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  • Reshaping Standards, Enabling Change

    by Colum Conway, Chief Executive, Social Work England | Mar 17, 2020

    On World Social Work Day, Colum Conway, Chief Executive of Social Work England, explains why professional regulation needs to be in a better position to provide a more responsive and proportionate approach, work collaboratively and re-focus on ‘up stream’ working.


    For those of us who have been in or around professional regulation for the past seven years conversations about reform in practice and legislation are familiar ground. There is a genuine desire in the sector for change. Professional regulation needs to be in a better position to provide a more responsive and proportionate approach and to introduce practice methods that are more collaborative and preventative in nature. The focus must be on investment in ‘up stream’ working.

    For me, the policy decision by government to establish Social Work England provides a specific focus on social workers and the social work profession. It is underpinned by the desire for change, to do things differently in the regulation of social workers and to have a different more dynamic impact on social work practice through a whole new approach. Our challenge is to fully embrace this desire for change within a robust regulatory framework.

    Throughout the set up phase of the organisation it has been important for us to develop our standards, rules and processes within this context of change and innovation. Most importantly, through involving those who will be impacted by that change and innovation. Supporting people coming into the organisation to focus on the ways in which we will do things differently has been fundamental to our approach.

    It has helped greatly that we been established under new legislation that contains many of the key elements that are proposed as part of the reform of professional regulation. This is one of the most interesting challenges, to be at the front edge of innovation in this area, developing new ways of working to implement new approaches and leading and enabling change.


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  • Public confidence in fitness to practise

    by Daisy Blench, Policy Manager | Mar 12, 2020

    Public confidence and public trust in the healthcare regulators are interlinked: without one, you probably wouldn’t have the other but how do the regulators interpret and apply ‘public confidence’ especially in relation to their fitness to practise processes? Policy Manager Daisy Blench looks in more detail where the concept of ‘public confidence’ came from and why it is such a challenge for the health/care regulators to pin down its exact meaning.


    Maintaining public confidence in the professional regulators

    The 10 healthcare professional regulators have an overarching duty of public protection. This encompasses three main elements:

    • protecting patients
    • upholding professional standards
    • maintaining public confidence.

    This duty guides how the regulators carry out all their functions but particularly how they operate their fitness to practise processes. This process is how regulators investigate complaints or concerns about the professionals on their registers and reach a decision about whether the registrant is fit to practise. They will also decide on whether a sanction is required to protect the public. (A sanction can be anything from a warning, several months’ suspension from practising, or for the most serious cases, the registrant may be removed from (struck off) the register.)

    Of the three elements mentioned above, maintaining public confidence is arguably the most challenging for the regulators to interpret and apply. It’s an amorphous concept – forever changing and shifting. For some, public confidence is entangled with outdated concepts arising from previous systems of self-regulation – related to defending and upholding the reputation of the profession rather than protecting the public. The former risks being seen as a self-interested approach. A more nuanced understanding of what is meant by maintaining and upholding public confidence is that the way in which the profession as a whole is viewed is an important facet of public confidence, an integral part of a patient trusting the health professional treating them.

    Two major inquiries have shaped the current regulatory system, and these can help us understand where the concept of public confidence came from; how it became part of the regulators’ overarching duty; and why it remains an important consideration for them. The inquiry into failures in paediatric heart surgery at the Bristol Royal Infirmary; and  the Shipman Inquiry marked crucial steps in the shift from a system of self-regulation to independent regulation to ensure that the ‘public interest’ is at the heart of the way the regulators operate and decisions made about professionals and their fitness to practise.  

    More broadly, research has demonstrated the importance of trust in healthcare providers and professionals and the potential loss of legitimacy if the public lose trust and confidence in those they are relying on to provide care for them.

    Recent events impacting on public confidence and how the regulators approach it

    The issue of public confidence – what it is or is not – was brought into sharp relief by the case of Dr Bawa-Garba. It highlighted the different ways in which public confidence may be perceived. A fitness to practise panel took the view that her actions should be seen in the context of the other pressures she faced within the hospital on that day, she had demonstrated insight and retrained. The panel suspended Dr Bawa-Garba from the medical register. However, the General Medical Council (GMC) took the view that public confidence would not be sufficiently maintained by this outcome and appealed the case, leading to Dr Bawa-Garba’s removal from the medical register. The case provoked an outcry from the medical community and a further appeal against the removal led to Dr Bawa-Garba being reinstated to the register.

    This case and the reports produced on the back of it, notably the Williams Review into Gross Negligence Manslaughter, commissioned by Government and the Hamilton Review commissioned by the GMC, examined the issue of public confidence in healthcare professionals. The Williams Review in particular highlighted the subjectivity associated with decisions about how public confidence should be maintained and the lack of guidance or consistency in approach across the professional regulators.

    The Williams review found: ‘that there [is] little understanding about the type of behaviours and failings that might lead to the public losing confidence in the profession and which therefore constitute grounds for regulatory action. This needs to be better understood in order for the professional regulators to give proper consideration to their duty to protect the public.’

    Following on from the Williams Review, we were commissioned to look at how public confidence is applied across the regulators’ fitness to practise processes. Our report found that there is no agreed definition of what public confidence is or which behaviours or regulatory action may impact on it in the context of health professional regulation. Though the regulators may share an overarching duty of public protection, the legislation that governs them is different, as is the language they use: phrases such as ‘reputation of the profession’ and ‘bringing the profession into disrepute’ are still used in guidance and standards and suggest an outdated perception of what public confidence is and why it is important.

    There is evidence of some alignment in the approach fitness to practise panelists take when considering public confidence in their decision-making. This is in a large part due to the case law which has established certain key principles for how the public interest should be interpreted, which are also reflected in guidance for panelists. It could also be because panelists often sit on more than one regulator’s panel and therefore develop a set of shared norms.

    What is less clear is whether these shared norms are based on a balanced understanding of who the public is and what kinds of behaviours are really of concern, particularly if there is no direct risk to patients or if misconduct occurs within a registrant’s private life. The panel chairs we spoke to referred to drawing on their knowledge of public perceptions gained from interactions with friends and family as well as the guidance they are provided with by the regulator. This approach, however, is inevitably shaped by factors including their socio-economic group, age and background.

    In reference to the case law, though it does provide a helpful broad framework for considering the application of public confidence as part of the wider public interest in decision-making, it is also steeped in the legalistic language mentioned above – referring to ‘reputation’ and ‘bringing the profession into disrepute’. These terms may appear outdated and out of step with a modern system of regulation which places the public’s confidence in health professionals at its heart.

    Whilst the Williams review suggested developing guidance to support a more consistent approach to public confidence, we took that view that this would be premature. A number of regulators have carried out relevant research,  including the GMC and the Health and Care Professions Council and there is further work ongoing. The General Dental Council is coordinating work examining the concept of seriousness in fitness to practise. This is likely to be relevant when considering this question further.

    Further research is needed. However, there may already be some actions for regulators. They could:

    • review the language used when describing public confidence in guidance and standards; and
    • consider the make-up and diversity of their fitness to practise panels.

    Ultimately, this remains a complex and challenging area but an essential one given the importance of public confidence both in individual fitness to practise decisions and in professional regulation as a whole.


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  • A tale of two duties (of candour)

    by Amy Hopwood, Policy Manager, Care Quality Commission | Feb 26, 2020

    Amy Hopwood, Policy Manager at the Care Quality Commission, writes about the organisational duty of candour: the difference between it and the professional duty of candour; the barriers that can hinder both organisations and professionals from being candid; and CQC's plans for launching new guidance in the spring.


    It has been fascinating reading the recent blogs about candour on the Professional Standards Authority website, and I’m pleased to be asked to respond with a view from the Care Quality Commission (CQC). Although the Authority, and the organisations it regulates, are primarily concerned with the professional duty of candour and CQC with the organisational duty, there is a great deal of overlap, and it seems that many of the barriers to proper implementation of these duties are common to both. It also seems that as our regulation of the two duties matures, we are both increasingly focusing on the role that organisational culture plays. In this blog I will explain what the organisational duty of candour covers; how it aligns with the professional duty; CQC’s experience of regulating the duty; and our plans for the future.

    What is the organisational duty of candour?

    The Duty of Candour is laid out in Regulation 20 of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014. It applies to any organisation carrying out health and/or social care activities which are regulated by the Care Quality Commission.

    Regulation 20 is specific about the procedure to carry out the duty of candour, and lays out:

    • the thresholds of harm which should trigger the duty
    • the various steps, meetings and records that should be carried out
    • what those meetings and records should cover
    • that the process should be carried out in a timely manner
    • that appropriate support should be provided to the person using the service or their representatives.

    How does it work with the professional duty of candour?

    Both duties have similar aims, that is, to ensure that those providing care are open and honest with the people using their services, particularly when something has gone wrong; however, the organisational duty of candour applies only in certain situations, known as ‘notifiable safety incidents’. These are defined in detail within the regulation.

    This means that there will be cases where the professional duty applies but not the organisational one. Where the organisational duty does apply, it may well be carried out by the same person who carries out the professional duty, so it is important to remember that the organisational duty carries with it particular steps that must be covered and records that must be made. Carrying out the professional duty alone will not be enough to meet the requirements of the organisational duty of candour.

    While the responsibility for carrying out the professional duty is clearly located with the individual professional, the responsibility for the organisational duty is located with the provider of regulated activities, and in particular the ‘registered person’ who represents that provider to CQC. In practice, however, notifiable safety incidents will occur at the point of care, so the registered person is more often responsible for ensuring that the duty of candour is being carried out appropriately by the professionals they employ, rather than actually carrying it out themselves. The two duties should mutually reinforce each other, creating a culture where it is in the providers’ interests to encourage their staff to be candid, and where professionals feel safe and supported to speak up and be honest when things go wrong.

    How CQC currently regulates the duty of candour

    The Care Quality Commission has been responsible for regulating the organisational duty of candour since November 2014 for NHS Trusts and April 2015 for other health and social care providers. During the registration process, we look for evidence that a prospective care provider understands Regulation 20 and will have robust systems in place to adhere to it from day one of operation. When we inspect an existing service, we review the provider’s performance around the duty, by interviewing staff, looking at data and reviewing their records. The evidence we find will affect the overall ratings we award to the service and may even lead to enforcement action.

    CQC can enforce breaches of parts 20(2)(a) and 20(3) of the regulation and is able to move directly to criminal enforcement action, including prosecution following an investigation. In 2019 we issued 14 Fixed Penalty Notices, in respect of eight incidents, occurring at two NHS Trusts.

    Future plans

    Towards the end of 2018, CQC undertook a review of the way we regulate the duty, consulting with our own staff, providers and other external stakeholders. We found that there remained some confusion around various aspects of the Regulation. For example, it can be hard for providers to determine which incidents fall into the harm threshold and require action (especially where thresholds are differently defined for different sectors). Others have queried what the Regulation means by ‘reasonable’ in terms of timescales and the support offered; how the duty applies in retrospective case reviews; and what to do when the notifiable incident has occurred in a different organisation.

    We are planning to clarify these and a wide range of other questions when we launch new guidance for both providers of care and our own inspectors in the spring.

    Any contributions to help us improve the guidance would be very welcome, please email Amy Hopwood


    Related material

    You can find all our work, including research on the duty of candour on our website.

  • The Duty of Candour – where are we now?

    by Peter Walsh, Chief Executive of Action against Medical Accidents (AvMA) | Jan 30, 2020

    Peter Walsh -AvMaIn this guest blog, Peter Walsh, Chief Executive of Action against Medical Accidents, sums up what progress has been made since the introduction of the organisational and professional duties of candour, but also questions what difference they have made. However, he remains hopeful, that the duty of candour will become much more than just a box-ticking exercise and believes, if we can get it right, it will be the biggest and most overdue advance in patients’ rights and patient safety that we have ever seen in health and social care.


