A clinical governance perspective on politics, politics aside
The challenges which COVID-19 presents to clinical governance has required intervention at the government level to promote safe, quality care in the context of a pandemic. This has been exemplified via government directives regarding elective surgery, to reduce the risk of infection to surgical teams and patients1 and ‘to preserve medical supplies and vital equipment needed for the anticipated surge in COVID-19 patients requiring high-acuity care.’2 In the spirit of collaboration, which is imperative to good clinical governance, the Royal Australasian College of Surgeons also commissioned guidelines to decision-making within this regulatory context.3
When, at the end of June, the Australian federal government decided to facilitate access to any COVID-19 vaccine (including AstraZeneca) by its population under the age of 604 - ostensibly contrary to medical recommendations on the safety of the AstraZeneca vaccine in this age group5 – it was arguably an exercise in support of clinical governance. Why?
Clinical governance and risk
Firstly, this decision was announced at a time when the risk profile of COVID-19 in Australia was changing, with restrictions re-introduced across most of Australia amidst concerns over the Delta variant of the virus.6 Clinical governance, on any scale, requires that risk be constantly reviewed, and appropriately responded to, as it evolves.
No medical intervention is devoid of risk; we accept these risks because we consider the benefits to outweigh them. It must be noted that the medical advice and assessment of risk had not changed. Specifically, notwithstanding a preference for the Pfizer (Comirnaty) vaccine over the AstraZeneca for people under the age of 60, the ATAGI advice remained that ‘COVID-19 Vaccine AstraZeneca can be used in adults aged under 60 years for whom Comirnaty is not available, the benefits are likely to outweigh the risks for that individual and the person has made an informed decision based on an understanding of risks and benefits.’7 As competent adults, we individually make decisions on the acceptability of risk every day.
Clinical governance and choice
Secondly, the government’s decision effectively supports person-centred care, which is at the very core of contemporary clinical governance.
By way of changes to the MBS and a promise of indemnity, it simply entitles and enables anyone, regardless of age, to consult a GP in relation to vaccination – that is, seek advice. Obtaining informed consent (or refusal of consent) is a component of duty of care in any medical treatment decision,8 and is fundamental to consumer (or patient) centred care.
- In exercising clinical governance, risk, benefit and safety must be considered as a whole and balanced against each other – whilst acknowledging they represent different domains that should be considered separately, as well as in tandem.
- In any context, risk must be specifically assessed (to the extent possible). The federal government’s decision to facilitate access to the AstraZeneca vaccine to the younger population, despite the increased risk of thrombocytopaenia syndrome (TTS) in this demographic, supports the right to such autonomy - by enabling individuals to balance the risk themselves, against their own personal circumstances and values, and with the advice of their GP.9
- Assessment of risk, at an individual level, can only rightly be made by that individual – not only on the basis of medical advice, recommendations and warnings, but according to that individual’s unique values, beliefs and preferences. This is what consumer-centred care is all about; autonomy, choice and informed consent. This is clinical governance.
1. See for example, https://www.health.gov.au/news/australian-health-protection-principal-committee-ahppc-statement-on-restoration-of-elective-surgery, accessed 4 July 2021.
2. W Babidge et al. ‘Surgery Triage during the COVID-19 pandemic’. ANZ J Surg 90 (2020) 1558-1565, DOI: 10.1111/anz.16196.
3. ‘Surgery triage: responding to the COVID-19 pandemic: a rapid review commissioned by RACS’. Version 2.0, 5 May 2020. Accessed on 4 July 2021 at: https://www.surgeons.org/-/media/Project/RACS/surgeons-org/files/news/covid19-information-hub/2020-04-22_racs-triage-of-surgery-web.pdf?rev=c28712668d7f45f19ca9df53b77011ea&hash=82A77A9AD9B8A5E23807E449386B80E1
4. As per the following:
- National Cabinet Statement, 28 June 2021, Prime Minister of Australia: https://www.pm.gov.au/media/national-cabinet-statement-5: ‘National Cabinet noted that the Commonwealth will establish a COVID-19 professional indemnity scheme to provide additional certainty to healthcare practitioners who are providing advice to people in relation to COVID-19 vaccination. The scheme covers COVID-19 vaccines approved by the TGA and approved for use in the vaccine program. National Cabinet noted that GPs can continue to administer AstraZeneca to Australians under 60 years of age with informed consent and that this measure will provide confidence to medical practitioners to administer both AstraZeneca and Pfizer vaccines to Australians.’
- On 29 June 2021, the Medicare item for GPs to ‘counsel patients and build confidence in the COVID-19 vaccine’ was expanded to all patients, irrespective of age (this only applied to patients over 50 when initially introduced on 18 June 2021). See RACGP ‘MBS COVID-19 vaccine suitability assessment service’ at https://www.racgp.org.au/running-a-practice/practice-resources/medicare/medicare-benefits-schedule/covid-19-vaccine-suitability-assessment-service, on 1 July 2021.’
5. ‘ATAGI advises that Comirnaty is preferred over COVI-19 Vaccine AstraZeneca from the age of 16 to under60 years. This is based on recent data regarding TTS cases in Australia and a reassessment of current age-specific risks and benefits of vaccination.’ See ‘ATAGI statement on revised recommendations on the use of COVID-19 Vaccine AstraZeneca, 17 June 2021’. Accessed on 4 July 2021 at: https://www.health.gov.au/news/atagi-statement-on-revised-recommendations-on-the-use-of-covid-19-vaccine-astrazeneca-17-june-2021
6. See National Cabinet Statement, 28 June 2021, Prime Minister of Australia (link above).
7. See ‘ATAGI statement on revised recommendations on the use of COVID-10 Vaccine AstraZeneca, 17 June 2021’, Australian Technical Advisory Group on Immunisation: https://www.health.gov.au/news/atagi-statement-on-revised-recommendations-on-the-use-of-covid-19-vaccine-astrazeneca-17-june-2021, accessed on 3 July 2021.
8. Rogers v Whitaker  HCA 58; 175 CLR 479
9. Some useful discussion in the following article by B Montgomery, Senior Lecturer in General Practice, the University of Western Australia: https://theconversation.com/how-can-younger-australians-decide-about-the-astrazeneca-vaccine-a-gp-explains-163733