Clinical audit is a process that has been defined as "a quality improvement process that seeks

to improve patient care and outcomes through systematic review of care against explicit
criteria and the implementation of change".[1]

The key component of clinical audit is that performance is reviewed (or audited) to ensure
that what should be done is being done, and if not it provides a framework to enable
improvements to be made. It had been formally incorporated in the healthcare systems of a
number of countries, for instance in 1993 into the United Kingdom's National Health Service
(NHS), and within the NHS there is a clinical audit guidance group in the UK. [1].

Contents
[hide]

• 1 History
• 2 The integration into contemporary healthcare
• 3 Types of audit
• 4 The place of clinical audit in modern healthcare
• 5 Management of clinical audit
• 6 Clinical audit - the process
• 7 Persuading hospitals and clinicians to undertake and apply clinical audit
• 8 See also
• 9 References

• 10 External links

[edit] History
One of first ever clinical audits was undertaken by Florence Nightingale during the Crimean
War of 1853-1855. On arrival at the medical barracks hospital in Scutari in 1854, Florence
was appalled by the unsanitary conditions and high mortality rates among injured or ill
soldiers. She and her team of 38 nurses applied strict sanitary routines and standards of
hygiene to the hospital and equipment, and with Florence's gift with mathematics and
statistics, kept meticulous records of the mortality rates among the hospital patients.
Following this change the mortality rates fell from 40% to 2%, and were instrumental in
overcoming the resistance of the British doctors and officers to Florence's procedures. Her
methodical approach, as well as the emphasis on uniformity and comparability of the results
of health care, is recognised as one of the earliest programs of outcomes management.

Another famous figure who advocated clinical audit was Ernest Codman (1869–1940).
Codman became known as the first true medical auditor following his work in 1912 on
monitoring surgical outcomes. Codman's "end result idea" was to follow every patient's case
history after surgery to identify individual surgeon's errors on specific patients. Although his
work is often neglected in the history of health care assessment, Codman's work anticipated
contemporary approaches to quality monitoring and assurance, establishing accountability,
and allocating and managing resources efficiently.
Whilst Codman's 'clinical' approach is in contrast with Nightingale's more 'epidemiological'
audits, these two methods serve to highlight the different methodologies that can be used in
the process of improvement to patient outcome.

[edit] The integration into contemporary healthcare

Despite the successes of Nightingale in the Crimea and Codman in Massachusetts, clinical
audit was slow to catch on. This situation was to remain for the next 130 or so years, with
only a minority of healthcare staff embracing the process as a means of evaluating the quality
of care delivered to patients.

As concepts of clinical audit have developed, so too have the definitions which sought to
encapsulate and explain the idea. These changes generally reflect the movement away from
the medico-centric views of the mid-Twentieth Century to the more multidisciplinary
approach used in modern healthcare. It also reflects the change in focus from a
professionally-centred view of health provision to the view of the patient-centred approach.
These changes can be seen from comparison of the following definitions.

In 1989, the White Paper, Working for patients, saw the first move in the UK to standardise
clinical audit as part of professional healthcare. The paper defined medical audit (as it was
called then) as

"the systematic critical analysis of the quality of medical care including the procedures used
for diagnosis and treatment, the use of resources and the resulting outcome and quality of life
for the patient."

Medical audit later evolved into clinical audit and a revised definition was announced by the
NHS Executive:

"Clinical audit is the systematic analysis of the quality of healthcare, including the procedures
used for diagnosis, treatment and care, the use of resources and the resulting outcome and
quality of life for the patient."

The National Institute for Health and Clinical Excellence (NICE) published the paper
Principles for Best Practice in Clinical Audit[2], which defines clinical audit as

"a quality improvement process that seeks to improve patient care and outcomes through
systematic review of care against explicit criteria and the implementation of change. Aspects
of the structure, processes, and outcomes of care are selected and systematically evaluated
against explicit criteria. Where indicated, changes are implemented at an individual, team, or
service level and further monitoring is used to confirm improvement in healthcare delivery."

[edit] Types of audit

• Standards-based audit - A cycle which involves defining standards, collecting data
to measure current practice against those standards, and implementing any changes
deemed necessary.
• Adverse occurrence screening and critical incident monitoring - This is often used
to peer review cases which have caused concern or from which there was an
 unexpected outcome. The multidisciplinary team discusses individual anonymous
cases to reflect upon the way the team functioned and to learn for the future. In the
primary care setting, this is described as a 'significant event audit'.
• Peer review - An assessment of the quality of care provided by a clinical team with a
view to improving clinical care. Individual cases are discussed by peers to determine,
with the benefit of hindsight, whether the best care was given. This is similar to the
method described above, but might include 'interesting' or 'unusual' cases rather than
problematic ones. Unfortunately, recommendations made from these reviews are
often not pursued as there is no systematic method to follow.
• Patient surveys and focus groups - These are methods used to obtain users' views
about the quality of care they have received. Surveys carried out for their own sake
are often meaningless, but when they are undertaken to collect data they can be
extremely productive.

[edit] The place of clinical audit in modern healthcare

Clinical audit is an essential and integral part of clinical governance.

