Written evidence from NHS England (CLI 04)

Public Administration and Constitutional Affairs Select Committee (PACAC) follow-up inquiry on the PHSO review into the quality of NHS complaints investigations where serious or avoidable harm has been alleged

Background

1. In 2015, the Parliamentary and Health Services Ombudsman (PHSO) conducted a review into how effectively NHS organisations were identifying patient safety incidents, conducting investigations and learning from mistakes. It found that there were serious failings and recommended a number of actions to bring improvements.

2. PACAC is conducting a short inquiry on the issues raised by the PHSO’s report and has invited written evidence from NHS England on the PHSO report. This evidence is provided below.

NHS England’s roles and responsibilities in relation to patient safety

3. To put this evidence in context, it is useful to explain NHS England’s roles and responsibilities in relation to patient safety.

4. Since the abolition of the National Patient Safety Agency in 2012 and the transfer of some patient safety functions to NHS England, the Patient Safety Domain of NHS England has had responsibility for formulating and supporting NHS policy with regards to the local response to patient safety incidents[1] and the response to, and particularly the local investigation of, Serious Incidents[2]. This responsibility includes setting expectations for when and how incidents should be investigated, locally. regardless of how they are identified (whether through recognition and reporting by a member of staff or through a complaint received by an organisation if the circumstances meet the definition of a Serious Incident).

5. NHS England is also currently responsible for related functions, including;
1. the commissioning of a National Reporting and Learning System (NRLS) that collates patient safety incident reports from health care organisations’ own local incident reporting systems (often termed ‘local risk management systems’);

2. the National Patient Safety Alerting System (NaPSAS) that alerts the whole NHS to newly identified patient safety risks and issues, and can provide advice and guidance on risk mitigation, and require organisations to take action; and

3. coordinating and commissioning patient safety improvement initiatives, programmes and advice. This includes overseeing the new Patient Safety Collaborative programme, working with the Health Foundation on the ‘5000 fellows’ initiative, and inputting to clinical programmes looking at issues such as avoidable deterioration (including sepsis), acute kidney injury, healthcare associated infections etc.

6. In relation to patient safety incident investigation and serious incident investigation, the Patient Safety Domain inherited policy responsibility and expertise from NPSA and has continued to promote best practice defined by the NPSA and further developed since its closure.

7. From 1 April 2016, the NHS England patient safety functions described above will be transferred to NHS Improvement, which will be formed from the conjoining of Monitor and the NHS Trust Development Authority.

Terms of Reference for the PACAC inquiry

8. PACAC have advised that they wish to consider the following;

1. The quality and content of the PHSO’s report

2. The PHSO’s recommendations for improving NHS clinical investigations at the local level

3. The role of the proposed new patient safety investigation body, currently known as IPSIS (Independent Patient Safety Investigation Service), in encouraging better clinical investigations and complaint handling

4. Actions that NHS organisations should be taking to ensure that they learn from serious clinical incidents and use this learning to improve their services

9. Evidence in relation to each of these topics from NHS England’s perspective is discussed in more detail below.

1. The quality and content of the PHSO’s report

10. NHS England welcomes the PHSO’s report as a contribution to our understanding of where the NHS needs to improve its response to things going wrong in healthcare. Undoubtedly, local investigations in the NHS need to be better and carried out to a more consistently high standard. The PHSO report contributes to our understanding of this issue.

11. The report does contain some inconsistencies with existing policy and some aspects that would benefit from further clarity:

• It defines patient safety incidents as low or moderate harm incidents. Actually patient safety incidents are defined as any unintended or unexpected incident that could have or did lead to harm for one or more patients receiving NHS-funded healthcare. They therefore include no harm/near miss incidents as well as those leading to severe harm and death.
• The PHSO asks whether investigations ‘get to the root cause’. However, there often is no single root cause to an incident – causes are often multiple and/or not traceable to a single factor.
• The PHSO suggests that in 73% of cases it found ‘failings’ where providers found none. It is unclear how this was determined. We understand that officials from PHSO attended a short Root Cause Analysis course identified by NHS England recently. It would be helpful to understand if this informed the judgments PHSO has made about investigation quality and how PHSO assess its own competence in investigation.
• The PHSO states that serious incidents are not being reliably identified by trusts; they judged 28 of the cases looked at to be serious enough to lead to a serious incident investigation, but only 8 had been treated as such by the relevant organisation(s). However, identification and declaration of a serious incident is, by definition, a judgement and it is difficult to know why PHSO’s judgement differed from the trusts in question and whether it is possible to state that one or other was correct.
• Identification of incidents, of whatever type, is a very context dependant process. It is affected by the individuals in place at the time, the culture they work in, the types of incident in question, the ease of reporting, the likely response to reporting, the ease of identification of the incident, previous experience of incident reporting, the potential impact of reporting on teams or colleagues and other factors. For that reason it is not possible to state an ‘expected’ level of reporting. Instead all reporting should be encouraged and supported.
• The PHSO states there is no national guidance for patient safety incident investigations. We are not clear whether the PHSO is aware of the Root Cause Analysis framework for patient safety investigation in the NHS. This provides the information the PHSO call for. More information is available at http://www.nrls.npsa.nhs.uk/resources/collections/root-cause-analysis/
• The PHSO’s methodology involved them considering 288 cases about the NHS in England that they had investigated in 2014. By definition, this sample only includes cases where patients were sufficiently dissatisfied to escalate their concerns to the PHSO. It does not take account of cases where escalation to the PHSO did not happen. As such, while the PHSO clearly identify unacceptable shortcomings, it is unclear whether the failings described can be fully extrapolated to the wider NHS, at least in terms of their scale.

2. The PHSO’s recommendations for improving NHS clinical investigations at the local level

12. PHSO made the following recommendations;

• IPSIS and NHS England should consider how the role of NHS complaints managers and investigators can be better recognised, valued and supported. This includes working with others to develop a national accredited training programme.
• To support all investigations to be carried out to a consistent and high quality, IPSIS should develop and champion broad principles of a good investigation. The emphasis should be on building capability and capacity at a local level whilst also allowing for flexibility and proportionality.
• IPSIS should work with others to lead, inspire and share learning from its own investigations in order to improve the capability of the local NHS. This includes demonstrating to organisations how they can take what they have learned from one investigation and apply it not just across divisions within a hospital, but across organisations too.
• Trusts should demonstrate to their boards that they have clear objectives both for their organisations and their staff to be open and honest, learn from investigations, and resolve complaints. Boards should be using My Expectations to assess to what extent local complaints services are meeting the needs of people who use the service.
• The Department of Health and NHS England should work with IPSIS to make clear who has accountability for conducting quality NHS investigations at a national and local level. The different roles of organisations that provide care, commissioners, regulators including NHS Improvement, should be clearly outlined.

13. NHS England agrees that the role of investigators in the NHS is a crucial one that must be recognised as such. As set out in the NHS Serious Incident Framework published by NHS England in March 2015, providers ‘’must ensure robust systems are in place for recognising, reporting, investigating and responding to Serious Incidents and for arranging and resourcing investigations’’. Providers also have to ensure ‘’investigations are undertaken by appropriately trained and resourced staff and/or investigation teams that are sufficiently removed from the incident to be able to provide an objective view’’

14. NHS England’s Serious Incident Framework also sets out the skills and resources that must be available to investigators. For ease, this is set out below;

‘’The investigation team should have a Lead Investigator with accountability to the appropriate Manager/ Director/ Chief Executive. It is essential to identify team members with:

• Knowledge of what constitutes an effective systems investigation process, and  the skills/ competencies to lead and deliver this;
• Skills/ competencies in effective report writing and document formulation;
• Expertise in facilitating patient/family involvement
• Understanding of the specialty involved – this often requires representation from more than one professional group to ensure investigation balance and credible;
• Responsibility for administration and documentation (or for there to be adequate administrative and IT support);
• Knowledge/ expertise in media management and a clear communication strategy – or access to this specialist support via the organisation’s communications team (see Appendix 7);
• Access to appropriate legal and/or information governance support where appropriate;
• Access to competent proof-reading services where required; and
• Appropriate links/mechanisms to share lesson locally and nationally during the investigation as required.

15. It is not within NHS England’s remit to provide training and as such this aspect of the recommendation is better responded to by the Department of Health. However, NHS England notes that there are a number of providers of investigation training in existence, many of whom use the recognised and recommended Root Cause Analysis tools, guidance and techniques that were developed by the NPSA and which are available at http://www.nrls.npsa.nhs.uk/resources/collections/root-cause-analysis/

16. NHS England understands that an Expert Advisory Group is currently formulating advice for the Secretary of State in relation to the form and function of the new investigation branch and so will not comment further on those recommendations.

17. In terms of responsibilities in relation to investigations, the NHS Serious Incident Framework sets out relevant accountabilities for conducting quality investigations in the NHS. These are as follows:

18. Providers are responsible for the safety of their patients, visitors and others using their services, and must ensure robust systems are in place for arranging and resourcing investigations and must ensure robust systems are in place for recognising, reporting, investigating and responding to serious incidents.

