Policy for the Reporting and Management of Serious Incidents and Never Events

NHS Nene and NHS Corby Clinical Commissioning Groups Policy for the Reporting and Management of Serious Incidents and Never Events Approved and ratified by the Quality Committee on behalf of the Governing Bodies of NHS Nene and NHS Corby Clinical Commissioning Groups For Review : August 2018

Version Control Version No. Date Who Status Comment 1.0 8/5/2015 Circulated for initial comment and Kate Longthorne Draft feedback. 1.1 19/5/2015 Kate Longthorne Final Draft Amended following comments and submitted to the Countywide Patient Safety Forum for comment/approval. 1.2 9/6/2015 Emma Clarke Approved Submitted to and approved by the Quality Committee. 1.3 16/6/2015 NHS Nene Clinical Commissioning Group: Governing Body Ratified Submitted to and ratified by the Governing Body of NHS Nene Clinical Commissioning Group. 1.4 30/6/2015 NHS Corby Clinical Commissioning Group: Governing Body Ratified Submitted to and ratified by the Governing Body of NHS Corby Clinical Commissioning Group. 2.0 Published on the NHS Nene and NHS 2/7/2015 Quality Committee Published Corby Clinical Commissioning Group Administrator websites. 2.1 18/11/2016 Kate Longthorne Patient Safety Lead Published Amended to include updated appendices 2.2 31/3/2016 Kate Longthorne Amended to include updated appendices - Published Patient Safety Lead RCA template 3.0 07/07/2016 Annual review. Minor amendments. Kate Longthorne Updates to: Draft Patient Safety Lead 5.5 Joint investigations 5.15 Inquests Amended following comments and 3.1 21/07/2015 Kate Longthorne Final Draft submitted to the Serious Incident Review & Assurance Group (SIARG) for comment/approval. 3.2 28/07/2015 Kate Longthorne Approved Submitted to and approved by SIARG. Submitted to and approved/ratified by the 3.3 9/8/2016 Emma Clarke Groups Approved & Quality Committee on behalf of NHS Nene Ratified and NHS Corby Clinical Commissioning Published on the websites of NHS Nene 4.0 18/8/2016 Helen Sutton Publication and NHS Corby Clinical Commissioning Groups 4.1 15/06/2017 Megan Scott Draft Annual Review. Amendments to: 2 Purpose 3 Definitions (appendix also removed) 5.5 Joint investigations 5.9 Extensions 5.12 Downgrading of incidents 6.1 Review of submitted investigation reports 6.3 Serious Incident Assurance and Review Groups (SIARG) Serious Incident Assurance Meeting (SIAM) Appendix 1 Appendix 6 Appendix 7 Published August 2017 Page 2 of 60

4.2 8/8/2017 Alison Jamson 5.0 24/8/ 2017 Quality Committee Administrator Approved & Ratified Published Submitted to and approved/ratified by the Quality Committee on behalf of NHS Nene and NHS Corby Clinical Commissioning Groups Published on the websites of NHS Nene and NHS Corby Clinical Commissioning Groups NHS NENE AND NHS CORBY CCGS ESSENTIAL CONTACT NUMBERS NHS Nene and NHS Corby CCGs Quality Team Quality Assurance Manager Tel: 01604 651299 Northants.SUI@nhs.net Published August 2017 Page 3 of 60

Contents 1. INTRODUCTION... 5 2. PURPOSE... 5 3. DEFINITIONS... 6 4. DUTIES... 6 4.1 Provider Organisations... 6 4.2 NHS Nene and NHS Corby CCGs... 8 4.3 NHS England... 9 5. REPORTING AND INVESTIGATION OUTCOMES... 9 5.1 Identifying/Assessing Serious incidents... 9 5.2 Reporting of Serious incidents... 10 5.3 Involvement of External Agencies... 11 5.4 Compliance with the Data Protection Act... 11 5.5 Joint Investigations... 11 5.6 Initial Incident Review (72 hour report)... 13 5.7 Investigation... 13 5.8 Terms of Reference... 15 5.9 Extensions... 15 5.10 Investigation report... 16 5.11 Action Plans... 16 5.12 Downgrading of incidents... 17 5.13 Updating STEIS following investigation... 17 5.14 Being Open and Patient Involvement/Duty of Candour... 18 5.15 Inquests... 19 6. ASSURANCE AND REVIEW... 19 6.1 Review of submitted investigation reports... 19 6.2 Requests for Further Information... 20 6.3 Serious Incident Assurance and Review Groups (SIARG)... 20 6.4 Serious Incident Assurance Meetings (SIAM)... 21 6.5 Clinical Quality Review Meeting (CQRM)... 23 7. MONITORING COMPLIANCE... 23 8. RELATED PROTOCOLS... 23 APPENDIX 1... 25 APPENDIX 2... 27 APPENDIX 3... 29 APPENDIX 4... 30 APPENDIX 5... 36 APPENDIX 6... 41 APPENDIX 7... 60 Published August 2017 Page 4 of 60

1. Introduction Reporting and learning from serious incidents (SIs) requiring investigation should be regarded as a positive action to improve patient safety. NHS England has provided a clear framework with the intention that it is embedded through local policy. Making services safe for patients is fundamental to the provision of high-quality care and it is essential that providers of healthcare have efficient and effective systems in place for staff to report when patients have, or could have been harmed. Open and honest reporting demonstrates a commitment to patients and their safety. The focus of reporting should be on analysing the care/service delivery problems which led to the incident, to identify lessons to be learnt and actions to reduce the risk of the incident reoccurring. It is only through active learning, sharing and service improvement from incidents that the benefits of experience are actually realised. It is an expectation that healthcare providers within their incident investigation processes adhere to the principle of Being Open and requirements of Duty of Candour as detailed within the NHS Standard Contract (Service Condition 35 1 ) and Care Quality Commission (CQC) regulation 20 2. NHS England will seek assurance from NHS Nene and NHS Corby CCGs that there are robust systems in place for reporting and monitoring performance of commissioned services. There is an expectation that all SIs will be thoroughly investigated by providers, associated action plans implemented and learning shared. 2. Purpose The purpose of this policy is to make explicit the local requirements for managing SIs and should be read in conjunction with both the NHS England Serious Incident Framework 2015 and the NHS England Never Event Framework 2015. NHS Nene and NHS Corby CCGs expect all organisations commissioned by them that provide NHS funded healthcare to incorporate the requirements of this policy into their own organisational policies. The provisions of this policy are a requirement within the NHS Standard Contract. This document outlines the approach for supporting learning and performance managing commissioned services. This policy does not replace the duty to inform the Police and other authorities, such as Social Care, where appropriate. Occasionally organisations will need to inform other agencies in accordance with national guidance, such as the Medicines and Healthcare Products Regulatory Agency (MHRA) in the case of equipment failure, the 1 NHS Standard Contract 2017/18-2018/19 https://www.england.nhs.uk/wp-content/uploads/2016/11/2-service-conditions-fl.pdf 2 Care Quality Commission regulation 20, Duty of Candour: http://www.cqc.org.uk/guidance-providers/regulations-enforcement/regulation-20-duty-candour Published August 2017 Page 5 of 60

