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Final Clinical Audit Reporting Guide 2020

This document provides guidance on documenting local clinical audits. It outlines the purpose of clinical audit documentation and reporting requirements at different organizational levels. It also includes a template for a clinical audit report that is intended to be adaptable for local use. The focus is on ensuring clinical audits are properly documented to meet regulatory requirements, allow information sharing, and facilitate quality improvement.

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0% found this document useful (0 votes)
74 views24 pages

Final Clinical Audit Reporting Guide 2020

This document provides guidance on documenting local clinical audits. It outlines the purpose of clinical audit documentation and reporting requirements at different organizational levels. It also includes a template for a clinical audit report that is intended to be adaptable for local use. The focus is on ensuring clinical audits are properly documented to meet regulatory requirements, allow information sharing, and facilitate quality improvement.

Uploaded by

Roberta
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
You are on page 1/ 24

Documenting local clinical audit: A guide to

reporting and recording

April 2020
Review 2020: Version history:
Sally Fereday, Quality Improvement Consultant September 2009: (first published as Template for clinical audit report)
Kim Rezel, HQIP January 2012: (revised)
Caroline Rogers, HQIP October 2016: (significantly revised and re-published as Documenting local clinical audit)
Eva Duffy, HQIP April 2020 (revised)
Previous authors: Next review:
Mandy Smith, HQIP April 2023
Sally Fereday, HQIP

© 2016 Healthcare Quality Improvement Partnership Ltd (HQIP) Design: Pad Creative www.padcreative.co.uk

Do you need to print this document? Please consider the environment before printing.

2 | Documenting local clinical audit – a guide to reporting and recording


Contents
Overview 4

The purpose of documentation 5

Producing the clinical audit report 5

Summary reports for clinical assurance and Trust management 7

Reporting requirements at different organisational levels 8

Sharing reports with commissioners 9

Involving patients and the public in clinical audit reporting 9

Publicising and promoting clinical audit and QI 9

A note on clinical audit posters 10

Appendix 1. Clinical audit report template 11

References 23

Documenting local clinical audit – a guide to reporting and recording | 3


Overview
This document is the result of wide consultation and and are detailed within HQIP’s publication, Statutory and
workshops with clinicians, service managers and clinical audit mandatory requirements in clinical audit.1 Our guidance on
staff, as well as representatives of a range of professional clinical audit strategy, policy, and programme development
bodies including the Academy of Medical Royal Colleges. aims to support NHS Trusts in meeting these requirements,
as well as ensuring that they use clinical audit effectively to
Clinical audit is one of a range of quality improvement improve the quality of their services. While the guidance itself
methodologies that can deliver improved processes and refers to clinical audit, many aspects can be applied to other
outcomes for service users. quality improvement methods, and can be used to develop
integrated policies. It is for each Trust to determine how they
The NHS Long Term Plan states: “Systematic methods
should approach clinical audit and quality improvement, and
of Quality Improvement (QI) provide an evidence-based
how they use this guidance.
approach for improving every aspect of how the NHS
operates. Through developing their improvement capabilities, HQIP suggests that the four organisational documents
including QI skills and data analytics, systems will move below are necessary for the effective management of clinical
further and faster to adopt new innovations and service audit. These documents are closely linked and should be
models and implement best practices that can improve read together.
quality and efficiency and reduce unwarranted variations in
performance. A programme to build improvement capability • A policy for the use and conduct of clinical audit:
is established in around 80% of the trusts rated ‘outstanding’ To set out the principles, roles, responsibilities and
by the Care Quality Commission.” practices a healthcare provider will follow in auditing
clinical practice, and improving the quality of services to
Similarly, the NHS Patient Safety Strategy states that the NHS meet the needs of patients, healthcare commissioners,
“must support continuous and sustainable improvement, healthcare regulators, and others
with everyone habitually learning from insights to provide
• A strategy for the development of clinical audit:
safer care tomorrow than today. Quality Improvement
To describe how a healthcare provider will implement the
provides the necessary coherence and aligned understanding
policy, and increase the impact of audit on clinical services
of this shared approach to maximise its impact. It offers
tools to understand variation, study systems, build learning • A clinical audit programme:
and capability, and determine evidence-based interventions To present a prioritised summary of planned clinical
and implementation approaches to achieve the desired audit activity and outcomes, that is regularly updated
outcomes.” and scrutinised in accordance with the above clinical
audit policy and strategy
Some NHS Trusts have integrated their clinical audit • A clinical audit report template:
activities into a wider programme of quality improvement. To provide consistency in clinical audit reporting.
Different approaches to such integration work well in
different organisations, and at present there is no single This publication describes how clinical audits undertaken at
consensus on how such an integrated approach should be a local level should be documented. It includes a template
achieved or governed. for a clinical audit report that is intended to be adaptable for
local use. While the focus of the guide is on clinical audit,
However, there are distinct statutory and contractual a similar approach can be used in documenting any quality
requirements for clinical audit that healthcare providers must improvement project undertaken by clinicians and clinical
meet. The statutory and mandatory frameworks that regulate teams working at a local level.
clinical audit within the NHS in England continue to evolve,

