10
CHAPTER
Clinical Governance and
Audit in Radiology
Richard A. Nakielny, Adrian Manhire
and Raymond J. Godwin
Clinical governance in radiology
Definition of clinical governance
Setting standards for clinical audit
Risk management
Revalidation
CLINICAL GOVERNANCE IN RADIOLOGY
Richard A. Nakielny
In the mid/late 1990s a series of perceived major failures of
the UK Medical Health System received intense media public-
ity. It was felt that the professional accountability of doctors to
the public needed reinforcing.The government response culmi-
nated in two White Papers, The New NHS: Modern, Dependable1
and A First Class Service: Quality in the New NHS2, in which the
concept of clinical governance was introduced and defined.
These two White Papers signalled a culture change from
an emphasis on numbers treated to an emphasis on quality of
care, cooperation and patient involvement3. The new system is
a multiprofessional approach which includes all the healthcare
professionals within a clinical team. One of the objectives of
this change was to reduce the substantial variations in medical
practice and outcome across the country. It was recognized that
this change would not happen overnight and the stated target
was a 10-year programme of modernization of the NHS.
DEFINITION OF CLINICAL GOVERNANCE
Clinical governance was defined as a framework through which
NHS organisations are accountable for continuously improv-
ing quality of their services and safeguarding high standards of
care by creating an environment in which excellence in clinical
care will flourish. The essence of clinical governance is local
accountability for the continuous monitoring and improve-
ment of clinical quality.The Trust Chief Executive has statutory
Clinical auditreality rather than belief
Clinical audits history and the wider perspective
The audit cycle/spiral
Achieving successful organization of audit
The re-launch of audit
responsibility for the maintenance and development of service
quality as well as the financial affairs of the Trust.
Most NHS Trusts have set up committees in the following
areas to satisfy external reviews of compliance with clinical
governance:
Clinical audit (critical analysis of clinical care set against
known standards)
Risk management
Clinical effectiveness (extent to which processes do what
they are intended to do, i.e. greatest health gain from avail-
able resources)
Quality assurance
Staff development
Research and development.
SETTING STANDARDS FOR CLINICAL AUDIT
Local self-regulation, particularly through personal audit, is a
cornerstone of clinical governance. All hospital doctors will be
required to participate in a national audit programme appropri-
ate to their specialty or subspecialty2. Within radiology, written
standards related to equipment, process and appropriate clinical
outcome need to be in place to comply with this aspect of clini-
cal governance. Most radiology departments already have a sub-
stantial number of standards in place, particularly with regard to
equipment and process. In addition, there are Royal College of
174 SECTION 1 IMAGING TECHNIQUES AND GENERAL ISSUES
Radiologists publications containing suggested standards4. These
can be categorized under the following headings:
1 Equipment standards
2 Process standards:
Referral guidelinesthere is national advice on referral
guidelines5
Requests for examinationlegible, sufficient clinical
detail, signed, dated, etc.
Proceduretarget times for waiting lists, satisfactory
patient identification, systems, informed consent, radia-
tion, protection protocols, etc.
Patient carewritten information about examination,
acceptable environment, user satisfaction questionnaire,
defined system for dealing with patient complaints, etc.
Reporting times
Critical incident reporting
Continuing professional development (CPD) for staff
induction programmes, fire regulations, radiation protec-
tion, cardiopulmonary resuscitation training, etc.
Staffing levelsnational advice is available6.
3 Outcome standards
These are much more difficult to set than process standards.
There are few nationally accepted figures for minimum
diagnostic accuracy in an everyday work situation.The accu-
racies of various imaging methods are published in the lit-
erature but these levels are often obtained by specialists who
are working under optimal conditions. It is essential that any
standards set under the auspices of clinical governance are
practicable and achievable in the working situation.
Mammography screeningthis was set up with pro-
cess and outcome standards in position from the outset.
However, mammography screening has the advantage of
dealing with a single anatomical area and, in effect, a sin-
gle pathological entity. This enables outcome standards
to be more readily set and monitored than in the more
complex everyday work situation where a wide number
of investigations and pathologies are encountered.
Interventional radiologyThe Society of Cardiovascular
Interventional Radiology (SCVIR) in the USA has devel-
oped and published extensive standards relating to the suc-
cess and complication rates of interventional procedures.The
British Society of Interventional Radiology (BSIR) is devel-
oping a comparable set of practical and achievable standards.
Radiologysetting outcomes standards in other subspe-
cialty areas of radiology is difficult and complex. National
advice has been issued on possible audit projects7 but the
majority are process rather than outcome audits. This
illustrates the practical difficulties of identifying viable out-
come audit projects. How, for example, does one assess the
accuracy of a chest X-ray report other than on the most
simplistic criteria?
As the issue of standards in radiology is so problematical, it
may be necessary to await central directives on standards in
radiology from the National Institute for Health and Clinical
Excellence (NICE) (NHS, UK) after appropriate consulta-
tion with national bodies and subsequently to set up audits
in these particular areas to ensure conformance with the
standards set by NICE. In the interim it will be essential to
develop an involvement with audit, not only to demonstrate
departmental conformance with clinical governance, but
also because individual revalidation by the General Medical
Council (GMC) will require proof of audit activity.
RISK MANAGEMENT
Clinical governance and risk management are inextricably
linked. There are two main components of risk management:
the identification of potential problems which could
compromise the safety of patients, visitors and staff
the installation of procedures and protocols to minimize
these.
There are already many areas of well-established risk man-
agement regulations including health and safety regulations,
equipment maintenance and safety, radiation safety, infection
control, cardiopulmonary resuscitation, IT security, etc. The
introduction of clinical governance has raised the profile of
several other important aspects in the practice of radiology.
Stafng levels/workload
Clinical governance emphasizes quality of care, and adequate
staffing levels are a prerequisite for this. Stress caused by under-
staffing will affect performance.There is at present a significant
undersupply of radiologists in the UK to accommodate the
increasing number of referrals and the complexity of modern
radiology. The Royal College of Radiologists has attempted
to define a reasonable workload for a radiologist, and also to
assess the impact of new clinical appointments in other clinical
specialties on radiology staffing6.
Skill mix
Team-working is emphasized by clinical governance. There
is national support from the Royal College of Radiologists
for a responsible introduction of skill mix8 so that appropri-
ately trained, supervised and audited (usually nonmedical
graduate) staff can help to offset the radiological workload.
An important prerequisite for this is that both the delegator
and the person to whom the task has been delegated agree
to the delegation which must conform to GMC guidelines9.
In particular, it must be established that the person to whom
the work is delegated is competent to carry out the task.This
person then assumes a clinical and medico-legal responsibil-
ity for their actions but overall medical responsibility can
only be transferred, by referral, to another medically quali-
fied practitioner.
It is essential that improved quality of patient care, rather
than a reduction in costs, is the main aim of skill mix. Improved
quality of care may be achieved with skill mix by releasing
highly trained medical practitioners from time-consuming yet
relatively straightforward tasks to allow them to concentrate
on tasks that require a level of expertise commensurate with
their ability and training.