Care Quality Commission (CQC), the Counter Fraud Operational Service in the case of fraud and Public Health England in cases of infection control. In such circumstances this SI policy should be followed in conjunction with the relevant national guidance. Further information can be found in appendix 1. 3. Definitions This policy follows the NHS England Serious Incident Framework in which a SI is defined as events in health care where the potential for learning is so great, or the consequences to patients, families and carers, staff or organisations 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 ongoing healthcare. As per the NHS England Serious Incident framework, the occurrence of a serious incident demonstrates weaknesses in a system or process that need to be addressed to prevent future incidents leading to avoidable death or serious harm to patients or staff, future incidents of abuse to patients or staff, or future significant reputational damage to the organisations involved. Serious incidents therefore require investigation in order to identify the factors that contributed towards the incident occurring and the fundamental issues (or root causes) that underpinned these. Serious incidents can be isolated, single events or multiple linked or unlinked events signalling systemic failures within a commissioning or health system. 3 The criteria against which providers should refer to help them determine whether an incident meets the Serious Incident threshold is detailed within the NHS England Serious Incident Framework 2015 4 4. Duties 4.1 Provider Organisations Providers of NHS funded care must have a clear governance structure and systems in place to appropriately assess each incident and whether it meets serious incident criteria. Providers must be able to demonstrate how a decision was made in each case as to why an incident was declared a serious incident or not; this may include incident assessment forms, a serious incident review group with senior leadership and corresponding minutes. This process should be open to altering decisions if new information about an incident comes to light at a later date. Where a decision cannot be made there should be open dialogue with the commissioners or the incident should be reported and investigated as a serious incident until further evidence 3 NHS England, Serious Incident Framework: Supporting Learning to Prevent Recurrence, 2015 4 NHS England Serious Incident Framework 2015: https://improvement.nhs.uk/uploads/documents/seriousincidnt-framwrk.pdf Published August 2017 Page 6 of 60

becomes available; a request to downgrade an incident from SI status can be made at any time during the investigation process. Providers must ensure they have in place: An executive director responsible for leading on the serious incident process. Clear procedures for the timely reporting and liaison with their commissioning bodies. Clear procedures for informing their lead commissioner of any other interested commissioners there may be with each case e.g. specialised commissioning, the CCGs funding the treatment for the patient concerned etc. Clear procedures for the timely reporting to additional reporting systems as required e.g. National Reporting and Learning System (NRLS), Medicines & Healthcare products Regulatory Agency (MHRA), Care Quality Commission (CQC), Health and Safety Executive (HSE) etc 5. Clear procedures for the compliance with reporting and liaison requirements with regulators and other agencies/partners 6. Mechanisms to support robust serious incident investigations, including processes to ensure the following: o In line with Being Open and Duty of Candour, providers should ensure early, meaningful and sensitive engagement with affected patients and/or their families/carers, 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. A specific person should be assigned to engage with the family to provide a single point of contact. o Clear procedures for taking immediate action following a serious incident including the collection and retention of evidence i.e. notes/clinical records, written accounts/statements from those involved, equipment involved, information from the location (site visit) and interviews with relevant individuals. o 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. o Investigations follow a systems-based approach to ensure any issues/problems with care delivery are fully understood from a human and systems factors perspective and that the root causes are identified (where it is possible to do so) in order to produce focused recommendations that result in SMART (specific, measurable, attainable, relevant, time-bound) actions and learning to prevent recurrence. 5 Please refer to Appendix 2: Notification of interested bodies, NHS England Serious Incident Framework 2015 https://improvement.nhs.uk/uploads/documents/serious-incidnt-framwrk.pdf 6 Please refer to Appendix 2: Notification of interested bodies, NHS England Serious Incident Framework 2015 https://improvement.nhs.uk/uploads/documents/serious-incidnt-framwrk.pdf Published August 2017 Page 7 of 60

o o o o Access to relevant specialists/ experts, communications expertise, administrative support and/or additional resources to support investigations where required. Mechanisms to ensure that actions from action plans are monitored until implemented and there is evidence of whether or not the action plan has resulted in the practice / system improvement anticipated. This should include oversight of implementation by organisation leaders. Mechanisms to support investigations being led by external agencies such as the police, HSE or local authority. Where required, providers must submit evidence to contribute towards external investigations. Processes (including interagency investigation policy and/or memorandum of understanding with relevant organisations) to support collaboration and partnership working where joint investigations are required to avoid duplication of activity or confusion of responsibility. Quality assurance processes to ensure completion of high quality investigation reports and action plans to enable timely learning and closure of investigations and to prevent recurrence. Mechanisms and effective communication channels to facilitate the sharing of lessons learned across the organisation and more widely where required. Clear procedures for the timely submission of serious incident investigation reports to commissioners. There should open communication with commissioners where compliance with agreed timescales cannot be met so that, with an evidence based rationale, an extension to those timescales can be agreed. 4.2 NHS Nene and NHS Corby CCGs NHS Nene and NHS Corby CCGs have a responsibility to be assured of the quality of commissioned services and hold providers to account for their assessment of and responses to serious incidents, compliance with national and local requirements, the robustness of investigations and the implementation of resulting action plans. In the event another commissioner has a commissioning interest in a serious incident (e.g. financial, geographical etc) for which the CCGs are the lead commissioner, the quality team will ensure they are informed of the incident and involved in the SI review/monitoring process. NHS Nene and NHS Corby CCGs Governing Bodies receive assurance through the reporting processes in place. On an annual basis the quality team will provide a report to the Quality Committee detailing themes and trends from reported Sis, and actions taken by both providers and the CCGs. A summary of SIs received is included in every quality and performance report provided to the Governing Bodies. The CCGs will ensure they have processes in place: to monitor the reporting and investigation of serious incidents to monitor and manage the NHS Strategic Executive Information System (STEIS) for new incident reports on a daily basis Published August 2017 Page 8 of 60

in the interests of confidentiality and the Data Protection Act, ensure entries to STEIS and subsequent investigation reports are anonymous to report incidents onto STEIS on behalf of provider services who do not have access for the receipt of serious incident reports, investigations and action plans and any corresponding evidence to acknowledge receipt of serious incident reports in a timely fashion to review the findings of investigations, seeking expertise as required and ensuring those with a commissioning responsibility for the provider/incident type concerned are involved to provide objective and constructive feedback within a timely fashion to monitor compliance with Being Open and Duty of Candour for sharing intelligence with relevant regulatory and partner organisations to close/downgrade incidents on STEIS once they have been subject to the CCGs review process and closure has been agreed to report and investigate serious incidents occurring within the CCGs 4.3 NHS England NHS England maintains oversight and surveillance of serious incident management within NHS funded care and assures that 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 must maintain mechanisms to support this function, including exploiting opportunities provided by their involvement and participation in local and regional Quality Surveillance Groups. (NHS England Safety Domain, 2015) NHS England will work in partnership with commissioners and provider organisations to provide leadership and vision for patient safety throughout the Midlands and East, encouraging openness and the development of a learning culture, providing support and expert advice to shape and train the workforce enabling commissioner clusters to have the capacity and capability to effectively undertake their role, and support providers in carrying out local investigations. NHS England will support the NHS Nene and NHS Corby CCGs as a critical friend supplying them with benchmarked information and offering solutions for improvement. They will also take a lead on serious incidents which fall within their remit. 5. Reporting and Investigation Outcomes 5.1 Identifying/Assessing Serious incidents When organisations become aware of an incident with a serious outcome or the potential for a serious outcome, an initial assessment of the incident should be Published August 2017 Page 9 of 60

