The recent adverse publicity in relation to CervicalCheck and wide ranging recommendations contained within the Scally report acts as a useful reminder to health service providers and medical practitioners concerning the risk of not being open and communicating as early as possible with patients when errors occur. Some practitioners are unsure whether they are obliged to inform patients when an error has occurred in medical treatment and many are terrified that if they do, they will risk litigation or a complaint to the Medical Council. Presently the law leaves disclosure of adverse incidents to a health service provider’s discretion[1].
However, new proposed legislation contained in Patient Safety Bill 2018 (the "Bill”) provides for mandatory disclosure of serious patient safety incidents. Significantly, health service providers who fail to make a disclosure which is mandatory under the Bill could face up to a €7,000 fine and 6 months imprisonment[2]. However, in certain specific circumstances when a disclosure is made, it cannot be used as evidence of liability or fault during litigation or for the purposes of Medical Council complaints. This legal protection for medical practitioners is aimed to encourage a culture of open disclosure.
The Bill sets out the circumstances in which mandatory open disclosure is to be made to the patient, the State Claims Agency and HIQA / the Mental Health Authority[3]. Open disclosure must occur when a “serious patient safety incident” happens. While specific incidents are to be prescribed in further Regulations, the Bill gives an indication of the sort of patient safety incidents which will be considered “serious” enough to require disclosure. The Bill proposes that a “serious patient safety incident” should include incidents which lead to:
- death
- loss of bodily or sensory function
- a change to a person’s body structure
- shorter life expectancy
- 28 day impairment or pain, or
- treatment in order to prevent one of the previously listed outcomes[4]
The proposed legislation also provides a list of examples of reportable incidents[5], which includes no harm events which could have been serious, but not “near misses”[6]. A final proposal worth noting is that the SCA is to publish anonymised information on reported incidents[7].
Benefits of Open Disclosure
Advocates for a duty of candour believe that it improves several aspects of healthcare, for example:
- Improved Quality of Healthcare – A system which allows for errors to be identified and eradicated arguably goes a long way to improving the standard of patient safety, which in turn leads to the provision of a higher quality of healthcare. A system of open disclosure also facilitates respect for patient autonomy.
- Attacking the Blame Culture – Open disclosure can go a long way to addressing the litigious blame culture that exists both outside and within the medical profession. A blame culture does little to make the system safer or prevent someone else from committing the same error, and can have an adverse impact on practitioners as they fear that admitting an error might impact their reputation amongst their peers.
- Systematic Improvements – This improvement results from errors which are disclosed under an “open” system being recognised and systematic measures being put in place to avoid a repeated future occurrence. Facilitating the open disclosure of adverse events could, for example, go a long way towards eradicating repeated avoidable errors by implementing an organised care provision system with clear lines of accountability, as seen in the aviation industry for example.
- Greater Trust Leading to a Reduction in Litigation – An atmosphere of open disclosure between a practitioner and a patient has the potential to lead to a reduced quantity of clinical negligence claims. An environment of open and honest disclosure could increase the sense of involvement felt by patients, and possibly render them less likely to sue their treating practitioner for an honestly disclosed error. This needs to be balanced against the proposition in the current version of the Bill that plaintiffs in any ensuing litigation will not be able to rely on disclosures in proceedings. Loss of trust in the system can compound any medical errors that occur, as displayed by the recent events surrounding CervicalCheck.
Practical Advice
Irrespective of what legalisation stipulates, it is important for health service providers and medical practitioners to understand and bear in mind the critical difference between an expression of regret that an error has occurred and a culpable apology.
It is always unwise to accept responsibility for a tragic event or an injury in circumstances where the causal link between the error and the injury suffered is yet to be determined. In those circumstances, the most prudent and best practice would be to inform patients or their loved ones that an error has occurred but the critical issue as to whether the error in management has caused the injury can only be determined by further investigation.
Imparting bad news can often be extremely stressful. It is always wise, if possible and particularly in challenging circumstances, to speak to a senior colleague, or if necessary have them present, when speaking to a patient or relative.
We will report further as matters unfold and following the Patient Safety Bill being fully finalised and signed into law. Given its “priority” status, this can be expected to take place sooner rather than later.
[1]. Civil Liability (Amendment) Act 2017, available at http://www.irishstatutebook.ie/eli/2017/act/30/enacted/en/html
[2]. Head 32 of the Bill. The approved General Scheme of the Bill can be found at https://health.gov.ie/wp-content/uploads/2018/07/General-Scheme_Patient-Safety-Bill_5-July-2018.pdf
[3]. Part 2 of the Bill.
[4]. The Bill (n 2) at page 10.
[5]. The Bill (n 2) at page 10.
[6]. Ibid at page 11.
[7]. Head 13 of the Bill.