19. Commissioners are accountable for quality assuring the robustness of their providers’ Serious Incident investigations and the development and implementation of effective actions, by the provider, to prevent recurrence of similar incidents. Commissioners do this by evaluating investigations and gaining assurance that the processes and outcomes of investigations include identification and implementation of improvements that will prevent recurrence of serious incidents.

20. CCGs have systems in place to appropriately manage serious incidents in the care they commission. They are responsible for reviewing trends, analysing quality and identifying issues of concern. They have a responsibility for providing the wider system with intelligence gained through their role as direct commissioners and leaders of the commissioning system. NHS England supports this function, including exploiting opportunities provided from involvement and participation in local and regional Quality Surveillance Groups.

21. The CQC makes authoritative judgements on the quality of health and care services, according to whether they are safe, effective, caring, responsive and well-led. The chief inspectors rate the quality of providers accordingly, and clearly identify where failures need to be addressed.  They have a role in encouraging improvement and may use the details of incident reports, investigations and action plans to monitor organisations’ compliance with essential standards of quality and safety, to assess risks to quality and to respond accordingly. The CQC works closely with commissioners and providers to gather intelligence and information as part of their pre-inspection process. The Health and Social Care Act sets specific requirements for registered organisations in relation to the type of incidents that must be reported to them. 

22. As a new organisation formed by the conjoining of the NHS Trusts Development Authority, Monitor, and certain NHS England functions including the patient safety function, NHS Improvement will need to set out its responsibilities in relation to safety investigations. NHS Improvement will act as the host body for the new investigation function, but we understand that the investigation branch will likely be operationally independent. More detail on the operation of NHS Improvement and the investigation function will be provided by NHS Improvement in due course.

Complaints

23. A number of reports over the last five years have documented some of the challenges affecting complaints handling in the NHS. System partners have come together and have:

• Reviewed education and training programmes: education and training tools have been produced by HEE (a complaints e-learning programme) and the Royal College of Nursing. These are currently being reviewed.
• Used contractual levers for change: added new commitments to the NHS Standard Contract on promoting information about how to complain locally and where to get advocacy support.
• Added complaints to CQC inspections: complaints now form part of every inspection in primary, secondary and social care.
• Developed information on how to complain: with the Department of Health produced a national advice guide and templates for posters in every hospital.
• Defined what ‘good’ looks like: the Ombudsmen and HealthWatch set of expectations defining what a ‘good’ complaints experience feels like from patient perspective by publishing My Expectations
• Worked together on a range of initiatives to help drive up standards in complaints handling and better monitor feedback from complainants: NHS England and PHSO has commissioned Picker Europe to develop a standardised way of measuring complainant satisfaction in primary and secondary care. NHS England has also published a Quality Framework for Complaints Handling to deliver better quality and a more consistent approach to the handling of complaints made to NHS England
• Worked to review information held by organisations to better triangulate data: including initially triangulating data from the GP Patient Survey and complaints data reported annually and held by the Information Centre (KO41 returns), with the intention to adding other data from incidents and other demographic information in 2016.

24. Whilst it is clear that work is being undertaken at a national level much of the responsibility for taking action rests locally, therefore, ensuring there is the right culture in individual organisations is crucial. NHS Chief Executives and Boards, local providers and commissioners must each take responsibility for ensuring their organisation is making full use of patient and other forms of public feedback.

25. Each organisation should use this feedback to improve experience and service quality over time, openly encouraging and welcoming feedback from more vulnerable people and their representatives.

3. The role of the proposed new patient safety investigation body

26. NHS England understands that an Expert Advisory Group is currently formulating advice for the Secretary of State in relation to the form and function of the new investigation branch and so will not comment further on this.

4. Actions that NHS organisations should be taking to ensure that they learn from serious clinical incidents and use this learning to improve their services

27. The primary aim of investigations in the NHS is to learn from incidents and determine what can be done to significantly reduce the likelihood of recurrence; the aim is not to apportion blame. As mentioned, Root Cause Analysis (RCA) is a method of incident investigation that allows a ‘systems approach’ to investigation and was selected as the method of choice by the National Patient Safety Agency when developing a framework for patient safety investigation in the NHS. This NHS approach is very closely aligned with best practice investigation methodology in use in healthcare and other high-risk industries across the globe.

