The tragic case of Vicky Phelan together with the recent media coverage of the Cervical Check Programme has led to renewed calls for mandatory open disclosure to be placed on a statutory footing in Ireland. Open disclosure has been defined as “an open, consistent approach to communicating with service users when things go wrong in healthcare. This includes expressing regret for what has happened, keeping the patient informed, providing feedback on investigations and the steps taken to prevent a recurrence of the adverse event”[i].
Medical practitioners in Ireland have had a long standing ethical duty to be open and honest with patients about adverse events that may have caused them harm. Section 67.2 of the ‘Guide to Professional Conduct and Ethics for Registered Medical Practitioners 8 Edition 2016’ in Ireland states that when discussing events with patients and their families practitioners should:
- Acknowledge that the event happened;
- Explain how it happened;
- Apologise if appropriate; and
- Assure patients and their families that the cause of the event will be investigated and efforts made to reduce the chance of it happening again.
While doctors understand their ethical duty, historically the lack of protective legislation has created uncertainty and reluctance in the mind of some practitioners in relation to providing information when things go wrong, for fear that it could be used against them in civil proceedings or impact on their standing with their regulatory body.
Since 2015 the UK has had a statutory duty of candour which imposes an obligation on Health and Social Care organisations registered with the Care and Quality Commission (“CQC”) to act in an open and transparent way and to report a notifiable safety incident. Failure to comply is a criminal offence and sanctions include a fine up to £2,500 and the possible revocation of the provider’s registration by the CQC.
In Ireland, open disclosure was not addressed in legislation until the enactment of the Civil Liability (Amendment) Act 2017 (the “Act”) late last year. Part 4 of the Act which deals with open disclosure will only come into operation by Order of the Minister for Health. It places open disclosure of a patient safety incident on a statutory footing and contains protective provisions in relation to the use of information relating to the open disclosure and the apology made, after the open disclosure meeting. Crucially the Act provides for voluntary open disclosure and does not impose a mandatory obligation to disclose on health service providers.
The Act describes a patient safety incident as an incident which occurred in the course of the provision of health service to a patient:
- Which caused unintended or unanticipated injury, or harm;
- Which did not result in actual injury or harm but was one which caused the health services provider to have reasonable grounds to believe placed the patient at risk of unintended or unanticipated injury or harm; or
- Where, in the absence of prevention by intervention, could have resulted in unanticipated or unintended injury or harm.
Section 16 of the Act provides a clear framework to assist health services providers in the process of open disclosure and sets out the timing of when an open disclosure meeting should take place and the information that should be provided to a patient. It provides that should the health services provider determine that an apology is appropriate then the apology may be made at the time of the meeting.
The protective provisions in respect of the information disclosed at the meeting and the apology are dealt with in Section 10 of the Act. The section provides that where information is provided and an apology is given it will not constitute an admission of liability, fault or professional misconduct and as such, will not be admissible in evidence nor will it invalidate a contract of indemnity or insurance.
Before the Act passed all stages of the Oireachtas, the Justice Committee proposed an amendment to Section 12 which, if passed, would have made open disclosure mandatory. At the time it was argued that voluntary disclosure would not go far enough to protect patients from harm but the proposed amendment was ultimately rejected.
In the aftermath of the Vicky Phelan case and in an attempt to address public concerns the Minister for Health presented cabinet with a number of proposals which would make mandatory the reporting of Serious Reportable Events (“SRE”) in the Health Service.
It is important to differentiate between open disclosure of a patient safety incident which is defined in the Act and the obligation to report an SRE. SRE’s are described in the 2015 HSE Special Report “as a defined list of serious incidents many of which may result in death or serious harm”. The mandatory reporting measures being considered by cabinet are to be introduced through the Health Information and Patient Safety Bill this year. The measures will allow the Minister for Health to prescribe a list of SRE’s that must be reported to HIQA, the State Claims Agency or the Mental Health Commission. It is not yet clear whether the Minister for Health proposes to impose similar sanctions to those in place in the UK.
In Ireland the provisions relating to open disclosure in the Act will be a significant step forward in fostering a relationship of trust between clinicians and patients. The Act provides a clear framework to assist health services providers with the process of open disclosure and the protective provisions should serve to allay fears among medical practitioners that information provided to patients in the spirit of open disclosure can be used against them in Civil or Regulatory proceedings
As part of the HSE’s National Open Disclosure Pilot in 2016 evidence was given about the significant impact open disclosure has on reducing legal claims and improving the often adversarial nature of the litigation process. Evidence was provided by hospitals in both Michigan and Australia as to the reported reduction in claims and the consequent savings for the health service.
Part 4 of Act has not yet been commenced and while hospitals in Ireland are already promoting open disclosure it is anticipated that on commencement of the Act open disclosure of patient safety incidents will become more common place across the HSE. Public opinion is strongly in favour of open disclosure and it is hoped that with the implementation of the protective provisions, the Act will serve to foster a culture of open and honest communication in all healthcare settings.