Image © Viktoriia Oleinichenko
In January 2019 the CQC announced that Bradford Teaching Hospitals NHS Foundation Trust had become the first NHS Trust in England and Wales it had prosecuted for failing in its duty of candour. The case related to a baby who died after being admitted to Bradford Royal Infirmary in July 2016. Although the Trust had recorded the baby’s care as a Notifiable Safety Incident – triggering the operation of the duty of candour – the family were not informed of this and did not receive an apology or explanation until October of that year.
The CQC guidance document 'Regulation 20: Duty of Candour March 2015' clarifies that the duty of candour applies to all 'unintended or unexpectedincidents' if they result in the requisite level of harm, even if they are a recognised (and consented) complications of the treatment. There doesn't have to be a failing in the care provided.
This prosecution is a sign that the CQC is beginning to flex its muscles to ensure compliance with certain minimum standards – standards below which care must never fall - and serves as a reminder that healthcare providers must be open and transparent with patients and their families when something goes wrong and they must do so in a timely manner. The fixed penalty notice of £1250 was equivalent to 50% of the maximum fine of £2500 a court could have imposed under the CQC's powers granted in 2015 to prosecute breaches of the Fundamental Standards including the duty of candour introduced after the Mid Staffordshire scandal.
The CQC’s chief inspector of hospitals, Professor Ted Baker, said: “The action that we have taken against Bradford Teaching Hospitals does not relate to the care provided to this baby, but to the fact that the Trust was slow to inform the family that there had been delays and missed opportunities in the treatment of their child. Patients or their families are entitled to the truth and to an apology as soon as practical after the incident, which didn’t happen in this case.”
A reminder that candour is derived from the Latin candor, meaning dazzling whiteness or brilliance, with connotations of honesty purity innocence and a current meaning of frankness and openness.
So how is the duty of candour working and being applied in practice now that we have passed the fourth anniversary of its application to all healthcare providers?
The CQC has faced criticism in a number of recent reports over how it is policing compliance.
CQC duty of candour inspections ‘inconsistent’ and ‘often superficial’.
A 2016 study carried out by Action against Medical Accidents (AvMA) published on the National Health Executive website on 8 August 2016 found that CQC duty of candour inspections were “inconsistent” and “often superficial." A quarter of CQC inspection reports included little or no evidence to show that the regulator was taking steps to ensure that NHS Trusts improved compliance, and 7% of reports did not refer to duty of candour at all. AvMA's research, which analysed 90 CQC reports of inspections of NHS trusts in 2015, revealed that nearly two- fifths of CQC reports contained criticism of how a Trust was implementing the duty, but only 14 of these went on to make a recommendation to improve. Where recommendations had been made to improve implementation the CQC was unable to “provide a single example” of a Trust having responded with details of the action they would take.
AvMA chief executive Peter Walsh said: “Having fought so hard to get a statutory duty of candour, we are deeply disappointed about how the CQC has regulated this so far. We still believe the duty of candour is potentially the biggest breakthrough in patient safety and patient rights in modern times, but we have always said that its success will depend to a large extent not only on the goodwill of providers, but on robust regulation by the CQC.”
Responding on behalf of the CQC Professor Ted Baker said AvMA’s review had looked at CQC’s assessment of the duty of candour requirement placed on NHS Trusts during (only) the first year of the regulation coming into force. Over this period the CQC had focused on Trusts’ awareness of the new duty and the systems and processes they were putting in place to support its implementation. From these early inspections the CQC had identified the need for a more systematic approach to inspecting how well organisations were embedding the duty as part of their broader approach to learning from incidents and supporting people who use services and their families. The CQC had since developed their methodology - with input from AvMA - and this was now allowing them to follow a more robust and consistent approach in assessing compliance with the regulation as part of their hospital inspections http://www.nationalhealthexecutive.com/Health- Care-News/cqc-duty-of-candour-inspections- inconsistent-and-often-superficial (8.8.16)
CQC Review: Failings in the way the NHS reports and investigates patient deaths
Later in 2016, the CQC published a report following a large scale review of deaths of patients in acute community and mental health care at NHS Trusts. Although the report centres around deaths of the elderly with acute mental health needs, the findings were relevant throughout the NHS. The CQC found that families were often left in the dark when a patient dies; unsure of where to find answers and have a poor experience of reviews and investigations; they are not always treated with sensitivity and feel overwhelmingly that the Trust is trying to 'delay, deny, defend'. The quality of investigations was criticised – those appointed to lead them were often untrained, the communication is poor and there was often confusion about timelines and guidance.
