With the commencement of mandatory open disclosure imminent, David Lynch examines the implications of this new era for medical professionals
Mandatory open disclosure is expected to commence next year.
The Patient Safety (Notifiable Incidents and Open Disclosure) Act 2023 was enacted on 2 May. There is no confirmed date for commencement; however, most observers predict that the legislation will come into force during the second quarter of 2024.
The Act has numerous elements of which open disclosure is only one. Writing in the Medical Independent (MI) in June, Dr James Thorpe of Medical Protection noted the legislation stipulates that “a specific list of notifiable incidents must be disclosed to the patient and/or their relevant person and reported to HIQA or the Mental Health Commission”. There are 14 notifiable incidents for which mandatory disclosure must be made. Examples cited by Dr Thorpe were ‘wrong-site surgery’ and ‘death due to medication error’.
The legislation will commence within what some observers regard as a difficult medico-legal culture in Ireland (see panel).
Last month saw the publication of the national open disclosure framework for the whole health and social sector. According to the Department of Health, this framework sets out a “consistent system-wide approach for our health and social care services to open communication” following a patient safety incident. The framework will apply beyond the HSE “to all private health and social care providers, as well as health regulators and educational bodies”.
Upon its launch, Minister for Health Stephen Donnelly said it “builds on existing HSE and other policies, as well as the views and experience of stakeholders and recommendations from the Independent Patient Safety Council”. He added that the framework “complements the new Patient Safety Act in building a culture of patient safety that is focused on continuous learning and improvement”.
Updating the HSE’s open disclosure policy “remains a key priority”, an Executive spokesperson told this newspaper.
Following the launch of the framework, the HSE’s policy will now be revised “to reflect alignment with these and other national developments”. The HSE has established a national working group to oversee implementation of the Patient Safety Act.
“Five workstreams have also been established to undertake the work required to implement the various sections of the Act,” according to the framework.
The HSE open disclosure policy was reviewed, updated and launched in 2019. A further review of the policy was undertaken three years later, but it was agreed by then that the policy must align with the publication of the framework, the enactment of the legislation and revision of Part 4 of the Civil Liability Amendment Act 2017.
Despite these differing moving parts, the HSE has continued open disclosure training of medical staff in recent years. There are two e-learning modules and face-to-face skills training. All staff are required to undertake module one which provides an introduction to open disclosure. Module two and the face-to-face training are intended for staff who will be leading on open disclosure discussions. Training is mandatory and a refresher is required every three years.
The HSE spokesperson said that it was “satisfied” with the current figures in relation to the uptake of training by medical staff.
The current training target is 30 per cent uptake per year for module one of the e-learning programme, which is based on a 90 per cent target over three years and a three yearly requirement for refresher training. The current percentage uptake of this module for medical staff is 27 per cent for this year to date.
“The data also demonstrates that the uptake of face-to-face training by doctors is continually improving,” added the spokesperson.
“We would like to increase the face-to-face training as it is invaluable for upskilling doctors, but this is limited by capacity.”
The spokesperson indicated that funding is a challenge in that regard.
“We hope to increase our training capacity to help deliver on the requirements of the legislation and national open disclosure policy framework and Patient Safety Act, but it is dependent on funding.”
In its recent annual report published in September, the national council of the IHCA said it had “made clear” to the HSE that “it is important that consultants are accommodated and assisted in relation to [mandatory open disclosure] training, having due regard to busy work schedules and time limitations”.
The HSE is not the only organisation in which open disclosure poses some workforce capacity challenges.
HIQA is currently in “final discussions” with the Department of Health on a workforce plan that seeks “necessary additional resources”, MI understands.
The new resources are required for the expansion of HIQA’s responsibilities under the Patient Safety Act 2023.
Under the Act, the Authority will have an expanded monitoring role in regards the inspection of privately provided inpatient healthcare facilities. HIQA will also have a role in receiving notifications related to mandatory open disclosure of certain serious patient safety incidents across the public and private sectors. These notifications will be received via the State Claims Agency’s national incident management system, with follow-up as required.
It is expected that the legislation “will substantially increase HIQA’s workload in the area of healthcare monitoring” leading to some workforce implications, the Authority informed this newspaper.
HIQA’s Director of Healthcare Regulation, Mr Sean Egan, told MI that “we have submitted a workforce plan to the Department of Health to provide us with the necessary additional resources to undertake this role”.
“We are currently in final discussions with the Department of Health with respect to securing necessary funding for this uplift in resources.”
Mr Egan added the “legislation aims to strengthen the approach to open disclosure to patients, so that they are fully informed when aspects of their care go wrong”.
“As part of HIQA’s approach to inspection under the Act, we will work to ensure that health service providers have put the necessary supports in place to fully promote implementation of open disclosure, including staff training and oversight of practice.”
On HIQA’s role in responding to clinicians’ concerns about how mandatory open disclosure will be carried out in practice, Mr Egan said this was more an area for the Medical Council and the health service providers.
“However, HIQA will have a role in ensuring that health service providers are working to support staff with necessary training, etc, to ensure that disclosure is occurring appropriately.”
The ninth edition of the Medical Council’s guide to professional conduct and ethics for doctors was launched on 1 November. It includes an updated section on open disclosure, which advises doctors they “must practise, promote, and support a culture of open disclosure” and comply with any applicable legislation and national policies regarding open disclosure. It signposts doctors to the Patient Safety Act.
