Department of Health

Dear Colleague

CLINICAL GOVERNANCE

Summary

1. This letter provides guidance on the implementation of clinical governance in the NHS in Scotland with effect from 1 April 1999.

Background

2. The White Paper, Designed to Care, announced the Government's intention to introduce clinical governance into the NHS in Scotland.

3. A working group, chaired by the Chief Nursing Officer, produced a consultation paper in August 1998. The attached guidance takes account of the large number of helpful comments received on the document.

Action

4. Trust Chief Executives designate and Board General Managers are requested to initiate action by their boards to put in place appropriate arrangements as set out in the guidance to meet their clinical governance responsibilities with effect from 1 April 1999.

5. They are also requested to ensure wide circulation of the guidance among their non-executive and executive colleagues at board level and among healthcare professional staff, including independent contractors, and managers.

Yours sincerely

27th November 1998

______________________________

GUIDANCE ON CLINCAL GOVERNANCE

"Clinical governance is the vital ingredient which will enable us to achieve a Health Service in which the quality of health care is paramount. The best definition that I have seen of clinical governance is simply that it means "corporate accountability for clinical performance". Clinical governance will not replace professional self regulation and individual clinical judgement, concepts that lie at the heart of health care in this country. But it will add an extra dimension that will provide the public with guarantees about standards of clinical care."

Sam Galbraith MP
Minister for Health
June 1998

Context

1. The White Paper, Designed to Care, made several commitments in relation to clinical governance (paragraph 68):

• The Government will amend Trusts’ statutory duties to make explicit their responsibility for quality of care.
  
  
• Trust Chief Executives will be accountable for the quality of care provided by their Trust, in the same way as they are presently accountable for proper use of resources.
  
  
• Trust Chief Executives will be expected to ensure that there are suitable local arrangements to give them, and the Trust board, the assurance they need that this duty is being met.
  
  
• The intention is to build on existing patterns of self-regulation and corporate governance principles, but offer a framework for extending this more systematically into the local clinical community.

2. Trusts’ duties will be amended in the forthcoming NHS Bill. This guidance, prepared in the light of comments received on the consultation document issued in August 1998, deals with the non-statutory aspects of clinical governance. It will be reviewed in the light of experience during the first 2 years of operation (i.e. in 2001).

What is Clinical Governance?

3. Clinical governance makes quality of care an integral part of the NHS governance framework. From 1 April 1999 the corporate governance of all NHS bodies in Scotland will encompass both financial and quality issues.

4. NHS boards will be expected to lead the development of clinical governance so as to ensure that quality of patient care is given the highest priority at every level in the organisations for which they are responsible.

5. Clinical governance applies to all patient services in the NHS, wherever they are provided, and to services the NHS commissions from other organisations. Its most obvious application therefore is in NHS Trusts, the Scottish Ambulance Service and the State Hospitals Board for Scotland. However, it also applies to Health Boards and the Common Services Agency in relation to services they provide. For ease of presentation, this document refers only to Trusts, but the principles of clinical governance need to be at the forefront of everyone’s attention (including the Management Executive).

6. Effective clinical governance will provide assurance to patients, clinical staff and managers alike that:

• quality of clinical care drives decision-making about the provision, organisation and management of services within each Trust;
  
  
• the planning and delivery of services take full account of the perspective of patients;
  
  
• care delivered within each Trust meets relevant standards; and
  
  
• unacceptable clinical practice will be detected and addressed.
  
  
• whilst ensuring that patient and staff confidentiality and the right of clinical staff to exercise individual clinical judgement are not compromised.

7. Clinical governance as such is about the governance of the Health Service, and thus about accountability and about structures and processes. However, it will only achieve the desired outcomes of improved quality of care and public reassurance about standards of care, if it is underpinned by a wide range of activities (see paragraph 12) most of which require to be owned and led by clinicians individually and collectively. Clinical governance is not the sum of all these activities; rather it is the means by which these activities are brought together into a structured framework and linked to the corporate agenda of NHS bodies.

8. A key purpose of clinical governance is to support clinical staff in improving quality of care. However, it will also ensure that wherever possible poor performance is identified and addressed. Doctors and other health professionals will remain responsible for their clinical decisions; independent clinical judgement is a vital pillar of service quality. Clinical governance is about putting in place a system within which this judgement is exercised so as to reduce the possibility of poor performance and to ensure that wherever possible problems are remedied before questions of discipline arise. Occasionally clinical governance processes will reveal unacceptable practice and the system must be able to respond in a speedy and effective manner to provide public reassurance.