    It is difficult to believe that until the Westminster parliament felt compelled at last to act following the Mid Staffordshire public inquiry, no NHS organisation was in breach of any statutory regulation or law if it covered up incidents which had harmed or even killed patients. It is surely something that will shock and intrigue future historians and students of the NHS. In effect, the system had frowned on cover ups, but had not been prepared to do anything serious to stop them and continued to tolerate them until public pressure became unbearable. The statutory duty of candour came into force in England at the end of 2014 and alongside it a renewed commitment on the part of health professional regulators to promote and regulate health professionals’ professional duty of candour.

    The lack of a statutory duty or any effective mechanism to hold either healthcare organisations or individuals to account for failing to be open and honest had long been a massive concern to Action against Medical Accidents (AvMA – the UK charity for patient safety and justice), based on the experience of many of the thousands of people we advise and support every year.

    The case of Robbie Powell had become a powerful symbol of the need for change, and no individual has done more to make the case than Robbie’s father Will Powell. AvMA will always be grateful for the Powell family’s work and for them allowing AvMA to use Robbie’s name in our campaign for a statutory duty of candour on organisations and more rigorous regulation of the professional duty.

    In spite of stern resistance from some parts of the system, our campaign was eventually successful in England. It has been followed by the introduction of a statutory duty in Scotland, and plans to bring one in in Wales and Northern Ireland. It is undeniable that awareness has been raised. It even featured in a recent episode of Holby City! There is now a stated determination in all parts of the United Kingdom to give this issue the priority it deserves. However, the jury is out as to just how much difference the duties of candour are making in practice.

    The duty of candour (both organisational and professional) is primarily about changing culture and giving prominence to the necessity of openness and honesty when things go wrong. It is about avoiding cover ups rather than having to punish those responsible for them. Changing culture can never be a quick fix, but we now have five years’ experience since the statutory duty was introduced in England and the health professional regulators refreshed their guidance on the professional duties. Anecdotally, things have got better. The health professionals and managers I speak to overwhelmingly agree that we are better off having a statutory duty of candour. Investigators and complaints staff tell me that they feel more empowered to be fully honest. Research led by Professor Graham Martin found that this had been the most effective of a range of measures designed to improve openness in the NHS in England. However, this is tinged with the feeling that the quest for compliance has in some places led to a ‘tick box’ approach. Added to that, it is still the case that some patients and families have continued to experience a lack of openness and honesty. Research by AvMA in 2016 Regulating the Duty of Candour  found that the Care Quality Commission’s (CQC) regulation of the statutory duty had so far been pretty woeful, and that no organisations had been held to account for breaches. Our report in 2018 Requires Improvement found that the situation had improved and regulatory action had begun to be taken over breaches but there were still significant weaknesses in regulating and promoting the duty. The Professional Standards Authority report on the professional duty of candour in 2019 found that regulators had improved their approach to regulating the duty of candour but that much more remained to be done system-wide to create the right environment for honesty and candour to flourish.

    England is still playing catch up over its statutory duty of candour. One has to remember that the Department of Health had been strongly against bringing it in and this was something that was forced upon it by the Mid Staffs inquiry recommendations and a mixture of public and political pressure. It was introduced in a hurry without the necessary preparation and training. AvMA even had to produce the only national information leaflet for the public on the duty of candour (endorsed by the CQC).  There remains no central training and awareness campaign to support the implementation of the duty of candour in England and a review of the legislation and guidance is well overdue.

    Nonetheless, progress has begun to be made and the introduction of statutory duties in Scotland, Wales and Northern Ireland provide an opportunity to learn from the experience in England. As the Professional Standards Authority report concluded, what is needed is a joined-up approach by Government, regulators and others to both design, implement and regulate for openness and honesty in a meaningful way. The statutory duties on organisations and those that apply to individual health professionals need to complement and support each other. If we get the duty of candour right, it will be the biggest and most overdue advance in patients’ rights and patient safety that we have ever seen in health and social care.

    You can find out more about Action against Medical Accidents (AvMA) from their website at www.avma.org.uk


    Related material

    You can find all our work, including research on the the duty of candour on our website.

  • Artificial Intelligence – what is it and what impact will it have on professional regulation?

    by Christopher Pawluczyk, Senior Scrutiny Officer | Jan 21, 2020

    artificial intelligence for website

    The new year (and new decade) had barely got underway and there was a flurry of news stories about how artificial intelligence had outperformed experts in spotting breast cancer. It is likely that as the 2020s progress, news stories like this will become commonplace. In this blog, we look at what AI is, how it is used and what the future might hold, especially in relation to professional regulation. 


    Technology is advancing at a significant rate, shaping as well as creating new industries. So much so, we have entered our fourth Industrial Revolution. This will take what was started in the third, with the development of computers and the digital age, and enhance it with machine learning and autonomous systems. The design of regulatory models has followed the challenges posed by innovative technological change. With the emergence of artificial intelligence in an ever-growing number of sectors including health and social care, what does the future regulatory landscape hold?

    What is artificial intelligence?

    There is no singular definition of what is, and is not, artificial intelligence or AI for short. To discuss this further would require a blog of its own. For our purposes here, we have taken the definition of artificial intelligence accepted by the House of Lords Select Committee on AI as:

    'Technologies and systems with the ability to perform tasks that would otherwise require human intelligence and have the capacity to learn or adapt to new experiences or stimuli.' (House of Lords Select Committee on Artificial Intelligence report, AI in the UK: ready, willing and able April 2018)

    How is it used?

    Artificial intelligence may sound like science fiction but the reality is coming into greater focus. It was recently reported in the Guardian that a computer generated AI machine that produces predictive analytics was being used to assist social workers to assess the probability of a child coming on to the 'at risk register'. Computer systems have been developed to enable councils to analyse vast amounts of data from a variety of sources such as police records, housing benefit files, social services, education and other information available and determine the level of risk posed to a child. With developments like this in mind, are machines making more accurate decisions?

    To find answers, a study was conducted to see how artificial intelligence compares with healthcare professionals when it comes to making medical diagnoses based on images. The use of AI in interpreting medical images has been a developing field; using algorithms to learn how to interpret images and classify them has diagnosed diseases from eye conditions to cancers. The study focused on research carried out from January 2012 to July 2019 and assessed AI performance versus expert human analysis. It concluded that the diagnostic performance of artificial intelligence was equivalent to that of health care professionals. It is envisaged that AI diagnostic systems can act as a tool to help tackle the backlog of scans and images and be deployed in places which lack experts to carry this out. However, the study did identify that the percentage of human errors and AI errors was roughly the same. With this in mind, it is important to recognise these risks and identify what measures can be put in place to reduce future risk and better protect patients.

    What is the current landscape?

    The Government has put the development of AI in the UK firmly on the map following the publication of its Industrial Strategy – Building a Britain fit for the future in 2017 and earmarked AI and Data Economy as one of four Grand Challenges 'to put the United Kingdom at the forefront of the industries of the future'.

    The UK is currently subject to European Union legislation concerning AI and big data, including the provisions of the General Data Protection Regulation. In April 2018, the UK was one of 25 European countries to sign up to the Declaration of Cooperation on Artificial Intelligence. When the UK leaves the EU in some form of Brexit, it may decide to remain aligned with EU legislation in this area.

    There is plenty of appetite and agreement to engage in dialogue surrounding artificial intelligence, harnessing expertise to expand its use. Yet, at present, there is no general agreement on whether there should be an overarching statutory framework or dedicated regulatory model to oversee the development of AI. What has been established is the Centre for Data Ethics and Innovation (CDEI). Its remit includes the review of existing regulatory frameworks and identifying any gaps; identifying best practice for the responsible use of data and AI; identifying mechanisms to ensure that the law, regulation and guidance keeps pace with developments; and advising and making recommendations to government.

    The Government has also created the Regulators’ Pioneer Fund and invested £10 million to assist regulators 'to help unlock the potential of emerging technologies'. With the help of this fund, the Care Quality Commission has been awarded funding to work on a project to explore how it can work with providers to encourage good models of innovation.

    A look to the future

    In providing evidence to the House of Lords Select Committee on AI, a number of witnesses provided examples of areas in healthcare that could benefit from artificial intelligence. These included AI assisted analysis of x-rays, MRI scans and breast imaging. The Select Committee was told that the emergence of such technology would dramatically reduce the cost of analysing scans and alleviate the strain on the health service at present due to staff shortages. (House of Lords Select Committee on Artificial Intelligence report, AI in the UK: ready, willing and able, April 2018)

    Healthcare professionals are going to need to know about the technology available, how to use it and understand its capabilities and limitations. Those embedding new technology in clinical settings will also need to engage with healthcare professionals and patients to help establish where artificial intelligence could be of most benefit.

    The emergence of artificial intelligence also raises challenges regarding legal liability in determining who should be held accountable for decisions made or informed by an algorithm which has had an impact on someone’s health.

    There are also challenges that would need to be addressed when developing artificial intelligence within a health and social care landscape from the handling of personal data, public trust and mitigating potential risk. AI is creating new challenges for regulation and it is important for regulators to be part of the discussion on the impacts of artificial intelligence, rather than reactive and called upon when something goes wrong.

  • There must be a better way? A patient perspective on going through the fitness to practise process

    by Sarah Seddon | Jan 07, 2020

    In this guest blog as part of our series looking at fitness to practise from different perspectives, Sarah Seddon tells about her personal experience as a patient going through the fitness to practise process and outlines her thoughts on the key considerations that she believes regulators should take into account to help 'humanise' the process.  


    “There must be a better way to determine fitness to practise”. This thought kept replaying in my mind during my time as a witness. Fitness to practise was not what I’d expected. As I was cross-examined on the stillbirth of my son, it felt like what I can only describe as a novel version of The Hunger Games. The ‘rules’ were constantly changing, I was terrified, traumatised, belittled and disrespected yet had no choice but to keep going. The process appeared to be set up to destroy people one by one whilst the audience watched. I had done nothing wrong (except to trust the advice of my midwife) yet this was the reality of fitness to practise for me as a patient. It made me question myself, my values, my reality and my purpose. 

    What I had wanted (and naively expected) from fitness to practise was transparency, honesty, compassion and fairness. I had hoped to feel respected, protected and supported. I thought the facts would be clearly established and an unambiguous decision made on the registrant’s current fitness to practise in everyone’s best interest.

    There must be a better way

    I was known as ‘Woman A’. To me, this embodies the entire impersonal, inhumane world of fitness to practise. I wasn’t a person with needs, thoughts and feelings; I wasn’t a bereaved mum; I wasn’t a professional anymore but simply a piece of evidence.

    I was on a ‘conveyor-belt’ which zig-zagged for two years along an inflexible, imperfect pathway. But this conveyor belt wasn’t particularly reliable and broke down a lot.  Sometimes pieces fell off or formed the wrong configuration, producing a final product that wasn’t fit for purpose. 

    Numerous people were in charge of the conveyor-belt at different times but they didn’t always try to fix errors or communicate what had happened during their shift. They couldn’t see the end of the belt from where they stood, so didn’t really concern themselves with the ‘finished product’. Some staff didn’t notice when vital parts had fallen off. Others noticed but didn’t appreciate the importance of the individual parts. 

    In my opinion, the conveyor-belt of fitness to practise should be taken apart and rebuilt from scratch. I have a unique viewpoint as I’ve actually ridden along it but as I’m just a spare part, I don’t have a voice. Focusing solely on the end product means you can do what you like to those parts on the conveyor belt – manipulate them, chop bits off or even crush them in order to get your optimal result. If things do go wrong, the damaged parts can be discarded – a bit of wastage is always to be expected…

    I don’t deny that the end product of fitness to practise is important – but how you get to that point matters immensely when you are dealing with real people. Legal requirements are mandatory but there are many ways to implement these in a truly person-centred manner, leading to the optimal outcome for everyone involved.

    What makes a good fitness to practise process?

    I can answer that in one word: “compassion”. For everyone involved – patients, families, registrants, employers and staff. If you can get this right, I honestly believe that everything else will follow.

    Healthcare is all about the patient. In addition to the specialist knowledge and skills required to be a safe, effective practitioner, each individual patient must be treated with humanity. Healthcare is nothing without compassion so it must be regulated with compassion.

