Title Investigations, Analysis & Improvement Policy

Document Control Title Investigations, Analysis & Improvement Policy Author Investigations Advisor Head of Corporate Governance Directorate Strategy & Transformation Date Version Status Issued Author s job title Investigations Advisor Head of Corporate Governance Department Corporate Governance Comment / Changes / Approval 0.1 11.09.15 Draft Initial version for consultation 0.2 14.01.16 Draft Amended version for consultation 0.3 08.02.16 Final draft 1.0 15.04.16 Final Amended version for publishing Main Contact Tel: Direct Dial 01271 349596 Head of Corporate Governance Suite 1 Munro House North Devon District Hospital Raleigh Park Barnstaple, EX31 4JB Lead Director Director of Strategy & Transformation Superseded Documents Incident Management and Investigation Policy Issue Date Review Date April 2016 April 2019 Consulted with the following stakeholders: (list all) Executive Directors Head of Quality & Safety Divisional General Managers Specialist Advisors Senior Nurses / Matrons Clinical Directors Corporate Governance Teams Approval and Review Process Quality Assurance Committee Approved at Quality Assurance Committee 08.02.16 with minor amends Review Cycle Three years Local Archive Reference G:\Corporate Governance\Shared folders\meetings\quality Assurance Committee\QAC 2015-16\09.02.16\Agenda Item 6.1 - Investigations, Analysis & Improvement Policy.docx Local Path G:\Corporate Governance\Shared folders\meetings\quality Assurance Committee\QAC 2015-16\09.02.16\Agenda Item 6.1 - Investigations, Analysis & Improvement Policy.docx Filename Investigations, Analysis & Improvement Policy v0.3 approved 09.02.16 Corporate Governance Page 1 of 35

Policy categories for Trust s internal website (Bob) Corporate Governance Serious Incidents Requiring Investigation Tags for Trust s internal website (Bob) SIRI, SEA, risk, serious incident, escalation, governance, investigation, Never Event, incident, candour Corporate Governance Page 2 of 35

CONTENTS Document Control... 1 1. Purpose... 5 2. Trust statement on incident management and investigation... 6 3. Responsibilities... 6 Role of the Director of Strategy & Transformation... 6 Role of Head of Corporate Governance... 7 Role of Head of Quality and Safety... 7 Role of Investigation Chair... 7 Role of Investigation Leads... 8 Role of the Serious Incident Review Group... 8 Role of Specialist Advisers... 8 Role of All Staff... 8 Role of the Quality Assurance Committee (QAC)... 9 4. Definitions... 9 Incident... 9 Harm (actual rather than potential)... 9 Datix system... 10 Specialist advisers... 10 Serious incident requiring investigation (SIRI)... 10 Never Event... 10 STEIS... 11 Incident decision tree... 11 Significant event audit (SEA)... 11 Root cause analysis (RCA)... 11 Working days... 11 Candour... 12 Root Cause... 12 Contributory Factor... 12 Lessons Learnt... 12 5. Immediate response to serious incidents... 12 6. Serious incidents requiring immediate escalation... 13 North Devon District Hospital, Northern Community Hospitals, Community Teams and Services... 13 Exeter, East and Mid Devon Community Hospitals, Community Teams and Services... 13 Public health hazard... 14 7. The incident escalation process... 14 Identifying events that require investigation... 14 Review of incidents... 14 8. The Serious Incident Framework... 16 Level 1 Concise internal investigation... 16 Level 2 Comprehensive internal investigation... 16 Level 3 Independent investigation... 17 9. The serious incident investigation (SIRI) process... 17 Corporate Governance Page 3 of 35

10. Approval of the serious incident report... 19 11. The significant event audit (SEA) and root cause analysis (RCA) investigation process... 19 12. Risks and actions identified through investigations... 21 13. Analysis, learning and improvement... 21 Quarterly reports... 21 Triangulation of data... 21 Sharing the learning... 22 Monitoring improvement... 22 14. Monitoring Compliance with and the Effectiveness of the Policy... 22 Standards/ Key Performance Indicators... 22 Serious incident reporting and investigation... 22 Significant event audits... 23 15. Equality Impact Assessment... 24 16. References... 24 17. Associated Documentation... 25 Corporate Governance Page 4 of 35

