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Peninsula Community Health
Clinical Audit Policy
Title:
Clinical Audit Policy
Procedural Document Type:
Policy
Reference:
CGP46
Version:
V1
Ratified by:
CIOS Community Health Services Board
Date ratified: 27 th January 2011
Freedom of Information:
This document can be released
Name of originator/author:
Sally Shipley
Name of responsible team:
Governance
Review Frequency:
3 Years
Review date: 27 th January 2014
Target audience:
All staff
Exec Signature (Hard Copy Only):
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Clinical Audit Policy
Contents
1 Introduction ........................................................................................................ 3
2 Definitions .......................................................................................................... 3
3 Equality Impact Assessment .............................................................................. 4
4 Good Corporate Citizen...................................................................................... 5
5 Duties................................................................................................................. 5
6 Commitment to Stakeholder Engagement, Collaboration and Partnership 7
7 Process for Setting Priorities for a Clinical Audit Programme Including
Participation in National and Local Audits 7
8 Process for Ensuring Appropriate Standards of Performance are Audited 8
9 Format for All Clinical Audit Reports 8
10 Process for Disseminating Audit Results / Reports 9
11 Process for Making Improvements 9
12 Process for Monitoring Action Plans and Carrying out Re-audits 9
13 Data Protection 9
14 Ethics and Consent 10
15 Training 10
16 Risk Management Strategy Implementation..................................................... 10
16.1 Implementation ................................................................................... 10
16.2 Training and Support .......................................................................... 10
16.3 Dissemination ..................................................................................... 11
16.4 Storing the Procedural Document....................................................... 11
17 Process for Monitoring Effective Implementation ............................................. 11
18 Associated Documentation............................................................................... 11
19 References....................................................................................................... 11
Appendix A Clinical audit proposal form 13
Appendix B Clinical audit report template 15
Please Note the Intention of this Document
“This policy provides guidance for all staff participating in clinical audit activities. It includes
the organisations procedures and expectations for registering and approving clinical audit
project proposals”.
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Clinical Audit Policy
1. Introduction
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 (Department of Health 2004)
Good Doctors Safer Patients (Department of Health, 2006)
Trust Assurance & Safety (Department of Health, 2007)
The NHS Next Stage Review Final Report, High Quality Care For All [the ‘Darzi Report’],
(Department of Health, 2008).
Essential Standards of Quality and Safety (Care Quality Commission, 2009)
Equity and Excellence, Liberating the NHS (Department of Health, 2010)
Essential Standards of Quality and Safety outcome 16 states that organisations are required
to regularly assess and monitor the quality of the services provided.
NHS LA Risk Management Standards: standard 5, criterion 1 has been developed as a pilot
for clinical audit for 2010/11.
Peninsula Community Health expects all qualified health care professionals to participate in
clinical audit as part of a structured programme of work including the annual record keeping
audit
The organisation 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.
2. Definitions
2.1 Clinical audit
Clinical Audit may be defined as “a quality improvement process that seeks to improve
patient care and outcomes through systematic review of care against explicit criteria and
the implementation of change. Aspects of the structure, processes, and outcomes of
care are selected and systematically evaluated against explicit criteria. Where indicated,
changes are implemented at an individual, team or service level and further monitoring is
used to confirm improvement in healthcare delivery”.
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Clinical Audit Policy
2.2 Difference between clinical audit and research
Clinical audit measures existing practice against evidence-based clinical standards.
Research is about obtaining new knowledge and finding out what treatments are the
most effective
Clinical audit is about quality and finding out if best practice is being practised. Research
tells us what we should be doing. Clinical audit tells us whether we are doing what we
should be doing and how well we are doing it.