Continuing professional development
The concept of lifelong learning is a firmly established com-
ponent of clinical governance. It is not sufficient to view a
qualification examination certificate, no matter how advanced,
as being the final stage of medical education. Most radiologists
have been voluntarily pursuing further learning throughout
their careers and the formalization of this process does not
pose any major conceptual difficulty. The public require reas-
surance that doctors, and indeed all staff, are keeping up to
date with advances in medical knowledge. Documentation
of this is a vital component of risk management and is also
required for revalidation.
Continuing medical education (CME) forms the backbone
of continuing professional development (CPD) but CPD also
includes the development of managerial, appraisal, teaching
and other skills where appropriate.
Quality of reporting
The quality and timeliness of reporting are central to the input
into patient care by a radiology department. However, the
setting of standards for quality of reports is problematical.
In diagnosis, errors in perception are much more com-
mon than errors of interpretation. Overload of work, fatigue,
repeated distractions and environmental conditions all have an
important bearing on the incidence of these errors and it is
important to minimize these adverse factors.
Attendance at clinicoradiological and multidisciplinary
team meetings is important to enable feedback on the accu-
racy of reporting to occur. Good communication between
team members involved in clinical care is emphasized repeat-
edly in clinical governance. Formal records of attendance at
these meetings would be useful documentary evidence for
revalidation.
Formal medical discrepancy meetings (see later) to discuss
(anonymously) cases where possible errors have occurred are
an essential development of clinical governance.
Working beyond competence
All clinicians are becoming more specialized and radiology
is no exception. Subspecialization is, however, a two-edged
sword. It can produce a high-quality service during normal
working hours but it also leads to a situation in which on-
call work may be in an area outside the expertise of the con-
sultant on-call. Consultant staff should together define who
within the department has adequate expertise to perform
and/or interpret the specialized procedures that may occur
in an on-call setting. Arrangements should then be put in
place, possibly involving other NHS Trusts, for on-call cover
for these procedures. If such cover cannot be made available
on an on-call basis owing to the local situation, risk managers
must be made aware of this.
National advice for on-call radiological practice10 includes
the following:
Only those examinations that will affect immediate patient
management during the out-of-hours period should be
CHAPTER 10 CLINICAL GOVERNANCE AND AUDIT IN RADIOLOGY 175
performed, and each department should have a portfolio
of examinations that it believes can be offered safely and
reliably out of hours. This list should be agreed with the
Trust.
Out of hours, a radiologist should only carry out those
procedures that they are competent to perform in nor-
mal working hours.
Appropriate staff and equipment must be available for out-
of-hours work that would normally be available for in-hours
work.
Another aspect of working beyond competence is the intro-
duction of new radiological procedures. New procedures need
to be evidence-based. Careful consideration should be given
to organizing adequate study leave to acquire the skills for
new procedures. The cost of complications incurred while
performing a new procedure for which the radiologist is not
adequately trained may be considerably more than the cost of
obtaining training in that procedure.
Informed consent
Clinical governance stresses greater patient involvement in
decision making. The attitude of the general public to the
amount and quality of the information they require before
consenting to medical procedures has changed radically. The
ease of access to information through the media and internet,
together with an irreversible move away from the presumed
infallibility of doctors, has resulted in a climate in which it is
no longer acceptable to give inadequate information about
medical procedures.
In an excellent review of informed consent11, the differ-
ences in attitude in the UK and America were highlighted.
In America the law requires that the patient is given all the
relevant information. This contrasts with the UK where the
law allows, to some extent, clinical judgement to determine
what information is given to the patient. There must still
be sufficient disclosure to allow the patient to make an
informed choice. The legal meaning of sufficient disclosure
is that patients must be informed of any serious risk, even
if it is of low frequency. They must also be told of less seri-
ous risks which occur more commonly. Details/risks of a
procedure may only be withheld if it is felt that they are
likely to cause serious harm to the mental or physical health
of a patient. If a patient asks a direct question about risks,
this must be answered truthfully and as fully as the patient
demands, i.e. information cannot be withheld if a direct
question is asked.
The GMC has issued advice on informed consent12.
Aspects of this advice relevant to radiological practice in
the UK have been incorporated into a guidance document
