In this article, Dr Cathal O’Keeffe, Head of Clinical Risk, and Marie Hutton, Clinical Risk Legal Advisor, in the State Claims Agency, look at the HSE’s updated National Consent Policy and how, when followed, it can help mitigate the risk of claims around patient consent arising.

In March the HSE published its updated National Consent Policy, which sets out one overarching HSE policy to guide staff on the issue of consent. The revised policy, which represents an extensive revision and rewriting of some elements of the original policy published in 2013, takes account of important legislative and policy changes that have occurred since then, including the Freedom of Information Act 2014, the Assisted Decision-Making (Capacity) Act 2015, the Children First Act 2015, the Health (Regulation of Termination of Pregnancy) Act 2018, the General Data Protection Regulation, and the Data Protection Act 2018.¹

The State Claims Agency’s perspective on consent

The State Claims Agency analyses both claims and incidents reported on NIMS (the National Incident Management System). Incidents related to consent recorded on NIMS include patients arriving to theatre without a signed consent form or where a different or additional procedure is undertaken, for which the patient had not provided consent.

Claims rarely arise due to one single error - more often several factors contribute. However, analysis of clinical claims shows that deficiencies in the consent process, as well as in relation to communication more broadly, frequently feature in claim causation. In a recent review of finalised claims, substandard or omitted consent was one of the most significant communication deficits identified, featuring in 31% of perioperative claims and 65% of claims in community services.

Although all procedures carry the risk of complications, claims may arise if the plaintiff alleges that they were not made aware of a potential complication, or if there is insufficient documented evidence of the consent process. Consent may also be a factor in claim causation if it was obtained by a junior member of staff who was neither familiar with (due to inexperience) nor involved in the procedure.

Getting consent right

As stated in the HSE policy, consent is a process.¹ It requires ongoing and effective dialogue between the health and social care worker and the service user, rather than a one-off, ‘last minute’ signing of a form. The consent process should also include the documentation of all discussions regarding the risks, benefits, and alternatives of interventions.

The importance of the consent process cannot be over-emphasised and getting it right can mitigate the risk of claims arising.

References available on request.