The National Institute for Health &Clinical

Excellence (NICE)

• "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."
Clinical audit is a process that has been
defined as
• a quality improvement process
• for improving patient care and outcomes
• through systematic review of care
• against explicit criteria
• and the implementation of change".
• The key component of clinical audit is that
• performance is reviewed (or audited) against explicit criteria-
standards
• to ensure that what you should be doing is being done,
• and if not it provides a framework to enable improvements to
be made.
 Clinical audit should:

• Be a multi-disciplinary, multi-professional activity.

• Follow general accepted rules and standards which are based on

• International, national or local legal regulations,
• Guidelines developed by international, national or local medical and
clinical professional societies.
• Be a systematic and continuing activity, whereby the
recommendations given in audit reports are implemented.

• not be research, quality system audit, accreditation or regulatory

activity.
 The general objectives of clinical audit should be
to:
• Improve the quality of patient care.
• Promote the effective use of resources.
• Enhance the provision and organization of clinical
services.
• Further professional education and training.
Clinical audit should:

• Address the practical clinical work by different professionals.

• Assess the local practice against the defined good practice, taking into
• consideration the local facilities and resources when the ultimate good
practice cannot be reached by one step. Have professional initiation and
foster an environment which enhancesprofessional relationships and
the multidisciplinary approach required to optimise patient care.
• All parties, those being audited and those carrying out the audit, should
respect the confidentiality of patient data, the interviews and
discussions with staff, audit reports and other performance data.
 HISTORY
• One of first clinical audits was undertaken by Florence
Nightingale during the Crimean War of 1853–55
• Mortality rates fell from 40% to 2%.
• Ernest Amory Codman, M.D., (December 30, 1869 –
November 23, 1940) was a pioneering Boston surgeon
[1]

"End Result Cards“- which contained basic demographic data

on every patient treated, along with the diagnosis, the
treatment he rendered, and the outcome of each case. Each
patient was followed up on for at least one year to observe
long-term outcomes.
• Clinical audit was slow to catch on & took next 130 years or
so
One of first clinical audits was undertaken by Florence Nightingale during the Crimean
War of 1853–55.
On arrival at the medical barracks hospital in Scutari in 1854, Nightingale 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; in addition, Nightingale had a talent for mathematics and
statistics, and she and her staff kept meticulous records of the mortality rates among the
hospital patients. Following these changes the mortality rates fell from 40% to 2%, and
the results were instrumental in overcoming the resistance of the British doctors and
officers to Nightingale'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
 Ernest Amory Codman, M.D., (December 30, 1869 – November 23, 1940)[1]
was a pioneering Boston surgeon who made contributions to anaesthesiology,
radiology, duodenal ulcer surgery, orthopaedic oncology, shoulder surgery, and
the study of medical outcomes.[

He was an advocate of hospital reform and is the acknowledged founder of what today is
known as outcomes management in patient care. Codman was the first American doctor to
follow the progress of patients through their recoveries in a systematic manner.[3] He kept
track of his patients via "End Result Cards" which contained basic demographic data on
every patient treated, along with the diagnosis, the treatment he rendered, and the
outcome of each case. Each patient was followed up on for at least one year to observe
long-term outcomes. It was his lifelong pursuit to establish an "end results system" to track
the outcomes of patient treatments as an opportunity to identify clinical misadventures that
serve as the foundation for improving the care of future patients. He also believed that all of
this information should be made public so that patients could be guided in their choices of
physicians and hospitals.
 The main stages of the clinical audit process
are:
1. Selecting a topic.
2 Agreeing standards of best practice
3. Collecting data.
4. Analyzing 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. Analyzing the re-audit data,
11. Feeding back the re audit results.
12. Discussing whether practice has improved
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 and 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 and 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 electronically 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.
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.
TYPES OF CLINICAL 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 - an
unexpected outcome/ 'significant event audit'.
• Surgical audit - Data collection of all surgical cases-review and
assessment of performance and outcomes.
• Peer review - An assessment of the quality of care provided by a
clinical team with a view to improving clinical care.
• Patient surveys and focus groups -
What can be audited?
• The quality of health care provided can be audited by examining
four interrelated component parts:
• Structure –building ,equipments
• Process –admission,discharge,
• Outcome -
• Patient satisfaction-
Precondition
• Good record keeping system is mandatory

• Performed by fair and impartial professionals

• Confidentiality of clinicians, nursing , other staff as well as

patient should be maintained

• should be done voluntarily with simple and clearly stated aim.

• Goal should be to effect positive change.

Clinical audit and research

• both aim to answer a specific question relating to quality of care

• both can be carried out either retrospectively (looking at

historical data) or prospectively (collecting data as care is given)

• both involve careful sampling, questionnaire design and

analysis of findings
Clinical Audit and Research

• Audit can pinpoint areas where the research evidence is lacking

• The audit process assists with dissemination of evidence-based

practice

• Clinical audit can be legitimately viewed as the final stage of a

good clinical research program

• Alternatively research could be viewed as a precursor to the

clinical audit process

• Research can identify areas for audit

Benefits. Patients

• Improves quality of care and service received

• Prompt changes in delivery of care

• Highlights precise patient needs

• Involves patients in decision-making

• Raises patients confidence in service and care levels

• Provides clear information about care and risks involved

Benefits: Health Care Professionals

• Provides workable standards

• Resolves problems
• Improves and increases team-working and levels of communication

• Ensures appropriate use of skills and resources

• Increases knowledge and skills
• Can identify training needs
• Measures quality in current practice
Benefits Organization

• Improved care of patients

• Enhanced professionalism of staff

• Efficient use of resources

• Aids in continuing education

• Aids in administration

• Accountability to those outside the profession

Overall Benefits

• Best practice
• Best outcome
• Best that we can deliver individually or collectively as a group of
health professionals
Sum Up…

• Clinical Audit is a quality Improvement process that measures

current patient care and outcomes against agreed standards of best
practice.
• Not all 'audit’ is clinical audit.

• Be aware of the differences between project categories:

• Clinical audit-audit against agreed standards of best practice.
• Research - aims to create new knowledge.
• Service Evaluation - assesses the effectiveness of a service.