Karen Bohane, Medical Negligence Department Cantillon Solicitors

Medical Negligence Litigation ConferenceTalbot Hotel, Stillorgan, Co. Dublin10th April 2019“Duty of Candour & Open Disclosure for Adverse Events – Recent Developments” Karen Bohane, Medical Negligence Department Cantillon Solicitors

Background to Duty of Candour • The Doctor/Patient relationship is based on trust. • A Patient expects their Doctor to be candid & truthful. • If there are adverse outcomes, it is axiomatic that the patient is entitled to be informed truthfully of events. • Whilst patients are of course the primary victims, medical teams are “second victims” of medical errors and cover-ups, and often suffer long-term psychological consequences.

Background to Duty of Candour • Duty of Candour Categories (1) Ethical duty – low threshold for notification. (2) Contractual Duty – higher threshold than ethical duty. (3) Statutory Duty – highest threshold. • Medical Council Guidelines In 2009, the Irish Medical Council included the following Guideline 18.3 re “Adverse Events”:

Background to Duty of Candour “Patients and their families are entitled to honest, open and prompt communication with them about adverse events that may have caused them harm. Therefore, you should: • Acknowledge that the event happened, • Explain how it happened, • Apologise, if appropriate, and • Give an assurance as to how lessons have been learnt to minimise the chance of this event happening again in the future.” • A Doctor who fails to adhere to the Guidelines may be guilty of professional misconduct.

Developments in the UK Mid-Staffordshire Enquiry • Inquiry of Robert Francis QC following a number of patient deaths and countless injuries due to negligent treatment. Faced with evidence of deliberate concealment and recklessness towards patients, Mr. Francis made 290 recommendations in his report. • Recommendation 174 stated that: “Where death or serious harm has been or may have been caused to a patient by an act or omission of the organisation or its staff, the patient (or any lawfully personal representative or other authorised person) should be informed of the incident, given full disclosure of the surrounding circumstances and be offered an appropriate level of support, whether or not the patient or representative has asked for this information.”

Developments in the UK • Robert Francis definition of candour: “The volunteering of all relevant information to persons who have or may have been harmed by the provision of services, whether or not the information has been requested and whether or not a complaint or report about that provision has been made.” • Once there is harm, the obligation to be candid automatically kicks in.

Developments in the UK • Mr. Francis advocated a statutory obligation of candour, where there is a belief or a suspicion that any treatment or care provided to a patient has caused death or serious injury. • He recommended the provision of the information should not, of itself, be evidence or an admission of civil or criminal liability, but that not disclosing information, should entitle the patient to a remedy (Recommendation 181). • Mr. Francis further recommended that it be a criminal offence to deliberately obstruct the duty of candour or to provide intentionally misleading or untruthful information.

Current Position in the UK • In November 2014 a statutory duty of candour was introduced for NHS bodies such as trusts and foundation trusts in England. (Regulation 20 Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 • (Some NHS organisations also have a contractual duty of candour). • In April 2015 it was extended to cover all other care providers registered with the CQC (Care Quality Commission).

Current Position in the UK • On 1st April 2018 – Statutory Duty of Candour came into effect in Scotland – Health (Tobacco, Nicotine and Care etc.) (Scotland) Act 2016 and the Duty of Candour Procedure (Scotland) Regulations 2018. • Northern Ireland – work has started on framing the duty of candour – the top recommendation from the HyponatremiaInquiry. • Wales – the Welsh Assembly Government proposes to introduce a statutory duty.

Developments in the USA • Dr. Tim McDonald, Professor of Anaesthesiology and Paediatrics and Chief Safety & Risk Officer for Health at the University of Michigan Health Service introduced a duty of candour. • Adverse incidents shot from 1,500 to 9,000 per annum. • However, damages payments per case were reduced by 47%. • Average settlement time reduced from 20 to 6 months.

UK Statutory Duty of Candour • Key Principles: • Care Organisations have a general duty to be open and transparent in relation to care. • The duty applies to organisations rather than individuals, but staff should co-operate to make sure the organisational obligation is met. • Patients should be told of a ‘notifiable safety incident’ as soon as is practical. • A ‘notifiable safety incident’ has 2 statutory definitions, depending on whether the healthcare organisation is an NHS body or not.

