Process for reporting and learning from serious incidents requiring investigation

Process for reporting and learning from serious incidents requiring investigation Date: 9 March 2012

NHS South of England Process for reporting and learning from serious incidents requiring investigation Table of contents Page No. Assessment sheet Preface Table of contents Section 1 Introduction 1 Section 2 Reporting of serious incidents requiring investigation 2 Section 3 Communicating with patients, carers and families 3 Section 4 Involvement of staff 3 Section 5 Out of hours reporting and media relations 3 Section 6 Overview of serious incidents requiring investigation management and monitoring performance 4 Section 7 Review and closure of incidents process and assurance 6 Section 8 Quarterly monitoring of trends 7 Section 9 Dissemination of learning 8 Section 10 Section 11 Appendices Appendix 1 Appendix 2 Appendix 3 Appendix 4 Appendix 5 Appendix 6 Appendix 7 Secure transfer of information Additional guidance Out of hours reporting and media relations Flowchart for the management of grade 2 serious incidents 72 hours reporting template Flowchart for the management of homicide incidents Investigation report template quality review Headings for trend monitoring of incidents Further guidance to follow 9 9

1. Introduction Process for reporting and learning from serious incidents requiring investigation 1.1 In March 2010, the National Patient Safety Agency published the National Framework for Reporting and Learning from Serious Incidents Requiring Investigation. This framework details how all organisations providing NHS funded care should report, investigate and monitor serious incidents. NHS South of England has adopted the framework in full and as such it should be read in conjunction with this document. The United Kingdom National Screening Committee has also produced guidance on managing serious incidents in the English NHS National Screening Programmes. This guidance should be followed for all screening incidents. 1.2 For the purposes of this document, the National Framework for the Reporting and Learning from Serious Incidents Requiring Investigation will be referred to as the Framework. 1.3 The organisation where the serious incident requiring investigation occurred has overall responsibility for the investigation and implementation of subsequent action plans. Lead Commissioners are responsible for monitoring the management of serious incidents requiring investigation reported by providers of NHS funded care. Where an incident relates to a patient whose treatment has been commissioned by the Specialist Commissioner, the local Commissioner should have in place a process of communication whereby the local Commissioner manages such incidents. 1.4 When an incident is reported by an organisation and the Commissioner who is responsible for the care of the patient is not the lead Commissioner (Associate Commissioner) the lead Commissioner should liaise with the Associate Commissioner and involve them in the sign off process. It is however, final responsibility of the lead Commissioner to sign off the report. 1.5 It is a requirement of all registered organisations to report serious incidents to the Care Quality Commission and other regularity bodies as appropriate. This process in no way replaces this requirement. 1.6 There are specific requirements relating to the reporting and management of Never Events. The Never Events Framework is provided by the Department of Health. All organisations should adhere to this Framework when reporting and investigating Never Events. Page 1 of 23

2. Reporting of serious incidents 2.1 Serious incidents requiring investigation should be reported on the Strategic Executive Information System (STEIS) within two working days of the organisation identifying the serious incident. Guidance on the use of the Strategic Executive Information System (STEIS) is set out in the supporting documentation Serious Incident Reporting Using the Strategic Executive Information System and is available from NHS South of England. 2.2 In the majority of cases, the date of the incident occurring is the same as the date the in which the reporting organisation identifies the incident. In some cases the date that the organisation identifies the incident may differ from the actual incident date. An example of this is when an incident comes to light following a retrospective casenote review. In these cases, the date the organisation identifies the incident becomes the incident date for monitoring purposes. Lead Commissioners will make the final decision on which date applies in consultation with the reporting organisation. 2.3 When an organisation does not have access to the Strategic Executive Information System (STEIS) for example independent contractors, a commissioning cluster level login will be implemented to allow the lead Commissioner to input the serious incident requiring investigation and sign off the report. In these cases, oversight of the reporting and investigation process detailed in this process remains in place. 2.4 Guidance on the types of incidents that must be reported can be found in the National Patient Safety Agency document Information Resource to Support the Reporting of Serious Incidents available from the National Patient Safety Agency website. This guidance is not exhaustive. Where further clarity is required, guidance should be sought from the responsible Lead Commissioner. 2.5 It should be noted that, in the interests of confidentiality, all reports should contain anonymised information. The content of any reports relating to serious incidents should not contain the names of practitioners or patients or information which could lead to the identification of practitioners or patients. Investigation reports may be disclosable under the Freedom of Information Act 2000. 2.6 If a patient is transferred to an organisation via the emergency department or medical assessment unit and clinical staff report that the patient may have previously been involved in a serious incident requiring investigation, the incident should be reported by the receiving organisation. The receiving organisation should also advise their Lead Commissioner who may negotiate transfer of the incident and responsibility for investigation to the originating organisation. An example of this may be the identification of suspected safeguarding incident or where a pressure ulcer is deemed to have been present on Page 2 of 23