    How can a regulator hold their registrants to account on a set of ethical, person-centred standards if they are not prepared to ensure that their staff are also working to the same standards?  Regulators risk damaging people further by the current adversarial, lengthy, traumatic, ambiguous processes which go against everything they are supposed to stand for. These processes certainly don’t promote patient safety in the long run as they discourage registrants from being open and honest when things go wrong and discourage the public from engaging with investigations. 

    It’s impossible to determine a ‘one size fits all’ fitness to practise process – an excellent process should be flexible to meet the needs of the people and the circumstances in each individual case and to fully take contextual factors into account. I truly believe that if the regulators routinely ask themselves the questions below, then they will be able to deliver an outstanding, person-centred process which will inspire confidence in both professionals and patients and will set a world-wide example for regulatory reform.

    Five considerations for regulators to apply to fitness to practise processes 

    Compassion

    1. Every patient and registrant is a real person – not a compound on a conveyor belt and (probably) not a criminal so do you give people respect, allow them to make choices and provide support? Fitness to practise is a grenade thrown into someone’s life and words matter, timings matter, promises matter. Support should be an integral part of any investigative process and not separated out as a ‘nice to have’. Treat people how you would like your loved ones to be treated – it can be very traumatic when things go wrong in healthcare.
    2. Organisational culture matters – do staff have the time, the training, the awareness, the support and the drive to be compassionate?

    Communication

    1. Is key information always clearly transferred, ideally via a single point of contact? Is there a choice in how communication happens and are deadlines met and issues explained?
    2. Are processes in place to (really) listen to all stakeholders? Don’t discourage communication between the registrant and the patient (unless for a specific reason). Early communication or mediation can help with remediation, help families and registrants to move forwards with their lives and could allow cases to be closed sooner.
    3. Do both registrants and families fully understand your role?
    4. Do you obtain qualitative feedback to assess impact on people’s lives rather than focusing on arbitrary quantitative targets?

    Transparency and fairness

    1. Don’t ask people why they want to know something but instead consider if there is any reason they shouldn’t be informed? Don’t be afraid to say sorry. Always be willing to explain the reasons behind decisions, actions or inactions…and if you can’t explain them then could/should that process be reviewed?
    2. Think about what you are asking people to do and would you be happy if that was your child, your husband, your parent or sibling?
    3. The evidence of the family is vital and should be treated with equal value to other evidence sources. The people who experienced the care are the only people who can truly give an insight into what that care delivered to them at that specific point in time. Care by its very nature is emotional and emotional impact is valuable evidence.

    Efficiency

    1. Is this really the only way of doing things? Can several processes take place at the same time? Does it have to go through multiple teams rather than one? Waiting is damaging and costly for all. The more stages there are, the more chance of things getting lost, the more convoluted things become and the more relationships break down. Are your processes achieving the aims they set out to achieve? And how do you assess this?
    2. Processes must be co-produced – people who have been through your processes have the best insight into both your areas of excellence and your biggest weaknesses.

    Safety

    1. Is patient safety truly at the heart of everything you are doing? Not just in terms of fitness to practise outcomes for the general public but in terms of what you are doing to the real people along your pathway?
    2. Are you doing all you can to eliminate fear? This is arguably the most difficult but the most important part of ensuring a just culture where people can be open about mistakes so that timely, heartfelt apologies can be encouraged and learning and remediation can happen effectively allowing registrants to excel in their vocation and feel supported whilst patients know that they have been heard and action has been taken in the best interest of everyone involved.

    I challenge all 10 regulators to adopt these five considerations and apply them to every stage of your fitness to practise processes.  You (or a loved-one) are all going to be patients one day and a health professional will probably have an enormous impact on your life. As regulators, you have both the responsibility and privilege of ensuring that this impact is a positive one. By implementing person-centred regulation I believe that you can achieve this aim.


    Sarah Seddon is a Specialist Clinical Pharmacist at Sherwood Forest Hospitals NHS Foundation Trust in Nottinghamshire. She became interested in fitness to practise after being called as a witness in the fitness to practise hearing of her midwife, following her son's stillbirth in 2017.  She now sits on the Public Support Steering Group for the Nursing and Midwifery Council and is passionate about person-centred regulation. You can read Sarah’s personal experience as witness in a fitness to practise hearing in her recent blog for the Pharmaceutical Journal. If you want to find out more you can also follow Sarah on Twitter: @sarahjseddon


    Related material

    Read more about our ideas for reforming fitness to practise or our blogs on this subject. You can find links to them here.

    Find out more about our power to appeal final fitness to practise decisions. Or watch a short animation which explains more about why we appeal some final fitness to practise decisions.

  • Truth will out? Two sides of the candour coin

    by Kisha Punchihewa and Dinah Godfree | Nov 29, 2019

    In this blog we look at two sides of the professional duty of candour – in the first part, Kisha Punchihewa our head of legal looks at it from the legal point of view in the context of fitness to practise, citing some examples where professionals have failed to be candid. In the second part, policy manager, Dinah Godfree looks at the possible barriers to telling the truth and why being candid can be much more complicated than ‘simply telling the truth’ makes it sound. 


    The duty on regulated healthcare professionals to be candid when something goes wrong with patient care was introduced following the tragic events at Mid Staffordshire. However, during the course of writing this blog, more tragic events – this time at Shrewsbury and Telford Hospital Trust – are coming to light and a failure to be candid when something has gone wrong with care continues to be an issue. So what is it that can hinder healthcare professionals from being candid? Our recent research looked at the kind of issues that can deter professionals from being candid. Also, as part of our scrutiny of the regulators' final fitness to practise decisions, we have seen cases where a professional has not been candid when something has gone wrong or where a regulator’s fitness to practise panel has not treated a lack of candour seriously as it should have been treated.


    What does it mean to be candid?

    Kisha Punchihewa | Head of Legal

    Senior Solicitor - Kisha PunchihewaIt seems obvious when we are looking at cases after the event – something goes wrong, you know something has gone wrong and as a healthcare professional you should be open about it…but that doesn’t always happen.  

    Telling the truth has been something we expect of our healthcare professionals, but it was brought into focus following the tragic events at Mid-Staffordshire. There is now an organisation duty of candour as well as a professional duty of candour; it is the professional duty that I am going to look at it in more detail here.

    Healthcare professionals must:

    • tell the patient (or, where appropriate, the patient’s advocate, carer or family) when something has gone wrong;
    • apologise to the patient (or, where appropriate, the patient’s advocate, carer or family);
    • offer an appropriate remedy or support to put matters right (if possible); and
    • explain fully to the patient (or, where appropriate, the patient’s advocate, carer or family) the short and long terms effects of what has happened.

    But this does not always happen and we know that it does not happen – one part of the solution is understanding the problem. The Authority’s report Telling patients the truth when something goes wrong looked at research around the barriers to candour – those things that stop people from telling the truth. We have seen these barriers to candour in cases we have brought via our [Section 29 appeal process] and I am going to focus on a couple of them.


    Case study 1 – A consultant neurosurgeon

    This case involves a consultant Neurosurgeon let’s call him Dr Smith (not his real name). Dr Smith’s patient required surgery on his back. The patient underwent his operation but did not know that the operation had been performed on the wrong site. We don’t know if Dr Smith realised this immediately after the operation. However, the patient complained about continued pain at a follow-up appointment. The patient was then told to come in for more surgery as more bone needed to be taken off because not enough disc had been taken away during the first operation.

    What Dr Smith did not say is “I’m sorry – I operated on the wrong site of your spine and that is why you are still in pain. I need to correct that mistake.” 

    What he did do however was say nothing, allowing his colleagues and, most importantly, his patient to believe that this second surgery was needed because essentially the first one had not quite done the job. The second surgery was successful. Dr Smith then completed the medical records containing false descriptions of the surgery. This meant he has either deliberately caused or allowed his colleagues to become a part of his deception. He also sent an incorrect letter to the patient’s GP. 

    None of this would have come to light if the patient had not brought a clinical negligence claim against the Trust. The doctor who he employed as his expert had noted the wrong-site surgery when reviewing the medical records. This review took place two years after the first surgery.

    This is not a case of someone making a spur-of-the-moment poor judgement call, but is a series of dishonest acts. There were enough opportunities for Dr Smith to be candid with both his patient and his colleagues. Why wasn’t he? When interviewed by his employer Dr Smith said when he discovered he had operated on the wrong site on his patient’s spine he thought it was a disaster; he knew that he should have informed his manager about the surgical error; but felt that reporting the wrong-site surgery ‘opens a can of worms’ and he was aware of that.

    The bottom line here is that he put his own interests before those of his patient and he lacked the moral courage to own up to his mistake.


    Case Study 2 – Nurse Jones

    Nurse Jones (not his real name) observed an incident where one of his colleagues failed to properly de-escalate a situation with a patient on a mental health ward. His colleague Nurse Brown (also not her real name) alleged that she had been assaulted by a patient and called the Police. The Registrant witnessed this incident and provided a brief factual report about the incident on the electronic record at the end of his shift. He was the next most senior nurse on shift.  As his colleague had reported the assault to the police – he was asked to provide them with a statement. A few days after the request was made, he sent an email to the Ward Manager saying he wanted his name to be removed from the list of witnesses for the police – he said the statement that I give would not help [Charge Nurse Brown’s] case as I did have concerns for the events of the shift/period in question”.  He added “I feel that I should be supportive to team members, and support their case. Please could you advise the most appropriate course of action…” He was told that he needed to co-operate with the police and if he had any concerns, he should discuss those with the Ward Manager. He didn’t do that. In a supervision session he said what he had seen – Nurse Brown was standing on a sofa, jumped onto the back of the patient and held her in a headlock, and she had been verbally abusive to the patient. He was told to write a statement based on those facts. 

    Go forward five months and the Trust brings disciplinary action against Nurse Jones. At this point he said, he gave his full account. He had seen Charge Nurse Brown jumping on the back of her patient and holding her [the patient] in a head lock on 22 April 2011; he had advised her to use the correct de-escalation procedure; Charge Nurse Brown had confronted her patient  and was hit with a hairbrush as a result. He reported also that many of the staff on duty had witnessed Charge Nurse Brown holding the patient incorrectly.

    The Trust Investigator spoke about the considerable difficulties in eliciting information, let alone reliable information from staff – she spoke about a collusion of silence. This example shows that workplace culture can influence a professional’s candour towards patients. In this case the Court described what the registrant did as a “crisis of conscience” and that he had a misplaced sense of loyalty to Charge Nurse Brown which may have prompted him not to speak out and so avoid getting her into trouble and that he was not prepared to give a partisan or partial account of what he saw to the police. 


    Why does this matter?

    In another appeal where two nurses lied to their employer and the Coroner about the treatment they had provided to a mental health patient following his death by suicide, the Court said:

    "The purpose of the Trust's investigation was to learn lessons from Patient A's death so that steps could be taken to avert similar problems in the future. It was therefore critical (and ought to have been obvious) that those giving evidence to the investigation should be candid. Anything other than candour would undermine the purpose of the investigation."

    In some of the work we have done on this topic, there has been some discussion about not knowing what candour means but that seems difficult to believe. A toddler knows when they have done something they shouldn’t have – they may have difficulty telling the truth about it but I would hope that an adult working in a field where their role is to care for and protect patients knows better. I recently heard it described as kindness and telling the truth – that seemed to chime with the audience. So perhaps we need to refer to it as ‘being candid – telling the truth’. Mistakes will happen – our healthcare professionals are human beings not robots.   But unlike robots our healthcare professionals need to learn from their mistakes and also uphold the trust that the public has in them.


    Being open when things go wrong – an ethically embarrassing debate?

    Dinah Godfree | Policy Manager

    "The way in which the Trust handled the matter can be viewed as an object lesson in how the tragedy of an avoidable death can be exacerbated by inappropriate handling of the case. It demonstrates the sad fact that, for all the fine words printed and spoken about candour, and willingness to remedy wrongs, there lurks within the system an institutional instinct which, under pressure, will prefer concealment, formulaic responses and avoidance of public criticism."