undertaken to determine whether the incident should be categorised and investigated as a serious incident. This assessment should consider: According to local/national policies/best practice, what should have happened? How did the care provided to this patient meet these requirements? How did the care provided to this patient fail to meet these requirements? Do these failures warrant a full SI investigation? If not, why not? This information should be completed on the CCGs dual purpose initial incident assessment/72 hour report form (appendix 2). For all incidents which the provider deems are serious incidents this form must be submitted to the CCGs within 72 hours. As part of their assurance processes, the CCGs will request a random sample of these forms, for incidents that were deemed not to be serious incidents, on a quarterly basis. Based on this assessment, a decision should be made by the provider through the appropriate governance routes and serious incident meetings as to whether the incident will be reported and investigated as a serious incident. It is through these routes that a lead investigator should be appointed, the level of investigation agreed upon and the terms of reference developed. 5.2 Reporting of Serious incidents Serious incidents must be reported to the NHS Nene and NHS Corby CCGs quality team and onto STEIS without delay and within two working days of the incident being identified. If there is a delay in reporting the incident a rationale must be provided to the quality team and recorded on STEIS by the reporting organisation. For those organisations without access to STEIS this rationale should be provided to the quality team who will update STEIS accordingly. If all of this information is not available at the time of reporting, it should be updated as soon as possible thereafter. NHS Nene and NHS Corby CCGs will review all SI notifications reported onto STEIS and inform any other commissioner, as detailed in any correlating RASCI (Responsible, Accountable, Supporting, Consulted, and Informed) agreement, as having a commissioning interest in the incident, service or organisation. Providers experiencing difficulties completing STEIS may contact NHS Nene and NHS Corby CCGs quality team for guidance. The STEIS administrator can, with the agreement of the provider and commissioning organisation, transfer or remove duplicate or inaccurate STEIS entries. 5.2.1 Out of Hours 17:01 to 08:59 NHS Nene and NHS Corby CCGs have out of hours systems in place to support the reporting of high profile SIs by their provider organisations to themselves and to NHS England. Providers should alert the CCGs through the county wide on call processes. Published August 2017 Page 10 of 60

The following incidents must be reported by NHS Nene and NHS Corby CCGs in a timely manner to the NHS England Director on call. Where there is any doubt, NHS Nene and NHS Corby CCGs will contact the NHS England Director for advice. incidents which necessitate activation of the NHS Trust or commissioner Major Incident Plan and where NHS England needs to take action e.g. attendance of the NHS England Director required at multi-agency gold command incidents that will give rise to significant media interest or will be of interest to other agencies such as the Police or other external agencies incidents that will be of significant public concern The Director receiving the call out of hours will in discussion with the NHS organisation make the decision to notify other NHS England senior managers out of hours and the DH Media Centre. NHS England will contact the NHS organisation on the next working day to receive a verbal progress report and discuss on-going management of the SI, briefing other senior managers and the DH media centre as appropriate. 5.3 Involvement of External Agencies If the police or Health and Safety Executive (HSE) are involved in any SI then the principles outlined in the Memorandum of Understanding between the Police, HSE and DH applies. (DH Guidance 22/11/2006). The purpose of the protocol is to promote effective working relationships setting out general principles when liaising with each other. A decision to report an incident to the Police or HSE needs to be made at a sufficiently senior level. 5.4 Compliance with the Data Protection Act All NHS organisations must comply with the Data Protection Act, therefore when reporting a SI the investigation reports must not contain names or identifiable information. To this end reporting from any service will be anonymous, with the proviso that there is an audit trail on a need to know basis. The CCGs cannot accept receipt of any reports submitted with identifiable information and will return any such reports to the provider for resubmission. It is the responsibility of the organisation that generated the investigation report to retain the document for a period of 30 years. Copies shared with other organisations must be transported safely (physically or electronically) between organisations and in accordance to local policies and procedures. Those copies shared may be destroyed in accordance with the local confidentiality procedure once the report is no longer of use. The CCGs must report any incident of identifiable information inappropriately sent to them through their internal incident reporting procedures. The Data Protection Act will be adhered to at all times. 5.5 Joint Investigations Often more than one organisation is involved in the care and service delivery in which a serious incident has occurred. The organisation that identifies the serious incident is responsible for recognising the need to alert other providers, commissioners and partner organisations as required via their respective risk Published August 2017 Page 11 of 60

management teams/governance teams in order to initiate discussions about subsequent action. A lead organisation should be appointed to coordinate the investigation. This should be agreed upon by all organisations involved, and recorded on the initial incident assessment/72hour form. The CCGs quality team will help to facilitate discussions relating to who is the most appropriate organisation to take responsibility for coordinating the process. Where no one provider organisation is best placed to assume responsibility for co-ordinating an investigation, the commissioner may lead this process. (Serious incident framework, NHS England Safety Domain, 2015). The incident will be reported onto STEIS by the lead organisation. The initial incident assessment/72 hour form should also record whether other organisations have been involved in the patient pathway leading to the serious incident, which providers they are, and whether they have been contacted to participate in the investigation process. A rationale will need to be provided should the organisation identifying the serious incident fail to alert other providers involved. Should the identifying organisation alert the other providers but do not receive a response, the CCGs can be asked to assist. All organisations and agencies involved should work together to undertake the investigation, using one consistent multi-agency panel wherever this is possible and appropriate. The full investigation panel should meet at the start of the investigative process to allocate tasks and agree clear terms of reference, defining each person/organisation s responsibility and involvement, the process the investigation will follow with clear timescales, the key questions and key deliverables. This should include the duty of candour process 7. All organisations should commit to openly sharing information relevant to the investigation or related circumstances surrounding and affecting this, and facilitate access to patient records, where necessary, in a timely manner. This process should culminate in the development of a single investigation report for final discussion and sign off by each respective organisation, prior to submission to the CCGs. If there is any difficulty the CCGs quality team must be contacted to facilitate the discussions/process on joint investigations; organisations failing to participate will be held to account. 7 Guidance on developing terms of reference can be found in appendix 7 of this policy and in appendix 1 of the NPSA Guide to Investigation Report Writing Following Root Cause Analysis of Patient Safety Incidents. Published August 2017 Page 12 of 60