admission either to the acute organisations or on discharge to the community. 2.7 Where serious incidents requiring investigation occur across organisational boundaries, the Lead Commissioner will facilitate the investigation to ensure that all stakeholders are involved. 3. Communicating with patients, carers and families 3.1 In November 2009 the National Patient Safety Agency issued an alert strengthening its 2005 Being Open safer practice notice. All organisations must have adopted the Being Open principles and processes by November 2010. The detail of the approach with the patients, families and/or carers should be included in all investigation reports. 3.2 The Government wishes to reinforce the principles of Being Open by the requirement of a contractual duty of candour. As at January 2012 this is the subject of a national consultation process. Once the mechanisms by which this will be implemented and monitored are known an update will be provided to this process. 3.3 Where statutory instruments deem contact with the patient / relatives is not indicated for example in safeguarding incidents, the statutory instrument should be adhered to. 4. Involvement of Staff 4.1 All organisations have a responsibility to ensure that staff are treated fairly and with consistency. NHS South of England recommends that where the nature of an incident requires further analysis against the actions of an individual the provider organisation must apply the National Patient Safety Incident Decision Tree to support its understanding. This process should be undertaken in conjunction with Human Resources and would not normally form part of the internal investigation but may inform the understanding for the purposes of learning and developing robust recommendations and actions. 5. Out of hours reporting and media relations 5.1 Appendix 1 covers the detail surrounding out of hours reporting. Page 3 of 23

6. Overview of serious incidents requiring investigation management and monitoring performance 6.1 The Framework provides clear guidance on a number of milestones to be followed from the point at which a serious incident requiring investigation is identified to closure of the incident. Details of key milestones together with additional grade two guidance serious incident is included below: 6.2 Incidents must be reported within two working days of identification of the incident occurring (see section 2.2). 6.3 Incidents must be graded as 0, 1 or 2. Definitions can be found in the Framework (page 17). The following additional incident categories have also been agreed as grade 2 by NHS South of England. A domestic homicide (a decision to report onto the Strategic Executive Information System (STEIS) should be made by the Commissioner in conjunction with NHS South of England). An adult safeguarding incident (following initial review). Significant media interest (related to patient safety). Serious failure of screening services that has caused or is likely to cause long term harm or reduced life expectancy. In these cases please refer to the United Kingdom National Screening Committee guidance on managing serious incidents in the English NHS National Screening Programmes. 6.4 Incidents that fall within a speciality or service should be shared with the appropriate lead, senior medical or nursing advisor. 6.5 Incident grades should be agreed with the Lead Commissioner for grade 1 incidents and the Lead Commissioner and NHS South of England for grade 2 incidents. 6.6 The ongoing monitoring of grade 1 incidents will be managed by the Lead Commissioner. Where a grade 1 incident occurs within a commissioner setting, NHS South of England will be responsible for ongoing review, monitoring and closure of the incident. 6.7 NHS South of England will review the progress of incident management on a quarterly basis with the Lead Commissioner. Page 4 of 23

