CO.022 CORPORATE POLICY FOR CLINICAL AUDIT

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					                                               CO.022
                  CORPORATE POLICY FOR CLINICAL AUDIT
Category / Policy               CORPORATE Policy Document.
Register No.                    CO.022, Version 1

Document purpose:               This policy provides guidance for all staff participating in clinical
                                audit activities. It includes the Trust’s procedures and
                                expectations for registering and approving clinical audit project
                                proposals and sets out a framework for the conduct of clinical
                                audits within the Trust.
Intended for use by:            This policy is for all employees of Darlington PCT who engage in
                                the clinical care of patients. It is also applicable to any person
                                engaged in the clinical audit process under the auspices of the
                                organisation, including students, volunteers and patients, as well
                                as staff.


Author(s) responsible for       Suzanne Jobson Clinical Effectiveness and Research
document upkeep:                Development Manager

Supported by:                   Clinical Effectiveness and Audit steering group.

Consultation process:           Head of Quality and Patient Experience
                                Clinical Audit team.

Sponsoring Director:            Director of Nursing AHPs and Patient Safety

Approved by:                    Patient Safety Committee

Dated:                          October 2009

To be reviewed before:          October 2012
                                The document will be posted on the intranet, internet and
Implementation
                                provider service internet.
arrangements:
                                All Directors must ensure that appropriate arrangements are in
                                place:
                                    • for the document to be cascaded to appropriate staff, and
                                    • to identify any training required to reach specific
                                        competencies identified in this document.
                                The implementation and effectiveness of this policy will be
Monitoring
                                reviewed at meetings of the Clinical Effectiveness and Audit
arrangements
                                Steering Group by checking whether the policy is being used and
                                receiving feedback on current effectiveness and possible future
                                revisions.

                                       VALIDITY STATEMENT
          This document is due for review on the latest date shown above.
         After this date, policy and process documents may become invalid.

Ref / Title:   Clinical Audit Policy                                                      Page 1 of 24
Author(s):     S Jobson                                                       Date:      October 2009
DOCUMENT INFORMATION


Document Title:             CO.022 Corporate Policy for Clinical Audit

Initial Issue:              Version 1 :October 2009



Document History

Version Date                     Significant Changes
     2                           •
     3                           •




CURRENT AUDIT ASSESSMENT:

Audit                       By / Date                  Result

Risk audit                  S Jobson 14/10/2009        No significant risks identified.

Equality audit              S Jobson 14/10/2009        No or very low potential for discrimination.

Human Rights audit          S Jobson 14/10/2009        No breach of Human Rights.




Ref / Title:     Clinical Audit Policy                                                      Page 2 of 24
Author(s):       S Jobson                                                        Date:     October 2009
               CL.022 CORPORATE POLICY FOR CLINICAL AUDIT

                                           CONTENTS

Section Title                                                                       Page
     1         INTRODUCTION                                                            6
     2         DEFINITIONS                                                             6
     3         DUTIES AND RESPONSIBILITIES                                             6
     4         PROCEDURE                                                               7
     5         DEFINITION OF CLINICAL AUDIT                                           10
     6         IMPROVEMENT AND ASSURANCE                                              10
     7         COMMITMENT TO STAKEHOLDER ENGAGEMENT,                                  10
               COLLABORATION AND PARTNERSHIP
     8         CHOOSING TOPICS AND PLANNING PROJECTS                                  11
     9         GOVERNANCE OF CLINICAL AUDIT                                           12
    10         REPORTING AND DISSEMINATION OF RESULTS                                 14
    11         ACTION PLANS AND IMPROVEMENT                                           15
    12         MONITORING EFFECTIVENESS                                               16
    13         IMPLEMENTATION AND TRAINING                                            17
    14         DOCUMENTATION                                                          17
    15         REFERENCES                                                             18
    16         AUDIT / IMPACT ASSESSMENT STATEMENTS                                    20

Appendices
  A     Terms of reference for Clinical Effectiveness & Audit Steering Group          22
     B         Confidentiality agreement                                              24
     C         Clinical Audit Registration Form                                       25
     D         Evaluation Template                                                    27




Ref / Title:     Clinical Audit Policy                                          Page 3 of 24
Author(s):       S Jobson                                           Date:      October 2009
               CL.022 CORPORATE POLICY FOR CLINICAL AUDIT


1.0      INTRODUCTION

NHS Darlington (Darlington Primary Care Trust) aspires to the highest standards of
corporate behaviour and clinical competence, to ensure that safe, fair and equitable
procedures are applied to all organisational transactions, including relationships with
patients, public, staff, stakeholders and the use of public resources. In order to provide clear
and consistent guidance, the Trust will develop documents to fulfil all statutory,
organisational and best practice requirements.

This document sets out the Trust’s approach to Clinical Audit.


This policy provides guidance for all staff participating in clinical audit activities. It includes
the Trust’s procedures and expectations for registering and approving clinical audit project
proposals and sets out a framework for the conduct of clinical audits within the Trust.