The report called for Trusts to make full and honest apologies and to listen to the concerns of families who should be 'meaningfully involved' in investigations. Trusts need to learn from their mistakes, clinically and administratively. Training should be cascaded throughout agencies, allowing a seamless multi-disciplinary approach. Changing the culture is imperative.
Deborah Coles, Director of INQUEST and member of the expert advisory group to the CQC Review, said: “This report must be a wakeup call and result in concrete action. It ratifies what INQUEST and families have been saying for years. There is a defensive wall surrounding NHS investigations, an unwillingness to allow meaningful family involvement in the process and a refusal to accept accountability for NHS failings in the care of its most vulnerable patients. https://www.cqc.org.uk/news/releases/cqc-calls- action-end-missed-opportunities-learn-patient- deaths (13.12.16)
CQC 'cannot be relied on' to enforce the duty of candour.
More recently, a further analysis carried out by AvMA, reported on by Shaun Lintern in the Health Services Journal on 2 October 2018, concludedthat the CQC 'cannot be relied on' to enforce the duty of candour. Although they felt that auditing the process for compliance with the duty should be relatively simple AvMA found there was a problem with regard to checking the factual accuracy of statements made to patients and families; the CQC having said they do not investigate individual cases it was difficult to see how they could be in a position to verify this.
The trend towards further prosecutions
New CQC chief executive, Ian Trenholm, confirmed in November 2018 that his organisation would be taking a tough stance on bringing prosecutions where Trusts breach the Fundamental Standards. The CQC would be carrying out more criminal investigations and had hired experienced staff to review evidence in 31 prosecutions under consideration. This reflects an increasing trend to prosecute providers where they have failed to provide safe care and treatment resulting in avoidable harm, or a significant risk of exposure to avoidable harm to a service user.
The first criminal prosecution of Mid Staffs NHS Foundation Trust (by the HSE under the Health and Safety at Work Act 1974) over events at Stafford between 2005 and 2008 was announced in 2013 regarding the death of a patient with diabetes who fell into a coma after staff failed to give her insulin.
In October 2017 the CQC prosecuted Southern Health Trust for failing to provide safe care to a patient who suffered serious injuries falling from a roof. The Trust had taken “no effective action” to prevent patients accessing the roof, despite previous safety incidents, and were fined £125,000 and ordered to pay £36,000 costs. The same Trust was fined £2m in March 2018 after an HSE prosecution over the 'entirely preventable' deaths of Connor Sparrowhawk and Teresa Colvin
In March 2019 the CQC prosecuted Sussex Partnership NHS FT in a case involving a 19-year- old man found dead from hanging in his cell in thehealthcare unit of HM Prison Lewes, East Sussex.
Background to the duty of candour: seeking the truth after the Bristol heart scandal
In 2001, the report of the Public Inquiry into children’s heart surgery at Bristol at which I jointly represented the parents of children who died or survived but suffered neurological and other injuries after undergoing operations in the 1990s, found serious, systemic failures at a unit that had clothed itself in a ‘club culture’ of wilful blindness to safety concerns and poor practice, with staff closing ranks to protect their colleagues.
Then as now, patients and families seek information and explanations if treatment has failed. This is not ‘hospital complaint’ territory. It should not have been left for lawyers, with the benefit of expensive expert reports - as it was when we pursued these cases through the courts – to have to explain to grieving parents what really happened to their child. Sadly it is only through the expensive, often long-winded litigation process that patients and their families learn the truth.