6.8 Grade 2 incidents will be monitored jointly by the Lead Commissioner and NHS South of England. The process for the ongoing monitoring and closure of grade 2 incidents can be found in Appendix 2. A template for 72 hour reports is detailed at Appendix 3 this is the minimum of information required at this stage and Providers may customise this template to meet any additional internal requirements. 6.9 The timescale for completion of investigations will be dependent on the grade of the serious incident. The following timescales will apply which are in line with the Framework: Grade 1-45 working days from the date the incident is notified on Strategic Executive Information System (STEIS); Grade 2 (those incidents not requiring independent investigation) - 60 working days from the date the incident is notified; Grade 2 Mental Health Homicide as defined by HSG (94) 27) internal investigation should be completed within 90 working days from the date of the incident. The process for the management of homicide incidents can be found in Appendix 3; Grade 2 Domestic Homicide as defined under Section 9 of the Domestic Violence, Crime and Victims Act (2004) the process followed should be the same as for other Grade 2 incidents; however the decision to proceed to a full multi-agency investigation will be subject to a decision by the local Community Safety Partnership and agreed by the Home Office. The lead commissioner will advise NHS South of England of the decision following which agreement will be reached regarding the status of the incident and anticipated timeframes in accordance with the Multi-Agency Statutory Guidance for the Conduct of Domestic Homicide Reviews April 2012. 6.10 On rare occasions, extensions to the above timescales can be agreed. The circumstances for an extension must be those that are outside the normal working arrangement such as witnesses being unable to be interviewed due to absence. The Department of Health Memorandum of Understanding: Investigating Patient Safety Incidents Involving Unexpected Death or Serious Untoward Harm is relevant here. Extensions must be agreed with the Lead Commissioner. The reason for the extension must be included in the further information section of the Strategic Executive Information System (STEIS) incident form. 6.11 Lead Commissioners will publish details of learning from serious incidents within their annual quality reporting arrangements (see page 26 of the Framework). 6.12 Lead Commissioners will produce quarterly reports on learning from serious incidents to ensure that trends are identified (see appendix 6). Page 5 of 23

The process for managing these reports will be dependent on local governance arrangements. 6.13 All organisations with a responsibility for notifying or receiving details of serious incidents requiring investigation have a responsibility for the dissemination of learning. Lead Commissioners and NHS South of England are responsible for ensuring that learning from a single incident, or from the review of aggregated incidents, are shared with other organisations within their area. 7. Review and closure of incidents process and assurance 7.1 Serious incidents requiring investigation should only be closed on the Strategic Executive Information System (STEIS) by the Lead Commissioner following the receipt of a robust investigation report that has been generated following a full root cause analysis with a time framed action plan that will be monitored by the lead commissioner. The Framework offers guidance on what should be included within an investigation report. As a minimum, reports should include*: a clear description of the patient pathway leading up to the incident; a clear description of information gathered; details of response taken with the patient, family or carers and staff; a detailed and uninterrupted timeline or chronology; identification of problems; key contributory (causal) factors leading to root cause(s); recommendations; learning points should be grouped or themed to support sharing and help the reader identify those points applicable to their team, service, speciality or division or wider organisation; a time bound action plan with a clear trajectory and named responsible officer. * occasionally some incidents may not have a full root cause analysis, for example in Human Resources performance investigations in these cases closure may be necessary without root causes 7.2 The Lead Commissioner should aim to provide feedback to reporting organisations within 20 working days of the report being shared with them. 7.3 An investigation executive summary, at the beginning of the investigation report, must be provided for each serious incident requiring investigation. It must include a précis of the incident and investigation and be fully anonymised to preserve the confidentiality of the people. This will enable the executive summary to be widely shared. 7.4 Evaluating the quality of investigation reports and drawing out key learning points is sometimes difficult, particularly where reports are Page 6 of 23

