Policy paper

Government response to the independent inquiry report into the issues raised by former surgeon Ian Paterson: 12-month implementation progress update

Published 15 December 2022

This was published under the 2022 to 2024 Sunak Conservative government

Applies to England

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, you can 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 [email protected].

Circle Health Group (formerly BMI Healthcare)

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 speak to the Patients Association on 0800 345 7115 from 9:30am to 5pm Monday to Friday.

You can also email them at [email protected].

Ministerial foreword

The nation was rightly shocked and appalled by the horrendous malpractice of the former consultant surgeon, Ian Paterson, when the damage he had done became clear. Far too many patients and their loved ones were harmed by his actions and continue to live with the consequences of what Ian Paterson did to them.

Today, I want to reiterate the apology the government has made previously to all of those impacted, while acknowledging that no number of apologies will ever be enough to meet the level of pain you have been caused.

Ian Paterson has been made to feel the full force of the law. The General Medical Council (GMC) has struck him from the medical register, and he has been convicted and sentenced by the courts. However, the systems that should have protected patients failed. His actions came to light too late. He was allowed to inflict harm for too long. There was no doubt that it was incumbent on us all to repair the system to prevent this from ever happening again.

That is why the independent inquiry into Ian Paterson’s malpractice was initiated – to hear the stories of hundreds of patients who were failed and to find ways to ensure these stories would not be repeated. The Right Reverend Graham James, Bishop of Norwich, produced a thorough and compelling report that challenged the government and all those involved in safeguarding our health system to do better. This is a challenge we have taken to heart.

In the government’s initial response to the inquiry’s findings, published in December 2021, we made clear that this government was committed to delivering real and lasting change across the NHS and the independent sector.

The government accepted the majority of the recommendations and made commitments to act on all the issues raised. Additionally, the government committed to an update in 12 months’ time to show that there was real progress achieved.

In this update, we set out the significant progress made to date in repairing the cracks in our health system that allowed Ian Paterson to escape notice for so many years. We commend all the organisations who have heeded this call to action and worked with us to deliver these changes.

Patients’ health, safety and wellbeing transcends service boundaries, and so too does our commitment to safeguarding it. Therefore, this is not work that stands in isolation, but as part of the government’s broader commitment to responding to areas where improvement is needed in our health system – irrespective of whether those areas are identified within the NHS, the independent sector or the interface between the two.

Alongside other inquiries, such as the Independent Medicines and Medical Devices Safety Review, we are ensuring the lessons of the past are learnt. We also know it was primarily women who were impacted by Ian Paterson, and this forms part of our broader work led by the government’s Women’s Health Strategy for England, which seeks to ensure our health service better serves women moving forward.

While the journey of strengthening the systems in place to protect patients is a continual one, we hope that the steps we have taken to date will help patients and their loved ones feel better protected.

Ian Paterson’s patients were failed. Through the work of the inquiry, the campaigning of the patient representatives and all the organisations that have been part of implementing its findings, we hope that no one should ever find themselves in a similar position in the future.

– Maria Caulfield MP

Introduction

Ian Paterson’s actions undermined the trust patients and those close to them have in our healthcare system. We must rebuild that trust by our actions to prevent the same harm befalling future patients.

Ian Paterson was trained as a general surgeon and later appointed as a specialist breast surgeon at multiple hospitals (both NHS and independent sector) in the West Midlands from 1993. While he was suspended briefly in 1996 and serious concerns were raised from 2003 onwards, he was not suspended from practice until 2011.

By this time, it was too late as thousands of people treated by Ian Paterson had been put in harm’s way. Many of them are living with the negative consequences of his malpractice, and all of them are living with the knowledge that the health system let them down.

In April 2017, Ian Paterson was convicted of 17 counts of wounding with intent and 3 counts of unlawful wounding. He was sentenced to 15 years in prison, increased to 20 years by the Court of Appeal for undue leniency. In July 2017, he was erased from the GMC medical register.

The independent inquiry into the issues raised by Ian Paterson was announced in December 2017 with Bishop Graham James appointed as its chair. This inquiry aimed to:

• give former patients of Ian Paterson and their families the opportunity to be heard
• inform an exploration of how the health system allowed such malpractice to go on for so long

The inquiry’s report was published in February 2020 and included summaries of the accounts from most of the 211 people who spoke to the inquiry about the treatment they or a loved one received. It also made 15 recommendations to the government and other organisations to improve protections for patient safety in the future.

The government’s response to the inquiry’s findings and recommendations was published in December 2021, delayed by the coronavirus (COVID-19) pandemic. In this response, the government reiterated its apology to those harmed by Ian Paterson and accepted the majority of the 15 recommendations. Additionally, the response set out an implementation plan of 40 actions that would be carried out, and committed to publishing an update report in 12 months’ time.

Paterson inquiry response – 12-month update

This 12-month update on the progress of implementing the government’s response to the Paterson inquiry aims to set out:

• the progress of the actions that were committed to in December 2021
• how these actions have positively impacted the health system

Thanks to the work of our partners across the health system, substantial progress has been made since December 2021. As was anticipated in the original implementation plan, there are many actions and programmes that are still ongoing but, in all these cases, there is tangible progress towards their goals. A small number of actions have not been delivered as anticipated but, where this is the case, we have ensured that there is progress on work related to the goals of those actions.

This report will set out the progress made to improve the health system along the lines drawn by the inquiry, organised into sections under the 4 themes of the government’s implementation plan from December 2021.

In addition, each section will note the impact these changes have had on the health system, and where there remains ongoing activity – whether to complete the actions from the previous response or to ensure the monitoring and evaluation of actions already taken.

Finally, at the end of each section, a table will show explicitly the progress against each of the actions from the 2021 response and Annex B will detail the progress made against the inquiry’s original 15 recommendations.

Patient engagement

The independent inquiry made patient experiences central to the evidence they collected and the findings they reached. Similarly, the government’s response has aimed to focus on the patients impacted by Ian Paterson. None of this work would have been possible without the courage and strength of the patients who spoke out and shared their experiences. They have taken the harm that was caused to them and campaigned selflessly to prevent other patients from facing the same treatment.

We are so thankful to all the patients, as well as their families and carers, who have stepped forward to contribute to the inquiry and subsequent work.

After conducting an intensive series of roundtables with representatives of patient groups prior to the publication of the government’s response to the inquiry report in December 2021, we have continued to engage regularly with these representatives on progress to date. We thank them for the time they have been willing to give towards informing the government’s work.

Additionally, patient engagement was conducted with a wider group who were not patients of Ian Paterson, thanks to the Academy of Medical Royal Colleges (AoMRC). It was useful to gain insight into the thoughts of patients with other experiences of the healthcare system and their priorities, and we thank all the participants.

Implementation of the action plan

The December 2021 update’s implementation plan has been the guiding set of actions we have sought to progress in the last 12 months.

At the time, we set them out according to the 4 themes we had identified among the inquiry’s findings and recommendations:

• providing patient-centred information
• making challenge heard
• ensuring accountability
• putting things right

These themes also formed the basis of work undertaken this year to ensure progress was being made and provide the format for this update. Due to the nature of the malpractice carried out by Ian Paterson, both the inquiry’s findings and the actions to implement its recommendations focus on acute secondary care.

The Paterson Inquiry Response Programme Board continued as the main governance body for this work with stakeholders from across the healthcare system represented and meeting every 2 months.

In addition, more focused task and finish groups (TFGs) were held on the same timescale to allow for in-depth discussion on specific actions – one TFG for each of the 4 themes of the government response. The members of the programme board and TFGs are listed in Annex A below.

We thank all of those who have engaged in this process for their commitment to driving forward progress and dedication to improving patient safety.

Through working to implement these actions, we have ensured they are clearly owned and embedded into the responsible organisations. We have also helped to build relationships across the NHS and independent sector so that the health system is considered ‘one system’, and can identify and tackle patient safety issues together.

Summary of progress

Patient-centred information

Patients now have more access to information relevant to their treatment than they did during Ian Paterson’s time practising. This includes access to information about the performance of consultants working for independent sector healthcare providers, and specialties in the NHS. These continue to be added to, so patients will have more – and better – access to independent information before choosing a consultant.

NHS England (NHSE) will work with the professions so that meaningful consultant-level information on the numbers and types of procedures performed should be made publicly available.

If patients choose to be treated in the independent sector, there is now more information about what to expect with further information to be made available over the coming year.

Patients now have the right to access their treatment records and clinicians are aware of the need to write to patients directly following a consultation or treatment, rather than only writing to their GP. This information gives patients a record of their condition and test results to reflect on, or to seek a second opinion if required.

This is reinforced by ensuring patients get the time they need to consider treatment options and have access to a range of new resources to help them consider their options – options that patients will also be able to discuss with medical professionals who are equipped to handle these conversations.

Making challenge heard

Doctors across more specialties now have independent data on their practice available, and will be required to use this as part of their appraisal and revalidation processes. This will help to identify issues and fix them.

Staff in the health system also have more opportunities to make their voices heard about a patient’s care, including through clarified guidance and assessment of multidisciplinary team (MDT) use as a forum.

The Care Quality Commission (CQC) updated its guidance on complaints processes in early 2022. It is now easier for patients to raise concerns about treatment they receive and access independent resolution of their complaint if they are unsatisfied with the provider’s handling.

As part of the implementation of the NHS patient safety strategy, NHSE has introduced measures to advance safety and the response to harm.

The government appointed the first ever Patient Safety Commissioner for England, Dr Henrietta Hughes OBE, in September 2022.

Ensuring accountability

CQC published the new single assessment framework in July 2022, which sets out what good care looks like, and the National Quality Board (NQB) published National Guidance on System Quality Groups (SQGs) setting out the requirements for quality governance in integrated care systems (ICSs). NHS Resolution launched new exclusion guidance in April 2022.

Alongside this, we have seen significant culture change in the independent sector, now leaving no doubt that independent providers must take responsibility for maintaining high standards of care in their facilities, irrespective of how the medical professionals involved are engaged by them (through employment or practising privileges).

This has been supported by the Independent Healthcare Providers Network’s (IHPN) refresh of the Medical Practitioners Assurance Framework (MPAF) in September 2022.

The 2022 to 2023 version of the NHS Standard Contract now requires independent sector providers delivering NHS-funded care to have regard to the MPAF as one of its conditions.

Putting things right

Patients who are impacted by potential issues with their care will be reviewed through recall processes that are now better informed of how to put patients at the centre of their focus. The new National Patient Recall Framework was published in June 2022 to facilitate this.

Patients will continue to receive apologies from healthcare professionals and providers for potential issues with their care when appropriate. Enhanced training and resources, such as an animation produced by NHS Resolution to explain the duty of candour, are now available to clinicians to ensure these apologies are delivered effectively and meaningfully.

The government is working to ensure that any future changes to indemnity and insurance arrangements will be made using the best evidence base available. This includes a thorough assessment of the impact on patients, healthcare professionals, providers and the wider market – with the aim of improving the position for patients when receiving treatment from any regulated healthcare professional, regardless of the setting.

The government’s ambition is that, when this work concludes, patients have confidence that they can access appropriate compensation if harmed while receiving care, including when harm arises from criminal or intentional acts or omissions.

Patient-centred information

Patients, their families and carers need to have the relevant 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.

Patients now have more access to information relevant to their treatment than they did during Ian Paterson’s time practising.

For example, patients now have access to information about the performance of consultants working privately, and particular specialties in the NHS. These continue to be added to so patients will have more – and better – access to independent information before choosing a consultant.