UK Statutory Duty of Candour • The organisation has to explain to the patient what is known at the time, what further enquiries will be made, offer an apology and keep a written record of the notification to the patient. (Failure to do so could be a criminal offence). • The patient should be given reasonable support. This could be practical (eg an Interpreter) or emotional (eg counselling). • The patient must get written notes of the initial discussion and of the notification, including details of further enquiries, their results and an apology.

UK Statutory Duty of Candour • Threshold for notification The Threshold for what constitutes a notifiable patient safety incident under the statutory duty of candour differs depending on whether the organisation involved is an NHS body. NHS Body (Trust, Foundation Trust etc.) Something unintended or unexpected in the patient’s care that, in the reasonable opinion of a health care professional, could result in or appears to have resulted in: • Their death (not relating to natural progression of an illness or condition). • Them suffering severe or moderate harm, or prolonged psychological harm.

UK Statutory Duty of Candour • Non-NHS body (GP, Independent Practitioners etc) Something unintended or unexpected occurring in the care of a patient that, in the reasonable opinion of a health care professional, appears to have resulted in: • Their death (not relating to natural progression of the illness or condition). • Impairment of sensory, motor or intellectual function, lasting or likely to last for 28 days. • Changes to the structure of the body (eg amputation). • Prolonged pain or psychological harm (defined as experienced or likely to be experienced for at least 28 days). • Shortening of life expectancy. • The need for treatment to prevent death or the above adverse outcomes.

UK Statutory Duty of Candour • Definitions of Harm Severe Harm – a permanent lessening of bodily, sensory, motor, physiologic or intellectual functions, directly related to the incident. Moderate Harm – needing a moderate increase in treatment, and significant, but not permanent harm. Prolonged Psychological Harm – experienced or likely to be experienced for at least 28 days.

HSE Policy of Voluntary Open Disclosure • In 2008 following wake of the Dr. Michael Neary scandal where hundreds of women had been subjected to unnecessary hysterectomies in Our Lady of Lourdes Hospital, Drogheda the Minister for Health (Mary Hearney) established the Patient and Safety Quality Commission. • Their Report “Building a Culture of Patient Safety” recommended the following:

HSE Policy of Voluntary Open Disclosure • National standards for open disclosure of adverse events to patients should be developed and implemented. • Barriers to open disclosure removed. • Legislation should be enacted to provide legal protection/privilege for open disclosure. • Specific Training and support should be provided on open communication for all healthcare professionals.

HSE Policy of Voluntary Open Disclosure • An open disclosure programme was piloted in Cork University Hospital and the Mater Misericordiae Hospital, Dublin from October 2010 to October 2012. • On 12th November 2013 HSE/SCA launched “Open Disclosure: National Guidelines – Communicating with service users and their families following adverse events in healthcare.” • Open Disclosure is 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 to be taken to prevent a recurrence of the adverse event.”

HSE Policy of Voluntary Open Disclosure • The Policy indicated that the following matters should be disclosed to “service users” (patients and clients of the HSE and of services funded by the HSE): • incident/adverse event (an incident which results in harm to a person that may or may not be the result of an error); • suspected adverse event (an adverse event suspected but not yet confirmed); • no harm event (an incident occurs which reaches the service user but results in no injury to the service user. Harm is avoided by chance or because of mitigating circumstances); and

HSE Policy of Voluntary Open Disclosure • near miss events (incidents which could have resulted in harm but did not either by chance or timely intervention) are to be assessed on a case-by-case basis and where there is a risk/potential for future harm, the event should be discussed with the patient/service user. • An expression of regret or apology is not an admission of liability or fault. • The Guidelines mirror the Health Information and Quality Authority (HIQA) standards have been in place since May 2012.

Obligations of Open Disclosure under Civil Liability (Amendment) Act 2017 • Signed into law on 22nd November 2017. • Sets out provisions for health service providers to make voluntary “Open Disclosure” of “Patient Safety Incidents.” These can into effect on 23rd September 2018. • 11th hour amendment to the proposed Bill making open disclosure mandatory. • The decision was based on advice given to the Minister for Health that the legal requirements compelling disclosure make doctors and nurses more fearful of adverse legal consequences and therefore, less likely to disclose openly and honestly. • International experience in Australia, Canada and the US is that voluntary systems are doomed to failure, despite significant resources and efforts expended on such schemes.