lengthy or adopt different writing structures. NHS South of England recommends that organisations adopt the structure of the Root Cause Analysis Report Writing tools available on the National Patient Safety Agency website. Adopting a standardised style and approach will enable both the reporting organisation and the reviewer to more easily assess the quality and robustness of the report and extract themes and trends for future learning. To support such analysis and review NHS South of England has developed an evaluation template that is attached at Appendix 5. 7.5 In all cases, organisations will have a formal mechanism for review and sign off of investigation reports that has a named Accountable Officer. There should be clearly defined internal robust governance arrangements for the monitoring and management of serious incidents requiring investigation from accountable committee to the board. There should be a clear process describing board level responsibility for implementing and monitoring requirements of the Framework and for ensuring compliance with the Health and Social Care Act 2008 (Registration of Regulated Activities) Regulations 2009 as set out by the Care Quality Commission should also be in place. 7.6 Serious incidents requiring investigation can be closed by the Lead Commissioner (Specialist Commissioning Group where relevant) before the completion of an action plan provided that assurance is received of ongoing monitoring of implementation. The exception to this is any incidents where an independent investigation has taken place. In these cases, the Lead Commissioner and NHS South of England will continue to monitor the action plan and only close the incident once assurance has been received that all action points have been completed. 8. Quarterly monitoring of trends 8.1 In order to comply with the requirements of the Framework, Trusts and commissioners must monitor trends in serious incident reporting. This trend analysis must include not only a quantitative report but also a qualitative analysis of those incidents where root causes and lessons learned have been identified. A reporting framework for this purpose is included in Appendix 6 and can be used by all organisations. 8.2 Ongoing compliance with the Framework will be monitored by both Lead Commissioners and NHS South of England using the following measures: Standard Detail Data source Incidents will be reported within two working days of identification of the incident Time from date of knowledge (see section 2.2) to incident reported on Strategic Executive Information System Strategic Executive Information System (STEIS) Page 7 of 23

Standard Detail Data source (STEIS) date Grade 1 incidents will be investigated and reported on within 45 working days (exclude agreed extensions) Time from incident reported date to investigation completed date. The reporting organisation should have at least a draft investigation report available for first review. Strategic Executive Information System (STEIS) Grade 2 incidents will be investigated and reported on within 60 working days (exclude agreed extensions) Incident investigations will follow the structure and process of Root Cause Analysis methodology. Understanding and analysis within the investigation should include a thorough analysis of key contributory factors to include description against these and identification and understanding of any Human Factors that may lead to wider learning. The Strategic Executive Information System (STEIS) must be kept up to date and incidents closed according to national timescales. Time from incident reported date to investigation completed date. The reporting organisation should have at least a draft investigation report available for first review. NHS South of England will maintain a register of grade 2 incidents Investigation structure to follow the National Patient Safety Agency Root Cause Analysis Guidance and Template or similar robust framework determined at local level Strategic Executive Information System (STEIS) will reflect the current status of the investigation. NHS South of England and Strategic Executive Information System (STEIS) Investigation reports Strategic Executive Information System (STEIS) 8.3 A review of compliance against the above standards will form part of NHS South of England performance management arrangements. 9. Dissemination of learning 9.1 One of the key aims of the serious incident reporting and learning process is to reduce the risk of recurrence, both where the original incident occurred and elsewhere in the NHS. The timely and appropriate dissemination of learning following a serious incident is core to achieving this and to ensure that these lessons are embedded in practice. Page 8 of 23

9.2 Learning can be demonstrated at organisational level by sustainable changes and improvements in process, policy, systems and procedures relating to patient safety within healthcare organisations. Key learning points that may be shared more widely may fall into the following areas: understanding and identification of the influence of Human Factors; solutions to address incident root causes that may be relevant to other teams, services and provider organisations; identification of the components of good practice that reduced the potential impact of the incident, and how they were developed and supported. systems and processes that allow early detection or intervention that will reduce the potential impact of the incident; lessons from conducting the investigation that may improve the management of investigations in future; documentation of identification of the risks, the extent to which they have been reduced, and how this is measured and monitored. 9.3 Reporting organisations and the Lead Commissioner should work together to plan how learning from serious incidents can be shared. 9.4 NHS South of England will share learning through its governance processes and learning networks. 10. Secure transfer of information 10. The reporting organisation, the Lead Commissioner and NHS South of England must ensure that any reports or documents related to the serious incident investigation are sent using secure NHS.net mail. 11. Additional guidance 11.1 Some reporting categories are complex and require further guidance to aid implementation. These categories are: child safeguarding; adult safeguarding; pressure ulcers. 11.2 Further guidance on these topics will be provided following agreement of the process across the South of England. Page 9 of 23