5.6 Initial Incident Review (72 hour report) An initial review should be undertaken by the provider, uploaded to STEIS and submitted to the CCGs for all SIs within three working days of the incident being reported. This report should, as a minimum: identify and provide assurance that any necessary immediate action to ensure the safety of staff, patients and the public is in place assess the incident in more detail (and to confirm if the incident does still meet the criteria for a serious incident and does therefore require a full investigation) and propose the appropriate level of investigation If during the course of the investigation significant information comes to light that was not included in the original 72 hour report this information will be shared with the CCGs and other required parties (e.g. safeguarding referrals), and uploaded to STEIS before submission of the full report. This may include, but is not limited to: new information to enter the public domain (e.g. the press) information that changes the reporting criteria of the incident (e.g. has the patient died since initial reporting, does the incident now meet Never Event criteria, does the incident no longer meet SI criteria etc.) safeguarding concerns not initially apparent subsequent incidents within the same area, involving the same/similar care delivery problems, which may indicate a trend/theme of incidents. 5.7 Investigation The level of investigation required for an incident will be determined by the severity of the incident and the complexity of the investigation required. For all never events, multi-agency and other complex investigations providers must supply the CCGs with progress updates and share terms of reference as requested. Following submission of these investigation reports the CCGs will arrange a meeting for the provider/s to present their findings to the CCGs. Where appropriate and if consideration as to whether an independent investigation is warranted NHS England may be invited to the meeting so a decision can be made. 5.7.1 Concise internal investigation These investigations are suited to less complex incidents which can be managed by individuals or a small group at a local level. The investigation will result in a concise investigation report which includes the essentials of a credible investigation. A concise investigation must be completed and a report submitted to the CCGs within 60 working days of the incident being reported. 5.7.2 Comprehensive internal investigation These investigations are suited to complex incidents conducted by an investigation team or multidisciplinary team, possibly involving experts and specialist investigators. The investigation will result in a comprehensive investigation report including all elements of a credible investigation. A comprehensive investigation must be completed and a report submitted to the CCGs within 60 working days of the incident being reported. Published August 2017 Page 13 of 60

5.7.3 Independent investigation These investigations are 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 or organisation or the capacity/capability of the individuals and/or number of organisations involved. A comprehensive investigation must be completed and a report submitted to the CCGs within six months of the investigation being commissioned. An independent investigation may also be commissioned in the event the commissioner(s), provider(s) or the patient/family feel that the nature of the potential causes of an incident warrant independent scrutiny in order to ensure lessons are identified and acted upon in a robust, open and transparent manner. When an independent investigation needs to be considered regarding a provider service, the CCGs quality team is responsible for making the final decision as to the level/type of investigation required. This decision can be made at any stage of the incident management process, depending on the nature and circumstances of the incident i.e. the CCGs quality team may wait until the submission of the provider s 60 day report before making a decision. NHS England, in rare and exceptional circumstances (for example, where an incident has the potential to cause significant harm throughout the system and/or where investigation of the commissioning system or configuration of services is required), may identify the need for a regionally or centrally led response, initiated by the commissioning of an independent investigation. Where this is the case an appropriate incident management plan (overseen by appropriate Officer/ Responsible Owner at either regional or national level) must be developed and implemented in line with the principles in this Framework. Further guidance regarding independent investigations can be found in appendix three of the NHS England Serious Incident Framework 2015. 5.7.4 Independent investigation: Homicide by a Patient in Receipt of Mental Health Care An independent investigation may also be commissioned in the event of a homicide by a patient in receipt of mental health care. The reporting/investigation process for these incidents is defined by three stages: 1. Providers report an incident onto STEIS or its successor mechanism and conduct an initial review and produce a 72 hour report: 2. Providers conduct an internal investigation and produce an investigation report within 60 days: 3. The NHS England Regional Investigation Teams, in conjunction with the Independent Investigations Review Group (IIRG), review these reports and consider commissioning an independent investigation. Published August 2017 Page 14 of 60

Further guidance regarding independent investigations can be found in appendix one of the NHS England Serious incident Framework 2015. 5.8 Terms of Reference Terms of reference should be developed at the outset of every investigation which will outline the remit, timescales and focus of the investigation. Terms of reference are not rigid and can be altered throughout the investigation as further information becomes available and more key questions are raised. Organisations should consider as early as possible whether the patient concerned and/or their family would like to contribute to and/or agree the terms of reference before the investigation commences to ensure that their key questions are answered. The CCGs will request the terms of reference of an investigation for all never events and joint investigations but may request these for any other SI dependent on the individual circumstances of the incident. Terms of reference should include as a minimum: The issues to be investigated The period under investigation The timescale for completion The key questions to be answered Outline of how different parties/processes have been considered/involved e.g. interface with a safeguarding investigation. Guidance regarding terms of reference is included in the investigation report guidance in appendix 7. 5.9 Extensions If required, extensions for investigations must be requested in a timely manner (as soon as the requirement is known); they will be agreed on a case-by-case basis). Unless there are very exceptional circumstances, extensions will not be granted where: there is a failure by the provider to co-ordinate internal discussions there is an inability to obtain an executive director sign off the request is submitted within 72 hours of the submission deadline The reason for an extension should be clearly recorded within the serious incident management system and included in the serious incident report. Extension requests must be completed using the extension request form and be made by the provider organisation s risk management team no less than three working days before the deadline. The extension request will be reviewed by the relevant Senior Quality Improvement Manager and a recommendation made to the Deputy Director of Quality and/or Medical Director / Clinical Vice Chair who will make the final decision. The extension request form is available at appendix 3. Published August 2017 Page 15 of 60

5.10 Investigation report Investigation reports have a wide audience and therefore how they are written should take each of those people into account e.g. patients, family members, board members, commissioners, coroner etc. It is recommended that reports are drafted on the basis that they may become public and that the anonymity of those be considered, seeking guidance from Caldicott Guardians as required. Investigation reports should detail the findings of the investigation and explain how any conclusions are reached. They do not need to include the investigation tools used or all information gathered. Investigation report templates should be used as a tool for writing a report and not for conducting an investigation. Investigation reports should: be simple and easy to read have an executive summary, index, contents page, and clear headings a title page including the version status of the document a footer including the version date, reference initials, document name, computer file path and page number disclose only relevant confidential personal information for which consent has been obtained, or if patient confidentiality should be overridden in the public interest; this should be considered by the Caldicott Guardian and where required confirmed by legal advice; outline 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 5.11 below); include a description of how patients/victims and families have been engaged in the process; include a description of the support provided to patients/victims/families and staff following the incident A countywide developed investigation report template can be found at appendix 7. 5.11 Action Plans An action plan will be submitted with each investigation report outlining how the recommendations from the investigation will be achieved. Organisations should consider the development of action plans to be an organisational responsibility not just those of the investigator and should be approved by all those affected, who will be best informed as to whether it stands a chance of achieving change. For example, the process could be: recommendations are made by the investigator/investigating team Published August 2017 Page 16 of 60

recommendations are then reviewed by the serious incident group and a decision made as to who would be best placed (at board, directorate, service level) to develop an action to achieve each an options appraisal is collated for review the serious incident group actions are agreed and collated into a comprehensive action plan that is reviewed, agreed and monitored by the serious incident group Action plans must be SMART: specific, measurable, attainable, relevant and timebound. The requirements of an action plan must include, as a minimum, the following: 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 (job title only) 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. 5.12 Downgrading of incidents At any stage during the investigation process evidence may come to light that proves an incident no longer meets the criteria of a serious incident. In this instance the provider must provide the CCGs quality team with a clear rationale as to why the incident no longer requires a serious incident investigation. The quantity and level of detail required by the CCGs will be dependent on several factors, including but not limited to the severity of the incident and how far in to the investigation timescale the incident is. The rationale will be reviewed by the CCGs via the Serious Incident Assurance Review group and, if agreed, a request will be made to remove the incident from STEIS and the incident status amended on the CCGs SI database. 5.13 Updating STEIS following investigation When the investigation has been completed provider organisations will update the following sections on STEIS: Duty of Candour Date Internal Investigation Report and action plan submitted Key findings (i.e. fundamental/root causes) and recommendations How will lessons be disseminated to interested parties Published August 2017 Page 17 of 60