Clinical audit comes under the Clinical Governance umbrella and forms part of the system for
improving the standard of clinical practice.

Clinical Governance is a system through which NHS organisations are accountable for
continuously improving the quality of services, and ensures that there are clean lines of
accountability within NHS trusts and that there is a comprehensive programme of quality
improvement systems. The six pillars of clinical governance include:

• Clinical Effectiveness
• Research & Development
• Openness
• Risk Management
• Education & Training
• Clinical Audit
Clinical audit was incorporated within Clinical Governance in the 1997 White Paper, "The
New NHS, Modern, Dependable", which brought together disparate service improvement
processes and formally established them into a coherent Clinical Governance framework.

[edit] Management of clinical audit

Within Strategic Health Authorities the clinical governance lead is responsible for ensuring
that there is a clinical audit programme within local trusts, and that this reflects national audit
priorities. The clinical governance lead ultimately retains accountability for clinical audit, but
may choose to delegate this role to another, the clinical audit lead. At a local level this
individual will then be responsible for creating a clinical audit strategy, setting audit
priorities, agreeing the audit programme, implementing the strategy and implementing the
audit programme. The clinical governance lead however retains responsibility for ensuring
that these tasks are completed and that clinical audit remains integrated with the other aspects
of clinical governance.

The clinical audit lead has a clear role in creating the strategy for embedding clinical audit
within the organisation, but the individual chosen must have more than just a nominal
strategic role. The clinical audit lead should have a high profile within the organisation, and
must champion clinical audit both to colleagues and management alike. The clinical audit
lead should be actively involved in linkages to the other aspects of clinical governance to
allow for the dissemination of clinical audit information and the setting of local clinical audit
priorities.

[edit] Clinical audit - the process

The clinical audit process seeks to identify areas for service improvement, develop & carry
out action plans to rectify or improve service provision and then to re-audit to ensure that
these changes have an effect.

Clinical audit can be described as a cycle or a spiral, see figure. Within the cycle there are
stages that follow the systematic process of: establishing best practice; measuring against
criteria; taking action to improve care; and monitoring to sustain improvement. As the
process continues, each cycle aspires to a higher level of quality.

Stage 1: Identify the problem or issue

This stage involves the selection of a topic or issue to be audited, and is likely to involve
measuring adherence to healthcare processes that have been shown to produce best outcomes
for patients. Selection of an audit topic is influenced by factors including:

• where national standards and guidelines exist; where there is conclusive evidence
about effective clinical practice (i.e. evidence based medicine).
• areas where problems have been encountered in practice.
• what patients & public have recommended that be looked at.
• where there is a clear potential for improving service delivery.
• areas of high volume, high risk or high cost, in which improvements can be made.

Additionally, audit topics may be recommended by national bodies, such as NICE or the
Healthcare Commission, in which NHS trusts may agree to participate. The Trent
Accreditation Scheme recommends a culture of audit to participating hospitals inside and
outside of the UK, and can provide advice on audit topics.

Stage 2: Define criteria & standards

Decisions regarding the overall purpose of the audit, either as what should happen as a result
of the audit, or what question you want the audit to answer, should be written as a series of
statements or tasks that the audit will focus on. Collectively, these form the audit criteria.
These criteria are explicit statements that define what is being measured and represent
elements of care that can be measured objectively. The standards define the aspect of care to
be measured, and should always be based on the best available evidence.

• A criterion is a measurable outcome of care, aspect of practice or capacity. For

example, ‘parents / carers are involved in negotiating or planning their child’s care’.

• A standard is the threshold of the expected compliance for each criterion (these are
usually expressed as a percentage). For the above example an appropriate standard
would be: ‘There is evidence of parent / carer in care planning in 90% of cases’.

Stage 3: Data collection

To ensure that the data collected are precise, and that only essential information is collected,
certain details of what is to be audited must be established from the outset. These include:

• The user group to be included, with any exceptions noted.

• The healthcare professionals involved in the users' care.

• The period over which the criteria apply.

Sample sizes for data collection are often a compromise between the statistical validity of the
results and pragmatical issues around data collection. Data to be collected may be available in
a computerised information system, or in other cases it may be appropriate to collect data
manually or electonically using data capture solutions such as Formic, depending on the
outcome being measured. In either case, considerations need to be given to what data will be
collected, where the data will be found, and who will do the data collection.
Ethical issues must also be considered; the data collected must relate only to the objectives of
the audit, and staff and patient confidentiality must be respected - identifiable information
must not be used. Any potentially sensitive topics should be discussed with the local
Research Ethics Committee.

Stage 4: Compare performance with criteria and standards

This is the analysis stage, whereby the results of the data collection are compared with
criteria and standards. The end stage of analysis is concluding how well the standards were
met and, if applicable, identifying reasons why the standards weren't met in all cases. These
reasons might be agreed to be acceptable, i.e. could be added to the exception criteria for the
standard in future, or will suggest a focus for improvement measures.