Appendices Appendix 1 Out of hours reporting and media relations Appendix 2 Flowchart for the management of grade 2 serious incidents Appendix 3 72 hour reporting template Appendix 4 Appendix 5 Appendix 6 Appendix 7 Flowchart for the management of homicide incidents Investigation report template quality review Headings for trend monitoring of incidents Further guidance to follow Page 10 of 23

Appendix 1 Out of hours reporting and media relations 1. Introduction 1.1 Serious incidents requiring investigation should be reported on the Strategic Executive Information System (STEIS) within two working days. If a reporting organisation or Lead Commissioner (Specialist Commissioning Group where relevant) needs to verbally inform NHS South of England of an incident, they should contact the Patient Safety Team at NHS South of England. The reporting organisation should also inform the Lead Commissioner (Specialist Commissioning Group where relevant). 1.2 During out-of-hours the senior manager or director on-call in the NHS trust or Lead Commissioner will be responsible for the reporting of any serious incidents requiring investigation. 1.3 All incidents falling into any of the serious incident categories listed below or where there is any doubt over the matter must be notified to NHS South of England senior manager on call: incidents which necessitate activation of the NHS Trust or Commissioner Major Incident Plan, where NHS South of England needs to take action such as the attendance of NHS South of England Director required at multiagency gold command; incidents which will give rise to significant media interest or will be of significance to other agencies such as the police or other external agencies; incidents which will be of significant public concern. 1.4 Having advised NHS South of England senior manager on-call, the organisation must complete the web-based Strategic Executive Information System (STEIS) form by 12:00 on the first working day. Once the on-line form has been completed and saved an automatic e-mail alert will be sent to NHS South of England nominated personnel. 1.5 If the serious incident does not fall within the categories listed above NHS South of England on-call manager need not be notified but the Strategic Executive Information System (STEIS) form should be completed as soon as possible by the Trust, certainly within two working days. Page 11 of 23

2. Media relations (also see pages 28-29 of national framework) 2.1 In many cases serious incidents requiring investigation can lead to a high level of media attention not only in the immediate aftermath. The management, investigation and learning from incidents can all be triggers for media coverage for months and in some cases years after the incident itself. Each organisation should have media relations policies in place which include the appropriate action to be taken in relation to serious incidents, including protocols with other local organisations and agencies on media handling and strategies for ongoing and longer term management of media coverage. 2.2 Communication regarding serious case reviews (child abuse) will be managed by the Chair of the Local Children s Safeguarding Board (LCSB). 2.3 It is expected that the communications leads in NHS organisations work closely with the communications team at NHS South of England on agreeing appropriate media handling strategies, working alongside the relevant colleagues responsible for the wider management of the incident. The Director of Communications and Corporate Services or on call communications lead at NHS South of England is responsible for briefing the Department of Health Media Centre as necessary. In forensic/criminal cases the police lead all communications with the media. 2.4 However, media coverage itself can also be the incident. Where adverse media coverage becomes the issue (and where it is not triggered by an adverse event as such) it would be expected that the communications lead for the NHS organisation would be in direct contact with the NHS South of England communications team to discuss handling and reporting strategies accordingly. 2.5 If the serious incident has occurred within an acute, mental health, ambulance trust or provider arm of the primary care trust, that trust will take the responsibility for advising the Lead Commissioner (Specialist Commissioning Group where relevant). 2.6 All incidents automatically receive a unique log number when entered within the Strategic Executive Information System (STEIS) system. To maintain confidentiality this number will be used in all communication with Trusts. Page 12 of 23

Appendix 2 Flowchart for provider organisations and Lead Commissioners the management of grade 2 serious incidents Serious incident requiring investigation is reported within 2 working days Incident is graded a 2 following national framework and local process 72 hour management report is received by Lead Commissioner and sent to NHS South of England see appendix 3 Completed investigation report is sent to Lead Commissioner and NHS South of England within 60 working days NHS South of England will provide feedback to Lead Commissioner within within 20 working days Agreement to close incident between NHS South of England and Lead Commissioner. If the incident is a Never Event, Lead Commissioner must follow Department of Health guidance on non payment for procedure Where appropriate, lessons learned are disseminated across the Commissioning cluster and NHS South of England Page 13 of 23

