The primary purpose of a quality assurance or quality improvement (QA/QI) activity is to monitor or improve the quality of service delivered by an individual or an organisation. Evaluation generally encompasses a systematic collection and analysis of information to make judgements, usually about the effectiveness and/or efficiency of an activity. Evaluation in a broad sense refers to any set of procedures, activities, resources, policies and/or strategies designed to achieve some common goals or objectives.
Data collection and analysis for QA/QI activities should:
- Be collected and analysed coincidentally to standard operating procedures with standard equipment and/or protocols; and
- Be collected and analysed expressly for the purpose of maintaining standards or identifying areas for improvement in the environment from which the data was obtained.
To register a QA/QI activity, complete the Central Adelaide Local Health Network (CALHN) Quality Improvement Plan and Report available on the CALHN QI Register. The document is used to plan the QA/QI activity and is uploaded to the CALHN Quality Improvement Register at the beginning of the project, following approval by the relevant medical/nursing/allied health lead, clinical practice director, or equivalent. When the QA/QI activity is complete the QA/QI Brief is updated with results/outcomes and is uploaded to the CALHN QI Register as the final report. Consultation with local Quality Coordinators or a Quality Improvement Consultant is strongly recommended at the initial planning stage, and ongoing support is available throughout the QA/QI activity. For further information, refer to the Safety, Quality and Risk Management webpage on the CALHN intranet.
Clinical audits are part of continuous quality improvement processes and focus on specific clinical practices and patients' clinical outcomes (eg rates and types of complications following a surgical procedure) using data from medical records collected as part of standard care. Analysis is usually just presentation of simple descriptive measures (averages, proportions etc) or basic measure of difference between groups (eg. t-tests).
Clinical audits should be conducted at a departmental level and should be directed/managed by the appropriate department head and/or nursing/allied health lead and when conducted for internal departmental purposes do not usually require research ethics oversight.
Clinical audits may sometimes 'overlap' with research where the audit addresses a gap in existing scientific literature. If unsure about whether an activity is an audit or research, submit a copy of the project plan for advice to CALHN Research Services via email to Health.CALHNResearchLNR@sa.gov.au
Where dissemination of results includes publication, or the results of a QA/QI or audit warrant publication but ethical review is not required to undertake the activity, CALHN Research Services will review the abstract or draft publication and issue a publication approval.
Submit to CALHN Research Services:
- The draft manuscript / poster / presentation and a copy of the CALHN QI Brief
- Confirmation from the relevant Head of Department (email is sufficient) that the activity was undertaken for QA/QI or departmental clinical audit purposes
Submission is via email to Health.CALHNResearchLNR@sa.gov.au
In some instances, ethical review of a QA/QI activity or clinical audit is required. These may include:
- Where the activity potentially infringes the privacy or professional reputation of participants, providers or the organisation
- Secondary use of data – using data or analysis from QA/QI activities for another purpose
- Gathering information about the participant beyond that which is collected routinely. Information may include biospecimens or additional investigations
- Testing of non-standard (innovative) protocols or equipment
- Comparison of cohorts
- Randomisation or the use of control groups or placebos
- Targeted analysis of data involving minority/vulnerable groups whose data is to be separated out of that data collected or analysed as part of the main QA/QI activity
Where one or more of the above triggers apply, prior to commencing the activity a copy of the CALHN QI Brief must be submitted to the relevant head(s) of department for review and approval. The approval must then be submitted with the CALHN QI Brief to CALHN Research Services for review. If the activity is determined to be ethically acceptable an ethics exemption will be granted. However, where the activity is determined to require a higher level of oversight a research project submission may be required.
For further information about ethical considerations, refer to the National Health and Medical Research Council’s Ethical Considerations in Quality Assurance and Evaluation Activities, or contact CALHN Research Services on 08 7117 2224, or via email at Health.CALHNResearchLNR@sa.gov.au.