Best practice in clinical audit

April 2020
Best Practice in Clinical Audit | 1
Contents
Introduction 3
The definition of clinical audit 4

Prerequisites to maximise the impact of clinical audit 5

Stages of the clinical audit cycle 8

Stage 1: Preparation and planning 8
Stage 2: Measuring performance 10
Stage 3: Implementing change 11
Stage 4: Sustaining improvement 12

2 | Best practice in clinical audit

1 Introduction
This document is the result of wide consultation and • Do we know where and understand why variation exists in
workshops with clinicians, service managers, and clinical audit our organisation?
staff, as well as representatives of a range of professional • Over time, where are the gaps in our practice that indicate a
bodies including the Academy of Medical Royal Colleges. need for change?

Clinical audit is one of a range of quality improvement • In our efforts to improve, what’s working?
methodologies that can deliver improved processes and
Many of the criteria described within this guidance also
outcomes for service users*. Audit and feedback aim to
apply to national projects, but there are complexities in
improve patient care by reviewing clinical performance against
designing and carrying out national clinical audit and quality
explicit standards and directing action towards areas not
improvement projects that are beyond the scope of this
meeting those standards.
document. The NCAPOP has continued to develop, and in 2014
The NHS Long Term Plan states: “Systematic methods of HQIP published ‘The Audit of Audits’, which identified good
Quality Improvement (QI) provide an evidence-based approach practice within audit work streams. By providing advice for
for improving every aspect of how the NHS operates. Through improvements to national clinical audit design and delivery,
developing their improvement capabilities, including QI skills HQIP aims to help individual national audit providers enhance
and data analytics, systems will move further and faster to their roles in delivering high quality national audits that can
adopt new innovations and service models and implement best contribute to improvements in the quality of patient care
practices that can improve quality and efficiency and reduce provided in NHS organisations.
unwarranted variations in performance. A programme to build
The purpose of this document is to set out updated criteria for
improvement capability is established in around 80% of the
best practice in local clinical audit. These criteria will:
trusts rated ‘outstanding’ by the Care Quality Commission.”

• Provide guidance for clinicians** and clinical audit staff on

Similarly, the NHS Patient Safety Strategy states that the NHS
how to plan, design and carry out clinical audit projects that
“must support continuous and sustainable improvement, with
will deliver improvements in the quality of services
everyone habitually learning from insights to provide safer
care tomorrow than today. Quality Improvement provides the • Support Boards and management of healthcare providers
necessary coherence and aligned understanding of this shared to evaluate and improve the quality of clinical audit
approach to maximise its impact. It offers tools to understand activities that take place within their organisations
variation, study systems, build learning and capability, and • Support those who commission or monitor healthcare
determine evidence-based interventions and implementation services to assess the quality of clinical audit evidence
approaches to achieve the desired outcomes.” provided to them

At a national level, projects such as the National Clinical Audit • Provide service users with information on how they can
and Patient Outcomes Programme (NCAPOP) allow service participate in clinical audit, increasing their involvement
providers to compare their performance with others and and understanding of the process so that they can assess
against nationally agreed standards, but the improvements and improve the quality of the projects they are involved in.
that should flow from these comparisons must be made at the
Where possible we have linked specific criteria to more
local service delivery level. This also helps organisations to
detailed and extensive guidance, which can be found in
answer the following questions:
supporting publications and resources from HQIP and
• Do we know how good we are? other organisations.

• Do we know where we stand relative to the best?

* The term ‘service user’ includes patients and carers

** The term ‘clinician’ is used throughout to refer to all clinical professionals and staff at all grades, unless otherwise specified

Best Practice in Clinical Audit | 3

The definition of clinical audit
With stages outlined in the diagram below, and in more detail
at Section 3 of this guide, clinical audit is defined as:

‘A quality improvement cycle that involves measurement of

the effectiveness of healthcare against agreed and proven
standards for high quality, and taking action to bring practice
in line with these standards so as to improve the quality of care
and health outcomes.’

HQIP ‘New Principles of Best Practice in Clinical Audit’,

Radcliffe Publishing, 2011.