4 | Documenting local clinical audit – a guide to reporting and recording


The purpose of documentation Producing the clinical
The proper documentation of clinical audit is an essential audit report
element of good practice (see HQIP’s Best practice in clinical
Appendix 1 is a template for a full clinical audit report, to be
audit).2 Documentation serves a number of purposes:
used as the permanent record of a local clinical audit. This
• It is required in order to register projects as part of the full report should be retained for a minimum of five years in
Trust’s clinical audit programme accordance with the Records Management Code of Practice for
Health and Social Care - Retention Schedules; see also HQIP’s
• Sharing plans for clinical audit with members of the clinical
guide, Information governance for local quality improvement.3
team and other stakeholders facilitates agreement and buy-
in to the process However this final full report is not the only documentation
• It allows the audit methodology, set out in an audit that might be required. Information about a clinical audit
protocol, to be shared, reviewed, and tested needs to be shared with colleagues, project stakeholders, the
Trust and others at various stages in the clinical audit cycle.
• Sharing the plans throughout the organisation prevents
Producing the full report on a clinical audit is often seen as
duplication of work by allowing other clinical services to
an activity that happens after the audit itself is complete, but
make use of the design
in practice the most effective way to compile the final report
• It facilitates monitoring of the audit process and outcomes is to make use of the interim documentation that should be
• It provides a permanent record of the audit produced as part of the audit process. The following table
• It provides evidence of quality of service and of actions sets out how this can happen.
undertaken to improve quality, which can provide
Please note that in this document, ‘audit lead’ means the
assurance for the Trust Board and other stakeholders
individual, normally a clinician, who takes responsibility for
• It allows the audit to be shared with the wider community, ensuring that a specific clinical audit is carried out. ‘Clinical
through posters, presentations, and other publications lead’ means the clinician who takes responsibility for clinical
audit activities across a clinical service or division. See HQIP’s
Guide for clinical audit leads.4

Documenting local clinical audit – a guide to reporting and recording | 5


Stage in the clinical
Documentation required
audit process
Audit proposal/ Audit proposal/registration documentation to be completed in accordance with Trust policy (see HQIP’s
registration as part guide, Developing a clinical audit programme)5. Should include title of the audit, name of audit lead,
of the clinical audit standards to be audited, etc.
programme Approved and signed off by the clinical lead and clinical audit manager.

Developing, piloting, A full audit protocol should be developed based on the audit proposal/registration form. It should include
and agreeing details of the audit sample and sample identification process, the data collection process including any
the clinical audit modifications made as a result of piloting data collection, and an analysis plan showing how the data will be
methodology used to measure compliance with the audit standards (see HQIP’s guide, Analysing quality improvement and
assurance data)6.
Approved and signed off by the clinical lead and stakeholders in accordance with Trust policy.

Sharing audit findings Analysed data should be presented in accordance with the plan set out in the audit protocol. Any changes
with stakeholders to the audit method made during the data collection process should be explained, together with any
additional analysis necessary to inform action planning.
In many cases this information will be shared in a presentation that summarises the findings, but the full
background and detail should be available so that the validity of the findings can be understood.
Reviewed and acted upon by the audit lead and stakeholders.

Action planning A clinical audit action plan should be developed that addresses any shortfalls in compliance with the audit
standards – see Appendix 1 for a template. Where necessary, root cause analysis may be undertaken into any
shortfalls. Where possible, system improvements should be proposed to prevent or reduce the likelihood of
identified non-compliance with standards.
– See HQIP’s guide, Using root cause analysis techniques in clinical audit 7 – and the details of the analysis
should be included in the full audit report.
Approved and signed off in accordance with Trust policy – as a minimum by the clinical lead and
stakeholders, but depending on the nature of the actions, this may require sign off by senior management or
at Trust Board level.

Implementation of Implementation of the action plan should be monitored, and the audit cycle is not complete until evidence of
the action plan and the impact of the action plan has been documented. Depending on the nature of the actions, this evidence
evidence of impact may take a variety of forms:
• Analysis of a second round of data collection using the same audit protocol – sometimes referred to as
‘re-audit’
• A summary of the outcomes of repeated ‘plan-do-study-act’ (PDSA) cycles, or other QI methods used to
achieve change (see HQIP’s A guide to quality improvement methods)8
• Annotated time series data such as process control charts showing the impact of interventions.
Approved and signed off by the clinical lead and clinical audit manager.

Production of the final Before the final report is completed, the whole project should be reviewed by the audit lead in order to
clinical audit report identify areas for improvement in relation to the clinical audit methodology. This review should include
how the data set has been defined, the sampling strategy, data collection, data cleansing and analysis.
The report of the National Advisory Group on the Safety of Patients in England (The Berwick Report, 2013)
highlighted the failure of the NHS to learn from past mistakes. Ensuring that any problems with an audit
are documented should mean that a repeat of the audit will be more successful.

