2011.
1.12 The Government will therefore seek to secure the legislative changes required to reconstitute councils with parity of membership as a minimum. For the General Chiropractic Council, which proposed a lay majority in its consultation response, the Government will put in place the necessary enabling legislation, subject to parliamentary approval.
1.13 For those regulators that adopt parity rather than lay majorities, the Government expects that they will put in place packages of measures to demonstrate to the public, patients and Parliament their commitment to conducting their responsibilities in a manner that commands public confidence and puts an end to accusations of partiality. Those that choose parity will be subject to review in 2011 to consider whether
these changes have been sufficient to secure that aim.
Areas to consider
Do you accept the move to medical/lay parity on the GMC?
Do you agree with the appointment procedure to the GMC replacing the election process?
5. Education
These recommendations should be uncontroversial because the GMC is to keep its function overseeing standards in undergraduate medical education.
6. Information
The report envisages an increase in the availability of information about doctors, an agreed definition of “good character”, possible medical student registration and making the medical register the authoritative source of information.