CLINICAL AUDIT final 4
CLINICAL AUDIT final 4
SCIENCES
By Amanuel Mengesha
Dessie, Ethiopia
1/2/2025
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Acknowledgment
I would like to express my sincere gratitude to my instructor, Melkam Tesfaye ( MSc, Assistant
Professor) for your unwavering support, guidance, and dedication to nurturing my academic and
personal growth. Your passion for teaching and commitment to excellence has truly inspired me
to strive for success and pursue knowledge with enthusiasm. I am immensely grateful for your
invaluable mentorship and the profound impact you have had on my educational journey.
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Table of contents…………………………………………………………page no
Acknowledgment .......................................................................................................................................... ii
Objectives .................................................................................................................................................... vi
Appendics.................................................................................................................................................... 17
Conclusion ................................................................................................................................................... 20
References .................................................................................................................................................. 21
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Acronym and abbreviation
HQIP …………………………Healthcare Quality Improvement Partnership
ID ……………………………Identification
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List of figures and tables
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Objectives
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CLINICAL AUDIT
The clinical audit process typically follows a cycle that includes five key stages: planning,
setting standards, measuring performance, implementing improvements, and sustaining
improvements. During the planning stage, the audit team selects a specific area of care to be
audited and defines the standards and criteria against which performance will be measured. The
measurement stage involves collecting and analyzing data to assess current practices against the
set standards. Based on the findings, the team identifies areas for improvement and implements
changes to enhance care quality(1)
The General Medical Council guidance requires all clinicians to seek to improve the quality of
care. Clinical audit provides a method for achieving such improvement. The definition or
description of Clinical audit can be summarized as “Clinical audit is 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, process and
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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”(2-4)
2.Historical background
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 recognized as one of the earliest
programs of outcomes management(3)
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. 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.
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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 health care. It also reflects the change in focus from a professionally-centered view of
health provision to the view of the patient-centered 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 standardize clinical audit as part of professional health care. The paper
defined medical audit, as it was called then, "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"(3, 5).
➢ Measure quality; “In order to work out how to improve we need to measure and
understand exactly what we do.
➢ Publish quality performance; “Making data on how well we are doing widely
available to staff, patients and the public will help us understand variation and
best practice ...
➢ Improve practice; “Making data on how well we are doing widely available to
staff, patients and the public will help us to focus on improvement and creating
real benefits in patient care and service delivery
➢ Develops openness to change and Provide assurance; meeting evidence-based
best practice
➢ Listening to patients, understanding their expectations;
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➢ Development of local guidelines or protocols
➢ Minimize error or harm to patients and reduce incidents, complaints, claims.
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➢ At an audit team meeting, discuss possible topics and priorities according to perceived
importance.
➢ Consult with any other relevant stakeholders, not on the audit team, about proposed
topics.
➢ Evaluate the topics according to topic selection criteria.
The clinical team has an important role in prioritizing clinical topics and each healthcare
organization may set its own priorities for clinical audit topic selection criteria.(3, 6)
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4.2, Involve stakeholders
Stakeholders include your associates and other departments and organizations that may have a
relationship to chosen topic, e.g.
➢ Surgeons
➢ Anesthetists
➢ Physicians
➢ Radiologists
➢ Psychiatrists
➢ Palliative care and pain control
➢ Nurses
➢ Allied Health Professionals
➢ Ancillary staff such as booking office, cleaners, catering, porters
➢ Medical engineering
➢ Ambulance service
➢ Primary health care providers
➢ Patients and careers
It is courteous to involve other relevant staff groups who may be affected and to discuss the
projected audit beforehand, so that they can provide suggestions and be supportive. It is a good
idea to include someone who has the authority to insist upon and fund any desirable changes that
may be identified by the audit.
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.
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A criterion is a measurable outcome of care, aspect of practice or capacity. For example, parents
or careers are involved in negotiating or planning their child’s care. A standard is the threshold
of the expected compliance for each criterion, usually expressed as a percentage. For the above
example an appropriate standard would be: ‘There is evidence of parent or career in care
planning in 90% of cases.
A standard should have a specific criterion and value and it should be realistic, evidence based,
where possible, practical and applicable to local circumstances. When setting standards tries to
remember that they should always be SMART:
Setting standards usually involves a number of stages. When trying to develop standards it is
worth considering the following points:
➢ Standards which are applicable to specific service should be set and should be agreed by
all relevant staff participating in the clinical audit.
➢ Where possible, standards should be based on the best available evidence regarding good
practice.
➢ The development of standards will usually involve a combination of clinical experience
and a review of the available evidence. Sometimes there are very few national guidelines
regarding clinical practice and there is limited robust research on certain topic areas.
Standards often, therefore, must be based on the clinical experience of the service
providers. In some circumstances, using clinical audit to observe your current practice
may help to generate standards.
Where standards come from Standards may be based on one, or any combination, of the
following sources:
➢ National guidance or standards;
➢ College or professional organization guidelines;
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➢ Laws;
➢ Previously agreed local guidelines or protocols, through consultation with
commissioners.