If patients choose to be treated in the independent sector, there is now more information about what to expect with further information expected to be made available over the coming year.

Patients also now have the right to access their treatment records and clinicians are aware of the need to write to patients directly following a consultation or treatment, rather than only writing to their GP. This information gives patients a record of their condition and test results to reflect on, or to seek a second opinion if required.

This is reinforced by ensuring patients get the time they need to consider treatment options and have access to a range of new resources to help them thoroughly consider those options – options that patients will also be able to discuss with medical professionals who are better equipped to handle these conversations.

The patients impacted by Ian Paterson’s malpractice told the inquiry that they were let down at several stages by not having the necessary information to make informed decisions.

This included a lack of information about:

• medical professionals – the inadequate provision of information on the acting medical professional meant patients had to simply trust Ian Paterson’s reputation
• how the health system works – the inadequate provision of information on how the health system works meant that patients only learnt important details when they were suddenly confronted by them
• their own condition and the options for their care – the inadequate provision of information on patients’ own condition and care options meant they had to trust in what Ian Paterson told them, without the opportunity to consider for themselves or get a second opinion

Without the above information, patients and those close to them were left feeling that they had made poor decisions that led to the problems they were facing when, in reality, they had been failed by a system that never gave them the opportunity to make informed decisions for themselves.

The government committed to ensuring that patients, families and carers had more information, and this information was accessible to them. Over the last 12 months, we have been working to ensure more information is available about:

• consultants and their abilities or performance
• a patient’s condition
• available treatment options

Information about consultants and their abilities or performance

To empower patients to make informed evidence-based decisions, the inquiry recommended that independent information about the abilities and performance of consultants should be accessible to the public. Our ambition is that patients have access to information that is meaningful to them. The government has been working with NHSE and the independent sector to progress this.

In the independent sector, the Competition and Markets Authority (CMA) has mandated the submission of data on both providers and consultant activity and performance to the Private Healthcare Information Network (PHIN) under the Private Healthcare Market Investigation Order 2014.

PHIN is an independent organisation that was approved by the CMA to publish the data it receives in a way that is accessible to the public, and can help patients to make informed decisions about where they receive care and from which consultants.

The CMA mandate is extensive, covering but not limited to:

• volumes of procedures
• average lengths of stay
• readmission and revision surgery rates
• mortality rates
• information on patient satisfaction
• frequency of adverse events

PHIN already publishes data on its website covering areas including:

• volume and length of stay
• adverse events
• infections
• patient feedback

In July 2022, PHIN published its Roadmap and delivery plan 2022 to 2026 for the Private Healthcare Market Investigation Order 2014 to meet the rest of the mandate it was given by the CMA.

The plan notes that significant progress has been made across the independent sector, and data on volume, length of stay and patient feedback is already published at consultant level. However, the plan also recognises that full delivery of the CMA mandate has not yet been achieved and there is still more to do.

In October 2022, the CMA warned it will take enforcement action against those private healthcare providers that have not been providing prospective patients with clear and consistent information, and therefore are in breach of the order.

The Health and Care Act 2022 includes provision that 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. Cross-system work is underway to understand how these powers could be harnessed to improve reporting and collection in a way that puts the needs of patients and their families first – actively improving patient safety and confidence in the process.

Ongoing work is determining how further measures set out by the CMA can be published at consultant level in a way that is helpful and accessible to patients. This includes considering where case-mix adjustments may be appropriate to ensure data is given proper context. PHIN’s delivery plan sets out the ambition for the final publications to include information on whether infection rates, readmission rates, mortality rates and frequency of adverse events lie within normal ranges or are outliers.

With this framework in place to ensure publication of performance data in the independent sector, the government and NHSE committed last year to working together on what information could similarly be published about care delivered within the NHS.

The Clinical Outcomes Publication initiative already provides some detailed performance information online for a range of specialties. Data used by this initiative, which is owned by NHSE and managed by the Healthcare Quality Improvement Partnership, comes from clinical audit programmes and is currently published on a range of websites, collated as data on specialty treatments via the NHS website.

Clinical Outcomes Publication data is a useful initiative and, particularly in some specialties, already provides detailed consultant-level information. However, we know it is not a comprehensive programme across specialties, and that the data is not presented in a way that is accessible to largely non-specialist audiences like patients and those close to them.

To drive improvements in quality and patient safety, NHSE is committed to developing consultant-level information. Initially, these outputs should be shared within the profession and enable peer review within the health system. NHSE will work with the professions so that meaningful consultant-level information on the numbers and types of procedures performed should be made publicly available.

This data will come from a new NHSE Outcomes and Registries programme, which will improve:

• the collection of clinical data
• quality assurance
• validation near to the episode of care

This programme of work will enable the NHS to meet its ambition to publish data at consultant and unit level on the number of procedures performed and the types of procedures. Further announcements about this programme will be made in the coming months. More detail is covered in the section on ‘Making challenge heard’ below.

There was an additional specific recommendation from the inquiry to bring together the locations where a consultant is employed or works under practising privileges, where there is an agreement granting them permission to work for a private healthcare provider, so that organisations have a regularly updated record of a consultant’s whole practice. Future development of the NHS Digital Staff Passport programme may offer an opportunity to support this.

The Digital Staff Passport is being developed and is expected to be in its second testing stage in December 2023, with a limited number of NHS organisations covering a limited number of scenarios. The Digital Staff Passport’s technology does present the opportunity for consultants to be issued with verified, tamper-proof and portable records of their practising privileges, with NHS providers and private healthcare companies potentially able to verify their validity as often as required. Expansion of scope to enable this capability is subject to future funding.

NHSE will continue to work across the health system with stakeholders such as PHIN (as a potential source for practising privilege information), the Department of Health and Social Care (DHSC), IHPN and GMC.

Information about a patient’s condition

Ian Paterson’s patients were unable to make informed decisions about treatment options. This was due to the:

• pressure they were put under to make decisions quickly
• inaccurate information they were given about their condition
• lack of information with which to get a second opinion or further details

The inquiry’s recommendations sought to address each of these difficulties.

The government and the health system fully support the inquiry’s recommendation that patients should directly receive a letter from their consultant providing details about their condition and care that they can easily understand. They should not just be copied into a letter written for a GP. In December 2021, alongside the publication of the government’s response to the inquiry, the AoMRC, the Professional Record Standards Body (PRSB), IHPN and NHSE wrote to its members to remind them of the best practice in this regard, pointing to the AoMRC’s Please, write to me: writing outpatient clinic letters to patients guidance.

While there is widespread support to make this change, it requires a cultural shift within the medical profession. We acknowledge that many patients are still not receiving these letters. NHSE is considering options for implementing a new project to drive this culture change, dependent on identifying the appropriate resources to achieve this successfully.

The ability to view health records through NHS IT services, including the NHS app, has helped to make information for patients more accessible. As of September 2022, patients had viewed their online records over 35 million times and 68% of adults had registered for the NHS app, according to the Patient Online Management Information dashboard.

In addition, the CMA order described above has required, since 2018, for independent practitioners to send letters to patients prior to consultations setting out estimated cost, potential conflicts of interest and other relevant information. They must also provide letters prior to further tests or treatment giving reasons for the procedure in question, an estimate of cost and other relevant information.

The CMA provides informal guidance and works with providers to ensure their template letters are accurate. Providers must get patients to confirm that they have received this information. This provides additional important context for patients in making treatment decisions in the independent sector.

GMC publishes Good medical practice, which details the duties of doctors in the UK. Communicating effectively with patients is one of the core duties. Throughout 2022, GMC has undertaken a review of Good medical practice, including its guidance on communicating effectively with patients. The inquiry’s work has informed this review. The updated version of Good medical practice is due to be published in 2023.

Information about treatment options

It is not enough to give patients information about their condition. Medical professionals must engage patients in a shared decision-making process to allow patients to make informed decisions about their own treatment and care. Ian Paterson was reported to bully patients into a particular course of action – we must ensure this does not take place in our health system today.

In September 2022, the government announced Our plan for patients. The plan commits to informing and empowering patients to play a full part in decision-making about their health and treatment. This includes a commitment to support all NHS trusts to put electronic patient records in place by 2025.

In line with the recommendation of the inquiry, NHSE committed in its delivery plan for tackling the COVID-19 backlog of elective care to require all providers to adopt 2-stage shared decision-making across all their admitted non-day case pathways by April 2023 and all admitted pathways by April 2024. This action introduces a short period of reflection for patients to decide on treatment and give their consent, letting patients take time to fully understand the benefits and risks of treatment, and choose the most suitable option for them.

While this change meets the direct recommendation made by the inquiry, we know that ensuring shared decision-making is embedded into our healthcare system requires much broader action. NHSE has set up a Shared Decision-Making Board to take forward work ensuring this is an important part of how the NHS operates. IHPN, on behalf of independent sector providers, is included in this work and will share information with its members.

One component of this work is the provision of decision support tools. In July 2022, 11 of these decision support tools initially became available on the NHS website. Each tool covers a specific condition, setting out the treatment options that are available, and the different potential benefits and risks each offers. They:

• give prompts to help patients think about which considerations are most important to them
• provide statistics about the potential outcomes
• discuss the experience the patient is likely to have undergoing each treatment option
• signpost to further information available from expert sources

Eight more of these tools focused on national policy priorities of elective care and maternity will become available in April 2023.

IHPN will work with NHSE, the Royal College of Surgeons of England (RCSEng) and other key stakeholders to make sure that the principles of shared decision-making are the same across independent and NHS-delivered care.

In June 2022, the PRSB published a standard to enable the information from shared decision-making conversations to be captured in a consistent way across the NHS and independent sector. This work, commissioned by NHSE, will enable shared decision-making to be more consistently and rigorously implemented, using evidence gathered by PRSB from its consultations and research in putting this standard together. It will also enable a patient’s decisions to be more effectively shared, as appropriate, between medical professionals and providers to improve the consistency of care experienced by the patient.

RCSEng and GMC are working on materials to support the shared decision-making process between patients and medical professionals. Workshops have been ongoing through 2022 to develop and test these materials. The resulting materials are expected to be published following the publication of the updated Good medical practice guidance in 2023. These will then be promoted through regional and employee liaison services and, specifically for surgery, through RCSEng. IHPN will also promote these materials with its members.

In the independent sector, the IHPN framework for clinical governance, the MPAF, has been refreshed. The MPAF was designed to help foster a more standardised approach to medical governance in the independent sector, and drive even further improvements in safety and quality. It is relevant for all organisations that engage medical practitioners, albeit through practising privileges or an employed model.

CQC also now uses the framework’s principles in assessing how well-led an independent service is, with the framework a requirement of the 2022 to 2023 NHS Standard Contract, which all independent sector providers of NHS-funded care must adhere to.

The refresh includes a specific review of the content on decision-making and consent processes. The framework now makes clear that independent providers must have clear policies around consent and decision-making, including:

• which professionals should be involved
• the need to provide full and independent information to patients about risks, benefits and alternatives
• the need to give appropriate time for decision-making
• detail on how these decisions are documented

IHPN has committed to continue to work across the sector to share best practice in this area.

Information about a patient’s treatment options must also include information to help patients decide whether to seek treatment in the NHS or the independent sector. The inquiry noted a lack of understanding around the differences in how these sectors operate and the need for further information for patients to be produced.