Civil Liability (Amendment) Act 2017 • Patient Safety Incident defined as an incident which occurs during the course of the provision of a health service which:- • has caused an unintended or unanticipated injury, or harm, to the patient, • did not result in actual injury or harm to the patient but was one which the health service provider has reasonable grounds to believe placed the patient at risk of unintended or unanticipated injury or harm, or: • unanticipated or unintended injury or harm to the patient was prevented, either by “timely intervention or by chance”, but the incident was one which the health services provider has reasonable grounds for believing could have resulted in injury or harm, if not prevented.

Civil Liability (Amendment) Act 2017 • Act outlines the procedure for making open disclosures – should be at a face-to-face meeting between the health service provider and the patient, that the meeting should take place as soon as practicable and that the patient should be provided with a signed statement containing the information in relation to the incident and an apology, if appropriate. • An Apology does not constitute an admission of liability.

Civil Liability (Amendment) Act 2017 • The Act states that the information provided in making an open disclosure, or an apology, if given:- - does not constitute an express or implied admission of fault or liability in relation to the incident or any clinical negligence action arising from the incident, - will not be admissible as evidence of fault or liability in Court in relation to the incident or clinical negligence action arising from the incident, • will not invalidate the indemnity or insurance cover of the health service provider, and:- • Shall not constitute an express or implied admission of fault, professional misconduct, poor professional performance or unfitness to practice in relation to any complaint made by the patient to a regulatory body subsequently.

Scally Report Dr. Gabriel Scally – Scoping Inquiry into Cervical Check (September 2018): • “The HSE’s open disclosure policy and HSE/SCA guidelines should be revised as a matter of urgency. The revised policies must reflect the primacy of the right of patients to have full knowledge about their healthcare as and when they so wish and, in particular, their right to be informed about any failings in that care process, however and whenever they may arise.”

Scally Report • Highlight the deficiencies in a voluntary disclosure policy. • Currently the decision on whether to disclose or not is left to the judgments of the clinicians involved. • A decision not to disclose is not subject to any further scrutiny. • Current HSE policy – non-disclosure is an option “if there is no evidence that the patient would benefit from such disclosure.”

Scally Report • The CervicalCheck scandal is an example of the dangers of voluntary open disclosure. • It was decided that disclosure of the outcome of the audit review should be sent to the treating healthcare clinicians. • Letters were dispatched to treating clinicians regarding 207 women – 204 Hospital Clinicians and 3 GPs. • Of the 204 women – 43 women or their relatives notified (Only 1 in 5).

Scally Report • An apology was given in 27 of the 43 cases. • Of the 3 women notified by GPs – information is only available in respect of 2 – disclosure and no apology for 1 women and no disclosure for the other women. • The March 2019 Report of Dr. Scally is critical of the fact that the policy on open disclosure which he said has been judged to be deeply flawed remains in place in the health system. • Timeframes for completion of actions to be managed closely to avoid slippage.

Patient Safety Bill 2018 • General Scheme brought to Cabinet in July 2018. • Minister for Health Simon Harris has recently offered assurances that this Bill will be given legislative priority and be enacted by the end of the year. • Provides for Mandatory disclosure of serious patient safety incidents.

Patient Safety Bill 2018 • Bill gives an indication of the sort of patient safety incidents which will be considered “serious” enough to require disclosure including; - death, - loss of bodily or sensory function, - a change to a person’s body structure, - shorter life expectancy, - 28 day impairment or pain, - Treatment in order to prevent one of the outcomes listed above.

Patient Safety Bill 2018 • Notification of serious patient safety incidents must also be made to SCA and either HIQA or the Mental Health Commission, as appropriate. • SCA will publish anonymised information on reported incidents. • Option not to disclose an error or mishap to a patient, to be only exercised in a very limited number of well-defined and explicit circumstances.

Patient Safety Bill 2018 • “Health Service Provider” broadly defined to cover public & private health services including HSE, section 38 service providers, private hospitals and a General Practitioner with an exclusively private practice or a mix of private and public patients. • Open Disclosure Information and Apology will not invalidate insurance, constitute admission of liability or fault; or not be admissible in proceedings.

Conclusion “To err is human, to cover up is unforgivable, and to fail to learn is inexcusable.” Sir Liam Donaldson Thank you for listening Karen Bohane, Medical Negligence Department Cantillon Solicitors 38/39 South Mall Cork 021 4275673 karen.bohane@cantillons.com

Karen Bohane, Medical Negligence Department Cantillon Solicitors