Policy paper

Government response to the independent inquiry report into the issues raised by former surgeon Ian Paterson

Published 16 December 2021

Contact details

If you or a member of your family were treated by Ian Paterson and you are concerned about any aspect of your care, please use the details below to contact the relevant health providers.

This can be for any treatment.

University Hospitals Birmingham NHS Foundation Trust

You can contact the patient services support line on 0121 424 0808 to speak with a specialist adviser.

The patient services support line operates from 9am to 5pm Monday to Friday with a message facility for out-of-hours queries.

Spire Healthcare

You can contact the dedicated patient helpline on 0800 085 8130 to reach a member of their specialist team. The helpline is in operation from:

• 8:30am to 7pm Monday to Thursday
• 8:30am to 6pm on Friday
• 9am to 3pm on Saturday

You can also email them at spirehealthcarehelplineianpaterson@spirehealthcare.com.

BMI

You can contact the National Enquiry Centre helpline at 0800 096 2254.

Patient Association

If you would like confidential support and advice from an independent organisation, you can also speak to the Patients Association on 0800 345 7115 from 9:30am to 5pm Monday to Friday.

Ministerial foreword

Patients rightly expect to be safe in the hands of the clinicians that treat them. They expect the regulatory system that wraps around the healthcare system to protect them and to have their concerns listened to when things go wrong.

This report has come about because, for too many people between 1997 and 2011, that trust broke down. I am clear that the system must never let them down like this again. This report follows 2 years of diligent work by the inquiry, led by the Right Reverend Graham James, Bishop of Norwich. I thank the bishop and his team for their extremely thorough and dedicated scrutiny of the evidence, piecing together the circumstances that allowed Ian Paterson to operate in the way that he did.

Their valuable work provided a series of recommendations for actions to improve patient safety, and to make sure that a health professional cannot place personal gain or advancement over the best interests of their patients.

The malpractice of the convicted surgeon Ian Paterson remains shocking. The inquiry rightly placed patients at the centre of its investigation, and what patients told the inquiry about their experiences makes incredibly difficult reading.

The personal tragedies set out in the report of the inquiry were compounded by what the inquiry found to be the failure of a regulatory system that was well resourced to prevent such abuse, but that did not respond to the signals or ‘join the dots’ – to devastating effect.

The inquiry also found that there were a series of failures across the entire healthcare system, stating that there was a lack of curiosity about Ian Paterson from his colleagues and those in charge of Heart of England NHS Foundation Trust and Spire [Healthcare] for a sustained period of time. This had devastating consequences for patients.

Like the recent First do no harm: the Report of the Independent Medicines and Medical Devices Safety Review, published in July 2020, this inquiry pointed to the fact that patients were not given information they needed and were not listened to when they raised concerns. We have put the voices and needs of those patients, families and carers at the very heart of our response to put an end to the failings they never should have encountered.

Patients of Ian Paterson have told us of the pain and suffering that they and their families have endured. For that, we and this government are truly sorry. The system put in place to protect you and your loved ones failed. Your strength and bravery in dealing with your mistreatment, standing up to prevent anything similar happening to other patients and engaging with the inquiry is truly inspiring.

The recommendations of the inquiry are not constrained to past events but are based upon what Ian Paterson’s crimes tell us about our health system today. They offer a way forward for the future and further protection of patients for the entire healthcare system. Many important steps have been taken since Ian Paterson’s crimes were committed, but there remains much more to do.

While this response has been delayed by the coronavirus (COVID-19) pandemic, the government is as committed as ever to ensuring that lessons are learnt and actions taken from this inquiry. As set out in this response, the government accepts in principle most recommendations, and we commit in this report to concrete actions to make the progress that is needed and that patients rightly expect to see. These actions are all set out in our ‘Implementation plan’ below.

Some of the recommendations require further consideration and consultation to ensure that we can deliver real and lasting change to hospital-based treatment in both the NHS and the independent sector. For that reason, we are committing the government to provide a further response to update on the progress of this plan in 12 months’ time.

We are committed to ensuring that the necessary actions be put in place to protect patients from the suffering experienced by so many of those who came forward to tell their stories to the inquiry.

The Rt Hon Sajid Javid MP
Maria Caulfield MP

Introduction

Background to the report of the independent inquiry into the issues raised by Ian Paterson

The independent inquiry into the issues raised by the convicted surgeon Ian Paterson (‘the inquiry’) was established to ensure that patients and the public get the answers they deserve – and that lessons are learnt to protect patients from suffering the same pain in the future.

This inquiry followed the Kennedy Review commissioned by the Heart of England NHS Foundation Trust (HEFT) and the Verita Review commissioned by Spire Healthcare (‘Spire’), each of which made specific findings for the boards of these organisations.

The inquiry, led by the Right Reverend Graham James, Bishop of Norwich, put patients at the centre and considered the roles and responsibilities of the entire system in order to make recommendations to the government. Over a period of 2 years, the inquiry:

• recorded detailed accounts of patients’ experiences at Ian Paterson’s hands
• reviewed the circumstances surrounding the surgeon’s malpractice
• made recommendations in the interests of enhancing patient protection and safety across the whole healthcare system

We welcome the report’s findings, published in February 2020. It is clear that everyone involved in the healthcare system must recognise the lessons learnt and the patient testimonies published in the report, all of which held a mirror up to a system that failed to work as it should. We must all accept responsibility for ensuring that these failings are not repeated.

Many important steps forward have been taken since Ian Paterson was suspended. However, the inquiry demonstrated the need to do more, making 15 recommendations to government and other health sector bodies to make improvements in areas that demonstrated weaknesses in Ian Paterson’s case.

Patient engagement

There is one group of people who know better than any other the impacts that Ian Paterson’s actions had and the ways in which the system failed them: the patients affected. We thank these patients, as well as their families and carers, for their bravery and candour, and for their fight to hold the system to account. Throughout the development of the government’s response, we have worked closely with patients affected by Ian Paterson to ensure that their voices, views and experiences have been heard and reflected.

In September 2020, we held a patient engagement forum event to reflect on the inquiry’s report and to discuss each of the recommendations. In October 2021, we held a series of follow-up roundtable sessions with representatives of patient groups and agencies and organisations from across the healthcare system to discuss the progress of each of the recommendations in more detail. Throughout all these sessions, we heard powerful testimony from the patient representatives regarding their experiences and their insight into how the healthcare system failed them. We are incredibly grateful to them for their contribution.

In addition, in October 2021, we commissioned the Patient Association to hold a focus group with patients and carers who were not affected by Ian Paterson to understand their views on the broader patient safety principles that should be considered in the government’s response.

Patient voices were rightly placed at the heart of the inquiry report. They are crucial to our response and will always remain at the heart of our implementation process.

Preparation of the government response

In February 2020, the Secretary of State for Health and Social Care made a written statement in response to the publication of the report of the inquiry. This was followed by an oral statement by the Parliamentary Under-Secretary of State for Health and Social Care. Both statements recognised the work of the inquiry and the need for the whole health sector to respond effectively to its lessons.

In April 2020, the Parliamentary Under-Secretary of State for Mental Health, Suicide Prevention and Patient Safety announced a delay in this work due to the coronavirus (COVID-19) pandemic. The pandemic put unprecedented pressures on the health system that necessitated a pragmatic response to the recommendations. In March 2021, the Minister for Patient Safety, Suicide Prevention and Mental Health provided an update on the government’s response to the inquiry with a commitment to respond in full during 2021.

In working through the consideration of the government’s full response, we have engaged with and sought the advice of stakeholders from the NHS, the independent sector and various arm’s length bodies. By engaging with these groups, we are ensuring that policy is being robustly tested, and that we are preparing implementable actions that will be effective in both the NHS and the independent sector.

The government would like to thank all these stakeholders for their support in meeting the challenges of the inquiry. We give our further thanks to all the organisations who will be acting to implement elements of this response and with whom we will be continuing to engage beyond publication.

The government’s response to the inquiry

The recommendations of the inquiry impact both the NHS and the independent sector. In this response, as in the inquiry report itself, the focus is on hospital-based treatment and care in both sectors.

In considering the 15 recommendations of the inquiry, and especially from our engagement with patients, a number of themes have emerged that must be thoroughly addressed to provide greater confidence in the systems in place for protecting patient safety. These themes cover the entirety of the patient journey:

• their initial consultations with clinicians, and the information they receive during their treatment to ensure that they are receiving the highest standard of care
• the fitness of their clinicians to practise
• post-treatment activity ensuring ongoing scrutiny of clinicians’ outcomes, pathways for raising concerns and rapid action in all cases where something goes wrong

Providing patient-centred information

Patients, their families and carers need to have the information to make informed decisions about their care before they engage with a provider, at every point of their treatment, and after their treatment is completed.

Ian Paterson was able to continue his malpractice and to harm so many patients because objective information was not made available to patients in a way that enabled them to be truly in control of their care. Between his local reputation, his manipulation of the information provided about patients’ conditions and the lack of information regarding the different providers of healthcare, patients remained uninformed on many important details of their own treatment.

Patients are currently only able to determine the quality of a consultant based on recommendations, whether those be from medical professionals or from other patients. There is no way to verify that this reputation is backed up by their practice. This has left patients with little option but to hope that a good reputation is a sign of high-quality treatment and not, as with Ian Paterson, a cover for poor practice.

The inquiry found that too often when patients were being seen, they were not given the information or time to make important decisions about their care. Ian Paterson’s patients were given incorrect information about their condition during consultations, and information that differed from that which was sent to their GP. They were pressured to make quick decisions about their care and lacked access to critical information that would have allowed them to seek alternative opinions from other medical professionals.

The healthcare system must be strengthened to give patients, families and carers more information and to ensure that this information is made accessible to them. We have heard from patients of Ian Paterson that they were left feeling that they had made bad decisions about their care. In reality, the system put them in a position where it was not possible for them to be fully informed. In their interactions with consultants, providers and treatment options, patients must be given the information that allows them to get the care and treatment they are looking for.

Making challenge heard

Staff, patients, families and carers should have the room to speak up consistently about concerns regarding any malpractice or suspected wrongdoing. Those challenges must then be heard and acted upon.

Ian Paterson’s malpractice lasted many years. There were numerous occasions where concerns should have been raised but were not, or where concerns were raised but appropriate action did not follow. In some cases, these concerns were suppressed by a domineering attitude on the part of Ian Paterson himself. In others, the system responded inadequately to signs of bad and unsafe practice.

All practitioners should face challenge as part of their overall learning and development. All consultants are required to go through processes of appraisal and revalidation. These processes should be informed by data on the consultant’s practice, which can flag possible issues, providing opportunities for improvement and identification of potential concerns at an early stage.

In complex areas, such as in Ian Paterson’s own specialty of cancer, multidisciplinary teams exist to allow the expression of multiple perspectives and the opportunity to ensure that treatment plans best respond to patients’ needs. Where they have concerns, both patients and colleagues should have clear avenues to raise these concerns and to know that they will be appropriately handled.

In Ian Paterson’s case, raising concerns using these processes did not result in appropriate action. Nurses and doctors did speak up regarding Ian Paterson’s practice, but these concerns were not adequately followed up – nor were they shared effectively between organisations and healthcare providers. Where patients made official complaints about their care, they did not receive adequate resolution and were often unable to access independent resolution processes – sometimes because there was inadequate information regarding the route for such processes, and sometimes because such processes were simply absent.

Responding to challenge and scrutiny should be considered a regular part of any medical practitioner’s work. Whether that comes from colleagues or patients, and whether it is routine or in response to a specific issue of concern, those challenges must be listened to and acted upon appropriately. This value must be ingrained into the culture of the health system.

Ensuring accountability across the system

Across the healthcare system, providers’ and regulators’ processes for ensuring the safety and quality of the health service must be robust, from the frontline to the boardroom. The inquiry report very clearly spells out that what permitted Ian Paterson’s malpractice was not a lack of regulators or regulation, but that these systems did not work adequately or in the interest of the patients.

Regulators exist to protect, promote and maintain the health, safety and wellbeing of the public. They work to uphold public confidence in healthcare professionals and the healthcare system by assuring proper standards and conduct. Regulators also provide oversight of healthcare professionals and healthcare systems, and take action when things go wrong.

Problems occurred in Ian Paterson’s case when issues arose and regulators were unclear about where responsibility lay. Regulators failed to adequately share concerns and were slow to establish which body should take action.

The regulation of the health system must work in a way that is robust, transparent and collaborative. There must be clear understanding, not just of the measures that need to be in place, but that there is assurance that these will be followed and mechanisms to alert if they are not. Regulatory bodies should not see themselves as isolated entities, but as part of an interconnected effort, working towards a common goal. Patients should be able to understand the way in which the system works, and to know how and where to direct their concerns when they arise. Professionals should also be able to navigate the system to successfully flag where there are issues relevant to the regulators.

The inquiry raised specific concerns about responsibility and accountability in the independent sector. The inquiry found a perception that Ian Paterson was simply ‘renting a room’ in the private hospital and that the independent sector provider did not take responsibility for monitoring the actions of consultants who had been granted practising privileges on their site.

Accountability is about more than the existence of regulators and guidance – it is about the ability of those things to work effectively in practice. Every patient going into a hospital should feel confident that these processes are there to safeguard their care. Every part of the system must work together to rebuild that confidence.

Putting things right

We must do all we can to improve safeguards for patients and, if something goes wrong, we must give patients confidence that the system will work to put things right – both in terms of their current and future health, and in providing the necessary onward support where appropriate.

Patients of Ian Paterson endured years of fighting to be heard, for proper review of their conditions and for appropriate compensation for the harm they had suffered. It should not be necessary to fight the health system for these purposes – the health system should be actively engaged in working with the patient to achieve these ends.

In the first instance, patients harmed must receive a sincere apology from the provider of their care. From this point, providers must engage in a process of learning to prevent similar incidents. Patients, families and carers must be supported – both in their physical health and emotionally – in dealing with the harm that has been caused. Robust processes must exist for recalling patients and reviewing patient care. Ultimately, where it is appropriate, patients should be able to access compensation and the process should not be one that causes patients additional pain.

Putting things right should mean acting not only for the specific patients impacted, but also for the benefit of all future patients. In any situation where something has gone wrong, lessons must be learnt across our health system. Every individual and organisation involved must make themselves confident that the next patient is protected from similar harms. No patient should ever be the victim of malpractice, but every patient should be able to have confidence that – if something goes wrong – things will be put right.