The information provided must include key details of the investigation including an overview of the incident, findings, contributory factors, root causes, recommendations and actions. If further information has become available during the course of the investigation that is relevant to any other STEIS fields this should also be updated. Any incidents reported on STEIS as pending review must be updated with an alternative incident type before the entry can be closed. For organisations without access to STEIS NHS Nene and Corby CCGs will update the root causes and lessons learnt section of STEIS with the executive summary provided. 5.14 Being Open and Patient Involvement/Duty of Candour There are three areas that organisations must refer to to ensure their compliance and for guidance on completing Duty of Candour: NHS Standard Contract (Service Condition 35) CQC Regulation 20 Duty of Candour NPSA Being Open: Saying sorry when things go wrong Patients, families and carers involved in adverse incidents should expect openness, transparency and candour from providers and the services commissioned by them, with timely communication. This principle is called Being Open. The Duty of Candour is defined as: a legal duty on hospital, community and mental health trusts to inform and apologise to patients if there have been mistakes in their care that have led to significant harm 8. An apology is not seen as an admission of an organisation s liability, but a courteous and sincere acknowledgement that a harmful patient safety incident has occurred. Patients and their families/carers must be involved, if they choose to be, and kept informed and supported throughout the investigation process. The final investigation report should provide sufficient assurances that similar events will not occur again. Adopting an open and honest approach when things go wrong is fundamental to the partnership between patients and those who provide their care. If patients, carers or families decide not to be involved in the investigation process or informed of an investigation outcome they will be informed that, should they change their mind they may request the information at any time. Providers should ensure adherence to the Duty of Candour process for all incidents with a harm level of moderate or above, regardless as to whether they meet the SI criteria. Providers will give assurance to the CCGs regarding the completion of duty of 8 NHSLA Duty of Candour: http://www.nhsla.com/otherservices/documents/nhs%20la%20- %20Duty%20of%20Candour%202014%20-%20Slides.pdf Published August 2017 Page 18 of 60

candour for patient safety SIs via their investigation reports and STEIS. Assurance with Duty of Candour requirements for all other incidents with a harm level of moderate and above will also be received from the provider via a quarterly report and through the Serious Incident Assurance Meetings (SIAM). 5.15 Inquests Providers must inform the CCGs of any serious incident that is being taken to inquest in the event that the outcome of which requires further internal investigation relating to the incident and/or additions to the action plan that will require monitoring through SIAM. The CCGs ask that providers share any regulation 28 reports received from the coroner with them and the corresponding regulation 29 report to ensure the requirements are addressed by the serious incident action plan where appropriate. In the event that a regulation 28 is issued regarding an incident that was not reported as an SI, the CCGs will seek assurance from the provider regarding the outcome of the initial assessment of that incident at their serious incident group and the rationale for their decision. Assurance of action implementation will be sought at SIAM. 6. Assurance and Review 6.1 Review of submitted investigation reports On receipt of a completed investigation report and action plan the CCGs Quality team will acknowledge receipt by email, the STEIS entry will be updated with the date the CCGs received the report and the report circulated for review to a commissioning multidisciplinary team: Members of the CCGs with a commissioning responsibility for the reporting organisation or the incident type, or specific aspects of the investigations findings e.g. relevant joint commissioner, medicines management team, safeguarding, information governance The CCG Clinical Executive for the organisation concerned/gp quality lead CCGs Quality Assurance Manager Senior Quality Improvement Managers Medical Director / Clinical Vice Chair and/or Deputy Director of Quality SI leads from any other CCGs that have an interest in the incident Any other commissioner, as detailed in any correlating RASCI (Responsible, Accountable, Supporting, Consulted, Informed) agreement, as having a commissioning interest in the incident, service or organisation All comments will be collated and reviewed by the lead Senior Quality Improvement Manager for that service. Based on the findings of the report they will make one of the following decisions: The investigation and action plan are sufficient, the CCGs are assured that the risk of future incident has been eliminated or sufficiently mitigated against and the incident can be closed. Published August 2017 Page 19 of 60

The investigation and action plan are insufficient and further information is required for the CCGs to be assured that all contributory care/service delivery problems have been identified and/or appropriate actions are taking place to prevent future incident. The Senior Quality Improvement Manager will determine whether further information is required and the feedback to be given. Feedback will be provided to reporting organisations within 20 calendar days of the report submission for all incidents. Where necessary an alternative timescale may be agreed, for example, due to the complexity of the investigation or questions asked or where there may be a need for wider consultation; this will be agreed on a case by case basis with the provider. When the NHS Nene and NHS Corby CCGs quality team are assured the investigation report clearly identifies learning and has developed a plan to prevent future incident a recommendation will be made to the SI Assurance and Review Group (SIARG) that the incident can be closed. 6.2 Requests for Further Information If NHS Nene and NHS Corby CCGs decide that a submitted report requires further information before it can be closed, a request will be sent to the reporting organisation detailing specific questions or highlighting where further information is required. Further information will normally be submitted in the form of an email however the CCGs may specify that the information must be submitted as an addendum to the original report or that the report itself be revised; the CCGs will provide a rationale if either of the latter is required e.g. presentation of a Never Event report at Quality Committee. A deadline will be given to the reporting organisation by which the further information must be provided. A standard timescale for return is ten working days however this will be determined on a case by case basis. If further information is required STEIS will be updated by the CCGs with the date requested, an explanation of what was required and, on receipt, the information provided. 6.3 Serious Incident Assurance and Review Groups (SIARG) The Serious Incident Assurance and Review Group (SIARG) membership consists of: Senior Quality Improvement Managers (when presenting SIs for closure) CCGs Quality Assurance Manager CCGs Clinical Executives (chair) Medical Director / Clinical Vice Chair and/or Deputy Director of Quality Other specialists if required, for example information governance, medicines management, safeguarding The group meets on a fortnightly basis to review and agree the closure of serious incidents that have already been subject to the CCGs review process. The group will Published August 2017 Page 20 of 60

