(2000)29

5. Trust Chief Executives and Board General Managers are requested to ensure wide circulation of the guidance among their non-executive and executive colleagues at board level and among healthcare professional staff, including all independent contractors, and managers.

Yours sincerely

GEOFF SCAIFE
Chief Executive

SIR DAVID CARTER
Chief Medical Officer

ANNE JARVIE
Chief Nursing Officer

CLINICAL GOVERNANCE

Introduction

1. MEL(1998)75 concentrated on the background to clinical governance and the structures that required to be established to ensure that quality of care was at the forefront of the development and delivery of services. This guidance seeks to confirm those structures but also to ensure that appropriate systems are in place to assure Health Boards, Trust boards and the Management Executive that clinical governance is being – and will continue to be - implemented effectively. It also seeks to allay confusion in the Service about clinical governance, particularly with regard to the different roles and responsibilities of clinical governance committees, clinicians and specialist support departments like audit.

2. The requirements of clinical governance extend to all Trusts and Health Boards, including the Scottish Ambulance Service and the State Hospitals Board. It is also relevant to services provided by the Common Services Agency. However, for simplicity, this document uses the term Trusts to cover all these organisations.

Role of Mainstream Trust Management Structure

3. Trusts should now be well on their way to establishing the structures and processes that put quality of care at the forefront of their work. Responsibility for the delivery of clinical governance rests with the Chief Executive, who will discharge this responsibility through the management structure of the Trust. Whatever management structure the Trust chooses to operate will require staff, at all levels of the Trust, to be well informed about relevant clinical quality issues and to be making decisions based on that information.

Role of Clinical Governance Committee

4. Each Trust should also by now have established a Clinical Governance Committee with a reporting line direct to the board. It is worth re-stating that the role of the Clinical Governance Committee is:

to oversee rather than deliver clinical governance;

to observe and check on the clinical governance activity being delivered by Trust management ;

to assure the board that appropriate structures are in place for clinical governance to be supported effectively by the Trust; that these structures are operating effectively and that action is being taken to address any areas of concern.

If the Clinical Governance Committee were to be removed from the structures in place in the Trust, clinical governance should continue to function as normal. The Committee is there to oversee the clinical governance process, it is not an integral part of that process.

Addressing Clinical Governance at 4 levels

5. Clarification of their own role and an appreciation of how this fits in with the overall picture of clinical governance responsibilities should help committees, and others, to focus their activities more effectively. The following breakdown of clinical governance responsibilities into 4 levels might be helpful in illustrating respective functions:

Overseeing role - clinical governance committees

Delivering role - management structure throughout Trust, including clinicians involved in management

Supporting role - eg staff employed in activities underpinning clinical governance such as those involved in clinical effectiveness, audit, complaints handling and risk management

Practising role - clinical and support staff.

Each of these roles is important if quality of care is to be given the highest priority within the NHS in Scotland.

Development Opportunities

6. A range of seminars and other events have been held over the past year to increase knowledge and understanding of clinical governance within the Service. A Clinical Governance Support Network has also been established to encourage the exchange of ideas and best practice.

7. Further Support Network meetings have been held in May and another is planned for June. These have been aimed primarily at members of clinical governance committees, medical directors, clinical directors and general managers. They have focused mainly on the practical implications for clinical governance of national and local issues and the various responsibilities of managers, clinicians and clinical governance committees.

Clinical Governance Web-site

8. A clinical governance web-site has been developed within the Scottish Health on the Web (SHOW) site. The web-site is now on-line. The main purpose of the site is to encourage the exchange of information and good practice in the area of clinical governance. Examples of work in progress on clinical governance are included on the site and a bulletin board allows users to exchange information, highlight good practice and problem-share. The site links in to other partner websites supporting clinical quality, including CRAG and SIGN. The web-site address is http://www.show.scot.nhs.uk/sehd/CG.

National Standards

9. The work of the Clinical Standards Board for Scotland will impact on the development of clinical governance. The Board is responsible for developing and running a national system of quality assurance and accreditation, which will involve the regular evaluation and revision of standards of clinical services. The Board will set standards that are stretching but achievable.

10. The Board recognised the need to establish generic standards for all clinical services, to complement the work of the project groups evaluating standards in specific clinical areas. A Generic Standards Group was established and its recommendations were recently issued for consultation. After the consultation process, a baseline review will take place to determine to what extent these generic standards are already in place in the Service. These generic standards will support the Service in taking forward clinical governance.

Monitoring Clinical Governance

11. MEL(1998)75 advised that annual reports should include a specific section giving a full account of activities related to clinical governance. This requirement has not changed. Further information is now required, however, to assure the Management Executive that systems are in place to enable clinical governance to operate effectively throughout the Service and to support the dissemination of good practice.