issued by the Royal College of Radiologists13. Careful expla-
nation and oral consent will be sufficient for the majority
of radiological investigations. High-risk procedures require
a full and careful explanation, and adequate time must be
allowed for the patient to assimilate this information. This
should occur prior to any pre-medication. Written aids and
176 SECTION 1 IMAGING TECHNIQUES AND GENERAL ISSUES
patient-focused literature have a positive role in this process.
The person explaining the procedure must have sufficient
knowledge and experience to answer any relevant questions
fully and truthfully. Written consent is then required, but it
is not a legal safeguard if complications arise that were not
explained to the patient. If any information is withheld on
the grounds that it may cause serious harm to the patient,
this must be recorded before the procedure in the clinical
notes together with the reason for doing so, as this may need
to be justified in law.
Examinations involving high radiation doses (e.g. CT,
extended fluoroscopy) should have the risks/benefits of the
procedure explained in terms that can be clearly under-
stood. Again, pre-prepared information sheets may well be
helpful.
Research procedures must not be contrary to the interests
of the patient, and a full explanation and written consent are
mandatory.
Professional registration
Policies must be in place for checking the professional registra-
tion of staff within the department. If the employment of cer-
tain groups of staff is subcontracted then the responsibility for
confirming appropriate staff registration must be clearly defined.
Patient record security
The confidentiality of patient records, both written and held
on computer, is an important part of risk management. Clear
policies must be in place for the maintenance of this security.
Safeguards governing the access to, and storage of, confidential
patient information must be in place.
Major accident response
Clear policies defining the departmental response in the face
of a major accident must be in place.
Critical incident reporting
Clear policies for recording, openly discussing and disseminating
any lessons learned from critical incidents must be in place.
Any lessons learned must be applied promptly.
The Royal College of Radiologists has produced an overview
of the impact of risk management on clinical radiology14.
REVALIDATION
Clinical governance incorporates both departmental and
individual performance. The GMC have stated their view
of the components of good medical practice for individ-
ual doctors9 and in future will require all UK doctors to
undergo a revalidation process to maintain their licence to
practise15. There is national guidance about how good med-
ical practice impacts on radiologists16. However, the Ship-
man Inquiry findings17 (where a general practitioner was
found guilty of the murder of more than 200 of his patients)
have criticized the proposed GMC revalidation procedure
for failing to incorporate a robust assessment of a doctors
fitness to practise. A leading article in the British Medical
Journal18 succinctly discusses the rationale that underpins
this criticism. The implementation of the GMC version
of revalidation had been planned for April 2005, but this
has now been postponed to allow for the incorporation of
any future recommendations resulting from the Shipman
Inquiry. The following is a summary of the principles of
the GMC revalidation so far; however, it should be borne
in mind that there will be additions to this when further
recommendations are published, taking into account the
findings of the Shipman Inquiry.
Individual clinical performance meets any national profes-
sional standards.
The basis will be appraisal and assessment of local
performance in the workplace in relation to any appro-
priate national standards (i.e. an examination system is
not thought to be appropriate).
It is seen to be fair to doctors and open and clear to the
public and employers.
It is capable of appraising and assessing all doctors whatever
the circumstances of their practice.
It is simple, unobtrusive, economical in time and effort,
and is as inexpensive as is consistent with effective-
ness (i.e. detailed performance assessment will only be
invoked in cases in which there is local evidence of
serious dysfunction in performance).
It has been proposed that revalidation should be primarily
based on the outcome of the local annual appraisal process
for those employed within a managed setting, and will occur
on a 5-yearly cycle. It will be essential for doctors to collect
and maintain appropriate documentary evidence for revali-
dation. The GMC has stated that there will need to be evi-
dence available in the following categories in order to obtain
revalidation.
Suggested documentary evidence for radiologists
1 Good medical practice:
Audit results and record of attendance at audit meetings
Medical discrepancy personal records
Record of attendance at medical discrepancy
meetings.
2 Maintaining good medical practice:
CME/CPD records
Personal development plan
Record of attendance at clinicoradiological and/or mul-
tidisciplinary team meetings.
3 Working with colleagues:
360-degree appraisal documentation (see later)
Record of attendance at any radiology team meetings.
4 Relationships with patients:
360-degree appraisal documentation (see later)
Record of complaints/plaudits.