Summary of the government response to each of the report’s recommendations

Overall, we have responded to 17 recommendations (recommendations 6 and 12 have each been split into 2 parts). We are:

• accepting 9 recommendations
• accepting in principle 5 recommendations
• not accepting 1 recommendation
• not accepting but keeping under review 1 recommendation
• pending an outcome on 1 recommendation

Recommendation 1

We recommend that there should be a single repository of the whole practice of consultants across England, setting out their practising privileges and other critical consultant performance data – for example, how many times a consultant has performed a particular procedure and how recently.

This should be accessible and understandable to the public. It should be mandated for use by managers and healthcare professionals in both the NHS and the independent sector.

Government response – accept in principle

Significant progress has been made on the collection of consultant performance data in the independent sector and the NHS. In 2018, the Acute Data Alignment Programme (ADAPt) was launched to move towards a common set of standards for data collection, performance measure methodologies and reporting systems across the NHS and the independent sector, with potential to be fully implemented by 2022 to 2023.

This data will be made available for managers and healthcare professionals across the system to help support learning and identify outliers.

Over the next 12 months, we commit to reaching a decision with key stakeholders on what information can be published and whether further government action will be needed to achieve this.

Recommendation 2

We recommend that it should be standard practice that consultants in both the NHS and the independent sector should write to patients, outlining their condition and treatment, in simple language, and copy this letter to the patient’s GP, rather than writing to the GP and sending a copy to the patient.

Government response – accept

Guidance across the healthcare system now states that consultants should write directly to patients and in a way that they understand. Key stakeholders have committed to writing to their members to encourage uptake.

Over the next 12 months, we will explore with providers how their systems can change to make the process of writing to patients easier for healthcare professionals and how this can be monitored.

Recommendation 3

We recommend that the differences between how the care of patients in the independent sector is organised and the care of patients in the NHS is organised is explained clearly to patients who choose to be treated privately, or whose treatment is provided in the independent sector but funded by the NHS. This should include clarification of how consultants are engaged at the private hospital, including the use of practising privileges and indemnity, and the arrangements for emergency provision and intensive care.

Government response – accept

The government will commission the production of independent information to make people aware of the ways in which their private care is organised differently from the arrangements in the NHS. Created in partnership with patients, families and carers, this will be published in 2022 and will include expert views on a range of relevant areas that are backed by data and evidence.

Recommendation 4

We recommend that there should be a short period introduced into the process of patients giving consent for surgical procedures to allow them time to reflect on their diagnosis and treatment options. We recommend that the General Medical Council monitors this as part of Good medical practice.

Government response – accept in principle

Many key organisations, including the General Medical Council (GMC), have taken steps to update their guidance and to confirm that doctors should give patients sufficient time to consider their options before making a decision about their treatment and care.

During annual appraisals, doctors must provide supporting information to demonstrate that they are continuing to meet the principles and values set out in ‘Good medical practice’. The Care Quality Commission (CQC) takes all GMC guidance into account during its assessments.

Recommendation 5

We recommend that CQC, as a matter of urgency, should assure itself that all hospital providers are complying effectively with up-to-date national guidance on MDT (multidisciplinary team) meetings, including in breast cancer care, and that patients are not at risk of harm due to non-compliance in this area.

Government response – accept

CQC has now added more detailed and specific prompts on multidisciplinary teamworking to the inspection framework for diagnostic imaging services in NHS and independent acute hospitals, including reference to NHS England and Improvement (NHSEI)’s guidance on streamlining multidisciplinary team meetings for cancer alliances.

When assessing providers in the NHS and the independent sector, CQC will continue to seek assurance that patients are not at risk of harm due to non-compliance with this guidance.

Recommendation 6a

We recommend that information about the means to escalate a complaint to an independent body is communicated more effectively in both the NHS and the independent sector.

Government response – accept

The Parliamentary and Health Service Ombudsman (PHSO) is currently piloting the NHS Complaint Standards, which set out in one place the ways in which the NHS should handle complaints, including the need for organisations to ensure that people know how to escalate to the Ombudsman. These have been developed with the Independent Sector Complaints Adjudication Service (ISCAS), who have included it in their code of practice.

We will continue to work closely with key organisations involved to ensure that standards are reinforced.

Recommendation 6b

We recommend that all private patients should have the right to mandatory independent resolution of their complaint.

Government response – accept in principle

CQC will strengthen its guidance to make clearer that it expects to see arrangements in place for patients to access independent resolution of their complaints regarding independent sector providers.

We will review uptake across the independent sector in the next year, and if uptake is not widespread, we will explore whether current legislation needs to be amended to ensure that all providers make provision for independent adjudication.

Recommendation 7

We recommend that the University Hospitals Birmingham NHS Foundation Trust board should check that all patients of Paterson have been recalled, and to communicate with any who have not been seen.

Government response – accept

By August 2020, University Hospitals Birmingham NHS Foundation Trust had contacted all known living patients of Ian Paterson.

By the end of June 2021, the trust had ensured that all known former patients had had their care reviewed, and that any outstanding concerns were addressed in a way that was determined by the patient.

Recommendation 8

We recommend that Spire should check that all patients of Ian Paterson have been recalled, and to communicate with any who have not been seen, and that they should check that they have been given an ongoing treatment plan in the same way that has been provided for patients in the NHS.

Government response – accept

By December 2020, Spire had proactively contacted all known living patients of Ian Paterson to check that their care had been fully reviewed, and that they were getting any ongoing support and treatment that they needed.

Spire have now reviewed the care of over two-thirds of the patients concerned. Spire have prioritised the review of patients according to clinical need, with the most likely in need of new intervention being reviewed first.

We have asked Spire to provide the Department of Health and Social Care (DHSC) with an update on progress in 12 months’ time.

Recommendation 9

We recommend that a national framework or protocol, with guidance, is developed about how recall of patients should be managed and communicated. This framework or protocol should specify that the process is centred around the patient’s needs, provide advice on how recall decisions are made, and advise what resource is required and how this might be provided. This should apply to both the independent sector and the NHS.

Government response – accept

A national framework has been developed that outlines actions to be taken by organisations in both the NHS and the independent sector in the event of a patient recall. The National Quality Board (NQB) will own the framework, which will be published in 2022 and periodically updated.

Recommendation 10

We recommend that the government should, as a matter of urgency, reform the current regulation of indemnity products for healthcare professionals in light of the serious shortcomings identified by the inquiry and introduce a nationwide safety net to ensure patients are not disadvantaged.

Government response – pending

In 2018, the government launched a consultation on appropriate clinical negligence cover for regulated healthcare professionals. This sought views on whether to change legislation to ensure that all regulated healthcare professionals in the UK not covered by state indemnity hold regulated insurance, rather than discretionary indemnity.

The government has now extended this programme to consider the issues raised by the inquiry and is committed to bringing forward proposals for reform in 2022.

Recommendation 11

We recommend that the government should ensure that the current system of regulation and the collaboration of the regulators serves patient safety as the top priority, given the ineffectiveness of the system identified in this inquiry.

Government response – accept

System and professional regulators have an overarching statutory objective to protect, promote and maintain the health, safety and wellbeing of the public.

The healthcare regulators referenced in the inquiry (GMC, Nursing and Midwifery Council (NMC), and CQC) exist to protect patient safety and this is reflected in their new corporate strategies. They have also taken a number of actions to encourage information-sharing between organisations and to enable patients and professionals to raise concerns.

DHSC’s 2021 consultation regulating healthcare professionals, protecting the public sets out proposals that address the issues raised in the inquiry, including a proposal to place a duty to co-operate on all regulators. DHSC plans to draft legislation in relation to the GMC in 2022.

Recommendation 12a

We recommend that if, when a hospital investigates a healthcare professional’s behaviour, including the use of an HR process, any perceived risk to patient safety should result in the suspension of that healthcare professional.

Government response – do not accept

We agree that exclusions and restriction of practice can be necessary, and in some cases immediate exclusion is an appropriate response while an investigation is ongoing. However, we do not believe it would be fair or proportionate to impose a blanket rule to exclude practitioners in such cases. Such a step may inadvertently cause a chilling effect, dissuading healthcare professionals from raising concerns and negatively impacting patient safety.

It is vital that investigations are robust and conducted in a timely manner. Guidance has been put in place to ensure that concerns are taken seriously, appropriate action taken and that robust investigation processes are implemented, and that clarity on when to exclude a healthcare professional is provided.

Recommendation 12b

If the healthcare professional also works at another provider, any concerns about them should be communicated to that provider.

Government response – accept in principle

The government agrees that, where patient safety is at risk, information should be shared with other providers. However, there must be an element of judgement by providers as they will be taking on responsibility to ensure that this information is appropriate and accurate. Regulators have taken key steps to make it easier for people and organisations to share information regarding patient safety risks. The Medical Profession (Responsible Officers) Regulations 2010 (revised in 2013), which apply to all medical practitioners, have also set out prescribed connections for sharing information regarding performance concerns between health organisations.

Recommendation 13

In the NHS, consultants are employees and the NHS hospital is responsible for their management, and accepts liability when things go wrong. The situation is very different in the independent sector where most consultants are self-employed.

Their engagement through practising privileges is an arrangement recognised by CQC. However, this recognition does not appear to have resolved questions of hospitals’ or providers’ legal liability for the actions of consultants.

We recommend that the government addresses, as a matter of urgency, this gap in responsibility and liability.

Government response – accept in principle

The government is clear that independent sector providers must take responsibility for the quality of care provided in their facilities, regardless of how the consultants are engaged.

The Medical Practitioners Assurance Framework (MPAF), published in 2019 by the Independent Healthcare Provider Network (IHPN), was created to improve consistency around effective clinical governance, and to set out provider and medical practitioner responsibilities in the independent sector.

CQC will continue to assess the strength of clinical governance in providers as part of its inspection activity, taking account of relevant guidance such as the MPAF.

As covered in our response to recommendation 10, we have set out a programme of work that will consider the case for reforms to the provision of indemnity cover. We will use this as our initial approach to dealing with the challenges faced by patients of Ian Paterson in accessing compensation.

Recommendation 14

We recommend that, when things go wrong, boards should apologise at the earliest stage of investigation and not hold back from doing so for fear of the consequences in relation to their liability.

Government response – accept

Healthcare organisations have a statutory duty of candour, which sets out specific requirements providers must follow when things go wrong with care and treatment, including providing truthful information and an apology. This duty is regulated by CQC.

NHS Resolution has consistently advised its members to apologise when things go wrong and to provide a full and frank explanation at the earliest possible stage, irrespective of the possibility of a legal claim. More work is underway to ensure that this NHS Resolution guidance is promoted.

Recommendation 15

We recommend that, if the government accepts any of the recommendations concerned, it should make arrangements to ensure that these are to be applicable across the whole of the independent sector’s workload (meaning private, insured and NHS-funded) if independent sector providers are to be able to qualify for NHS-contracted work.

Government response – do not accept – keep under review

This recommendation, if implemented, would change the way in which independent sector providers qualify for NHS contracts. As demonstrated in our response to the other recommendations, independent sector providers are fully committed to implementing changes alongside NHS providers. They must already meet the same regulatory standards, as required by CQC.

We will continue to monitor the independent sector uptake of the other recommendations and we will review our position on this recommendation in 12 months’ time, setting out further steps if necessary.

Future actions

DHSC will provide an update on this work 12 months after the publication of this response. This follow-on report will update on the progress made against the ‘Implementation plan’ below.

Recommendation 1

We recommend that there should be a single repository of the whole practice of consultants across England, setting out their practising privileges and other critical consultant performance data – for example, how many times a consultant has performed a particular procedure and how recently.

This should be accessible and understandable to the public. It should be mandated for use by managers and healthcare professionals in both the NHS and the independent sector.

Accept in principle

Significant progress has been made on the collection of consultant performance data in the independent sector and the NHS. In 2018, ADAPt was launched to move towards a common set of standards for data collection, performance measure methodologies and reporting systems across the NHS and the independent sector, with potential to be fully implemented by 2022 to 2023.

This data will be made available for managers and healthcare professionals across the system to help support learning and identify outliers.

Over the next 12 months, we commit to reaching a decision with key stakeholders on what information can be published and whether further government action will be needed to achieve this.

The inquiry found that patients lacked the means to verify the information they had received about Ian Paterson and his practice, and that both patients and those with a managerial or clinical responsibility for consultants would welcome a single repository of information.

We have also heard from patients and organisations about the importance of consultant performance data being made available for use by managers and healthcare professionals to support benchmarking, appraisal and revalidation, and to drive the improvement in quality of clinical practice through evidence.

The effective use of data, for example, means that outliers can be identified for further investigation and resolved. This offers an additional pathway to the identification of concerns alongside the reports of colleagues.

We also want to ensure that the principle of ‘collect once, use often’ – one of the overarching themes of the First do no harm: the Report of the Independent Medicines and Medical Devices Safety Review– sits at the heart of this response.

We approach this recommendation in 3 key stages:

1. The collection of consultants’ data across the NHS and the independent sector.
2. The use of that collected data by managers and healthcare professionals to identify possible areas of concern.
3. The publication of that data for use by patients and members of the public.

In each area, a number of important actions are already underway, which the government remains committed to. We are confident these actions will make significant progress in improving the quality and transparency of consultant data. However, there are many challenges in moving towards a single repository, as set out in the recommendation, which will require further work across the system.

The collection of data

NHS Digital already collects substantive data regarding NHS-funded care. Improvements continue to be made to the quality and scope of this data collection. As the Secretary of State for Health and Social Care announced in November 2021, NHS Digital will be brought into NHSEI to help put technology at the heart of long-term planning.

The collection of independent sector data has improved hugely since Ian Paterson was operating. Since 2016, independent providers of acute inpatient care have been mandated by the Competition and Markets Authority (CMA) to submit data to the Private Healthcare Information Network (PHIN) on inpatient and day case activity, including:

• mortality rates
• infection rates
• the number of patients readmitted to hospital following surgery
• the number of patients transferred to an NHS hospital from a private hospital
• measures of patient satisfaction
• measures of improvement in healthcare outcomes following treatment

Consultant-level data is included in the CMA mandate.

We are also taking steps to improve the standardisation of the data collected to enable NHS and independent sector data to be brought together. The Secretary of State for Health and Social Care in 2018 launched ADAPt to move towards a common set of standards for data collection, performance measure methodologies and reporting systems across the NHS and the independent sector. The programme is jointly led by NHS Digital and the PHIN in partnership with DHSC, NHSEI, CQC and other observer bodies.

