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Summary of recommendations The following recommendations are made to support the delivery of a new regional policy/procedure for reporting, investigating and learning from adverse events. The Department of Health should work collaboratively with patient and carer representatives, senior representatives of Trusts, the Strategic Performance and Planning Group, Public Health Agency and Regulation and Quality Improvement Authority to co-design a new regional procedure based on the concept of critical success factors. Central to this must be a focus on the involvement of patients and families in the review process. Health and Social Care organisations should be required to evidence they are achieving these critical success factors to the Department of Health. The Department of Health should implement an evidence-based approach for determining which adverse events require a structured, in-depth review. This should clearly outline that the level of SAI review is determined by significance of the incident and the level of potential deficit in care. The Department of Health should ensure the new Regional procedure and its system of implementation is underpinned by ‘just culture’ principles and a clear evidence-based framework that delivers measurable and sustainable improvements. The Department of Health should develop and implement a regional training curriculum and certification process for those participating in and leading SAI reviews.

Everyone who works in health and social care should listen to this podcast in full. I've followed Will's search for justice and I am proud to know Will. A man of great integrity who is campaigning for an individual #dutyofcandour in #healthcare, for the benefit of us all. I remain shocked, when I teach on this, how few know Robbie's story. There has been so much lost learning, a failure of accountability, and a failure to deliver an effective statutory duty of candour. For me, this appalling story of failure and cover up highlights clearly why we have to recognise the value of whistleblowers in #healthcare. When staff don't/can't speak out, or are ignored and bullied, it falls to patients or relatives to do this, at huge cost. #Robbieslaw Related post: English and Welsh Ombudsman set out the case for '... a proper public inquiry into the tragic death of Robbie Powell'

"Many voices are not heard in British mental health care (and beyond), significant flaws are overlooked. If you are not satisfied with the status quo or just curious, follow us!" Here's a sample of some of the podcasts: Episode 33 - Basaglia's International Legacy: From Asylum to Community... review Episode 8 - Lived experience in Trieste, a mental health system without psychiatric hospitals, with Marilena and Arturo Episode 25 - Clinical Psychology vs Psychotherapy in Italy and the UK Episode 18 - The Trieste model cannot be exported to the UK because... let's unpack the main objections Episode 27 - Substance dependency, colonialism and sexism with Dr Sonia Soans (@PSYfem) Episode 26 - From the horse's mouth...patient & nurse teaching together as equals Listen to all the podcasts from link below.