5 Research
6 Teaching/training:
Feedback documentation (anonymous).
7 Health/probity:
Sickness record
Self-signed statement that health (of the doctor) has
never endangered patients or colleagues
Self-signed statement that conduct work to highest ethi-
cal and moral standards
360-degree appraisal documentation (see later).
Most of the above documentary evidence can be collected
relatively easily. However, documentary evidence for two of
the cornerstones of clinical governancenamely medical
discrepancy meetings (quality improvement by learning from
errors) and 360-degree appraisals (team working)requires
more active organization. The following is a prcis of sug-
gested methods for setting up these two processes with the
emphasis on simplicity.
Medical discrepancy meetings
Empathic lead person: involves everyone in the process,
encouraging a constructive, nonconfrontational atmosphere.
Case collection: lockable collection boxes placed in easy-
to-reach sites with standardized forms adjacent (and replen-
ished regularly!).
Meetings at regular intervals (e.g. monthly).
Cases presented by a lead person: the radiologist involved
should remain anonymous. It is impossible to re-create the
original reporting conditions but it is important to present
the same clinical information that the reporting radiologist
had available.
Discussion focused on learning, not blame.
Consensus vote on whether error actually has occurred.
Simple consensus scoring system for degree of error (grade
and significance).
Lead person gives confidential feedback if an error has
occurred.
Annual analysis by lead person of cases discussed to see if
there are any patterns that may require a more structured
solution.
Attendance recorded formally (documentary evidence for
revalidation).
360-degree appraisal
Satisfactory team working and a willingness to listen and act
on constructive comments about performance from patients
and colleagues (medical and nonmedical) are essential in
clinical governance.Three hundred and sixty degree appraisal
is a process where the views of patients and colleagues are
CHAPTER 10 CLINICAL GOVERNANCE AND AUDIT IN RADIOLOGY 177
gathered together and fed back to the individual at prede-
termined time intervals (approximately 3 years if there are
no significant problems). Although 360-degree appraisal is
viewed as an essential part of the overall appraisal process
(and hence for revalidation), it must be stressed that 360-
degree appraisal is only one part of this overall appraisal, and
is not a pass/fail process.
The tasks and interactions of radiologists are different
from those of physicians and surgeons. Consequently, the fol-
lowing suggested method for 360-degree appraisal has been
adapted to conform to the requirements of radiologists, and
has been issued as guidance by the Royal College of Radi-
ologists on their website, www.rcr.ac.uk. The essence of the
360-degree appraisal questionnaire is as follows:
Five sections, the first three to be completed only by the
relevant professional group (medical colleagues, radiogra-
phers/nurses and clerical/secretarial staff) and the final two
sections to be completed by all staff groups.
Each section has about 10 simple questions relevant to that
professional group in appraising the radiologist. There is a
simple numerical scoring system ranging from 1 (poor) to
10 (excellent).
Within the radiographer/nurse section there are ques-
tions relating to patient interactions. This element allows
radiologists with infrequent patient contact to obtain
some documentary evidence for the relationships with
patients section for revalidation.
The penultimate section contains a simple question on the
health and probity of the radiologist undergoing the 360-
degree appraisal.
The final section is for free text comments.
A pilot study has shown that the average time taken to
complete the questionnaire is 7 min.
A minimum of 1012 questionnaires (e.g. four from each of
the three professional groups chosen) must be completed to
give a reasonable overview and also to maintain anonymity
of the staff completing the questionnaires.
A system for collecting the questionnaires anonymously and
analysing them for feedback at the overall appraisal process
needs to be in place.
A reasonable time interval between 360-degree appraisals,
assuming there are no particular problems, would be 3 years
to allow documentary evidence to be available for the 5-
yearly revalidation process.
In an age where form filling is in danger of proliferating
out of control, it is important that the 360-degree appraisal
questionnaire is kept as simple as possible. If any significant
problem areas are identified, these can then have in-depth
assessment at the annual appraisal.
178 SECTION 1 IMAGING TECHNIQUES AND GENERAL ISSUES
CLINICAL AUDITREALITY RATHER THAN BELIEF
Adrian Manhire and Raymond J. Godwin
You will almost certainly have been referring to other chap-
ters in this publication, using it as a reliable source of current
opinion in diagnostic radiology, searching for best practice and
the latest knowledge, and for research evidence in support
of it. Having gathered such knowledge, are you able to show
that you are practising to these new standards of care? Clinical
audit is the tool that should enable you to produce evidence
to show that you have achieved these standards in your own
practice and you need to be able to do this.
Audit is an integral part of clinical governance. In the fore-
word to Principles for Best Practice in Clinical Audit, Hine (Chair
of Commission for Health Improvement) and Rawlins (Chair-
man, National Institute for Clinical Excellence) state19:
Public and professional belief in the essential quality of clinical care
has been hit hard in recent years, not least by a number of highly
public failures. Clinical governance is the organizational approach
for quality that integrates the perspectives of staff, patients and
their carers and those charged with managing our health service.
Clinical audit is at the heart of clinical governance.
One of the most prominent of the public failures was investi-
gated in the Shipman report20.
How well doctors carry out their professional activities has
also been brought to the centre of public debate, along with
the process of audit as a method of enquiry21.
In this section, we review the origins of clinical audit, con-
sider what audit is, how it can be carried out, how it can help
underpin clinical governance, and how it might be built into
departmental practices, creating the environment in which
clinical audit can flourish.
The denition of audit
The systematic, critical analysis of the quality of medical or
clinical care, including the procedures used for diagnosis and
treatment, the use of resources, and the resulting outcome and
quality of life for the patient.
Secretaries of State for Health, Wales,
Northern Ireland and Scotland (1989)22
CLINICAL AUDITS HISTORY AND THE WIDER
PERSPECTIVE
Audit of medical care is not new. As early as the Crimean War
(18541856), Florence Nightingale used a form of audit as
an aid to her management of the injured and sick in her care,
using standardized methods for the collection of information
on death and infection23. She used this audit evidence to assist
her argument for resources and changes in practice.
In the United States, in 1917, the American College of Sur-
geons introduced a process of reviewing clinical notes against
a set of minimum explicit standards, questioning their quality
and adequacy of facilities (including radiology)24. These pro-
cesses developed into criterion-based patient outcome audit
by 1975 under the overview of a national body, the Joint
Commission on Accreditation of Healthcare Organisations25.
At the same time, mainly as an aid to keeping public health-
care spending under control, the US Congress created Profes-
sional Standards Review Organisations. These were instituted
to review the appropriateness of medical services and their
quality through medical audit. There is a marked similarity to
the development of the Commission for Health Improvement
(CHI) and the UK National Institute for Health and Clinical
Excellence (NICE).
Audit in the UK
In the United Kingdom, prior to the late 1980s, there was no
requirement within the NHS for clinicians to demonstrate any
evidence of the quality of their clinical practice. In 1989, the
UK government introduced medical audit as a requirement
within all doctors job plans22, extended this in 1997 to include
all healthcare professionals as clinical audit1,2,26, and integrated
it into clinical governance. Together with the logical require-
ment to practise evidence-based medicine, the infrastructure
for clinical governance was now in place, awaiting its formal
introduction2.
Not only is there now a mandatory requirement for all
doctors to participate in clinical audit, the GMC9 advises all
doctors that they:
must take part in regular and systematic medical and clini-
cal audit, recording data honestly. Where necessary, you must
respond to the results to improve your practice, for example by
undertaking further training.
Although most doctors routinely practise audit informally by
comparing their work to published data, there is now a clear
obligation to record this and have it available to validate their
personal practice and that of their clinical team, department
and hospital.
Making it possible
There are two factors that are important for successful audit:
creating a local environment that is supportive of audit (includ-
ing providing adequate resources in terms of time and assis-
tance, and ensuring that the resulting change occurs)
using audit methods that are most likely to lead to audit
projects that result in real improvement.
Difculties in audit
Many of those involved in audit have unfortunately lost enthu-
siasm because of the difficulties that they have encountered.
Poor project design has led to data of poor quality. Informa-
tion has been collected because it is available rather than
being a relevant measure of clinical quality.
Many projects are poorly managed. Demonstrating
inadequate care is not sufficient unless it can be carried
through into changes that improve practice. Change is