01 02
Preparation and Planning Measuring Performance
(including for repeated cycles)

04 03
Sustaining Improvement Implementing change
(including for repeated cycles)

4 | Best practice in clinical audit

2 Prerequisites to maximise the impact
of clinical audit
If organisations are to gain the greatest benefit from clinical
audit, there are certain prerequisites that must be in place. The Recommendation 5:
role of Trust Boards in ensuring that clinical audit is undertaken
in accordance with best practice standards was emphasised in The Board should institute a programme of improving
the 2010 Francis Inquiry report. the arrangements for audit in all clinical departments
and make participation in audit processes in accordance
with contemporary standards of practice a requirement
for all relevant staff. The Board should review audit
processes and outcomes on a regular basis.
The Francis Inquiry report, 2010

Clinical audit best practice criteria Links to further information

1 Clinical audit is a quality improvement activity and therefore it functions best HQIP, A guide for NHS Boards and partners
as part of a planned programme of quality improvement, or a continuous
improvement strategy, that has been approved by the Board and senior
management of the organisation.

2 The Board should have dedicated time set aside to review both the clinical HQIP, A guide for NHS Boards and partners
audit programme and the outcomes of individual projects.

3 An effective clinical audit programme will cover the requirements and needs HQIP, Clinical audit policy and strategy guidance
of a number of stakeholders including the Board, clinicians, service users and
commissioning bodies. The programme should be developed in accordance HQIP, Developing a clinical audit programme
with clear policy and agreed following consultation with clinicians, managers
and patient representatives. The programme should be closely monitored and
progress reported regularly at Board and service delivery level. An annual
report, linked where appropriate to the Trust’s quality account, should be
presented to both the Board and/or relevant clinical/divisional/directorate
committee meetings and patient groups for scrutiny before publication.

4 Service user and public involvement in clinical audit should be embedded in HQIP, Patient and Public Involvement (PPI)
the organisation’s public engagement strategy. The clinical audit programme Strategy
should include patient-focused projects, and the roles played by service users
and lay representatives should be acknowledged in clinical audit reporting at HQIP, Patient and public involvement in
all levels. quality improvement

HQIP, Developing a patient and public

involvement panel for quality improvement

HQIP, Introduction to quality improvement for

patients and public

Best Practice in Clinical Audit | 5

 5 In deciding which clinical audits should be undertaken, the following factors HQIP, Developing a clinical audit programme
should be considered:
• Clinical priorities, including clinical risks, adverse incidents, near-misses, HQIP, Using clinical audit in commissioning
and patient safety
• Organisational priorities, including service redesign and development HQIP, Statutory and mandatory requirements
for clinical audit
• Patient and service user priorities
• Commissioner priorities and specifications, including Commissioning for Guide to involving junior doctors in clinical
Quality and Innovation frameworks (CQUINs), Best Practice Tariffs (BPTs), audit and quality improvement
National policies such as the NHS Long Term Plan, and NHS Standard
Contract requirements GMC, Guidance on revalidation
• Outputs from the National Clinical Audit and Patient Outcomes Programme
(NCAPOP), and other national clinical audits
• Professional revalidation, appraisal, and training needs.

6 Clinical audit is only one of a range of quality improvement methodologies and HQIP, Guide to quality improvement methods
should not be used if another is more appropriate.

7 Organisations must have governance arrangements in place to ensure that HQIP, A guide for NHS Boards and partners
clinical audits are planned, prioritised, undertaken and reported in a way that
maximises the benefit of the audit to the organisation. HQIP, Clinical audit policy and strategy guidance

The findings from clinical audits may be used as part of the Board Assurance HQIP, Developing a clinical audit programme
Framework, but full assurance can only be obtained if the quality improvement
aims of the project have been achieved.

Governance plans should include arrangements for participation in local and

regional cross-organisational audits.

8 Policies and procedures must be in place to ensure that clinical audits (and all HQIP, Information governance in local quality
other quality improvement activities) are undertaken in a way that complies improvement
fully with current information governance legislation and guidance, and in
consultation with local information governance leads and Caldicott Guardians.

9 All staff within an organisation should be made aware of, and comply with, HQIP, Clinical audit policy and strategy
the governance arrangements in place, including local policy and protocols on guidance
proposing, registering, undertaking and reporting on clinical audits.
HQIP, Developing a clinical audit programme

HQIP, Guide for clinical audit leads

6 | Best practice in clinical audit

10 The organisation must enable the conduct of good quality clinical audit HQIP, Developing a clinical audit programme
by providing appropriate resources to support the process. This includes
dedicated time for audit and an appropriate level of funding. HQIP, Guide for clinical audit leads
Organisations should have in place:
• A senior clinician able to lead on clinical audit across the whole Guide to involving junior doctors in clinical
organisation audit and quality improvement
• Clinical leads for quality improvement at service delivery level in
all specialties
• Clinical audit practitioners who can manage the audit programme and
support the process
• A programme for supporting doctors in training to ensure that the clinical
audit and quality improvement activities they undertake as part of their
training deliver benefits to the organisation.