28. RCA is a diagnostic tool rather than a safety solution in itself. Just as diagnosis provides the key to clinical effectiveness, so identifying root causes and contributory factors provide a key approach for developing improvements in patient safety. Given the RCA investigation methodology is characterised by a systems approach (i.e. looking at the role of systems in the incident rather than solely looking at the role of individuals), any investigation that focusses only on individuals is not consistent with RCA.

29. Appropriate external or objective scrutiny can be introduced into these investigations through the use of investigation leads and subject matter experts from other directorates/departments or organisations, or from oversight panels.

30. For serious incidents, NHS policy is that an investigation must take place according to good practice methodologies, such as RCA, and that providers are accountable to the commissioner of the care within which the serious incident occurred for ensuring they undertake a robust response. Providers are accountable for their response to serious incidents in order to ensure the processes and outcomes of serious incident investigations include the identification and implementation of improvements that will prevent recurrence of serious incidents.

31. As part of this process providers have responsibilities in relation to serious incident management, include supporting and engaging with those affected.  Early, meaningful and sensitive engagement with those affected, from the point at which a serious incident is identified, throughout the investigation, report formulation and subsequent action planning through to closure of the investigation process is an essential part of the process.

32. Fully independent investigations are investigations where the investigator and all members of the investigation team are independent of the provider in question and where the investigation is commissioned independently of the organisation whose actions and processes are being investigated. Fully independent investigations are not commonly required but should be considered where the integrity of the investigation is likely to be challenged or where it will be difficult for an organisation to conduct an objective investigation internally due to the size of organisation or the individuals and/or number of organisations involved. Independent investigations are usually commissioned for mental health homicides and some mental healthcare related suicides of concern, and for issues of significant national concern or public interest, or where provider organisations choose to outsource duties to investigate in this way for reasons of objectivity or operational integrity.

33. It is important to recognise that the end of the investigation process simply marks the start of the improvement phase. The NHS Serious Incident Framework therefore sets out that investigations must conclude with an investigation report and action plan. The Framework requires reports to:

• Be simple and easy to read;

• Include evidence and details of the methodology used for an investigation (for example timelines/cause and effect charts, brainstorming/brain writing, nominal group technique, use of a contributory factor Framework and fishbone diagrams, five whys and barrier analysis);
• Identify root causes and recommendations;
• Ensure that conclusions are evidenced and reasoned, and that  recommendations are implementable (see section 4.4.2. below);
• Include a description of how patients/victims and families have been engaged in the process.

34. The Framework recommends use of national reporting templates, including use of the NPSA Action Plan template available online: http://www.nrls.npsa.nhs.uk/resources/collections/root-cause-analysis/

35. The Serious Incident Framework states that the minimum requirements for an action plan include the following:

• Action plans must be formulated by those who have responsibility for implementation, delivery and financial aspects of any actions (not an investigator who has nothing to do with the service although clearly their recommendations must inform the action plan);
• Every recommendation must have a clearly articulated action that follows logically from the findings of the investigation;
• Actions should be designed and targeted to significantly reduce the risk of recurrence of the incident. It must target the weaknesses in the system (i.e. the ‘root causes’ /most significant influencing factors) which resulted in the lapses/acts/omissions in care and treatment identified as causing or contributing towards the incident;
• A responsible person must be identified for implementation of each action point;
• There are clear deadlines for completion of actions;
• There must be a description of the form of evidence that will be available to confirm completion and also to demonstrate the impact implementation has had on reducing the risk of recurrence;

36. A SMART approach to action planning is essential. That is, the actions should be: Specific, Measurable, Attainable, Relevant and Time-bound. To ensure that the most effective actions/solutions are taken forward, it is recommended that an option appraisal of the potential actions/solutions is undertaken before the final action plan is developed and agreed

37. It is important that providers and commissioners monitor and progress with long term actions, particularly where these address the causes contributing to other incidents across the system.

38. Patients and families may wish to maintain their involvement with the organisation after the investigation is closed and where this is the case, they can help provide effective assurance that action is being taken and that lessons are really being learned. Opportunities for future involvement should be made available where this would be welcomed.

39. In order to prevent issues from being considered in isolation and common trends from being missed, investigation reports and action plans should also be reviewed collectively by providers on a regular basis. A more collective approach can help to make the delivery of multiple action plans more manageable and can also help inform wider strategic aims for the organisations involved.

40. A decade ago, the NHS faced an ‘evidence gap’. However, as a result of the work to develop investigation policy, the NHS has moved beyond this point and there is no doubt that the NHS’s response to patient safety incidents and serious incidents is far better than it was a decade or more ago.

41. While much more is known about how to improve care and safety, the implementation of patient safety interventions is still in its infancy however and is not yet as effective as desired[3].