often the most difficult part of audit but it is often left to
inexperienced junior staff without appropriate support,
influence and resources. As much attention needs to be
devoted to change for improvement as to the collection
and analysis of data. It is the perception of improvements
in care that drives the individual on to further audit.
What does audit really mean?
Many clinicians find the term audit, with its financial under-
tones and rather formal definition (above), confusing and
difficult to remember. Fowkes27 has given a more pragmatic
definition:
Comparison of actual practice to a standard of practice and
as a result of the comparison, any deficiencies in actual prac-
tice may be identified and change undertaken to rectify the
deficiencies.
The words actual practice, standard of practice, compari-
son, deficiencies and change undertaken to rectify clearly
describe the audit cycle and emphasize the essential need for
change for the better if standards are not achieved.
Donabedian28 has subdivided audit into three types:
structure, process and patient health outcome.
StructureWhat you need The availability and organiza-
tion of resources (material as well as human) required for the
delivery of a service. An example of this is the availability of
adequate resuscitation equipment within a department of
radiology.
ProcessWhat you do How well has a required procedure
been followed? Have all radiology reports been checked and
validated by the reporting radiologist prior to circulation?
Patient health outcomeWhat you expect This describes
the alteration in healthcare status of an individual which is
directly attributable to clinical intervention. Outcome audits
in radiology are often related to interventional radiology
procedures, where the clinical improvement achievable with
such techniques is more readily measured; however, it is not
unreasonable to include accuracy of imaging diagnosis as
an outcome audit, as it can also aid in the patients clinical
improvement or cure29.
Audit is not research
Research and audit are often confused.There are clear differences,
the awareness of which enables differentiation. Donabedian30
distinguished between the assessment of medical technology
Table 10.1 DIFFERENCES BETWEEN RESEARCH AND AUDIT
Research
Identifies what is best practice
Is concerned with techniques, instruments or materials
Uses statistical models and usually requires statistical compliance
Usually requires a long time scale for completion
CHAPTER 10 CLINICAL GOVERNANCE AND AUDIT IN RADIOLOGY 179
(research) and the assessment of the quality of medical care
(audit) (Table 10.1).
The most important illustration of these differences is that
an audit can be carried out on a relatively small number of
cases and does not always require the time and expense of
a research programme. Research sets the standards and audit
determines whether clinical practice meets them.
What not to audit
There is a tendency for new users of audit methodology to use
it as a tool to demonstrate the inadequacies of other clinicians
practice. It is tempting to audit how others use imaging services
and the use of the published guidance on how best to use imaging
encourages this31,32. Audit of third parties is unlikely to achieve
the essential elements of change and improvement, which are the
key features of a successful audit33. All involved should be com-
mitted to the audit or it will generate ill-feeling and the results
are likely to be dismissed or ignored. Using such standards as part
of an inclusive multidisciplinary audit process alongside nonra-
diological colleagues is much more likely to achieve change and
reinforce, not strain, local professional relationships. Audit of per-
sonal practice should take the prime place.
A standard is the keystone to the process and unless a clear
standard is identified at the beginning of an audit, it is unlikely to
succeed. It helps to ensure that a project is audit and not research.
Audit activity must be relevant to current local activity and needs,
and must reflect the problems encountered in everyday work.The
likely required change should be achievable, otherwise effort used
in trying to implement it is likely to be wasted. It is also better
not to attempt audits with a high level of complexity, as these are
more likely to fail to complete their second cycle34.
THE AUDIT CYCLE/SPIRAL
The main aims of audit are to demonstrate either:
compliance with an agreed standard of care, or
to use the results of the initial audit to identify pos-
sible change(s) which, following implementation of those
changes, may enable the standard to be achieved.
The original concept was the audit cycle (or loop) (Fig. 10.1).
Firstly, a topic is chosen for audit and a standard is identified.
By identifying a suitable indicator (see later) and collection of
related data, the reality of practice is identified and compared
with a previously agreed target.
If the set target is achieved, the audit, on this occasion, is
completed, reassurance has been achieved, and the audit
result is available as governance evidence.
Audit
Determines if this has been put into practice
Is concerned with the performance of individuals or teams
Does not have to reach statistical significance
May be carried out in a very short time (sometimes a matter of a few hours)
180 SECTION 1 IMAGING TECHNIQUES AND GENERAL ISSUES