11 The organisation should seek to improve the knowledge and skills of all A promise to learn – a commitment to act:
staff in quality improvement. Training in clinical audit should be available improving the safety of patients in England
for all staff and where appropriate for lay representatives. All staff should (the Berwick report)
be encouraged to participate in clinical and other networks that provide
knowledge sharing and opportunities for staff development. Guide to involving junior doctors in clinical
audit and quality improvement

HQIP, Developing a patient and public

involvement panel for quality improvement

Best Practice in Clinical Audit | 7

3 Stages of the clinical audit cycle
Stage 1: Preparation and planning
Clinical audit best practice criteria Links to further information
1 Every quality improvement, project should be reviewed to ensure that the topic HQIP, Developing a clinical audit
is amenable to improvement and to determine the quality improvement method programme
most likely to deliver improvement. Clinical audit should only be undertaken if it
is deemed the most suitable methodology. HQIP, Guide to quality improvement
methods

2 Every clinical audit should have a clearly-stated quality improvement aim and HQIP, Guide to ensuring data quality in
clearly-stated objectives. clinical audits

3 The audit should measure performance against standards for process and HQIP, Guide to ensuring data quality in
outcomes that are based on the best available evidence and clearly referenced. clinical audits

4 Every clinical audit should be carried out under the leadership of a named Guide to involving junior doctors in
clinician. If the named lead is a junior doctor working on rotation, a more senior clinical audit and quality improvement
clinician should oversee the project to ensure that it is completed, and that the
quality improvement aims are met.

5 All clinical audits should be carried out in compliance with local governance HQIP, Clinical audit policy and strategy
arrangements, including local policy and protocols on proposing, registering, guidance
undertaking and reporting on clinical audits.
HQIP, Developing a clinical audit
programme

6 All aspects of the clinical audit must be carried out in full compliance with the HQIP, Information governance in local
law and best practice on information governance, General Data Protection quality improvement
Regulation (GDPR), and data security. This includes sample identification, data
collection and analysis.

8 | Best practice in clinical audit

7 All members of the clinical team engaged in delivering the service to be audited HQIP, Clinical audit policy and strategy
should be informed about the project from the start. guidance

In addition, a stakeholder group should be identified and engaged in the project. HQIP, Developing a clinical audit programme
This should include:

• Representatives of the clinical team

• Other clinicians whose practice may be impacted by the findings of the audit
• Service managers responsible for the service to be audited
• Relevant service users, carers, and lay representatives.

Requirements for the registration and monitoring of clinical audit should ensure that
senior clinicians and management are aware of the project, but in some projects the
stakeholder group might include senior clinicians and managers, Board members,
commissioners, and others.

NOTE: The size of the stakeholder group and the degree to which members are
engaged in the project will depend on the nature of the audit and this criterion
should be applied proportionately. The key factor is to ensure that anyone who may
be involved in acting on the findings of the audit is engaged from the beginning.

8 Any ethical or information governance concerns should be escalated to the HQIP, Information governance in local
appropriate clinical lead and acted on in accordance with best practice. quality improvement

HQIP, Ethics guide for clinical audit and

quality improvement

9 Wherever possible, the stakeholder group must sign off the audit aim, HQIP, Clinical audit policy and strategy
objectives, standards, and audit method before data collection begins. guidance

Data collection without stakeholder sign off must only be undertaken on the HQIP, Developing a clinical audit programme
authorisation of the senior clinician leading the project.

Best Practice in Clinical Audit | 9

Stage 2: Measuring performance
Clinical audit best practice criteria Links to further information
1 The data set to be collected should be defined with reference to the audit HQIP Guide to ensuring data quality in
standards, which should then be turned into valid measures of performance. Data clinical audits
that is not required to measure compliance with the audit standards should not
be collected.

2 The population of patients to be included in the audit should be defined with HQIP, An introduction to analysing quality
reference to the audit standards. The audit sample size should be set, and improvement and assurance data
the sample selected, in accordance with best practice guidance. The rationale
behind the size and selection method should be documented.