1. Purpose 1.1. The purpose of this document is to help ensure that the organisation is using serious incident investigations effectively and delivering meaningful learning to support the quality and safety of patient care and patient experience. 1.2. This document details the processes in place that support this purpose whilst ensuring that the Trust responds to and manages serious incidents appropriately, and meets nationally recognised best practice for the investigation and analysis of incidents. 1.3. The Incident Management Policy details the process for incident reporting and should be viewed in conjunction with this policy. 1.4. Implementation of this policy will ensure that: The response to serious incidents is appropriate and timely. There is early, meaningful and sensitive engagement with affected patients and/or their families/carers, from the point at which a serious incident is identified. Serious incidents are reported in a timely fashion and there is appropriate and proportionate liaison with the Clinical Commissioning Group. Incidents are managed and investigated in the most effective and appropriate way, minimising risks to patients, their families, carers and staff. Serious incident investigations are undertaken by appropriately trained and resourced staff who are sufficiently removed from the incident to be able to provide an objective view. The investigation and analysis of incidents follow a consistent, systems-based approach and focus on identification of learning to inform changes to practice and procedures to eliminate or minimise associated risks. There are mechanisms in place to ensure that actions from action plans are SMART (specific, measurable, attainable, relevant, time-bound), monitored until implemented, and there is demonstrable evidence that the action plan has resulted in the anticipated practice or system improvement. Quality assurance processes are in place to ensure completion of high quality investigation reports and action plans to enable timely learning and to prevent or minimise the risk of recurrence. There are mechanisms and effective communication channels to facilitate the sharing of lessons learned across the organisation and more widely where required. 1.5. The policy applies to all Trust staff directly and indirectly employed within the Trust and has been designed to ensure that staff know how to respond to a serious incident, how the investigations process is managed, and understand their responsibility and role if involved in an investigation. 1.6. This policy does not over-ride existing lines of accountability nor does it replace the duty to inform the police and/ or other organisations or agencies where appropriate. Corporate Governance Page 5 of 35

2. Trust statement on incident management and investigation 2.1. In a service as large and complex as the NHS, things will sometimes go wrong and sometimes users will not be satisfied with their level of care. When this happens, the response should not be one of blame and retribution, but of learning and a drive to reduce risk and improve the service for future patients, visitors and staff. 2.2. When a serious event or incident occurs we need to ensure there are systematic measures in place for safeguarding patients, staff, property, NHS resources and the reputation of the organisation and wider NHS. This includes the responsibility to learn from these incidents to improve the quality and safety of patient care and minimise the risk of them happening again. 2.3. A robust approach to investigation, analysis, and learning from incidents is required in order to identify how something happened and what recommendations/solutions should be put into place to avoid future recurrence. 2.4. There are no exceptions to the Trust's commitment to reporting and learning from incidents and it is therefore expected that all staff will comply with this policy. In addition, there is an understanding by the Trust that learning requires open, honest and timely reporting. This can only be achieved within an open and fair blame culture in which no disciplinary action will result from reporting incidents (including serious incidents) unless the incident is malicious, negligent and/or criminal, i.e. where one or more of the following applies: The incident has resulted in a police investigation that results in a prosecution; There are repeated occurrences involving the same individual; or In the view of the Trust and/ or any professional body, the action causing the incident was far removed from acceptable practice, constituting gross misconduct. 2.5. Investigations are conducted for the purposes of learning to support delivery of safe, high quality care and prevent recurrence. They are not conducted to hold any individual to account. Other processes exist for that purpose including criminal proceedings, disciplinary procedures, employment law and systems of service and professional regulation, such as the Care Quality Commission and the Nursing and Midwifery Council (NMC), the Health and Care Professions Council (HPC), and the General Medical Council (GMC). 2.6. This organisation advocates justifiable accountability and a zero tolerance for inappropriate blame. The Incident Decision Tree will be used to promote fair and consistent staff treatment within the context of this policy. 3. Responsibilities Role of the Director of Strategy & Transformation 3.1. The Director of Strategy & Transformation is responsible for: Corporate Governance Page 6 of 35

Ensuring that the Trust s incident reporting and management processes are robust and effective; and Ensuring that non-compliance with this policy is addressed with individuals and teams as appropriate. Role of Head of Corporate Governance 3.2. The Head of Corporate Governance is responsible for: Ensuring that systems are in place to identify and learn from clinical and nonclinical incidents and near misses; Ensuring that the correct incidents are investigated in terms of learning and contributing to the quality and safety agenda; and in line with national requirements; Supporting development of a culture of fair blame, learning from mistakes and adopting best practice and ensuring this is promoted through serious incident investigations; Providing advice and support to the Investigation Chair and Leads; and Liaising with and reporting to the NEW Devon CCG. Role of Head of Quality and Safety 3.3. The Head of Quality & Safety is responsible for: Ensuring that the correct incidents are investigated in terms of learning and contributing to the quality and safety agenda; and in line with national requirements; Supporting development of a culture of fair blame, learning from mistakes and adopting best practice and ensuring this is promoted through serious incident investigations. Role of Investigation Chair 3.4. The Investigation Chair for serious incident investigations is responsible for: Understanding the incident which they have been nominated to investigate; Supporting the Investigation Leads throughout the investigation, unblocking barriers to engagement in the process and timely completion; Ensuring that the incident is fully investigated and the methodologies used are appropriate to maximise learning; Chairing the round table review meeting where this is used as part of the investigation; Reviewing and approving the final draft investigation report ensuring it is clear, comprehensive, and that the supporting action plan is SMART and will deliver changes that will reduce the risk of a similar event occurring; and With the responsible clinician, sharing investigation reports and findings with the patient and/or their family as appropriate. Corporate Governance Page 7 of 35