The specific aims of ADAPt are to:

• make it easier to monitor the quality and safety of services by including private healthcare data within healthcare reporting systems
• help staff keep accurate and complete records when a patient journey spans both private and public providers
• ensure transparency for patients by publishing comparable performance measures relating to quality of care and patient safety for both privately and NHS-funded healthcare

To further help with the collection of data from independent sector healthcare providers and support ADAPt, a draft clause in the Health and Care Bill, which is on course to pass into law by April 2022, will enable NHS Digital to require data from private healthcare providers where directed to do so by the Secretary of State for Health and Social Care. This will allow data for both sectors to be collected by NHS Digital in an aligned way.

Although work has been delayed slightly due to the COVID-19 pandemic, we are pleased that ADAPt is now in its pilot phase. Subject to the outcomes of these pilots in 2021 to 2022, we will then consider options for fuller implementation of ADAPt, with the potential for initial adoption commencing in 2022 to 2023.

NHS Digital will continue to work closely with PHIN and other partners under ADAPt to ensure that this single database of both independent and NHS activity at consultant-level exists, enabling healthcare systems and professionals to access consultants’ activities at a glance across sites and specialties for the first time.

The use of collected data

As we have heard from the inquiry and from organisations, it is not enough simply to collect data across institutions and sectors. That data must then be used within and across organisations to identify anomalies – both in the regular annual appraisal and revalidation process (usually every 5 years) that consultants are required to undertake and to raise a warning flag, if required, outside those regular processes.

Within the NHS, the National Consultant Information Programme (NCIP) will make information available to managers and healthcare professionals. This will help them to understand variation in clinical practice and identify any areas of concern.

For example, the information could enable the identification of instances where there are unusually high rates of readmission or complications for a procedure and give managers and clinicians the opportunity to investigate the cause. It can also provide objective information that can inform the appraisal process for all consultants, helping to identify patterns that may otherwise go unnoticed, and facilitating learning and improvement.

NCIP currently focuses on surgical specialties, operating in 42 trusts for urology and 17 trusts for 8 surgical specialties. NCIP will expand its operation to reach all NHS hospitals over the next 3 years across more surgical specialties. It will continue to explore the possibility of extending into other interventional or medical specialties.

For independent sector consultants, there is currently information collected and interpreted by PHIN that could be used for a similar purpose. Through ADAPt, the aim is that the information made available about consultants in the independent sector will align with the information made available in the NHS through NCIP. The development of ADAPt will continue as outlined above.

To ensure this data is used within appraisal and revalidation, the GMC will update their guidance, during their next review, on supporting information for appraisal and revalidation. The guidance sets out the types of supporting information that all licensed doctors are required to collect and reflect on at their appraisals, and must cover any work a registrant does, including independent sector and private work.

The GMC will update this guidance so that, where clinical outcomes data is mentioned, the guidance will refer to ‘independently verified data, where available, for the practitioner’s specialty’. Alongside this, the GMC will publish best practice case studies (from NCIP, PHIN or IHPN) on using independently verified data as quality improvement activity evidence in appraisal and revalidation.

This use of data as a crucial part of appraisals processes will ensure that consultants with outlying quality improvement activity are picked up by managers and auditors, and that this activity is discussed – vastly decreasing the chances of another Ian Paterson. This impact will not be confined to when appraisals are being performed.

Turning this data into useful metrics through these methods will enable managers and healthcare professionals to note patterns in treatment and outcomes consistently, and identify areas of concern for further exploration. The use cases for NCIP include clinical audit meetings, morbidity and mortality meetings, and Evidence-Based Interventions Programme data.

This recommendation specifically references the collection and availability of information on practising privileges. A typical private consultant practises at 2 hospitals or clinics, but it is not unknown for consultants to practice at 10 or more over a couple of years. We have heard from patients and organisations the need to have a regularly updated record of the practice of a consultant by one hospital, such that other hospitals are aware and can respond appropriately. The absence of such a system made it possible for Ian Paterson to flout restrictions by moving his practice among 3 hospitals.

We are therefore exploring ways in which the system could gather and use information on how consultants are engaged by their private hospitals – whether contracted, working under practising privileges or on an employed basis. We will work with NHSEI, IHPN and PHIN to explore options for using the framework of the digital staff passport or other means as a mechanism for holding key consultant information, such as employment and practising privileges.

The measures outlined here should aid with detection of concerning patterns throughout the health system. We also acknowledge in the government response to the report of the Independent Medicines and Medical Devices Safety Review the significance of early signal detection, and the ways in which the role of a system-wide healthcare intelligence unit could safeguard the interests of patients and other members of the public. The government has committed to look into this further in collaboration with other system-wide healthcare bodies, and this work remains ongoing.

The publication of data

The final aspect of this recommendation concerns the publication of data collected. We have heard from patients how important it is that they can verify for themselves the information they receive on specific consultants, and we know we must go further.

We have also heard from the medical profession about the complexity of providing information in a way that provides full context and fairly reflects a consultant’s practice. An example of this complexity is that different consultants may take on patients with more or fewer risk factors in their treatment, which will impact their rates of complications or mortality in a way that does not directly relate to the abilities of the consultant. It is important that information provided is appropriately contextualised and does not paint a misleading impression of consultants.

Within the independent sector, some data collected under the mandate from the CMA is already presented as patient-facing information by PHIN. A range of indicators are currently available on the PHIN website, including:

• volume and length of stay data
• infections data
• patient feedback data
• data on the occurrence of ‘never events’ (serious, preventable incidents where a patient has been put at unnecessary risk)

PHIN will set out a 5-year plan in 2022 to implement the remaining publication of information about private consultants, which they have been mandated to complete, for the period 2022 to 2026.

NCIP currently has no mandate to publish consultant performance data. It has been developed as a resource for the profession and access is limited to internal use. We commit to exploring with NHSEI the potential publication of data regarding NHS consultants, and the best approach to doing this in a manner that suits the needs of patients and consultants. Our overall objective is to ensure the information provided is meaningful to patients and the public in an open and transparent manner, so that they can interpret the information and make an informed choice about their care. However, it is vital that the data collected is not only accurate and comprehensive, but fairly reflects the complexities of different healthcare services.

We will work closely with organisations and patients over the coming months as we develop this understanding further to safeguard against future failings. We will work towards making information publicly available across the sector and will explore the best ways to achieve this.

Over the next 12 months, we will:

• reach a decision on what information can be published in the NHS and the independent sector
• review whether existing programmes can achieve this or whether further action is needed from government to achieve these goals

Next steps

ADAPt will be piloted in 2021 to 2022 to better align the collection and processing of data in the NHS and the independent sector, and assess the impact that a wider rollout could have. If the pilot is successful, there may be a recommendation to fully implement ADAPt in 2022 to 2023.

NCIP will expand its operation to reach all NHS hospitals and specialties over the next 3 years, providing data for use of managers and healthcare professionals. GMC will update its guidance on supporting information for appraisal and revalidation so that, where clinical outcomes data is mentioned, the guidance will refer to ‘independently verified data, where available, for the practitioner’s specialty’ and will publish best practice case studies (from NCIP, PHIN or IHPN) on using independently verified data as quality improvement activity evidence in appraisal and revalidation.

DHSC will work with NHSEI, IHPN and PHIN to explore options for using the framework of the digital staff passport or other means as a mechanism for holding the practising privileges of consultants.

PHIN will set out a 5-year plan in 2022 to implement the remaining publication of information about private consultants, which they have been mandated to complete, for the period 2022 to 2026.

We will work towards making information publicly available across the sector and will explore the best ways to achieve this. Over the next 12 months, we will:

• reach a decision on what information can be published in the NHS and the independent sector,
• review whether existing programmes can achieve this or whether further action is needed from government to achieve these goals

As a whole-system response is required to sufficiently drive forward this recommendation, we will review progress overall over the next 12 months.

Recommendation 2

We recommend that it should be standard practice that consultants in both the NHS and the independent sector should write to patients outlining their condition and treatment in simple language, and copy this letter to the patient’s GP, rather than writing to the GP and sending a copy to the patient.

Accept

Guidance across the healthcare system now states that consultants should write directly to patients and in a way they understand. Key stakeholders have committed to writing to their members to encourage uptake.

Over the next 12 months, we will explore with providers how their systems can change to make the process of writing to patients easier for healthcare professionals and how this can be monitored.

The government accepts this recommendation in full and agrees that the language used by consultants when writing to patients should always be accessible.

The inquiry heard that the information in Ian Paterson’s letters to patients’ GPs differed from that conveyed by him during their consultations. It also noted that consultants’ letters are not always written in a way that is easy to understand.

We are pleased that various organisations have already taken significant steps in response to the inquiry to develop their guidance, good practice and expected standards around communication with patients.

The publication of guidance

In 2018, the Academy of Medical Royal Colleges (AoMRC) published the Please, write to me: writing outpatient clinic letters to patients guidance on communicating and informing patients using simple, appropriate language. This guidance includes an example letter, which can be used as a template to send directly to the patient, copying in their GP.

This guidance is included in the National Institute for Health and Care Excellence guidance on shared decision-making, published in June 2021:

1.2.20 When writing clinical letters after a discussion, write them to the patient rather than to their healthcare professional, in line with Academy of Medical Royal Colleges’ guidance on writing outpatient clinic letters to patients. Send a copy of the letter to the patient (unless they say they do not want a copy) and to the relevant healthcare professional.

This guidance is for everyone who delivers healthcare services.

As of 2018, the GMC ensures effective written and vocal communication of undergraduate training for doctors. This includes communicating clearly, sensitively and honestly with patients, their relatives, carers and other advocates. The GMC’s ‘Good medical practice’ also includes guidance on the need for doctors to communicate effectively with patients, so that patients understand the treatment that is being provided.

Specifically, point 32 states:

You must give patients the information they want or need to know in a way they can understand. You should make sure that arrangements are made, wherever possible, to meet patients’ language and communication needs.

The GMC will review ‘Good medical practice’, their guidance on what it means to be a good doctor, specifically with respect to communicating effectively. Consultations on potential changes will take place in 2022. If a doctor does not follow this guidance, then it should be raised as a concern by the employer, who could either act on the concern at a local level or escalate the concern to the GMC.

In October 2021, the Professional Record Standards Body (PRSB) updated its guidance on standards for outpatient letters to strengthen the wording on this matter. The guidance makes clear that it is best practice for most outpatient letters to be written directly to patients and they should be written in a way that is understandable to the general public. The NHS Standard Contract states that outpatient letters should be consistent with the standards published by the PRSB. The Royal College of Paediatrics and Child Health also signpost to this guidance for communications to children and young people.

These updates to organisations’ guidance and best practice are a significant step in placing patients at the heart of their own care and treatment, but we know that guidance alone is only one part of the solution. We have heard from patients that this guidance is not always followed, and that there needs to be further modernisation of the communication used by some medical professionals.

The implementation of guidance

It is the responsibility of the boards of providers to ensure that letters to patients are following this guidance. All NHS and independent acute sector hospitals are regulated by CQC, and their assessments include how services ensure that patients, and those close to them, understand and are involved in decisions about their care.

CQC’s health assessment framework specifically asks ‘Do staff communicate with people so that they understand their care, treatment and condition and any advice given?’ This should ensure all providers consider how they are communicating with patients, families and their carers.

Next steps

The AoMRC, PRSB, IHPN and NHSEI have committed to write to their members to remind them of this guidance and encourage them to use it in conjunction with the publication of this government response. This will include additional information on occasions when it may not be appropriate to write directly to the patient, such as where there is a concern that the contents of the letter might endanger the individual, as well as on the importance of using appropriate language and electronic letters where suitable.

We recognise that this will require a significant cultural shift in the way in which information is conveyed to patients regarding their treatment, and we know that more must be done in order to understand why guidance is not always followed even where it is in place.

Over the next 12 months, we will explore with providers:

• how their systems can change to make the process of writing to patients easier for healthcare professionals
• how this can be monitored

Recommendation 3

We recommend that the differences between how the care of patients in the independent sector is organised and the care of patients in the NHS is organised is explained clearly to patients who choose to be treated privately, or whose treatment is provided in the independent sector but funded by the NHS.

This should include clarification of how consultants are engaged at the private hospital, including the use of practising privileges and indemnity, and the arrangements for emergency provision and intensive care.

Accept

The government will commission the production of independent information to make people aware of the ways in which their private care is organised differently from the arrangements in the NHS. Created in partnership with patients, families and carers, this will be published in 2022, and will include expert views on a range of relevant areas that are backed by data and evidence.

Patients who spoke to the inquiry were unaware of the significant differences in how the NHS and the independent sector were organised at the time they chose to be treated privately by Ian Paterson. And we have since heard from patients that they received little to no advice regarding the different care patients receive in the NHS and the independent sector.

The issues underpinning this recommendation are not straightforward. The independent sector is made up of hundreds of providers that are independent of each other, and vary in terms of size and specialty. There is therefore significant variation in the way in which care is organised in the independent sector, and there is also significant variation in the facilities available to different private hospitals. This makes it difficult to provide specific information about how care is delivered in the independent sector in comparison with the NHS.

However, there are questions that patients may wish to consider when electing to be treated in the NHS or the independent sector and when choosing a provider. Since the inquiry published its report, the quality and availability of information for people considering private healthcare has improved.

In January 2020, IHPN and the Patients Association jointly published a short video on what to expect from independent healthcare. Recognising it to be vital that patients who choose to self-fund their care or use private medical insurance are as fully informed as possible when receiving independent healthcare, the video sets out their rights around:

• being treated safely
• receiving the highest professional standards of care
• having a good patient experience

As well as on the IHPN and the Patients Association’s websites, the video can be found on Patient Safety Learning’s ‘the hub’ and on ISCAS’s website, as well as on many providers’ websites.

IHPN and the Patients Association have since developed a second video, which includes more detail on how to pay and how to get a referral, and on receiving care from both the NHS and the independent sector. This video will be published early next year.

Next steps

We recognise, however, that more must be done to make people aware of how their private care might differ from care received in the NHS and empower patients to make the choice most appropriate to them.

We will therefore commission the production of a range of independent information to be published in 2022 about how the organisation of private care might differ from the NHS, which will be available to all patients, families and carers. This includes patients being treated in the NHS, patients being treated in the independent sector, and NHS patients being treated in the independent sector.

The information will include expert views on a range of relevant areas backed by data and evidence. Patients will play a leading role in the specification, creation and approval of this material. Example topics might include:

• general working arrangements of independent practice, including the use of practising privileges
• indemnity arrangements
• complaints procedures
• emergency care arrangements

Given the breadth and complexity of the health and care system, this information will focus on hospital-based care in the first instance.

Once this information has been published, we will work with providers in both the NHS and the independent sector to ensure they are signposting to this information as part of the general information patients receive about their care.