    DinahThese are the words of Robert Francis QC, in his report on the serious failings at the Mid-Staffordshire NHS Foundation Trust, published in 2013 (the sentence underlined is our emphasis). They refer specifically to the case of a previously fit young man, who died from an undiagnosed ruptured spleen following a mountain-bike accident. An internal report found that his death would almost certainly have been avoided if a more thorough examination had been carried out when he presented himself to A&E. But this report was neither sent to the coroner, nor disclosed to the family. The pain that his family went through was exacerbated by these actions, and by further reluctance by the Trust to admit any wrongdoing.

    Robert Francis was not the first to highlight failings in openness and honesty with patients and families when care has gone wrong. The Kennedy Report into the failings at Bristol Royal Infirmary called for the introduction of a duty of candour: ‘when things go wrong, patients are entitled to receive an acknowledgement, an explanation and an apology.’

    That was nearly 20 years ago. Why are we still engaged in what was described by Leape and Berwick in 2005 as an ‘ethically embarrassing debate’, when being open and honest about mistakes is so obviously the right thing to do?

    Why is it hard to be open when things go wrong?

    In 2013, we at the Professional Standards Authority studied the literature on candour, disclosure and openness to try to understand where the barriers lay to professionals either reporting their own errors or enabling others to do so. In 2018, we carried out further research to understand whether professional regulators had made any headway in encouraging professionals to be candid when care had gone wrong. What we found across both pieces of work was a complex and persistent set of social, cultural, psychological, and practical barriers.

    It’s not my responsibility – someone else will report it

    One of the main psychological barriers is ‘bystander apathy’ – in our context, this can be described as the diffusion of responsibility that arises where a number of people are involved in, or aware of, an incident and subsequent failures to report it or be open about it – usually resulting in no one taking action. Combined, perhaps, with a hierarchical deference that means some professionals take the lead from those higher up the chain – more on this below – this kind of apathy is likely to play an important part in the non-disclosure of incidents, particularly if it is not clear who can or should report an incident.

    A workplace culture where standards start to slip

    Attitudes to openness may be specific to professions, or groups within professions – though it should be noted that at the time we carried out our literature review, most of the research related to doctors. For doctors in high-risk branches of medicine, such as surgery and anaesthetics, suboptimal, uncertain, and dangerous situations may become normal features of care. These doctors become less sensitive to abnormal care incidents, and are therefore less likely to identify, respond to, and learn from them. What is striking here is the obvious read-across to care settings with low standards of care – if incidents of poor care become normalised, this is likely to be accompanied by a loss of sensitivity about what counts as an incident worth reporting. This is supported by analysis of the Space Shuttle Challenger disaster, which found that there had been a ‘normalization of deviance’, in which incremental deviations from normal procedures were accepted, despite their resulting in standards that would not have been tolerated if the slippage had happened suddenly.

    Not wanting to own up to mistakes because others may think I am incompetent

    Other studies suggest that there is, for some doctors at least, an expectation that medicine is an exact science that can be practised flawlessly. This means that error is considered a sign of incompetence, and psychological defences are developed to avoid classifying incidents as errors, or to diffuse responsibility for them. The fear of being judged by one’s peers for making a mistake – if you believe that everyone else is flawless and will judge you for your error – is likely to be a significant barrier to openness in itself, and a problem that is somewhat self-perpetuating.

    We did see some research with nurses that showed perhaps a greater willingness than doctors to be open about incidents, but the effects of this may be undermined by a deference to professionals of perceived higher status. Some nurses reported developing strategies for encouraging more senior colleagues to disclose, such as confronting them directly, or suggesting that patients ask them themselves. It seemed from this that there was not necessarily a shared expectation between doctors and nurses about what to disclose and when, and that this could create tensions and impediments to open reporting. 

    A toxic workplace where a culture of blame thrives

    Telling patients the truth - visual of factors that can discourageBut perhaps the most significant barrier to the disclosure of incidents is the fear of what this might mean for yourself as a professional, and your career. So much of this stems from workplace culture – how do you expect your colleagues, both clinical and non-clinical, to respond to finding out about an incident? Are you supported to be open and honest by the people and structures in place (including compliance with the statutory duty of candour placed on NHS providers in England and Scotland, with plans for similar duties to be introduced in Wales and Northern Ireland) – or on the contrary discouraged, either explicitly or in more subtle ways? What do you know of what has happened to others in this situation? Do you fear medico-legal action, or possible consequences for your indemnity insurance?

    This last question is crucial. The UK, like the US, has embraced the tort system, under which individuals are legally liable for their actions as professionals. In contrast, countries like Denmark and New Zealand have adopted a no-fault approach to compensation. There are though some misconceptions in this country about litigation in this area, and what it means for indemnity insurance. Within the NHS, there is clear guidance that being open is the right thing to do, and should not prejudice any future litigation. However, this may still not be fully understood, and there continue to be mixed messages about the possible impact on the cost of indemnity. Research suggests that staff take the lead from their employers on this: managers in the US who took part in a widescale survey in 2002 were twice as likely not to disclose preventable harm if the hospital itself has concerns about the malpractice implications of disclosure. This is therefore another area where employers exert influence.

    How can we overcome these barriers?

    What is striking about these barriers to openness is how familiar and relatable they are to people even outside healthcare. We are most of us motivated by wanting to do the right thing, but before doing so, we tend to assess the impacts on our own lives of taking a particular course of action. Without even thinking about it, we might carry out a rudimentary cost-benefit analysis of even relatively trivial actions, such as reporting that we’ve clipped the wing mirror of a parked car, or challenging someone’s antisocial behaviour on public transport. Is it worth the costs to me? What will it achieve? We may also find ourselves looking for reasons to justify a decision not to act.

    Health and care professionals are bound by a professional duty of candour, as set out by their professional regulator – this should be an important motivating factor, that in a perfect world would eliminate the need for a cost-benefit analysis. Should I be open about what happened? Yes. Why? Because it is your duty as a professional and it says so here. It should also act as an enabler insofar as it can be used to justify to others a decision to be open.

    But of course, professionals are humans with complex motivations and fears, and they operate within complex systems alongside other humans. Where the mere existence of this duty (and potential consequences if the professional is reported to the regulator) fails to bite is if the influence exerted by barriers to openness is greater than that exerted by the professional duty combined with their personal drive to do the right thing.

    Addressing these barriers is a sector-wide challenge. Indemnity providers could do more to reward candour and punish its absence. Employers can play a huge part in reducing the disincentives, and in reassuring professionals that not only will they not face unfair negative consequences in being candid, they will also be actively supported in doing so. This is part and parcel of what is often referred to as a learning culture, as set primarily by those at the top of organisations – a topic too vast to explore in more detail here. The statutory duty of candour for NHS providers, along with other initiatives such as the Health Safety Improvement Board in England (which we have expressed some reservations about) aim to improve responses to incidents as well learn from them.

    Alongside this, regulators have made progress in encouraging candour, not least through working together on a joint statement. However, they still could place greater emphasis on the importance of candour in their fitness to practise proceedings, and educate their registrants on what it means and why it matters, reinforcing the messages at every opportunity, including through revalidation. There is also an important role for pre-qualifying education to equip future professionals to deal with the mistakes they will inevitably make, and develop the moral courage that they will need to do the right thing in the face of adversity. None of this represents a solution on its own, but it would be a significant step in the right direction.


    Related material

    For a full bibliography and references for this blog, you can read through our reports. You can find all our work on the duty of candour on our website.

  • The role of regulators in encouraging a Speak Up culture

    by Russell Parkinson, Head of Office, National Freedom to Speak Up Guardian for the NHS | Nov 06, 2019

    ‘See it Say it. Sorted’ – you usually hear this if you are taking any kind of public transport and it applies to being vigilant – keeping a look out for unusual behaviour that could put people at risk. However, you could also apply this principle to speaking up and raising concerns in a health/care setting – concerns which, if ignored, could also put people at risk. In his blog, Russell Parkinson explains that without positive and supportive organisational cultures and good leaders, staff can ‘see it’; they can ‘say it’, but it might not always get ‘sorted’.


    Background

    On 1 April 2017 a new legal duty came into force which required all prescribed bodies to publish an annual report on the whistleblowing disclosures made to them by workers. In September 2018, the health professional regulators published their first joint report on whistleblowing disclosures made to them. A year later the Authority organised a seminar bringing the regulators together to discuss the work they have been doing to strengthen arrangements to encourage a Speak Up culture.

    Russell Parkinson came along to the seminar in his role as Head of Office, National Freedom to Speak up Guardian for the NHS. In his guest blog, Russell outlines the progress made by the Freedom to Speak up Guardians, but also underlines that for Speaking Up to be effective, there needs to be supportive organisational cultures with good leaders.


    Encouraging a culture which supports freedom to speak up

    The Interim People Plan aims to ‘to grow the NHS’s workforce, support and develop NHS leaders and make our NHS the best place to work’. The plan says that in addition to recruiting extra staff, much more needs to be done to improve staff retention and transform ways of working. Secretary of State Matt Hancock MP has said that ‘we need …. a more supportive culture to make that plan a reality’. A positive speaking up environment where workers feel valued and listened to is fundamental to developing a supportive culture. 

    If it is the role of regulators to protect patients, service users and the public, then it stands to reason that they also have a role to play in encouraging a supportive culture for those they regulate.

    The events at Mid Staffs and Gosport War Memorial Hospital serve as reminders of the harm that can occur to patients when a Speak Up culture does not exist. Following the publication of the Francis Freedom to Speak Up Review in 2015, Trusts and Foundation Trusts in England have appointed Freedom to Speak Up Guardians. The network has now grown to over 1,000 guardians, champions and ambassadors in NHS trusts and FTs, independent sector providers, national bodies and primary care organisations. Thousands of cases have been brought to Freedom to Speak Up Guardians since April 2017.

    The National Guardian’s Office supports this network of Guardians through training, disseminating good practice, undertaking case reviews, and providing challenge and works across the system to tackle barriers to speaking up.

    What is a ‘healthy workplace culture’ and how do you measure it?

    The saying ‘what gets measured, gets done’ was never truer than when faced with an inspection from a regulator. But culture is a difficult thing to measure, despite its acknowledged importance. A healthy culture is hard to define in concrete terms, it seems vague and difficult to pin down. Culture by its very nature is what happens when nobody’s looking – so measuring it seems impossible. Yet there are some indicators which can give an insight into what a Speak Up culture looks like.

    In the National Guardian’s Office Freedom to Speak Up Guardian Surveys, we showed that guardians in organisations rated Outstanding by the Care Quality Commission were more positive in their perceptions of the speaking up culture. We wanted to understand how other NHS workers perceived speaking up in their organisations, so we have created a single measure from four questions from the 2018 NHS Staff Survey. 

    The questions ask how workers feel their organisation treats staff who are involved in an error, near miss or incidents; whether they are encouraged to report these; if they would know how to report unsafe clinical practice; and if they would feel secure raising concerns about it.

    By bringing these four questions together into a ‘Freedom to Speak Up (FTSU) index’ and comparing them with CQC overall and Well-Led inspection results, we are able to see a correlation between workers’ perception of a supportive Speak Up culture and organisations which are managed well. For regulators, this is potentially a lead indicator which can be viewed together with other information about safety, workforce and culture. 

    The regulators’ role

    Regulators also have a role to play in offering safe spaces for workers to speak up, when other internal routes may not have been successful. But it is not enough to listen to what workers have to say, it is also important to ensure that action is taken as a result. Sending the message that regulators are listening will also help focus leaders’ minds that their workers voices are important. Leaders will be held accountable if they fail to promote an open and learning culture.

    Creating the right workplace environment

    We also need to model this behaviour in our own workplaces. We all have a responsibility to encourage an environment where candour and feedback are business as usual. A supportive Speak Up culture is one where all of us should be able speak up about anything. Where we can share ideas, seek advice, offer feedback, challenge decisions or raise concerns without fear of repercussions.