Role of Investigation Leads 3.5. The Investigation Leads for serious incident investigations are responsible for: Understanding the incident which they have been nominated to investigate; Using methodologies appropriate to the incident to maximise learning; Developing robust recommendations and sharing the report with the relevant team(s) and subject specialists for them to develop a SMART action plan before the draft report is finalised; Providing a comprehensive structured and clear investigation report that sets out the investigation team s findings, conclusions and recommendations; Sharing the draft investigation report with all relevant staff/departments to share the learning; Presenting the final draft report to the Serious Incident Review Group; and Meeting deadlines for completion of the investigation to ensure statutory timescales are met for submission of the final draft report to the NEW Devon CCG. Role of the Serious Incident Review Group 3.6. The role of the Serious Incident Review Group is to provide assurance that serious incident processes are robust, effective and delivering learning and improvement to support safe, high quality care and to facilitate the timely delivery of investigations across the organisation. Role of Specialist Advisers 3.7. The role of the specialist advisers is to review all incidents they have been notified of and request escalation for investigation following their review of an incident where they have identified concerns. Role of All Staff 3.8. All staff are responsible for: Ensuring that immediate action is taken to prevent further harm or a repeat incident; Escalating potential serious incidents to their line manager at the time of the incident; Reporting all incidents as soon as possible; Complying with this policy; Supporting the open and fair blame culture towards incidents and investigations and supporting the investigation process appropriately; and Actively working towards sharing and embedding the learning identified from incidents and investigations. Corporate Governance Page 8 of 35

Role of the Quality Assurance Committee (QAC) 3.9. The Quality Assurance Committee is responsible for: Receiving serious incident investigation reports and ensuring they have sufficient assurance that a robust investigation has been carried out and that the supporting action plan will address the recommendations and mitigate the identified risks. Approving serious incident investigation reports before ratification by the Trust Board. Receiving quarterly serious incident investigation reports identifying trends and themes and changes in working practice. 4. Definitions Incident 4.1. An incident may be defined as any event that has given rise to actual or possible harm such as injury, patient dissatisfaction, property loss or damage. Examples of this are a patient or a staff injury; distress or death due to clinical error; noncompliance with Trust policy incidents where equality discrimination has occurred; a theft or fraud; a health and safety injury. Harm (actual rather than potential) 4.2. Moderate harm: Any patient safety incident that resulted in a moderate increase in treatment (e.g. the length of a hospital stay increased by four to 15 days) and which caused significant but not permanent harm to persons receiving NHS-funded care. Moderate increases in treatment may mean an unplanned return to surgery, an unplanned re-admission, a prolonged episode of care, extra time in hospital or as an outpatient, cancelling of treatment, or transfer to another treatment area (such as intensive care); 4.3. Serious harm (as defined in the NHS England Serious Incident Framework): Severe harm (patient safety incident that appears to have resulted in permanent harm to one or more persons receiving NHS-funded care); Chronic pain (continuous, long-term pain of more than 12 weeks or after the time that healing would have been thought to have occurred in pain after trauma or surgery ); or Psychological harm, impairment to sensory, motor or intellectual function or impairment to normal working or personal life which is not likely to be temporary (i.e. has lasted, or is likely to last for a continuous period of at least 28 days). 4.4. Prolonged psychological harm: Psychological harm experienced for a period of 28 days or more. Corporate Governance Page 9 of 35

Datix system 4.5. The DATIX system is a risk management system used by the Trust to record information on the following modules: Incidents Risks Complaints Claims Patient Advice and Liaison Service Freedom of Information Specialist advisers 4.6. The Specialist Advisers have a professional responsibility to advise the organisation on statutory and national guidance. They include but are not restricted to: Resuscitation Lead Fire and Security Adviser Local Security Management Specialist Health and Safety Manager Tissue Viability Lead Infection Control Nurse Head of Information Governance Safeguarding Adults Lead Named Nurse Safeguarding Children & Young People Serious incident requiring investigation (SIRI) 4.7. In broad terms, serious incidents are events in health care where the potential for learning is so great, or the consequences to patients, families and carers, staff or organisations are so significant, that they warrant using additional resources to mount a comprehensive response. Serious incidents can extend beyond incidents which affect patients directly and include incidents which may indirectly impact patient safety or an organisation s ability to deliver on-going healthcare. 4.8. A full definition is included in the NHS England Serious Incident Framework published on 27 March 2015. Never Event 4.9. Never Events are a subset of serious incidents that meet all the following criteria: They are wholly preventable, where guidance or safety recommendations that provide strong systemic protective barriers are available at a national level, and should have been implemented by all healthcare providers. Corporate Governance Page 10 of 35