look at the investigation report, action plan and any further information provided, alongside the Senior Quality Improvement Manager s recommendation for how the case should proceed, and decide whether the incident can be closed. The group also considers requests to downgrade incidents at any stage of the investigation process. Requests to downgrade at the 72 hour report stage will be taken to SIARG as soon as practicable to ensure the provider receives a timely response to their request. If SIARG require further information before agreeing closure or downgrade, this will be taken forward by the Quality Assurance Manager. If SIARG agree the closure of the SI, the STEIS entry will be closed, the incident closed on the CCGs database and the provider informed. Publication of serious incident investigation reports and action plans are considered best practice. To support openness and transparency, SIARG will recommend SI reports that they believe demonstrate good learning that others may benefit from and providers will be asked to share the root causes and learning and/or present these at the countywide Patient Safety Forum. In accordance with both the NHS England Serious Incidents Framework and the NHS England Never Events Framework, incidents may be closed on receipt of the investigation and action plan where it is considered acceptable to do so and robust arrangements are in place to ensure implementation from actions is reviewed. However there may be times where the gravity and severity of the incident is such that it is both necessary and proportionate for the CCGs to see these through to full completion, including a clinical visit for assurance purposes, before the incident is suitable for closure. SIARG, in consultation with the Senior Quality Improvement Manager, will be responsible for making a decision as to whether an incident is to remain open for full completion or whether it can progress to closure once the investigation report, action plan and responses to any further questions have been received and reviewed. The monitoring of an incident to full completion, including a clinical visit, will be monitored by the quality team, with periodical updates provided to SIARG. When assurance of the implementation of actions from these serious incident or never event investigations is received, they will be returned to SIARG for agreement of closure. SIARG will also review and consider both emerging and established SI themes and trends, to influence discussion at forums for wider learning. Minutes will be kept of this meeting and clearly describe the roles and responsibilities of those involved in the reporting, investigation, oversight and closure of the serious incident to demonstrate good governance and provide a clear audit trail. 6.4 Serious Incident Assurance Meetings (SIAM) SIAMs are formal meetings between NHS Nene and NHS Corby CCGs quality team and the main providers: Kettering General Hospital NHS Foundation Trust, Northampton General Hospital NHS Trust and Northamptonshire Healthcare NHS Foundation Trust. The purpose of the SIAM is to: Published August 2017 Page 21 of 60

Ensure implementation of, and gain assurance for all actions agreed as a result of SI investigations. Ensure that quality evidence of demonstrable outcomes from SI action plans are available. Discuss any additional actions that the provider was asked to consider at point of closure. Agree dissemination of learning from SIs across other providers. Review any identified trends and agreement or completion of thematic reviews Understand the change an investigation has made to clinical practice/outcomes for patient. Provide feedback from any clinical visits that have been undertaken following the reporting of an SI. SIAM timescale 8 weeks prior to SIAM CCGs review which action plans are due for completion since the last SIAM 6 weeks prior to SIAM CCGs select incidents for visit, clinical presentation and paper review at meeting and informs providers. Provider to co-ordinate clinician attendance, and ward/area visit (if required) 2 weeks prior to SIAM Provider to send: Evidence of completed actions for incidents identified for both clinical and paper presentation; RAG rated overview of all other action plans which were due for completion since the last SIAM CCGs to circulate meeting papers CCGs to review evidence submitted by providers The SIAM will take place as: A focused ward/area based clinical visit to gain first-hand assurance of the implementation of learning from an SI, A meeting with the providers where selected evidence is presented by clinicians, As well as a paper based evidence review; or A combination of both. The Senior Quality Improvement Manager will decide on the form of the SIAM dependent on the SIs due for review at that particular SIAM, and taking into account recommendations from SIARG. The CCGs will also seek assurance regarding provider initial incident assessment processes; providers will be expected to bring their initial assessment forms to SIAM and the CCGs will undertake a random review of these. Where any learning is identified at SIAM that is thought would be useful to other providers the CCGs will seek the providers consent to share this anonymously with other providers. Published August 2017 Page 22 of 60

SIAMs will take place quarterly or as case load and concerns demand. Bespoke arrangements are in place with other providers to gain assurance around their serious incidents and never events. 6.5 Clinical Quality Review Meeting (CQRM) There is a contractual requirement that Clinical Quality Review Meetings (CQRM)/contract meetings are held with providers to monitor the quality and safety of services based on information submitted via quality schedules and CQUINs. Concerns and exceptions will be escalated to the CQRMs where issues cannot be resolved as part of the incident management process, SIAMs or as deemed necessary. 7. Monitoring Compliance NHS Nene and NHS Corby CCGs monitor provider organisations adherence to the policy by: timeliness of reporting in accordance with the standards laid out in this policy o the time between the date the incident being identified and the date reported to the CCGs and onto STEIS (within 48 hours or 2 working days) o compliance with the initial incident review report being submission and upload to STEIS (72 hours) o compliance with investigation report submission requirements (60 working days as standard/6 months for an independent investigation) o compliance with the provision of further information (10 working days unless otherwise stipulated) compliance with Duty of Candour (service condition 35 and CQC regulation 20) quality of investigation and report provided quality of the corresponding action plan suitability of evidence demonstrating action plan implementation learning is (by whom and with whom) shared compliance with the joint investigation process This information will be measured through a variety of methodologies such as performance data, audit and review of documentary evidence which demonstrates compliance (linked to CQC Standards and NHS litigation Authority). 8. Related Protocols A number of protocols relate to the management of SIs, which should be followed as appropriate in individual cases. Child protection procedures in respect of children who have been or are suspected of being abused Safeguarding Adults policies DH guidance on Serious Adverse Events relating to the discharge of mentally disordered people and their continuing care in the community relating to: violent incidents, victims under 18 years of age, or homicides and suicides (HSG (94) 27 and amendments) Published August 2017 Page 23 of 60

Retained Organs Good Practice guidance NHS Complaints Procedure Major Incident Plan/Event policies Memorandum of Understanding NPSA Being Open Information Governance and Code of Conduct guidelines The Coroners (Investigations) Regulations 2013, paragraph 7, schedule 5 Published August 2017 Page 24 of 60

Appendix 1 Initial Incident Assessment Form/72 hour Report [Insert Logo] Incident details Datix number: STEIS number: Date of incident: Incident type: Level of harm: Ward/service: Incident reviewed by: Patient/Carer/Family notified Best practice Please reference all guidance relevant to this incident, at the time of the incident, and specify the relevant sections Local policies/processes/ standard operating procedures National guidance CAS Alerts Overview of Incident this must include: compliance/deviation from best practice Situation: Background: Assessment: Recommendations: What immediate actions have been taken to prevent further incident/mitigate risk? Rationale why the incident does or does not warrant either a single event or multiple linked root cause analysis investigation. Including supporting evidence. Outcome of review against Never Event criteria? Were there any safeguarding concerns? Please provide details and confirm whether a referral has been made Published August 2017 Page 25 of 60

Additional comments: e.g. media interest, externally reportable, multiagency incident, police and/or HSE investigation, Coroner s inquest. Were other organisations involved in the patient s pathway in relation to this incident? If so, which organisations? How were the other organisations involved in the patient s care? (i.e. reported incident, joint care, lack of communication) Have the organisations been notified and invited to join the investigation? If no, please provide a rationale State the lead contact in the other organisation(s) involved Will this be a joint investigation? Y/N Date of notification Outcome of governance review/decision (e.g. serious incident sign off meeting) Level of investigation required: Investigation team: Lead organisation: Being Open/Duty of Candour Lead: Approved by: Date: Published August 2017 Page 26 of 60