a successful audit such as the success and complication rates

Select a topic of angioplasty. Audit is a tool for showing how a practitioner
measures up to local and national standards which are now
becoming more readily available. In the UK, nationwide audits
Accept a standard are now organized by the Royal College of Radiologists
of practice (RCR) or one of the affiliated clinical interest bodies, such as
(e.g. from Research) the audit of nephrostomy practice (RCR and British Society
of Interventional Radiology).This enables comparison of local
practice and its outcomes with similar institutions across the
country. At the individual level, the collected evidence may
assist in revalidation, and take its place in a personal folder for
discussion at annual appraisal.
However, with clinical governance, there is a need to dem-
Observe your onstrate corporate accountability for clinical performance2
Implement
practice through a process of regular and systematic formal Clinical
change
(i.e. Audit)
Review (or clinical audit). Quality monitoring within the
specific areas described earlier will be essential to provide this
evidence. Some of these areas may require the creation of
running audits as a monitoring process (e.g. waiting times for
Compare your radiological examinations). Suggestions for what these areas of
practice with audit could be are available in a publication from the RCR35
the standard which contains illustrative recipes. Topics and standards for
governance issues are frequently incorporated into NICE
Figure 10.1 The audit cycle. guidance and Department of Health publications.
An illustration of likely audit activity related to governance
is shown in Figure 10.3.
If the target is not achieved, the need for some form of It is also possible to prioritize the choice of subjects for
change is indicated to enable the required improvement in audit using the list below36, recognizing that not all areas can
performance. After the introduction of the agreed change(s), be audited at once.
the process of data collection is repeated. The second cycle As an aid to prioritization, consider audit topics of activities
will show if the changes have improved practice and whether which involve:
the target has been achieved. high risk
high volume
The concept of the audit spiral (Fig. 10.2) adds a third dimen-
high cost
sion of continued improvement, recognizing that standards
wide variation in clinical practice
and targets can change with time and new developments. The
local clinical anxiety (e.g. untoward events or questionable
more important audits are likely to be continuous processes,
clinical performance).
with multiple cycles year on year, rather than closed loops.