The Independent Inquiry into the Issues raised by Paterson was prompted by the case of Ian Paterson, a breast surgeon who was convicted of wounding with intent some of the 11,000 patients he treated and jailed for 20 years in 2017. More than 200 patients and family members gave evidence as part of the Inquiry and it is estimated that he could have harmed more than 1000 patients. Its findings and recommendations were set out in a report published on the 4 February 2020. Summary of the Government response to each of the 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. Government response – accept in principle. Significant progress has been made on the collection of consultant performance data in the independent sector and the NHS. In 2018, the Acute Data Alignment Programme (ADAPt) was launched to move towards a common set of standards for data collection, performance measure methodologies and reporting systems across the NHS and the independent sector, with potential to be fully implemented by 2022 to 2023. This data will be made available for managers and healthcare professionals across the system to help support learning and identify outliers. Over the next 12 months, we commit to reaching a decision with key stakeholders on what information can be published and whether further government action will be needed to achieve this. Recommendation 2 – We recommend that it should be standard practice that consultants in both the NHS and the independent sector should write to patients, outlining their condition and treatment, in simple language, and copy this letter to the patient’s GP, rather than writing to the GP and sending a copy to the patient. Government response – accept. Recommendation 3 - We recommend that the differences between how the care of patients in the independent sector is organised and the care of patients in the NHS is organised is explained clearly to patients who choose to be treated privately, or whose treatment is provided in the independent sector but funded by the NHS. This should include clarification of how consultants are engaged at the private hospital, including the use of practising privileges and indemnity, and the arrangements for emergency provision and intensive care. Government response – accept. Recommendation 4 – We recommend that there should be a short period introduced into the process of patients giving consent for surgical procedures to allow them time to reflect on their diagnosis and treatment options. We recommend that the General Medical Council monitors this as part of Good medical practice. Government response – accept in principle. Many key organisations, including the General Medical Council (GMC), have taken steps to update their guidance and to confirm that doctors should give patients sufficient time to consider their options before making a decision about their treatment and care. During annual appraisals, doctors must provide supporting information to demonstrate that they are continuing to meet the principles and values set out in ‘Good medical practice’. The Care Quality Commission (CQC) takes all GMC guidance into account during its assessments. Recommendation 5 – We recommend that CQC, as a matter of urgency, should assure itself that all hospital providers are complying effectively with up-to-date national guidance on MDT (multidisciplinary team) meetings, including in breast cancer care, and that patients are not at risk of harm due to non-compliance in this area. Government response – accept. Recommendation 6a - We recommend that information about the means to escalate a complaint to an independent body is communicated more effectively in both the NHS and the independent sector. Government response – accept. Recommendation 6b – We recommend that all private patients should have the right to mandatory independent resolution of their complaint. Government response – accept in principle. CQC will strengthen its guidance to make clearer that it expects to see arrangements in place for patients to access independent resolution of their complaints regarding independent sector providers. We will review uptake across the independent sector in the next year, and if uptake is not widespread, we will explore whether current legislation needs to be amended to ensure that all providers make provision for independent adjudication. Recommendation 7 – We recommend that the University Hospitals Birmingham NHS Foundation Trust board should check that all patients of Paterson have been recalled, and to communicate with any who have not been seen. Government response – accept. Recommendation 8 – We recommend that Spire should check that all patients of Ian Paterson have been recalled, and to communicate with any who have not been seen, and that they should check that they have been given an ongoing treatment plan in the same way that has been provided for patients in the NHS. Government response – accept. Recommendation 9 – We recommend that a national framework or protocol, with guidance, is developed about how recall of patients should be managed and communicated. This framework or protocol should specify that the process is centred around the patient’s needs, provide advice on how recall decisions are made, and advise what resource is required and how this might be provided. This should apply to both the independent sector and the NHS. Government response – accept. Recommendation 10 – We recommend that the government should, as a matter of urgency, reform the current regulation of indemnity products for healthcare professionals in light of the serious shortcomings identified by the inquiry and introduce a nationwide safety net to ensure patients are not disadvantaged. Government response – pending. In 2018, the government launched a consultation on appropriate clinical negligence cover for regulated healthcare professionals. This sought views on whether to change legislation to ensure that all regulated healthcare professionals in the UK not covered by state indemnity hold regulated insurance, rather than discretionary indemnity. The government has now extended this programme to consider the issues raised by the inquiry and is committed to bringing forward proposals for reform in 2022. Recommendation 11 – We recommend that the government should ensure that the current system of regulation and the collaboration of the regulators serves patient safety as the top priority, given the ineffectiveness of the system identified in this inquiry. Government response – accept. Recommendation 12a – We recommend that if, when a hospital investigates a healthcare professional’s behaviour, including the use of an HR process, any perceived risk to patient safety should result in the suspension of that healthcare professional. Government response – do not accept. We agree that exclusions and restriction of practice can be necessary, and in some cases immediate exclusion is an appropriate response while an investigation is ongoing. However, we do not believe it would be fair or proportionate to impose a blanket rule to exclude practitioners in such cases. Such a step may inadvertently cause a chilling effect, dissuading healthcare professionals from raising concerns and negatively impacting patient safety. It is vital that investigations are robust and conducted in a timely manner. Guidance has been put in place to ensure that concerns are taken seriously, appropriate action taken and that robust investigation processes are implemented, and that clarity on when to exclude a healthcare professional is provided. Recommendation 12b – If the healthcare professional also works at another provider, any concerns about them should be communicated to that provider. Government response – accept in principle. The government agrees that, where patient safety is at risk, information should be shared with other providers. However, there must be an element of judgement by providers as they will be taking on responsibility to ensure that this information is appropriate and accurate. Regulators have taken key steps to make it easier for people and organisations to share information regarding patient safety risks. The Medical Profession (Responsible Officers) Regulations 2010 (revised in 2013), which apply to all medical practitioners, have also set out prescribed connections for sharing information regarding performance concerns between health organisations. Recommendation 13 – In the NHS, consultants are employees and the NHS hospital is responsible for their management, and accepts liability when things go wrong. The situation is very different in the independent sector where most consultants are self-employed. Their engagement through practising privileges is an arrangement recognised by CQC. However, this recognition does not appear to have resolved questions of hospitals’ or providers’ legal liability for the actions of consultants. We recommend that the government addresses, as a matter of urgency, this gap in responsibility and liability. Government response – accept in principle. The government is clear that independent sector providers must take responsibility for the quality of care provided in their facilities, regardless of how the consultants are engaged. The Medical Practitioners Assurance Framework (MPAF), published in 2019 by the Independent Healthcare Provider Network (IHPN), was created to improve consistency around effective clinical governance, and to set out provider and medical practitioner responsibilities in the independent sector. CQC will continue to assess the strength of clinical governance in providers as part of its inspection activity, taking account of relevant guidance such as the MPAF. As covered in our response to recommendation 10, we have set out a programme of work that will consider the case for reforms to the provision of indemnity cover. We will use this as our initial approach to dealing with the challenges faced by patients of Ian Paterson in accessing compensation. Recommendation 14 – We recommend that, when things go wrong, boards should apologise at the earliest stage of investigation and not hold back from doing so for fear of the consequences in relation to their liability. Government response – accept. Recommendation 15 – We recommend that, if the government accepts any of the recommendations concerned, it should make arrangements to ensure that these are to be applicable across the whole of the independent sector’s workload (meaning private, insured and NHS-funded) if independent sector providers are to be able to qualify for NHS-contracted work. Government response – do not accept – keep under review. This recommendation, if implemented, would change the way in which independent sector providers qualify for NHS contracts. As demonstrated in our response to the other recommendations, independent sector providers are fully committed to implementing changes alongside NHS providers. They must already meet the same regulatory standards, as required by CQC. We will continue to monitor the independent sector uptake of the other recommendations and we will review our position on this recommendation in 12 months’ time, setting out further steps if necessary. Read full response here Related reading A year on from the Paterson Inquiry: Reflections on the Government’s initial response (Patient Safety Learning, 26 March 2021 Patient Safety Learning’s response to the Paterson Inquiry (11 February 2020)