6 | Documenting local clinical audit – a guide to reporting and recording


Summary reports for Trust clinical audit policy should specify the form that these
summary reports should take. The aim should be to ensure
clinical assurance and that the committee has sufficient information to assure

Trust management themselves that:

• The clinical audit programme is progressing satisfactorily


The need for NHS Trust Boards to take the lead in reviewing
clinical audit processes and outcomes was emphasised in the • Any clinical risks or ethical issues raised by audits are being
2010 Francis report. properly addressed (see HQIP’s Guide to managing ethical
issues in quality improvement or clinical audit projects)10
• Action is being taken to address any shortfalls in
Recommendation 5: compliance with standards
The Board should institute a programme of • Action plans are supported and resourced.
improving the arrangements for audit in all
Given the volume of clinical audits that are undertaken, these
clinical departments and make participation in
summary reports will inevitably lack the detail included in the
audit processes in accordance with contemporary
full documentation. While in most cases a standard summary
standards of practice a requirement for all relevant
report will be sufficient, there may be occasions when a more
staff. The Board should review audit processes and
detailed report is required. It is the responsibility of both
outcomes on a regular basis.
the audit lead and the clinical lead to ensure that the report
that is reviewed by the committee contains all the necessary
Robert Francis Inquiry report into Mid-Staffordshire
information to highlight any areas of particular concern, and that
NHS Foundation Trust, 2010
appropriate action is taken.

The responsibility for reviewing clinical audit outcomes is


generally delegated to a Board committee or subcommittee that
takes responsibility for clinical audit and clinical effectiveness.
Each clinical division should submit regular reports to this
committee, summarising both the clinical audit activity that has
taken place, and the outcomes of completed audits. See HQIP’s
guide, Developing a clinical audit policy 9 Appendix 1 – Example
terms of reference for a clinical audit committee.

Documenting local clinical audit – a guide to reporting and recording | 7


Reporting requirements at different
organisational levels
The reporting requirements at different organisational levels are described in the
following table. NOTE: the full audit report should be available for anyone at any
level in the Trust to review.

Organisational level Reporting requirement


Clinicians, multidisciplinary care teams, and Should be fully involved in the development of documentation through the clinical
managers directly responsible for the service audit process, including the full audit report.
being audited and any other audit stakeholders

Audit leads, clinical leads and management at Should review and approve the full audit reports and ensure that the executive
clinical service level summary includes all necessary information, including drawing to the attention
of the clinical director and directorate management any areas of concern or areas
requiring directorate level action.
Should also review progress by completing the directorate clinical
audit programme.

Clinical directors and directorate management, Should review the executive summaries for all clinical audits and ensure that
directorate level clinical audit and/or clinical the report that goes to the clinical audit and/or clinical effectiveness committee
effectiveness committees includes all the necessary information.

Note: clinical audits that affect more than one Should also review progress in completing the directorate clinical audit
clinical directorate should be reviewed in all of programme, including the implementation of action plans, and should take action
the affected directorates as necessary to address any delays.

Trust clinical audit and/or clinical Should review the reports provided to them by clinical directorates and ensure that
effectiveness committee the attention of the Trust Board is drawn to any areas of concern or requiring
Board action.

Trust Board Should review the reports provided to them and take action to address any issues.
See HQIP’s Clinical audit: A guide for NHS Boards and partners.11

In addition to this clinical oversight of the programme, Trusts are increasingly relying on their overarching audit committee to review
the effectiveness of clinical audit and other quality improvement activities as part of the Board assurance framework. HQIP’s
Clinical audit: A guide for NHS Boards and partners11 includes assurance questions that can guide Trust divisions and departments on
the information that should be available to the audit committee.

8 | Documenting local clinical audit – a guide to reporting and recording


Sharing reports with Selected audit reports e.g. to demonstrate improvement can
also be made available on Trust external websites, and examples
commissioners of local audits should be included in the Trust’s quality accounts.

Clinical audit reports should be shared with local commissioners Posters displaying the outcomes of clinical audits and other
as part of a joint approach to improving the quality of local quality improvement projects are an increasingly common sight
services. HQIP’s guide, Using clinical audit in commissioning in the waiting areas of hospitals, clinics, and GP surgeries.
healthcare services12, includes guidance on what information Posters may be entered into local, regional, and national
should be shared and how commissioners should make use of competitions and clinical audits may be submitted to journals
this information. for publication. All of these activities have merit in that they
publicise the steps that Trusts are taking to meet their obligation
under the NHS Constitution to monitor and continually improve
Involving patients and the the quality of care they provide. However some basic rules
should be followed in order to ensure that the Trust and the
public in clinical audit reporting patients whose care has been audited are protected from any
potential pitfalls.
Patients and the public have an important role to play in all
aspects of clinical audit and quality improvement, and HQIP has
First, all clinical audits carried out in the Trust should be
produced a range of guidance to explain the benefits of involving
registered on the clinical audit programme, and subject to the
patients (see HQIP’s resources, www.hqip.org.uk/involving-
monitoring and approval process specified in the Trust clinical
patients/ 13). As key stakeholders in the audit process, patients
audit policy – See HQIP’s guides, Developing a clinical audit
can help with ideas on how to communicate audit outcomes to
policy 9 and Developing a clinical audit programme.5 Publication
the public, as well as champion projects to promote them and
of a clinical audit report in any form must be approved in
gain additional support for actions from the Trust Board.
accordance with Trust policy.