This policy is for all employees of Darlington PCT who engage in the clinical care of patients.
It is also applicable to any person engaged in the clinical audit process under the auspices of
the organisation, including students, volunteers and patients, as well as staff.

Other organisations and their staff are welcome to use all or part of this document as a
means of adopting good practice.


2.0       DEFINITIONS

“NHS Darlington” is the public or colloquial term for the organisation known for legal
purposes as Darlington Primary Care Trust.

Where the words “PCT” or “Trust” appear in the text, they refer to Darlington Primary Care
Trust.

Special terms or abbreviations used in this document are defined as they occur.


3.0       DUTIES & RESPONSIBILITIES

General:
Trust Board, Chief Executive, Directors and Lead Managers general duties in respect of all
PCT policies and procedures are described in CO.001 “Guidance on writing policies and
procedures.

Specific:
The Sponsor Director and Author/Lead Manager for this document are identified on the front
page. Other specific group and individual duties and responsibilities are described below:




Ref / Title:    Clinical Audit Policy                                                  Page 4 of 24
Author(s):      S Jobson                                                    Date:     October 2009
All PCT Staff
All staff, including temporary and agency staff, are responsible for:
    • Compliance with PCT policies and procedures. Failure to comply may result in
         disciplinary action being taken.
    • Co-operating with the development and implementation of policies and procedures
         and as part of their normal duties and responsibilities.
    • Identifying the need for a change in policy or procedure as a result of becoming
         aware of changes in practice, changes to statutory requirements, revised
         professional or clinical standards and local/national directives, and advising their line
         manager accordingly.
    • Identifying training needs in respect of policies and procedures and bringing them to
         the attention of their line manager.
    • Attending training / awareness sessions when provided.
The Patient Safety Committee is the corporate committee tasked with overseeing the Trust’s
clinical audit activities.
The Clinical Effectiveness and Audit Steering Group (CE&ASG) is responsible for the
operational implementation of Clinical Audit in the Trust
The Chief Executive is responsible for the statutory duty of quality and takes overall
responsibility for this policy.
The Clinical Effectiveness and Research Development Manager (CE&RDM) is responsible
for ensuring that Clinical Audit is carried out in the Trust.
All service managers are responsible for ensuring that development and delivery is
underpinned by clinical audit and forms part of Continuing Professional Development.
Professional staff are individually accountable for ensuring they audit their own practice as
defined by their codes of conduct.


4.0       NATIONAL CONTEXT
 
4.1       Key policy drivers
The expectation for healthcare professionals to participate in regular clinical audit was first
established in the 1989 Government White Paper, ‘Working for Patients’. This has been
reinforced and extended by a succession of key national publications, including:
•     The New NHS — Modern Dependable (Department of Health, 1997)
•     A First Class Service (Department of Health, 1998)
•     Clinical Governance — Quality in the NHS (Department of Health, 1999)
•     Learning from Bristol: the report of the public inquiry into children’s heart surgery at
      Bristol Royal Infirmary 1984–1995 [the ‘Kennedy Report’] (Department of Health, 2002)
•     Good Medical Practice (General Medical Council, 2001)
•     National Standards, Local Action
•     Good Doctors Safer Patients (Department of Health, 2006)
•     Trust Assurance & Safety (Department of Health, 2007)


Ref / Title:    Clinical Audit Policy                                                   Page 5 of 24
Author(s):      S Jobson                                                    Date:      October 2009
•    The NHS Next Stage Review Final Report, High Quality Care For All [the ‘Darzi Report’],
     (Department of Health, 2008).

•    Clinical Negligence Scheme for Trusts (CNST)

Since the creation of Standards for Better Health by the Department of Health in 2004, all
NHS Trusts have had to make an annual Declaration including their compliance with
Standard C5d, which states that “Healthcare organisations [must] ensure that clinicians
participate in regular clinical audit and reviews of clinical services.”

Furthermore, in 2008, the Healthcare Commission introduced an Engagement in clinical
audits indicator which places the following expectations on NHS Trusts:
•    To participate in local and/or national audits of the treatment and outcomes for patients
     in each service covered by the Trust
•    To have a clinical audit strategy and programme related to both local and national
     priorities with the overall main aim of improving patient outcomes
•    To make available suitable training, awareness or support programmes to all clinicians
     regarding the Trust’s systems and arrangements for participating in clinical audit
•    To ensure that all clinicians and other relevant staff conducting and/or managing clinical
     audits are given appropriate time, knowledge and skills to facilitate the successful
     completion of the audit cycle
•    To undertake a formal review of the local and national audit programme undertaken in
     the Trust to ensure that it meets the organisation's aims and objectives as part of the
     wider quality improvement agenda
•    To provide the Trust’s management and governance leads with regular reports on the
     progress being made in implementing the outcomes of national clinical audits, and
     review the outcomes, with additional or re-audits being conducted where necessary.