Appendix 2 NHS NENE AND NHS CORBY CCGs SERIOUS INCIDENT EXTENSION GUIDANCE Please ensure that both pages of the extension request are forwarded as soon as you are aware that a deadline will not be met. Please email the request to: Northants.SUI@nhs.net Providers are given timeframes in accordance with the NHS England framework to complete a full SI investigation and root cause analysis in order and produce a final report and action plan following a SI. If a provider organisation is unable to meet any of the deadlines an extension can be requested and will be considered on a case-by-case basis. Such requests may be granted under the following circumstances: - Sickness/availability/absence of a Key individual. If short-term sickness/absence NHS Nene and NHS Corby to consider length of absence and extend accordingly. o Negotiation of extension to a maximum of 20 working days. If long-term sickness/absence (exceeds 20 working days) - a contingency plan must be in place to ensure that the report is investigated within the agreed timeframe. Multi-agency involvement if a SI investigation involves multi-agencies and a delay is encountered. o Negotiation of extension to a maximum of 20 working days. Ad hoc requests outside the categories above will also be considered on a case-bycase basis. o Extension may be granted to a maximum of 20 working days. N.B. Unless there are very exceptional circumstances, extensions will not be granted where: There is a failure by the provider to co-ordinate internal discussions There is an inability to obtain an executive sign off The request is submitted 72 hours prior to the submission deadline Published August 2017 Page 27 of 60

Serious Incident Final Report - Extension Request Form Name of person completing this form:.. Provider Name: STEIS Number:. Please specify the length of extension required in number of working days:. Reason for request: CCG Use only Incident report original due date: Date request received: Extension granted: Y / N Number of working days extended: New submission date: decision: Date Provider informed of STEIS updated with new date and rationale: Y / N Name of individual considering the extension request: Reason for granting/refusing the extension request: Published August 2017 Page 28 of 60

Appendix 3: NHS England SI Framework Flowchart 9 Incident occurs Within 2 working days Manage in line with local risk management policy Report on LRMS/ NRLS and to other bodies such as safeguarding lead as applicable No Is it a serious incident? Unknown Review and discuss with commissioner Engage with those involved/affected Yes Report/notify other stakeholders as required e.g. safeguarding, CQC,TDA etc. Report on STEIS Within 3 working days 60 working days or 6 months for independent investigation 20 days* Ongoing Complete initial review and submit to commissioner where possible this should be the provider s lead commissioner who can liaise with others as required. This should be outlined in the RASCI model. Confirm level of investigation required Lead investigator identified. Team established. Terms of reference set. Management plan established Gathering and mapping information Undertake the investigation Analysing information Submit final report and action plan Generating solution Commissioner (with relevant stakeholders) undertakes a review of the final report and action plan and ensures it meets requirements for a robust investigation (see appendix 8). Feedback given to provider (*calendar days) Commissioner closes investigation and confirms timescales/mechanism for monitoring the action plan where actions/improvements are still being implemented. Support and involve those affected (including patients, victims and their families and staff) Opportunities for feedback and learning identified and information shared 9 NHS England, Serious Incident Framework: Supporting Learning to Prevent Recurrence, 2015 Published August 2017 Page 29 of 60

Appendix 4 Northamptonshire Interagency Procedures: Interface between Serious Incidents Reporting in Health Services and Multi-agency Safeguarding Adults Procedures Published August 2017 Page 30 of 60

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Appendix 5 Northamptonshire Interagency Procedures: Interface between Serious Incidents Reporting in Health Services, Serious Case Reviews and Child Death 1. Aims and objectives This procedure seeks to ensure effective interface between child protection procedures and procedures carried out through the serious incident investigation process for health services. An effective interface ensures comprehensive investigation, transparency and learning across the multi-agency safeguarding children partnership. 2. Context Health organisations providing NHS care are required to report serious incidents to their commissioning body. Serious incidents include incidents such as serious harm, unexpected or avoidable death and abuse (inflicting or failing to act to prevent harm). In relation to children and young people, it is important to consider whether the nature of the serious incident has implications for safeguarding children and whether any lessons learned will be beneficial to share across the multi-agency safeguarding partnership. Where a child dies, the death is notified through the child death review process in order for themes and individual lessons to be identified. In some circumstances, the child s death may also be notifiable to health commissioners as a serious incident. 3. Process for serious case review Where a serious incident is reported to the health commissioner, the patient safety team will identify whether there are potential implications for safeguarding children in the broadest sense. The team will seek specialist advice via the Designated Professionals for Safeguarding Children. The Designated Professionals will identify whether the case meets the threshold for referral through to the SCR committee in line with inter-agency procedures. a. Referral of the serious incident to SCR committee Where a referral is made to the SCR committee, the committee will determine whether the criteria for a serious case review are met or whether there may be learning from an individual management review (IMR). Where the committee decision is to manage the case as a SCR or IMR, the serious incident investigation process will be integrated with this process so that the serious incident investigation forms the basis of the IMR carried out under the remit of the SCR committee. Terms of reference for the SCR/IMR should be shared with the investigating health organisation and the health commissioner s designated professionals & patient safety team so that they are aware of any additional requirements not currently covered under the serious incident terms of reference. The patient safety team must Published August 2017 Page 36 of 60

also be made aware of timeframes for the SCR/IMR as this may have implications for timeframes required for the serious incident investigation. b. Decision that serious incident should not be referred to SCR committee Where a serious incident is assessed by the Designated Professionals as not reaching the threshold for referral to SCR committee, the serious incident will continue to be investigated as defined by patient safety procedures. The investigation may identify new information and trigger referral to the SCR committee as described in 3.1 above. Published August 2017 Page 37 of 60

FLOWCHART INTERFACE BETWEEN SERIOUS INCIDENTS AND SERIOUS CASE REVIEW Health organisation identifies that an incident involving a child has occurred Commissioners Patient Safety Team (PST) advised PST consult designated professionals Designated professionals determine potential for safeguarding children issues & need for referral to SCR committee Reporting organisation commences investigation LSCB reviews information against the SCR criteria Reporting organisation amends original ToR if required LSCB establish terms of reference (ToR) and advice commissioners and investigating organisation/s Reporting organisation submits investigation report Commissioner reviews investigation report with input from designated professionals. Considers whether information within the report raises any additional concerns re safeguarding children If additional concerns are identified the reporting organisation and LSCB informed If no additional concerns closes incident and works with trust to monitor outcomes. Report to LSCB Learning shared via SCR committee Published August 2017 Page 38 of 60

4. Process for child deaths When a child dies, deaths are notified by the professional confirming the child death to the LSCB child death coordinator (designated person). The lead paediatrician carries out a review with the relevant agencies and professionals involved and presents findings to the Child Death Overview Panel. Health organisations that have provided NHS care must also consider whether the circumstances of the death constitute a serious incident. Where investigation as a serious incident is required, this will be reported to their commissioning body. Where a child s death is being investigated as a serious incident, the investigation may also identify learning that the patient safety team and Designated Professionals identify as beneficial to share across the multi-agency safeguarding partnership. This will be shared through the CDOP The child death coordinator will share information with the patient safety team about all child deaths in order to triangulate information and provide robust assurance that deaths are being appropriately reported as serious incidents. Published August 2017 Page 39 of 60