Recommendation 4

We recommend that there should be a short period introduced into the process of patients giving consent for surgical procedures to allow them time to reflect on their diagnosis and treatment options. We recommend that the GMC monitors this as part of ‘Good medical practice’.

Accept in principle

Many key organisations, including the GMC, have taken steps to update their guidance, and to confirm that doctors should give patients sufficient time to consider their options before making a decision about their treatment and care. During annual appraisals, doctors must provide supporting information, including information to demonstrate they are continuing to meet the principles and values set out in ‘Good medical practice’. CQC also takes all GMC guidance into account during its assessments.

The government accepts this recommendation in principle, and agrees that patients, families and carers should be given enough time to consider relevant information before deciding to undergo treatment.

The inquiry found that Ian Paterson:

• often failed to obtain consent from his patients
• did not properly discuss their treatment with other healthcare professionals
• often delegated the consent process to other members of staff
• put patients under pressure to decide to go ahead with surgery
• did not give patients sufficient or correct information about procedures

Patients have told us there was a need for clearer enforcement, and oversight of decision-making and consent guidance at a local level. They also felt strongly that patients need access to information and expert support, along with time, to make informed decisions about their treatment and care.

We therefore want to ensure that:

• there is clear guidance and training on shared decision-making and consent for doctors
• systems are in place to support patients to make informed decisions about their treatment and care
• there is effective implementation and oversight of decision-making and consent processes by providers

All licensed doctors are required to participate in annual appraisals for revalidation and, through the collection of supporting information, demonstrate that they are continuing to meet the principles and values set out in ‘Good medical practice’.

CQC assesses the uptake and use of ‘Good medical practice’ at a provider level, and can take regulatory action if a provider is failing to ensure that patients’ consent is being lawfully gained.

Decision-making and consent guidance

Many key organisations, including the GMC, have already updated their guidance to clarify that doctors should give patients sufficient time to consider their options before making a decision about their treatment and care.

The GMC’s revised guidance on decision making and consent came into effect in November 2020. The guidance specifies that doctors should give patients the time and opportunity to consider relevant information, both before and after making a decision about their treatment and care. Doctors must explain to patients their reasons for recommending a treatment option, and share information about reasonable alternatives, including the option to take no action. It is the responsibility of the doctor providing treatment to seek consent and to make sure patients understand their right to choose whether to proceed with a treatment option. If, in rare cases, consent is delegated, the treating doctor is still responsible for making sure that the patient has been given the information, time and support they need to make an informed decision.

In 2018, the Royal College of Surgeons of England (RCSEng) published its guidance on consent and supported decision-making. This states that – aside from in certain medical emergencies, such as when a patient is admitted to hospital unconscious – surgeons should allow sufficient time for patients to consider the available treatment options. Surgeons should provide information to patients to enable them to reflect on and confirm their decision, and, when possible, this should include written information, such as reading materials and online resources. As outlined in Good surgical practice, patients should sign a consent form at the end of the discussion, provided they have reached a decision to go ahead with treatment.

For general surgical procedures, the GMC and the RCSEng do not state a specific length of time between a consultation taking place and a decision being made. This is because the time required will vary depending on the patient and the procedure. It is, however, clearly stated that patients should have sufficient time and information to make a voluntary and informed decision about their surgical procedure. This may require discussions to take place over more than one session for particularly complex or life-changing decisions. Doctors should also inform patients that they can change their mind at any point in the decision-making process.

For surgical cosmetic interventions, the RCSEng guidance on cosmetic surgery and ‘Good surgical practice’ state that surgeons must ensure consent is obtained in a 2-stage process with a cooling-off period of at least 2 weeks between the stages. The guidance states that cosmetic surgeons must also ensure that patients sign a consent form at the end of the consent discussion, allowing the patient to take a copy for reference and reflection. On the day of the procedure, surgeons must check with the patient if anything has changed since the consent discussion. The RCSEng guidance is reinforced by the GMC’s guidance for doctors who offer cosmetic interventions.

Doctors must market their services responsibly without using promotional tactics that might encourage people to make ill-considered decisions. As the GMC’s ‘Good medical practice’ states, all doctors must be honest in financial and commercial matters relating to their work, and should not allow commercial incentives to influence the consent process or treatment offered to patients. This is in line with the government’s response to recommendation 8 of the report of the Independent Medicines and Medical Devices Safety Review, which states it is a regulatory requirement for all registered healthcare professionals to declare their relevant interests and that this information is published locally at employer level.

NHSEI fully supports the move to build a period of reflection into care pathways. In 2019, NHSEI published guidance on shared decision making. This includes a summary guide to shared decision making and an implementation checklist.

NHSEI has also developed guidance, tools and training for each of the 3 primary drivers of shared decision making:

• training teams
• prepared patients
• supportive systems

The developments include new e-learning for teams via the Personalised Care Institute, updated information for patients, and work to design supportive systems and treatment pathways.

Implementation and oversight

The GMC is the regulator of all medical doctors practising in the UK. It sets and enforces the standards all doctors must adhere to. To maintain their licence to practise, doctors must be familiar with all guidelines and developments that affect their work as part of ‘Good medical practice’. A serious or persistent failure to follow guidance in a way that poses a risk to patient safety or public trust in doctors will put a doctor’s registration at risk.

All licensed doctors are required to participate in local clinical governance systems including incident reporting and complaints management, as well as annual appraisal. For revalidation, they are required to collate, discuss and reflect on core supporting information from across their scope of practise at appraisal to demonstrate that they are continuing to meet the principles and values set out in ‘Good medical practice’.

If supporting information indicates that a doctor should reflect on or undertake development to improve their practice in relation to consent, then the GMC would expect them to:

• discuss this with their appraiser
• add it to their personal development plan
• complete any continuing professional development, where appropriate

It is the responsibility of the Responsible Officer to ensure that local processes are in place for raising and acting on concerns, with issues escalated to the GMC as appropriate. By law, all NHS and independent providers must ensure that patients have given informed consent before any care or treatment is provided. If a provider is failing to ensure that patients’ consent is being lawfully gained, the CQC can take regulatory action. CQC takes all GMC and RCSEng guidance and standards into account during its assessments, and when making a judgement about the quality and safety of services being provided.

Next steps

The GMC and RCSEng are currently working together to develop tools to promote their guidance and enable surgeons to apply it routinely in their practice. The GMC and RCSEng are targeting a publication date of winter 2021 to 2022 and this will be distributed by RCSEng regional and GMC outreach teams.

We will continue to work with NHSEI as it undertakes work to identify specific pathways where a period of reflection can be robustly supported. We will also continue to work with NHSEI as it works towards digitising the decision-making and consent process.

NHSEI will work with the Winton Centre to develop a pipeline of decision support tools. The tools will help patients and clinicians come to an informed decision on the benefit and harm of available treatment options. The first tools will be published in winter 2021 to 2022 on the Personalised Care Institute website, with notification of publication taking place via NHSEI regional teams.

IHPN will review the MPAF by September 2022, and will include a review of the content on decision-making and consent processes.

We will continue to work with CQC to ensure there is robust oversight of decision-making and consent.

Recommendation 5

We recommend that CQC, as a matter of urgency, should assure itself that all hospital providers are complying effectively with up-to-date national guidance on MDT [multidisciplinary team] meetings, including in breast cancer care, and that patients are not at risk of harm due to non-compliance in this area.

Accept

CQC has now added more detailed and specific prompts on multidisciplinary teamworking to the inspection framework for diagnostic imaging services in NHS and independent acute hospitals, including reference to NHSEI’s guidance on streamlining multidisciplinary team meetings for cancer alliances.

When assessing providers in the NHS and the independent sector, CQC will continue to seek assurance that patients are not at risk of harm due to non-compliance with this guidance.

The government accepts this recommendation in full and agrees it is vital that multidisciplinary team (MDT) arrangements are effective and fit for purpose, and that they meet the most up-to-date guidance regarding their use.

The inquiry recommends that every patient with breast cancer should have their case discussed at an MDT meeting – we have heard from patients that this was not the case while Ian Paterson was practicing at Spire. The inquiry also heard that, when independent sector patients had their treatment discussed at MDT meetings in the NHS, the quality of those discussions varied.

First do no harm: the Report of the Independent Medicines and Medical Devices Safety Review also heard how MDT working is helpful in ensuring balanced and considered decisions. The review recommended that:

A culture must exist where all MDT members feel able to speak up and that their input will be listened to. MDTs where decisions are dominated by one individual do not serve anyone well. Trusts must work to create a culture that facilitates effective MDTs.

To ensure that MDTs are fit for purpose going forward, we must address both the guidance regarding their use, and the implementation of that guidance by all relevant organisations. This must be effectively and consistently monitored to ensure patient safety remains the first concern.

Up-to-date national guidance on the use of MDT meetings

Organisations are already taking steps to improve the guidance itself. In January 2020, NHS England issued cancer alliances with guidance on streamlining MDTs. The guidance states that all patients should be listed and recorded at the MDT meeting, and that no patient should be removed from oversight of the MDT or the responsibility of the MDT.

Patients should be stratified into those where a full MDT discussion is required (for example, due to clinical complexity or psychosocial issues), and those cases where a patient’s needs can be met by a standard treatment protocol or standard of care. Even for those patients who do not require a full discussion, the guidance is clear that the MDT will maintain oversight of all patient cases. This is to ensure there is adequate time for discussion of patient cases, where it is required, and to make best use of clinical and diagnostic time.

Patients listed not for ‘discussion’ must have a completed minimum data set and if there is any doubt, or if any query arises regarding a patient or if new information becomes available, then the patient should be discussed at MDT. The MDT should also undertake regular audit of patient cases not discussed.

Ensuring compliance with national guidance

Updates to the guidance are simply the first stage. To ensure that MDTs are fully fit for purpose in all organisations in which they operate, we must ensure that teams and organisations comply with the guidance put in place.

As part of the CQC’s health assessment framework, under the ‘effective’ key line of enquiry, providers are asked: “How well do staff, teams, and services within and across organisations work together to deliver effective care and treatment?”, as well as specific questions on multidisciplinary working across all services.

In response to the findings of the inquiry, CQC has also now added more detailed specific prompts on MDT-working to the inspection framework for diagnostic imaging services in NHS and independent acute hospitals. This asks more detailed questions on the practical arrangements for MDTs, as well as including references to appropriate national guidance, including the aforementioned NHSEI guidance on streamlining MDT meetings for cancer alliances.

These additional prompts on MDT meetings have also been incorporated into CQC’s transitional monitoring arrangements for NHS and independent acute providers and, during monitoring calls, inspectors may ask providers more specifically about their MDT arrangements.

In June 2021, CQC wrote to all NHS trusts, independent sector chief executives, and independent sector hospital directors to ensure that providers were following and complying with national guidance on MDTs.

As NHSEI’s guidance is referenced by CQC, it should also be followed by the independent sector. If an independent sector provider chooses to conduct MDTs differently, that provider must be able to demonstrate to CQC that their approach is at least as good as, if not better, than this guidance.

Next steps

In CQC’s assessments of providers, it will continue to seek assurance that they are complying effectively with up-to-date national guidance on MDT meetings and that patients are not at risk of harm due to non-compliance.

CQC is developing an updated regulatory model in line with its new organisational strategy from 2021. As part of this, it will ensure that the assessment of compliance with up-to-date national guidance on MDTs continues to be a focus for the NHS and the independent sector.

We recognise that existing guidance on MDTs focuses on cancer care and that MDTs take place in other medical settings. Over the next 12 months, we will continue to work with NHSEI, IHPN and CQC on whether it’s necessary and appropriate for further national guidance on MDTs to be developed.

Recommendation 6a

We recommend that information about the means to escalate a complaint to an independent body is communicated more effectively in both the NHS and the independent sector.

Accept

The PHSO is currently piloting the NHS Complaint Standards, which set out in one place the ways in which the NHS should handle complaints, including the need for organisations to ensure people know how to escalate to the Ombudsman. These have been developed with ISCAS, who have included it in their code of practice. We will continue to work closely with key organisations involved to ensure that standards are reinforced.

The government accepts this recommendation in full and agrees the means to escalate a complaint to an independent body should be clearly communicated in both the NHS and the independent sector. We have split out the recommendation into 2 parts in the interests of the coherence of our response.

The inquiry found that information on how to escalate a complaint by patients who have received treatment from the independent sector needs to be better communicated. The Mid Staffordshire NHS Foundation Trust Public Inquiry and the Morecambe Bay Investigation also emphasised the need for a change in culture promoting more openness and transparency, so that all forms of feedback, concerns, compliments and complaints can be welcomed and acted upon.

We are pleased that this change in culture has already been given root by a range of initiatives across the system.

In the NHS, there are already regulatory requirements in place under the Local Authority Social Services and National Health Service Complaints (England) Regulations 2009 that require NHS organisations to make arrangements for the handling and consideration of complaints. If patients are not satisfied with the outcome of their complaint, they have the right to escalate it to the independent PHSO, who will investigate and make a final decision. NHS patients who receive NHS-funded treatment from an independent sector provider are also covered by these arrangements.

Meanwhile, organisations providing healthcare to patients on a private basis can choose to subscribe to an independent complaint resolution service, such as ISCAS, to support patients in the escalation of complaints.

These schemes provide independent adjudication on private patient complaints, but they are voluntary in the sense that independent sector providers are not required to subscribe to them. There are several arrangements and initiatives already in place that aim to provide patients with the information they need about how to escalate a complaint to an independent body, including:

• regulation 16 of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 requires providers to have a complaints process in place, and requires that these arrangements be checked as part of CQC’s regulatory oversight of the NHS and the independent sector. While independent review stages are not required by the regulations, providers are encouraged to have them and are required to inform people of what options they have in the event of being dissatisfied with a provider’s own resolution of a complaint, including turning to legal action
• as also referenced in our response to recommendation 3, the IHPN, in partnership with the Patients Association, have produced a patient information video that highlights the key differences between the NHS and the independent sector. The video includes information about how to make a complaint about both NHS and privately funded care
• this video complements signposting provided by a range of relevant organisations – such as the RCSEng, the Private Patient Forum and the PHSO – to inform patients about ISCAS and how the service may be able to help with complaint escalation and resolution

However, we recognise that more could be done within the existing system to increase patients’ awareness of complaint escalation in both the NHS and the independent sector. We heard from patients the importance of making the complaints process as open and transparent as possible.