9. Many clinical governance issues will relate to the organisation and management of clinical services rather than to individual clinical decisions, and to the wider clinical environment in which care is delivered. The emphasis should be to ensure that the environment supports clinicians to deliver good quality care based on evidence and on sound judgement.

10. Similarly, clinical governance will complement not replace professional self-regulation. The proposals agreed recently in principle by the Academy of UK Medical Royal Colleges outlining a range of scenarios for action in relation to standards of clinical care with appropriate involvement of the Colleges, professional associations and regulatory bodies in providing support and advice to Trusts and to individual doctors, clarifies respective responsibilities. Equivalent clarification of the roles of professional and regulatory bodies for other healthcare professions would be helpful.

Activities Underpinning Clinical Governance

11. All aspects of a Trust’s business should be driven by and designed to support efforts to deliver the best possible quality of clinical care. Clinical governance, however, is principally concerned with those activities which directly affect the care and treatment of patients.

12. In a Trust where clinical governance is working well:

• services will be provided, organised and managed in a manner which supports the delivery of high quality care;
  
  
• the wider clinical environment in which care is provided will support the delivery of high quality care;
  
  
• effective quality assurance and improvement processes will be in place covering all aspects of service delivery;
  
  
• those providing care will be appropriately trained and have the skills and competencies required to deliver the care needed; continuing professional development and lifelong learning will be taking place; and there will be mechanisms for further training and re-training and re-assessment where necessary;
  
  
• poor performance which impacts upon the quality of clinical care will be recognised and appropriate action taken;
  
  
• there will be mechanisms through which staff can raise concerns over any aspect of service delivery which they feel may be having a detrimental effect on patient care, including the performance of clinical colleagues, or the management of services, without prejudicing the principles of patient and staff confidentiality;
  
  
• patient and public representatives will be involved effectively in quality-related activities;
  
  
• evidence-based practice will be in day-to-day use, and there will be an infrastructure and support for clinical effectiveness activity, including appropriate information systems;
  
  
• techniques such as risk management will be utilised to anticipate and minimise potential problems;
  
  
• techniques such as clinical audit and critical incident reporting will be in use to monitor and improve existing practice;
  
  
• programmes of research and development will be pursued and the lessons applied;
  
  
• complaints will be handled in accordance with national guidance and lessons will be learned from their investigation and resolution (including reports of the Health Service Commissioner and the Mental Welfare Commission); and
  
  
• the provisions of the Codes of Practice on Openness and on Confidentiality of Personal Health Information and related statutory provisions will be applied and monitored.

13. Clinical governance should ensure that these activities are pursued in a systematic and documented manner, and that they are co-ordinated in such a way that they are discussed in a shared forum; and that the findings of one inform, and are informed by, the others.

14. Patient information and involvement are key components in the development and implementation of clinical governance. All NHS bodies must be able to demonstrate that they have taken steps to involve patients and the public in the clinical governance process. Trusts will be required to publish a report on clinical governance, the content of which will be specified by the Management Executive (see paragraph 25).

Implementing Clinical Governance

15. Clinical governance is the responsibility of the board of each NHS body. Each board must satisfy itself that the organisation for which it is responsible is pursuing clinical governance in an appropriate manner, i.e. that the activities which support the delivery of clinical governance (see paragraph 12) are in place, and that information is flowing and action is being taken at appropriate levels up to and including board level, on quality of care issues both routinely and specifically when problems are identified.

16. Clinical governance has major implications for the agenda of boards and for the way in which they conduct their business. Issues relating to the quality of clinical care will feature much more prominently on their agendas; and will form a complementary and equal strand alongside financial and probity issues in their accountability. Their task is to:

- create a culture where the delivery of the highest standard possible of clinical care is understood to be the responsibility of everyone working in the organisation, and is built upon partnership and collaboration within health care teams and between health care professionals and managers;

- introduce structures and processes which assure them that this is happening whilst at the same time empowering clinical staff to contribute to the improvement of standards, and involving patients and the public in this process.

17. The Trust Chief Executive will be responsible to the Trust board for delivering clinical governance, and for ensuring that suitable local arrangements are in place and are integrated with existing structures such as clinical directorates. In this role, the Chief Executive will look especially to the Medical and Nursing Directors to provide support, particularly on professional matters, but the Chief Executive himself/herself will be responsible for reporting to the board, and for taking any action it decides, and this should be reflected in his/her job description.

