The Civil Liability (Amendment) Bill 2017, has passed both houses of the Oireachtas and has recently been signed into law by the President. However, the Act still awaits a commencement order. The main changes being established by the Act are in relation to:
- Open Disclosure
- Periodic Payment Orders
- Pre-Action Protocols
In this article, I will deal with the one main provisions of the Act, open disclosure. In that respect, prior to the enactment of the Bill, there was much debate on whether this duty should be mandatory or voluntary. Ultimately it has been passed into law that this duty should be voluntary.
Open Disclosure The Act provides that a health care service provider should inform a patient of any patient safety incidents and the Act sets out what information should be given to a patient when there is a patient safety incident while a patient is in their care.
Key Definitions The definitions of a “health practitioner” and a “health service provider” are very broad and capture the full range of public and private health services and include:
(a) a registered medical practitioner within the meaning of the Act of 2007 or a medical practitioner practising medicine pursuant to section 50 of that Act, (b) a registered dentist within the meaning of the Act of 1985, (c) a registered pharmacist, or registered pharmaceutical assistant, within the meaning of the Pharmacy Act 2007, (d) a registered nurse, or registered midwife, within the meaning of the Act of 2011,
A patient is defined as, “in relation to a health service provider, a person to whom a health service is, or has been provided.”
A “relevant person” is defined by this section as a “person who is a close family member, spouse, civil partner, cohabitant of the patient or someone nominated in writing by them thereby authorising that person to receive clinical information in relation to that patient.”
A “patient safety incident” is defined as:
- An incident which has caused injury or harm to a patient which was unintentional or not anticipated.
An incident where no actual injury or harm resulted but the health service provider has reasonable grounds for the belief that the patient was at risk of being subjected to unintentional or unanticipated injury or harm
An incident where a patient was prevented from being subjected to unintentional or unanticipated injury or harm and the health care provider reasonably believes that had such prevention not taken place that the patient would have suffered such injury or harm
What does the Act do? This act establishes a legal basis for the provision of information in relation to a patient safety incident as defined above and also protects the provision of an apology to the Patient by the service provider, by stating that this cannot be interpreted as an admission of liability and cannot be used in litigation against the provider.
How did this come about? This policy has been formed by an evidenced based research of best practice in open disclosure in other countries that have had open disclosure standards in place for some time such as Australia, Canada, America and the UK.
How does a Health Service Provider Comply? The framework for open disclosure is set out the National Policy on Open Disclosure which was developed jointly by the HSE and the State Claims Agency and is also endorsed by the Medical Council in their “Guide to Professional Conduct and Ethics” 2016.
The process for same is that a Health Service Provider must:
- Acknowledge that the event happened;
- Give an explanation as to how it happened;
- Afford an apology if appropriate; and
- Give an assurance as to how lessons have been learned to minimise the chance of this event happening again in the future
Section 10 of The Act states that the disclosure made of a patient safety incident in accordance with this Act to a patient, a relevant person or both in an open disclosure meeting shall be considered an open disclosure. Section 10 also states that this information and apology does not invalidate insurance; constitute admission of liability or fault; or is not to be admissible in proceedings
Section 11 of the Act establishes that a health service provider must produce a written statement detailing the procedure for making an open disclosure. It remains to be seen what precisely this will entail, it is stated in the act that the minister may make guidelines on the form of this statement.
Does an Apology amount to Fault? Information or an apology given as part of an open disclosure shall not amount to an admission of fault or liability by a health service provider nor shall it be admissible as evidence of fault or liability in court in relation to that patient safety incident or any clinical negligence action which may arise from it.
Furthermore, a policy of professional indemnity insurance is not to be invalidated as a result of information or an apology given in respect of the open disclosure of a patient safety incident made by a health care provider or any other such person as specified in the Act.
What is the aim of Open Disclosure? The overall aims of this provision, according to the Department of Health, is to ensure that patients are aware of when a patient safety incident has occurred thus resulting in improved patient safety and quality of care and increased trust between patients and clinicians.
What does this all mean? It remains to be seen what impact this will have in practice and some commentators have argued that this duty should have been mandatory in nature to compel complete disclosure of patient safety incidents.