Unique in my 30 years' experience of handling clinical negligence claims was the fact that a number of parents hoped that our experts would not be able to find negligence and that their claims would fail. Those who sought explanations after their children died had received limited explanationsfrom the surgeons. In most cases, parents only came forward in response to the news reports around the time of the GMC hearings in 1998 and the Public Inquiry that began a year later. Letters to parents from the Trust’s new Chief Executive were written in sympathetic, compassionate tones but, as he was relying on medical and surgical staff still at the hospital for his information, they were of little benefit. The hospital sought to explain that the surgeons had encountered unexpected presentations of the children’s particular defects or abnormal anatomies that could not have been foreseen. The letters attempted to deflect blame from the surgeons, cardiologists and other members of the team.
Parents were given no insight into the experience of the surgeons and their medical support team. Before surgery, they had been given optimistic success rates in the various procedures, which reflected national but not local experience. They were not given the choice of a second opinion or a referral to another centre with a superior safety record. None of the 25-30 sets of parents of children who had suffered brain damage over the 10-year time span covered by the Inquiry were, to my knowledge, offered any explanation, even though they had to return to Bristol for their children’s continuing cardiology care. We referred to these unfortunate parents and children as the ‘forgotten families’.
The need for a duty of candour became obvious after Bristol: a duty on doctors and hospitals to report untoward incidents and to raise concerns. The Kennedy report recommended that doctors should also, if necessary, blow the whistle on failings and incompetence of colleagues or if they are aware of safety concerns within their hospitals, with proper legal safeguards to protect them from dismissal or victimisation if they have cause to take action.
Following publication of the Kennedy report, the Chief Medical Officer at the time, Sir Liam Donaldson, demanded that doctors should admit to patients when an error in their surgery had occurred. Recommendation 12 of his 2003 Making Amends consultation report stated:
“A duty of candour should be introduced together with exemption from disciplinary action when reporting incidents with a view to improving patient safety.”
The appalling scandal that then emerged at Mid Staffs demonstrated that the lessons of Bristol had not been learned. The report of 2013 following the public inquiry chaired by Robert Francis QC was the fifth official report and Francis's second into the failings at Stafford. There had been major problems at all levels, including a culture of bullying and a lack of governance on the part of the Trust. Worryingly high mortality data had not been made available to patients and their families before they received treatment. Reminiscent of the Kennedy Bristol recommendations was Francis's call for a statutory duty of candour, placing a legal obligation on professionals and organisations to be honest with patients and their families regarding incidents which have resulted in medical harm.
The post-Francis review 'A promise to learn – a commitment to act', led by Professor Donald Berwick published in August 2013 included a number of recommendations for the NHS: embracing a culture of learning, placing quality at the top of priorities and making sure that patients are present, powerful and involved.
Then Health Secretary, Jeremy Hunt, commissioned the Dalton-Williams 'Building a Culture of Candour' review. The report published in March 2014 proposed that 'when things do go wrong, patients and their families expect three things: to be told honestly what happened, what can be done to deal with any harm caused, and to know what will be done to prevent a recurrence to someone else. Health and care organisations have a responsibility to ensure that all of these are reliably undertaken'.
Addressing how a duty of candour should be framed Professor Williams recommended that: 'A willingness to be open with patients must also include honesty about organisational problems that may have contributed to harm, such as losing notes, problems with discharging patients or poor management of resources'.
The reaction to this report was seen as the first indication that the push towards a duty of candour could be jeopardised by the Government's desire to prevent what they feared would be a deluge of litigation from patients who, armed with evidence that they might have suffered avoidable harm, would now grasp the opportunity to sue for compensation. AvMA's Peter Walsh responded: “(this is) misconceived and grossly unfair. You get to know the truth but you can't do anything with it”.
Some commentators argued that introducing a statutory duty of candour was unnecessary as doctors have always had an ethical duty to be candid with patients when things go wrong. For over 50 years the MDU has advised members to tell patients when things go wrong, to put things right and to apologise. The ethical duty is set out in unambiguous terms in GMC guidance. Clearly, however it was thought that more needed to be done to ensure compliance.
A contractual duty of candour as a service condition of the NHS standard contract was introduced in April 2013, by which all NHS and non NHS providers of services to NHS patients under the NHS standard contract must disclose cases of 'moderate' and 'severe' harm or death. Francis, however, had called for a direct obligation to patients and their families and not just to NHS Commissioners in the form of a statutory duty of candour.