At a national level, HQIP has published guidance on producing


Secondly, care must be taken to ensure that personal
patient-friendly reports (www.hqip.org.uk/resources/how-to-
confidential data is not disclosed. This applies both to the
develop-patient-friendly-clinical-audit-reports/ 14). However at
patients whose care has been audited, and to the staff of all
a local level, the aim should be to ensure that every report is
grades and professions who have provided that care. As a
as accessible as possible. While the full report might have to
matter of good practice, all personal confidential data should
include a level of technical detail that cannot be simplified, the
be anonymised at the earliest possible stage in the audit
aim should be to produce reports that use plain English and
process – See HQIP’s guide, Information governance for local
avoid or explain any technical terms, jargon or abbreviations.
quality improvement 3. If the audit is to be published, particular
These universal design principles benefit all readers.
care needs to be taken to ensure that patients cannot be
identified – for example, if sample size is small, or exceptional
cases are highlighted.
Publicising and promoting
clinical audit and QI
All staff should have access to a central repository of completed
clinical audit reports, generally through the Trust intranet. This
allows good practice to be shared and provides a valuable
resource for developing new clinical audits.

Documenting local clinical audit – a guide to reporting and recording | 9


A note on clinical audit posters
HQIP employees are sometimes invited to judge clinical audit
poster competitions, both for Trusts who are holding internal
events and for regional and national events and conferences.
These events are a very good way of sharing best practice and
ideas for improving the quality of care, but excellent projects can
be let down by poor posters. Some specific points that apply to
clinical audit posters:

• Explain the problem. Why was this particular audit carried


out – was it in response to new guidance being issued?
A clinical risk being identified? Remember the audience
will not necessarily be familiar with the technical terms
used in a specialist service, so give clear explanations of
any abbreviations
• Quote the standards being audited, with references
• Give brief but clear information about how the audit
sample was identified and how the data was collected, but
remember this is only to put the findings in context – the
poster is an abstract of your work, not a substitute for a
full report
• Always state the sample size; failure to do so is one of
the most common mistakes, but without the sample size,
quoting percentage compliance with standards
is meaningless
• The point of any clinical audit is to improve care, so be
clear about what actions have been taken or are planned,
and what evidence you have to show those actions have
been successful.

10 | Documenting local clinical audit – a guide to reporting and recording


Appendix 1. Clinical audit report template
Department/Organisation name
Clinical audit title
Clinical audit number
Audit cycle number

Division/type of organisation
Specialty/service/operational area (locality)

Project team

Name of project lead Title and grade

Name Title and grade

Name Title and grade Data period

Name Title and grade Report completion

Documenting local clinical audit – a guide to reporting and recording | 11


Contents
Executive summary 13

Background/rationale 13
Aims/objectives 13
Key findings 13
Implementation of actions 14

Clinical audit report 15

Clinical audit title 15


Division/type of organisation 15
Specialty/services/operational area (locality) 15
Disciplines involved 15
Project lead 15
Other staff members involved 15
Background/rationale 15
Aim 16
Objectives 16
Standards/guidelines/evidence base 16
Sample 16
Data source 17
Methodology – including data collection methods 17
Caveat 18
Findings 18
Observations 19
Presentation/discussion 19
Recommendations 20
Action plan 20
Evidence of improvement 20
Learning points 21
References 21

Clinical audit action plan 22

12 | Documenting local clinical audit – a guide to reporting and recording


Executive summary
An executive summary may not be required for all projects but
can be a useful way, either as part of the full report or a stand-
Key findings
alone document, of presenting the relevant data in a quick and The executive summary should include a clear statement of how
easy-to-read manner for a chief executive, medical director, the care measured by the audit compares with the standards
director of nursing, operational manager, practice manager, being audited, and how this has changed as a result of actions
patient representative, etc. This will help the reader to identify taken as part of the audit. Where possible, comparison with
whether they need to read the full report. previous rounds of data collection should be included.

The executive summary should briefly describe the background Trusts have adopted a number of different ways of displaying
and rationale for the project, the main aims and objectives, key this data in summary form, and one approach in common
findings and recommendations, and should be written after the use is a system of “traffic light” or “red, amber, green (RAG)”
clinical audit report has been completed. ratings, as shown in the table on the next page, which may
be supplemented by annotated time series data such as
process control charts to show the impact of interventions.
Background/rationale Such annotated time series data also helps to identify how the
day of the week, time of day, or particular staff on duty affect
Briefly describe the reasons for undertaking this clinical
compliance with standards, enabling further exploration for
audit, e.g.
improvement, for example through root cause analysis (see
• New guidance issued HQIP guides, Using root cause analysis techniques in clinical
• Evidence of a potential quality problem audit 7, and A guide to quality improvement methods).8

• Recent clinical incidents. The table key can be adapted to suit your particular project,
i.e. it may be agreed that only the areas achieving the 90%

Aims/objectives threshold or above should be coloured amber . A decision as


to the appropriate thresholds for your clinical audit should be
What will the audit tell us? Specify the main objectives in agreed by the multi-disciplinary team. This decision should be
undertaking this piece of work. These should be identified made following identification of the clinical guidance/evidence
from the outset of the clinical audit as part of the process of base to be measured against. The scheme is a simple way
proposing the clinical audit and registering it as part of the to inform the reader of areas of good practice and areas for
clinical audit programme, e.g. improvement, at a glance, as red has come to signify “danger”,
and green “safety”. This is useful, but it must be implemented
• To ensure that births after a previous caesarean section are
with caution. For example, a green threshold indicating “safety”
managed in accordance with the national guideline
at 75% adherence suggests that in practice it is “safe” if one in
• To ensure that the removal of wisdom teeth is undertaken four/a quarter of cases do not meet the threshold. However, if a
as per National Institute for Health and Care Excellence quarter of cases are non-compliant with an audit standard that
(NICE) guidance relates to missed essential steps in a quarter of cases of clinical
care, this can be considerably unsafe. Green should be reserved
for a 100% compliance rate.