2.3 National Clinical Audit Advisory Group (NCAAG)
The National Clinical Audit Advisory Group (NCAAG) has been established to drive the
reinvigoration programme and provide a national focus for discussion and advice on
matters relating to clinical audit. The NCAAG also provides strategic advice and
guidance to the Department of Health’s National Clinical Audit & Patient Outcomes
Programme (NCAPOP), and in particular on proposals for new national clinical audits
and for discontinuing existing ones
2.4 Healthcare Quality Improvement Partnership (HQIP)
The Healthcare Quality Improvement Partnership (HQIP) was established in April 2008
to promote quality in healthcare, and in particular to increase the impact that clinical audit
has on healthcare quality in England and Wales. It is led by a consortium of the
Academy of Medical Royal Colleges, the Royal College of Nursing and National Voices
(formerly the Long-term Conditions Alliance).
HQIP is contracted by the Department of Health to deliver a programme of activity to
reinvigorate clinical audit
HQIP hosts the contract to manage and develop the National Clinical Audit and Patient
Outcome Programme (NCAPOP)
2.5 National Clinical Audit and Patient Outcome Programme (NCAPOP)
National clinical audit is designed to improve patient outcomes across a wide range of
medical, surgical and mental health conditions. Its purpose is to engage all healthcare
professionals across England and Wales in systematic evaluation of their clinical practice
against standards and to support and encourage improvement and deliver better
outcomes in the quality of treatment and care.
The programme comprises more than 25 clinical audits that cover care provided to
people with a wide range of medical, surgical and mental health conditions and will be
extended to other areas of healthcare that are considered a priority by the National
Clinical Audit Advisory Group (NCAAG) and the Department of Health.
3. Equality Impact Assessment
Peninsula Community Health aims to design and implement services, policies and measures
that meet the diverse needs of our service, population and workforce, ensuring that none are
placed at a disadvantage over others.
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Clinical Audit Policy
As part of its development, this strategy and its impact on equality have been reviewed in
consultation with trade union and other employee representatives in line with the Equality
and Diversity Policy. The purpose of the assessment is to minimise and if possible remove
any disproportionate impact on employees on the grounds of race sex, disability, age, sexual
orientation or religious belief. No detriment was identified.
The Equality Impact Assessment Tool has been used to help consider the needs and assess
the impact of this policy and has been completed alongside this document.
4. Good Corporate Citizen
As part of its development, this policy was reviewed in line with the Good Corporate Citizen
Action Plan. The implementation of this strategy promotes good governance.
5. Duties
5.1 Chief Executive
The Chief Executive is responsible for the statutory duty of quality and takes overall
responsibility for this policy.
5.2 Peninsula Community Health Services Board
The Cornwall & Isles of Scilly Community Health Services Board has delegated
overall responsibility for clinical audit to the Integrated Governance Committee. The
board will act on the recommendations contained in ‘Clinical audit: A simple guide for
NHS boards (2009) including the Board Engagement Matrix (2010)’ available at
www.hqip.org.uk.
5.3 Clinical Quality and Safety Committee
Responsibility for clinical audit has been delegated by the board to the Integrated
Governance Committee.
The committee is responsible for:
Agreeing the organisations priorities for clinical audit
Approving the annual clinical audit plan
Ensuring participation in all relevant audits contained in the National
Clinical Audit and Patient Outcome Programme
Ensuring all high contracted clinical audits (CQUINs, quality clinical
audit plan) are undertaken and completed.
Receiving summaries of completed clinical audit projects including
taking appropriate action where necessary
5.4 Director of Nursing and Professional Practice
The Director of Nursing and Professional Practice provides board leadership
for clinical audit
5.5 Senior Managers / Service leads
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Clinical Audit Policy
Senior managers and service leads are responsible for:
Maintaining the services local clinical audit programme
Ensuring the organisations priorities for clinical audit are met in the
first instance.
Approving clinical audit proposals from staff within their service
Forwarding all clinical audit proposal forms to the clinical effectiveness
manager
Ensuring all local clinical audit activity is completed in accordance with
this policy
Ensuring all clinical audit reports are sent to the clinical effectiveness
manager
5.6 Clinical Effectiveness Manager
The Clinical Effectiveness Manager is responsible for:
Developing, implementing, supporting and monitoring progress of the
annual clinical audit plan.
