Mesurement Quality

Clinical Audit 6 Stages

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.

The clinical audit can be described as a cycle or a spiral. 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.

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.

criterion is a measurable outcome of care, aspect of practice or capacity. For example, mortality rate.

standard is the threshold of the expected compliance for each criterion.

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. 

Stage 4: Compare performance with criteria & 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. 

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. 

Stage 6: 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.



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  • 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)
  • ^ “”. Principles of Best Practice in Clinical Audit 2002. Retrieved Aug 2010.
  • ^ “”. Principles of Best Practice in Clinical Audit 2002. Retrieved Aug 2010.
  • 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.
  • Formic – Clinical Audit Data Capture Solutions, used by over 300 NHS Trusts.
  • “Clinical Audit Support Centre” – provide accredited training and expert support in clinical audit and other quality improvement techniques.
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Dr. Khalid Abulmajd

Healthcare Quality Consultant

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