Quality assurance quality improvement and audits

In some instances, ethical review of QA/QI activities or audits is required. These instances may include:

• Any infringements on the privacy or professional reputation of participants, providers or the organisation.
• Secondary use of data meaning using the data or analysis from QA/QI activities for another purpose.
• Gathering information about the participant beyond that which is routinely collected.
• 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 vulnerable groups whose data is to be separated out of the data collected or analysed as part of the main QA/QI activity.

Where any of the above triggers apply, prior to commencing the activity a copy of the QI brief must be submitted to the relevant head(s) of department for review and approval. 

The approval can then be submitted with the brief to CALHN research services for review. If the activity is determined to be ethically acceptable an ethics exemption will be granted. 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 please refer to the National Health and Medical Research Council’s Ethical Considerations in Quality Assurance and Evaluation Activities.

QA focuses on maintaining consistent high standards within processes and procedures ensuring that established standards are consistently followed, for quality and integrity purposes.

Data collection and analysis for QA activities should 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.

QI aims to improve processes or practices within existing frameworks to increase procedural efficiency or optimise the effectiveness of practises.

Data collection and analysis for QI activities should be collected and analysed coincidentally to standard operating procedures with standard equipment and/or protocols.

Audits examine and verify the level of compliance within existing criteria, standards, and regulations. They focus on identifying areas for improvement and recommending corrective actions.

Clinical audits focus on specific clinical practices and patient clinical outcomes by using data from medical records collected as part of standard care. Analysis involves a presentation of descriptive measures such as averages, proportions or t-tests.

Audits should be conducted at a departmental level and should be managed by the appropriate department head and/or nursing/allied health lead. When conducted for internal departmental purposes audits do not usually require research ethics oversight.

Clinical audits may sometimes become research when the audit addresses a gap in existing scientific literature.

When results are planned to be published but ethical review is not required to undertake the activity, the abstract or draft publication will be reviewed and a publication approval will be issued.

Submit to CALHN Research Services:

• the draft manuscript, poster, presentation and the QI brief
• confirmation from the relevant Head of Department (email is sufficient) that the activity was undertaken for QA, QI or audit purposes.

To register a QA/QI activity, complete the Central Adelaide Local Health Network (CALHN) QI plan and report available on the CALHN QI Register located on the CALHN intranet. 

The plan and report will be uploaded to the CALHN QI Register at the beginning of the project, following approval by the relevant medical/nursing/allied health lead, clinical practice director or equivalent. Once the QA/QI activity is complete the brief is updated with results and is uploaded to the CALHN QI Register as a 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.