12. A clinical governance monitoring template has been prepared and is attached at Annex A. The template seeks information about the systems and procedures that deliver effective clinical governance in NHS organisations. The questions are divided into 3 groups, targeting information/communication, systems/procedures and clinical effectiveness. Ultimately, these combine to assure the Trust Chief Executive and management board that clinical governance is operating well and quality of care considerations are driving the development of services.

13. Some initiatives and issues which impact on clinical governance will be relevant at both a local and national level. There will be specific matters of which local clinical governance committees will want to be aware that are also being monitored centrally. An example of this is the new Clinical Negligence and Other Risks Indemnity Scheme, details for the management and monitoring of which were contained in MEL(2000)18. Clinical governance committees should still assure themselves that systems are in place locally to ensure that such initiatives are operating effectively.

14. The clinical governance monitoring template includes questions on clinical effectiveness and replaces previous advice regarding the structure, content and delivery date for annual clinical effectiveness reports. The 10 Goals for Clinical Effectiveness, and associated guidance notes, circulated under MEL(1999)76, describe the direction of travel for clinical effectiveness in Scotland and should be used as the framework for reporting progress to the Management Executive. CRAG will continue to seek information on progress towards implementation of clinical effectiveness but within the overall reporting arrangements for clinical governance.

15. There are 2 main differences in the clinical effectiveness reporting arrangements proposed for 1999-2000, namely:

the information should be based primarily on progress against the 10 Goals for Clinical Effectiveness; and
individual reports should be provided direct to the Management Executive from all Trusts and Health Boards. Trusts are asked, however, to provide their Health Boards with copies of their reports.

16. Clinical governance issues will be discussed during the Management Executive’s annual Accountability Review meetings with Health Boards. General Managers and Trust Chairmen should be ready to provide reports on progress with clinical governance. In future Accountability Review meetings, clinical governance will be a central theme for discussion.

17. Responses to the questions raised in Annex A should be returned to the Management Executive by 14 July 2000. Responses should only cover the specific issues included in the template. As a guide, we would expect them to extend to between 6 and 10 sides of A4, no more. The returns and any queries about this MEL should be addressed to Ms Aileen Bearhop, Health Gain Division, Room 151, St Andrew’s House, Regent Road, Edinburgh EH1 3DG, Tel 0131 244 5062. Specific enquiries about the structure and content of the clinical effectiveness element of the report should be directed to Mr David Cline, Clinical Effectiveness Co-ordinator, Health Gain Division, Room 153, St Andrew’s House, Tel 0131 244 2235.

Annex A

CLINICAL GOVERNANCE MONITORING TEMPLATE

	INFORMATION/COMMUNICATION
1.	What systems are in place to ensure that information, on issues of relevance to clinical governance, is communicated to the appropriate levels up and down the organisation?
2.	What systems are in place to ensure that all staff understand the importance of their individual contribution to the quality of clinical care?
3.	What are the links between the Health Board and Trust with regard to governance of services provided by the Trust?
	SYSTEMS/PROCEDURES
4.	To what extent is the Clinical Governance Committee in a position to confirm that procedures are in place to assure the board that clinical governance is operating effectively within the organisation?
5.	What authority does the Clinical Governance Committee have to ensure that remedial action is taken where deemed necessary?
6.	How does your organisation identify and address organisational and management issues that impact on quality of care?
7.	What systems are in place to identify gaps or inadequacies in clinical care? Once identified, what are the procedures for handling these deficiencies?
8.	What systems are in place to assess the implications for your organisation of the introduction of reports, guidance and key legislation and to ensure appropriate action is taken?
9.	What systems are in place to address the immediate and longer-term consequences of a significant or unexpected incident (of a clinical or non-clinical nature)?
10.	What systems are in place to ensure that all staff have the relevant competencies to carry out the duties for which they are employed?
11.	How do you "quality assure" the systems that underpin clinical governance and the processes within the Trust management structure for considering and taking action on their output?

	CLINICAL EFFECTIVENESS
12.	What systems are in place to direct and implement clinical effectiveness goals?
13.	What progress has been made against the goals for clinical effectiveness?

Answers to question 12 and 13 should include:

brief details of progress against the strategic aims outlined in the 10 goals;
an organisational chart (or equivalent) describing arrangements for clinical effectiveness and the relationship with clinical governance;
a brief summary of the training supported by the non-recurring allocations distributed by the CRAG Implementation Subgroup in October 1999.

Health Board reports should also address on-going area wide clinical effectiveness initiatives facilitated by them and comment on the efficiency of arrangements within Trusts providing services to their populations.