The PHSO is currently piloting the NHS Complaint Standards, which will set out in one place the ways in which the NHS should handle complaints. This includes the following statement:

Organisations make sure people know how to access advice and support to make a complaint, including giving details of appropriate independent complaints advocacy and advice providers, any patient advice and liaison service, and other support networks.

ISCAS have worked with PHSO on these standards and have included the NHS Complaint Standards in their own code of practice for independent sector providers.

Next steps

We will work closely with the PHSO and ISCAS, as well as CQC, IHPN and others, to ensure that these new standards provide strong reinforcement of both regulatory requirements and best practice to NHS and the independent sector providers about making a complaint to an independent body.

In particular, the impact of the standards on signposting within the NHS complaints process will be measured as part of the overall evaluation of the effectiveness of the complaint standards. This will involve making sure that the final version of the standards contains strong references on the importance of informing NHS patients about how they can escalate their complaint.

The NHS Complaint Standards will be refined following the pilots, with wider rollout towards the end of 2022 and into 2023.

ISCAS are also in the process of adopting the standards in their own code of practice, and we will work closely with them and others to ensure best practice in this area is reinforced across the independent sector.

Recommendation 6b

We recommend that all private patients should have the right to mandatory independent resolution of their complaint.

Accept in principle

CQC will strengthen its guidance to make clearer that it expects to see arrangements in place for patients to access independent resolution of their complaints regarding independent sector providers.

We will review uptake across the independent sector in the next year and if uptake is not widespread, we will explore whether current legislation needs to be amended to ensure that all providers make provision for independent adjudication.

While NHS-funded patients have the right to take their complaint to the PHSO for independent resolution, it is voluntary for independent sector providers to subscribe to an independent adjudication service such as ISCAS. We would like to see as many independent sector providers as possible have arrangements in place for patients to access independent resolution of their complaints.

CQC will strengthen its guidance to make clearer that they expect to see arrangements in place for patients to access independent resolution of their complaints, where appropriate, by spring 2022. Where a provider fails to comply with regulation 16 of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014, CQC will take appropriate enforcement action.

Next steps

We expect the changes to CQC’s guidance to increase uptake of independent resolution in the independent sector without the need to make this a mandatory requirement for providers.

However, we will keep this under review and, in the longer term, we will work with CQC, IHPN and bodies such as ISCAS to explore whether and how current legislation could be amended to ensure that all providers make provision for independent adjudication where the PHSO’s remit does not extend to their care.

Recommendation 7

We recommend that the University Hospitals Birmingham NHS Foundation Trust board should check that all patients of Paterson have been recalled and communicate with any who have not been seen.

Accept

By August 2020, University Hospitals Birmingham NHS Foundation Trust had contacted all known living patients of Ian Paterson. By the end of June 2021, the trust had ensured that all known former patients had had their care reviewed and that any outstanding concerns were addressed in a way that was determined by the patient.

We accept this recommendation in full and we are pleased it has been fully implemented by the University Hospitals Birmingham NHS Foundation Trust (UHB) for all known living patients of Ian Paterson. We recognise the importance of all patients of Ian Paterson being recalled in a thorough and compassionate way, and the need to ensure all patients are empowered and informed regarding the next steps for their care and treatment.

The inquiry found that almost a third of the patients who were recalled by HEFT and Spire, and who gave evidence to the inquiry, had never received communication about recall or attended an appointment. Although when Ian Paterson was operating Solihull Hospital was run by HEFT, this recommendation was about the ongoing care of patients treated by Ian Paterson and so it was addressed to UHB.

Between May and August 2020, UHB contacted all known living patients of Ian Paterson. By the end of June 2021, UHB had ensured that all known former patients of Ian Paterson had their care reviewed and that any outstanding concerns were addressed in a way that was determined by the patient.

Prior to and post publication of the inquiry’s report, UHB have been in regular contact with affected patient support groups to ensure a patient-centred approach to any actions taken in respect of the recall.

Some of Ian Paterson’s patients are registered with both UHB and Spire (covered under recommendation 8 of this inquiry response). In these cases, the 2 organisations are working together to co-ordinate their recall activity.

Recommendation 8

We recommend that Spire should check that all patients of Paterson have been recalled, and to communicate with any who have not been seen, and that they should check that they have been given an ongoing treatment plan in the same way that has been provided for patients in the NHS.

Accept

By December 2020, Spire had proactively contacted all known living patients of Ian Paterson to check that their care had been fully reviewed, and that they were getting any ongoing support and treatment that they needed. Spire have now reviewed the care of over two-thirds of the patients concerned.

Spire have prioritised the review of patients according to clinical need, with the most likely in need of new intervention being reviewed first. We have asked Spire to provide DHSC with an update on progress in 12 months’ time.

We accept this recommendation in full, and we are pleased that Spire have proactively contacted all known living patients of Ian Paterson and are making progress on the reviews of patients’ cases.

The inquiry heard from patients that there had not been an ongoing treatment plan appropriate to their health needs at Spire.

Spire has since examined its programme of review and recall of patients treated by Ian Paterson, and has worked with those patients not seen previously to determine the most appropriate form of communication to discuss their care. These include all patients who consulted Ian Paterson but did not go on to have a procedure under his care.

By December 2020 (following delays resulting from the COVID-19 pandemic), Spire had written to all living patients of Ian Paterson to offer ongoing support and verify that a treatment plan was in place if appropriate.

By October 2021, Spire had reviewed the care of over two-thirds of patients to date. Spire have prioritised the review of patients according to clinical need with those with the most likely need of new intervention being reviewed first. Many of the cases are very complex and require considerable time to review, and ensure that the right support and follow-up care is in place. Spire have told us that they are committed to doing what is best for patients who have suffered at the hands of Ian Paterson, and that means ensuring that it takes the time to put in place the right support and plan that is tailored to their individual needs.

In July 2021, Spire announced a new compensation fund to deal with any new patient claims relating to treatment by Ian Paterson in their hospitals that have arisen as a result of the current review exercise. In addition, Spire made a successful application to the High Court to relax legal undertakings by firms that had acted for Ian Paterson’s patients in earlier litigation so that those firms could advise patients and apply to the new scheme on their behalf.

BMI Healthcare

BMI Healthcare participated and provided evidence in the inquiry but was not included in the recommendations regarding recall. Following a review exercise in 2013, BMI identified a small number of patients who had undergone breast surgery by Ian Paterson at a BMI hospital. These patients were initially contacted by BMI in January 2014. Their records were then reviewed by an independent breast surgeon and, in conjunction with Spire where appropriate, arrangements have been made for follow-up where this was recommended.

In August 2021, following discussion with DHSC, BMI undertook a secondary risk assessment specifically looking at the general surgery patients who were treated by Paterson at its facilities. This review did not identify any patient safety concerns in relation to the care those patients had received.

BMI has confirmed that its helpline remains open for any BMI patients who wish to discuss the care they received from Ian Paterson at its facilities.

Next steps

The government will provide an update on the outstanding cases being reviewed by Spire in 12 months’ time.

Recommendation 9

We recommend that a national framework or protocol with guidance is developed about how recall of patients should be managed and communicated. This framework or protocol should specify that the process is centred around the patient’s needs, provide advice on how recall decisions are made, and advise what resource is required and how this might be provided. This should apply to both the independent sector and the NHS.

Accept

A national framework has been developed that outlines actions to be taken by organisations in both the NHS and the independent sector in the event of a patient recall. The NQB will own the framework, which will be published in 2022 and periodically updated.

The government accepts this recommendation in full, and recognises the need for a consistent approach and experience of recall for both patients and clinicians.

The inquiry found that there was a lack of guidance to the healthcare sector on good practice when recalling patients for review of their care following adverse incidents. It heard evidence that the recall of patients was generally inadequate, not patient-focused, and lacked transparency in both the NHS and the independent sector. We also heard from patients that the recall process was not adequately patient-centred, which impacted their trust in the trusts and in the healthcare system as a whole.

Based on their experience of the Ian Paterson case and other recent cases, Spire produced a standard operating procedure in 2021 for conducting patient notification exercise and recalls. In 2019, UHB also created a recall toolkit based on their own learning points. The 2 hospitals have now embedded their respective frameworks and toolkits as standard procedure in recall cases, ensuring that patients’ values, preferences and expressed needs are at the heart of plans for recall.

Within the NHS, overarching principles of recall are outlined in the Serious Incident Framework. These highlight the importance of:

• putting people – both patients and staff – at the centre of the recall process *being open and transparent
• adopting a just culture approach
• generating insight that is used to create effective and sustainable change, and reduce risk

Over recent months, building on these existing documents and in discussion with government, NHSEI, Public Health England, Spire, UHB, IHPN, CQC and NHS providers have developed a national framework for the actions to be taken by organisations in the event of a patient recall. This framework is applicable to both the NHS and the independent sector, and will take a principles-based approach to enable each organisation to establish processes that work for them and their patients.

Once the framework has been finalised and agreed, NQB will own the framework going forward and ensure it is periodically updated.

NQB is co-chaired by NHSEI and CQC and is composed of senior clinical professional leaders from across healthcare, social care and public health, alongside patient and public representatives. NQB’s purpose is to provide advice, recommendations and endorsement on matters relating to quality, and acts as a collective to influence, drive and ensure system alignment of quality programmes and initiatives.

Next steps

The national recall framework will be published in 2022 on both NQB and IHPN websites. Following its publication, CQC will then consider the national recall framework as part of their new assessment process to ensure it has been adequately implemented by all providers.

Recommendation 10

We recommend that the government should, as a matter of urgency, reform the current regulation of indemnity products for healthcare professionals in light of the serious shortcomings identified by the inquiry and introduce a nationwide safety net to ensure patients are not disadvantaged.

Pending

In 2018, the government launched a consultation on appropriate clinical negligence cover for regulated healthcare professionals. This sought views on whether to change legislation to ensure that all regulated healthcare professionals in the UK not covered by state indemnity hold regulated insurance, rather than discretionary indemnity.

The government has now extended this programme to consider the issues raised by the inquiry and is committed to bringing forward proposals for reform in 2022.

The government’s response to this recommendation is pending. We recognise that a system needs to be in place to ensure patients have confidence that they can access appropriate compensation if harmed while receiving care, including when harm arises from criminal acts or omissions. We are now building on previous work in this area to address the root causes of the difficulties faced by Ian Paterson’s patients.

The inquiry highlighted serious concerns with the current system of clinical negligence indemnity for healthcare professionals. This included concerns that Ian Paterson’s private patients were unable to access compensation through the cover provided by his medical defence organisation (MDO) – in this case, the Medical Defence Union.

Organisations which provide discretionary indemnity, such as MDOs, are not contractually bound to pay claims and are not subject to financial conduct regulation. Patients have expressed their surprise to us that their ability to access compensation can be decided at the discretion of such an organisation. In addition, insurance products can have exclusions that limit their cover. This, combined with the lack of clarity about private healthcare providers’ liability, means that there are potential gaps in clinical indemnity in the independent sector that do not exist in the NHS.

While this is a complex and wide-reaching subject, we are determined to ensure that any changes implemented are in the best interests of patients and healthcare professionals. We are committing now to continue this work and bring forward proposals for reform in 2022.

Clinical negligence indemnity products

All regulated healthcare professionals in the UK must hold appropriate indemnity or insurance cover.

Most staff in the NHS in England and Wales benefit from state indemnity for clinical negligence. Many of those who do not, including many private practitioners and dentists around the UK, and GPs in Scotland and Northern Ireland, hold discretionary indemnity through membership of an MDO. The main alternative to discretionary indemnity is regulated insurance.

In 2018 to 2019, the government consulted on whether to change legislation to require all regulated healthcare professionals to hold regulated insurance, rather than discretionary indemnity, or to leave arrangements as they are.

While requiring regulated insurance was our preferred option, we recognise that this could lead to other adverse impacts. For example, in a transition from discretionary indemnity to insurance products, providers could be unable or choose not to continue to provide cover and there could be higher overall costs of clinical negligence cover. This could impact both healthcare professionals and their patients.

Just over 100 organisations and individuals participated in the consultation. We received responses in favour of both options and several others were proposed. These included, for example:

• introducing a code of conduct for discretionary indemnity providers
• creating a route of escalation should patients or clinicians have a claim denied
• requiring discretionary indemnity providers to report more transparently on their finances

Compensation for criminal injuries

We do not believe making the reforms proposed in the consultation alone would prevent a recurrence of the issues identified by the inquiry. This is because standard insurance products usually exclude cover for policy holders who make a claim relating to an incident which occurred during the course of them committing a criminal act.

Where patients have not been able to obtain compensation through other sources, the Criminal Injuries Compensation Scheme may be available as a last resort. This provides compensation for serious physical and mental injuries occurring as the direct result of a violent crime that is intentional or reckless. However, unlike compensation awards for clinical negligence, payments under the scheme are tariff-based payments that are intended to provide recognition of the harm suffered.

Possible responses

We are now:

• considering how best to address both the issues identified by the inquiry and our pre-existing concerns about discretionary indemnity;
• exploring whether there are any other potential gaps in the system to be addressed

Possible responses include:

1. Changing the type of cover that clinicians are required to hold. This could involve requiring all regulated healthcare professionals to hold regulated insurance or regulating the discretionary indemnity products available to clinicians.
2. Introducing safeguarding measures to the current system of discretionary indemnity, such as ensuring greater transparency by providers, voluntary codes of conduct, the establishment of an ombudsman and escalation procedures.
3. Requiring providers of clinical negligence cover – both discretionary indemnity providers and insurers – to ensure that patients can be compensated for harm arising from criminal activity in the context of clinical care. This could potentially be implemented by providers changing their practices or by contributing to a sector-wide safety net.

We will also consider any consequential indemnity or insurance issues raised by private healthcare providers’ potential liability for their self-employed consultants’ actions, as per recommendation 13 of the inquiry.

Next steps

Changes to clinical negligence cover requirements could have wide-ranging implications for healthcare professionals and patients across the UK. Therefore, we need to ensure we have sufficient evidence in order to develop the most effective solutions.

In order to obtain this, we will undertake 3 actions:

1. Conduct a survey of healthcare professionals in early 2022 to help us understand their current indemnity and insurance arrangements and assess the possible impact of different options
2. Continue engagement with key stakeholders – such as patients, indemnity and insurance providers, clinical representative bodies, professional regulators and the devolved administrations – to understand their views on potential solutions
3. Consult on the detail and arrangements for implementing reform, recognising that providers would need time to prepare for any changes.

We will publish a summary of responses received to the previous consultation on appropriate clinical negligence cover for regulated healthcare professionals in early 2022.

Recommendation 11

We recommend that the government should ensure that the current system of regulation and the collaboration of the regulators serves patient safety as the top priority, given the ineffectiveness of the system identified in this inquiry.