Documenting local clinical audit – a guide to reporting and recording | 13


The table below provides space for each standard to be listed which is useful in benchmarking and to encourage collaborative
along with the “N” or “n” (number or fluctuating number) and improvement. Rows can be added for further explanation of the
the relevant results. For repeated audit cycles, extra columns data if this is necessary. Arrows can also be used to indicate
can be added to allow for comparison to previous cycles. A areas where adherence to standards has increased, decreased
column could also be added to compare the findings within a or remained the same.
particular department with those across the Trust as a whole,

No. Standard N 2015 Compliance Compliance


2014 2015

1. All patients should be admitted within 2 hours 90 80% 100%

2. All patients should receive drug A unless contraindicated or


70 100% 100%
already receiving it

On admission all patients should have the following observations: N 2015 Compliance Compliance
2014 2015

3. Blood pressure 90 81% 50%

4. Pulse 90 36% 85%

5. Oxygen saturations 90 25% 25%

6. Temperature 90 87% 100%

Key:

Adherence Adherence Adherence


100% 80%-99% ≤79%

If your findings do not fit into a tabular format, this section Data on the impact of the action plan should be presented
could include the key observations in bullet point format, or either as comparison data from second stage data collection (as
other adjusted format to suit. described above) or in other formats as appropriate.

Implementation of actions If for any reason actions have not been implemented, the
reasons should be stated.
Key actions taken as a result of the audit findings should be
summarised, together with evidence of their implementation.

14 | Documenting local clinical audit – a guide to reporting and recording


Clinical audit report
Clinical audit title Disciplines involved
Specify the clinical audit title followed by number if used. The Detail all types of healthcare professionals involved, for
title should be no more than one sentence and should clearly example:
and concisely state the focus of the audit. • Consultants

Where applicable the following should be included in the title: • Physiotherapists

• Whether the audit is a repeated cycle • Occupational therapists.

• Whether the audit has been undertaken on a national,


regional, or local basis.
Project lead
For example:
The full name, title, and base of the designated project lead (the
• Third audit cycle of the recognition of and response to person with overall responsibility for the project), for example:
acute illness in adults in hospital, in line with NICE Clinical
• Mr F Bloggs, Consultant Cardiothoracic Surgeon, St
Guideline 50 (Project 199)
Elsewhere University Hospital
• Regional audit of breast cancer follow-up in accordance
• Dr N Simpson, Senior Partner, Park Surgery,
with the cancer network guideline (Project 293).
Wykley, Coventry.

Division/type of organisation Other staff members involved


Detail division here (if used) and type of organisation, for List full names and titles of those involved and state their role in
example: the clinical audit, for example:
• General surgery/acute Trust • Dr R Smith, F2 – data collection, presentation, and
• Substance misuse/mental health Trust. report writing
• Mr K Franks, Consultant Obstetrician – advisor
• Ms T Jones, lay representative – proforma design.
Specialty/service/operational
area (locality)
Background/rationale
Detail specialty/service/operational area (locality) here,
for example: Briefly describe the reasons for undertaking this clinical audit,
for example:
• Paediatrics/dietetics/Shropshire
• Evidence of a potential quality problem
• Orthopaedics/physiotherapy/Islington.
• Recent clinical incidents
• Following a previous audit, actions were implemented to
improve practice and a further audit cycle is now required
• An audit is required to ensure adherence to new clinical
guidelines following their implementation.

Documenting local clinical audit – a guide to reporting and recording | 15


Aim Sample
State what you expect the audit to achieve. The aim should Which patients will be included in the audit, and from which time
specify clear improvement focused goals, for example: period has the sample been selected? Give details, for example:
• To ensure that a particular practice is safe • All patients with post-partum haemorrhage (PPH) during
• To ensure that a recent change in practice has improved the three-month period from 1st May 2015 to 31st July 2015
compliance with evidence-based standards were included in the audit

• To ensure that practice is compliant with NICE guidance. • All patients with diabetes in the year from 1st January to
31st December 2015 were included in the audit.

