ARERO PRIMARY HOSPITAL

CLINICAL AUDIT PROTOCOL

Arero ,Borena
By [Link] .K (MD)
11/12/2022
Table of Contents
Introduction.................................................................................................................................................1
The key messages being that.......................................................................................................................2
THE HISTORY OF CLINICAL AUDIT................................................................................................................3
CLINICAL AUDIT & RESEARCH: WHAT IS THE DIFFERENCE?.........................................................................4
UNDERTAKING A CLINICAL AUDIT PROJECT AT OUR HOSPITAL...................................................................6
[Link] A CLINICAL AUDIT TOPIC............................................................................................................6
2. FORM A PROJECT TEAM..........................................................................................................................7
3. SET THE AIM, OBJECTIVES AND STANDARDS..........................................................................................8
4. ETHICS & ENGAGEMENT..........................................................................................................................9
5. SELECT AN AUDIT SAMPLE.....................................................................................................................10
6. PLAN AND CARRY OUT DATA COLLECTION............................................................................................10
7. ANALYSE THE DATA...............................................................................................................................11
8. PRESENT THE FINDINGS........................................................................................................................11
9. IMPLEMENT CHANGES AND RE-AUDIT..................................................................................................12

Introduction
Clinical and Healthcare Audit involves comparing current practice to

evidence based best practice in the formof standards, identifying areas for

quality improvement and implementing changes to practice to meet the

standards.
It is the duty of all healthcare professionals to ensure they deliver care to the

highest standard to their patients/clients so by definition all staff should be

auditing their work. Clinical and Healthcare Audit ideally should be multi-

disciplinary but uni-disciplinary audits may also be conducted.

Each department/specialty/service within the organisation should have an

annual programme of audit based on the criteria for audit selection e.g. high

risk, high cost, high volume. The effectiveness of the audit and the

implementation of changes should be evaluated by re-auditing.

“Clinical audit is a quality improvement process that seeks to improve patient

care and outcomes through

systematic review of care against explicit criteria…Where indicated, changes are

implemented…and furthermonitoring is used to confirm improvement in
healthcare delivery.”

It is the duty of all clinicians to ensure thatthey deliver the best care to their
patients.

All clinicians should be auditing their work. Clinicians have a duty to use the

findings of audit to improve clinical care and move towards best practice i.e. audit
isan essential tool for Continuous Quality Improvement (CQI). Audit should not be

seen as a stand alone CQI activity but should be part of a structured

organizational quality and risk management programme.

The key messages being that:

1. Clinical audit is not just a data collection exercise:

• It involves measuring current patient care and outcomes against explicit audit
criteria (also termedstandards).
• There is an expectation from the outset that practice will be improved.

2. Further clinical audit may be required to confirm that practice has improved.

The main stages of the clinical audit process are:

1) Selecting a topic.

2) Agreeing standards of best practice (audit criteria).

3) Collecting data.

4) Analysing data against standards.

5) Feeding back results.

6) Discussing possible changes.

7) Implementing agreed changes.

8) Allowing time for changes to embed before re-auditing.

9) Collecting a second set of data.

10) Analysing the re-audit data.

11) Feeding back the re-audit results.

12) Discussing whether practice has improved.

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This process is called the Audit Cycle and is summarised in the diagram above.

THE HISTORY OF CLINICAL AUDIT

Medical audit undertaken by doctors was first formalised in 1989. Prior to this
audit activity was isolated and infrequently undertaken. Four years later, in
1993, Medical, Nursing and Therapy audit were brought together to form the
multi-disciplinary activity that we now recognise as clinical audit.

ince 2008 there has been a shift in the national clinical audit strategy, which has
seen the ‘reinvigoration’ of clinical audit at a local level. In line with this the
Health Quality Improvement Partnership (HQIP) and the

At a local level clinical audit links into both clinical effectiveness and clinical
governance.

Firstly, clinical effectiveness aims to identify and appraise existing evidence of

best practice. Onceidentified,if necessary, local practice may be amended to
ensure that it is conforming to best practice. Once implemented a clinical
audit project might be undertaken to ensure that:
a. Best practice is being followed.

b. That patient outcomes are the desired ones.

Secondly, concerns regarding clinical care are often identified through other
clinical governance structures.

These concerns can often be used to inform a clinical audit project. This includes:

1. User views or complaints.

2. Adverse incident/near miss reporting, aka clinical/critical incident reporting.

3. Identified local priorities or concerns e.g. areas of high volume, risk or cost.

CLINICAL AUDIT & RESEARCH: WHAT IS THE DIFFERENCE?