A 75-year-old patient suffered a stroke in the early hours of the morning. He had woken feeling unwell (two hours after going to bed) and waited to see if his symptoms would improve. They didn’t improve and nearly three hours later, his wife called an ambulance. Before they set off with the patient, one of the paramedics contacted the emergency department (ED) at the first hospital (Trust A) to ‘pre-alert’ them of his arrival. The ED advised that they could not accept the patient as their stroke service was closed between 11pm and 8am, and that the paramedics should contact a neighbouring hospital (Trust B). Trust B advised that they could not take the patient as he was outside of the window for immediate stroke treatment and should be taken to Trust A. Trust A then reiterated that they could not accept the patient. The paramedic phoned Trust B again and they agreed to accept the patient. Once at Trust B, the patient had to wait 40 minutes in an ambulance as the ED was very busy. It was then confirmed by CT scan that he had suffered an ischaemic stroke (a stroke caused by a blood clot in the brain), and he was taken to the intensive care unit. Findings The investigation found that: There was no cross-trust policy in place that clearly defined which FAST-positive patients (patients who show symptoms outlined by the Face, Arms, Speech, Time acronym) should be taken to Trust B overnight. This resulted in different local interpretation of the overnight stroke arrangement. The different local interpretation resulted in the patient being “double bounced” between the two hospitals. Staff stated that this was “not uncommon” but would likely resolve once a centralised regional stroke treatment unit (a hyper-acute stroke unit) is in place. The electronic search tools accessible to ambulance crews provided inconsistent information about the availability of local stroke services. This was particularly confusing for the paramedics in the safety event, who did not routinely work in the local area. When the patient arrived at the hospital, his care was not handed over within the recommended 15 minutes. Recommendations The report makes the following local safety recommendations: HSIB recommends that Trust A and Trust B update the information provided to the Directory of Service on the availability of stroke services once they have created a harmonised cross-trust stroke policy. HSIB recommends that the Ambulance Trust works with Trust A and Trust B to ensure that their local stroke policies are aligned and direct ambulance crews to the most appropriate service. HSIB recommends that Trust B works collaboratively with Trust A to develop a harmonised, cross-trust stroke policy with a clearly defined joint emergency department overnight stroke protocol for FAST-positive patients.

The report provides information on the patient involved and background to the adverse incident, analyses the reasons for the incident and provides recommendations for the administration of intrathecal chemotherapy to prevent a similar incident occurring in the future: Recommendations include: changes to operational practices in pharmacy and ward settings changes to protocols in pharmacy and ward settings the provision of separate prescri0ption charts for intrathecal drugs formal, appropriate training on practical chemotherapy administration for senior house officers and specialist registrars enhanced checking procedures, involving the patient and family as well as medical staff agreed limits on the involvement of staff under supervision or shadowing a targeted communications campaign about the dangers of incorrect administration of Vincristine distinctive and clear labelling for intrathecal drugs the development of a new spinal needle with a different connection, to avoid accidental introduction of intravenous drugs. Related reading Safe administration of intrathecal chemotherapy (2003)