Appendix 3 Serious Incident Requiring Investigation (SIRI) 72 Hour Report SIRI Reference Number: STEIS Identification Number: Date/Time/Location of Incident including hospital / ward / team level information Incident type Description of incident including reason for admission and diagnosis (for mental health please include Mental Health Act status and date of referral and last contact) Details of any police or media involvement/interest Details of contact with or planned contact patient/family or carers Immediate actions taken including actions to mitigate any further risk Details of other organisations/individuals notified Lead Commissioner Report completed by Designation Date / time report completed Please insert below a brief chronology of key events Page 14 of 23

Liaison with police and other key stakeholders regarding investigation process Mental HealthTrust and SHA communications team updated with progress of investigation by Mental Health Trust Lead Appendix 4 Flowchart for the management of mental health homicide incidents Homicide occurs. Mental Health Trust informed of arrest by police Mental Health Trust Lead identified Serious Incident Requiring Investigation (SIRI) confirmed by Mental Health Trust Mental HealthTrust identifies police contact and police confirm the record number SI logged onto STEIS as grade 2 homicide 2 working days Trust communications lead liaises with SHA communications lead to develop a media handling strategy Mental Health Trust completes initial service management review report within 72 hours 5 working days Terms of reference for internal investigation are agreed 15 working days Internal investigation undertaken and report received and agreed by Trust, Lead Commissioner and SHA 60 working days Page 15 of 23 Internal investigation report and action plan considered by Lead Commissioner and SHA Homicide Review Group

60 working days Decision made at NHS South of England Homicide Review Group to commission an independent investigation. Letter sent from Chair of SHA Homicide Review group and Lead Commissioner Yes No Close incident when assurance received that robust action plan is in place and monitoring arrangements confirmed Independent investigation commissioned 26 weeks Independent investigation reported Time-framed action plan developed from the recommendations of the independent investigation monitored by Lead Commissioner and SHA. Close incident only when assurance received that all actions contained within the action plan have been implemented Page 16 of 23

Appendix 5 Quality review of a root cause analysis investigation report Serious incident Investigation Review Template and Contributory Factor Grid The aim of this template and contributory factor grid is to provide guidance and support towards a structured approach of the review of Serious Incident Investigation reports as defined in the National Framework for the Reporting and Learning from Serious Incidents Requiring Investigation, NPSA May 2010 and the NHS South of England Process. Application of a root cause analysis approach is recognised as a robust methodology, this template aligns with that methodology. It may be useful as an internal checklist by quality leads in provider organisations and by commissioners. For ease of completion the responses are primarily designed as Yes No. The last section of the template is set aside for the reviewer to use as an aide memoire of the review but may be also used to provide feedback or request for additional information or improvement. To support wider identification of key themes and trends the key contributory factors may be captured in the Contributory Factors theme grid. Reviewed by: Designation: Date: SECTION 1 Details Reporting organisation: Lead Commissioner: Organisation type: Specialty: Incident Date: Incident type: Grade: Choose an item. STEIS Number: Actual Effect on patient: Never Event: Choose an item. Coroner s Inquest pending Choose an item. Choose an item. SECTION 2 - Further detail may be provided in the summary at the end of the report 1. Background and Content Is there a clear overarching description of the events leading up to the incident with detail of the type of care or treatment provided? Choose an item. 2. Details of Investigator/Investigative team Is the membership of the team appropriate to the incident? This is particularly relevant in the case of Grade 2 incidents and incidents where specialist advice should be provided e.g.; drug incidents? Choose an item. 3. Does the scope of and level of the investigation seem appropriate? The report should make clear the point (date) in the patient pathway from which information to support the investigation has been gathered. This should include a review of all relevant contacts. The level (Grade) of investigation should follow the National Framework and local Strategic Health Authority process Choose an item. Page 17 of 23