The statutory duty of candour and the 'fit and proper person's requirement' for directors were introduced for NHS bodies on 27 November 2014. This was extended on 1 April 2015 to cover all other health and social care providers registered with the CQC including GPs and independent healthcare providers to the NHS.
A generation later, how has the duty of candour affected the position in children's heart surgery?
There have been improvements and cardiac units across the country continue to achieve incredible outcomes for young children with life-threatening conditions, but in some ways little has changed in since the 1990s. Parents of a child with a certain complex defect may not be informed as part of the consenting process that another unit is well known as having significantly greater expertise in the corrective surgery for that lesion and achieve better outcomes in terms of lower mortality rates and a lower incidence of, and ability to deal with, post-operative complications.
What can parents expect from the duty of candour if their child has undergone surgery at a unit that lacked expertise in this procedure? They may be given a frank explanation of why their child died, or why he or she suffered complications, but in the same way that they should have been informed of the facts and options before surgery, shouldn't they be informed that there may have been a quite different outcome if their child had been operated on at another centre with a superior safety record?
The failure to disclose this kind of information after a child has died, or survived with neurological damage, whether or not avoidable, is not going to satisfy a parent's understanding of what they can expect from the duty of candour. Families choosing a cardiac centre often struggle to interpret the data to make properly informed decisions about units and surgeons. The availability of readily understandable data to enable parents to make an informed choice is surely a facet of a wider duty of candour across the wider NHS. Although research is being undertaken on non-fatal outcomes and how morbidity information can be collected and made available to rectify this, it is unsatisfactory that the only data available is limited to 30 day mortality.
Whilst being open and honest is second nature to the vast majority of doctors, there are pressures which may have the (unintended) consequence of making doctors reluctant to admit that errors have taken place. If the duty of candour is to have its full meaning, I believe a patient must be informed of the part that the known incompetence of a surgeon or lack of essential resources and appropriate specialist experience has played in the adverse outcome? But can doctors employed by a Trust be as frank as they would wish if the Trust may risk censure or a negligence claim if it is found to have provided inadequate care?
What should the duty entail if harm has been suffered against a background of a pending investigation into concerns over a particular doctor or surgeon or where a whistleblower has raised concerns over lack of resources or systemic problems at the unit where the treatment was carried out or where the surgeon lacked experience in the operation performed? Any of these factors individually or collectively might have played a part in causing a notifiable safety incident.
Although there has been a significant improvement in the culture within the NHS since Bristol, scandals continue to occur. Blowing the whistle still appears to be regarded as career suicide and whistleblowing doctors continue to be suppressed and victimised, yet the suspicion is that the human misery and financial cost of the scandals that continue to emerge could have been avoided if warnings had been heeded.
Much of the guidance from professional bodies when the duty of candour was introduced appeared to focus on the 'say sorry but don't admit blame or acknowledge fault' mantra and the fear was that compliance would become a box ticking exercise, with the use of template letters providing formulaic responses. My concern after representing patients and seeing many who have had to pursue endless journeys of discovery to establish 'the truth' was that they would not be content with explanations that satisfy the wording of the duty but would not deliver what they expect in accordance with what I believe was the intended spirit of the duty. We are in a post-Montgomery era of increased patient autonomy and greater degree of transparency is expected. The quality and extent of the information that is required to be given before treatment is not matched by the information received by the patient after he has undergone treatment that may have resulted in harm.
The position of the healthcare provider
For their part, healthcare providers have complained of an inconsistent approach by the CQC and uncertainty over the regulations and the requirements of the duty. The Bradford case may have been a particularly egregious example of a failure to comply. We don't know all the details. If this case does represent an increasing trend on the part of the CQC to crack down on non-compliance, it remains to be seen whether providers will seek to rely on any lack of certainty - a requirement of the 'rule of law' - to defend further Regulation 20 prosecutions.
Some have questioned what a financial penalty on an NHS body can achieve. The maximum fine of £2,500 is comparatively small but the reputational damage is something Trusts and other providers will wish to avoid and in the future we may even see the CQC revoking a provider’s registration.
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