Prof Deirdre Madden, Professor of Law at University College Cork and member of the HSE board, addressed the IHCA Annual Conference in September on the issue of the practical implications of the new Act for patients and doctors.
Prof Madden described patient safety as a “global issue” and that “healthcare can be very complex, bureaucratic, and opaque for people who are outside of it”, with some “very hierarchical structures”.
She noted that there can be “a perceived failure to learn from mistakes because we see the same things happen over and over again, I think that is very frustrating for you [doctors] who work within it [the health system], and it is also very frustrating to patients, their families and the public in general”.
She added that “an expectation of transparency is something that has grown a lot over the last number of years”.
“What I’m interested in is whether that openness helps to improve the quality of the service.”
During the questions and answers session, Prof Madden was asked if she thought the new legislation had achieved its objectives and struck the “right balance”.
“We have to consider what the objectives are,” she responded.
“There were of course policy objectives, political objectives… open disclosure [is] just one part of the Act, although obviously a really important one.
“I’m not convinced that the Act is achieving the right balance. Even though I have advocated for open disclosure for many years…. I think it’s hugely important, it’s a moral imperative…. I think everyone in the room should support open disclosure and I believe that most clinicians do.”
However, she considered that open disclosure “is not well suited” to the kind of “formulaic, legalistic process that the legislation now obliges doctors to engage in order to get the protection of the Act”.
Prof Madden highlighted how as a result of the Act, the failure to comply with an open disclosure process could result in a criminal conviction.
“I don’t necessarily think that was the right approach,” she said.
“I think it doesn’t really solve the problem of why doctors in some circumstances choose not to disclose.”
“I think fear of litigation is only one part of it; I think there are also cultural factors, there are training factors, there are issues around support, doctors being ‘hung out to dry’… legislation can’t tackle those issues.”
She said that these factors touch on wider aspects of “leadership and culture”.
Ireland’s ‘unsustainable’ medico-legal landscape
Whenever its date of commencement, the Patient Safety Act will be introduced within a medico-legal landscape described as “unsustainable” in one recent academic review. This is a description that many doctors would agree with.
“While progress is being made, the escalating trends of clinical claims and their costs are unsustainable,” wrote the authors of the review article published in July in BMJ Open Quality and titled Current Irish medico-legal landscape: An unsustainable trajectory.
The paper found that the number of outstanding clinical claims that “are yet to be resolved as well as their associated estimated costs are at a record high in Ireland”. By the end of 2022, the Government faced 3,875 active clinical claims, which were expected to cost €3.85 billion in total.
The authors noted that if current trends continued, “the opportunity costs of the current medico-legal landscape will impact the future provision of healthcare.”
“Aside from the financial consequences, clinical claims have numerous negative impacts on all parties involved.”
The paper noted that “at the centre” of each of these claims “is a patient and their family”. However, the impact on clinicians of rising claims was also highlighted. The “second victim” of medical error was the medical professional involved.
“For the doctor, the emotional and psychological impact can progress from initial shock and worry to profound numbness, guilt, and isolation,” noted the review. “The protracted legal process can prevent those involved from moving on and is compounded by the need to continue practising during resolution of the claim.”
The review found that experiencing litigation or a serious adverse event “impacts medical practice”.
On attempts to improve the medico-legal landscape, the review highlighted the possibility of convening a citizens’ assembly to address the issue. This idea was also posited by some speakers at the IHCA Annual Conference in September.
“With regard to a citizens’ assembly, it is important that all stakeholders who are involved in clinical claims be actively involved in the process,” Dr Clara Forrest, lead author of the review article, told the Medical Independent (MI).
“Those include patients and families who have pursued legal actions as well as clinicians who have been sued,” added Dr Forrest, who commenced her research while on the Academic Track Intern Programme, Intern Network Executive, School of Medicine, University College Cork.
“According to the citizens’ assembly website, the aim of an assembly is to ‘engage in rational, reasoned debate on complex issues’. With regards to this issue, a balanced and informed debate would only ensue if there was specific input from all parties.”
Dr Forrest’s article also noted the possible impact of the Patient Safety Act on the current situation in regard to clinical claims.
“The full introduction and implementation of mandatory open disclosure has the potential to address some of the reasons clinical claims are brought as failure to communicate can foster mistrust, anger, and upset, leading to legal action,” Dr Forrest told MI.
“Data from studies in the US and the United Kingdom support the idea that a better outcome for all parties can result from greater patient and family engagement.”
However, she noted that it “will likely take time firstly for the full introduction of mandatory open disclosure and secondly, to see if it impacts the escalating numbers of clinical claims and their associated costs”.
“The hope is that a climate of honestly and open disclosure will ultimately result in better care for patients in Ireland.”
There have been some other initiatives to address rising costs in health claims. At the end of January, the Government approved the establishment of an interdepartmental working group to examine the rising cost of health-related claims and consider mechanisms to reduce costs. The group has been charged with examining the rising cost of clinical negligence claims in the health system, with a particular focus on high value claims, and to identify measures that could be put in place to reduce future costs.
The group is chaired independently by Dr Rhona Mahony, Consultant Obstetrician and Specialist in Foetal Medicine at the National Maternity Hospital, Dublin. The group is comprised of membership from across relevant Government departments and agencies.
A Department of Health spokesperson told MI that the group held its first meeting in March 2023 and has met on 11 occasions to date. It is “expected” to produce a final report within nine months of its first meeting.