In this regard, it is perhaps worth noting the policy that is set out in relation to “near miss events”, such events should be assessed on a case by case basis and the potential impact of informing the patient of the “near miss event” must be weighed up. This clearly recognises that the overriding duties of clinicians must be the health and welfare of their patients and it is likely that this consideration was a factor in the making the provision of open disclosure mandatory in nature.
Other commentators have taken issue with the name itself and by its very meaning disclosure seems to imply that a wrong had been committed. In that respect, “open communication” may have been a more appropriate description of ultimately what the Department is trying to achieve here, an open channel of communication between our health service providers and patients to the benefit of all.
Other Jurisdictions: The reality The reality of all of this is that it will require a great deal of “buy in” from practitioners. In Australia, which was one of the first countries to implement this policy, there have been numerous surveys and research carried out on this topic. In a study in 2011, it was concluded that only about one third of incidents were being disclosed. This is what academics are referring to as the “incident disclosure gap”. In the USA, a paper by the Department of Health highlighted that hospital staff did not report 86% of events to voluntary incident reporting systems.
The issues identified by health service providers were primarily a fear of being sued. Thereafter, the actual fear of giving the information was listed as the next biggest barrier. In that respect, Health Service Providers in the US and Canada have implemented a policy of training medical professionals in how to deal with open disclosure and how to communicate an adverse event effectively to a patient.
It should be pointed out here that the State Claims Agency Report analysing data from 2010 to 2014 showed an increase in the number of clinical incidents being reported by 16.2%. However, given the evidence illustrated above, it would seem reasonable to conclude that a lot of patient safety incidents are not being reported.
Legal protection of the Information Disclosed As already outlined, the Act provides that information disclosed does not constitute an admission of liability or fault; and is not to be admissible in proceedings, but how will this work and what does it mean?
In Australia, once again, information gathered in the investigation of an incident by a ‘declared committee’ such as a root cause analysis committee, in order to facilitate free and thorough inquiry and information gathering and to maximise learning from incidents is protected under statute. Communications in and findings of quality assurance committees and reports to root cause analysis committees are generally not able to be used in evidence in subsequent proceedings and specifically protected as under Statute.
In Ireland the position would appear to be different in so far as the courts have previously ruled that information such as this is only privileged if it has been prepared in contemplation of legal proceedings and if the information in a document has been compiled as part of a safety audit, i.e. to maximise learning from incidents then it is discoverable in the context of legal proceedings. The question arises therefore, unless some form of protection of this information is provided to Health Service Providers then where is the incentive to collate same. It is to be noted that the Act does state that information given in open disclosure cannot be used as part of proceedings, but there is no specification of same which would have been helpful from a practical point of view particularly in light of the Courts attitude in this jurisdiction towards any information generated as part of a quality improvement/ safety audit.
Another question arises in so far as all of the protections afforded under the Act are relevant in the context of civil proceedings, but what about criminal proceedings. In the UK, the case of Dr. Bawa-Garba, is of note. In that case, the doctor had been found guilty and was convicted of gross negligence manslaughter in 2015 following the death of a six-year-old boy. A question arose over the privilege of reflective entries from her e-portfolio. It was confirmed by the General Medical Counsel that these were not used to secure the 2015 conviction, although notes made by her duty consultant on a meeting he had with her after the incident formed part of his witness statement. After guidance was sought by the NHS on this issue, the GMC confirmed that 'Recorded reflections (such as e-portfolios) are not subject to legal privilege under UK criminal law. As a result, these documents might be requested by a court if it is considered that they are relevant.'
The above are illustrations of the difficulty that the Department faces to assuage the fears of Health Service Providers with respect to open disclosure.
Where will this all end up? The Act sets out that the duty to make open disclosure is voluntary and for a number of reasons, as already outlined, when a patient safety incident occurs, Health Service Providers can be slow to inform a patient that same has occurred. In this regard, one could envisage an emerging tort of nondisclosure in these scenarios whereby a health service provider, who has not disclosed a patient safety incident and even in circumstances where the original mistake was not negligent, the patient may be able to recover damages for the additional loss suffered as a result of not being told of the mistake. Will we see the Judiciary start to penalise health service providers in the form of aggravated damages in circumstances such as these.