The government will work with stakeholders to produce and publish information on the difference in how care is organised between the NHS and independent sector to be delivered during 2023. This is supplemented by an animation, published by IHPN in conjunction with the Patients Association around how the independent sector works and what patients should expect. IHPN has also committed to produce resources for independent providers to share with patients on safety and governance in the sector, including key questions to ask their provider and/or consultant.

Person-centred care is one of CQC’s fundamental standards that all registered healthcare providers must comply with. This includes:

enabling and supporting relevant persons to make, or participate in making, decisions relating to the service user’s care or treatment to the maximum extent possible.

CQC will continue to assess providers to ensure this fundamental standard is being met.

Ongoing actions

NHSE will work with the professions so that meaningful consultant-level information on the numbers and types of procedures performed should be made publicly available.

PHIN is implementing its plan to fulfil the CMA mandate by 2026, as published.

NHSE is continuing developmental work on the Digital Staff Passport with stakeholders such as PHIN, DHSC, IHPN and GMC, expected to be in its second testing stage in December 2023.

The GMC review of Good medical practice is underway with new guidance set to be published in early 2023.

Two-stage decision-making is being implemented in the NHS across all admitted non-day case pathways by April 2023 and all admitted pathways by April 2024.

Eight more decision support tools focused on national policy priorities of elective care and maternity will become available in April 2023.

IHPN will work with NHSE, RCSEng and other key stakeholders to make sure that the principles of shared decision-making are the same across independent and NHS-delivered care.

RCSEng and GMC will publish materials to support the shared decision-making process between patients and medical professionals over treatments in 2023.

IHPN will be producing resources for independent providers to share with patients on safety and governance in the sector.

DHSC will work with stakeholders to produce and publish information on how the organisation of private care might differ from the NHS for publication in 2023.

Progress against 2021 implementation plan

Note: NHS England and Improvement (NHSEI) became NHS England (NHSE) in July 2022, but in the table below we have retained the original wording of the actions from the 2021 implementation plan.

Action	Progress
DHSC will work with NHSEI, IHPN and PHIN to explore options for using the framework of the NHS Digital Staff Passport or other means as a mechanism for holding key consultant-level information, such as employment and practising privileges.	The Digital Staff Passport is being developed and is expected to be in its second testing stage in December 2023. The passport has the potential in the future to receive verified information on consultants’ practice privileges, but this is subject to future funding.
PHIN will set out a 5-year plan in 2022 to implement the remaining publication of information about private consultants, which it has been mandated to complete for the period 2022 to 2026.	PHIN has published its plan for 2022 to 2026, which has been signed off by the CMA, and is now proceeding to implement it.
Over the next 12 months, DHSC will reach a decision on what information can be published in the NHS and independent sector, and review whether existing programmes can achieve this or further action is needed from government to achieve these goals.	NHSEI will work with the professions so that meaningful consultant-level information on the numbers and types of procedures performed should be made publicly available.
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.	The review of Good medical practice is on track to be completed in 2022 with new guidance published in early 2023.
The AoMRC, PRSB, IHPN and NHSEI have committed to write to their members to remind them of guidance on writing to patients and will encourage them to use it in conjunction with the publication of this government response.	This was completed in December 2021 by IHPN, PRSB, AoMRC and NHSEI.
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.	NHSE is considering taking a project forward to drive culture change in this area, dependent on the availability of the necessary resource.
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 that 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 independent sector to ensure they are signposting this information as part of the general information patients receive about their care.	DHSC will work with stakeholders to produce and publish this information in 2023. This would then be signposted to patients.
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 or outlook teams in winter 2021 to 2022.	Materials have been developed through workshops and will be published in 2023. These will then be promoted by GMC and, specifically for surgery, through RCSEng.
DHSC will continue to work with NHSEI as it works with its Improvement Directorate to identify specific pathways where a period of reflection can be robustly supported. DHSC will also continue to work with NHSE as it works towards digitising the decision-making and consent process.	NHSE has set up a Shared Decision-Making Board to take forward this programme of work. Two-stage decision-making is being implemented in the NHS across all admitted non-day case pathways by April 2023 and all admitted pathways by April 2024.
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 benefits and harms of available treatment options. The first tools will be published in winter 2021 to 2022 on the Personalised Care Institute webpages, with notification of publication taking place via NHSEI regional teams.	NHSE has constituted a team within the personalised care group to lead the work programme on 2-stage decision-making. A core component of 2-stage decision-making is the provision of decision support tools. An initial tranche of 11 tools became available in July 2022 on the NHSE and Personalised Care Institute webpages. Eight more tools will become available in April 2023.
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.	The MPAF refresh was published in September 2022 including a new paragraph specifically on consent processes.

Making challenge heard

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

Doctors across more specialties now have independent data on their practice available, and will be required to use this as part of their appraisal and revalidation processes. This will help to identify issues and fix them.

Staff in the health system also have more opportunities to make their voices heard about a patient’s care, including through clarified guidance and assessment of MDT use as a forum or through the many new ways they can raise concerns.

It is now easier for patients to raise concerns about treatment they receive and access independent resolution of their complaint if they are unsatisfied with the provider’s handling.

Ian Paterson did not face sufficient challenge to his work to stop his malpractice at an early stage. This was due to a lack of opportunities for challenges to be raised and raised issues being resolved inadequately.

Being appropriately challenged is an important mechanism for scrutiny, self-development and continuous improvement in any field, particularly in the medical profession. We all rely on medical professionals to have up-to-date expertise and to exercise good judgement to deliver the highest possible quality of care. Responding to challenge should serve the dual purposes of stopping behaviour that is harming patients and enabling all professionals to continuously improve.

Three avenues through which improvements needed to be made to how medical professionals faced challenge in their work were identified:

1. Making better use of existing data to strengthen appraisal and revalidation processes, and for performance management.
2. Hearing and acting on challenge from colleagues and others within the health system.
3. Hearing and acting on challenge from patient complaints.

Making better use of existing data to analyse whole consultant practice

The inquiry recommended that critical consultant performance data be collated and mandated for use by managers and professionals across the health system. This would provide an independent basis to perform appraisals, revalidation and performance management – based on the quantitative evidence of performance, which may highlight issues that are not otherwise apparent. This practice would:

• flag issues where a consultant is unaware of a problem
• allow them to learn and correct this
• identify rarer cases where a consultant is wilfully engaging in malpractice, such as Ian Paterson

National programmes such as Getting it Right First Time and the National Consultant Information Programme (NCIP) have shown that better use of existing Hospital Episode Statistics data sets can be useful in detecting practice outliers. This is by combining reviews of current data by clinicians with more detailed practice-level comparative analysis of re-admissions, recurrence, diagnosis, procedure and follow-up rations.

Furthermore, the Acute Data Alignment Programme (ADAPt) has also successfully demonstrated that NHS and private admitted patient care data can be linked to provide a view of consultant full practice, and can capture complete patient pathways and outcomes.

NCIP is an NHSE programme that aims to support NHS consultants with learning and self-development by providing an online portal giving consultants access to their personal activity and performance metrics. The portal allows consultants to review their activity and patient outcomes against local and national benchmarks. Further to this, NCIP aims to provide information to managers and healthcare professionals across the system to help support learning, perform appraisals and identify outliers. Effective use of this tool enables consultants to identify areas for improvement and support their appraisal.

In 2021, we reported that NCIP operated in 42 trusts for urology and was piloted across 17 trusts for up to 8 surgical specialties. As of November 2022, NCIP is live in 104 trusts (77% of all total national trusts) across at least one specialty, with 11 surgical specialties being actively implemented.

NCIP is on track to meet the original commitment of reaching all NHS hospitals over a 3-year period, including across more specialties. The programme is continuing to tackle issues with technology, data and utilisation, specifically ensuring that all procedures are attributed to doctors accurately to ensure the insight they provide is robust.

NCIP works exclusively within NHSE and on NHS consultant activity. It is important to ensure similar insights are available in the independent sector. As previously stated, PHIN is the body responsible for collating and publishing data in the independent sector that may be useful to contribute to performance management.

PHIN has worked alongside NHS Digital to jointly lead ADAPt, which aims to move towards a common set of standards for data collection, performance measure methodologies and reporting systems across the NHS and independent sector.

Phase one on co-operation – ensuring shared understanding of the aims of the work – and aligning systems was completed in the period 2018 to 2020.

Phase 2 consisted of 3 pilot programmes to test how data could be effectively shared between NHS Digital and PHIN, and what benefits there may be from combining these data sets for service delivery and patient care.

Pilots 1 and 3 completed in July 2022 (pilot 2 is still to complete) and a report on these pilot programmes has now been published, concluding that this data sharing has “obvious value”.

As a result, ADAPt is now preparing to enter its phase 3, where it will aim to achieve broader alignment in data collection and use across the 2 sectors.

ADAPt and NCIP facilitate the provision of robust data for managers and healthcare professionals to assess the performance of consultants, and identify outliers and opportunities for improvement when necessary. GMC has committed to updating 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.

GMC will also publish best practice case studies (from NCIP, PHIN or IHPN) on using independently verified data as quality improvement activity evidence in appraisal and revalidation.

The supplementary guidance will be updated in 2023 following the wider review of the Good medical practice guidance. IHPN has included reference to use of these data sets as part of its refresh of the MPAF, specifically with respect to the granting and reviewing of practising privileges.

NHSE has an objective to publish comprehensive data at consultant level on the number of procedures performed and the types of procedures. There are, however, data quality and completeness issues with Hospital Episode Statistics data sets that undermine reporting accuracy in different ways and to varying degrees in each specialty or procedure. These issues include:

• the lack of universal recording of NHS numbers in the private data
• unreliable attribution of activity to consultants
• cross-border data and patient flow issues

Interpretation of whole-sector activity will therefore, in the short term, need to be adjusted to allow for these issues while data quality is improved at source over time.

Outcome registries have emerged internationally to address gaps in patient outcome and clinical data that are not collected in existing clinical systems, but that are needed to assure patient safety and improve quality of care. Outcome registries are also emerging as the means to enable learning health systems to address systemic issues, such as medical device issues, medicine safety, and the increasing demand for real-world data for innovation, evidence and evaluation. 

Exemplar UK registry data collections have demonstrated a path to improved clinical data submission, quality assurance and validation near to the episode of care. They offer the opportunity to address limitations in the current data sets in areas such as:

• clinical coding
• consultant attribution
• clinical data validation
• medical device or medicine attribution

We are fortunate to have exemplar registries with world-leading expertise. There are already over 600,000 patients a year being recorded in exemplar registries, providing a springboard to improved data quality.

These outcome registries enable:

• improved clinical feedback data for direct care and performance appraisal
• comparative measures and analysis with which to detect emerging quality and safety signals
• improved data linkage, reporting and access – for example, for whole consultant practice analysis, performance appraisal or patient safety and outcomes analysis
• patient-reported outcome and experience data with structured and unstructured patient feedback about the quality of their care, further enhancing the utility and sensitivity of the resulting registry data set

A new NHSE Outcomes and Registries programme is addressing these issues, and is prioritising specialties, pathways and procedures for coverage. It will create a sustainable route to collecting improved clinical data once and in as automated a way as possible, while being flexible enough to accommodate the challenges of variable provider digital maturity.

When a registry is implemented, close-to-event clinical data validation by healthcare providers will be made possible, resulting in a significant increase in data quality and confidence in reported numbers.

