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when risk changes

Published 26 June 2021

When risk changes, governance of that risk must also change.1

In addition to proactive, continuous assessment of risks (acknowledging their inherently multi-faceted nature), clinical governance involves planning, implementing and reviewing measures to reduce the risk of harm, and support our duty of care – and often to also comply with regulatory obligations.2 Risk management by way of clinical governance is also a professional responsibility.3

Risk is not static, as the data that informs it is not. This is a particularly stark reality in the context of a continually evolving pandemic. On 17 June 2021, the Australian Technical Advisory Group on Immunisation (ATAGI) again changed its advice in relation to the AstraZeneca vaccine for COVID-19. ATAGI’s revised recommendation was in response to the evolving risk of thrombosis and thrombocytopaenia syndrome (TTS) associated with this vaccine - balanced against its benefits, assessed in the Australian context.4 Risk assessment is dynamic and multi-factorial.5 As such, in Australia, it is now recommended that the AstraZeneca vaccine be limited to those aged 60 and over.6

Similarly, on 9 June 2021, ATAGI recommendations changed as to the appropriate time interval between administration of COVID-19 and seasonal influenza vaccines,7 and also as to the safety of the Pfizer mRNA vaccine in pregnant women.8

ATAGI’s clinical governance role in Australia’s vaccination rollout involves, amongst other things, providing ‘technical input to policy development through epidemiological reviews, promotion of research, and assessment of the evidence for vaccination programs’, and communicating its findings and recommendations.9

Of course, health practitioners also play a role in clinical governance when managing novel and emerging risks, and as such they must be cognisant with contemporaneous guidelines.10 Under the Health Practitioner Regulation National Law,11 it is incumbent on all registered health practitioners to undertake continuing professional development.12 Ongoing learning is essential, as is continuous improvement at the practitioner and provider levels.

Finally, patient and consumer factors must always be considered. Informed consent is integral to good clinical governance, and to our duty of care.13 Consumer engagement and partnership is central to clinical governance,14 so information must be presented in a way that can be understood (in line with health literacy and cultural perspectives), and discussions should be facilitated at the point of care.

Responsibility for clinical governance flows through all tiers of the system, regardless of context. Clinical governance must always remain flexible and adaptive to appropriately respond to complex and evolving (and emerging) risks.


1. See discussion in M Tan, ‘Clinical governance in changing times: balancing risk, regulation and duty of care in aged care’, Australian Health Law Bulletin, November 2020. Dr Tan is now working as an independent consultant and is no longer with Russell Kennedy, however, the article can be found at: https://www.russellkennedy.com.au/insights-events/news/senior-associate-dr-melanie-tan-has-had-an-article-published-in-the-australian-health-law-bulletin-titled-clinical-governance-in-changing-times-balancing-risk-regulation-and-duty-of-care-in-aged.

2. See, for example, Aged Care Quality Standards (Quality of Care Principles 2014) and NDIS Practice Standards, January 2020 (National Disability Insurance Scheme (Provider Registration and Practice Standards) Rules 2018.

3. See for example ‘Good Medical Practice: a code of conduct for doctors in Australia’ (October 2020), Medical Board, AHPRA - clause 8.2.1 (risk management), ‘Good medical practice in relation to risk management involves acknowledging that all doctors share responsibility for clinical governance.’ Found at: https://www.medicalboard.gov.au/codes-guidelines-policies/code-of-conduct.aspx

4. https://www.health.gov.au/news/atagi-statement-on-revised-recommendations-on-the-use-of-covid-19-vaccine-astrazeneca-17-june-2021

5. See ATAGI ‘Principles underpinning the revised recommendations’: potential risk of severe illness and death from COVID-19 over the coming months; minimising harms to people due to adverse events following immunisation; Australian data on the age-specific risks and severity of TTS following COVID-19 Vaccine AstraZeneca; expected vaccine supply over the months ahead; impacts of any change in recommendation on the COVID-19 vaccine program. Found at: ATAGI statement on revised recommendations on the use of COVID-19 Vaccine AstraZeneca, 17 June 2021 | Australian Government Department of Health

6. Previously, the recommendation had been that people under the age of 50 should be administered the AstraZeneca vaccine. https://www.canberratimes.com.au/story/7283763/everything-you-need-to-know-about-getting-a-covid-19-vaccine/

7. https://www.health.gov.au/news/updated-atagi-advice-on-administering-seasonal-influenza-vaccines-in-2021

8. https://www.health.gov.au/news/joint-statement-between-ranzcog-and-atagi-about-covid-19-vaccination-for-pregnant-women

9. ‘Policies and procedures for the administration of the Australian Technical Advisory Group on Immunisation’, effective 1 July 2019, found at: https://www.nitag-resource.org/sites/default/files/7c8984ccfc15c35204981874ff6a2824bea3d29b_1.pdf

10. See for example ‘consensus guidelines’ in https://www1.racgp.org.au/newsgp/clinical/identifying-and-treating-vaccine-linked-blood-clot.

11. Enacted consistently in each state and territory: https://www.ahpra.gov.au/About-Ahpra/What-We-Do/Legislation.aspx

12. See https://www.ahpra.gov.au/Registration/Continuing-Professional-Development.aspx

13. See Rogers v Whitaker [1992] HCA 58: https://jade.io/article/67721

14. See figures 3 and 4, National Model Clinical Governance Framework, Australian Commission on Safety and Quality in Healthcare, found at: https://www.safetyandquality.gov.au/sites/default/files/migrated/National-Model-Clinical-Governance-Framework.pdf

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