    A positive speaking up culture is often associated with higher performing organisations. It is a reflection in how psychologically safe people feel, that they are able to speak up, feedback, and work together to innovate and perform effectively.

    Workers are the eyes and ears of an organisation and they should be listened to when considering patient safety and experience. The best leaders understand how important this is. These leaders create an inclusive speaking up culture where everyone’s insight and expertise is valued, and all workers are empowered to speak up and contribute to improvements in patient care.

    Ultimately, speaking up protects patient safety and improves the lives of NHS workers. For regulators, whose role it is to bring peace of mind to the public, it is important to show that those they are regulating are listening and learning.


    Related material

  • Patients and professionals - striking a balance

    by Christine Braithwaite, Director of Standards and Policy | Sep 27, 2019

    The health profession regulation sector is about to embark on some significant reform. It is a time of great opportunity to modernise and address the weaknesses of the previous regulatory system.

    The changes proposed to extend regulators’ powers to dispose of all cases, whether relatively minor or serious, under consensual disposal are major.

    Ordinarily, consensual disposal by a pair of decision-makers (case examiners) is used in less serious cases, where the facts are agreed and the registrant demonstrates insight. The proposed changes, to be implemented first by the new regulator, Social Work England, will allow regulators to dispose of serious cases this way too.

    Health and care professionals may be breathing a sigh of relief at the shift in dialogue from regulators and reformers as they recognise the need to hear and respect the clear messages from the professions that they are under pressure as never before. The health professions have never lacked a voice and they are not shy of expressing their frustrations and unhappiness about clunky fitness to practise processes that they feel add to their stress and do not reflect the realities of modern healthcare delivery. At root, they feel some regulation is unfair - and a system perceived as unfair can alienate those it is meant to regulate - and those it is meant to protect.

    As colleagues in the sector know, the Authority is a firm proponent of evidence-based regulation and we have a keen interest in understanding the psychology of health and care professionals. I therefore fully acknowledge that it is important for professional regulators to draw upon Professor Gerry McGivern’s work on ‘relational regulation’ and re-position their connection and discourse with the professions.

    But, it is necessary that patients’ and the public voice are equally heard. Doctors were deeply unhappy over the Bawa-Garba case, where rumours and mis-apprehensions still abound - patients and the public however were by comparison, largely silent. Those that did speak, including Jack Adcock’s mother, opposed any leniency.

    When patients and the public have spoken out it has been to express their dismay not just at the mishaps that have befallen them, but also at the secrecy which has sometimes appeared to surround them. Health professionals in Northern Ireland were criticised by Judge O’Hara following the Hyponatraemia Inquiry and some are uncertain about the impact of a statutory duty of candour on individuals - the first of its kind. Patients and the public, however, mostly appear to support it.

    The failure of a regulatory system to hear patients and to take seriously the concerns of those affected by poor care risk impeding safe care and not being perceived to be fair. It can also deter patients from raising concerns, which ultimately makes it harder for regulators to protect the public.

    Our research with the public demonstrates that the public, when properly informed, support the move to resolving cases without a panel hearing provided they continue to be involved and the process and results are entirely transparent.

    The Authority fully supports moves to reform fitness to practise processes where we retain appropriate oversight to ensure the public are protected. But, regulators and reformers must take care to involve and listen to patients and the public at least as much as they do the professions and regulators. To do otherwise risks unfairness, loss of public confidence and diminished public protection. Public protection thrives in the light. 


    Related material

    You can find out more about our thoughts on regulatory reform from here. You can also find more details on how we think the fitness to practise process should be reformed:

  • Public interest and the fitness to practise process

    by Mark Stobbs, Director Scrutiny and Quality & Dinah Godfree, Policy Manager | Jul 11, 2019

    We recently attended an event at the Faculty of Advocates in Edinburgh. It posed some very interesting questions around public interest and fitness to practise. In this blog, Director of Scrutiny and Quality, Mark Stobbs and Policy Manager, Dinah Godfree, recap some of the main discussion points.


    The Faculty of Advocates in Edinburgh recently held a very interesting conference on fitness to practise issues. One of the major discussion points there was the concept of the public interest in the fitness to practise process and where this fits in the light of the recent Bawa-Garba case and the pressures on health care professionals in the present environment.

    In assessing a registrant’s fitness to practise, regulators look at three factors:

    1. Public protection
    2. Upholding professional standards
    3. Maintaining public confidence in the profession.

    The first point is uncontroversial. Regulators need to assess whether the registrant poses a risk to the public because there is a likelihood that, because of deficient clinical skills, adverse health conditions or a poor attitude, the registrant will cause harm to patients.

    The second and third points are more difficult, particularly in cases, such as that of Dr Bawa-Garba, where a panel is satisfied that the clinical concerns have been addressed.

    The purpose of those factors is (a) to send a signal to the profession as a whole that conduct is unacceptable and (b) to let the public know that serious concerns are dealt with appropriately by the regulator, in order to maintain their confidence in the profession.

    Public interest sanctions

    These public interest elements are, in many ways, akin to criminal sanctions and, while the mantra of the courts and regulators is that sanctions in fitness to practise processes are not punitive, the sanctions imposed in such cases tend to have a punitive effect in that the registrant is prevented from earning a living in that profession for a period or has an adverse finding on their record.

    Typically, public interest sanctions are imposed where the registrant has received a criminal conviction or the behaviour has been particularly bad:

    • it has involved dishonesty or breached professional boundaries
    • has been ongoing over a considerable time
    • had very serious consequences, or
    • has involved seriously bad practice.

    There is little guidance from the courts on what this involves and panels have to consider what an intelligent, informed member of the public, aware of all the facts would feel about the conduct. This, as one of the speakers pointed out, is a high bar. It is also a subjective one. We have written about the lack of clarity on the meaning of public confidence and how this test should be applied in a recent report.

    How can regulators deal with a wide spectrum of criminal offences?

    There are a number of interesting questions arising out this concept.

    Firstly, how should regulators deal with the wide spectrum of criminal offences?  Should drink driving offences (where there are no health issues) or minor ‘Friday night’ criminal damage offences attract the attention of a regulator? Does the answer depend on the status of the profession?  The Authority’s research on attitudes to dishonesty and the research conducted for Leslie Hamilton’s review provides some evidence of the public’s attitudes to these questions, both suggesting that the public is particularly interested in issues surrounding harm and abuse of position.

    Secondly, how should regulators deal with other matters that happen outside practice – offensive tweets or disputes that get out of hand or dishonesty in a private dispute? There hasn’t been significant research on this but, again, it may well be that the public are concerned about issues which are clearly relevant to practice in health and social care.

    What about contextual factors?

    How should these sanctions work in the context of a health and social care system where there are significant pressures on staff? Is it right to deprive the health and social care system of competent practitioners because of non-clinical concerns? These questions are brought up particularly starkly in the Bawa-Garba case where the registrant had been practising safely for four years after the events that gave rise to her case and was generally agreed to be a better than average doctor. Many people, including the parents of the child who died in her care would say that she should not be allowed to practise again. Many parents might be concerned about entrusting the care of their child to someone who has been convicted of gross negligence manslaughter. Others might say that there is strong evidence that she won’t make the mistakes again, the country needs good doctors and that, as a result of the fitness to practise proceedings she has become deskilled to the extent that she agreed that conditions of practice were appropriate to assist her return.  

    Panels frequently refer to the public interest in returning competent practitioners to practice and the balance to be drawn in these cases is difficult.

    With that in mind, it was interesting at the conference to hear of the NMC’s fitness to practise strategy which aims to address clinical problems locally, where the registrant accepts that there is a problem and is willing to address it. The Authority supports this, subject to two caveats. Firstly, there is a public interest in serious matters being addressed openly rather than behind closed doors. Secondly, there is an incentive for busy regulators to get rid of cases at an early stage without necessarily investigating all aspects. We will watch this development with interest.

    What do the public think?

    There is no doubt that there are some actions which, whether as part of clinical practice or outside it, are so serious that a regulator will need to take action simply because it needs to signal to the profession that such conduct is unacceptable and to show the public that it is taking it seriously. What is much less clear is the point at which conduct engages these concerns. More work on public attitudes may assist. The conference did not provide any answers but it did a service by identifying and discussing the issues.


    Related material

    Find out more about all our work on dishonesty and our views on reforming fitness to practise.

  • Professional identity - regulation plays only a small role but could it be about to get bigger?

    by Daisy Blench, Policy Manager | Jun 13, 2019

    Question: When is a nurse not a nurse?

    Answer: When she runs the London marathon dressed in the uniform she wears to work every day, a similar uniform worn by nurses across the UK.

    In our latest blog, our Policy Manager, Daisy Blench reflects on a recent talk she gave to nursing associate students at Solent University, and the Authority’s work on professional identity and the factors that influence its formation.


    Professional identities media image

     

    Nurse Jessica Anderson hit the headlines recently during April’s London Marathon when she beat the Guinness world record for being the fastest female marathon runner dressed as a nurse. Later, she was rather put out to discover that, as her scrubs and trousers did not in fact match their (somewhat outdated) uniform criteria, her achievement would not be recognised.

    According to the Guiness Book of World Records, a nurse’s outfit should include a blue or white dress, a white pinafore apron and a white nurse’s cap, a description most definitely stuck somewhere in the mid 20th century. This was news to Jessica who, along with the majority of her colleagues (male and female), wears scrubs to work. Jessica was subsequently awarded the record after a backlash and the Guinness Book of World Records have announced that they are reviewing their criteria for what constitutes a nurse’s uniform.

    The case raises interesting questions about the different factors affecting professional identity, including the wearing of uniforms and how much identity as a professional is defined by external factors. The media and popular culture have no doubt played a role in creating a fixed image of a nurse which perpetuates and that many still identify with.  

    What role for regulation in forming professional identity?

    We have commissioned research into professional identity, in particular looking at the role that regulation plays in its formation and maintenance. We found that whilst regulators have a part to play in the shaping of identity through their role in the quality assurance of education and training, professional identity is primarily formed and affected by factors closer to professionals. These include interaction with patients and colleagues, everyday tasks and the context in which an individual works.

    I recently went to talk to nursing associate apprentices and healthcare assistant practitioners at Solent University in Southampton about professional identity and many of these issues were raised by attendees. A key theme on the day was role confusion and uncertainty with attendees discussing the challenges they faced when nursing, and other, colleagues didn’t understand their role. They also highlighted the impact on professional identity when there is a lack of validation of their role from colleagues within the healthcare team.

    Can wearing a uniform help strengthen professional identity?

    For some, what they wore was a key issue, with one attendee suggesting that standardised national uniform could help to strengthen identity and help patients differentiate between registered nurses, nursing associates and healthcare assistants. However, nursing associate students working in a mental health setting highlighted that for them, uniform could be a barrier to effective engagement with patients who preferred them to wear ordinary clothing in the workplace.

    Regulation as a badge of honour

    Whilst regulation was not raised as a key influence on identity, the disparity between those who would ultimately be registered as nursing associates and those who have chosen to continue as unregistered assistant practitioners raised questions of legitimacy for the assistant practitioners who were present. They felt that they were working at the same level as nursing associates, albeit in a more specialised area, and that lack of regulation was seen to raise issues of fairness and imply a lower status or level of experience. This echoed a commonly heard view that regulation is seen as a badge of status and provides legitimacy to the professional.  

    Despite our findings that regulation generally has only a limited impact on the formation of professional identity, an interesting observation from one attendee was that the nursing associate role may be slightly unique in that it was developed in close cooperation with the Nursing and Midwifery Council following the Government’s decision that the role would be regulated in January 2017.

    This raises the question of what impact regulation might have on the formation of the scope and identity of new roles, if decisions about whether a role should be regulated are made partly in response to workforce objectives rather than being based primarily on a need to manage risk to patient safety.     

    The recently published interim NHS People Plan developed by NHS Improvement stated that: ‘The government’s commitment to regulate physician associates is a significant step towards maximising their capability and embedding this critical role in our workforce.’