The objective is to increase outcome registry coverage to over 80% of high-risk procedures within the next 3 years, where current priority specialties or therapeutic areas include implant and surgical procedures in the following specialties:

• musculoskeletal (including joint reconstruction, trauma and spinal)
• cardiology
• cardiac surgery
• vascular surgery
• interventional radiology
• ear, nose and throat (beginning with a new cochlear implant registry)
• urogynaecology and colorectal surgery (including pelvic floor)
• breast and cosmetic implant surgery
• urology
• neurosurgery
• neurology

Developments at a sub-national, national and UK level are underway, and include both NHS and independent sector providers.

This programme of work will enable the NHS to meet its ambition to publish data at consultant and unit level on the number of procedures performed and the types of procedures. Further announcements about this programme will be made in the coming months.

Challenge from within the health system

Ian Paterson did not work alone. As with all medical professionals, he worked in large teams with a range of staff who would have witnessed his malpractice. Yet many felt unable to speak out as they did not have the appropriate avenues to do so.

While some did speak up, their concerns were not appropriately handled. We know that serious concerns were raised as early as 2003, yet Ian Paterson continued to operate until 2011. Both barriers must be tackled.

MDT meetings are a forum where different members of staff should be able to speak up and prevent a single medical professional from pursuing an ill-advised treatment plan. These meetings play an important role in the treatment of a range of complex conditions.

This is especially true in cancer, where NHS Guidance for Cancer Alliances and the National Cancer Vanguard refers to care by an MDT as the ‘gold standard’. Holding an MDT meeting to review the care of cancer patients was mandated as far back as the National Cancer Plan in 2000.

Similar advice holds for a range of other conditions, with the National Institute for Health and Care Excellence (NICE) publishing guidance for many conditions recommending consideration by an MDT.

In the case of Ian Paterson, MDT meetings were being improperly held. The inquiry reported that there were occasions where meetings attended by Ian Paterson and one nurse who regularly worked with him were claimed as properly constituted MDT meetings – this is far from appropriate. The inquiry’s recommendation was for CQC to ensure all providers are complying with up-to-date guidance on MDT meetings.

CQC had already incorporated specific prompts on MDT working into its existing inspection frameworks that are used for inspection of NHS and independent acute hospitals. These prompts include detailed questions on the practical arrangement for MDTs with reference to appropriate national guidance. CQC is currently updating its regulatory model in line with its new organisational strategy. This update will ensure the continuation of effective monitoring of MDT use.

Through engagement with healthcare providers to ensure the implementation of this action, 2 additional areas for improvement were identified.

Firstly, while guidance for MDT use in cancer is clearly understood, there is a lack of clarity around the expectation for their use in the treatment of other conditions. We were told that clearer expectations of when an MDT was required would help to ensure consistency. As previously stated, NICE published guidance on best practice for treatment for essentially all conditions and many of these pieces of guidance reference the use of MDTs.

Secondly, there are challenges with the operation of MDTs within the independent sector. While some independent providers have the required range of staff to conduct their own MDTs, many do not and rely on their local NHS hospitals for the discussion of their patient cases.

As part of the sector’s work in response to the inquiry to ensure all hospital providers are complying with the latest MDT guidance, IHPN brought together a group of independent sector Chief Medical Officers and representatives from private medical insurers to share best practice, and help drive further improvements in this area.

Following this, IHPN will be developing further principles to support MDT working in the independent acute sector, which may, for example, include:

• which specialties or patient groups should be considered for MDTs
• governance arrangements
• audits

However, there will be times where a medical professional is engaging in malpractice and colleagues will have concerns that need to be further escalated.

The National Guardian’s Office and the role of Freedom to Speak Up Guardians were created in response to the Independent inquiry into care provided by Mid Staffordshire NHS Foundation Trust (known as the Francis report) to encourage and support workers to speak up.

As of July 2022, there were 288 Guardians across NHS trusts and foundation trusts, and 104 Guardians in other sectors including independent healthcare. The National Guardian’s Office has published guidance and training to help develop a culture where leaders and managers encourage workers to speak up, and matters raised by workers drive learning and improvement.

As part of the implementation of the NHS Patient Safety Strategy, NHSE has introduced a number of substantial measures to advance safety and the response to harm. This includes the new Patient Safety Incident Response Framework (PSIRF), launched in August 2022, which represents a significant shift in the way the NHS responds to patient safety incidents.

The PSIRF codifies the NHS’s new approach to managing patient safety, which puts raising concerns and taking a system-wide view of learning from mistakes at its core – as opposed to a simplistic focus on individuals as the cause – creating a culture where staff and patients feel able to speak up in confidence. It will also ensure compassionate engagement and involvement of patients and families, and clear communication of the learning outcomes that are taken forwards to prevent harm to others in the future.

Organisations that deliver NHS care are expected to transition to the new framework by autumn 2023, and it is a contractual requirement under the NHS Standard Contract that applies to all providers delivering acute NHS services, whether an NHS body or an independent provider.

A new national NHS Learn from patient safety events (LFPSE) service is in the public beta phase as a central service for the recording and analysis of patient safety events that occur in healthcare. The service will facilitate the generation of new insights and learning to help prevent future harm to patients. A patient-focused discovery phase will begin in spring 2023, enabling NHSE to explore the potential for patient experiences to inform and improve the recording of and response to patient safety events.

The Framework for involving patients in patient safety clarifies how organisations should appoint and support Patient Safety Partners (patients, carers, family members or other lay people) to be involved in wider governance and leadership of safety activities. The framework is important for:

• improving general safety
• addressing specific safety challenges faced by certain groups of people
• reducing inequalities in the delivery of healthcare

It is expected that NHS trusts and integrated care boards will have 2 patient safety partners on their safety-related clinical governance committees by autumn 2022.

Challenge from patients

While we always aim to prevent issues from impacting patients, a patient complaining about the treatment they have received is the final line of defence in protecting other patients from receiving similar treatment in the future. Patients must be able to easily find out about their right to complain and how to do so.

The inquiry found that patients often did not know about their right to escalate a complaint for independent resolution if they are unhappy with how it was resolved by the provider – in the case of NHS-funded care, by the Parliamentary and Health Service Ombudsman (PHSO).

The inquiry also found that independent sector patients did not know of the option to access independent resolution from a subscription service, commonly the Independent Sector Complaints Adjudication Service (ISCAS) and, in several cases, the provider in question was not subscribed to such a service, meaning this option was not available.

It is important that patients can raise complaints easily and have them appropriately dealt with in the first instance, as well as knowing that they have the option for independent resolution should they be unsatisfied with that first step. The government and our partners in the health system have been working to make improvements in all these areas.

Under health regulations, there are a set of fundamental standards (set out in the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014). These are the standards below which a patient’s care should never fall. All registered healthcare providers – NHS or independent sector – must comply with these standards, which are monitored by CQC.

One of these standards is the right to be able to complain about care or treatment provided. All providers must have a system in place to handle and respond to complaints, and they must investigate thoroughly and act if problems are identified. This includes ensuring that information on how to complain is available and meets accessibility requirements. CQC will continue to assess providers to ensure this fundamental standard is being met.

To improve the handling of complaints within the health system, PHSO has been piloting the NHS Complaint Standards. These set out how all organisations providing NHS services (whether NHS or independent sector) should approach complaint handling. The NHS Complaint Standards are based on a set of expectations that:

• outline what patients expect to see when they make a complaint about services
• describe how staff can meet these expectations

This pilot will complete by the end of 2022 ahead of full implementation in 2023.

As well as applying to independent sector providers who provide NHS-funded care, these standards have been incorporated by ISCAS into its Code of Practice for Complaints Management and significant effort has been undertaken to engage independent providers in these new standards. An independent provider is included in the pilot programme and outreach to these providers has led to an increase in the number joining the PHSO community of practice.

The inquiry specifically addressed signposting and access to independent complaints resolution mechanisms. NHS-funded patients have access to PHSO for this purpose, and the new NHS Complaint Standards make clear how providers must correctly signpost independent complaints resolution processes. These standards extend to NHS-funded care delivered by independent sector organisations, but do not extend to privately funded care.

In the December 2021 response, the government committed to reviewing access to independent resolution for patients being treated in the independent sector. Subscription to a complaints resolution service such as ISCAS is currently voluntary, but organisations across the health system agree that this is best practice. Since 2021, CQC has strengthened the guidance for providers on regulation 16 relating to the fundamental standard of being able to raise a complaint to clarify that there is an expectation that patients should have access to independent resolution, and that providers who do not provide such a mechanism must be able to show that patients are not disadvantaged by this.

To assess the proportion of patients who do not have access to independent resolution, the government reviewed the published data from PHIN and ISCAS.

The findings showed that 94% of patient episodes included in the PHIN data were provided by a provider subscribed to ISCAS – meaning that almost all private sector activity (based on what is reported to PHIN) provides patients with an option for independent complaint resolution. This rose to 98% of patient episodes when only considering independent sector providers specifically.

The remaining providers covered by the data are NHS private patient units (PPUs) – private treatment facilities run by NHS trusts. A minority of patient episodes delivered in PPUs were delivered by providers subscribed to ISCAS. Patients in a PPU do not have access to complaints resolution through PHSO and these sites should therefore be subscribed to a complaint resolution service as best practice. CQC has written to NHS PPUs to clarify this situation and ensure they understand it is best practice for them to subscribe to a resolution service.

More targeted action is being taken to increase uptake of independent resolution by NHS PPUs, where most of the patient episodes not covered by ISCAS resolution occur. ISCAS, alongside PHSO, seeks to pilot its service with 2 NHS PPU sites as a demonstration of best practice in how resolution can be incorporated by NHS PPUs. ISCAS is engaging with NHS PPUs across England to increase the number subscribing to independent resolution.

As a result of these findings, we have determined that it is not necessary to change legislation relating to independent complaints resolution, given that 98% of patient episodes in the independent sector are covered by ISCAS resolution. ISCAS continues to engage with providers who are not subscribed and the government will continue to monitor this progress. We expect the change in guidance from CQC will continue to encourage providers to subscribe.

Beyond the complaints system, the government has appointed the first ever Patient Safety Commissioner for England, Dr Henrietta Hughes OBE. Dr Hughes will be a champion for patients, ensuring patient voices are heard across the medical system (both NHS and privately delivered healthcare).

The role was instituted as part of the response to the Independent Medicines and Medical Devices Safety Review.

The Patient Safety Commissioner will be an independent point of contact for patients and will help the government and whole healthcare system to better understand what can be done to put patients first.

Ongoing actions

NCIP continues to implement its strategy of expanding its activity to more hospitals and specialties over a 3-year period.

ADAPt will aim to progress into its full implementation phase after completion of the pilot phase.

GMC will be publishing the updated version of Good medical practice in early 2023.

CQC will be rolling out its new regulatory model in 2023.

IHPN is developing further principles to support MDT working in the independent acute sector.

NHSE will continue to implement key initiatives from the NHS Patient Safety Strategy, including the LFPSE system and PSIRF.

NHSE will begin the patient-centred discovery phase of a new national LFPSE service in spring 2023.

NHS trusts and integrated care boards will have 2 patient safety partners on their safety-related clinical governance committees by autumn 2022.

The NHS Complaint Standards framework will be more widely rolled-out in 2023 after successful pilots are undertaken.

ISCAS and PHSO have agreed a plan to work together to promote increased uptake of independent complaints resolution by NHS PPUs.

