Quality improvement / assurance activities

A Quality Improvement (QI) or Quality Assurance (QA) project is one which measures, monitors and evaluates performance. It is an essential component of clinical practice, specific to the organisation in which it was conducted. A QI or QA activity usually has no impact on present patient care, nor does it pose additional risks for the patients involved.
Quality improvement / assurance activities may raise ethical issues requiring review.

Individuals engaged in these activities should refer to the NHMRC Ethical Considerations in Quality Assurance and Evaluation Activities

A QI/QA activity may require ethical review when:
o It is a departure from standard care (eg testing of non-standard protocols or equipment)
o It Involves direct contact with patients or staff members (eg a survey)
o It involves allocation to different treatment options
o It involves the gathering of data about a patient beyond what is routinely collected
o access to health information extends beyond those who are part of the clinical team
o it is a targeted analysis of data involving minority or vulnerable groups
o the data collected may identify individuals
o it may be submitted for publication

Before commencing a QI/QA activity, you are advised to consult with each Public Health Organisation (PHO) involved in order to determine the process adopted by the PHO for the ethical review of quality improvement/assurance activities. Most ethics committees will not grant retrospective ethics approval.