Accept

System and professional regulators have an overarching statutory objective to protect, promote and maintain the health, safety and wellbeing of the public.

The healthcare regulators referenced in the inquiry (GMC, NMC and CQC) exist to protect patient safety and this is reflected in their new corporate strategies. They have also taken a number of actions to encourage information-sharing between organisations, and to enable patients and professionals to raise concerns.

DHSC’s 2021 consultation regulating healthcare professionals, protecting the public sets out proposals that address the issues raised in the inquiry, including a proposal to place a duty to co-operate on all regulators.

DHSC plans to draft legislation in relation to the GMC in 2022.

The government accepts this recommendation in full. Patient safety is at the heart of healthcare regulation, and both system and professional regulators have an overarching statutory objective to protect, promote and maintain the health, safety and wellbeing of the public.

The inquiry pointed to the considerable resources committed to the regulation of healthcare. Despite this, the inquiry found that the regulatory landscape is disjointed, with insufficient linkage between CQC as a systems regulator, and the GMC and the NMC as professional regulators. All regulators appeared to be waiting for someone else to act.

The inquiry also called for the roles of the different regulators to be more clearly explained to the public, with a need for regulators to improve their patient focus and ensure better signposting for patients wishing to raise a concern.

We need to ensure systems are in place that enable regulators to collaborate and share information in an effective and timely manner. We also need to make sure there are clear pathways for patients and professionals to raise concerns, and that any barriers preventing patients and professionals from reporting concerns to regulators are removed.

DHSC is taking forward reforms to professional regulation that will provide improved public protection.

Raising concerns

The inquiry highlighted a need for increased visibility of how professionals and patients raise concerns to regulators.

The GMC has focused on promoting the reporting of concerns through a range of routes. This includes publicising information on the types of concerns the GMC can investigate for patients through better signposting on its patient-facing webpages, and encouraging professionals to raise concerns through the creation of a Speaking up hub for doctors. The GMC is also developing and piloting a number of programmes that aim to help improve doctors’ skills and confidence in addressing unprofessional behaviours, and create environments that empower and incentivise individuals to raise concerns.

The NMC has also created online content to support professionals (Caring with Confidence: the Code in Action), which includes advice and support on speaking up and accountability.

It is the responsibility of the Responsible Officer to ensure that local processes are in place for raising and acting on concerns about doctors, with issues escalated to the GMC as appropriate. DHSC is working on changes to the Medical Profession (Responsible Officers) Regulations 2010. The planned work on the regulations will reduce patient safety risks identified in relation to the revalidation of doctors and bring the regulations up to date to ensure they are fit for future use in the changing healthcare landscape. Any changes to the regulations will be subject to a consultation.

Information sharing

The regulators in the Paterson inquiry – including CQC, GMC and NMC – have already taken steps to improve collaboration, and to facilitate information-sharing and raising concerns across organisations.

This has resulted in shared protocols, memoranda of understanding (MOUs), and joint statements that set out the arrangements for collaboration and information-sharing between regulators and other stakeholders. For example:

• the GMC’s MOUs and the NMC’s MOUs with system regulators both in England and the rest of the UK, public protection bodies, and NHS agencies
• the CQC’s joint working agreements, which include MOUs, joint working protocols and information-sharing agreements with a number of stakeholders

Since 2018, all professional healthcare regulators in England, CQC, Health Education England, Local Government and Social Care Ombudsman, and the PHSO have also been signatories to the emerging concerns protocol.

The protocol sets out arrangements for partners to share information about emerging concerns and provides a clear mechanism for raising concerns and ensuring a collaborative approach to any proposed actions. Concerns that may be shared under the protocol fall into 3 categories:

1. Concerns about individuals or groups of professionals.
2. Concerns about healthcare systems and the healthcare environment (including the learning environments of professionals).
3. Concerns that might have an impact on trust and confidence in professionals or the professions overall.

Reform of professional regulation

We recognise there is a need to change the UK model of regulation for healthcare professionals to better protect patients, support health and care services, and help the workforce meet future challenges.

In March 2021, DHSC published the consultation regulating healthcare professionals, protecting the public. This proposed that regulators be provided with a consistent set of duties to ensure they collaborate and operate transparently and proportionately. While many regulators are already under a duty to co-operate, this is set out in different ways in legislation. We, therefore, proposed a specific duty to co-operate that will apply to:

• all organisations concerned with the regulation of healthcare professionals
• the employment, education and training of healthcare professionals
• the regulation of health and care services
• the provision of health and care services

We also propose to provide a consistent regulatory framework for fitness to practise across all professional healthcare regulators. Our proposed changes will enable faster resolution of cases and deliver public protection more quickly.

We also propose to remove the 5-year rule, which was highlighted by the inquiry as a potential barrier to public protection. The removal of the 5-year rule will ensure that regulators are able to investigate concerns based on evidence, rather than an arbitrary time limit. DHSC will consult on reformed GMC legislation in 2022.

Strategies and next steps

We recognise that changes to legislation are just one way of strengthening the regulatory system and ensuring patient safety. However, there is still far more regulators can do to ensure effective collaboration and that patient safety remains their top priority.

A key strategic theme in the GMC’s 2021 to 2025 corporate strategy is “enabling professionals to provide safe care” and the NMC corporate strategy 2020 to 2025 sets out its commitment to learning the lessons from inquiries into major failings of care. To further improve patient safety and system-wide learning, during the COVID-19 pandemic, the NMC established pilot work with the GMC and CQC to share data and support safe cultures, and worked with the Healthcare Safety Investigation Branch (HSIB) to collaborate on information sharing.

CQC recently launched its strategy for 2021 and beyond, which sets out an ambition to strengthen its assessments of safety with a stronger focus on positive organisational cultures, safety skills, and the involvement of patients and people who use services. The strategy builds on experience and learning from the past 5 years, and has been developed with input and feedback from people accessing and using health and care services, service providers and CQC partners. CQC has also begun to revise its assessment frameworks and provider assessment methodology to strengthen its focus on patient safety and collaboration. CQC anticipate implementation will start in 2022.

NQB is updating its guidance on how information and intelligence is shared and acted upon by regulators. These changes will be produced and delivered in partnership with regional NHSEI teams, CQC, healthcare professional regulators, the Professional Standards Authority (PSA) and other stakeholders. This guidance will also consider how the Quality Surveillance Groups model could extend to the independent sector.

The PSA is responsible for overseeing the UK’s health and care professional regulatory bodies. Although the PSA does not investigate specific complaints, it does carry out performance reviews of regulatory bodies. This provides assurance that regulators are effectively protecting the public, and promoting confidence in health and care professionals. The PSA has also recently announced a project named Bridging the gap, which looks at the structures by which regulators collaborate, and share data and information.

We will continue to work with all healthcare regulators to ensure that patient safety remains their top priority. The existing shared agreements between organisations, the proposed changes to legislation, and the new strategies outlined in this response will make sure there is effective collaboration and information-sharing between organisations.

This will ensure that regulators are able to identify and address barriers that could prevent the regulatory system from responding to concerns in a timely and effective manner.

Recommendation 12a

We recommend that if, when a hospital investigates a healthcare professional’s behaviour, including the use of an HR process, any perceived risk to patient safety should result in the suspension of that healthcare professional.

Do not accept

We agree that exclusions and restriction of practice can be necessary and, in some cases, immediate exclusion is an appropriate response while an investigation is ongoing. However, we do not believe it would be fair or proportionate to impose a blanket rule to exclude practitioners in such cases.

Such a step may inadvertently cause a chilling effect, dissuading healthcare professionals from raising concerns, and negatively impacting patient safety. It is vital that investigations are robust and conducted in a timely manner.

Guidance has been put in place to ensure that concerns are taken seriously, appropriate action taken and that robust investigation processes are implemented, and that clarity on when to exclude a healthcare professional is provided.

We agree that there are circumstances where exclusion and restriction of practice are necessary. However, accepting this recommendation would lead to the potential for many professionals to have their practice restricted in circumstances where it would not be reasonably warranted.

For the purpose of this response, it is worth noting that ‘exclusion’ or ‘restriction’ of practice is the term used for the action described in the recommendation. ‘Suspension’ is a separate regulatory act.

The inquiry found that Ian Paterson could have been stopped from practising in 2003, and should have been stopped in 2007 rather than in 2011. There is an important balance to be struck when it comes to the exclusion or restriction of healthcare professionals from all or part of their practice. On the one hand, patient safety should be protected and, in cases such as Ian Paterson’s, the decision to exclude must be taken where that is justified.

On the other hand, the procedures must:

• be rigorous
• allow for a wide range of scenarios that may be faced
• result in action taken that is seen to be reasonable, fair and proportionate

We do not believe this recommendation, as stated above with its provision of an automatic suspension (either regulatory or employment), strikes this balance correctly. Guidance on how to handle concerns and investigations must be able to work in all the circumstances in which it may be applied.

An automatic exclusion of medical professionals could have a chilling effect on raising concerns. A colleague who knows that speaking up over a concern will lead to this level of response automatically may be more reluctant to do so at an early stage, causing opportunities to protect patients and improve care to be missed.

We have also heard in our engagement with stakeholders in the health sector that certain groups of professionals, such as those from ethnic minority backgrounds, are disproportionately likely to face complaints and so may be disproportionately impacted by a measure such as this, despite there being no evidence that their practice is worse in any way.

Rather than setting automatic sanctions, we believe the problem that manifested in the case of Ian Paterson can be addressed by 3 steps:

1. Ensuring concerns are taken seriously.
2. Implementing robust investigation processes.
3. Providing clear guidance on decisions to suspend or exclude a healthcare professional.

These steps can meet the underlying goal of this recommendation while maintaining the right balance of responsibilities that providers in the sector hold.

Taking concerns seriously

In the NHS, Maintaining High Professional Standards in the NHS (MHPS) (applies to England only; other documents exist in Wales and Northern Ireland) outlines NHS policy in relation to handling of concerns about an employed doctor or dentist’s capability, conduct or health, including considerations around restrictions or exclusion from work. The rationale for the decisions to exclude or restrict should be clearly documented – whether in favour or against these actions.

DHSC is committed to continuing its work with NHS Resolution, key stakeholders and employers in the NHS to ensure the MHPS framework is brought up to date, and strikes the right balance of protecting the safety of patients while treating practitioners fairly.

NHS Resolution’s Being fair guidance outlines that the Practitioner Performance Advice service provides expert advice to healthcare organisations, including those in the independent sector, to help them effectively resolve performance issues.

Within the independent sector, the MPAF was published by the IHPN in October 2019. This sets out arrangements for creating effective clinical governance structures, including the support of appraisal and responding to concerns.

The statutory duty of candour, implemented in regulation in 2014, provides definitions of identifiable safety issues that cause moderate harm, and specifies how NHS and independent providers must act when these incidents occur. Providers must ensure that they have processes in place to make sure staff are supported to deliver the duty of candour, and have a system in place to identify and deal with a notifiable safety incident.

GMC has also published guidance on reporting concerns, including a Speaking up hub for doctors in October 2019. This includes the development of a pilot training programme on professional behaviours and patient safety to help improve doctors’ skills and confidence to address unprofessional behaviours.

Robust and timely investigation processes

Concerns about patient safety should be investigated effectively locally and concluded as soon as possible. All designated bodies should prioritise the protection of patient safety, then the resolution of the concern and then support for the doctor.

The NHS Standard Contract 2020 to 2021 requires NHS providers (including private providers in receipt of NHS contracts) to report on local procedures for reporting, investigating and implementing lessons learnt from serious incidents, notifiable safety incidents and patient safety incidents. In April 2020, NHS Resolution published interim guidance to NHS organisations on managing concerns in accordance with MHPS during the COVID-19 pandemic. NHS Resolution offers training on case investigation and case management.

NHS England also published a practical guide for responding to concerns about medical practice in 2019. This provides general, practical advice for Responsible Officers in all designated bodies in England to address a potential concern about a doctor’s practice in a manner consistent with guidance and established principles. NHS Resolution are also updating their guidance on investigation of concerns.

In the independent sector, the MPAF makes clear that independent providers:

should have a transparent clinical governance framework that is explicit about responsibility for medical performance, and how performance issues are identified, managed and escalated.

The framework points private providers towards NHS England and GMC guidance to aid in developing their own systems.

Where an employer or contracting body has serious concerns about a doctor’s fitness to practise, as well as conducting a thorough local investigation and any other appropriate intervention, the Responsible Officer should discuss their concerns with their GMC employer liaison adviser.

Where risks to patients can’t be addressed locally and there are questions of impaired fitness to practise, the GMC can refer a doctor to an interim orders tribunal at the Medical Practitioners Tribunal Service, which can suspend the doctor while the GMC investigates.

Clear guidance on exclusion

NHS Resolution provide healthcare organisations with guidance on excluding medical professionals. This guidance notes that this is a measure that should be used in a proportionate manner, subject to senior-level oversight and is a measure of last resort. This is to protect against the inappropriate use of exclusion, recognising the impact on patient safety, but does empower organisations to exclude practitioners where there is appropriate rationale and concerns to do so.

Responsible Officers, who are in place in both the NHS and the independent sector, are given induction training that provides guidance on thresholds for action and engages Responsible Officers in practical exercises to calibrate that those carrying out this role will take consistent action in similar circumstances across the health sector. NHS Resolution also provides training which includes understanding the appropriate thresholds for taking specific actions.

Next steps

NHS Resolution will provide guidance to the system on exclusion, including publishing a checklist to support decisions to exclude. Guidance will be supplemented by case study examples and interactive training materials, and will be published in early 2022.

NHSEI will work with stakeholders to develop a Common Management Framework in line with its guidance on excluding medical professionals, which should be in place from summer 2023.

The IHPN will review the MPAF by September 2022.

Recommendation 12b

If the healthcare professional also works at another provider, any concerns about them should be communicated to that provider.

Accept in principle

The government agrees that, where patient safety is at risk, information should be shared with other providers. However, there must be an element of judgement by providers as they will be taking on responsibility to ensure that this information is appropriate and accurate.

Regulators have taken key steps to make it easier for people and organisations to share information regarding patient safety risks. The Medical Profession (Responsible Officers) Regulations 2010 (revised in 2013), which apply to all medical practitioners, have also set out prescribed connections for sharing information regarding performance concerns between health organisations.

The government accepts this recommendation in principle and agrees that, where a provider has evidence that an individual is shown to be acting in an unsafe way, they should share concerns about that individual’s practice with other providers who they work with.