See HQIP’s An introduction to analysing quality improvement


Objectives and assurance data 6 for guidance on sample size and sample
selection. Specify the total sample size/population, any specific
Identify how you will conduct the audit project to address the
inclusion/exclusion criteria, and explain in detail how you
aim. See HQIP’s Guide to ensuring data quality in clinical audits 15
selected the sample for clinical audit purposes (e.g. random
for guidance on setting effective objectives. Objectives should
sample, stratified sample, etc.). Include justification for your
be identified from the outset of the clinical audit project and
sample size and method of selection, for example:
SMART (Specific, Measurable, Achievable, Realistic, and Timely),
for example: • There were a total of 1158 deliveries during this period and
146 (12.6%) cases of post-partum haemorrhage. The health
• To collect data on the management of births following
records of 138/146 patients experiencing post-partum
a previous caesarean section, and to change practice if
haemorrhage were reviewed as eight sets of health records
management is not in accordance with the national guideline
could not be accessed because they were in use for other
• To increase the proportion of patients with type II clinical purposes during the data collection period, thus
diabetes who have annual assessments to prevent and N=138.
enable management of foot problems and to improve the
• 143 wisdom teeth removals were identified from 1st January
education of patients in foot care
to 31st December 2019. Information on 105/143 cases was
• To ensure that the removal of wisdom teeth is undertaken needed in order to achieve 95% confidence in a result +/-
as per NICE guidance 5%, thus N=105.
• To ensure adherence to the WHO surgical safety checklist.
Describe how you identified your sample; this could be via clinic
codes, ICD10 codes, OPCS4 codes, registers such as theatre
Standards/guidelines/ logs, computer records, prospectively at an appointment, upon
presentation etc., for example:
evidence base • Patients with a primary diagnosis of stroke were identified
using ICD10 codes I61, I63 or I64
What standards and guidelines have you compared practice
with? What criteria have been used? Specify the full title, • All patients who attended clinic 9 from 1st May 2019 to 31st
reference, and source, for example: May 2019
• Royal College of Obstetricians and Gynaecologists (RCOG) • All caesarean section patients identified from theatre logs
(October 2015). Green-top Guideline No. 45: Birth after for two months from 1st November 2020 to 31st December
previous caesarean birth 2020
• St Elsewhere NHS Trust (January 2020). Guideline for the • All diabetes patients were identified from GP computer
prevention and management of foot problems in patients records from 1st January to 31st December 2019.
with type II diabetes.

16 | Documenting local clinical audit – a guide to reporting and recording


Data source • Data validation – were the data validated, if so, explain how
this was completed and by whom, e.g. the first 10% of the
Which data sources have been used in the clinical audit? Give patient sample was reviewed twice, by a consultant and
details, for example: by an F2, and the results were compared before continuing
with data collection
• Health records
• Data analysis:
• X-ray reports
• Detail the packages used, e.g. SPSS, MS Excel, MS Access
• Clinical management system
• You may wish to include whether the data analysis was
• Patient survey
validated and by whom, e.g. in order to validate the
• Observation. data, a draft set of findings was produced and checked/
randomly checked by a second facilitator for accuracy
• Report writing:
Methodology - including data • Detail who completed the report including their job
collection methods title, e.g. Mr R Singh, Clinical Audit Facilitator, Mr R
Lowe, Community Pharmacist, Mrs B Wise, Occupational
Describe how the clinical audit was undertaken. This should Therapist, etc.
be written in narrative format (including bullet points where
• Presentation:
required) and the following should be considered:
• Include the date, the meeting title, where the
• Establishing the project team, e.g. grades and disciplines of
presentation took place, and the presenter.
the staff who provided advice and relevant expertise when
planning the clinical audit, frequency of meetings, etc.
Each aspect of the methodology should detail the member(s) of
• Developing and piloting a data collection tool (this can be staff responsible.
included as an appendix)
• Data collection:
• How data were obtained, for example:
The description of the methodology should be
• From the drug kardex/partogram/ambulance sheets/ sufficient to allow the clinical audit to be repeated
GP computer system, patient health records, etc. by someone who has had no previous involvement
• Prospectively/retrospectively/real-time in it. This is particularly important with regard to
staff changes, as audits may require further cycles
• Who collected the data, e.g. practice nurse, F2,
after staff have moved on, as is often the case with
paramedic, etc.
junior doctors.
• Where the data were collected e.g. on the ward, in clinic, in
theatre, etc.
• How the data collection process was piloted, the outcome
and any changes that were made as a consequence

Documenting local clinical audit – a guide to reporting and recording | 17


Caveats • Note: Five cases were exceptions. In three cases patients
were already prescribed drug A and in two cases there was
Occasionally there may be caveats that are required to explain a contraindication to drug A. Thus either subtract the five
some of the data. This section should contain an explanation of cases that were exceptions from the total number of cases
any factors the reader should be aware of that may affect the (therefore, the n will be 45) or include the cases that are
results. These are factors that have usually been discovered exceptions because they represent clinically acceptable
during/following data collection, for example: care (therefore, the N will remain at 50).

• A valid consent form should be present in all cases. 5/50 The standards used in the clinical audit should be highlighted
(10%) cases did not contain a consent form, therefore these in bold. Compliance against the standards should be detailed,
cases are excluded from the total sample for the standards to include the number and percentage compliance with further
relating to consent forms; the finding that 10% of cases did explanation of non-compliance where required, for example:
not contain a consent form would be reported
• Standard: All diabetic patients must have an annual review
• Consent is often wrongly equated with a patient’s (N=125)
signature on a consent form; a signature on a form is
• Exceptions: None
evidence that consent has been sought, but it is not proof
of valid consent • Compliance: 120/125 (96%) diabetic patients had an
annual review
• In cases where the relevant information had not been
documented on the proforma this was taken to be non- • Non-compliance: In 4/125 (3%) cases, patients were offered
compliance with the standard. an annual review on two occasions but, on both occasions,
did not attend. In 1/125 (1%) case there was no record that
an annual review had been offered.
Findings
Initially state your “N” number; N represents the total number of
cases identified as the representative sample for inclusion in the
clinical audit, for example:
• 50 cases were identified for inclusion in the audit of
thromboprophylaxis, thus N=50

Fluctuating N: Please note that the N may fluctuate, that can be


shown by using “n”, for example:
• Standard: All patients should receive drug A
• Exceptions: Patient has a contraindication to drug A or is
already prescribed it.