Each Never Event type has the potential to cause serious patient harm or death. However, serious harm or death is not required to have happened as a result of a specific incident occurrence for that incident to be categorised as a Never Event. There is evidence that the category of Never Event has occurred in the past, for example through reports to the National Reporting and Learning System (NRLS), and a risk of recurrence remains. Occurrence of the Never Event is easily recognised and clearly defined this requirement helps minimise disputes around classification, and ensures focus on learning and improving patient safety. 4.10. Full details and definitions are available in the NHS England Revised Never Events Policy and Framework published on 27 March 2015. STEIS 4.11. The Strategic Executive Information System (STEIS) developed by the Department of Health and used to report serious incidents requiring investigation and manage them to completion. Incident decision tree 4.12. The incident decision tree (IDT) is an online tool devised by the National Patient Safety Agency (NPSA) to help support fair and consistent staff treatment within and between healthcare organisations. Link to IDT - http://www.nrls.npsa.nhs.uk/resources/?entryid45=59900 Significant event audit (SEA) 4.13. A structured tool to investigate events in a systematic and detailed way to ascertain what can be learnt from the overall quality of care and to indicate changes that might lead to future improvements. Root cause analysis (RCA) 4.14. A structured investigation following National Patient Safety Agency (NPSA) guidance that aims to identify the true cause of a problem and identify learning and the actions necessary to either eliminate or significantly reduce risk. RCA is the process used for undertaking systems-based investigations that explore the problem (what?), the contributing factors to such problems (how?) and the root cause(s)/fundamental issues (why?) Working days 4.15. Days that exclude weekends and bank holidays calculated from 23:59 on the day the incident is raised to 23:59 on the day the incident is reported. Corporate Governance Page 11 of 35

Candour 4.16. Any patient harmed by the provision of healthcare services is informed of the fact and an appropriate remedy offered, regardless of whether a complaint has been made or a question asked. Root Cause 4.17. Any action/inaction that, because it occurred meant that the incident was, on the balance of probabilities, bound to occur. Contributory Factor 4.18. Any action/inaction that increased the likelihood of the incident happening, but did not make it certain that it would occur. Lessons Learnt 4.19. Actions or inactions identified during the course of an investigation that had no bearing on the likelihood of the incident occurring, but did not comply with policies, procedures or otherwise recognised best practice. 5. Immediate response to serious incidents 5.1. The immediate response to an incident will depend on its severity. In all instances, the first priority is to ensure the needs of individuals affected by the incident are attended to, including any urgent clinical care which may reduce the harmful impact. Staff must: Take immediate action to manage the incident and prevent further harm, e.g. make area safe, quarantine affected equipment, remove patient / staff member from harm, isolate hazard. Ensure appropriate medical assessment and treatment is provided as necessary. Ensure all concerned are safe and supported. In the event of an incident involving a machine or equipment, the device must be taken out of service immediately, retained for inspection and clearly identified with a label. The equipment should be left exactly as it was at the time of the incident and no adjustments or intervention must be made unless required for safety reasons. Details of the equipment involved must be recorded on the incident form, including the bar code where relevant. Retain any relevant evidence related to the incident that may be required for further investigation (e.g. medication packaging). Copy and secure all relevant documentation to preserve evidence to facilitate any investigation and maximise learning. Make a decision about the seriousness of the incident and whether they need to inform their senior manager and lead professional. Corporate Governance Page 12 of 35

Seek extra help or specialist support if required. Ensure an incident report is completed, with further statements of fact if necessary, as soon after the event as possible and within 24 hours. 6. Serious incidents requiring immediate escalation 6.1. In the case of a serious incident that requires immediate escalation, e.g. unexpected death or major outbreak of a serious infectious disease, it should be reported immediately irrespective of the time of day. North Devon District Hospital, Northern Community Hospitals, Community Teams and Services The ward/department/team/service must immediately notify the Clinical Site Management Team via Bleep 500. They must also immediately notify the relevant divisional management team. The Clinical Site Management Team must inform the Duty Manager / Manager on call (if out of hours) as soon as possible, but within 15 minutes of receiving notification. If the incident occurs out of hours, the Executive Director on-call and Manager on-call must be informed without delay via the Clinical Site Management Team. Where appropriate the Chief Executive, Consultant in charge and Medical Director or Director of Nursing must be informed of the incident as soon as possible, via line management and/or on-call arrangements. An incident report should be completed as soon as possible. Exeter, East and Mid Devon Community Hospitals, Community Teams and Services The ward/department/team/service must immediately notify the Clinician on call via Devon Doctors on 01392 269460 as soon as possible. They must also immediately notify the relevant divisional management team. The Clinician on call must inform the Duty Manager / Manager on call (if out of hours) as soon as possible, but within 15 minutes of receiving notification. If the incident occurs out of hours, the Executive Director on-call and Manager on-call must be informed without delay via the Clinical Site Management Team. Where appropriate the Chief Executive, Consultant in charge and Medical Director or Director of Nursing must be informed of the incident as soon as possible, via line management and/or on-call arrangements. An incident report should be completed as soon as possible. Corporate Governance Page 13 of 35