Ensuring clinical audit (CQUINs, quality clinical audit plan) targets
contained in the Community Health Services contract are included in
the clinical audit plan and progress reported via the contract
monitoring process
Developing and reviewing Peninsula Community Health clinical audit
policy.
Providing advice and support in all aspect of clinical audit for all staff
employed by Peninsula Community Health s
Providing training in clinical audit including developing suitable
guidance / leaflets and tools taking into account guidance developed
by HQIP
Ensuring PCH are aware of national clinical audit arrangements /
initiatives and relevant clinical audits.
Acting as the organisations contact point for all national clinical audits
Maintaining systems for co-ordinating all clinical audit activity across
the organisation.
5.7 All clinical staff
All staff involved in the provision of care, treatment and support for patients
should participate in clinical audit.
All clinical staff undertaking clinical audit must:
Ensure all clinical audit activity is approved by their relevant service
lead and registered with the Clinical Effectiveness Manager.
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Undertake clinical audit in accordance with this policy and guidance
obtained from the Clinical Effectiveness Manager
6. Commitment to Stakeholder Engagement, Collaboration and
Partnership
6.1 Involving Patients and the Public
Patients and the public are usually involved in clinical audit / quality
improvement initiatives via patient surveys and other patient experience
methods. Where a patient survey is undertaken to determine whether clinical
standards are being met, the project should be treated as any other clinical
audit project. If the patient survey asks questions about patient satisfaction
and experience the project should be registered with the Clinical Quality and
Patient Experience Manager
6.2 Multi-disciplinary and Multi-professional Audit, and Partnership
Working with other Organisations
The organisation supports collaboration on multi-professional clinical audits of
interest to other parts of the local health economy, both within and outside of
the NHS e.g. primary/secondary care, local authorities, social services etc
7. Process for Setting Priorities for a Clinical Audit Programme
Including Participation in National and Local Audits
Effective Clinical Audit is not a simple task and the pressure of incorporating complex
requirements into an ever increasing workload presents yet another demand on clinical time.
It is therefore important for Peninsula Community Health to demonstrate a systematic
approach to audit topic selection, taking into account any organisational priorities and new
government initiatives together with any local needs. This will ensure time is spent efficiently
by concentrating on well-structured audit projects that produce effective results and
highlights areas of practice requiring change. The aim is to increase audit activity across
Peninsula Community Health and to reduce the number of poorly conducted audits that are
often unsupported, carried out under pressure, and on occasions never completed.
The Clinical Audit Plan will be determined by the Clinical Quality and Safety Committee
based upon the four categories below:
1: External ‘must do’ audits: Failure to participate or deliver on these externally driven
audits may carry a penalty for PCH (either financial or in the form of a failed target or
non-compliance). These are externally monitored and assessed by the CQC and in
some areas by the local PCT commissioner.
National Clinical Audit & Patient Outcome Programme (NCAPOP)
Audits demonstrating compliance with regulation requirements e.g. NICE
guidance, NSFs, NPSA alerts
CQUINS and other commissioner priorities
DH statutory requirements, e.g infection control monitoring
External accreditation schemes, e.g., NHS Litigation Authority (NHSLA),
Information Governance Toolkit (IGT)
2: Internal ‘must do’ audits: Priorities reflective of organisational objectives for clinical
audit as outlined in the local clinical audit strategy or strategic objectives
Clinical risk issues
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Serious untoward incidents/adverse incidents
Organisational clinical priorities
Priorities identified via Patient and Public Involvement initiatives
Complaints
Access
Patient Safety First Campaign
3: Business Unit / Service priorities
Local clinical interest audit agreed by business units/services as a priority
National audits not part of NCAPOP, e.g. some Royal College initiated projects
that lie outside of NCAPOP
Locally adopted clinical standards benchmarking e.g., Essence of Care
4. Clinician interest
8. Process for Ensuring Appropriate Standards of Performance
are Audited
All clinical audit activity must be registered with the Clinical Effectiveness Manager giving
details of the guideline / policy / protocol to be audited. This will ensure that projects that do
not measure compliance e.g. patient satisfaction surveys, research, and baseline
assessments are managed by the appropriate departments
Guidance developed by the Clinical Effectiveness Manager will describe how to develop
measurable audit criteria
The Clinical Effectiveness Manager is part of the consultation process for all procedural
documents to ensure appropriate monitoring arrangements.