“Research is concerned with discovering the right thing to do; audit with ensuring
that it is done right”

Research addresses clearly defined questions and hypotheses using systematic

processes to generate new evidence to refute, support or develop a
hypothesis, by asking the question ‘what is best practice?’ As a result of
which a new service or new practice may be developed. The methodology is
designed so that itcan be replicated and so that the results can be generalised to
other similar groups.

Research may involve a completely new treatment or practice, the use of

control groups or placebo treatment for purposes of comparison, or
allocatingservice users randomly to different treatment groups.

Patients should be involved in the design, implementation and analysis of the

work.

Research must comply with Research Governance, and be registered with the
Research and Development Department. It also has to be submitted to the
Research Ethics Committee (REC) for approval.
Alternatively, clinical audit aims to improve the quality of local patient care and
clinical outcomes through the peer-led review of practice against evidence-based
standards, implementing change where [Link] asks the questions ‘are we
following best practice?’ and ‘what is happening to patients as a result?’

Clinical audit is initiated by national bodies, commissioners (PCTs) or service

providers, including local healthcare staff and managers. The methodology is
designed to address clearly defined audit questions that establish whether a
specific clinical standard is being met. Results are specific and local to a particular
team or service although the audit tool may be used by more than one team or
service.

A clinical audit project will never involve a completely new treatment or practice,
never involve the use of control groups or placebo treatments, nor does it
involve allocating patients randomly to different treatment groups. It may,
however, involve input from patients, service users or carers at a number
oflevels, e.g.

• Participation in surveys which help to determine whether standards have been

met.

• Involvement in the design of individual clinical audit projects or whole

programmes of activity.

Clinical audit projects must be registered with the Clinical Audit Team, and
therefore will have been approved by the relevant Clinical Audit Convenor. The
use of survey methodologies as part of a clinical audit is also subject to approval
by the Trust’s Questionnaire Interview & Survey Group (QIS). Whilst clinical audit

projects should be scrutinised for ethical implications, REC approval is not

required.
UNDERTAKING A CLINICAL AUDIT PROJECT AT OUR HOSPITAL
Clinical audit at APH is supported by divisional Clinical Audit Facilitators, co-
ordinated by the Clinical Audit Commitee. Before undertaking a clinical audit
project, you must discuss your proposed project with a member of the
Clinical Audit Team and complete the clinical audit project proposal
paperwork.

[Link] A CLINICAL AUDIT TOPIC

Your topic should be chosen systematically. Clinical audit projects take time
and resources so the topic that you choose to address should be of
potential benefit to the service as a whole.
Clinical audit projects are best focussed on the processes, e.g.
investigations, treatments, or procedures, which have been shown that by
following result in the best patient outcomes.
Possible sources for your clinical audit project include the:
 Patient individual folder
 Client compliants
 From staff reports
 From community reports
 From idea box and etc…

If you would like to carry out a clinical audit project but are unsure
about appropriate topics your divisional,

Clinical Audit Facilitator will be able to help you to identify key subjects
in your clinical area.

2. FORM A PROJECT TEAM

Clinical audit projects are generally described as being either
unidisciplinary, e.g. involving only one staff group, or
multidisciplinary, e.g. involving more than one discipline or
profession. It is important that a clinical audit project assesses patient
care as provided by the whole clinical team, in order to identify how
 care can be improved. Therefore if your project hasimplications for a
profession or discipline other than your own, whether within or outside
the clinical area you work in, it is important to ensure that they are
represented on the project team.

If your clinical audit project is looking at the patient journey across

different care sectors i.e. ‘interface’ audit, try to include staff
representatives from these other care sectors in your project team. An
example of an interface audit would be looking at the process of referral
into the hospital from primary care.

Consider including a patient, service user and/ or carer

representative(s) on your project team or gaining their views on what
they would like to see from the service. Engagement is important
as healthcare is a partnership between clinicians and their patients/
service users. Whilst we strive to provide the best quality

of care as we see it, patients/ service users mightwant something

different. Direct engagement is best e.g. through participation of
identified individuals on project steering groups or
divisional/specialty audit committees. However, indirect engagement is
another possibility e.g. through the completion of a survey, usually
administered at the end of an episode of care.

It is important that your project is supported by colleagues who have

the authority and commitment to see that any necessary changes
indicated by the audit results are put into practice.

3. SET THE AIM, OBJECTIVES AND STANDARDS

To define the aim of your clinical audit project consider

what it is that you hope to achieve i.e. the overall

purpose of the project. The aim can be written as either a

statement that about what you want to happen as a

result of the audit or as a question that you want your

audit to answer. Statements should be phrased positively,

to ensure that the audit brings about improvements in

practice.

audit
topic

aim

objective objective

standard standard standard standard

Your aim is then broken down into a series of smaller objectives.