Public health hazard Special action must be taken in the event of a public health hazard such as a major incident, chemical contamination or nuclear emergency. Specific national guidance governs arrangements for dealing with major incidents. Local arrangements are detailed in the Trust s Incident Response Plan. 6.2. Appropriate remedial action should be taken for all incidents as soon as possible after the incident has occurred regardless of whether the incident is subsequently escalated for investigation or not. 7. The incident escalation process 7.1. A key part of incident management is investigation. All incidents should be investigated to learn lessons and take remedial action. However, the investigation should be proportionate to the scale or complexity of the incident or near miss and the likelihood of it recurring. The majority of incidents can be followed-up locally by the manager reviewing the incident. Local action may be taken before the incident is closed by the reviewing manager. The relevant incident report on Datix should always be updated as appropriate to provide a complete record of all reviewing and investigation activity for that incident. Expected timescales for the review and closure of incidents on Datix are outlined in the Incident Management Policy. Identifying events that require investigation 7.2. Events or incidents that require investigation to ensure that the organisation is learning and improving are not always recorded on the Datix Incident module. They may be identified through other routes such as notification of an inquest or legal claim; through information received from a formal complaint; or via an enquiry and request to investigate received from the CCG. 7.3. Where no incident has been recorded, the member of staff who has identified the concerns should complete an incident report on Datix with a request that the incident is reviewed for escalation to an investigation. Review of incidents 7.4. All incidents reported via the electronic incident reporting system are reviewed by the Datix and Incident team, the responsible manager for the incident, and if appropriate a specialist adviser and the Patient Safety Team as recorded in the Incident Management Policy. 7.5. Any incident that the Datix and Incident Team review that may be a potential serious incident is forwarded to the Head of Corporate Governance and the Head of Quality and Safety (or their designated deputy) for review. Corporate Governance Page 14 of 35

7.6. If the incident is considered by both reviewers to meet the definition of a serious incident requiring investigation (SIRI) confirmation of the decision is sought from members of the SIRI Review Group. 7.7. Once confirmed as a SIRI, the relevant divisional management team is immediately notified and the incident is reported externally onto the Department of Health Strategic Electronic Information System (STEIS) as a potential SIRI. A 72-hour report is commissioned from the relevant divisional team (see section 9 below). The Trust Development Authority (TDA) is also informed. 7.8. Where a reviewed incident does not meet the SIRI criteria, the options are as follows (See Appendix C for process map): Not for escalation no further action required. This may also apply if there are currently open actions on the corporate risk register that once completed would have prevented this incident from occurring. Not for escalation for local follow up. Actions taken locally should be recorded on Datix. Escalate to the divisional team for Significant Event Audit or Root Cause Analysis investigation see section 11 below. Escalate to the divisional team for 72-hour report (cardiac arrests outside the Emergency Department; safeguarding issues). 7.9. In order to ensure a consistent approach to incidents where investigation may be required outside the SIRI process, the following principles will be applied as appropriate: Was the patient harmed? Was the incident caused by person or process? Is there evidence of local investigation and sufficient local remedial action? If so, what additional learning is there to be gained by investigating further? 7.10. In the event that an incident is not forwarded to the Head of Corporate Governance or the Head of Quality and Safety for review by the Datix and Incident team, there are further safeguards in place for identifying potential serious incidents. All responsible managers, specialist advisers and Patient Safety Officers have a duty to request escalation for investigation following their review of an incident where they have identified concerns. The incident will also be reviewed retrospectively by the Investigations Adviser. Corporate Governance Page 15 of 35

8. The Serious Incident Framework 8.1. The NHS England Serious Incident Framework published in March 2015 is designed to support the NHS in ensuring that robust systems exist for investigating serious incidents so that lessons are learned and appropriate action taken to prevent future harm. It builds on and replaces the National Framework for Reporting and Learning from Serious Incidents Requiring Investigation issued by the National Patient Safety Agency (NPSA, March 2010) and NHS England s Serious Incident Framework (March 2013). 8.2. The revised Framework takes a pragmatic, sensible approach to reporting and learning from serious incidents and whilst the fundamental principles of serious incident management remain unchanged there are some key changes that have been instigated in order to simplify processes and improve the timeliness of reporting and investigating. Most notably, serious incidents must be identified based on the consequences for the patient/family or staff and the potential for learning and prevention of future harm, rather than on a definitive list. For example, under the revised Framework not all grade 3 and 4 pressure damage incidents will meet the serious incident criteria. 8.3. The Framework also advocates striking an appropriate balance between the resources applied to the reporting and investigation of individual incidents and the resources applied to implementing and embedding learning to prevent recurrence. The former is of little use if the latter is not given sufficient time and attention. As a result, there is a greater focus on the production of high quality reports and specifically action plans, with actions now being formulated by those who have responsibility for implementation and delivery. In addition, there should be evidence to demonstrate the improvement made by implementing the actions. 8.4. The Framework recognises three levels of investigation into serious incidents: Level 1 Concise internal investigation 8.5. This is suited to less complex incidents which can be managed by individuals or a small group at a local level. The outcome of this investigation is a concise report which includes the essentials of a credible investigation. To be completed within 60 working days of reporting. Level 2 Comprehensive internal investigation 8.6. This is suited to complex issues which should be managed by a multidisciplinary team involving experts and/or specialist investigators where applicable. The outcome is a comprehensive root cause analysis investigation and report which include all elements of a credible investigation. To be completed within 60 working days of reporting. Corporate Governance Page 16 of 35