18 | Documenting local clinical audit – a guide to reporting and recording


Present data in table form where possible (this is usually
sufficient for most clinical audits), for example:
Observations
Standard: The following signs should be recorded on What overall observations can be drawn from your findings?
admission (N=51): Detail any key themes arising from the analysis of data or
any other information gained as part of the audit process
Criteria Adherence (use bullet points), in terms of good practice, and areas for
n (%) improvement. Ensure your observations are supported by the
Heart rate 50 (98%) project findings and include the key points (this section of the
Respiratory rate 50 (98%) report is more likely to be read than any other), and known
Temperature 48 (94%) root causes of gaps in systems or care. Definitions of good
Blood pressure 45 (88%) practice and areas of practice requiring improvement should be
determined by the project team, for example:
Be selective with the use of charts, remembering to use the Areas of good practice:
most appropriate method to present the data, e.g. pie charts
• All asthmatic patients were given a yearly review
to show proportions and bar charts for comparisons between
different areas/time periods/audit cycles. See HQIP’s An • 98% of people with schizophrenia had their physical health
introduction to analysing quality improvement and assurance monitored by a GP or primary healthcare professional at
data 6 for guidance on the analysis and presentation of clinical least once a year.
audit data. Areas for improvement:
• Only 50% of patients with schizophrenia had
Individual clinicians/sites/wards whose practice is being
documentation to confirm they were routinely monitored
audited should not be identified within the report. When
for co-existing conditions, because the relevant proforma
presenting data, only an identifier should be used, for example:
weren’t routinely made available
• Clinician A
• The doctor’s signature was present on the consent form in
• Clinician B, etc. only 75% of cases.

If required, individuals could be informed of their own identifier,


e.g. clinician A/site A, before or after the presentation.
Presentation/Discussion
Patient identifiable data, e.g. surname, date of birth, NHS
Include information on where and when the project was
number, hospital number, etc., should never be included in a
presented and the discussion following the presentation (this
clinical audit report, in line with Caldicott Principles. See HQIP’s
can be copied from the minutes of the relevant meeting),
guide, Information governance for local quality improvement 3
for example:
for further information.
• The audit was presented at the cardiology clinical audit
NOTE: The full report for a completed clinical audit should meeting on 19th February 2020, and the following
include comparative data from at least two rounds of data comments and observations were made:
collection, in order to assess the impact of actions taken to
improve compliance. See section below - Evidence
of improvement.

Documenting local clinical audit – a guide to reporting and recording | 19


Recommendations All recommendations in the clinical audit report should be
numbered and mirrored in the action plan. For example:
Recommendations should be made based on the clinical audit 1. By 31st May 2020, the lead consultant for fractured neck
results and any other relevant finding identified during the of femur will have updated the local guidelines for the
course of undertaking the audit, for example: management of fractured neck of femur patients, to
• An audit of consent in radiology identified a process where include standards for the transfer of patients from the
consent forms were scanned onto a system; some staff were Emergency Department to the Orthopaedic ward within
not scanning the whole consent form. It is recommended two hours of arrival.
that the process for recording consent should be reviewed
and changed to ensure all details are scanned.
Evidence of improvement
Action plan The clinical audit cycle is not complete until evidence has
been obtained to show that compliance with standards, and
An action plan must be developed to address any shortfalls in hence quality of care, has improved. This evidence should
compliance with the audit standards, and the report should be obtained by a second round of data collection, so that
explain, in narrative form, how the action plan has been comparative data from both rounds can be included in the
developed, for example: audit findings section above.

• The audit findings were presented to the multidisciplinary This is not the only way that evidence of the impact of
care team at the monthly planning meeting. A root cause changes may be obtained, and any other evidence should be
analysis exercise identified a number of key areas for documented here. This may include:
improvement, and a working group was set up to develop
• Annotated time series data such as process control charts
an action plan to address these areas.
showing the impact of interventions
The action plan must be based on a clear understanding of the • A summary of the outcomes of repeated ‘plan, do, study,
reasons for shortfalls in the quality of care identified by the act’ (PDSA) cycles
audit – see HQIP’s guide, Using root cause analysis techniques • An improvement in patient satisfaction demonstrated by
in clinical audit 7 for guidance on techniques that can be used patient reported experience measures
in developing action plans.
• Evidence of reductions in length of stay or changes in
prescribing habits that will generate financial savings for
Where possible, system improvements should be proposed
the Trust.
within the action plan to prevent or reduce the likelihood
of identified non-compliance with standards – for example,
patient record redesign, rather than repeated use of reminder
stickers, which lose impact over time.

The action plan should be SMART – that is, all the actions
should be:
• Specific – target a specific area for improvement
• Measurable – quantify or at least suggest an indicator of
progress
• Achievable – specify who will do it, given available
resources
• Realistic – state what results can realistically be achieved
• Time-related – specify when the result(s) can be achieved.