9. Format for All Clinical Audit Reports
All clinical audit reports will follow an agreed format. A template can be found in Appendix B
Introduction / Background
Policy / guideline audited
Methodology
Summary / Conclusions
Recommendations
Action plan
Results
Appendices
10. Process for Disseminating Audit Results/Reports
All clinical audit reports should be discussed at the relevant service team meetings and
circulated to all staff affected by the results.
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A summary will be taken by the Clinical Effectiveness Manager to the Clinical Quality and
Safety Committee for information / action. The committee will take appropriate action where
indicated. This could include adding to the risk register, requesting a formal response,
attendance at the next meeting.
11. Process for Making Improvements
All clinical audit reports must include recommendations and actions before the audit can be
classed as ‘final’
Action plans should be specific, measurable and achievable/realistic. They should have clear
implementation timescales with identified leads for action. Action plans should also have
been approved by the relevant head of service or department.
A summary of each audit including recommendations and actions will be taken to the Clinical
Quality and Safety Committee by the Clinical Effectiveness Manager
Final reports will be added to the Peninsula Community Health intranet site by the Clinical
Effectiveness Manager.
12. Process for Monitoring Actions Plans and Carrying out Reaudits
Re-audit is important to determine whether agreed actions have been implemented
according to the action plan.
The monitoring of action plans will be undertaken by the Clinical Quality and Safety
Committee.
The Clinical Effectiveness Manager will follow up actions resulting from clinical audit reports
on a 6 monthly basis. Concerns will be taken to the Clinical Quality and Safety Committee
for action.
Re-audits will be undertaken as required and where indicated by the initial results included in
the action plan. Advice should be sought from the Clinical Effectiveness Manager
13. Data Protection
All clinical audit activity must take account of the Data Protection Act 1998 and the ‘Caldicott
principles’ (Caldicott Committee, 1997). This means, for example, that data should be:
adequate, relevant and not excessive
accurate
processed for limited purposes
held securely
not kept for longer than is necessary.
All clinical audit data must be anonymised in accordance with the Peninsula Community
Heath Pseudoanonymisation Policy (2010) once the patient sample has been identified. Any
records containing patient identifiable data must be destroyed as soon as the audit has been
completed.
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Clinical audit records should be stored and retained for a period of 5 years in accordance
with the Peninsula Community Health Records Management Policy and Procedure.
The NHS Confidentiality Code of Practice (DH, 2003, p.21) 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”. Peninsula
Community Health makes provision for this in its leaflet entitled ‘Protecting Your Data, How
we use your health records’. This allows patient identifiable data to be collected for clinical
audit purposes as agreed in section 60 of the Health and Social Care Act 2001
14. 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 that considers whether
there is a benefit to existing or future patients or others that outweighs
potential burdens or risks;
each patient’s right to self-determination is respected;
each patient’s privacy and confidentiality are preserved;
the activity is fairly distributed across patient groups.
15. Training
All clinical staff should be involved in clinical audit activities in order to develop their own
capability around audit and effectiveness and to proceed with making clinical audit part of
routine practice.
The Clinical Effectiveness Manager will provide training in clinical audit to enable clinical
staff to undertake clinical audits with minimal support.