The inquiry reported that, while concerns about Ian Paterson were raised at his NHS trust, these were not communicated to other providers he worked for. We also heard from patients and the inquiry that Ian Paterson’s investigation under HR processes meant that he was guaranteed a degree of anonymity, which allowed him to keep operating.

It is important that providers retain some judgement regarding when best to flag concerns to other providers as they will be taking on responsibility to ensure this information is appropriate and accurate.

Providers have obligations to consultants they engage with in respect to their personal data (for example, under the General Data Protection Regulation (GDPR)) and must satisfy themselves that they are complying with those obligations when sharing data. They additionally must satisfy themselves that investigations have been conducted properly and that they will not face action from consultants for sharing of flawed information, which may lead to action for loss of earnings, for example.

However, where providers have assured themselves that the information is accurate, we accept the principle that this information should be shared with other providers that the individual works with.

Regulators have taken important actions to make it easier for people and organisations to share information regarding patient safety risks.

The GMC is clear in its guidance that patient safety is paramount when deciding whether to share information about doctors. When it is appropriate, this sharing of information should occur in a timely manner. The Medical Profession (Responsible Officers) Regulations set out prescribed connections and enact systems for sharing information about performance concerns between organisations. Responsible Officers should act as hubs, receiving information about the practice of their connected doctors and sharing this with appropriate individuals in other places where the doctor works.

These regulations also set out arrangements for professional standards including:

• monitoring the quality of a doctor’s performance
• managing concerns about performance
• undertaking appropriate employment checks
• providing an effective appraisal system

DHSC is also currently undertaking a review of the regulations. This will consider the information-sharing duties at the point of revalidation (every 5 years) and when doctors move organisations.

Healthcare Professional Alert Notices (HPANs) are another key mechanism to inform other providers of concerns about the safety of a healthcare professional. HPANs are issued by NHS Resolution to inform NHS bodies and others about health professionals who may pose a significant risk of harm to patients, staff or the public.

In December 2019, National Health Service Litigation Authority (Safety and Learning) Directions 2019 concerning HPANs were amended to encourage uptake in the NHS. In April 2020, NHS Resolution published interim guidance to reinforce requirements on the use of HPANs during COVID-19. NHS Employers also strengthened the requirements to check and make referrals to the HPAN system in the NHS employment check standards, which apply to all NHS organisations in England.

Doctors in the independent sector are normally not employees, but the same obligations exist for sharing information between all organisations where they provide care (including, but not limited to, organisations where those doctors are employed or have practising privileges).

IHPN’s MPAF makes clear that, where an investigation leads to the restriction, suspension or removal of practising privileges on a temporary or permanent basis, or where a practitioner withdraws during an investigation, this needs to be communicated to any other organisations where they practice and to their Responsible Officer. Many independent providers can also request a HPAN if they are contracted to deliver NHS services.

In addition, a wide range of regulatory bodies have adopted the emerging concerns protocol, working alongside NHSEI, which provides a robust mechanism to share information about emerging concerns with each other and system partners in a timely fashion. It strengthens existing arrangements, providing a clear mechanism for raising concerns and ensuring a collaborative approach to any proposed actions.

Next steps

DHSC will continue to engage with regulators, NHS Resolution and IHPN to monitor the impact that these actions have made to the sharing of concerns when an individual has been shown to be acting in an unsafe way, and will assess this in 12 months’ time.

DHSC is also currently undertaking a review of the Medical Profession (Responsible Officers) Regulations 2013. This will consider the information-sharing duties at the point of revalidation (every 5 years) and when doctors move organisations.

Recommendation 13

In the NHS, consultants are employees and the NHS hospital is responsible for their management, and accepts liability when things go wrong. The situation is very different in the independent sector where most consultants are self-employed. Their engagement through practising privileges is an arrangement recognised by CQC. However, this recognition does not appear to have resolved questions of hospitals’ or providers’ legal liability for the actions of consultants.

We recommend that the government addresses, as a matter of urgency, this gap in responsibility and liability.

Accept in principle

The government is clear that independent sector providers must take responsibility for the quality of care provided in their facilities, regardless of how the consultants are engaged. The Medical Practitioners Assurance Framework (MPAF), published in 2019 by the IHPN, was created to improve consistency around effective clinical governance, and to set out provider and medical practitioner responsibilities in the independent sector.

CQC will continue to assess the strength of clinical governance in providers as part of its inspection activity, taking account of relevant guidance such as the MPAF.

As covered in our response to recommendation 10, we have set out a programme of work that will consider the case for reforms to the provision of indemnity cover. We will use this as our initial approach to dealing with the challenges faced by patients of Ian Paterson in accessing compensation.

The government accepts this recommendation in principle and recognises there must be appropriate responsibility taken for the actions of all consultants operating within the independent sector.

Liability arrangements must be fit for purpose, and patients must not be left without compensation where compensation is warranted.

Gap in responsibility in the independent sector

The inquiry found that many patients did not feel that the private providers accepted responsibility for their treatment. We heard from patients that they were given the impression that private providers simply ‘rented a room’ to consultants engaged through practising privileges.

Arrangements via practising privileges for consultants working in the private sector are recognised by CQC. Under this arrangement, CQC expects all independent providers that grant practising privileges to medical practitioners to have robust and effective processes in place for ensuring they are fully compliant with meeting the requirements of schedule 3 of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014. Ultimately, independent sector providers are responsible for the quality and safety of care that they offer, including the services of any medical practitioners working under practising privileges they use.

As such, we are clear that independent sector providers are responsible for the activities of the staff (whether directly employed or engaged through practising privileges) falling within CQC’s scope of their registration.

Independent providers are taking steps to improve the processes in place to govern the actions of all their consultants.

The IHPN published the MPAF in October 2019. This framework was developed with the former National Medical Director at NHS England, Sir Bruce Keogh, to improve consistency around effective clinical governance for medical practitioners across the independent sector. This is a voluntary framework that has been shared with all member organisations of IHPN.

The MPAF is regularly reviewed and updated by IHPN to ensure that it is fit for purpose, with training provided to registered managers on its application. IHPN will continue to work with CQC and other stakeholders to ensure that the MPAF is being adequately used across the independent sector, and IHPN will conduct a further refresh of the MPAF to be completed by September 2022.

Next steps

We welcome the adoption of the MPAF across the independent sector, encourage all private healthcare providers to adopt it, and will engage with the refresh process in 2022 to ensure it sets a high standard to better protect patient safety. When next updating the NHS Standard Contract, NHS England will also consult on including a new requirement for non-NHS providers to have regard to the MPAF.

CQC will continue to assess the strength and implementation of clinical governance in providers as part of its regulatory activity, taking account of relevant guidance such as the MPAF. As part of its assessments, CQC will seek assurance from providers that their processes support medical practitioners to deliver high-quality care to patients. CQC will deploy the principles set out in a new strategy to ensure that regulation is flexible with up-to-date, high-quality information and ratings available for the public, providers and patients.

Gap in liability in the independent sector

The recommendation also addresses the difficulties that private patients of Ian Paterson faced in accessing compensation. Private patients experienced stress and uncertainty in attempting to access compensation for the harm caused because there appeared to be no clear avenue through which to achieve this.

In the NHS, consultants are directly employed by their hospitals, which accept liability when things go wrong. Private providers, however, do not accept liability for the actions of consultants engaged through practising privileges. Ian Paterson’s indemnity provider also declined to pay out to patients because his actions were criminal. While these patients were eventually compensated, their experience is unacceptable. In circumstances where compensation is deemed to be appropriate, patients should not have to overcome these hurdles to access it.

Providers of private healthcare are now taking greater responsibility for the actions of consultants working in their hospitals, as described above.

Next steps

One avenue to address the challenges that presented for patients of Ian Paterson is through changes to indemnity arrangements. As covered in our response to recommendation 10, we have set out a programme of work that aims to identify potential solutions to the problems encountered by private patients within the current system. This set of actions will make up our initial approach in trying to meet this part of the recommendation.

DHSC will:

• keep under review the issue of what liability these providers may hold for the actions of consultants working through practising privileges as we continue to work towards the implementation of this recommendation
• continue to work with the sector to explore the need for reform, should the measures set out above fail to address the problems of responsibility and liability highlighted by the inquiry
• consider the need for further action based on the progress of reforms relating to indemnity at the 12-month review and will provide an updated programme of action on that basis

Recommendation 14

We recommend that, when things go wrong, boards should apologise at the earliest stage of investigation and not hold back from doing so for fear of the consequences in relation to their liability.

Accept

Healthcare organisations have a statutory duty of candour, which sets out specific requirements providers must follow when things go wrong with care and treatment, including providing truthful information and an apology. This duty is regulated by CQC.

NHS Resolution has consistently advised its members to apologise when things go wrong, and to provide a full and frank explanation at the earliest possible stage, irrespective of the possibility of a legal claim. More work is underway to ensure that this NHS Resolution guidance is promoted.

The government accepts this recommendation in full and agrees that patients should receive an apology from boards at the earliest stage of investigation when things go wrong.

The inquiry found that patients felt they did not receive any meaningful apology from the hospitals, and that, despite guidance on being open and saying sorry, the inquiry found no evidence to show how boards accept and implement accountability for apologising.

Since 2014, organisations registered with CQC in England have a statutory duty of candour. Candour requires organisations to be open and transparent when something has gone wrong. In addition, there is a professional duty of candour, which is overseen by regulators such as the GMC and NMC. This responsibility is set out in their respective professional codes of conduct.

Failure to uphold and adhere to the principles of such codes and supporting guidance could lead to fitness to practise proceedings against the registered professional concerned.

NHS Resolution has consistently advised its members (both NHS trusts and independent sector providers of NHS care) to apologise, and to provide a full and frank explanation at the earliest possible stage, irrespective of the possibility of a legal claim. This is set out most recently in its widely circulated Saying sorry leaflet in 2018, which highlights the importance of making a meaningful apology when things go wrong.

More recently, NHS Resolution’s Being fair leaflet sets out clear guidance for a just and learning culture charter for healthcare organisations to adapt and adopt. This guidance makes clear that a patient’s health must remain the paramount concern of any health professional, whether or not there is a dispute over that treatment or an allegation of clinical error, and that patients have a right to explanations and to seek an apology. NHS Resolution also has a module in their Faculty of Learning resources on point of incident resolution for patients and families.

CQC’s trust-wide well-led framework for NHS trusts provides a mechanism for identifying inappropriate reasons given by trusts refusing to apologise, and enables feedback to be provided on both a case-by-case basis and at a national level.

In addition, the NHS Patient Safety Strategy, published by NHSEI in July 2019, sets out actions focused on better insight into healthcare harm, education and training for staff and patient involvement.

Next steps

We have heard from patients that there are occasions where boards do not apologise at the earliest stage possible. Therefore, we will continue to build on the work that has already been undertaken.

NHS Resolution will continue to develop, publicise and evaluate their range of resources focused on signposting and helping to embed best practice with respect to making apologies within a just and learning culture. At every engagement with its members and every event that it hosts, NHS Resolution will promote the ‘Saying sorry’ and ‘Being fair’ guidance, as well as promoting and highlighting these resources on social media and other channels.

NHS Resolution will work with others across the safety system to develop resources to support clinicians in the provision of direct support for patients and families when an incident occurs. This will include modules on giving meaningful apologies within a learning organisation.

The new cross-system National Patient Safety Programme Board, chaired by DHSC, will take an overview of measures and actions across health services to improve patient safety and the response to harm.

We will review progress on these actions in 12 months.

Recommendation 15

We recommend that, if the government accepts any of the recommendations concerned, it should make arrangements to ensure that these are to be applicable across the whole of the independent sector’s workload (meaning private, insured and NHS-funded) if independent sector providers are to be able to qualify for NHS-contracted work.

Do not accept – keep under review

This recommendation, if implemented, would change the way in which independent sector providers qualify for NHS contracts. As demonstrated in our response to the other recommendations, independent sector providers are fully committed to implementing changes alongside NHS providers. They must already meet the same regulatory standards, as required by CQC.

We will continue to monitor the independent sector uptake of the other recommendations and we will review our position on this recommendation in 12 months’ time, setting out further steps if necessary.

The government does not agree that independent sector providers should only qualify for NHS-contracted work if they apply all the other recommendations accepted by government across their entire workload.

We agree that patients treated in the independent sector have the same right to safe treatment as those treated in the NHS. For that reason, it is important that, where the NHS is adopting certain recommendations from the inquiry, these recommendations are also adopted in the independent sector. Throughout this response, we have indicated the ways in which we have, and will continue to, work with the independent sector to ensure this is the case.

There are, however, important differences in the ways in which the 2 sectors operate and the governance models adopted in each case. Different approaches are therefore often required for achieving change in the independent sector.

The government view is that contractual levers should only be used to support regulation and guidance, rather than directly driving patient safety improvement via contractual terms. Not only is this a less effective method to force patient safety change but, as many private providers do not deliver any NHS work, this approach would leave these providers completely unaffected. Accepting this recommendation would also be incredibly difficult for the NHS to monitor and could have serious repercussions by impacting the independent sector’s contribution to supporting the NHS with the recovery from COVID-19.

Therefore, as we will be taking significant steps to implement the vast majority of the other recommendations as set out in the ‘Implementation plan’ below, accepting this recommendation is neither necessary nor appropriate.

However, we recognise the importance of being able to hold organisations to account for any actions to which they have committed to ensure this happens in practice. To address this, we commit to reviewing the independent sector’s progress of implementing the actions detailed in the implementation plan and review the government’s position on this recommendation in 12 months’ time.

We will also continue to engage with the safeguards that apply to the independent sector and NHS-contracted work, as discussed below.

Actions taken to ensure that NHS-contracted services are safe

Since Ian Paterson was convicted, several safeguards have been put in place to ensure that the quality of care provided by independent providers that may be contracted through the NHS meets these standards.

Regardless of whether care is NHS-funded, paid for by private insurance or self-funded by the individual, since 2015, all independent providers must be registered with CQC, as in the NHS. This means that every independent provider is subject to the same range of regulatory powers from CQC as NHS services to ensure a consistent standard of care across the health system.

These regulations have been updated since Ian Paterson has been suspended, and reference updated guidance from other organisations that addresses the patient safety failures that occurred. For example, IHPN are working with CQC to support consistency in how inspectors incorporate the MPAF in their inspections. These new steps will help ensure a greater parity of standards across the health sector.