Progress against 2021 implementation plan

Action	Progress
NCIP will expand its operation to reach all NHS hospitals over the next 3 years across more surgical specialties.	NCIP is now live in 77% of trusts across at least one specialty, with 11 surgical specialties being actively implemented.
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.	The ADAPt programme successfully completed pilots 1 and 3 during 2022 (pilot 2 is ongoing) and has published the findings from those pilot programmes. These findings have noted the usefulness of the programme, and have recommended progressing to phase 3 and broader rollout.
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 independent sector.	Following initial testing that began in 2022, CQC intends to start the full rollout of the new regulatory model in 2023. This will include the assessment of compliance with MDT guidance.
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.	The review of Good medical practice is on track to be completed in 2022 with publication in 2023. Following on from this, GMC will review the supplementary guidance as per this commitment.
DHSC will work closely with the PHSO and ISCAS, as well as CQC, IHPN and others, to ensure that the new complaints 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 to 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.	The NHS Complaint Standards pilot was successfully completed in 2022, with these standards to be more widely rolled out in 2023. An independent sector site was included within the pilot, and independent sector outreach was conducted through webinars.
CQC will strengthen its guidance on complaints processes to make clearer that it expects 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.	Guidance on regulation 16 was updated in early 2022, and this change was communicated by CQC in partnership with ISCAS. CQC additionally re-stated its clarification that NHS PPUs do not have access to independent resolution via PHSO and that it is best practice to subscribe to a resolution service or make suitable arrangements to ensure complainants are not disadvantaged.
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.	Following further analysis, DHSC took the decision that legislation was not a proportionate response. The main source of patient episodes without access to independent resolution is from NHS PPUs, which are being engaged via ISCAS and PHSO to increase uptake.

Ensuring accountability

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.

Regulators have updated their ways of working to ensure they put patients at the heart of their work, and that they are able to collaborate effectively in sharing of information and concerns.

Alongside this, there has been a significant culture change in the independent sector, now leaving no doubt that independent providers must take responsibility for maintaining high standards of care in their facilities, irrespective of how the medical professionals involved are engaged by them (through employment or practising privileges).

Where there is reason to investigate the behaviour of a medical professional, these investigations now have more thorough guidance to ensure proper processes are followed that protect patients, and to ensure decisions on whether to exclude or restrict the practice of an individual are taken appropriately.

There are many regulators and regulatory mechanisms in the health system. The inquiry report is clear that the issue in this case was not a lack of regulation – it was the inability of systems of regulation to work effectively, to work together and to work in the best interests of patients.

Regulators play a vital role in providing an outside voice and expertise to scrutinise the way healthcare is delivered, and point out where standards are not being met. Effective and timely action must then be taken to ensure those issues are resolved. Medical professionals must be accountable for the quality of care they deliver, and providers must be accountable for the environment they create within their hospitals and clinical settings.

The actions designed to improve the accountability of the health system following the inquiry focused on 3 specific areas:

• making regulators more effective
• improving governance in the independent sector
• ensuring appropriate investigations of medical professionals

Making regulators more effective

The inquiry was clear that additional regulatory mechanisms were not required. The report notes that there are many existing organisations regulating providers and professionals within health and care, with a large combined budget and workforce. The priority was to ensure this system worked effectively in the interests of patients and in a collaborative fashion to ensure issues do not fall through the gaps between organisations.

Significant steps had been taken prior to the government’s response to the Paterson inquiry in December 2021. A range of shared protocols, memoranda of understanding and joint statements established clear mechanisms for collaboration between different regulators. This included the Emerging concerns protocol for sharing specific concerns among all regulators and signatories. The new strategies launched by GMC, Nursing and Midwifery Council (NMC), and CQC all focused on improving on the areas of weakness identified by this inquiry and others.

CQC continues to develop its approach to regulation to deliver on the ambitions of the 2021 strategy, which include a stronger focus on:

• organisational cultures
• safety
• involvement of patients
• collaboration

A new single assessment framework – to be applied across all health and social care settings, as well as to ICSs and local authorities – was published in July 2022. The framework uses quality statements that set out what will be expected from providers and describe what good care looks like. The new approach will also change how CQC’s staff work, moving to a team-based approach that will combine the expertise and experience of colleagues from across all the sectors that CQC regulate. Implementation of the new regulatory model will start for all providers in 2023.

CQC, GMC and NMC have been working together on a shared data platform that can be used jointly to identify potential concerns. Currently this platform is limited to analysis of maternity services, but the organisations intend to expand this scope in time.

The initial phase of this work has succeeded in delivering indicators from the data that have been found to correlate strongly with maternity services with known issues, and so are likely to be useful early warning indicators of issues at other maternity services. The next phase will continue to explore how these indicators can be used in practice.

This work will help the regulators to jointly identify areas of concern earlier than they otherwise may have achieved, either working without this data or working alone.

NQB has published National Guidance on SQGs, which builds on and replaces the previous guidance on Quality Surveillance Groups and sets out NQB’s requirements for quality governance within ICSs.

SQGs are required in all ICSs, and their purpose is to enable quality improvement across the system by routinely and systematically sharing and triangulating intelligence to identify quality concerns and risks across the ICS. An explicit aim of this action was to consider how this model for quality surveillance could extend to the independent sector. The new System Quality Group guidance explicitly includes independent providers within its scope and should aid in improving quality across the entire health system.

The Professional Standards Authority (PSA) is responsible for overseeing the UK health and care professional regulatory bodies, including performance reviews of these bodies. In September 2022, PSA published a report relating to key challenges for patient and service user safety and identifying gaps in regulation entitled Safer care for all – solutions from professional regulation and beyond. This considers 4 key themes:

• tackling inequalities
• regulating for new risks
• tackling workforce issues
• accountability, fear and public safety

This includes recommendations specifically discussing the need for regulators to work collaboratively. The government will be considering those recommendations made that apply to the government itself. As part of the work to progress the recommendations and commitments within the Safer care for all report, PSA will be proceeding with its Bridging the gap project, including creation of a gaps register and looking in more detail at how regulators collaborate.

As set out in the government’s 2021 consultation document Regulating healthcare professionals, protecting the public, DHSC remains committed to introducing a programme of reform to modernise the regulatory system for healthcare professionals in the UK. This includes a specific duty to co-operate between organisations concerned with the:

• regulation, employment, education and training of healthcare professions
• regulation of health and care services
• provision of health and care services

The changes will be implemented for each of the healthcare professional regulators through a series of statutory instruments made under Section 60 of the Health Act 1999. The timeline remains challenging, but we intend to introduce the first in a series of statutory instruments to achieve this by the end of 2023.

Once the legislative programme has been rolled out to all professional regulators, we will evaluate which regulators are using the new powers most effectively and identify areas where greater collaboration or adoption of best practice could be beneficial.

Improving governance in the independent sector

A key set of findings from the inquiry was that governance and accountability in the independent sector had significant deficits. The perception that a consultant merely ‘rented a room’ from an independent healthcare provider, which then took no responsibility for their practice, gave license to a consultant such as Ian Paterson to do as they pleased.

In responding to the findings of the inquiry, we are clear that independent sector providers must take responsibility for ensuring the safety and quality of care provided in their facilities. This is true irrespective of whether a healthcare professional is employed directly or is engaged through practising privileges, which describes an agreement granting a healthcare professional permission to work for a private healthcare provider. This is also the view embedded in the healthcare regulations and therefore also by CQC.

Within health regulation, healthcare professionals engaged through practising privileges are regarded the same as employees. Ensuring good governance is one of the fundamental standards set out in the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014. This is a standard below which the standard of care should never fall, and against which CQC assesses all providers – including independent healthcare providers.

We are pleased that IHPN – the trade body for the independent healthcare sector – and its member organisations agree that they must take responsibility for ensuring high standards of care are maintained in their facilities. This is embodied by the MPAF – a document created and published by IHPN to improve consistency of clinical governance across the independent sector. The MPAF itself states:

The responsibility for quality of care rests with the independent provider delivering services through their employees or through those working in their organisations using other contractual arrangements such as practising privileges. Ultimately, the executive and non-executive members of the independent provider’s board are accountable for the quality of care provided by the organisation, which includes a safe and effective governance system for medical practitioners.

There can therefore be no doubt that providers in the independent sector must take responsibility for ensuring the quality of care provided by all medical professionals within their facilities. The MPAF provides guidance on best practice in an independent setting, helping independent providers maintain high standards and meet their obligations under the regulations. CQC will continue to assess all providers against the fundamental standards and will take frameworks such as the MPAF into account when doing so.

In 2022, IHPN has refreshed the MPAF to update its content and bring it up to date. This process included the continued engagement of providers, regulators and government. The 2022 to 2023 version of the NHS Standard Contract now requires independent sector providers delivering NHS-funded care to have regard to the MPAF as one of its conditions. This was implemented following consultation on changes to the standard contract earlier in 2022. NHS contracts with providers can be, and are, terminated if these conditions are not met.

IHPN has created a development plan within the latest version of the MPAF to continue to drive progress in clinical governance in the independent sector. IHPN has also committed to continuing to refresh the framework as needed in the future.

CQC rating data provides an insight into how well independent sector hospitals are meeting the required standards of quality in patient care. In late 2014, CQC extended its inspection approach to include independent hospitals as well as NHS trusts, having been given the duty to rate independent hospitals in the same way as NHS hospitals are rated.

293 locations had been rated by July 2021, with the majority of locations not yet rated having been registered since 2020. The COVID-19 pandemic impacted how quickly CQC has been able to carry out comprehensive inspections required to rate these locations for the first time.

The overall ratings are improving, as are the ratings for the safe, effective and well-led key questions, as seen in the table below.

Domain	Percentage of good and outstanding independent acute non-specialist hospital locations as of 31 July 2017 (197 locations)	Percentage of good and outstanding independent acute non-specialist hospital locations as of 31 July 2021 (293 locations)
Overall	71%	85%
Safe	59%	75%
Effective	81%	92%
Well-led	67%	79%

Appropriate investigations of medical professionals

The inquiry recommendation relating to investigation and exclusion of medical professionals called for 2 elements. The government response accepted that, where there are concerns about the behaviour of a professional at one provider, it should be communicated to other providers where they may work.

Since the inquiry – and as set out in the government’s response – regulators have taken important actions to make it easier for people and organisations to share information regarding patient safety risks. For example, 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. In addition, the government has continued to consider how best to strengthen information-sharing systems around professionals as part of the reforms to the Medical Profession (Responsible Officers) Regulations 2010 (‘Responsible Officers regulations’).

The other element was that any investigation where there is any potential risk to patient safety should lead to the exclusion of that medical professional from practising. This part was not accepted, as it was considered necessary to have discretion on a case-by-case basis to determine the appropriate course of action, given the specific circumstances of the concerns in question.

Irrespective of the specific response to each element of this recommendation, the government committed to the broader principle that investigations when concerns are raised about medical professionals should be conducted in an appropriate, timely and thorough manner.

Responsible Officers must ensure that local processes are in place for raising and acting on concerns about doctors, with issues escalated to GMC as appropriate. DHSC is working on changes to the Responsible Officers regulations to ensure they are fit for use in the changing healthcare landscape. Work is ongoing to bring the regulations up to date and to ensure changes are as effective as possible. The proposed changes will be subject to consultation before implementation. We expect the reformed regulations to be laid in spring or summer 2023.

Maintaining High Professional Standards in the NHS (MHPS) was originally published in December 2003 and provides a framework for handling concerns about doctors and dentists in the NHS. This includes:

• the action to take when a concern arises
• restriction of practice and exclusion
• conduct hearings and disciplinary matters
• procedures for dealing with issues of capability
• handling concerns about a practitioner’s health

In responding to the inquiry, commitments were made to ensure MHPS continues to support employers to handle and resolve concerns about a doctor’s practice in a manner that is fair and just while suitably protecting patient safety.