    If in the future roles are regulated in part due to a desire to develop their potential and meet workforce objectives, does this mean that regulation will come to play a greater part in the formation of professional identity? Furthermore, will this have implications for how the role is subsequently regulated and for the role of the regulator in balancing the interests of patient safety against workforce objectives? 

    A right-touch approach to regulating risk

    The Authority continues to highlight the need for regulation to be used proportionately and for decisions to be based clearly on risk of harm. However, it is clear that the interaction between regulation, professional identity and indeed workforce will continue to develop and the questions this raises will warrant further exploration and discussion. 

    Related Material

    You can find all of our publications on professional identity here. Or watch our short video on the findings of our literature review on professional regulation.

  • Bringing practitioners and their work together: human factors in health and social care regulation

    by Denham Phipps | May 16, 2019

    No matter how many policies, procedures, processes, checklists and codes of practice are in place to assure safety and mitigate risk, in healthcare settings, there is always one unknown factor – people. In his guest blog Denham Phipps – a Lecturer at The University of Manchester and a Chartered Ergonomist and Human Factors Specialist – explains more about 'human factors' and how they can relate to practitioner regulation.


     

    The human actor

    For all of the scientific and technological advances in health and social care, its safe and effective delivery depends on the people who work within it.  At their best, they bring expertise, creativity, adaptability and intuition to their work. However, the human contribution is a double-edged sword: people are also prone to becoming tired, misguided, distracted or stressed. How well health and social professionals carry out their activities, and how well they feel as a result of this work, can depend on the physical and social conditions in which it occurs.

    The latter observation inspired the National Quality Board to publish The Human Factors in Healthcare Concordat in 2017. The concordat challenges healthcare organisations to examine the impact of their work settings on clinical performance.  Extending this challenge to health and social care regulation raises a question: what happens when we take a human factors perspective on regulatory work?

    Let’s begin by taking a brief look at practitioner risk management more broadly.

    Managing risks in health and social care practice

    Take a moment to consider the work that goes on within a healthcare profession. What could go wrong in this work?  What could happen as a result?  How would you know any of this was happening?  And what could be done to prevent it?

    In thinking about these questions you might imagine a pathway leading from a hazard (the potential for something to go wrong) to an undesirable event (something actually going wrong). Take for example a practitioner who should refer a client to a general practitioner, but does not.  As my figure shows, this is an undesirable event brought about by a hazard such as lack of access to patient information, an inability to understand the information or act on it, or routinely disregarding patient information out of hand. Extending the pathway past the event itself, you might arrive at some consequences: the patient coming to harm; increased burden on other practitioners; a lowering of trust in the profession, distress to the practitioner involved.

    human factors diagram for blog

    Along the pathway, though, there may arise opportunities to block the evolution of a hazard into an event, or of an event into harm. In our example, such 'barriers' could include reminders, alerts or follow-ups. Alternatively, the hazards could be addressed at source by ensuring that the practitioner has the knowledge required to undertake the task, is encouraged to carry out appropriate actions and is not unduly burdened by doing so.

    This approach to understanding practitioner risk (about which you can read more here and here) places that risk in the context of the practitioner’s work system. In doing so, it leads us to a discussion about human factors.

    What is 'human factors'?

    In simple terms, human factors (which, incidentally, is also known as 'ergonomics', although I’ll keep to the one term here for simplicity) is the study of the relationship between people and work systems. It is based on the premise that a work system has physical, cognitive and social characteristics that influence how people within the system perform. Human factors incorporates knowledge from several scientific and technical fields – most notably physiology, psychology, and branches of engineering.  However, the hallmark of human factors is its focus on the interaction between people and systems, rather than either of these in isolation. 

    In health and social care, a human factors approach typically looks at how the following elements come together in the course of a care activity:

    • People;
    • Technology and tools;
    • Tasks (for example their nature and scheduling);
    • The immediate environment (for example, noise, temperature and lighting);
    • The organisation (for example, organisational priorities and incentives).

    What could this tell us?  Here is just a selection of the various insights from human factors work that are relevant to the current discussion:

    • Anaesthetists and community pharmacy staff sometimes act differently to how practice guidelines or standard operating procedures suggest they should.This, though, often occurred in order to ensure that their goals are achieved given the way that their work system is operating at the time – maybe even to keep the system itself functioning;
    • In the paediatric intensive care unit and the emergency department, characteristics of the work system such as workload, distractions and poor decision support have been implicated in the occurrence of prescribing errors, possibly due to the mental demand that is imposed on prescribers;
    • Nurses working on a healthcare helpline have been found to change their decision-making about referring callers over the course of a shift. As the number of calls since their last rest break increases, they appear more inclined to make an urgent referral for each caller.

    Having looked at what 'human factors' tells us about health and social care, we can now think about how it relates to practitioner regulation.

    What are the implications for regulation?

    Fitness to practise, as typically dealt with in health and social care regulation, is often framed as a matter concerning an individual practitioner – hence the focus of previous studies on personal characteristics predisposing a practitioner to performance problems. The challenge that a human factors approach poses for regulators is to reconcile this 'person-centred' view with the alternative 'system-centred' view, such that the conditions surrounding the practitioner’s work are also taken into account. In other words (and as suggested in NHS Improvement’s just culture guide) we should account for the possibility of a less than perfect work setting being implicated in a fitness to practise concern.

    Two well-publicised cases illustrate this point. The first is that of Elizabeth Lee, a pharmacist who received a criminal conviction for making a dispensing error. During the shift in which this error occurred, Lee had apparently dealt with a high volume of prescriptions, possibly while fielding interruptions to her work, and had not taken a break during her 10 hours of work.

    The second case is that of Dr Hadiza Bawa-Garba, who also faced prosecution after a delayed diagnosis of sepsis was implicated in the death of a hospitalised patient. In this case, Dr Bawa-Garba cited concerns about the work system, including the limited availability of staff to provide her with the support she needed and IT problems that made it difficult to gather the clinical information in a timely manner; these issues apparently making the already difficult task of diagnosing sepsis even more so.

    My point here is not that health and social care practitioners – either the two mentioned here or any others – should be absolved of their professional responsibility regarding patient care. It is, though, that any scrutiny of the way in which this responsibility is discharged should include an understanding of the setting in which the practitioner is working. In other words: how much does the system help (or hinder) in doing the right thing?

    So, having recognised the role of human factors in clinical performance, what should regulators do now? One recommendation is to seek human factors expertise and incorporate this into fitness to practise processes. The General Medical Council, for example, is shortly to do this, through a combination of human factors guidance during fitness to practise reviews and awareness training for investigators. Another recommendation is to incorporate human factors knowledge into the prospective work that regulators do to promote quality and safety. They could, for example, incorporate an appraisal of human factors that might affect practice in a given setting; alternatively, they could provide incentives and support for registrants to use human factors knowledge in their own quality and safety improvement programmes.

    Some outstanding questions

    Finally, a couple of brief thoughts about what remains to be understood about human factors and practitioner regulation. My discussion has focused on clinical performance – but where does this leave other types of issues, such as conduct and health concerns? As it happens, what is good for practitioner performance is probably also good for practitioner health, at least from a human factors perspective. In our own work on pharmacy regulation, we have explored a possible link between practitioners’ working conditions and their engagement in behaviours that could generate practice concerns of any type.

    Much of what I’ve discussed here concerns doctors, nurses and pharmacists. What, though, of the various other professions that deliver health and social care, whether statutorily regulated or overseen by the Authority’s accredited registration scheme: the opticians; the podiatrists; the psychotherapists; and the clinical scientists; to name but a few?  They have quite diverse roles, functions and working arrangements. For example: some professions involve solo practitioners; some are based in healthcare facilities while others work predominantly in the community; some use mainly relational rather than technical or medicinal interventions; others have a relatively limited and proceduralised scope of practice. There is a need to consider how human factors insights apply across these groups, both in terms of specific human factors issues and the strategies for addressing them.

    Summary

    I have given you an overview of what human factors is and how it relates to health and social care regulation.  There is more to be said about this topic – and indeed, more to be yet studied – than I am able to fit into a single article. However, you now have an appreciation of why human factors matters in health and social care and what you as regulators need to know about it. I and the Authority would be pleased to hear your thoughts about the role of human factors, and what you would like to do about it.

    Denham Phipps is a Lecturer at The University of Manchester and a Chartered Ergonomist and Human Factors Specialist.  He can be contacted on denham.phipps@manchester.ac.uk.


    Related material

    The WHO defines human factors as: the study of all the factors that make it easier to do the work in the right way. A failure to apply human factors principles is a key aspect of most adverse events in health careor  another definition of human factors is the study of the interrelationship between humans, the tools and equipment they use in the workplace, and the environment in which they work.

  • ‘Good… or good-enough…’ As a regulator, where do you fit?

    by Deanna Williams, President Dundee Consulting | May 02, 2019

    Deanna and Deborah Q&A

     

    Recently, Professor Deborah Bowman of St George’s University in London, shared her musings on ‘What is it to be a good regulator?’ Not long afterwards, she and I had the opportunity to explore this together, as panelists in a Q&A conversation at the Authority's recent academic and research conference.

     


    What does it mean to be good?

    In the regulatory context, it’s perhaps easier to define what is good by considering what ‘bad’ regulation looks like. Examples of regulatory failure, resulting in the loss of regulatory privilege*  has been seen across jurisdictions, professions and occupations. We have seen teachers in the UK and engineers, denturists, teachers and real estate brokers in various Canadian provinces lose their regulatory privileges. In each example there were common contributing factors in evidence. These related to:

    • governance
    • relationships
    • conflicts management
    • competing interests, and
    • loss of public confidence and trust.  

    In my experience, most regulators do experience one or more of these at some point in time. But two or more occurring simultaneously can give rise to ‘a perfect storm.’ As regulators, it’s important that we do not make the assumption that we are ‘good’, just because no one has told us we are not. To do so puts us at risk of being a complacent regulator – good enough, but perhaps not as good as we could be.

    Being ‘good enough’ is not bad

    In my view, it’s actually where most regulators fit; indeed, where we’ve not been seen to be ‘good enough’ in serving and protecting the public interest, governments have acted quickly to impose sweeping change. The Shipman case and subsequent Inquiry forever changed regulation of health and care professions in the UK, resulting in significant changes. These included establishing:

    • clear separations of regulatory and advocacy functions;
    • smaller council sizes;
    • appointments of competency-based councils with equal professional and lay representation; and
    • creating the Professional Standards Authority (formerly the Council for Healthcare Regulatory Excellence, or CHRE) to oversee, monitor and report annually on the regulatory performance and effectiveness of the nine professional health regulators.

    Regulatory best practice is demonstrated where regulators act with both competency and courage to exceed expectations in their service and commitment to the public interest.

    Courage versus complacency

    Consider, for a moment, this line of thinking: that the ‘good enough’ regulators do what they are (at minimum) required to do, while the ‘good’ regulators strive to go beyond and exceed the minimum expectations. This clearly aligns ‘good’ with courageous-ness and ‘good enough’ with complacency. But be clear, complacency is not necessarily a bad thing, and it’s certainly a safe place for a regulator to land. Amidst higher levels of scrutiny and calls for greater oversight and accountability, today’s regulators must accept that going beyond being ‘good enough’ will always be a challenge.

    In my view, the courageous regulator pushes boundaries and regulates to the edge of, but within, the law. Consider recent changes in Ontario, where health regulators must strike off a registrant who is found guilty of committing certain acts that constitute sexual abuse under the Regulated Health Professions Act.  The complacent regulator will generally only revoke a licence where a registrant is found to have committed one or more of the defined acts of sexual misconduct. However, regulators who view the defined list of acts that constitute sexual misconduct as maximums rather than minimums are more likely to seek alternate penalties for committed acts that are not included on the defined list and to demonstrate reluctance to challenge past precedents for fear of losing on appeal. The courageous regulator will revoke a licence of a registrant in matters where it believes that revocation is both necessary and appropriate in the public interest, whether or not the act committed by the registrant is part of a defined list. More importantly, the courageous regulator is less likely to be deterred by prior decisions or precedents, undertaking to challenge past precedents – of its own and others – simply because it is the right thing to do.