Ref / Title:   Clinical Audit Policy                                                 Page 6 of 24
Author(s):     S Jobson                                                   Date:     October 2009
5.0       DEFINITION OF CLINICAL AUDIT

5.1       Locally accepted definition

Clinical Audit is one of a number of activities focussed on improving the care of patients by
looking at practice, comparing it to pre agreed standards, identifying discrepancies, learning
from them, and, if necessary, changing practice.




                                       IDENTIFY TOPIC




                                                                                     SET CRITERIA
      RE-AUDIT                                                                      AND STANDARDS




IMPLEMENT
 CHANGES                                                                   COLLECT DATA

                                            ANALYSE DATA




6.0       IMPROVEMENT AND ASSURANCE
The Trust supports the view that whilst Clinical Audit is fundamentally a quality
improvement process, it also plays an important role in providing assurances about the
quality of services.


7.0  COMMITMENT TO STAKEHOLDER ENGAGEMENT, COLLABORATOIN
AND PARTNERSHIP

7.1       Involving patients and the public
The Trust promotes a commitment to the principle of involving patients/carers in the clinical
audit process either indirectly through the use of patient surveys/questionnaires or directly
through participation of identified individuals on project steering groups such as Essence of
Care and Patient Information Review Group.



Ref / Title:   Clinical Audit Policy                                               Page 7 of 24
Author(s):     S Jobson                                                 Date:     October 2009
7.2    Multi-disciplinary and multi-professional audit and partnership working with
other organisations

The Trust encourages clinical audit undertaken jointly across professions and across
organisational boundaries. Partnership working with other local and regional organisations
will be encouraged where improvements to the patient journey may be identified through
shared clinical audit activity.


7.3       Involving clinical managers

The Trust will ensure that any clinical audit work is carried out in conjunction with Clinical
Managers, ensuring commitment where any identified changes raise resource implications.

7.1       Working with commissioners

The Trust will work proactively with its Commissioners to ensure that there is assurance of
quality improvement. The Clinical Effectiveness and Research Development Manager will
meet regularly with their contemporary in the Commissioning PCT and agree programmes of
audit to be carried out within and across the PCTs.


8.0       CHOOSING TOPICS AND PLANNING PROJECTS

8.1       Agreeing an annual programme of activity
A corporate programme of audit will be agreed by the Board and delivered by the Clinical
Effectiveness and Audit Team.
Prior to the start of the financial year, an annual programme of local audit will also be agreed
with each of the teams within all of the Functions in the PCT, to ensure that Clinical Audit is
being carried out systematically.
It is acknowledged that individual clinicians may initiate a clinical audit project on the basis of
personal interest, personal development or as part of an educational or training programme.
It is important that all projects, audit, research or otherwise are registered with the Trust and
reported through existing clinical governance structures to maximise organisational learning.

Ad hoc audits will also be carried out at the request of the Board, Directors, Assistant
Directors and in response to Serious Untoward Incidents, Complaints and areas of specific
concern.

Where practicable, the PCT will also ensure participation in National Audits.

The Clinical Effectiveness and Audit team will facilitate and support Clinical Audit within the
Trust and will prioritise resources according to the following priorities:




Ref / Title:   Clinical Audit Policy                                                   Page 8 of 24
Author(s):     S Jobson                                                     Date:     October 2009
Level Description Examples

1 National Priority                     National Institute of Health and Clinical Excellence,
                                        National Service Frameworks (as above)
2 Trust Priority                        Business Plans, Response to Incidents, Risk
                                        Management
3 National Good Practice                Essence of Care, Work identified by Professional Bodies
4 Clinician Interest                    Locally initiated audits not covered by the above



8.2       Choosing and prioritising local clinical audit topics

Generally, audits are prioritised in accordance with local need. Audit prioritisation will be
initially managed by the CE&RDM ensuring that the Clinical Effectiveness and Audit team
have the capacity to react according to need. It should be noted that program priorities are
subject to change (although audits will not be suspended once commenced).

Audit topics should be carefully selected to address aspects of care whose standards are
known to or are suspected to require improvement, i.e. where there is a known or suspected
quality issue. When prioritising audit activity, the audit topic should reflect at least one of the
following:
• High volume service
• High cost procedure
• High risk (morbidity, disability, mortality)
• Known problems with care (variations in practice, complaints)
• High priority: national or local
• Interface with other agencies
• Clear standards of good practice (NICE, NSFs, Royal Colleges)
• Link to service users’ priorities

9.0       GOVERNANCE OF CLINICAL AUDIT

9.1       Systems for registering and approving audits
All clinical audit activity must be registered with the Clinical Effectiveness and Audit Team
irrespective of the level of facilitation being requested of the Department. A registration form
is available from the Clinical Effectiveness and Audit team (Appendix C). The Clinical
Effectiveness and Audit Team will maintain a register of all Clinical Audit Projects taking
place throughout the Trust. The Clinical Effectiveness and Audit Team MUST receive a copy
of the final audit report on completion of the project. This will be kept in the department
library.


9.2       The use of standards (or criteria) in clinical audit

By definition, clinical audit involves measuring clinical practice against predetermined
standards of best practice.