Choosing topics to audit What standard should be used?

Areas of concern in clinical practice that arouse the interest When designing an audit, it is essential to identify an appropri-
of an individual are more likely to produce enthusiasm for ate standard at the beginning of the process.

Figure 10.2 The audit spiral.

(From Godwin R J, DeLacey G, 5 Re-audit
Manhire A (eds) 1996 Clinical audit
in radiology: 100+ recipes. Royal 1 Select a standard
College of Radiologists, London, with
permission.)
4 Implement change
2 Assess local practice

3 Compare with standard Improvement

or reassurance
 CHAPTER 10 CLINICAL GOVERNANCE AND AUDIT IN RADIOLOGY 181

Adverse events detected.

Investigated. Lessons
learnt and translated into
change in practice.

Poor clinical performance Systematic learning from

identified early. Then dealt clinical complaints.
with skilfully, speedily Translated into change in
and sensitively, in order to practice.
avoid harm to patients.

Where
Quality of data necessary Continuing professional
for monitoring clinical care
to be of a consistently high
is development programmes
in place.
standard.
your
Quality improvement
Leadership skills developed evidence processes (clinical audit) to be
integrated into an organizational
at the clinical team level.
quality programme.

?
Clinical risk reduction Evidence-based practice
programme in place and and infrastructure in place
of high quality. and utilized.

Clinical audit will provide:

the evidence
indication of where changes need to be made
the help needed in order to meet the Trusts
statutory obligation1,2

Figure 10.3 Acquiring the evidence on effective governance. (Courtesy of Dr G DeLacey.)