    A call to a challenge

    What would it take to move a regulator from being good enough to good?

    *('Regulatory Privilege' is the right of a profession to regulate ‘its own’ with independence from government. Degrees of such independence varies across jurisdictions but governments generally assume control where such privilege has been lost)


    Related material

    Academic conference 2019  highlights thumbnail

    Watch highlights of the conference or read through the presentations

    Find out more about more about our research here or you can see a full list of our research reports here.


    Find out more about Deanna

    Deanna Williams is known nationally and internationally for her work in professional and occupational regulation. She spent 18 years at the Ontario College of Pharmacists, Canada’s largest pharmacy regulatory authority, retiring as its Registrar in 2011. The Minister of Health and Long Term Care appointed Deanna as Supervisor to the College of Denturists of Ontario during the loss of its regulatory privileges in 2012 and 2013 and she also served as Risk Officer, for the Retirement Homes Regulatory Authority (RHRA) from 2014 through 2018. Since 2011, Deanna has been consulting in areas relating to professional and occupational regulation in Canada, the US and abroad, through Dundee Consulting Group Ltd. Most recently, from 2017-2018 Deanna served as Expert Technical Advisor to Ontario’s Minister of Health and Long Term Care, providing advice on best regulatory practices across professions and international jurisdictions respecting processes for complaints, investigations and discipline of matters related to sexual abuse of patients by regulated health care practitioners.

    In 2010, Deanna was recognised by the international regulatory community as the recipient of the CLEAR International Award for Regulatory Excellence.

    Deanna received her designation as a Certified Association Executive (CAE) from the Canadian Society of Association Executives (CSAE) and her Corporate Director (C.Dir ) designation from the Chartered Director program, DeGroote School of Business, McMaster University. She has served on the Finance and Audit Committee of the University of St Michael’s College, University of Toronto and is Immediate Past-Chair of the Board of Directors of Haldimand War Memorial Hospital in Dunnville Ontario on the north shore of Lake Erie.

  • The professional duty of candour: widening the lens

    by Annie Sorbie and Zahra Jaffer, University of Edinburgh, School of Law | Apr 16, 2019

    In our latest guest blog Annie Sorbie and Zahra Jaffer of the University of Edinburgh’s School of Law, discuss that momentum needs to be maintained on embedding the professional duty of candour in healthcare professionals, but we also need to widen the lens beyond individual interactions and direct attention to the wider context in which healthcare is provided.

    Annie Sorbie Blog photoZahra Jaffer Blog photo

    Annie Sorbie is Lecturer in Medical Law and Ethics and Zahra Jaffer is a PhD candidate.  Annie worked with the Authority to facilitate discussion groups with staff from regulators and fitness to practise panellists for our recent report Telling patients the truth when something goes wrong - how have professional regulators encouraged professionals to be candid to patients?


    Across healthcare there has been a renewed focus on the need for healthcare professionals to be open and honest when something has gone wrong with patient care (this was highlighted in in the latest blog by Michael Warren). As recently as January 2018 the report of the Hyponatraemia Inquiry of Northern Ireland identified repeated failures in openness and honesty. The Professional Standards Authority’s 2019 Report – Telling patients the truth when something goes wrong – reflects its continued commitment to reviewing how the duty of candour has been embedded – and indeed enacted – in the wake of events at Mid-Staffordshire Foundation Trust and following the regulators’ joint statement on candour in 2014.

    Maintaining momentum

    In this blog we consider some of the work that has been done to continue the momentum created by the 2019 Report. In particular we reflect on insights from the Professional Standards Authority’s annual academic conference and our joint interactive workshop on the duty of candour that we delivered at that event. We also consider how widening the lens on candour – for example by looking at research and initiatives across professions, sectors and jurisdictions – can provide valuable lessons for the implementation of the duty of candour as it is translated from policy to practice.

    What is it to be a good regulator?

    The central question of the Professional Standards Authority’s 2019 academic and research conference, held last month, asked: what is it to be a good regulator? The programme, curated in partnership with Professor Deborah Bowman (St George’s, University of London), explored the myriad challenges and opportunities of achieving ‘goodness’ and provoked varied and thoughtful responses.

    To those of us who have been working on the duty of candour it was striking how strongly these presentations and discussions resonated with the key themes of the 2019 Report. For example, Dr Suzanne Shale, Clearer Thinking, and Sharon Burton, General Medical Council, underlined the importance of creating compassionate workplace cultures and the link between positive workplaces and better patient outcomes, a recurrent theme across both days. In our consideration of the factors that can encourage or discourage candour in the 2019 report, we too had found that ‘toxic workplace environments with a blame/defensive culture are not places where openness, honesty and transparency will thrive’. Fiona Browne, General Osteopathic Council, spoke about the need to embed professional standards into healthcare professionals’ everyday practice. This again echoed our findings on the need to bridge the gap between regulation and policy, on the one hand, and practice on the other. The conference also offered broader insights to the value and contribution of academic research to regulation at the coalface, as exemplified by the work of Professor Rosalind Searle (University of Glasgow) on workplace sexual violence.

    A key feature of the Authority’s work on candour so far has been its focus on the operationalisation of this duty, and how it can best be communicated and embedded on a day-to-day basis. Here Harry Cayton’s presentation on governance was particularly pertinent. He noted, amongst other matters, that ‘…much of what is said about good governance misses the point by concentrating on board and committee procedures rather than on the personal qualities, skills and behaviours of board members.’ He elaborated further on the key role of ‘thoughtful, respectful relationships’. It seems to us that the same observations might also be made in relation to the professional duty of candour. In particular, the view of the discussion group participants was that candour was something that professionals needed to ‘take to heart’. Further the 2019 Report suggests that collaborative work and consistency are key to supporting professionals and encouraging candour. Harry Cayton’s observations, albeit in a different context, point us back to ‘skills and behaviours’ and away from reliance solely on a top-down, rules-based approach to regulation.

    In our own interactive workshop on the professional duty of candour we continued to benefit from participants’ views on matters including how to take into account patient and carer views on candour, the communication skills required by professionals and the role of authentic apologies.

    Looking forward: next steps

    Our workshop also provided us with the opportunity to introduce and seek feedback on our new research on the professional duty of candour in the context of surgery. This is being undertaken in a collaboration between the Professional Standards Authority, the Royal College of Surgeons of Edinburgh and the University of Edinburgh. This project is just getting underway and has commenced with a literature review that builds on that undertaken by the Professional Standards Authority in 2013. Some preliminary observations from our review are already proving interesting. It is perhaps predictable that, since 2013, there has been a growing body of literature addressing the duty of candour as a stand-alone concept.  However, we have noted that academic attention has often focused on the technicalities of the operation of the statutory duty of candour at an organisational level – and in particular on reporting thresholds – rather than on the professional duty of candour and the factors that underpin whether and how this is enacted. In considering the underlying factors that can encourage or discourage candour we have also looked across jurisdictions, for example to learning on ‘open disclosure’ practices in New South Wales, Australia. This work is ongoing and we look forward to disseminating our findings in due course, as well as tailoring these to the specific context of surgery.

    Concluding thoughts

    The need for openness and honesty in healthcare is by no means a new concern, but the implementation of the duty of candour remains persistent and pressing. Our research, research across the wider regulatory and healthcare sectors, and work across jurisdictions underlines that consideration of candour is not just about interactions on an individual level. Our attention is also directed to the wider context in which healthcare is provided and the links between positive workplace cultures and better patient outcomes. Complex issues require multi-faceted responses and now is the time to widen the lens on our consideration of the professional duty of candour if we are to effect a step-change towards its full implementation by professionals.


    Related material

  • The professional duty of candour is a commendable principle but to what extent can regulators influence their registrants to put it into practice?

    by Michael Warren, Policy Adviser | Feb 28, 2019

    Trust is undoubtedly the basis on which any successful healthcare professional-patient relationship is going to be built. If there is a lack of trust, we cannot realistically expect patients to agree to be examined or undergo risky surgical procedures. The professional duty of candour – that is telling the truth when something has gone wrong with care – is integral to building this trust.


    duty-of-candour visual for page

    Background and context

    The duty of candour, like many policy initiatives was borne out a crisis, by events such as those at the Mid-Staffordshire Foundation Trust – these often result in a push for change and UK policymakers have been focusing on how openness and honesty can be encouraged, this is usually referred to as ‘candour’. In 2014, eight of the nine professional regulators published their joint statement on candour encouraging their registrants to be candid; and enforcing the professional duty of candour through fitness to practise processes.

    We have previously undertaken work around candour: advising the Secretary of State in 2013 on whether professional regulation could do more to encourage professionals to be candid. We followed this up with two further reports: one in late 2013 aimed at understanding the limits and potential for regulatory action in this area; and then in November 2014 we published a report outlining progress made on strengthening professional regulation’s approach to candour and error-reporting.

    A renewed focus

    We felt the time was right to renew focus on candour. We wanted to find out how far policy interventions have come in ensuring that patients can expect professionals to be candid with them. Our recent publication –  Telling patients the truth when something has gone wrong is the result. Two main data sources fed into the final report:

    • discussion groups with regulators’ staff (mainly staff involved in the fitness to practise process, such as panellists) – discussions were facilitated by Annie Sorbie, Lecturer in Medical Law and Ethics at Edinburgh University
    • questionnaires completed by regulators and stakeholders across health and care.

    What the report reveals

    One obstacle to fully understanding the effects of regulatory interventions on candour is that it is difficult to measure candour quantitatively. How do you measure whether a workforce is more or less candid? It’s even more difficult to measure whether regulatory interventions/encouragement have made any difference. Therein lies the problem. Much of the data and detail around candour is inconsistent and stems from the qualitative nature of candour. One of the research participants highlighted that regulators are in a better position to measure the absence of candour rather than its presence. Regulators can do this through their fitness to practise processes. We need more consistency in collecting the data, the terminology used and look at candour in the wider context, not just from fitness to practise data.  

    What progress have the regulators made?

    The regulators have embarked on various initiatives to embed and encourage candour in their registrants during the last four years. Even with the above caveat in place (about data), the regulators have made progress. They have all pressed ahead in multiple areas to encourage candour in their registrants. They have put in place specific standards requiring registrants to be open and honest when something has gone wrong, and five of the regulators have produced accompanying guidance.

    Learn by example

    However, our report also reveals that being candid is all very well in principle, putting it into practice can be more complex. Registrants can feel that their regulators are far-removed from the everyday practice of their profession, not subject to the same pressures they face. Questionnaire answers suggested that regulators need to show rather than tell their registrants how to be candid and bring the duty of candour to life. Case studies can provide guidance to registrants based on real-life situations they may find themselves in or, at least, be familiar with.

    The Nursing and Midwifery Council (NMC) has produced a number of case studies to help its registrants with the duty of candour, what it means for their practice and how to meet it in a range of scenarios. Other regulators have included specific sections on candour in their indicative sanctions guidance as part of their fitness to practise process.

    A proactive rather than a reactive approach to candour

    Fitness to practise though is reactive and usually involves an incident where candour is absent rather than present. It could be possible therefore to gauge the absence of candour’s impact on patients and professionals, but not the benefits of professionals being candid. It is also not possible from the fitness to practise data to set the scene. What was the wider context? Is candour absent in the individual healthcare professional or does the place where they work inhibit candour? If so, what are the wider implications for patient safety in this particular organistion?

    Telling patients the truth -  factors to encourage

    For patients to really benefit, we need to switch to a more proactive and preventative approach to embedding candour. Regulators need to cooperate with education and training providers to raise awareness about the professional duty of candour to trainees/students and those professionals at the start of their career. Education and training can play a pivotal role in this and regulators have made moves to embed candour, for example, by:

    • introducing education and training provider standards which specifically mention candour
    • speaking directly to trainees and students to flag and discuss candour issues
    • through continuing professional development/revalidation.