Level 3 Independent investigation 8.7. This is required 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 capacity/capability of those available. To be completed within 6 months of reporting. 9. The serious incident investigation (SIRI) process 9.1. Once a serious incident has been designated a potential SIRI and reported onto STEIS the following process will be followed. 72-hour report The investigations team will send an email request to the divisional coordinator and other key members of the divisional team for completion of a 72-hour report. (Appendix D). The divisional co-ordinator will identify a lead for the 72-hour report, notify the investigations team of that lead and follow up progress of the report to ensure compliance with the due date. Following receipt of the 72-hour report by the investigations team, a quality checked copy (redacted where appropriate) will be submitted to the CCG by the Head of Corporate Governance. If following review of the report there is agreement between the Trust and the CCG that the serious incident criteria is not met then the incident can be downgraded. There may be further investigation through an SEA or no further investigation, depending on the 72-hour report findings. Once the SIRI has been agreed with the CCG, the divisional team will be notified along with any relevant specialists. Nomination of Investigators The SIRI Review Group will nominate an Investigation Chair and two Investigation Leads to take the investigation forward. Note: All Investigation Leads will have received formal training in Root Cause Analysis training (Dineen 2011) and will be supported by their Investigation Chair and members of the Investigations Team as appropriate. Investigation process 9.2. The investigation process should be carried out in line with the Root Cause Analysis training supported by the associated book, Six Steps to Root Cause Analysis by Maria Dineen, using the methodology most appropriate for the incident. There are a number of methodologies available. Historically too much emphasis has been placed on the Round Table Review approach to the exclusion of other, potentially more suitable methods. Templates to support investigations 9.3. There is a selection of templates and supporting guidance available on the Corporate Governance pages of the Trust intranet, including the SIRI report and guide. Corporate Governance Page 17 of 35

9.4. It is a legal requirement that the Duty of Candour must be met for all investigations where the patient has come to moderate or severe harm, or suffered prolonged psychological harm. Early contact should be made in the investigation process and it is the responsibility of the clinical team to ensure that Duty of Candour is met. Investigation report 9.5. Care must be taken to ensure that the investigation report and the action plan are written in an accessible and understandable way as it may be shared with the patient and their family. 9.6. Once a draft report has been produced using the template provided, it should be circulated to all those involved in the investigation, reviewed for accuracy and amended accordingly. The aim is to conduct a thorough and robust investigation which is reflected in a high quality report and ultimately an action plan. 9.7. Once the SIRI report content has been agreed by the Investigation Chair and Leads a draft copy of the SIRI report with recommendations is sent to the divisional team in which the incident occurred. They will be responsible for identifying SMART actions from the report recommendations and completion of the action plan. 9.8. Draft SIRI reports should be fully completed and submitted to the Corporate Governance Team within the deadline outlined in the SIRI process schedule (Appendix C) provided to Leads at the start of an investigation. Reports will be returned to the Investigation Leads if not fully completed. Submission of report to CCG 9.9. The final draft copy of the report is submitted to the CCG via the Investigations Team to meet statutory timescales (60 working days from the date the incident was reported via STEIS). 9.10. The CCG will then review the report and action plan to ensure that they provide evidence of a robust investigation with appropriate SMART actions for prevention of future harm. Should the CCG query any of the report contents or challenge elements of the action plan, the Investigations Team will liaise with the Investigation Chair and Leads to ensure an appropriate response. Serious Incident Review Group 9.11. The Serious Incident Review Group will meet regularly and monitor progress on all live SIRIs. In particular they will: Approve the Terms of Reference and confirm the investigating team for any new SIRIs; Recommend the most appropriate methodology to be used; Recommend sources of specialist advice; Facilitate the sourcing of external specialist advice and/or external witnesses; If necessary, provide support to the Investigation Chair and Leads to unblock blockages; Corporate Governance Page 18 of 35

Review the final draft report and action plan and request amendments as appropriate; Recommend approval of the final draft report and action plan to the Quality Assurance Committee. 10. Approval of the serious incident report 10.1. The draft serious incident report is presented in full to: The Trust Solicitor to review and comment (if the incident relates to an inquest or legal claim against the Trust); The Serious Incident Review Group to review and provide assurance that the incident has been robustly investigated and appropriate recommendations and actions identified; The Quality Assurance Committee for approval. 10.2. An executive summary of the serious incident report is presented to the Trust Board for ratification of approval. 10.3. Where a serious incident report is not approved at the Quality Assurance Committee, an agreed date for re-presentation will be agreed at the meeting and recorded in the formal minutes. 11. The significant event audit (SEA) and root cause analysis (RCA) investigation process 11.1. Where an incident has been reviewed by the Head of Corporate Governance and the Head of Quality and Safety and it is not identified as a serious incident but would still benefit from being investigated, the incident is escalated by the Investigations Team for a Significant Event Audit (SEA) or more detailed Root Cause Analysis investigation (RCA). These are structured tools used to investigate events in a systematic and detailed way to ascertain what can be learnt from the overall quality of care and to indicate changes that might lead to future improvement. SEAs and RCA investigations are internal reviews of incidents which do not meet the criteria of a reportable incident under the NHS Serious Incident Framework and are therefore not reported externally through STEIS. 11.2. The Investigations Team will send an email request to the divisional co-ordinator and other key members of the divisional team for completion of an SEA or RCA investigation. A copy of the incident form and the SEA/RCA template (Appendix E) will be attached to the email request, together with a report of any relevant open risks on the Corporate Risk Register. It is the divisional co-ordinator s responsibility to identify a lead for the investigation, to notify the Investigations Team of that lead and follow up progress of the report to ensure compliance with the due date. Corporate Governance Page 19 of 35