3 Where data is to be extracted from electronic health records, the data extraction HQIP, Guide to ensuring data quality in
process should be tested to ensure that the correct data source is being used, clinical audits
and the correct sample and data are being extracted.

4 Where the data is to be collected from paper health records, the following HQIP, Guide to ensuring data quality in
factors should be considered: clinical audits
• Design of the data collection tool - an existing validated tool may be used,
or a tool should be designed and piloted, and the results from the piloting
process reviewed before full scale data collection begins
• Data collectors should be appropriately qualified. Where data collection
takes place over an extended period, or multiple data collectors are
involved, a protocol for data collection should be developed. This should
define the data sources and provide all the information necessary to ensure
that data is collected consistently. The protocol should be piloted alongside
the data collection tool.

5 Clinical audit data should be analysed to measure compliance with standards. HQIP, An introduction to analysing quality
The statistics used should be appropriate for the purpose and should aim to improvement and assurance data
provide the clearest possible picture of performance.

6 In planning the analysis, consideration should be given to the level of HQIP, Guide to clinical audit reporting
granularity* required for reporting, particularly if clinicians wish to use clinical
audit findings as part of their appraisal and revalidation.

*Breaking down results by ward, consultant, or clinic etc.

7 Full details of the clinical audit method must be recorded, to ensure that any HQIP, Guide to clinical audit reporting
necessary repeat data collection to measure the impact of interventions is
carried out in exactly the same way. Any unavoidable variation in the repeat data
collection method must be documented and reported alongside the results.

10 | Best practice in clinical audit

Stage 3: Implementing change
Clinical audit best practice criteria Links to further information
1 The results should be shared with the stakeholder group. If the findings show HQIP, Using root cause analysis techniques
non-compliance with standards, the underlying causes for non-compliance must in clinical audit
be established using various methods/tools/creative approaches to enhance
understanding of results. https://improvement.nhs.uk/improvement-
hub/quality-improvement/

https://q.health.org.uk/get-involved/
creative-approaches-problem-solving-caps/

2 Once the underlying causes have been established, an action plan must HQIP, Guide to quality improvement
be developed to address them. Improvements may be designed through methods
techniques such as process-mapping and adjustment, introducing
communication tools, decision trees, new technology, ‘plan, do, study, act’ HQIP, Guide to using quality improvement
(PDSA) cycles, and Lean Six Sigma. tools to drive clinical audit

Where possible, system improvements should be proposed to prevent or reduce

the likelihood of identified non-compliance with standards.

The action plan must be signed off by the stakeholder group and in accordance
with local governance arrangements.

3 The action plan must be implemented, and the effects monitored. Any HQIP, Guide to using quality improvement
unforeseen negative impacts must be addressed, and data must be collected tools to drive clinical audit
to ensure that the impact of the action plan has improved compliance with
standards. This will usually be by repeat data collection, although other
monitoring methods such as run charts may be used.

Best Practice in Clinical Audit | 11

Stage 4: Sustaining improvement
Clinical audit best practice criteria Links to further information
1 The audit cycle is not complete until evidence has been obtained to HQIP, ‘New Principles of Best Practice in
demonstrate that implementation of the action plan has resulted in an Clinical Audit’, Radcliffe Publishing, 2011
improvement in the quality of services.

2 In order to ensure that the improvement is sustained, the stakeholder group HQIP, Clinical audit policy and strategy
should determine whether the audit needs to be repeated, and if so, when. They guidance
should also determine whether refinements are required to the audit protocol
and data collection tool for greater focus on shortfalls identified. Alternative HQIP, Developing a clinical audit programme
approaches to ensuring that quality of service is maintained, such as some form
of ongoing monitoring, should also be considered.

3 The results of the audit, including the outcome of the implementation of the HQIP, Guide to clinical audit reporting
action plan, should be documented and shared with key stakeholders and the
rest of the organisation. The results and outcomes should also be shared with
service users and with the public.

4 Where possible, share the learning from the audit project with colleagues, both HQIP, Guide to clinical audit reporting
within the organisation (at board and clinical/divisional/directorate committee
meetings), and across partner organisations, including commissioners, clinical
networks, and other professional groups. Learning points could include:
• Audit methodology
• How change was implemented
• Impact on patient care / clinical outcomes
• Impact on service efficiency
• Challenges and how they were overcome.

12 | Best practice in clinical audit

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April 2020. Next review: April 2023

Best Practice in Clinical Audit | 13