In her report, the coroner highlights two matters of concern in this case: Initial delay in seeing a doctor Mr Collinson was not seen by a Doctor until eight hours after he arrived at hospital. The reason given for this was that the department was highly pressured on this date, and although a junior doctor had assigned the case to them by "clicking", that doctor had not in fact been able to see Mr Collinson. He did not "unclick" the patient and therefore other doctors who may have had capacity were not aware that Mr Collinson had not been seen. The coroner expressed concerns that that the current system for allocating patients requires a manual check to see whether a patient has actually been seen once they have been allocated. She noted that if they are not seen, there is currently no way of other clinicians being aware of that, and therefore patients could be left for long periods of time without being assessed. Flaws in the electronic prescribing system process The doctor who saw Mr Collinson prescribed a prophylactic dose of Enoxaparin rather than the therapeutic dose which she had intended to prescribe. The reason for this was that the electronic prescribing system involves a drop-down box with confusing tables to select the medication. The doctor was under pressure due to the busy department and accepted that this was human error, having accidently selected the wrong medication. The coroner stated that the current electronic prescribing system does not require a doctor to perform a secondary check to ensure that they have selected the correct medication. She expressed concerns that it is easy to select the wrong medication, particularly when the department is busy and doctors are under pressure. She suggests that this could lead to further fatal outcomes for patients if they are given incorrect medication. This report was sent to University Hospitals Birmingham NHS Foundation Trust.

'Dr Lucy Johnstone, one of the lead authors of the Power Threat Meaning Framework, said: "The Power Threat Meaning Framework can be used as a way of helping people to create more hopeful narratives or stories about their lives and the difficulties they have faced or are still facing, instead of seeing themselves as blameworthy, weak, deficient or ‘mentally ill’. It highlights and clarifies the links between wider social factors such as poverty, discrimination and inequality, along with traumas such as abuse and violence, and the resulting emotional distress or troubled behaviour, whether it is confusion, fear, despair or troubled or troubling behaviour. It also shows why those of us who do not have an obvious history of trauma or adversity can still struggle to find a sense of self-worth, meaning and identity.“ In traditional mental health practice, threat responses are sometimes called ‘symptoms’. The Framework instead looks at how we make sense of these experiences and how messages from wider society can increase our feelings of shame, self-blame, isolation, fear and guilt. The approach of the Framework is summarised in four questions that can apply to individuals, families or social groups: What has happened to you? (How is power operating in your life?) How did it affect you? (What kind of threats does this pose?) What sense did you make of it? (What is the meaning of these situations and experiences to you?) What did you have to do to survive? (What kinds of threat response are you using?) Two further questions help us think about what skills and resources people might have and how they might pull all these ideas and responses together into a personal narrative or story: What are your strengths? (What access to Power resources do you have?) What is your story? (How does all this fit together?)' Further reading The British Psychological Society: 'Power, Threat, Meaning Framework' The British Psychological Society: The Power Threat Meaning Framework: (2 page) Summary Boyle M. Johnstone L. A straight talking introduction to the Power threat meaning framework: A alternative to psychiatric Diagnosis. PCCS Books 2020.

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This report is not simply a story about a rogue surgeon. It would be tragic enough if that was the case, given the thousands of people whom Ian Paterson treated. But it is far worse. It is the story of a healthcare system which proved itself dysfunctional at almost every level when it came to keeping patients safe, and where those who were the victims of Paterson’s malpractice were let down time and time again. This video report was streamed live on ITV News on 4th February 2020.

Recommendations from the report 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 independent sector 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. Differences between how the care of patients in the independent sector is organised and the care of patients in the NHS is organised, should be 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 219 Recommendations 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. There should be a short period introduced into the process of patients giving consent for surgical procedures, to allow them time to reflect on their diagnosis and treatment options. We recommend that the GMC monitors this as part of ‘Good Medical Practice’ The 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. Information about the means to escalate a complaint to an independent body is communicated more effectively in both the NHS and independent sector. All private patients should have the right to mandatory independent resolution of their complaint. 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. We recommend that Spire should check that all patients of Paterson have been recalled, and to communicate with any who have not been seen, and that they should check that they have been given an ongoing treatment plan in the same way that has been provided for patients in the NHS. 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 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. 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. 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. If the healthcare professional also works at another provider, any concerns about them should be communicated to that provider. The Government addresses, as a matter of urgency, this gap in responsibility and liability.