The Practitioner Performance Advice service, delivered by NHS Resolution, provides expertise to help foster a fair and compassionate approach, and a learning culture when supporting employing and/or contracting organisations and practitioners when concerns are raised about an individual’s practice, ensuring that patient safety is paramount. It delivers a range of specialist services including case advice, assessment and remediation action plans, as well as education programmes and other expert services to healthcare organisations across England, Wales and Northern Ireland.

NHS Resolution encourages organisations and practitioners to use this service as early as possible when concerns come to light. CQC is clear that it considers accessing this service for appropriate support as a positive indicator of a well-led organisation.

DHSC is committed to working with key stakeholders to support the practical application of the framework by local employers to ensure it strikes the right balance between protecting patients while adopting a just and learning culture. We will continue to consider whether a formal review of MHPS is required.

NHSE is also exploring the feasibility of providing a framework along similar lines to MHPS for the management of concerns about other healthcare professionals beyond doctors and dentists.

Following the tragic death by suicide of Amin Abdullah during disciplinary proceedings in 2016, an NHS England and Improvement (NHSEI) Advisory Group was set up to consider what could be learnt from the failings in the investigation and disciplinary proceedings identified in Amin’s case. In 2019, the Chair of NHS Improvement, Baroness Dido Harding, wrote a letter to NHS providers to share NHSEI’s Advisory Group’s findings (PDF, 144KB).

In response to this case, a set of new guidance and recommendations was issued to make improvements to investigation and disciplinary procedures. These changes aim to ensure these important processes are carried out rigorously and fairly. Follow-up work relating to these recommendations shows that over 100 trusts have now updated their disciplinary policies to reflect these principles, bringing their processes in line with examples of best practice.

NHSE is exploring the most appropriate approach further with stakeholders to ascertain if the recommendations have been put into practice, which will help guide any future amendments to MHPS and act as valuable input into the future development of a common management framework for handling concerns relating to all NHS staff.

The Paterson case highlighted the importance of ensuring appropriate decisions are made about when to exclude a practitioner. Managers also need to have discretion to assess the appropriate course of action on a case-by-case basis, given the specific circumstances of the concerns in question.

In April 2022, NHS Resolution published a suite of resources to support decisions relating to the exclusion of professionals. These resources aim to help ensure consistency across the health system, and support those making these decisions to do so rigorously and in a way that ensures patients are protected from harm. The resources include:

• case studies
• a flowchart for decision-making
• templates for recording and communicating exclusion decisions
• insights from an analysis of over 1,000 exclusion cases

A wide range of health system partner organisations contributed to ensure these resources would be relevant to those who will need to use them. It is worth specifically noting that communicating an exclusion decision to other providers that may engage the practitioner in question – a key element of the inquiry recommendation – is incorporated within this guidance.

In the planned reform programme to modernise the regulatory system for health professionals in the UK (see above), DHSC intends to also propose a consistent regulatory framework for fitness to practise across all professional healthcare regulators, and to remove the ‘5-year rule’ that limits the time in which an allegation can be investigated.

The timeline remains challenging, but we intend to introduce the first in a series of statutory instruments to achieve this by the end of 2023.

Ongoing actions

CQC will complete the rollout of its new regulatory model after the completion of the initial testing phase.

CQC, NMC and GMC will continue to work on how to best use their shared data platform, including how to expand its scope beyond maternity.

PSA will be proceeding with its Bridging the gap project on regulator collaboration.

DHSC will introduce a programme of reform for the healthcare professional regulatory system through secondary legislation by the end of 2023.

IHPN will continue to work on implementing its MPAF development plan to drive further progress in clinical governance in the independent sector.

DHSC is working on changes to the Responsible Officers regulations and expect the reformed regulations to be laid in spring or summer 2023.

DHSC will continue to consider whether a formal review of MHPS is required.

NHSE is exploring the feasibility of providing a framework along similar lines to MHPS for the management of concerns about other healthcare professionals beyond doctors and dentists.

NHSE is evaluating whether the recommendations from Baroness Dido Harding’s letter to NHS providers have been implemented, which will help guide any future amendments to MHPS and future development of a common management framework.

DHSC intends to introduce the first in a series of statutory instruments to achieve a consistent regulatory framework for fitness to practise across all professional healthcare regulators by the end of 2023.

Progress against 2021 implementation plan

Note: NHS England and Improvement (NHSEI) became NHS England (NHSE) in July 2022, but in the table below we have retained the original wording of the actions from the 2021 implementation plan.

Action	Progress
In the 2021 consultation document, 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 – employment, education and training of healthcare professionals – regulation of health and care services – provision of health and care services DHSC also proposes 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 GMC in 2022.	The DHSC Professional Regulation Reform team is leading a programme of reform to modernise the regulatory system for healthcare professionals in the UK. These changes are being implemented for each of the healthcare professional regulators through secondary legislation made under Section 60 of the Health Act 1999. These reforms will be introduced by the end of 2023.
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.	DHSC is continuing to work on changes to the Responsible Officer regulations. Any changes will be subject to consultation before implementation. We expect the reformed regulations to be laid in spring or summer 2023.
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.	NHS Resolution launched this new guidance on exclusion of professionals on 28 April 2022. This guidance was sent to all NHS chief executives, chairs, medical directors, HR directors and strategic stakeholder engagement leads. IHPN also shared the resources with its members, including Chief Nurses and Chief Medical Officers. NHS Resolution will follow up to evaluate the success of this guidance.
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.	NHSE is continuing to consider the feasibility of providing a common management framework as well as a framework along similar lines to MHPS for the management of concerns about other healthcare professionals beyond doctors and dentists.
CQC will revise its assessment frameworks and provider assessment methodology to strengthen focus on patient safety and collaboration. CQC anticipates implementation will start in 2022.	The new single assessment framework has now been published. CQC is restructuring in line with its strategic ambitions, including operational staff moving into regional multidisciplinary teams. Testing of the new regulatory model has commenced and full rollout will follow in 2023.
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, PSA and other stakeholders. The guidance will also consider how the Quality Surveillance Groups model could extend to the independent sector.	NQB published National Guidance on System Quality Groups (SQGs), which builds on and replaces the previous guidance on Quality Surveillance Groups. This guidance sets out the requirements for quality governance in ICSs, including how SQGs can routinely and systematically share and triangulate intelligence, and identify quality concerns and risks across the ICS. The scope of the SQGs explicitly includes local independent providers.
PSA is conducting its project Bridging the gap, which looks at the structures by which regulators collaborate and share data and information.	PSA published a report related to gaps in the regulatory system that may lead to harm to patients and service users in September 2022. PSA will be following up on the recommendations and commitments from this report. Further work to progress the Bridging the gap project will fall within this.
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 multipurpose and expandable build, incorporating lessons learned from the first version.	The initial phase of this work delivered 2 indicators derived from pooled data, which have been found to relate to locations of concern. All organisations continue to explore how these indicators can be used and how this work can be expanded beyond maternity.
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.	DHSC will continue to consider whether a formal review of MHPS is required.
IHPN will refresh its 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.	IHPN published the updated MPAF document in September 2022. IHPN is engaging with partners across the UK nations to discuss extending its applicability beyond England. IHPN is conducting further work following the publication of the refreshed MPAF on implementation to ensure members have the support they need to implement the framework. The MPAF will continue to be refreshed in future years.
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.	The updated NHS Standard Contract for 2022 to 2023 included a requirement for independent providers to have regard to the MPAF following consultation.
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 of implementing actions set out in this response.	This action has been implemented through the publication of this report.

Putting things right

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 necessary onward support where appropriate.

Patients who are impacted by potential issues with their care will be reviewed through recall processes that are now better informed of how to put patients at the centre of their focus. This will provide patients with a better experience and ensure their ongoing healthcare needs are met.

Patients will continue to receive apologies from healthcare professionals and providers for potential issues with their care, when appropriate, and professionals have better training and resources to ensure these apologies are delivered effectively and meaningfully.

The government is working to ensure that any future changes to indemnity and insurance arrangements will be made using the best evidence base available. This includes a thorough assessment of the impact on patients, healthcare professionals, providers and the wider market with the aim of improving the position for patients when receiving treatment from any regulated healthcare professional, regardless of the setting.

The government’s ambition is that, when this work concludes, patients have confidence that they can access appropriate compensation if harmed while receiving care, including when harm arises from criminal or intentional acts or omissions.

Putting things right takes different forms in different circumstances. Patients harmed by poor care may need urgent review to correct a treatment that has been ineffective and have long-term care needs that must be addressed. There will also be some patients – as with those of Ian Paterson – who have a right to financial compensation for the harm caused.

In every case, an apology is the right first step to rebuilding trust between the patient harmed and the health system that caused that harm.

These are the 3 elements where actions have been taken to make improvements to how the health system puts things right when harm is caused:

• patient recall processes
• ensuring apologies are given
• access to compensation

Patient recall processes

Where there is a patient safety incident, the patients affected should be recalled to:

• ensure they are at no further harm
• resolve any harm they may still be at risk of
• determine any longer-term care they may require

Ian Paterson’s patients had an inadequate experience of the recall processes organised by their healthcare providers (Heart of England Foundation Trust or University Hospitals Birmingham and Spire Healthcare). The inquiry found the process was not patient-focused and lacked transparency.

There were 2 elements to rectifying this situation. The first was to ensure all patients of Ian Paterson were recalled and in receipt of an onward treatment plan. The second was to provide guidance for future recall processes that may take place to ensure these mistakes were not repeated.

Ian Paterson did most of his work in hospitals run by University Hospitals Birmingham (UHB) NHS Foundation Trust (at the time Heart of England Foundation Trust) and Spire Healthcare (at the time operating as Bupa). As was noted in the 2021 government response, by August 2020, UHB had contacted all known living patients of Ian Paterson. By the end of June 2021, the trust had ensured that all known former patients of Ian Paterson had had their care reviewed and that any outstanding concerns were addressed in a way that was determined by the patient. UHB has a fast-track process in place for patient groups to raise concerns if needed.

Over the past 12 months, UHB has reported that a small number of patients have contacted them regarding the care they received from Ian Paterson. These cases have all been reviewed and did not raise any concerns. UHB has also received enquiries from the families of patients who have been evaluated by His Majesty’s Coroner and these cases are also being reviewed.

Spire had contacted all known living patients of Ian Paterson by December 2020 and reviewed over two-thirds of patients concerned prior to the publication of the government response in December 2021. Spire agreed to provide the government with an update on this progress ahead of this report.

Spire has now completed its reviews of the care of nearly all those patients. We are pleased to hear of this progress since 2021 and expect to see the final patient reviews completed in the near future. To ensure this exercise has not omitted any patients of Ian Paterson, Spire continues to interrogate the complex legacy IT systems that pre-dated Spire’s formation and takeover of Bupa hospitals. Spire will continue to contact any patients they identify as a result of this.

The inquiry noted that there was no national guidance in place at that time for how healthcare providers should undertake a recall process and that such guidance needed to be developed.

DHSC co-ordinated a working group made up of representative bodies (NHSE, Public Health England – now the Office of Health Improvement and Disparities – and IHPN), healthcare providers (NHS Providers, UHB and Spire) and regulators (CQC) to develop a framework for conducting a patient recall in a secondary care setting. This working group was informed by the experiences of the Paterson patient representatives, which were gathered through a roundtable held in October 2021.