The Trust requires that all Clinical Audits clearly identify the source of the Clinical Standard,
be it locally (through a PCT Policy) or nationally agreed. Where no clear standard is
identified, the project will not be registered as a Clinical Audit but as a Base Line
Ref / Title:    Clinical Audit Policy                                                   Page 9 of 24
Author(s):      S Jobson                                                    Date:      October 2009
Assessment. It will be recorded on the Organisation Register. Staff will be encouraged to
develop local standards where no National standards are available.

Publications such as How to write a guideline from start to finish (Bowker et al) and
Principles for Best Practice in Clinical Audit (NICE/CHI, 2002) set out a familiar model for
how standards should be constructed.


9.3       Equality and diversity

Clinical audit practice must take account of equality and diversity issues. The organisation
will ensure that the process for determining choice of clinical audit projects, and the manner
in which project patient samples are drawn up, does not inadvertently discriminate against
any groups in society based on their race, disability, gender, age, sexual orientation, religion
and belief.

9.4       Information governance: collection, storage and retention of data and
          confidentiality

All clinical audit activity must take account of the Data Protection Act (1998) and the
Caldicott Principles (1997). This means that:
•     Data should be accurate, adequate, relevant and not excessive
•     Data gathered as part of clinical audit may contain information that is confidential
•     If it is in paper format then it is imperative that such data is kept in a secure place, under
      lock and key
•     It should be processed for limited purposes
•     It should not be kept for longer than is necessary
•     Audit data held electronically should be stored on the server according to the
      management and retention policy of the PCT.


Clinical audit activity must also conform to the requirements of the NHS Confidentiality Code
of Practice (2003) which states that “Patients must be made aware that the information they
give may be recorded, may be shared in order to provide them with care, and may be used
to support local clinical audit” (page 21). If patients have been so informed, Section 60 of
the Health and Social Care Act 2001 makes provision for the collection of patient identifiable
data for the purposes of clinical audit; however best practice directs that data be anonymised
unless there is a compelling reason not to do so.

Guidance provided in the Department of Health publication Records Management: NHS
Code of Practice (2006) requires “audit records” to be retained for a period of five years,
although the document does not define the term “record” in this context.

As a matter of good practice, all staff carrying out audits should ensure that they respect the
confidentiality of the patient in discussions which take place at audit meetings, including not
discussing individual clinician performance as clinical audit is about quality assurance and
improvement, not performance management.




Ref / Title:    Clinical Audit Policy                                                    Page 10 of 24
Author(s):      S Jobson                                                      Date:      October 2009
9.4.1     Confidentiality agreements

There may be occasions when the Trust engages individuals in its clinical audit activities
who are not directly employed by the organisation, e.g. staff who are on honorary contracts,
volunteers, patients and the public. It is important that these individuals understand the
“rules” which apply to the practice of clinical audit. It is recommended that individuals in this
situation sign a confidentiality agreement, an example of which is provided at Appendix 2.


9.4.2     Clinical audit database

The Clinical Effectiveness and Audit Team will maintain a central database of all clinical
audit activity carried out within the Trust. All Clinical Audit, Research and Service
Evaluations must be recorded on the database.

On such occasions whereby the CE&RDM decides that the details on the registration form
represent an evaluation rather than a clinical audit, the identified lead will be sent an
Evaluation Plan Template (APPENDIX D)

The information stored on the register will be used as evidence to support ‘Standards for
Better Health’ and CNST as well as internal Quality Assurance requirements.

9.5 Ethics and consent

By definition, clinical audit projects should not require formal approval from a Research
Ethics Committee. However one of the principles underpinning clinical audit is that the
process should do good and not do harm. Clinical audit must always be conducted within an
ethical framework.

The ethical framework must consider the following four principles:
1. There is a benefit to existing or future patients or others that outweighs potential burdens
   or risks.
2. Each patient’s right to self-determination is respected.
3. Each patient’s privacy and confidentiality are preserved.
4. The activity is fairly distributed across patient groups.

See Review of Ethics and Clinical Audit and Quality Improvement Literature, Guide on Ethics
and Clinical Audit and Template for Policy on Ethics and Clinical Audit available from HQIP.


10.0      REPORTING AND DISSEMINATION OF RESULTS

10.1      Reporting

The Clinical Effectiveness and Audit Steering Group will present clinical audit findings to the
Patient Safety Committee and where relevant, report back to and liaise with team, service
and function leads.


Ref / Title:   Clinical Audit Policy                                                 Page 11 of 24
Author(s):     S Jobson                                                   Date:      October 2009
10.2      Dissemination
Regular summary reports, together with recommendations, must be communicated to all
relevant areas of the organisation and Trust committees. A successful audit in one area
may be transferable to other parts of the organisation.
The Clinical Effectiveness and Audit Steering Group will review all summary reports on
completion of the project.
Details of completed audits must also be presented at Service Manager meetings where the
findings should be discussed, action plans agreed and a commitment to re-audit made in a
designated time.


11.0      ACTION PLANS AND IMPROVEMENT

11.1      Action plans

Where the results of a clinical audit indicate sub-optimal practice, an action plan should be
produced. A suggested format for a project action plan is provided below.