11.3. The SEA/RCA report must be completed by the nominated lead with input from relevant specialist advisers and/or senior staff as appropriate and returned to the Investigations Team within 20 working days (SEA) or 60 working days (RCA). 11.4. Investigation reports which are not returned within the deadline will be notified to the Head of Quality & Safety & Head of Corporate Governance and followed up with a reminder to the relevant lead. If no response is received within 5 working days of the first reminder, a second reminder will be sent, which will be copied to the Divisional General Manager. If the Lead does not respond for a third time they will be invited to a meeting with the Head of Quality & Safety or Head of Corporate Governance to explain the reasons for delay and lack of response. All no responses will be reported in the quarterly Analysis Reports to the Safer Care Delivery Committee (SCDC) and Clinical Services Executive Committee (CSEC) as part of performance monitoring. 11.5. The investigations team will review the completed report to ensure that a credible investigation has been undertaken and that the report including the action plan is of sufficient quality to address the learning identified. 11.6. All sections of the SEA/RCA template should be completed and it is the Investigation Team s responsibility to check the report and challenge any aspects that may need completing or amending. The SEA/RCA lead should also liaise with nominated action leads to ensure that the actions are SMART and appropriate. 11.7. The final draft of the SEA/RCA is submitted to the Head of Corporate Governance and the Head of Quality and Safety for review. The purpose of this review is to provide a decision on the subsequent action required. This action may be: Additional information required; No further escalation or investigation required follow up actions to completion; Escalate to a SIRI due to the findings of the preliminary investigation. 11.8. The SEA/RCA investigation and report is also subject to Duty of Candour requirements and may be shared with the patient. Compliance with Duty of Candour will be assessed at the point that the SEA/RCA report is reviewed by the Head of Corporate Governance and the Head of Quality and Safety. The divisional teams will be notified when compliance is required but not yet achieved. 11.9. The relevant divisional teams and specialist advisers are notified by email at each stage of the investigation. Datix is also updated throughout the investigation with key documents and emails. Corporate Governance Page 20 of 35

12. Risks and actions identified through investigations Identifying risks 12.1. The divisional management team and appropriate specialty leads should review existing risks and actions recorded on the Corporate Risk Register and consider whether a new risk has been identified as a result of the investigation. If a new risk is identified, a risk assessment should be completed in the usual way and forwarded to the Risk Team for adding to the Corporate Risk Register. Where appropriate, actions should be cross-referenced to existing risks and action plans to avoid duplication. If no new risk is identified, action plans will be recorded on the Corporate Risk Register and managed in line with established processes. Any identified new risks will be added to the Trust s Corporate Risk Register in the usual way. All actions from incident investigations are performance monitored and followed up monthly by the Risk Team. 13. Analysis, learning and improvement Quarterly reports 13.1. Quarterly serious incident analysis reports and significant event audit reports include both qualitative and quantitative data including the identification of trends and analysis of aggregated trends and themes, identified causal factors, projects planned or on-going to address the identified risks, and any subsequent changes in practice. 13.2. These are presented to the Quality Assurance Committee and Safer Care Delivery Committee respectively. A summary of relevant learning from each report is also presented at the Learning from Patient Experience Group to ensure that strong links with the effect of incidents on patient experience are maintained. Triangulation of data 13.3. The learning from SEA and SIRI investigations will be triangulated wherever possible with other sources such as complaints, legal claims and a variety of patient safety initiatives. Where there is a common theme or a specific concern emerges, the incidents or reports may be aggregated to include a deep dive and the production of an overarching action plan. Corporate Governance Page 21 of 35

