Clinical Audit - Clinical Audit - The Process

The Process

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 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.

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.