18. It was clear from the consultation process that there was a desire that structures for delivering clinical governance should as far as possible not be prescribed centrally. With the exception of the provisions in paragraphs 17 and 19, the introduction of clinical governance will not affect the scope for local initiative and ownership of these arrangements (including the question of whether to establish a clinical board as a means of involving clinicians directly in the management of the Trust). Whatever structures and processes Trusts put in place, it will be crucial that they are effective and that they ensure that all the activities outlined in paragraph 12 are an integral and integrated part of the mainstream business of the Trust.

19. (please note that this paragraph was amended by HDL(2001)74 on 9 October 2001). In addition to the structures it develops to deliver clinical governance, each Trust board will establish a Clinical Governance Committee. It will be responsible for oversight of the clinical governance of the Trust so as to assure the board that the arrangements are working and to bring to the attention of the full board regular reports on the operation of the system and specific reports on any problems that emerge. The status of the Committee should be commensurate with that of the (financial) Audit Committee. The Committee should report direct to the board; and it should be chaired by a non-executive Trustee. Its members should comprise at least 3 non-executive Trustees; and it should have the power to co-opt up to 2 additional members from outwith the board. The Chairman of the Trust board should not be a member but should have the right to attend meetings. The Chief Executive, Medical Director and Nursing Director will not be members of the Committee but they should attend meetings as required. The Committee should develop mechanisms for engaging effectively with representatives of patients and clinical staff.

20. Part of the remit of the Clinical Governance Committee will be to check and report back to the board that appropriate structures are in place to undertake the activities which underpin clinical governance (see paragraph 12). It will not replace them; nor will it duplicate their work. Its task is to make sure that appropriate machinery is working effectively, that information is flowing appropriately throughout the organisation, and that action is being taken when required.

21. The principles of clinical governance apply fully to primary care services, but their application will require to reflect the independent contractor status of family health service professionals. Appropriate structures for delivering clinical governance and Clinical Governance Committees will be established in Primary Care Trusts. They should involve all the professions within the Trust; and should aim to support and facilitate the activities of clinical governance at local level, including in each Local Healthcare Cooperative.

22. Many of the activities supporting clinical governance are already in place and resourced, but there are gaps in most NHS bodies and variations in practice. The introduction of clinical governance in itself will not require substantial additional resources. However, the higher profile these activities will have and the need for protected time and systematic documentation will require some further investment.

23. In addition, programmes of organisational development and of training for clinicians, managers, and Trustees are being developed to assist in undertaking their new roles and in operating in this new environment. Further information will be issued shortly, including the forthcoming Education and Training Strategy for the NHS in Scotland.

Health Boards and the Common Services Agency

24. Health Boards and the Common Services Agency will be expected to adopt the principles of this guidance in relation to the services they provide (e.g. in the field of public health, the blood transfusion service) and commission, and these principles will guide their planning of services and the development of health improvement programmes (HIPs). Their boards will be held responsible for clinical governance in just the same way as Trust boards but it will be for them to decide on the best way to meet this obligation. As part of the HIP and TIP process, Health Boards will also have a general interest in clinical governance issues regarding services for their resident population.

Monitoring Clinical Governance

25. Trust boards will be responsible for clinical governance in pursuit of the statutory duty of quality, and accountable for its discharge in their Trust. They (and the Island Health Boards, the Scottish Ambulance Service and the State Hospitals Board) will be required to include a specific section in their annual report, the content of which will be prescribed by the Management Executive, giving a full account of their activities related to clinical governance.

26. Problems in relation to clinical governance in a Trust will be pursued by the Management Executive through established performance management processes. Clinical governance issues will also feature in the Management Executive’s annual Accountability Review meetings with Health Boards, which in future will be attended by Trust Chairmen.

27. The proposed Clinical Standards Board for Scotland will have a close interest in the impact of clinical governance on standards of care but it will not be directly involved in monitoring the structures and processes that deliver clinical governance. It will also produce an annual report outlining its assessment of the position of the NHS in Scotland in relation to quality of clinical care.

Clinical Governance Network

28. A clinical governance network will be facilitated by the Management Executive, incorporating representatives from Trusts, Health Boards and patient and professional bodies, to share good practice. This will support further development of clinical governance and ensure that it continues to be driven by the experience and views of all stakeholders.