Sharing the learning 13.4. Both the SEA and the SIRI templates require the investigating team to record how the learning from that specific investigation will be shared with the relevant operational teams and other key groups. Locally this may include sharing at team meetings, staff supervision and divisional governance meetings as appropriate. The report will be available on Datix for reference but is also sent to the divisional team once the investigation is complete. Completed SIRI reports are also sent to all those involved on the investigation. 13.5. Final versions of SEA and SIRI reports are made available to specialist advisors for reporting back to their specialist committees or groups to ensure the same information is shared across the whole organisation. 13.6. Where appropriate, learning will be shared by a variety of other means. This may be through for example, a Patient Safety Alert or the weekly Chief Executive Bulletin or as an agenda item at a nursing or medical forum. Monitoring improvement 13.7. Copies of reports and action plans arising from serious incident investigations are sent to the Clinical Audit Department by the Risk Lead to ensure that any audit requirements are captured and included in the annual clinical audit programme. This helps to ensure that any changes in practice are measured, have an impact on the quality of care and lead to improvements in quality and safety. 14. Monitoring Compliance with and the Effectiveness of the Policy Standards/ Key Performance Indicators 14.1. The SIRI and SEA processes have different key performance indicators (KPIs) which reflect compliance with individual elements of this policy. Serious incident reporting and investigation 14.2. Key performance indicators comprise: KPI Detail RAG Comment 1 2 Incident reported to STEIS < 2 working days of confirmation Deadline for submission of 72 hour report to CCG met R 74.9% or less A 75% - 84.9% G 85% or more R 89.9% or less A 90% - 94.9% Corporate Governance Page 22 of 35

3 4 Deadline for submission of draft SIRI report to CCG met Number of Never Events reported G 95% or more R 89.9% or less A 90% - 94.9% G 95% or more 0% Significant event audits KPI Detail RAG Comment 1 Number of incidents escalated for SEA N/A 2 Number de-escalated N/A 3 4 Number of incidents on-going and % within timescales Number of no responses to requests for overdue SEA reports R 89.9% or less A 90% - 94.9% G 95% or more Number of draft SEAs R 89.9% or less 5 received/ submitted for SIRI decision and % within A 90% - 94.9% timescales G 95% or more 6 % SEA reports with duty of candour completed (where appropriate) R 89.9% or less A 90% - 94.9% G 95% or more 14.3. Key performance indicators are routinely provided to the Quality Assurance Committee and Safer Care Delivery Committee through the quarterly reports; the Trust s Performance Team, and reported monthly through the Departmental KPI dashboard. 14.4. Divisional performance against SEA timescales is also reported on a quarterly basis through the Clinical Services Executive Committee (CSEC). Corporate Governance Page 23 of 35

15. Equality Impact Assessment 15.1. The author must include the Equality Impact Assessment Table and identify whether the policy has a positive or negative impact on any of the groups listed. The Author must make comment on how the policy makes this impact. Table 1: Equality impact Assessment Age Disability Gender Group Gender Reassignment Human Rights (rights to privacy, dignity, liberty and non-degrading treatment), marriage and civil partnership Pregnancy Maternity and Breastfeeding Race (ethnic origin) Religion (or belief) Sexual Orientation Positive Impact Negative Impact No Impact Comment 16. References Dineen, M (2011) 3 rd edition. Six Steps to Causal Analysis. Consequence UK, Malvern Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 http://www.legislation.gov.uk/ukdsi/2014/9780111117613/contents Information Governance Toolkit, Department of Health https://www.igt.hscic.gov.uk/ NDHCT Clinical Risk Management Standards formerly NHS Litigation Authority (2007) Risk Management Standards for acute Trusts Revised Never Events Policy and Framework. NHS England (2015) http://www.england.nhs.uk/wp-content/uploads/2015/04/never-evnts-polframwrk-apr.pdf Incident decision tree, NHS England http://www.nrls.npsa.nhs.uk/resources/?entryid45=59900 Corporate Governance Page 24 of 35

17. Associated Documentation Being Open and Duty of Candour Policy (2015) http://ndht.ndevon.swest.nhs.uk/policies/wpcontent/uploads/2013/06/being-open-duty-of-candour-v5.0-24mar15.pdf Incident management Policy (2014) http://ndht.ndevon.swest.nhs.uk/policies/wpcontent/uploads/2013/11/incident-management-policy-v2-0-21nov14.pdf Incident Response Plan (2015) http://ndht.ndevon.swest.nhs.uk/policies/wpcontent/uploads/2011/08/incident-response-plan-v5-1-12jan15.pdf Information Governance Policy http://ndht.ndevon.swest.nhs.uk/policies/wpcontent/uploads/2011/02/information_governance_policy-v2.2-23jan14.pdf Listening into Action http://ndht.ndevon.swest.nhs.uk/?page_id=36875 Root Cause Analysis Guidance http://ndht.ndevon.swest.nhs.uk/policies/?p=3188 Risk Management Policy http://ndht.ndevon.swest.nhs.uk/policies/wpcontent/uploads/2013/05/risk-management-policy-v3.1-21aug13.pdf Corporate Governance Page 25 of 35

APPENDIX A INVESTIGATION PROCESS Corporate Governance Page 26 of 35

Recommendation Assessment Background Situation Investigations, Analysis & Improvement Policy Title APPENDIX B 72-HOUR REPORT TEMPLATE 72-HOUR REPORT IR number IR Date of incident This is the title stated in the email request S Description B Relevant A of incident, including place and time history, e.g. admission date/time; past medical history; presenting condition; diagnosis (currently being treated for); risks identified/care plans in place Please list problems identified, (include any safeguarding concerns): 1. Please list immediate actions taken, including those to mitigate any further risk: 1. R Please state also any actions required to prevent future recurrence: 1. Corporate Governance Page 27 of 35