Project                                                                                     title:
________________________________________________________________

 Action agreed                         Staff member responsible   Target date for completion




Planned re-audit date:
Project Lead (Name, signature and date):
Senior Clinician (Name, signature and date):

Ideally the action plan should include routes of escalation if difficulties in implementation are
encountered.

The main purpose of clinical audit is to deliver improvements in clinical practice. A
systematic approach to the implementation of clinical audit action plans is therefore strongly
advised.


Action plans should be specific, measurable and achievable/realistic. They should have clear
implementation timescales with identified leads for each action. Action plans should also
have been approved by the relevant head of service or department.
Not all clinical audits will require an action plan e.g. where an audit shows that standards are
being met or guidance followed. For such audits there should be an explicit statement saying
‘no further action required’ in the audit summary report and a reason given for no re-audit.
The Clinical Audit and Effectiveness Department will monitor the implementation of actions,
ensuring that any identified changes are incorporated into relevant business plans as
appropriate.

Ref / Title:   Clinical Audit Policy                                                 Page 12 of 24
Author(s):     S Jobson                                                   Date:      October 2009
11.2      Re-audit

Re-audit is important to determine whether agreed actions have been implemented
according to the action plan.

As a matter of good practice, where an action plan has resulted from a clinical audit, re-audit
should be carried out within nine months of the full implementation of the action plan.

Where no action plan has resulted from an audit and no change in practice is required, re-
audit should still occur to ensure that standards continue to be achieved.

12        MONITORING EFFECTIVENESS

12.1      Monitoring the effectiveness of clinical audit activity

Compliance with this policy will be monitored by the CE&RDM who will provide an annual
report on clinical audit activity on a rolling programme.

The annual report will be presented to the Clinical Effectiveness and Audit Steering Group
and the Patient Safety Committee which will identify any areas for improvement in the form
of actions and these will be monitored by the Committee until all actions are completed.

12.2      Monitoring the effectiveness of the policy

In accordance with the requirements of the NHS Litigation Authority, and in common with all
policy documentation, the clinical audit policy should also include a section describing how
the effectiveness of the policy will be monitored within the organisation. In Darlington PCT
the following will be monitored:
•    staff are receiving training
•    there is a rigorous system for determining what goes into the annual clinical audit
     programme
•    stakeholders are being involved
•    projects are approved and registered
•    project are standards-based
•    projects are meeting data protection and confidentiality guidelines
•    results are being reported and disseminated
•    action plans are being agreed and implemented
•    timely progress reports are being sent to commissioners.




Ref / Title:    Clinical Audit Policy                                               Page 13 of 24
Author(s):      S Jobson                                                   Date:    October 2009
13.0      IMPLEMENTATION AND TRAINING

The Primary Care Trust wishes to make a reality of Life Long Learning (LLL) and are
working towards providing the culture of support and opportunity to enable all staff to grow
and develop in accordance with the NHS Knowledge and Skills Framework (KSF) and in line
with organisational and business objectives.

The Trust actively promotes quality of opportunities for all employees and secures a diverse
workforce that reflects the community in which they operate.

               Darlington PCT Education, Learning and Development Policy and Procedure (2007)


Specific aspects of clinical audit require specialist skills to enable successful clinical audit,
for example using the correct clinical audit methodology. This policy sets out how the Trust
will ensure that all clinicians and other relevant staff conducting and/or managing clinical
audits are given appropriate time, knowledge and skills to facilitate the successful
completion of the audit cycle.

The competencies required to implement this policy are described below.


13.1      Provision of clinical audit training

The Trust will make available suitable training, awareness or support programmes to all
clinicians regarding the Trust’s systems and arrangements for participating in clinical audit.
This can be accessed via the Clinical Effectiveness and Research Development Manager.
Appropriate educational resources on clinical audit processes are available through the
Trust Intranet and bespoke training will be given to groups and individuals on request.
The Trust will also provide sufficient and appropriate resources to support and deliver a
robust programme of clinical audit for local, regional and national activities via the Clinical
Effectiveness and Audit Department.


13.2      Employment and development of clinical audit staff
The Trust will endeavour to employ suitably skilled clinical audit staff to support its
programme of clinical audit activity. The Trust will also ensure that these staff has access to
further relevant training in order to maintain and develop their knowledge and skills.
All Directors and Managers are responsible for ensuring that relevant staff within their own
directorates and departments have read and understood this document and are competent
to carry out their duties in accordance with the procedures described.