The resulting National Patient Recall Framework was published on 1 June 2022. This contains principles for conducting a patient recall in the interests of safety for providers of secondary care. It includes key elements that should be considered in order to conduct a rigorous and patient-centred recall process. These elements include:

• the scope of inclusion and exclusion criteria
• patient engagement
• resources required
• the process to undertake

The framework was developed with – and is applicable to – providers in the independent sector. The publication of the framework was publicised through all the relevant organisations to increase awareness of it. This framework is now owned by NQB – an organisation that champions the importance of quality across health and care on behalf of NHSE and CQC, alongside other system partners. NQB will keep the framework under review and update it as may be required in future.

In addition, CQC will take the recall framework into account as part of its assessments of healthcare providers in its new regulatory model as it is implemented in 2023. This will help to ensure this new framework is being appropriately implemented.

Ensuring apologies are given

There is unanimity across the health system that apologising where there is harm caused or where patients were put unduly at risk of harm is the right thing to do.

It has been clearly stated by all relevant organisations, including indemnity providers and NHS Resolution, that giving an apology should be done and does not have an impact on any potential litigation that may result. Despite this, the inquiry found that some professionals remained reluctant to apologise to patients because of the concerns over legal liability.

The inquiry recommendation acknowledged that there has been guidance indicating the importance of apologising over a number of years. It also noted the introduction of the duty of candour – both the statutory duty and the professional duty – since the time of Ian Paterson’s practice. The statutory duty is set out in regulation 20 of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014, and applies to registered healthcare providers with its implementation assessed by CQC. This was introduced in response to the Francis Report (report of the Mid-Staffordshire NHS Foundation Trust public inquiry). At the same time, professional regulators strengthened the professional duty that applies to healthcare professionals.

Both duties require that those providing healthcare are open and transparent with patients about their care.

CQC guidance for providers on the statutory duty of candour is explicit that saying sorry is not admitting fault. It describes apologising as “a crucial part of the duty of candour” that does not amount to an admission of liability.

NHS Resolution is similarly clear. It notes that saying sorry is “always the right thing to do” and is “not an admission of liability”. Indeed, both organisations acknowledge it is the lack of an apology that can persuade people to seek legal redress.

NHS Resolution has published guidance on saying sorry effectively. In March 2022, NHS Resolution published a new animation on the duty of candour explaining how to comply with both the professional and statutory duties. NHS Resolution promotes this guidance at every engagement with its members and every event that it hosts.

NHS Resolution promotes its learning resources via social media and has published a number of resources on response to harm in the last year, which include signposting to help embed best practice with respect to making apologies.

NHS Resolution continues to work with academic partners and Health Education England to develop e-learning modules incorporating ‘Being fair’ and ‘Saying sorry’ resources, the first of which focuses on maternity and is expected to be published in early 2023.

While it can be difficult to shift attitudes, the health system is offering a unified voice that apologies are essential, and is giving those responsible the tools and resources to make those apologies.

Assessing that the duty of candour is being complied with is the responsibility of:

• CQC for the statutory duty
• the professional regulators for the professional duty

These bodies will continue to monitor that these duties are being put into action and patients are receiving the apologies as a first principle.

Access to compensation

The inquiry raised a concern that Paterson’s private patients were unable to access compensation for the harm caused by his actions, highlighting a potential gap in clinical indemnity within the independent healthcare sector that does not exist in the NHS. The 2 issues highlighted by the inquiry were the:

• use of discretion to withdraw cover
• exclusion of criminal acts from both discretionary indemnity and insurance cover

As set out in our response to the inquiry in December 2021, the government was already examining unregulated discretionary indemnity arrangements for healthcare professionals (under which an indemnity provider has discretion on whether or not to cover claims made against their indemnified members). The government ran a consultation on appropriate clinical negligence cover during 2018 to 2019 seeking views on whether all regulated healthcare professionals not covered by state indemnity should hold regulated and contractual insurance rather than unregulated discretionary indemnity. The summary of responses received to this consultation was published on 15 December 2022.

While discretion may be exercised by providers of discretionary clinical indemnity cover on whether to accept claims, regulated insurers’ cover is provided via contracts of insurance. Insurance claims are therefore required to be paid, provided they fall within the scope of cover and all policy conditions have been met. Judicial decisions appear to uphold the principle that discretion is not absolute and should not be applied in a way that is capricious, arbitrary or irrational.

Following the recommendations of the Paterson inquiry, we have broadened the scope of this work to cover the issues regarding criminal or intentional acts and omissions. As changes to clinical negligence indemnity requirements could have wide-ranging implications for healthcare professionals and patients across the UK, we are developing an evidence base to inform our assessment of the possible impacts of any changes.

Our evidence-gathering includes an extensive programme of stakeholder engagement including a mixture of one-to-one and roundtable discussions with the following groups:

• professional regulators
• professional bodies
• discretionary indemnity providers
• commercial insurance providers
• independent healthcare providers
• patient groups

We also carried out a survey of healthcare professionals in September and October 2022. It was aimed at regulated healthcare professionals whose work was not covered by state indemnity schemes. We expect to publish the results of this survey in early 2023.

The stakeholder engagement and initial survey reports have improved our understanding of the current discretionary indemnity and regulated insurance arrangements, and will underpin further policy options development.

However, a major issue emerging from this work is the gap in publicly available data on clinical negligence cover. In part, this is due to the commercial sensitivity of this information. We have had to enter into non-disclosure agreements in order to access data that is important to inform our assessment of the possible benefits, risks and impacts of proposed policy options. Consequently, we are also considering options for ensuring that, in the future, reliable data sources are available to provide better insight into discretionary indemnity and regulated insurance arrangements.

The limited evidence we have obtained so far suggests that discretionary indemnity providers appear to only exercise their discretion to decline indemnity in a very small proportion of claims each year, although it is important to recognise the particular impact of a decision to decline indemnity – for example, in the case of Paterson, where many hundreds of patients were affected by that decision.

Of that small proportion, the examples shared with us appear to be for reasons such as the healthcare professionals’ work and financial details not being declared fully, such that there is not fully appropriate cover for their work. Such declarations are also likely to be required to meet the policy conditions for insurance products that provide clinical negligence cover.

The legislative framework requires healthcare professionals to hold an adequate and appropriate level of cover for their practice without defining ‘appropriate’ or ‘adequate’. The level of indemnity cover required by healthcare professionals depends on several individual factors (such as the doctor’s risk appetite and their choice, the type or nature of their clinical work, the requirements of organisations that employ their skills in the independent healthcare sector or financial details), all of which are taken into account by indemnity and insurance providers at the point of purchase. There are also several indemnity providers in the market, each of which offers its own range of products. This makes the ‘appropriate’ level of cover for healthcare professionals complex to define in general terms.

This, in turn, creates challenges for monitoring the adequacy of cover. Any checks by professional regulators or independent healthcare providers are likely only to require healthcare professionals to confirm that they simply have clinical indemnity cover, rather than checking that they hold a certain level or type of cover, or establishing if it is adequate and appropriate.

On the criminal issue, stakeholder engagement and information gathered so far confirms that neither discretionary indemnity providers nor regulated insurers will cover clinical negligence claims that involve a criminal or intentional act or omission. This reflects the position for Paterson’s private patients. However, the relevant state indemnity scheme, Clinical Negligence Scheme for Trusts, paid compensation to Paterson’s NHS patients on the basis of clinical negligence.

We recognise that one related issue here, in some cases, is the role of independent providers in terms of their vicarious liability (a relationship of employment or one akin to employment giving rise to employer’s liability for the tortious act of their employee).

The compensation fund for Paterson’s private patients resulted from a settlement (the contents of which are private and confidential between the parties to that litigation) and so no liability was established in court. The inquiry report identified failures in clinical governance and oversight that might well leave a healthcare organisation who retained such a doctor with direct liabilities for harm caused to patients.

Recent developments in the law of vicarious liability could allow future or similar claimants to try to argue that the relationship between consultants engaged through practising privileges and independent healthcare providers is one akin to employment. This could affect interpretation of a provider’s vicarious liability to patients. The MPAF also does highlight that:

the regulations define doctors working under practising privileges as employees of the provider for the purposes of the regulations.

Alongside the evidence-gathering process, we have been assessing the possible responses covered in the government’s 2021 response as follows:

1. Changing the type of cover that clinicians are required to hold. This could be through either of 2 potential options:

• professional regulation, which would require all regulated healthcare professionals in the UK not covered by a state-backed indemnity scheme to hold appropriate clinical negligence cover that is subject to appropriate supervision, in the case of UK insurers, by the Financial Conduct Authority and Prudential Regulation Authority
• financial regulation – that is, bringing discretionary products within scope of financial regulation, which could have unintended consequences and needs further review

On both options, some stakeholders have questioned whether it is proportionate, highlighting:

• the wide-ranging implications for the current system of clinical negligence cover
• the potential impact on business models and products
• likely disruption during transition to a new system

2. Introducing safeguarding measures to the current system of discretionary indemnity. This could include:

• a code of conduct with internal escalation procedures
• financial and decision-making transparency standards
• an independent escalation procedure, which could involve third-party adjudication or arbitration (such as an ombudsman)

The latter could enable healthcare professionals and patients to escalate complaints about unfavourable decisions not to provide cover. More transparency may also improve our evidence base on use of discretion, and we could monitor the impacts of these safeguards and review whether further actions are necessary.

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 or intentional acts or omissions in the context of clinical care.

This could be through new products or a safety net that provides compensation for criminal or intentional acts or omissions. Some stakeholders have raised the question of whether criminal cover could be included as a requirement for healthcare professionals, while others are concerned about the ethics of providing cover for criminal or intentional acts and omissions.

A further route for us to explore is the role of independent providers that are hosting private consultants in terms of the providers’ vicarious liability and duty of care to patients, as well as the guidance set out in the MPAF.

We will continue to engage with stakeholders on the suitability and feasibility of these options, as well as exploring whether any alternative options could also contribute to improving the position for patients and healthcare professionals.

This work is ongoing. Following continued appraisal of the options and engagement with stakeholders, we will provide a further update, including proposals, in 2023.

Ongoing actions

Spire will continue to ensure recalled patients have their continuing care needs met appropriately.

NQB will keep the National Patient Recall Framework under review and consider updates as needed.

CQC will incorporate the recall framework within its new assessment processes.

NHS Resolution will continue to promote the need to apologise and the duty of candour at all of its engagement events, and CQC will continue to monitor compliance with the statutory duty of candour through its assessment processes.

DHSC will continue to engage with key stakeholders to understand and consider their views on potential solutions for indemnity and insurance arrangements.

DHSC will consider options for improving access to data and information about healthcare professionals’ clinical negligence cover arrangements with indemnity and insurance providers.

DHSC expects to publish the report from the survey of healthcare professionals in early 2023.

DHSC will provide a further update on the proposed solution for the issues raised by the Paterson inquiry in 2023.

