Quality Assurance (QA) is an activity where the primary purpose is to monitor or improve the quality of service delivered by an individual or organisation and includes terms such as ‘quality assurance’, ‘quality improvement’, ‘quality activities’, ‘clinical audit’ and ‘audit’.
The National Health and Medical Research Council (NHMRC) has published Ethical Considerations in Quality Assurance and Evaluation Activities (NHMRC; 2014) to facilitate oversight of Quality Assurance activities for individuals and organisations conducting quality assurance activities who are responsible for ensuring that:
participants are afforded appropriate protections and respect
QA activities comply with all relevant legislation and regulations
organisations provide guidance and oversight to ensure activities are conducted ethically including a pathway to address concerns
At the Eye and Ear, staff are encouraged to undertake QA activities.
How to apply to the Eye and Ear Research Office for a QA activity
Applications are submitted via email to the Research Office.
What documents need to be submitted?
Below is a list of the documents required for submission. Minimum standards apply to all applications:
Applications must be complete; incomplete applications will be returned to the researcher
Handwritten applications will not be accepted
Head of Unit/Clinic/Department is required prior to undertaking any QA activity
Core Documents
Project Dependent Additional Documents
Eye and Ear Quality Assurance Activity Application Form
Quality Assurance Supplementary Form – Privacy
Quality Assurance Supplementary Form – Databanks
Participant Information Sheet & Consent Form
Survey/Questionnaire
Head of Supporting Department Form
Agreements
Eye and Ear forms, templates and guidelines can be found here.
Further details can be found below.
The answer is not simple and does require consideration and judgement.
Irrespective of whether an activity is QA, evaluation or research, the activity must be conducted in a way that is ethical.
In many situations, oversight of the activity is required, but ethical review is not necessary.
As explained in the NHMRC guidance, where ethical review by an HREC is not required, organisations should consider providing a statement which affirms that an alternative approach to ethical review was considered to be appropriate for the specific QA/evaluation activity if this is required for publication purposes.
The Research Office provides an oversight process to facilitate QA activities (and clinical audit).
Staff are required to also seek approval from the Head of Unit / Clinic / Department prior to undertaking any QA activity.
The Clinical Improvement and Risk and Quality teams initiate and support quality improvement activities to improve models of care, patient safety programs and compliance with accreditation standards.
Clinicians do not usually need HREC approval for writing and publishing a Case Report. However, clinician-researchers are encouraged to determine the requirements of specific journals early as some journals require HREC review and approval and submit a completed Quality Assurance Project Application Form (selecting Case Report in Section A.1).
Staff are required to also seek approval from the Head of Unit / Clinic / Department.
Clinicians should also obtain patient consent, unless otherwise exempt. The Medical Journal of Australia provides a template Consent Form you could use.
Some journals do require evidence of review if there are more than a minimal number of cases, e.g., 3 cases.
Eye and Ear staff can submit Case Reports using the Quality Assurance Project Application Form to the Research Office for review at ethics@eyeandear.org.au and a letter of organisational endorsement may be issued.
The Eye and Ear letter of endorsement is for use of Eye and Ear patient health information. If you are proposing to use health information of patients at other organisations, then you will also need to seek organisational authorisation from each organisation according to their requirements.
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