20 | Documenting local clinical audit – a guide to reporting and recording


Learning points
Include any learning points relating to the clinical audit
methodology and process that may need to be considered and
addressed before undertaking a re-audit, for example:
• Difficulties with identifying the patient sample
• Required updates to the clinical audit proforma.

References
Where applicable detail any references in Harvard format, for
example:
• NICE (March 2014). Clinical Guideline: Psychosis and
schizophrenia in adults: prevention and management.

There is no need to repeat any references already detailed in


the standards/guidelines/evidence base section. References to
previous audit reports should also be included here,
for example:
• St Elsewhere Community Trust (January 2020) Audit of
asthma management in paediatrics (Audit number 111)

Documenting local clinical audit – a guide to reporting and recording | 21


Audit Number: KEY (Change status)
1. Recommendation agreed but not yet actioned
2. Action in progress
3. Recommendation fully implemented
4. Recommendation never actioned (please state reasons)
5. Other (please provide supporting information)
Clinical Audit Action Plan
Project title Ensure this is exactly the same as the title detailed on the front cover of the report.

Action plan lead Name: Job Title: Contact No:

Ensure that the recommendations detailed in the action plan mirror those recorded in the “recommendations” section of the report. The “actions required” should specifically
state what needs to be done to achieve the recommendation. All updates to the action plan should be included in the “comments” section.

Comments/action status
Actions required (provide examples of action in progress,
Person responsible changes in practices, problems Change stage
Recommendations (specify “None”, if Action by date
(name and grade) encountered in facilitating change, reasons (see Key above)
none required)
why recommendation has not been
actioned, etc.)
1. Need to incorporate the Update the local patient management 31st May 2020 Mrs R Riding, 29th May 2020 – Mrs R Riding forwarded 3
standard for transfer of patients guideline for fractured neck of femur the updated local guideline to the clinical
with fractured neck of femur to include standards for the transfer Lead Consultant for Fractured audit department as evidence that the
from Emergency Department to of patients from the Emergency Neck of Femur action has been completed.
ward within two hours, into the Department to the Orthopaedic ward
local guideline. within two hours of arrival.
Replace previous version of guideline 5th June 2020 Mr A Smith, 4th June 2020 – Awaiting Clinical Guideline 2
with updated version on the Trust Group sign off, 10 June 2020.
electronic guideline system. Clinical Guidelines
Administrator
2.

22 | Documenting local clinical audit – a guide to reporting and recording


References
1. Statutory and mandatory requirements in clinical audit 12. Using clinical audit in commissioning healthcare services
(HQIP): www.hqip.org.uk/resources/hqip-statutory-and- (HQIP): https://www.hqip.org.uk/resource/using-clinical-
mandatory-requirements-in-clinical-audit-guidance/ audit-in-commissioning/#.Xhr1Bb77Rdg

2. Best practice in clinical audit (HQIP): www.hqip.org.uk/ 13. Involving Patients (HQIP): www.hqip.org.uk/involving-
resources/Best-Practice-in-Clinical-Audit-hqip-guide/ patients/

3. Information governance for local quality improvement 14. How to develop patient-friendly clinical audit reports
(HQIP): www.hqip.org.uk/resources/information- (HQIP): www.hqip.org.uk/resources/how-to-develop-
governance-for-local-quality-improvement/ patient-friendly-clinical-audit-reports/

4. Guide for clinical audit leads (HQIP): www.hqip.org.uk/ 15. Guide to ensuring data quality in clinical audits (HQIP):
resources/guide-for-clinical-audit-leads/ www.hqip.org.uk/resources/hqip-guide-to-ensuring-data-
quality-in-clinical-audits/
5. Developing a clinical audit programme (HQIP): www.hqip.
org.uk/resources/developing-a-Clinical-Audit-Programme/

6. An introduction to analysing quality improvement and


assurance data (HQIP): https://www.hqip.org.uk/resource/
an-introduction-to-statistics-for-local-clinical-audit-and-
improvement/#.Xhrgyb77Rdg

7. Using root cause analysis techniques in clinical audit


(HQIP): www.hqip.org.uk/resources/using-root-cause-
analysistechniques-in-clinical-audit/

8. A guide to quality improvement methods (HQIP): www.


hqip.org.uk/resources/guide-to-quality-improvement-
methods/

9. Developing a clinical audit policy (HQIP): www.hqip.


org. uk/resources/clinical-audit-policy-and-clinical-audit-
strategy/

10. Guide to managing ethical issues in quality improvement


or clinical audit projects (HQIP): www.hqip.org.uk/
resources/ethics-for-clinical-audit-and-qi/

11. Clinical audit: A guide for NHS Boards and partners


(HQIP): www.hqip.org.uk/resources/clinical-audit-a-
guide-for-nhs- boards-and-partners/

Documenting local clinical audit – a guide to reporting and recording | 23


Further information is available at: www.hqip.org.uk
ISBN NO 978-1-907561-53-5

Dawson House, 5 Jewry Street, London EC3N 2EX


T 020 3857 5030
E [email protected]

www.hqip.org.uk
Registered Office: 70 Wimpole Street, London W1G 8AX
Registration No. 6498947
Registered Charity Number: 1127049
© 2020 Healthcare Quality Improvement Partnership Ltd. (HQIP)
All rights reserved

April 2020. Next review date: April 2023

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