In theory, any case where the standard (criteria or exceptions) was not met in 100% of cases
suggests a potential for improvement in care. In practice, where standard results were close to
100%, it might be agreed that any further improvement will be difficult to obtain and that
other standards, with results further away from 100%, are the priority targets for action. This
decision will depend on the topic area – in some ‘life or death’ type cases, it will be important
to achieve 100%, in other areas a much lower result might still be considered acceptable.

Stage 5: Implementing change

Once the results of the audit have been published and discussed, an agreement must be
reached about the recommendations for change. Using an action plan to record these
recommendations is good practice; this should include who has agreed to do what and by
when. Each point needs to be well defined, with an individual named as responsible for it,
and an agreed timescale for its completion.

Action plan development may involve refinement of the audit tool particularly if measures
used are found to be inappropriate or incorrectly assessed. In other instances new process or
outcome measures may be needed or involve linkages to other departments or individuals.
Too often audit results in criticism of other organisations, departments or individuals without
their knowledge or involvement. Joint audit is far more profitable in this situation and should
be encouraged by the Clinical Audit lead and manager.

Re-audit: Sustaining Improvements

After an agreed period, the audit should be repeated. The same strategies for identifying the
sample, methods and data analysis should be used to ensure comparability with the original
audit. The re-audit should demonstrate that the changes have been implemented and that
improvements have been made. Further changes may then be required, leading to additional
re-audits.

This stage is critical to the successful outcome of an audit process - as it verifies whether the
changes implemented have had an effect and to see if further improvements are required to
achieve the standards of healthcare delivery identified in stage 2.

Results of good audit should be disseminated both locally via the Strategic Health Authorities
and nationally where possible. Professional journals, such as the BMJ and the Nursing
Standard publish the findings of good quality audits, especially if the work or the
methodology is generalisable.

[edit] Persuading hospitals and clinicians to undertake

and apply clinical audit
While clinical audit makes great sense, there can be an issue around persuading hospitals and
clinicians to undertake and apply clinical audit to their everyday work.

In the UK, clinical audit is part of the clinical governance mantra expected of all
organisations and workers within the NHS.

Outside of the UK, hospital accreditation schemes, such as the Trent Accreditation Scheme
have taken forward audit as a part of clinical governance and promoted its development and
execution in places such as Hong Kong and Malta.

[edit] See also

• Healthcare Quality Improvement Partnership
• National Health Service
• Clinical Governance
• Trent Accreditation Scheme

[edit] References
• Healthcare Quality Improvement Partnership. Criteria of best practice in clinical audit
• Healthcare Quality Improvement Partnership. Clinical audit resources
• Department of Health, Working for patients. London: The Stationery Office, 1989
• NHS Executive, Promoting clinical effectiveness. A framework for action in and
through the NHS. London: NHS Executive, 1996
• National Institute of Clinical Excellence, Principles of Best Practice in Clinical Audit.
London: NICE, 2002. (ISBN 1-85775-976-1)
• Swage T.; Clinical governance in health care practice. Oxford: Butterworth-
Heinman, 2000
• Clinical Governance Support Team, A Practical Handbook for Clinical Audit. 2004
• Clinical governance and re-validation: the role of clinical audit, Education in
Pathology. 2002;117:47-50
• The New NHS, Modern, Dependable, London:HMSO, 1997, (ISBN 0-10-138072-0)
• Jones T., Cawthorn S.; What is Clinical Audit?. Evidence Based Medicine, Hayward
Medical Communications, 2002
• How to choose and prioritise audit topics, UHBristol Clinical Audit Department.
2010
• How to do clinical audit - a brief guide, UBHT Clinical Audit Central Office. 2005
• How to collect audit data, UBHT Clinical Audit Central Office. 2005
• How to analyse audit data, UBHT Clinical Audit Central Office. 2005
• How to get your audit published, UBHT Clinical Audit Central Office. 2005
• Ghosh R., ed; Clinical Audit for Doctors. Nottingham: Developmedica, 2009. (ISBN
978-1-9068390-1-7)
 1. ^ "www.nice.org.uk". Principles of Best Practice in Clinical Audit 2002.
http://www.nice.org.uk/media/796/23/BestPracticeClinicalAudit.pdf. Retrieved Aug 2010.
2. ^ "www.nice.org.uk". Principles of Best Practice in Clinical Audit 2002.
http://www.nice.org.uk/media/796/23/BestPracticeClinicalAudit.pdf. Retrieved Aug 2010.

[edit] External links

• DCBA, Inc. DCBA, Inc. provides clinical audit and clinical documentation
improvement programs.
• Healthcare Quality Improvement Partnership (HQIP) Promoting quality for better
health services, HQIP is funded by the Department of Health to increase the impact
that clinical audit has on healthcare quality in England and Wales.
• Core5 - Clinical Effectiveness Manager. A web based tool to help manage data for
audit & effectiveness projects
• Clinical Audit Tool. PCS Clinical Audit Tool (CAT) is a population reporting
enhancement to the leading GP Clinical Desktop Systems in Australian general
practice
• DRINFO Practice Audit Tool. DRINFO is the leading clinical and practice auditing
tool in New Zealand used for auditing and taking action on gaps identified in GP
practices.