Training will be provided on an ad-hoc basis by the Clinical Effectiveness Manager when
requested.
The Clinical Effectiveness Manager will develop and make available clinical audit guidance
materials.
16. Risk Management Strategy Implementation
16.1 Implementation
The Clinical Effectiveness Manager will be responsible for the implementation of
this policy.
The policy will be circulated to all members of the Clinical Quality and Safety
Committee, Professional Practice Forum and all service/ business leads, within 2
months of the date of ratification
16.2 Training and Support
Training and support for the implantation of this policy and clinical audit in general
will be provided by the Clinical Effectiveness Manager
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16.3 Dissemination
Once ratified this policy will be loaded to the intranet (read only)
Staff will be made aware of its existence through the daily briefing email and the
fortnightly Team Briefing.
Confirmation of receipt is not required for this procedural document.
16.4 Storing the Procedural Document
The signed procedural document will be stored (hard copy) centrally, as will the
digital (soft copy) version.
17. Process for Monitoring Effective Implementation
The effective implementation of this policy will be monitored by the Clinical Quality and
Safety Committee.
An annual clinical audit report will be produced by the Clinical Effectiveness Manager
outlining compliance with the annual clinical audit programme and the policy.
The Clinical Effectiveness Manager will monitor the use of appropriate standards at the time
of initial project registration and again once the final report has been produced.
The clinical audit programme includes details of which committee and the date the audit
results were presented. The programme is updated on a monthly basis by the Clinical
Effectiveness Manager and taken to the Clinical Quality and Safety Committee for
monitoring. Where it is identified that audits haven’t been presented, the service lead will be
contacted to expedite matters.
18. Associated Documentation
This document references the following supporting documents which should be referred to in
conjunction with the document being developed.
Records Management Policy and Procedure 2010
Pseudonymisation Policy 2010
19. References
Health and Social Care Act 2001. London: The stationary Office. Available at
www.opsi.gov.uk
Healthcare Quality Improvement Partnership: clinical audit guidance and support, Available
at http://www.hqip.org.uk/guidance-support/
National Institute for Clinical Health and Excellence. Principles for Best Practice in Clinical
Audit. Abingdon: Radcliffe Medical Press; 2002, p. 1.
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Clinical Audit Policy
Appendix A
File ref: __________
(Audit use only)
Clinical Audit Proposal Form
All clinical audit projects should be registered with the Clinical Audit Department for inclusion
in the annual Clinical Audit Plan. This form should be completed for all clinical audit projects
you wish to undertake. Please return completed forms to:
Clinical Effectiveness Manager, Sedgemoor Centre, St Austell, PL25 5DS
Title of Project:
Your Details: (Audit Project Lead)
Name:
Address:
Position / Job Title:
Contact Tel No:
E-mail Address:
Priority: See guidance on page 2.
Please delete as appropriate
Rationale: e.g. Contract requirement, NICE, SUI,
Service Priority
1 2 3 4
Guidelines, Policies, Protocols to be audited:
Why are you undertaking this audit and what are your objectives?
Start date:
Completion date:
For further information and assistance please contact Tim Bowler
on 01726 627643
Peninsula Community Health Clinical Audit Plan will be determined by the Clinical
Quality and Safety Committee based upon the four categories below:
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Clinical Audit Policy
1: External ‘must do’ audits: Failure to participate or deliver on these externally driven
audits may carry a penalty for PCH (either financial or in the form of a failed target or noncompliance).
These are externally monitored and assessed by the CQC and in some areas
by the local PCT commissioner.