14.0      DOCUMENTATION

14.1      Other related Policy documents

•    Writing PCT Policies, CO.001 rev.3.
•    Trust Equality/Diversity policy, strategy and action plan.
•    Clinical Records Policy

Ref / Title:       Clinical Audit Policy                                               Page 14 of 24
Author(s):         S Jobson                                                 Date:      October 2009
•    Implementation of NICE Guidance Policy
•    Darlington PCT Education, Learning and Development Policy and Procedure (2007)

14.2            Relevant Legislation / Statutory Requirements

14.2.1          Legislation
Health & Safety At Work Act 1974
General duties of Employers and Employees. Requirement that employers assess and
manage risks to health and safety.
Human Rights Act 1998
Rights and freedoms protected under the European Convention on Human Rights.
Freedom of Information Act 2000
Trust policies and procedures are subject to disclosure under the Freedom of Information
Act 2000 (FOI). From January 2005 the Act allows anyone, anywhere to ask for information
held by organisations, although some information, such as patient identifiable information, is
exempt.
Mental Capacity Act 2005
Statutory framework to empower and protect vulnerable people who are not able to make
their own decisions. It makes it clear who can take decisions, in which situations, and how
they should go about this. It enables people to plan ahead for a time when they may lose
capacity. See also Clinical Policy CL.034 (HR Policy HR.034) “Mental Capacity Act Policy”.
Equality Act 2006
Provisions relating to Human Rights and discrimination on grounds of race, religion or belief
sexual orientation; sex; amends the Disability Discrimination Act 1995.

14.2.2          Statutory Requirements / Best Practice Recommendations

•   Healthcare Quality Improvement Partnership Clinical Audit Resources


15.0      REFERENCES

Department of Health (1997) - The New NHS-Modern Dependable. The Stationary Office,
London.
Department of Health (1998) - A First Class Service. The Stationary Office, London.
Department of Health (1999) - Clinical Governance - Quality in the NHS. The Stationary
Office, London.
Department of Health (2002) - Learning from Bristol: the report of the public inquiry into
children’s heart surgery at Bristol Royal Infirmary 1984–1995 [the ‘Kennedy Report’].
London.
Department of Health (2004) - National standards, local action. The Stationary Office,
London.
Department of Health (2006) – Good Doctors, Safer Patients. The Stationary Office, London.
Department of Health ( 2007) – Trust Assurance and Safety. The Stationary Office, London.
Department of Health (2008) – The NHS Next Stage Review Final Report (High Quality Care
for All). The Stationary Office,London.
General Medical Council (2001) - Good Medical Practice. GMC, London.




Ref / Title:   Clinical Audit Policy                                               Page 15 of 24
Author(s):     S Jobson                                                 Date:      October 2009
The clinical audit policies of the following Trusts were reviewed as part of the development of
this product. These documents were either available in the public domain via the internet or
were volunteered to the product development team:


•    Basingstoke and North Hampshire Foundation Trust
•    Bath and North East Somerset Primary Care Trust
•    Bedfordshire Primary Care Trust
•    Berkshire Healthcare NHS Foundation Trust
•    Bury Primary Care Trust
•    Ceredigion and Mid Wales NHS Trust
•    Cheshire and Wirral Partnership NHS Foundation Trust
•    Dartford and Gravesham NHS Trust
•    Devon Primary Care Trust
•    Dorset Healthcare NHS Foundation Trust
•    East of England Ambulance Service NHS Trust
•    Hampshire Partnership NHS Trust
•    Heatherwood and Wexham Park Hospitals NHS Trust
•    Manchester Mental Health and Social Care Trust
•    North Somerset Primary Care Trust
•    North West Ambulance Service NHS Trust
•    Northumberland NHS Care Trust
•    Nottingham University Hospitals NHS Trust
•    NHS Plymouth
•    NHS Sheffield
•    NHS Western Cheshire
•    Redbridge Primary Care Trust
•    Salisbury NHS Foundation Trust
•    South West Essex Primary Care Trust
•    Southampton University Hospitals NHS Trust
•    Sunderland Teaching Primary Care Trust
•    University Hospitals Bristol NHS Foundation Trust




Ref / Title:   Clinical Audit Policy                                               Page 16 of 24
Author(s):     S Jobson                                                 Date:      October 2009
16.0      AUDIT / IMPACT ASSESSMENT STATEMENTS

16.1      Risk Assessment

New policies and procedures must include an assessment of clinical, financial, business and
operational risks. Significant risk should be escalated to the appropriate Executive Director
and be considered at the Governance and Assurance Committee. Indicate “No” if the
implementation of the policy will eliminate risk, or reduce risk to a low level.
                                                                         Significant Risks
RISK CATEGORIES
                                                                        identified Yes/No
1. Risks relating to organisational objectives                                   No
2. Risks to patient experience / outcome                                         No
3. Risk to or from service / business interruption                               No
4. Risks relating to staffing and competence                                     No
5. Financial risks                                                               No
6. Risks to compliance with inspection/audit standards                           No
7. General risks to organisational reputation                                    No
8. Specific health and safety (inc. fire) risks to anyone (staff,                No
       patients, public etc.)
OUTCOME (tick appropriate box):                               ACTION
No significant risks identified            Proceed with ratification process.
                                           Complete a full risk assessment form and action plan for all
Significant risks identified
                                           risks identified. Include in the Appendices.
There is doubt about whether               Take further advice from appropriate directorate or
risks are significant or relevant.         department.