    Communicating with their registrants

    Regulators have also encouraged candour by engaging directly with their registrants. This can be through newsletter articles, short animated videos, training sessions and advice lines, as well as working with stakeholder organisations such as system regulators.

    This figure (below) provides an overview of the regulatory tools in place to help registrants understand candour (and can be found on page 31 of the report).

    Where do the regulators go from here?

    Turning a negative into a positive

    Candour is currently viewed and discussed from a more negative angle – usually where there has been a lack of candour, especially as part of a fitness to practise process. Many questionnaire respondents/discussion group participants believed that regulators should take the opportunity to rethink their approach to candour, looking at when a professional has been candid with a patient, or ‘positive’ candour. Fitness to practise could provide the framework for this – as one professional body noted ‘fitness to practise can be an opportunity for regulators to emphasise that candour is not just a duty to be discharged, but a quality to be sought and valued’.

    Not by regulation alone: cooperation and consistency

    Regulators need to take a consistent approach to incorporating the professional duty of candour in their four core regulatory functions (guidance and standards, education and training, registration and fitness to practise), but they also need to work with other stakeholders.

    As already touched on, registrants can feel a degree of separation from their regulators. The capacity of individuals to be candid is mostly influenced by their work environment. In our 2013 report, we identified that many of the barriers that inhibit candour are in the workplace (and these barriers are still present). Regulators are not well-positioned to help their registrants overcome these barriers and need to work in concert with employers, system regulators, professional bodies and other groups who have a more direct impact on professionals’ daily lives.

    Read the full report to find out more or see a visual summary of the key findings in this infographic. You can find all our material related to the professional duty of candour here.


    Related material

    You can find all our work on duty of candour here. Candour is often linked to dishonesty - you can find all our research on dishonesty here.

  • Healthcare professionals - ‘shock absorbers’ in a system under pressure?

    by Christine Braithwaite, Director of Standards and Policy | Feb 08, 2019

    According to the Point of Care Foundation (Behind Closed Doors), healthcare staff are taking the brunt of pressures in the healthcare system, which is not sustainable and may jeopardise care. On 18 September 2018, Unison surveyed over 18,000 staff to understand what it was like to work in the health service over a 24-hour period. Just Another Day reported compromised care, staff shortages and serious stress and, they point out, that’s before the winter pressures came into play. Whether it is reports of staff vacancies, waiting lists rising, financial deficits or social media chatter, it seems pretty clear that many healthcare professionals are working in a tough environment. When Brexit finally arrives whatever that transpires to be – healthcare professionals will shoulder some of the impact.

    Hitherto, UK professional regulators do not get involved in workforce or workplace matters, but should they now – and if they do enter this uncharted territory, what role should they play and how far does the border extend?

    The strength of the professional regulatory system is that it sets universal standards capable of being applied to the multitude of situations encountered by professionals delivering healthcare. Regulators may provide additional guidance such as that about the professional duty of candour, to help professionals understand how to interpret their standards in certain situations. A plea as to workplace conditions impacting fitness to practise may potentially be considered a mitigating factor, but generally regulators expect professionals to abide by their standards and to be held to account for their practice. 

    The furore that erupted following the General Medical Council's decisions about Dr Bawa-Garba threw into sharp relief the tension between professional responsibility and accountability and challenging workplace conditions. The GMC has responded by, amongst other things, announcing the introduction of human factors training for its staff. The General Dental Council similarly is providing training. Regulators are also beginning to sound alarms about workplace pressures and are considering the potential impacts of Brexit including the impact on supplies of workers, medicines and devices.

    Whilst hoping that the worst-case Brexit scenarios prophesised do not materialise it is nonetheless sensible to consider them when testing business continuity plans. One issue likely be uppermost in health professionals’ minds is ‘if something goes wrong, how will I be judged?’  And for patients, ‘will my care be less safe?’. For regulators therefore the question is, if exceptional circumstances prevail, where should the thresholds for regulatory action lie? It is easy – and perhaps correct – to say the standard must prevail, but achieving fairness for everyone may require a careful balancing act.

  • A new year provides a new opportunity to strive for regulatory reform

    by Alan Clamp, Chief Executive | Jan 03, 2019

    In our first blog of 2019, Alan Clamp explains why setting intentions is the smarter approach to succeeding than the usual new-year resolutions. One of our 2019 intentions is to continue to push for regulatory reform.


    Happy New Year to one and all. Let me first wish everyone health and happiness for 2019 whatever politics and fate might have in store for us.

    There’s often a tendency to revert to the cliché of resolutions when writing a New Year blog. It’s certainly a handy editorial device but I’m loath to rely too heavily on it. Resolutions are traditionally made to be broken. Google ‘new year resolutions’ and you’ll easily stumble across a survey or two which aim to prove the point. Over time, more humans than not will eventually break their resolve and abandon the promises they made to themselves and others.

    And so, it appears that resolutions have had a rebrand. We’re being encouraged to set intentions, not resolutions. Intentions can be made daily, weekly or monthly, but the idea is they are more achievable, less onerous and therefore more likely to succeed.

    This concept appeals to me. In these uncertain times, setting intentions to do the best job in regulation that we can, be it daily, weekly and monthly, feels like the right path to take. That said, it’s not something new here at the Authority. We’ve always strived to improve regulation for public protection and it’s at the heart of our operating principles.

    Twelve months ago, we were in the throes of the government’s consultation on regulatory reform, Promoting professionalism, reforming regulation. Open for 12 weeks, it closed on 23 January 2018 and we are waiting for the government to publish its response to the feedback received. While this is understandable, given the demands of Brexit legislation, we will continue to push for confirmation of much-needed change to professional healthcare regulation. In a recent blog, we outlined our views on why radical reform of regulation must begin now.

    To all those who work in this field, it’s clear – and has been for some time – that the current system is flawed. Significant changes are needed, such as those put forward in many of our publications, but crystallised in Rethinking regulation. We have every hope that 2019 is the year in which these changes are realised. But until that time comes, we have every intention of continuing to perform our role to the best of our ability, to improve what we do and to play our part in protecting patients and the public.


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  • Radical reform of regulation must begin now

    by Christine Braithwaite, Director of Standards and Policy | Dec 10, 2018

    We are still waiting for the government's response to its consultation on Promoting professionalism, reforming regulation. In this blog, our Director of Standards and Policy, Christine Braithwaite explains why the regulatory system cannot afford to stand still and sets out the five key areas where we would like to see reform.


    Three years ago, we called for radical reform of professional regulation. Our publication, Rethinking regulation set out the problems with the current system, which was not designed to support modern, multi-disciplinary team led care. It struck a common chord with health professionals and others who agreed reform is urgently needed and long overdue.

    Whilst we still await the government’s response to its consultation Promoting professionalism, reforming regulation the regulatory system cannot afford to stand still. Whether we get all the radical solutions we called for in Right-touch reform and our response to the consultation or only some, the radical shift we called for is crucial. As we said, much can be achieved with ‘cooperation, imagination, innovation and determination’.

    There are five key areas for action:

    • Defining and developing the regulators’ role in preventing harm. Work many of them refer to as moving ‘upstream’ to help avert harm before it happens. This includes using data from registration, education and fitness to practise.
    • Modernising fitness to practise balancing efficiency, flexibility, and a more rehabilitative approach with maintaining public protection and public confidence. Much of this requires legislation but regulators are already changing the way they work.
    • Shaping professionalism through standards, education and training and continuing fitness to practise processes, such as revalidation.
    • Achieving greater coherence and coordination between regulators and others so that they work together seamlessly to protect the public and promote professionalism.
    • Future-proofing – developing the agility to adapt and respond to innovations such as online services, robotics, artificial intelligence, new workforce roles, many of which present new ethical and regulatory challenges.

    In our next series of blogs, we will shine a light on the work being done by regulators, the Authority and others to advance these. Our first Futurology Symposium will be held early next year, bringing regulators and innovators together to discuss and prepare for the future.


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  • Alan Clamp - an introduction

    by Alan Clamp, Chief Executive | Nov 21, 2018

    In this first blog, Alan Clamp explains that, though he may be new to the Professional Standards Authority, he is an old hand when it comes to regulation.


    At the beginning of this month I was delighted to take on the role of chief executive of the Professional Standards Authority. It is a privilege to work for an organisation that plays a vital role in maintaining and improving professional standards in health and social care. In this short blog post, I would like to take a few moments to introduce myself and share some thoughts about the role of the Authority.

    So, who am I? Well, regulation is in my DNA. I have worked in a range of regulatory roles in the education, health, legal and security sectors for over 20 years. I have been the chief executive of two statutory regulators; the Human Tissue Authority and, most recently, the Security Industry Authority. In those roles, I grew accustomed to working closely with government departments, other regulators and the NHS. And now, I bring my experience and enthusiasm to the Authority at a time when appetite for regulatory reform is gathering pace.

    I am very pleased to be here. The Authority does an important job and I am fortunate to work with a talented team of expert staff. Simpler, more responsive, effective and efficient regulation leading to higher standards and better protection from harm. That’s our vision for the future. 

    In a recent speech, the health secretary, Matt Hancock, said, ‘Improving patient safety is a determined and unwavering commitment from us all.’ In my view, that goes for professionals, establishments, regulators and the Professional Standards Authority. We have different roles, but we are on the same team. Getting regulation right is a key factor in patient safety. There is no room for complacency.


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    The Authority announces its new chief executive - press statement July 2018 

  • Right-touch reflections

    by Harry Cayton CBE, Chief Executive | Oct 26, 2018

    Harry Cayton steps down as the Authority's Chief Executive at the end of October. In this blog, he reflects on his 11 years at the Authority and also ponders what key qualities are vital to be successful in the regulatory field.


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    Harry with the Authority's Chair George Jenkins at the event held on 19 September to celebrate Harry's time at the Authority

     

    In my 11 years at the Professional Standards Authority I have had the privilege to work with many talented, opinionated and dedicated individuals. In that time people have, of course, come and gone, each leaving their mark and also taking something of our values and ideas with them to new places. A select few have stayed, as I have, bringing continuity to our approach to regulatory oversight and policy.

    We are a small organisation. Everyone is an expert in their own right and we are diverse in background and interests. So I have been thinking about what qualities we share, what brings us together and indeed what qualities might be characteristic of the best people in our regulatory field.

    I’d like to suggest; curiosity, tenacity, scepticism and precision.

    Let me start with the last because regulation is essentially a nerdy occupation; it requires attention to detail, it thrives on process, it loves rules, it resists change. Precision however does not mean pedantry but accuracy and a thorough commitment to facts.

    This is where curiosity comes in. ‘An enquiring mind’, is a more lofty way of putting it but I’ve always preferred simple English. Curiosity wants to know, it pursues enquiry, it always asks another question. It’s not merely nosiness; it doesn’t seek information for its own sake but rather to find the truth.

    Tenacity is the enabler of effective curiosity but also of the possibility to effect change. In social policy and law, which after all is what regulation is, tenacity is necessary to bring about change. Winning the argument is relatively easy; winning changes in behaviour let alone in government policy or law is not. That is a long-term endeavour and without tenacity we will not succeed.

    But why scepticism? Quite simply because when I first came into regulation I found a complacent somewhat self-regarding world. Characteristics one might say that are not unknown to our royal colleges and learned societies of the Liberal Professions. I found regulators who earnestly advised their registrants to reflect on their practice, while themselves reflecting very little on what they did or why.

    ‘Why do we do it like this?’, indeed, ‘Why do we do it at all?’ were the  questions that came to my mind when I encountered professional regulation for the first time. Many, many colleagues here at the Authority and in regulators around the world have helped shape some answers to those questions and some alternative ways of thinking and acting as regulators.

    In leadership programmes they go on a lot about vision and values. I sometimes do myself. But vision and values are pointless without the curiosity, scepticism, tenacity, precision and simple hard work to put them into practice.

    I leave the Professional Standards Authority as I started, with many unanswered questions and full of curiosity as to what happens next.

    More photos from the 19 September celebration

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