The Health and Care Bill contains provisions to set up the Health Services Safety Investigations Body (HSSIB), an independent statutory body to investigate incidents which occur in England during the provision of health care services which have, or may have, implications for the safety of patients. The HSSIB will build on the work of HSIB which became operational in April 2017 as part of NHS Improvement. In October 2021, the HSIB conducted a national investigation to support the delivery of safe care to NHS-funded patients undergoing surgery within independent hospitals. The remit of the HSSIB will be broader than the HSIB’s; it will be able to investigate patient safety concerns in healthcare provided in and by the independent sector, however it is funded. This recognises that incidents in the independent sector can have implications for the safety of patients in the NHS too.

Whenever the NHS commissions work from the independent sector, there are quality indicators attached to ensure that patients experience a high quality of care, no matter who delivers that care. Strong contractual levers are available to NHS commissioners where there are quality or safety concerns about an individual provider or service. For example, all independent providers delivering NHS-funded activity are subject to the NHS provider licence, which contains a number of requirements around:

• fit and proper persons
• financial stability
• standards of corporate governance
• financial management
• the provision of data and information

All providers delivering NHS services do so under the NHS Standard Contract, which is updated a reviewed regularly. The NHS Standard Contract is a mechanism through which commissioners of NHS services from private providers specify the quality requirements of the services. For example, the NHS Standard Contract:

• contains a comprehensive set of nationally mandated quality and operating requirements around service quality
• mandates national reporting requirements
• requires each provider to operate a consent policy that accords to the national practice
• mandates the use of Freedom to Speak Up Guardians
• imposes a requirement on all providers to uphold the statutory duty of candour

When next updating the NHS Standard Contract, NHS England will consult on including a new requirement for non-NHS providers to have regard to the MPAF.

Finally, failure to comply with the clinical or information requirements, requirements under the Standard Contract or NHS guidance can result in a penalty or a detailed contract management process with a remedial action plan, suspensions or terminations.

Collectively, these measures amount to a considerable degree of scrutiny placed on independent providers before they are able to qualify for NHS contracts.

Ensuring continual uptake of recommendations

Throughout the development of our response to the inquiry’s recommendations, we have worked closely with the acute independent sector, represented by the IHPN. This has helped reassure us that our response is applicable across the entire healthcare system and not solely NHS focused. We welcome the full engagement of the IHPN with the process of responding to the inquiry’s report.

The independent sector has already done significant work to ensure the recommendations from the inquiry to improve quality and patient safety are taken up by the independent sector. For example, the IHPN developed the MPAF to improve the governance of consultants working in the independent sector and has already been widely implemented across the sector. It is used by CQC as evidence of good governance and to inform judgement about how well-led services provided by independent providers are.

Next steps

We will continue to work with the independent sector to ensure that all appropriate measures are taken so that – regardless of where they are treated or how their care is funded – patients can be confident that:

• the care they receive is safe
• their care meets the highest standards, with appropriate protections
• they are supported by clinicians to make informed decisions about the most appropriate course of treatment

We will continue to engage with the independent sector to help ensure all providers and medical practitioners come on board. We recognise that independent providers already carrying out NHS-contracted work are likely to make changes across the whole of their workload rather than implement parallel clinical governance and quality assurance arrangements for different services. This may be less applicable to providers offering exclusively private-funded care.

Work to review and further the implementation of the MPAF is ongoing and IHPN will produce a refresh of the MPAF by September 2022, following consultation with providers and other stakeholders.

As we move towards integrated care systems (ICS), as outlined in the Health and Care Bill, the independent sector and the NHS will continue to work closely together. ICS and NQB will be monitoring quality across the entire health system, and ensure that patients are receiving safe, high-quality care wherever they receive it and however their care is funded.

We will continue to monitor the implementation of these recommendations across both the NHS and the independent sector, and commit to publishing an update on our position on this recommendation in 12 months after publication of this government response.

In our follow-up report, we will evaluate the progress that has been made and set out further steps, if necessary, should we find that there has not been sufficient progress in the implementation of actions set out in this response.

Implementation plan

We know that, on their own, no words published make patients safer or correct the failures that allowed Ian Paterson’s malpractice. It is what happens next that will deliver the change past and future patients deserve.

This response has outlined the action that has already been taken, but there is considerable work still to do. This implementation plan details the actions the government and other organisations in the health system are committed to carrying out, across the themes that the inquiry and this response have explored.

This plan will be reviewed in 12 months’ time to assess progress and refresh the actions, where appropriate.

Providing patient-centred information

1. DHSC will work with NHSEI, IHPN and PHIN to explore options for using the framework of the digital staff passport or other means as a mechanism for holding key consultant information, such as employment and practising privileges.

2. PHIN will set out a 5-year plan in 2022 to implement the remaining publication of information about private consultants, which they have been mandated to complete, for the period 2022 to 2026.

3. Over the next 12-months, DHSC will reach a decision on what information can be published in the NHS and the independent sector, and review whether existing programmes can achieve this or whether further action is needed from government to achieve these goals.

4. The GMC will review Good medical practice – their guidance on what it means to be a good doctor – specifically with respect to communicating effectively. Consultations on potential changes will take place in 2022.

5. The AoMRC, PRSB, IHPN and NHSEI have committed to write to their members to remind them of existing guidance on writing to patients, and will encourage them to use it in conjunction with the publication of this government response.

6. Over the next 12 months, DHSC will explore with providers how their systems can change to make the process of writing to patients easier for healthcare professionals and how this can be monitored.

7. DHSC will commission the production of a range of independent information to be published in 2022 about how the organisation of private care might differ from the NHS, which will be available to all patients, families and carers. Once this information has been published, DHSC will work with providers in both the NHS and the independent sector to ensure they are signposting this information as part of the general information patients receive about their care.

8. The RCSEng and GMC will publish materials to support the shared decision-making process between patients and medical professionals over treatments, and promote this through their regional and outlook teams, in winter 2021 to 2022.

9. DHSC will continue to work with NHSEI as it undertakes work with its improvement directorate to identify specific pathways where a period of reflection can be robustly supported. DHSC will also continue to work with NHSEI as it works towards digitising the decision-making and consent process.

10. NHSEI will work with the Winton Centre to develop a pipeline of decision support tools. The tools will help patients and clinicians come to an informed decision on the benefit and harm of available treatment options. The first tools will be published in winter 2021 to 2022 on the Personalised Care Institute website, with notification of publication taking place via NHSEI regional teams.

11. The IHPN will review the MPAF, including a review of the content on decision-making and consent processes. This work will be completed by September 2022.

Making challenge heard

12. NCIP will expand its operation to reach all NHS hospitals over the next 3 years across more surgical specialties.

13. ADAPt will be piloted in 2021 to 2022 to better align the collection and processing of data in the NHS and the independent sector, and assess the impact that a wider rollout could have. If the pilot is successful, there may be a recommendation to fully implement ADAPt in 2022 to 2023.

14. As CQC develops its updated regulatory model in line with its new organisational strategy from 2021, it will ensure that the assessment of compliance with up-to-date national guidance on MDTs continues to be a focus for the NHS and the independent sector.

15. GMC will update its guidance on supporting information for appraisal and revalidation so that, where clinical outcomes data is mentioned, the guidance will refer to ‘independently verified data, where available for the practitioner’s specialty’, and will publish best practice case studies (from NCIP, PHIN or IHPN) on using independently verified data as quality improvement activity evidence in appraisal and revalidation.

16. DHSC will work closely with the PHSO and ISCAS, as well as CQC, IHPN and others, to ensure that the new standards provide strong reinforcement of both regulatory requirements and best practice to NHS and independent sector providers about making a complaint to an independent body. The impact of this will be measured as part of the overall evaluation of the effectiveness of the NHS Complaint Standards that are being piloted. This will involve making sure that the pilot evaluation looks closely at this aspect of the Complaint Standards and that the final version of the standards contains strong references about the importance of informing patients about how they can escalate their complaint. The Complaint Standards will be refined following the pilots, with wider rollout towards the end of 2022 and into 2023.

17. CQC will strengthen its guidance on complaints processes to make clearer that they expect to see arrangements in place for patients to access independent resolution of their complaints, where appropriate, by spring 2022. Where a provider fails to comply with regulation 16 of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014, CQC will take appropriate enforcement action.

18. DHSC will keep independent resolution of complaints under review and, in the longer term, will work with CQC, IHPN and bodies such as ISCAS to explore whether and how current legislation could be amended to ensure all providers make provision for independent adjudication where PHSO’s remit does not extend to their care.

Ensuring accountability across the system

19. In the 2021 consultation regulating healthcare professionals, protecting the public, DHSC propose a specific duty to co-operate that will apply to all organisations concerned with the regulation of healthcare professionals; the employment, education and training of healthcare professionals; the regulation of health and care services; and the provision of health and care services. DHSC also propose to provide a consistent regulatory framework for fitness to practise across all professional healthcare regulators and to remove the 5-year rule. These proposed changes will enable faster resolution of cases and deliver public protection more quickly. DHSC plans to draft legislation in relation to the GMC in 2022.

20. DHSC is working on changes to the Medical Profession (Responsible Officers) Regulations 2010 to reduce patient safety risks identified in relation to the revalidation of doctors, and bring the regulations up to date to ensure they are fit for future use in the changing healthcare landscape. Any changes to the regulations will be subject to a consultation.

21. NHS Resolution will provide guidance to the system on exclusion, including publishing a checklist to support decisions to exclude. Guidance will be supplemented by case study examples and interactive training materials, and will be published in early 2022.

22. NHSEI plans to work with stakeholders to develop a Common Management Framework in line with its guidance on excluding medical professionals, which should be in place from summer 2023.

23. CQC will revise its assessment frameworks and provider assessment methodology to strengthen focus on patient safety and collaboration. CQC anticipate implementation will start in 2022.

24. NQB is updating its guidance on how information and intelligence is shared and acted upon by regulators. These changes will be produced and delivered in partnership with regional NHSEI teams, CQC, healthcare professional regulators, the PSA and other stakeholders. The guidance will also consider how the Quality Surveillance Groups model could extend to the independent sector.

25. PSA is conducting its project Bridging the gap, which looks at the structures by which regulators collaborate and share data and information.

26. A system or model to identify potential concerns based on CQC, GMC and NMC data is expected to be in operation by December 2021. While use of the current iteration of the Shared Data Platform is limited to analysis of maternity services and, for legal and contractual reasons, can only be accessed by the above 3 organisations, work is currently underway on the next iteration. It is expected that it will be a multi-purpose and expandable build, incorporating lessons learned from the first version.

27. DHSC is committed to continuing its work with NHS Resolution, key stakeholders and employers in the NHS to ensure the MHPS framework is brought up to date and strikes the right balance of protecting the safety of patients while treating practitioners fairly.

28. The IHPN will refresh their MPAF, completed by September 2022, to update its guidance on creating effective clinical governance structures, including the support of appraisal and responding to concerns. IHPN will continue to work with CQC and other stakeholders to ensure that the MPAF is being adequately used across the independent sector.

29. When next updating the NHS Standard Contract, NHSEI will consult on including a new requirement for non-NHS providers to have regard to the MPAF.

30. In the follow-up report, DHSC will evaluate the progress that has been made on adopting these recommendations and set out further steps, if necessary, should we find that there has not been sufficient progress in implementing the actions set out in this response.

Putting things right

31. The government will provide an update on the outstanding cases being reviewed by Spire in 12 months’ time.

32. The national recall framework will be published in 2022 on both NQB and IHPN’s websites.

33. Following its publication, CQC will consider the national recall framework as part of their new assessment process to ensure it has been adequately implemented by all providers.

34. DHSC will publish a summary of responses received to the previous consultation on appropriate clinical negligence for regulated healthcare professionals in early 2022.

35. DHSC will conduct a survey of healthcare professionals in early 2022 to help us understand their current indemnity and insurance arrangements, and assess the possible impact of different options.

36. DHSC will continue engagement with key stakeholders – such as patients, indemnity and insurance providers, clinical representative bodies, professional regulators and the devolved administrations – to understand their views on potential solutions for indemnity and insurance arrangements.

37. DHSC will consult on the detail and arrangements for implementing reform on indemnity and insurance arrangements, recognising that providers would need time to prepare for any changes.

38. NHS Resolution will continue to develop, publicise and evaluate their range of resources focused on signposting and helping to embed best practice with respect to making apologies within a just and learning culture. At every engagement with its members and every event that it hosts, NHS Resolution will promote the Saying sorry and Being fair guidance, as well as promoting and highlighting these resources on social media and other channels.

39. NHS Resolution will work with others across the safety system to develop resources to support clinicians in the provision of direct support for patients and families when an incident occurs, including modules on giving meaningful apologies within a learning organisation.

40. The new cross-system National Patient Safety Programme Board, chaired by DHSC, will take an overview of measures and actions across health services to improve patient safety and response to harm.

Conclusion

The inquiry report has highlighted the appalling behaviour and actions of one disgraced surgeon, whose malpractices caused suffering to thousands. However, it has also shone a spotlight on a healthcare system that failed to keep patients safe and subsequently let these victims down on many levels.

This inquiry has been a wake-up call to all healthcare providers. This response cannot lessen the suffering experienced by patients, their families and carers, but it does commit this government to:

• ensure that the inquiry’s findings and recommendations are heard and implemented
• galvanise processes in both the NHS and the independent sector to ensure that such events cannot happen again

This progress report highlights where action is being carried out or has already been taken to address the issues raised by the inquiry. We know that there is still more work to be done. Next year, DHSC will produce a follow-up report, updating on progress and addressing any outstanding issues across all the inquiry recommendations. It will set out a detailed plan for the continued implementation of our responses, to which we expect to be held to account.

We expect all relevant agencies and organisations, both nationally and locally across the whole healthcare sector, to implement the actions outlined in our responses.

Together, we must ensure that – regardless of where patients are treated and regardless of how their care is funded – all patients can be confident the care they receive is safe in a system that works for them.

Annex A – Programme Board and Task and Finish members

The following organisations were members of the Programme Board or Task and Finish groups who supported the preparation of this response. We thank them for their time and insight.

• Academy of Medical Royal Colleges
• Breast Cancer Now
• Care Quality Commission
• Competition and Markets Authority
• General Medical Council
• Independent Healthcare Providers Network
• Independent Sector Complaints Adjudication Service
• Macmillan Cancer Support
• National Consultant Information Programme
• National Guardian’s Office
• NHS Digital
• NHS England and Improvement
• NHS Providers
• NHS Resolution
• NHSX
• Private Healthcare Information Network
• Professional Record Standards Body
• Professional Standards Agency
• Public Health England
• Royal College of Surgeons England
• Spire Healthcare

• University Hospitals Birmingham NHS Foundation Trust