4. Is there evidence that all relevant information has been gathered to support full exploration of problems This should align with 3 above. Such information gathering should include relevant patient records, staff rotas, interview transcriptions or statements, referral and discharge letters, diagnosis, police or other external agency information as appropriate to the level and complexity of the incident. Policies, procedures and guidance both national and local. Choose an item. 5. Is there evidence of appropriate support and communication for patients and relatives? This should reflect the principals of Being Open and (as appropriate) include details of how the findings will be shared. Choose an item. 6. Support for staff Is there evidence that appropriate support for staff is in place including where appropriate the application of the Incident Decision Tree? Choose an item. 7. Chronology/timeline Has a detailed chronology or timeline been included with the report? Any gaps in the chronology or timeline should have been satisfied. Choose an item. 8. Does the report identify good practice? It is helpful to reflect where things went well as well as those were problems existed. The learning from good practice should not be lost. Choose an item.. 9. Problem identification? Any problems identified in the early stages of the analysis should be clearly listed and noted at the point at which they occurred within the chronology or timeline, some may have little or no impact but will help inform overall learning. Choose an item. 10. Analysis of problems leading to contributory factors? Identification of contributory (or causal) factors is achieved through further in-depth analysis of problems identified (asking and answering WHY ). Is there evidence of clear and in depth analysis of problems leading to the identification of contributory factors? (see attached contributory factor grid) Choose an item. 11. Key contributory (causal) factors Root Cause/s? the investigation should seek to identify the key contributory(causal) factors, root causes that had the most significant impact on the outcome - these should be clearly stated and can be tracked back to the original incident Choose an item.. 12. Recommendations Do the recommendations address the key contributory (causal) factors, root causes as identified? Choose an item. 13. Action plan Is there a clear time framed action plan that includes named individuals or departments responsible for implementation and review? Choose an item. 14. Lessons learned Has the investigation identified learning and stated how this investigation will be shared internally and more widely if appropriate. Choose an item. Page 18 of 23

Section 3 - Reviewer comments: This section should be used to provided supportive information for the decisions made above together with any further information required or other relevant details in relation to the incident; e.g. referred to independent investigation etc. Is the reviewer satisfied that the investigation is robust, with in depth analysis, thorough identification of any contributory or causal factors root causes and a time framed action plan: Choose an item. Give brief details to support decision (it may be helpful to refer to the relevant section in the report) How will the action plan be monitored and reviewed? Has a contributory factor grid been completed and attached to the review Has the contributory factor grid identified any recurring themes from other similar incidents? If yes, state what action will be taken? Has this review identified the need for further information or action? State Section and item number and brief details Choose an item. Page 19 of 23

Contributory (Causal) Factors (Root Causes) identification grid - Findings from analysis within report Description - Patient Factors Task Factors Individual Staff Contributory/ causal Factors / Root causes Team and Social/ Leadership/supervision/ Education and training Equipment / Resources Communication Working Conditions/Environment Organisational / strategic The above taxonomy has been taken from the National Patient Safety Agency Root Cause Analysis Taxonomy. The chart should be completed describing the contributory or causal factor where applicable in each of the taxonomy headings above. Some investigation reports may have applied this approach in their analysis in which case these could be cut and paste to this review. All factors may not be present in all investigations. Those with the most significant impact are generally considered to be key, leading to Root Cause/s where if eradicated or significantly reduced would or may have prevented the outcome. It is these factors that require the most robust actions (solutions) to remove or mitigate any similar incident from occurring. Over time capturing these factors in a structured way should lead to identification of any key themes reoccurring and subsequently to the building an organisational memory Page 20 of 23

Appendix 6 Headings for quarterly trend monitoring of serious incidents Each organisation will have standard reporting templates to report serious incidents to its Board or sub-committee. The issues below form the minimum dataset that should be included in these reports. Quantitative section The number of serious incidents by provider that have occurred in the quarter that is being reported. The number of serious incidents by provider that have been closed during the quarter. The number of serious incidents by provider that remain open and why? Qualitative section The root causes and lessons learned of each incident that has been closed in the quarter that is being reported. Any themes that have emerged over the quarter and/or previous quarter and what has been done to reduce the likelihood / risk of reoccurrence. How the learning has been shared across the trust / commissioning primary care area Any exemplar reports that can be shared across the trust / region. Page 21 of 23

Appendix 7 Further guidance Further guidance on the management of serious incidents relating to Child safeguarding Adult safeguarding Pressure ulcers Will be provided once agreement is reached across NHS South of England Page 22 of 23