16.2      Equality Audit

New policies and procedures should be reviewed to ensure that implementation will not lead
to direct or indirect discrimination.
QUESTION                                                                                  RESPONSE
Does this policy contain any criteria which could restrict availability, or access to     No
facilities or services?
If the answer to the above question is “yes”, is there a clear evidence base for this?
Will this policy have a disproportionate effect on certain people or groups of people?    No
OUTCOME (tick appropriate box):
Potential for discrimination is very low          Proceed with ratification process.
or non-existent.
Potential for discrimination exists.              Amend the document as appropriate to clarify
There is doubt about the potential for            exceptions or remove potential. If in doubt, take
discrimination                                    further advice from the Equality Lead Manager.




Ref / Title:     Clinical Audit Policy                                                       Page 17 of 24
Author(s):       S Jobson                                                         Date:      October 2009
16.3     Human Rights Audit

The development or review process must include an assessment potential to restrict any
Human Rights. Any potential restriction of a right should be discussed with the Legal
Services Manager.1
QUESTION                                                    RESPONSE
Does the policy document interfere with a Convention
                                                            No
right?
Could the actions described in the policy document touch
                                                            No
on one of the Convention rights?
OUTCOME (tick appropriate box):
No rights affected.                           Proceed with ratification process.
Potential to affect a right has been          Amend the document as appropriate to clarify
identified.                                   exceptions or remove potential. If this is not possible,
There is doubt about the potential to         take further advice from Corporate Services Manager /
affect a right.                               Legal Advisers.




1
  The Rights most likely to be affected by the actions of NHS staff are Article 2 “Right to Life” and
Article 8 “Right to respect for Private & Family Life”. Further information can be found at
http://www.nhsla.com/humanrights/ .
Ref / Title:   Clinical Audit Policy                                                     Page 18 of 24
Author(s):     S Jobson                                                      Date:       October 2009
                                                                                  APPENDIX A



        The Clinical Effectiveness and Audit Steering Group

                                          Terms of reference


     1. The purpose of the group

The Clinical Effectiveness Steering Group has been convened to ensure that NHS
Darlington has a robust system in place which ensures that communications from NICE are
disseminated to the appropriate staff and implemented throughout the PCT and become an
integral part of the daily functioning of the PCT.


     2. Membership
        The membership of the group will comprise:

          •     Head of Quality and Patient Experience
          •     Medical Director
          •     Pharmacy/medicines management
          •     Allied Health Professional Leads
          •     Finance
          •     Business Support
          •     Public Health
          •     Clinical Development Lead
          •     Clinical Effectiveness and Research Development Manager
          •     Head of Psychology
          •     PCT Dental Services
          •     Senior Clinical Manager Children’s Services
          •     Senior Clinical Manager Adult Services
          •     Senior Clinical Manager Specialist Services
          •     Senior Clinical Manager Mental Health
          •     Senior Clinical Manager Prisons


          Chair
          Head of Quality and Patient Experience

          Deputy Chair
          Medical Director
          Quorum
          A meeting shall be regarded as Quorate when at least one third of members are
          present including either the Chair or Deputy Chair

     3. Frequency of meetings

          3.1      Meetings shall be held monthly to coincide with the publication of
                   Guidance by NICE.
          3.2      Both the Chair and Deputy Chair may request additional meetings

Ref / Title:      Clinical Audit Policy                                                 Page 19 of 24
Author(s):        S Jobson                                                Date:         October 2009
                   according to requirements

     4. Attendance at Meetings

          4.1      Other members of NHS Co Durham and NHS Darlington may
                   attend meetings at the request of either the Chair or Deputy chair.
          4.2       Members should provide an appropriate deputy in their absence
                    who has the authority to make decision


     5. Responsibilities of the NICE Implementation Group

          5.1        Determining if guidance is relevant to the PCT
          5.2        Ensuring dissemination of guidance to the relevant clinical staff
                     within County Durham and Darlington Community Health
                     Services using a variety of methods and raise awareness of NICE and its
                     benefits within the PCT
          5.3        Identifying a clinical lead for each piece of guidance to be
                    responsible for baseline assessment of compliance and
                    timescaled action plan and audits.
                    Public Health guidance will be assigned to the lead for public
                    health for appropriate delegation within Public Health.
          5.4        Ensuring systems are in place for the monitoring and recording of
                    progress on the implementation of NICE Guidance.
          5.5        Receiving, supporting, monitoring and evaluating action plans
          5.6        Identify guidance which will have a financial impact on County Durham and
                     Darlington Community Health Services
          5.7       Receive reports from Finance regarding the financial impact of Guidance
                     and allocate action plans
          5.8       Ensure that the Finance Directorate is advised of the financial implications of
                     all NICE communications
          5.9        Forward plan/horizon scan draft NICE guidance
          5.10       Have a strategic overview of NICE and Audit within County Durham and
                     Darlington Community Health
          5.11       Establish a sub group which will design a programme of audit and
                     education to improve compliance to NICE guidance and monitor continued
                     compliance
          5.12       Establish an up to date database of NICE Guidance and ensure this is
                     integrated in to the relevant operations systems in place within County
                     Durham and Darlington Community Health
          5.13       Raising awareness of NICE guidance and its benefits throughout
                     County Durham and Darlington Community Health

6. Reporting Structure


Reporting arrangements

The group will report to the Patient Safety Committee.