National Clinical Audit & Patient Outcome Programme (NCAPOP)
Audits demonstrating compliance with regulation requirements e.g. NICE
guidance, NSFs, NPSA alerts
CQUINS and other commissioner priorities
DH statutory requirements, e.g infection control monitoring
External accreditation schemes, e.g., NHS Litigation Authority (NHSLA),
Information Governance Toolkit (IGT)
2: Internal ‘must do’ audits: Priorities reflective of organisational objectives for clinical audit
as outlined in the local clinical audit strategy or strategic objectives
Clinical risk issues
Serious untoward incidents/adverse incidents (SUIs)
Organisational clinical priorities
Priorities identified via Patient and Public Involvement initiatives
Complaints
Access
Patient Safety First Campaign
3: Business Unit / Service priorities
Local clinical interest audit agreed by business units/services as a priority
National audits not part of NCAPOP, e.g. some Royal College initiated projects
that lie outside of NCAPOP
Locally adopted clinical standards benchmarking e.g., Essence of Care
4. Clinician interest
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Appendix B
Report Title
Author
Department
Date
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Audit Title
Date Range
CQC Essential standards of quality and safety
This report supports
Domain:
Outcome:
Background/Introduction
This should be a paragraph outlining the background information and expected benefits, ie.
what the process is that you are auditing (remember, this report will be read by people
outside your service). What was the problem? What were you hoping to achieve? If you
undertook a literature search, say what you found giving a short description of good practice.
Aims/Objectives
State explicitly the specific objectives of the project (why did you do the project)?
Guidelines, Protocols etc.
An audit report should always be measuring against standards, guidelines or benchmarks of
some sort; you need to state what these are and where they come from (references/
bibliography). If the intention is to set standards at the end of the project, say so and state
which aspects of care those standards pertain to.
Methodology
A short sequential list of steps that you took to carry out the audit (written in paragraph form)
including any assumptions or limitations on methods. You should state your chosen
population for this study (e.g. “patients referred to the one-stop breast clinic for suspected
cancer”), go on to say how the sample was selected ie. “a sample of all patients seen at the
clinic during 1999”, in which case you would need to state the size of your sample and how it
has been calculated or agreed upon. Say how you collected your data, e.g. “Data was
collected from patients’ case notes using an audit tool (see Appendix)”. The method of data
analysis may be mentioned briefly.
Summary / Conclusions
These should be written in line with the results making sure the conclusions relate to the
aims and objectives of the audit.
Recommendations
Ensure you give specific recommendations, improvements in methods and specifications for
design.
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Action Plan
After the report has been written the project lead should write an action plan saying who will
be responsible for carrying out changes and a time-scale in which they will do it. What has to
change, who has to change or is affected by the change and who is responsible for
implementing that change. When will the change take place and how will the change be
monitored.
1
Action Date Lead
2
3
4
5
6
7
8
9
References
List any references that you have quoted from and include titles, names of authors/editors
and year of publication and any other details to help others find source of information if
necessary
Results
When analysing your data you need to state what your compliance rate is with the standard
you are measuring against e.g 95% of records were legible
Appendices
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Equality Impact Assessment Tool – Clinical Audit Policy
To be completed and attached to any procedural document when submitted to the
appropriate committee for consideration and approval.
Yes √
No X
Comments
1. Does the document/guidance affect one
group less or more favourably than another
on the basis of:
Race X
Ethnic origins (including gypsies and
travellers)
X
Nationality X
Gender X
Culture X
Religion or belief X
Sexual orientation including lesbian, gay,
transgender and bisexual people
X
Age X
Disability - learning disabilities, physical
disability, sensory impairment and mental
health problems
2. Is there any evidence that some groups are
affected differently?
3. If you have identified potential
discrimination, are there any exceptions
valid, legal and/or justifiable?
4. Is the impact of the document/guidance
likely to be negative?
X
X
N/A
X
5. If so, can the impact be avoided? N/A
6. What alternative is there to achieving the
document/guidance without the impact?
7. Can we reduce the impact by taking
different action?
N/A
N/A
If you have identified a potential discriminatory impact of this procedural document, please
refer it to the Equality and Diversity lead, together with any suggestions as to the action
required to avoid/reduce this impact.
For advice in respect of answering the above questions, please contact the Equality and
Diversity lead.
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