➢ Standards used locally by colleagues or competitors;
➢ Research evidence, from which standards can be developed;
➢ Literature review of other clinical audits which have published their standards or results;
➢ Current knowledge from clinical experience and/or Current practice, observe and assess
current practice.
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➢ Interval Sampling: assumes audit population will change over the period of the audit. In
these circumstances, the audit sample is often determined by a period of time, e.g. all
patients transfused during May and June.
➢ Consecutive Sampling: is closely linked with interval sampling. You simply choose the
first agreed number of subjects after an agreed start date.
➢ Stratified Sampling: is a method used to ensure that the proportions of different groups in
the population are reflected in the sample. For example, if investigating donor deferrals
and male blood donors make up 40% of the donor population, you would ensure that 40%
of samples are male.
As mentioned above, occasionally a ‘snapshot’ sample will not provide the level of assurance
required. This only tends to apply to clinical audit when outcomes are being assessed. In this
instance there may not want to look at every patient in population, but need to calculate a sample
size that is representative of the whole population. Sample size calculations depend on four
variables:
i. Size of population;
ii. Degree of accuracy required. What margin of error can you accept? 5% is a common
choice
iii. Degree of confidence required. What confidence level do you need? Typical choices are
90%, 95%, or 99%
iv. How often you expect your audit criteria to be met. What is the response distribution?
Leave this as 50%
Sample Size Calculator software considering the above four factors can be found in;
www.raosoft.com/samplesize.html. Once the sample size has been determined and knows what
information is going to collect, it needs to decide how you are going to obtain that information
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organization, it may be that someone else already collects the information you require. So talking
to people is often a good way of finding out what is already available. If the information is not
available, you will have to develop a method to access the information you need. This may
include either yourself and / or Health Care Professionals collecting the data at the point of care,
or you could collect the information you require from observing practice or questioning staff or
patients / donors. When you have identified data sources it needs to decide
There are advantages and disadvantages to each method and the topic and data sources will
influence which is the most suitable method to choose. Retrospective data collection is good if
auditors are collecting data from established sources and the information is well documented.
However, it provides information about past practices that may have changed. Prospective /
Concurrent data collection is good if it requires additional information to that normally
documented. However, this requires additional resources to collect data.
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V. Ensure Reliable and Valid Data
Reliability relates to the extent to which your audit findings are repeatable and is concerned with
the level of error in the measurement process. Variation in the measurement process will lead to
unreliable data, so it needs to ensure your data collection tool and method is specific and
unambiguous. Validity is concerned with the extent to which the audit measures what it is
supposed to measure. This can be improved by ensuring that audit is well designed, clear,
unambiguous objectives and standards and you use robust data collection and checking methods.
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4.6, Developing agreed strategy and 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 organizations, 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(3, 6)
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not seek new knowledge; it seeks to evaluate performance against explicit standards. Research
requires ethical approval. Audit is a routine part of NHS practice and does not require such
approval. If there is any doubt as to whether a project, or an element of a project, might be
regarded as research and so might require ethics approval, seek further guidance.
Audit is also frequently confused with data collection and it is important to recognize that
gathering data is only one component of the process of clinical audit. Collecting general
information concerning what happens in practice is not audit, it is data collection. Clinical audit
must include reflection on the data collected, a plan for improving care and, if necessary further
rounds of data collection to ensure standards are improving.
➢ Research asks the question ‘what is best practice?’ researches will seek to find new
knowledge.
➢ Clinical Audit asks the question ‘are we following agreed or evidence based practice?’
auditors will seeks to find out if we are achieving the things we have agreed we should be
achieving.
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5.2, Similarities between Audit and Research
➢ Both answer questions about quality of care or service.
➢ Both involve sampling, data collection and analysis of findings.
➢ Both should involve all stakeholders.
The audit team will prepare the finalized draft report discussed during the exit briefing with the facility/
institution. At all times the audit report will be confidential and available only to clearly designated
recipients and the auditing body. The report will be reviewed by the auditing body, which will discuss the
contents of the report with the auditors and, if required, with the facility/ institution. Once the report has
been completed and approved by the audit team and auditing body, it will be disseminated. The document
template for the audit report should follow the headings outlined below.(10, 11)
Title page and contents page The title page should include the name and address of the
facility/institution audited the names of the members of the audit team (including identification of the
leader), the date of the audit and any identification required by the auditing facility/institution. A contents
page is essential, and this is generated automatically by the document template.
Executive summary or abstract The summary should describe the reasons for a comprehensive
clinical audit, and comment on the extent to which the facility/institution has met the criteria for good
practice, along with the vision of the facility/institution for the future, concluding with a summary of
recommendations to the clinical facility and the external organizations.
Introduction Briefly describe the reasons for undertaking this clinical audit..
Aims/Objectives of the audit
Aims: State what you need the audit to tell you/what you hope to identify. The aim is the goal
you wish the audit to achieve.
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Objectives: Identify how you will conduct the audit project to address the aim. Objectives should
be identified from the outset of the clinical audit project and SMART (Specific, Measurable,
Achievable, Realistic, Timely).
