The Irish Minister for Justice Charlie Flanagan recently announced the passage of the Civil Liability (Amendment) Act 2017. When commenced, the Act will, amongst other things, provide for a statutory process of open disclosure (OD) of patient safety incidents (PSIs). PSIs include incidents causing actual harm as well as 'near miss' and 'no harm' events. This long awaited legislation builds on national guidelines developed over recent years by the Health Service Executive (HSE), the State Claims Agency and other stakeholders. The key difference though, is that the statutory process finally implements a Law Reform Commission recommendation to "allow medical practitioners to make an apology and explanation without these being construed as an admission of liability in a medical negligence claim".
The statutory OD process is an entirely voluntary one. There is no obligation on a Healthcare Service Provider (HSP) to engage in this process whether requested to do so or not. Equally, there is no bar to disclosing patient safety incidents outside of this statutory process, under existing practices and policies. However, to avail of the legal protections, the detailed statutory process must be used.
What legal protection applies?
Information provided and any apology made during an "open disclosure meeting" (ODM):
- shall not constitute an admission of, and shall not be admissible as evidence of, fault or liability in later proceedings
- shall not invalidate an insurance/indemnity
- shall not constitute or be admissible as evidence of fault, professional misconduct, poor professional performance in any disciplinary proceedings
If a HSP does choose to use the OD process, then a very detailed process must be followed, including:
- The disclosure must be made at a specific ODM by the patient's principal healthcare practitioner to the patient
- The ODM must be a face-to-face meeting, or by telephone if a face-to-face meeting is not possible
- Generally, the ODM must be held as soon as is practicable after the patient safety incident. It is recognised, however, that an ODM may not happen immediately in instances where the likely consequences of the PSI are not clear or have not developed before the ODM
- Before the ODM, the HSP must consider
a number of matters including:
- When the disclosure should be made and who should make it
- Whether an apology will be required
- Designation of a person to liaise between the HSP and the patient
- Whether other parties (for instance, service providers to the HSP) who may have an interest in the disclosure should attend
- At the ODM, the patient must be
provided with specific information, including the following:
- The persons present at the ODM
- The date on which the PSI occurred, and on which it came to the notice of the HSP (if different)
- The manner in which it came to the notice of the HSP
- A description of the PSI and its consequences (including whether further consequences are likely)
- The actions, policies and procedures the HSP proposes or has taken to address the PSI
- An apology, if appropriate
- A statement in writing in a prescribed form which includes the information referred to above, the wording of the apology and the date of the meeting. The statement must be signed by the HSP
- There is also provision for 'additional information' and 'clarification' meetings where relevant additional information becomes available, which have similar procedural requirements and privileges/legal protections
Open disclosure is hugely beneficial to patients, to families and also to healthcare practitioners, as it represents an opportunity to learn and build trust. However, practitioners and HSPs have understandable fears that disclosures may be interpreted as an admission of liability which can have significant consequences. While the new process will not necessarily avoid subsequent litigation arising out of any event, it should encourage a more open response to adverse clinical events.
However, for the process to be utilised, and the legal protections availed of, HSPs and practitioners will need to engage in significant advance planning and training. Appropriate resources will need to be committed to the process to ensure that the new statutory procedures are implemented, tested, and effective, and are ultimately reflected in professional practice, not just in legislation.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.