Date:                       01 May 2009

Review Date                 01 May 2010




Ref / Title:     Clinical Audit Policy                                                   Page 20 of 24
Author(s):       S Jobson                                                   Date:        October 2009
                                                                                APPENDIX B

                           EXAMPLE CONFIDENTIALITY AGREEMENT

This declaration must be signed by any person who is not employed by the [name of
organisation], or deemed an honorary employee through association with the appropriate
department of the [academic body], who will be reviewing patient-related information for the
purposes of clinical audit.


Declaration

I hereby declare that I fully understand that all patient-related information to which I have
access, whether held on computer or in written form or given to me verbally, is confidential
and I undertake never to divulge information to anyone without the authority of a senior
member of administrative staff. I understand that this includes the divulging of information to
the police.

I also understand that the names, addresses and details of patients contained in any
documents or indexes are confidential and must not be accessed or divulged for personal
interest or gain, or any other purpose other than healthcare business.

By signing this form I accept that I have been informed that under the provisions of the Data
Protection Act 1998, unauthorised disclosure of data may result in personal prosecution.

 Name

 Project title:

 Post:                                        Department:

 Email address:

 Mobile/telephone no:

 Signature and date:


 Witnessed by and date:




Ref / Title:      Clinical Audit Policy                                            Page 21 of 24
Author(s):        S Jobson                                              Date:      October 2009
                                                                                            APPENDIX C
            Clinical Effectiveness Department
                Project Registration Form


   Name                                                          Project Ref. No

   Job Title

   E-mail address                                                Function

   Contact Number                                                Service

   Proposed Start Date                                           Proposed End Date


  Project Title




  Objectives




Background
 Project initiated by
   National/Local Framework               Trust Business Plan         Educational issue
   National Confidential Enquiry          User involvement            Directorate Business Plan
   National/high profile issue            Re-audit              Care pathway
   National Sentinel Audit                NICE guidelines             Local issue
   Complaint/incident
 Existing standards         Yes           No             Evidence-based     Yes        No      Not known




 Support from Clinical Effectiveness Department Facilitator:
   Literature search       Planning         Patient identification                 Pro-forma/questionnaire
   Casenote handling        Data collection  Data entry                            Database/spreadsheet design
    Data analysis           Report writing   Presentation preparation               Presentation
    Pathway development




          Ref / Title:   Clinical Audit Policy                                               Page 22 of 24
          Author(s):     S Jobson                                                   Date:    October 2009
Method

Scope      National        Health Auth                Regional        Multi-trust     Trust wide
           Fern Court      Dr Piper House             Henson Close    Greenhouse      John Snow House
           Community         Primary care             Merrington House Multi-professional
            Multi-speciality




  Sample Size



Duration                           From … …………..…..                   To … …….….…….

Case identification                  Other: ………….………………………………

Data sources         Case notes Concurrent data collection
                           Questionnaire      Interview    Focus group
                           Other
                               ……………………….…………………………………………..…


Key results




Outcomes
  Compliance with standard  No problems identified      +ve result from R&D/exploratory project
  Non-comp. with standard   Problem(s) identified       -ve result from R&D/exploratory project
  Change in practice New/changed standard         Re-audit commencing …………………….
  Recom. change in practice Recom. new/changed stand           Project abandoned




Dissemination of results
  Presented to peers                              Presented to multi-disciplinary forum         Report circulated
  Article submitted for publication               Article published                     Report/results sent to CG lead
Project management observations




           Ref / Title:   Clinical Audit Policy                                                        Page 23 of 24
           Author(s):     S Jobson                                                           Date:     October 2009
                                                                                   APPENDIX D


                      EVALUATION APPROVAL TEMPLATE & PROCESS


[Title of Evaluation]
1. Background
        History of subject (local and national)
        Reason for evaluation
        Objectives of evaluation
2. Methodology
        Population
        Inclusion and exclusion criteria
        Sample size & sampling method
        Method of data collection – tool development
            • Who collecting data
            • What data is to be collected
            • When is it to be collected
            • From where is it to be collected
            • How is it going to be collected
        Consent for collecting data
        Security issues of collected data/Caldicott issues
        Analysis of data
            • Who will be analysing data
            • What analysis method will be used
            • What analysis tools will be used
            • Will data be transcribed by a third party? – Security/Confidentiality issues
3. Dissemination
        What format will the report be in?
        Who will receive the report?
        Who will be responsible for recommended improvement implementation?
4. General
        What resources are required for the evaluation?
        • Human
        • Financial
        • Estates/equipment
        • External help (i.e. for analysis etc)
        What timescales are given for each stage?




Ref / Title:   Clinical Audit Policy                                                 Page 24 of 24
Author(s):     S Jobson                                                    Date:     October 2009