Criteria and standards
What criteria and standards have you compared practice against? Please specify the source of the criteria.
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comparison between different areas/time periods. Compliance with criteria can be displayed in a
table as follows:
Ensure all findings are reflected (without bias to either positive or negative) Comparison of
performance with results from a previous audit should be included. Patient identifiable data e.g.
surname, date of birth, ID number etc should never be included in a clinical audit report.
Discussion ;What overall observations can be drawn from the results? Detail any key themes
arising from the analysis of data or any other data/information gained as part of the audit process
(use bullet points). Ensure observations are supported by the results of the audit and include the
key points (this section of the report is more likely to be read than any other). Areas of good
practice and areas of practice requiring improvement should be highlighted, with interpretation
where possible. Reference to poor quality/completeness of data should be made. Ways to
improve the quality/completeness of data in the re-audit should be suggested. Conclusions about
performance and need for changes in practice and conclusions about educational needs arising
from the audit should be stated. Any learning points related to the audit methodology which may
need to be addressed/ considered before undertaking a re-audit should be included.
References; Proper referencing system should be applied.
Action plan; Any recommendations arising from the audit findings should be documented in an
action plan. Recommendations should be SMART (Specific Measurable Achievable Realistic
Timely) Action plans should include any plans for re-audit (including when and whose
responsibility). Action plans should be recorded using the template on the following pages.
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Appendics
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Conclusion
A clinical audit is a systematic process used in healthcare settings to evaluate and improve the quality of
patient care. It involves comparing current clinical practices against established standards and guidelines
to identify areas for improvement. The primary goal is to enhance patient outcomes by ensuring that
healthcare services are effective, safe, and patient-centered. Clinical audits are an essential component of
clinical governance and quality improvement initiatives.
The clinical audit process typically follows a cycle that includes five key stages: planning, setting
standards, measuring performance, implementing improvements, and sustaining improvements. During
the planning stage, the audit team selects a specific area of care to be audited and defines the standards
and criteria against which performance will be measured. The measurement stage involves collecting and
analyzing data to assess current practices against the set standards. Based on the findings, the team
identifies areas for improvement and implements changes to enhance care quality(1).
Implementing improvements may involve changes in clinical practice, staff training, or the introduction
of new protocols. The final stage, sustaining improvements(12), focuses on monitoring the implemented
changes to ensure they are maintained over time and continue to deliver positive outcomes. Regular audits
help create a culture of continuous improvement within healthcare organizations, promoting better patient
care and safety.(12)
Clinical audits are crucial for maintaining and improving healthcare quality. They help identify gaps in
care, enhance patient safety, and ensure that medical practices align with established standards and
guidelines. By systematically reviewing and evaluating clinical practices, healthcare providers can make
evidence-based changes that lead to better patient outcomes(13).
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References
1. https://radarhealthcare.com/news-blogs/clinical-audit-examples-and-types/.
2. Clinical Audit Support Centre | what is clinical audit? [Internet]. [cited 2012 Oct 27]. Available
from: http://www.clinicalauditsupport.com/what_is_clinical_audit.html.
3. Clinical audit - Wikipedia, the free encyclopedia [Internet]. [cited 2012 Oct 27]. Available from:
http://en.wikipedia.org/wiki/Clinical_audit.
4. . Jonathan Potter, Claire Fuller, Martin Ferris. Local clinical audit: handbook for physicians. HQIP;
2010.
5. Neuhauser D. Ernest Amory Codman MD. Quality & Safety in Health Care 2002;11(1):104-05.
6. National Institute for Health and Clinical Excellence. Principles for best practice in clinical
audit. Oxford: Radcliffe Medical Press, 2002.
7. Novo A, Ridanovic Z, Maric V. Clinical audit as method of quality improvement of healthcare in
patients with diabetes, stroke and in cesarean section. Medicinski Arhiv 2006;60(3):185-9.
8. Travaglia J, Debono D. Clinical audit: a comprehensive review of the literature. Centre for
Clinical Governance Research in Health, Faculty of Medicine, University of New South Wales;
2009. .
9. Hysong, S., R. Best, et al. (2006). "Audit and feedback and clinical practice guideline adherence:
Making feedback actionable." Implementation Science 1(1): 9.
10. Hearnshaw, H., R. Harker, et al. (2002). "A study of the methods used to select review criteria for
clinical audit." Health Technology Assessment 6(1): 1-78.
11. Comprehensive clinical audits of diagnostic radiology practices: a tool for quality improvement.
— Vienna: International Atomic Energy Agency, 2010.
12. Dilnawaz M, Mazhar H, Shaikh ZI. Clinical audit: A simplified approach. Journal of Pakistan
Association of Dermatologists. 2012;22(4).
13.
https://www.phecit.ie/Images/PHECC/Clinical%20Practice%20Guidelines/CPG%20Approved%20
Orgs/STN019%20Practical%20Guide%20to%20Clinical%20Audit.pdf.
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