Progress against 2021 implementation plan

Action	Progress
The government will provide an update on the outstanding cases being reviewed by Spire in 12 months’ time.	Spire has now completed its reviews of the care of nearly all known living patients of Ian Paterson.
The National Patient Recall Framework will be published in 2022 on both NQB and IHPN’s websites.	The new National Patient Recall Framework was published on 1 June 2022. NHSE, CQC and IHPN have signposted relevant organisations to this new guidance.
Following its publication, CQC will consider the National Patient Recall Framework as part of its new assessment process to ensure it has been adequately implemented by all providers.	CQC will incorporate the National Patient Recall Framework into its new assessment process to ensure it is being appropriately used.
DHSC will publish a summary of responses received to the previous consultation on appropriate clinical negligence for regulated healthcare professionals in early 2022.	The summary of responses received to this consultation was published on 15 December 2022.
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.	This survey of healthcare professionals was launched in September 2022 and ran for 7 weeks. Once analysed, a report of the results of the survey will be made publicly available in early 2023.
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.	The first phase of an extensive programme of stakeholder engagement has been crucial for developing the evidence base for understanding current indemnity arrangements, as well as gathering initial views on potential solutions. We are now conducting the second phase of discussions and information-sharing to assess in more detail the potential solutions and implications for stakeholders.
DHSC will consult on the detail and arrangements for implementing any reform on indemnity and insurance arrangements, recognising that providers would need time to prepare for any changes.	We are developing and analysing the evidence base for potential solutions, and therefore a consultation has so far not been required. Once feasible solutions have been developed in more detail, we will consider with stakeholder groups whether a consultation would be appropriate in 2023.
NHS Resolution will continue to develop, publicise and evaluate its 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 has produced a short animation to help those working in health and social care to better understand the duties of candour and how they can be fulfilled effectively. This includes: – the need to be open and transparent – that saying sorry is always the right thing to do and is not an admission of liability – that all conversations must be bespoke and appropriate to the sensitivities of a situation
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.	NHS Resolution continues work with its academic partners and Health Education England to develop e-learning modules incorporating ‘Being fair’ and ‘Saying sorry’ resources. The first resource focused on maternity and is expected to be published in early 2023.
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.	Work to improve patient safety continues, with NHSE’s August 2022 publication of a new Patient Safety Incident Response Framework. This is a key part of the 2019 NHS Patient Safety Strategy, which consists of substantial programmes underway by NHSE to create a safety and learning culture across the NHS.

Annex A: Paterson Inquiry Response Programme Board, and task and finish group members

The following organisations were members of the Paterson Inquiry Response Programme Board or TFGs and supported the progress outlined in this report. We thank them for their time and insight.

• Academy of Medical Royal Colleges
• Care Quality Commission
• Competition and Markets Authority
• General Medical Council
• Independent Healthcare Providers Network
• Independent Sector Complaints Adjudication Service
• National Guardian’s Office
• NHS Digital
• NHS England
• NHS Providers
• NHS Resolution
• Office of Health Improvement and Disparities (formerly Public Health England)
• Private Healthcare Information Network
• Professional Record Standards Body
• Professional Standards Agency
• Royal College of Surgeons England
• Spire Healthcare
• University Hospitals Birmingham NHS Foundation Trust

Annex B: progress against the Paterson inquiry recommendations

The following annex summarises the actions that have been taken to respond to the inquiry’s recommendations, as detailed in more depth throughout this report and organised according to those 15 recommendations.

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.

The NCIP is on track to meet the original commitment of reaching all NHS hospitals over a 3-year period.

PHIN has published its Roadmap and delivery plan 2022 to 2026, as approved by the CMA, to meet the rest of its mandate to publish performance data on consultants in the independent sector by 2026.

The CMA has warned that it will take enforcement action against private healthcare providers that have not been providing prospective patients with clear and consistent information, in breach of the Private Healthcare Market Investigation Order 2014.

The Health and Care Act 2022 includes provision that 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.

The IHPN has included reference to use of independent data sets in its MPAF with respect to granting and reviewing of practising privileges.

The ADAPt programme has been piloted by NHS Digital and PHIN to co-ordinate the collection and processing of data on performance across the NHS and independent sector, and will now aim to move into the full implementation phase.

NHSE will work with the professions so that meaningful consultant-level information on the numbers and types of procedures performed should be made publicly available.

As part of the Digital Staff Passport programme, NHSE will work with stakeholders such as PHIN – on the potential in the future to receive information on consultants’ practising privileges – DHSC, IHPN and GMC.

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.

In December 2021, the AoMRC, PRSB, IHPN and NHSE wrote to their members to remind them of best practice in writing letters to patients, pointing to the AoMRC’s Please, write to me: writing outpatient clinic letters to patients guidance.

Independent practitioners must, as per the CMA order, send letters to patients prior to consultations or further tests and/or treatments setting out:

• costs
• reason for the procedure
• other relevant information

NHSE will consider a project plan to drive culture change in this area, dependent on availability of appropriate resource.

Communicating effectively has been incorporated into the GMC review of Good medical practice. Updated guidance is due to be published in early 2023.

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.

DHSC will work with stakeholders to produce and publish information on the difference in how care is organised between the NHS and independent sector, which is due to be delivered in 2023.

IHPN has produced, in conjunction with the Patients Association, an animation on what to expect from treatment in the independent sector.

IHPN has committed to produce resources for independent providers to share with patients on safety and governance in the sector.

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.

NHSE is implementing 2-stage shared decision-making across all admitted non-day case pathways by April 2023 and across all admitted pathways by April 2024.

NHSE has published a range of decision support tools to provide more information for patients on their treatment options.

NHSE has set-up a Shared Decision-Making Board to take forward work ensuring this is an important part of how the NHS operates.

PRSB has published a standard to improve consistency in facilitating and recording shared decision-making conversations.

RCSEng and GMC have developed materials to support shared decision-making processes, and will be publishing these in 2023.

IHPN has reviewed the MPAF and specifically incorporated new content on consent and decision-making in the independent sector. IHPN will also continue to share best practice in this area with the sector.

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 meetings, including in breast cancer care, and that patients are not at risk of harm due to non-compliance in this area.

CQC has incorporated specific prompts on MDT working into its existing inspection framework for all registered independent healthcare providers, including detailed questions on practical arrangements for MDTs with reference to appropriate national guidance.

CQC has been developing its updated regulatory model, which will include continued effective monitoring of MDT use.

IHPN brought together a group of independent sector Chief Medical Officers and representatives from private medical insurers to share best practice and help drive further improvements in MDT use.

IHPN will be developing further principles to support MDT working in the independent acute sector, which may, for example, include:

• which specialties or patient groups should be considered for MDTs
• governance arrangements
• audits

Recommendation 6

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.

CQC assesses all registered healthcare providers against the fundamental standard of ‘complaints’ (see Regulation 16: receiving and acting on complaints) – including ensuring information is available and accessible on how to complain.

The PHSO has piloted the NHS Complaint Standards to improve how providers meet patient expectations when they make a complaint – including increasing awareness of independent resolution.

ISCAS has incorporated the Complaint Standards into its Code of Practice for Complaints Management and engaged independent providers in taking them up.

The government has appointed the first ever Patient Safety Commissioner for England, who will ensure that patient voices are heard across both NHS and privately delivered healthcare.

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

CQC has strengthened the guidance for providers on regulation 16 relating to complaints to make clearer that it is good practice for patients to have access to independent resolution.

DHSC has found that 98% of patient episodes in independent sector providers have access to independent resolution and, therefore, have decided that it is disproportionate to change legislation relating to independent complaints resolution.

The remaining providers covered by the data are NHS PPUs. CQC has written to NHS PPUs to ensure they understand it is best practice for them to subscribe to a resolution service.

ISCAS and PHSO have agreed a plan to engage NHS PPUs in subscribing to independent resolution services.

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.

As was noted in the 2021 government response, by August 2020, UHB 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.

Over the past 12 months, UHB has reported that a small number of patients have contacted them regarding the care they received from Ian Paterson. These cases have all been reviewed and did not raise any concerns.

UHB has received enquiries from the families of patients who have been evaluated by His Majesty’s Coroner and these cases are also being reviewed.

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.

Spire reports that the reviews of nearly all the patients contacted since the inquiry report have been completed.

To ensure that this exercise has not omitted any patients of Paterson, Spire continues to interrogate the complex legacy IT systems that pre-dated Spire’s formation and takeover of Bupa hospitals. Spire will continue to contact any patients they identify as a result of this.

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.

The National Quality Board Recall Framework has been developed by a range of system partners and published by the National Quality Board to provide guidance on conducting a patient-centred recall process.

CQC is incorporating this framework into its new assessment process to ensure it is being used appropriately.

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.

DHSC is making progress on several fronts, building on a previous consultation on appropriate clinical negligence for regulated healthcare professionals, and broadening the scope of the work to criminal or intentional acts and omissions. The summary of consultation responses was published on 15 December 2022.

Developing the evidence base is a key component of this work. We are achieving this through extensive stakeholder engagement and a survey of healthcare professionals to help us understand the impacts of potential solutions. We will provide a further update in 2023.

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.

CQC, NMC and GMC have launched new strategies with a focus on collaboration and patient safety.

CQC has published the new single assessment framework and is in the process of developing a new regulatory model, with this due to be rolled out in 2023.

CQC, NMC and GMC have worked together on a shared data platform, initially for maternity services, to help share data and identify concerns.

NQB has published National Guidance on System Quality Groups, including how SQGs can share intelligence to identify quality concerns and risks in an ICS. This guidance explicitly includes independent providers within its scope.

PSA has published a report relating to gaps in regulation entitled Safer care for all - solutions from professional regulation and beyond.

DHSC is working on changes to the Medical Profession (Responsible Officers) Regulations 2010 and expect the reformed regulations to be laid in spring or summer 2023.

DHSC has been preparing a programme of reform to modernise the regulatory system for healthcare professionals, including a duty to co-operate, and will be introducing the first in a series of statutory instruments to achieve this by the end of 2023.

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.

This element of recommendation 12 was not accepted by the government. The government set out that the underlying goal of this recommendation could be met and 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.

NHSE is continuing to consider the feasibility of providing a common management framework, as well as a framework along similar lines to MHPS for the management of concerns about other healthcare professionals beyond doctors and dentists.

NHSE is considering if best practice for investigations of professionals – as set out in Baroness Harding’s 2019 recommendations (PDF, 144KB) – are being adequately implemented.

In April 2022, NHS Resolution published a suite of resources to support decisions relating to the exclusion of professionals.

IHPN has refreshed the MPAF for clinical governance in the independent sector. This framework makes clear that independent sector providers must take responsibility for the quality of care provided in their facilities.

Recommendation 12b

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

NHS Resolution has launched new guidance on making decisions relating to exclusions, which specifically includes the need to communicate these decisions to other providers who work with the professional in question.

The government has continued to consider how best to strengthen information-sharing systems around professionals as part of the reforms to the Responsible Officer regulations.

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.

IHPN has refreshed the MPAF for clinical governance in the independent sector. This framework makes clear that independent sector providers must take responsibility for the quality of care provided in their facilities.

CQC assesses all providers, including independent sector providers, on their mechanisms for ensuring high standards of care, taking into account frameworks such as MPAF as appropriate.

Issues relating to liability have been considered together with recommendation 10.

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.

CQC has produced guidance on the statutory duty of candour, which explicitly states that apologising is “a crucial part of the duty of candour” that does not amount to an admission of liability.

NHS Resolution has launched a new animation on the duty of candour, which underlines that apologising is always the right thing to do.

NHS Resolution continues to provide resources and engagement on both the need to provide apologies when appropriate, and on how to do so effectively.

Compliance with the statutory duty of candour is assessed as part of the CQC assessment process.

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.

The government will continue to keep this recommendation under review.

It is now a condition of the NHS Standard Contract that independent providers must have regard to the MPAF for clinical governance in the independent sector.