Objectives are the steps that you need to take in order to assess
whether or not you have achieved your aim. Your objectives can be
written as either specific tasks to be undertaken or as the different
aspects of quality that your project will address,

e.g. appropriateness - right treatment for patient; timeliness -

treatment given at right time; or effectiveness - treatment given in
right way? With desired effect?

Standards should be SMART and are more specific than objectives.

They are quantifiable statements detailing the specific aspects of
 patient care and management that you intend to measure current
practice against. Standards should always be based on the
strongest, most up-to-date, evidence of what constitutes best
practice. If standards are available in the form of guidelines, you

should base your audit on the most widely applicable guidelines

available, e.g. national guidelines rather than regional or local
guidelines

4. ETHICS & ENGAGEMENT

Unlike research, clinical audit projects do not need to be submitted to a
Research Ethics Committee (REC) for ethical approval. This is one of the
key reasons why you must ensure that your project is clinicalaudit

rather than research. If you think that there are ethical issues with your
project you must discuss these with your divisional Clinical Audit
Facilitator.

Clinical audit should always be conducted within anethical framework.

This means abiding by the principles of the Data Protection Act e.g.
by ensuring patient and staff confidentiality and by ensuring that
data is collected and stored appropriately.

If you are including a patient survey as part of your project it

must be submitted to the Questionnaire, Interview and Survey (QIS)
Group for approval. Contact details for the QIS group are listed at the
end of this guide.

5. SELECT AN AUDIT SAMPLE

The sample population will be dependent upon your topic. Occasionally
an aspect of treatment or care that applies to all patients is audited.
However, the majority of clinical audit tends to assess the care of a
defined group of patients who share certain characteristics.
 Typically the fact that they have the same medical condition, have
received the same form of treatmentor were seen within a certain time
frame.

It is not always practical to audit all patients within your population.

Therefore you will need to select an appropriate sample size. The
sample should be largeenough so that senior clinicians/managers are
willing to implement changes based on your findings. A ‘snapshot’ is
often sufficient (roughly 20-50 cases) for process based audit.

It is important that your sample contains current/recent patients.

Clinical audit is about improvement. We cannot change the past but you
can change the future.

6. PLAN AND CARRY OUT DATA COLLECTION

Data should only be collected if it is necessary to enable you to measure
current practice against your audit criteria (standards). Any extra data
means more time spent on your project without any additional benefit

and is contrary to the principles of the Data Protection Act.

If data is routinely recorded either in the patient’s notes or

electronically it is possible to carry out a retrospective audit i.e.
assessing past episodes of patient care. If the data is not routinely
recorded prospective data collection is required i.e. assessing the
patient care at the time it is given. Data can be collected using an
audit form (proforma) or entereddirectly onto a computer.

Before you collect the data for your entire sample it is important
to pilot your data collection form. The purpose of the pilot is to try
out your data collection form on a small sample to make sure that it
works, especially if someone else is going to be collecting the data for
you. The pilot may reveal that some of your instructions on how to
complete the form or the questions asked are ambiguous, that the form
 is difficult to complete or that you are simply not getting the information
you wanted.

7. ANALYSE THE DATA

Your data analysis should establish which standardsare being met and
which are not. If a standard is not being met you need to identify why
and how practice can be improved to ensure that the standard is met in
the future. You may also consider if there were other, acceptable
reasons for the standard not being met, i.e. an exception not considered
during the planning stage

8. PRESENT THE FINDINGS

The findings of your project should be discussed by theproject team and
presented to colleagues. If full compliance with the standards was
not achieved an action plan should be developed to address any
[Link] completed projects should be presented both verbally and
written up as a report. Both should address how well the standards
are being met and highlight any problems that need to be
addressed. The presentation gets the message of your audit across
to key staff and should generate discussion and agreement about
changes to practice in light of theaudit results.

You will need to complete a Summary and an Action Plan form at the
end of your project A draft report can then be compiled from this
information and given to you to check and finalise. The finalised report
acts as the official record of what you have done and contains more
detail than the presentation. It should also include all the
information needed to plan a re-audit.
9. IMPLEMENT CHANGES AND RE-AUDIT
If an audit shows that current practice needs to be improved, making
changes is important. The public has the right to expect that
practitioners will providecare that is consistent with recognised good
[Link] all changes will be improvements. Do not make
changes for change’s sake. At an appropriate time, repeat the audit
(re-audit) to ensure that changes have been implemented and that
practice has improved.