Standards may be based upon research evidence, but this
is frequently not available. A guideline may also be used as a
standard, derived either nationally (e.g. from a specialty group
or the National Institute for Health and Clinical Excellence)
or locally agreed, based upon the best available information,
respected opinion and local circumstances.
Each standard has three components:
A recommendation + an indicator + a target
A Recommendation: a statement about the structure, pro-
cess or outcome against which the quality of performance
is to be judged.
B Indicator: the variable (or item of information) that needs
to be measured in order to determine whether the recom-
mendation is being met.This is also known as the criterion.
It may be represented as a percentage of compliance with
a standard.
C Target: the expected level of achievement or the mini-
mum score that is considered locally to be acceptable in
good practice. It may be that when auditing for the second
or third time, the target can be gradually raised. In this
way, early failure, disappointment and disillusion might be
avoided33.
The measurable indicator
There may be more than one indicator within a single audit,
each representing a step along a multilevel standard. This situ-
ation arises within audits of care pathways, where a number
of criteria for completeness are required for the standard to
be achieved.
As an example of an indicator within an audit of double
reading of breast screening mammograms, the recommenda-
tion might be that all screening mammograms will be read
by two radiologists. The indicator here would be the actual
percentage of mammograms reported by two radiologists.The
target would be the minimum percentage conformity such as
90%.
Similarly, the recommendation may be that pneumothoraces
after lung biopsy should not exceed 15% at 1 h post-procedure.
182 SECTION 1 IMAGING TECHNIQUES AND GENERAL ISSUES
The indicator would be the number of patients with a pneu-
mothorax on a chest film taken at 1 h post-procedure, and the
initial target might be 20%.
The standard will indicate ideal expectation, the indicator
signifies reality, and the target gives the required minimum
achievable result locally, perhaps during the development
period of the biopsy service.
Numbers for audit
As mentioned in the section on audit and research, large num-
bers are not necessary for a successful audit and may indeed
lead to failure of completion of the audit cycle.
The choice of sample size can be difficult and should be
decided for each individual circumstance.The number of cases
or episodes audited should reflect the number seen locally in
practice. There is no need for controls. In audits where a high
percentage compliance is required (e.g. 100%) a relatively
small sample might show failure of compliance early on (even
after review of the first case). It may be that in an audit of
a high risk, low frequency activity (e.g. percutaneous neph-
rolithotomy), the preference may be to include all cases for
audit prospectively, running the audit as a continuous process,
reviewing results on a month-by-month, or year-by-year basis,
in order to show trends.
For a higher frequency clinical activity, it may be decided
to review only a randomly chosen 5% sample of cases or
reports within the audit (e.g. double reporting of CT stag-
ing scans in cases of lung cancer). The error rate in report-
ing can be a useful audit process to improve the quality of
report content and structure37.
Audit of even a low number of cases may indicate that there
is a cause for concern and that further work is required. It is
important not to draw premature conclusions without consid-
ering all the factors influencing the initial audit outcome.
An excellent analysis of numbers in audit is available in a RCR
governance publication (see Suggested Further Reading).
Implementing change and re-audit
The most difficult, but also the most satisfying aspect of audit,
is the successful implementation of any required or recom-
mended change. The change required will depend upon local
circumstances, available resources, and a willingness to adopt
change in practice. The most important aid to introducing
change is the acceptance by those involved in the audit of
the need for change, should the audit show a failure to reach
target. It is also essential to involve and inform those with
the authority to introduce (and fund) change, and identify
and empower those who will implement the changes. It has
been shown that when the real cost of carrying out an audit is
known to managers and clinicians, the recommended changes
are more likely to be implemented38.
Clinical audit can be a powerful force in the process
of introducing new techniques, managing staff develop-
ment and creating improved services and circumstances for
staff and patients. As a business tool, it can be a two-edged
sword, not only identifying poor performance but also
supplying the evidence of need where resource inadequa-
cies exist39,40. The date by which any changes should have
been introduced must be made clear and also the date by
which any second audit will be carried out. Re-audit is an
essential part of the process in order to demonstrate that the
changes have really produced the expected improvements.
To these ends, it is essential to create written reports of any
audits carried out, with the associated recommendations
for change clearly stated. Circulate these effectively and use
them in the clinical governance report to the directorate
and Trust. These actions will make the results and the pro-
cess for change explicit and available as part of the gover-
nance process, and available for review. Here we come to
the important matter of confidentiality.
Condentiality
In the collection of data during the audit process, details
about patients and clinicians will be identified. If this infor-
mation is available within the public domain, clinicians will
inevitably become less willing to give further information
and to cooperate.
Although the results of audit need to be available to those
with a legitimate interest in generating high clinical standards
(Trusts, Royal Colleges, managers, purchasers and patients),
such results should be of a general nature rather than person
specific. Such person-specific audit information needs to be
protected. There is, of course, a requirement that a responsible
individual within each Trust (usually the Medical Director)
has access to information relating to any one individual or
group. This is particularly important where matters of clinical
performance are brought into question.
The GMC recommends that patient data should be kept
anonymous for the protection of individuals41.
ACHIEVING SUCCESSFUL ORGANIZATION
OF AUDIT
The essential requirements for successful departmental audit
are time, facilities, clarity of organization and responsibil-
ity, multidisciplinary involvement and a readiness to accept
change. An absence of any of these, particularly time42, makes
the achievement of successful audit much more difficult.
Time allocation for audit work and meetings to receive
and discuss results is essential. It is part of the agreed job
plan for doctors under the new NHS contract introduced
in 2003 and should be achievable and acceptable to the
directorate.
Advice and help with data collection and IT support are
present within all Trusts, funding having been allocated for
audit staff.
Each department requires a clearly identifiable leader for audit
with the responsibility to organize meetings, coordinate appro-
priate audits and create an annual audit report to the Trust43.
The audit leader is also supported by the RCR audit sub-
committee. Opportunities should be sought for cross-specialty
audit and the creation of multidisciplinary care pathways with
agreed standards.

All staff groups should ideally be included within the audit
processes and consideration must also be given to inclusion of
patients in the audit process44.
THE RE-LAUNCH OF AUDIT
It is well recognized that since its launch in the UK, the
expected improvements in clinical practice from clinical audit
have not materialized, despite major investment and work by
many to facilitate its acceptance. One reason for this is the
tendency for medical staff to see audit as a time-consuming
process separate from the rest of their clinical activities, rather
than as an integrating tool to show what they are achieving
and what resources they need. The bulk of the work is often
left to junior medical staff or radiographers who do have a role
to play as team members. Furthermore, there may well be dif-
ferent agendas and priorities held by clinicians and managers.
With the requirement to develop real clinical governance,
and the responsibility for quality of care now clearly lying with
chief executives, we may now see the tool of audit being used
more coherently with less divergence of opinion and priority45.
The development of multidisciplinary working and clear stan-
dards of care and process in recent years should make it easier
to identify effective and reproducible audit processes that can
be shared nationally and allow comparison of outcomes and
methods over the whole National Health Service.
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CLINICAL AUDIT 100+ recipes. RCR, London
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DeLacey G, Godwin R J, Manhire A R (eds) 2000 Clinical governance and clinical audit. Radcliffe Medical Press, Oxford
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