FLOWCHART INTERFACE BETWEEN SERIOUS INCIDENTS AND CHILD DEATH REVIEW Professional confirming child s death notifies LSCB child death coordinator Strategy discussions and early professionals meeting (if sudden and unexpected death) i) May an SCR be indicated? recommendation via LSCBN Health organization considers if serious incident Liaison between child death coordinator and PST for all child deaths Commissioners Patient Safety Team (PST) advised of serious incident confirm notification has been made SI TOR agreed in line with procedures for child deaths (including unexpected deaths) & advice commissioner and CDOP ii) May an SI be indicated? lead paediatrician makes recommendation to health organisation Reporting organisation commences investigation Professionals review meeting reconsiders whether SCR or SI may be indicated (as above) and makes recommendation Reporting organisation submits investigation report SI report informs CDR discussions. Commissioner reviews investigation report with input from designated professionals CDOP informed of outcome If no additional concerns, actions agreed and serious incident closed Implementation of actions and monitoring outcomes agreed from SI and CDOP process Published August 2017 Page 40 of 60

Appendix 6: Investigation Report Template [Insert Organisation Logo/s] INVESTIGATION TEMPLATE SUPPORTING DOCUMENT This document has been developed in line with the NPSA Guide to Investigation Report Writing Following Root Cause Analysis of Patient Safety Incidents. This and other NPSA investigation support documents can be found at http://www.nrls.npsa.nhs.uk/resources/?entryid45=59847 Serious Incident Details and Summary complete those applicable STEIS Number: Datix Number Incident Type: (as per STEIS entry) Reason for Reporting: (as per STEIS entry) Actual Effect/Harm to Patient: Incident Date: Organisation/s involved: Ward/Service: Investigation Lead (Organisation): Patient Date of Birth: Author(s): (Name, Job title) Report Date: Signed Off By Name: (Name, Job title) Serious Incident Group Sign Off: Document Version: Published August 2017 Page 41 of 60

TABLE OF CONTENTS Published August 2017 Page 42 of 60

Executive summary This section should be no more than one or two pages long and summarises the main body of the report. The section should include as a minimum the following sections: Brief incident description Findings/Conclusion Recommendations Published August 2017 Page 43 of 60

1. Patient details Age Diagnosis and other comorbidities Gender Disability Marital/civil partnership status Ethnic origin Religion/belief Sexual orientation Level of harm GP location Details: Yes No N/A Service/speciality involved Directorate/Division/Clinical Business Unit Safeguarding incident Yes No Current admission date Current ward / location / nursing team / care home Other clinical services/ organisations involved Commissioner funding care 2. Terms of reference 2.1. Purpose In brief, what does the investigation need to achieve, for example, To identify the root causes and key learning from an incident and use this information to significantly reduce the likelihood of future harm to patients. Consider how this will be achieved. What investigation methods will be used? 2.2. Involvement of patient/relatives How will the patient and/or their family be involved in the investigation? What information will be provided to them and when? Consider the Duty of Candour requirements. Who will be the duty of candour lead? If conducting a multi-agency investigation, will there be one duty of candour coordinator? 2.3. Objectives For example: Published August 2017 Page 44 of 60

To establish the facts i.e. what happened (effect), to whom, when, where, how and why (root causes) To establish whether failings occurred in care or treatment To look for learning points and improvements rather than to apportion blame To establish how recurrence may be reduced or eliminated To formulate realistic recommendations and an action plan to address root causes and lessons learned To provide a report and record of the investigation process and outcome To provide a means of sharing learning from the incident To identify routes of sharing learning from the incident Appendix one of the NPSA Guide to Investigation Report Writing Following Root Cause Analysis of Patient Safety Incidents provides a list of prompts for consideration in the development of the terms of reference. 2.4. Key Issues and Scope What timeframe will the investigation cover? From which date/time until which date/time? Why this timeframe? Deadlines and scope are to be clear, especially with regards to joint investigations. What are the key questions this investigation needs to address, specific to this incident? For example: Why was the patient s dose missed? Why was the early warning score not escalated appropriately? Was the risk to the patient correctly assessed? 2.5. Key Deliverables For example, but not limited to: Investigation report, by when Action plan Implementation of actions Completion of the organisation s duty of candour, how and by when 2.6. List of Data Sources For example, but not limited to: Patient notes Interviews Statements Previous SIs or incident forms Meeting minutes Training records Local policies (in place at the time of the incident) Equipment Emails Visit reports Photographs 2.7. Investigation Team Published August 2017 Page 45 of 60

Members of the investigation team should not have been directly involved with the incident. Consider who has the expertise to be involved in this investigation? Who is leading/coordinating the investigation? What other teams/organisations need to be involved e.g. NCC Safeguarding, GP practice etc? When were they advised and have they had the opportunity to be involved? If they are not participating in the process, what is the rationale for this? If it is appropriate for any of the organisations involved to leave the investigation at this stage, please explain it here. Is it clear what everyone s responsibilities are? Name Job Title Organisation Role/responsibility Ensure each member of the investigating team are clear of what their individual responsibilities are but also the responsibilities of the team as a whole and as individuals. Is there a plan of how the investigation will be undertaken? What are the key dates for everyone to know? When will the team come together again? 3. Background 3.1. Description of Patient Provide a brief description of The patient Their relevant medical history and comorbidities The current diagnosis and reason for their recent contact with services 3.2. Description of Service/s Involved For each service involved in the incident: What sort of service is it? What area does it cover? How many beds/patients does it treat? Has the service/s been involved in similar incidents in the past? 3.3. Other Services Provided to Patient What other services were being provided to the patient other than those mentioned above? 3.4. Relevant National and Local Policy/Guidance (at time of incident) What were the relevant national and local policies/guidance in place at the time of the incident, including but not limited to NICE guidance and CAS alerts? 4. Support Published August 2017 Page 46 of 60

4.1. Description of Support for Patient and/or Family/Carers/Guardians What support is being provided to the patient and/or family/carers/guardians following the incident, e.g.: Explanation of the investigation process Bereavement counselling Further medical/clinical treatment Referrals to other services 4.2. Description of Support for Staff What support is being provided to the staff involved in the incident or treatment of the patient, formal or informal, e.g.: Increased supervision Counselling Occupational health Medical/clinical treatment 5. Description of events Provide a detailed account of the incident, the events that led to it, the consequences and the outcome. This should cover the scope of the investigation (timescale) as agreed in the terms of reference. This should be a summary of the mapped chronology completed as part of the investigation. This can be written in narrative or tabular form. This section should ascertain when the incident/error was detected, analysing how far the problem progressed before identification. 6. Good practice What elements of the patient s care have been highlighted through the investigation as being good/best practice? What aspects of the patients care can be highlighted as a good example to those involved and others? Were any aspects of the patients care considered to have gone above and beyond standard practice? Bearing in mind that this report will be read by the patient and/or their relatives so ensure this is recorded with appropriate sensitivity. 7. Care Management and Service Delivery Problems What happened that should not have happened? What should not have happened that did? What aspect of the patient s care or act by staff did not comply with agreed policy? Be specific. 8. Contributory Factors Why/how did each care/service delivery problem occur? What failed to prevent the care/service delivery problems from occurring? Why weren t agreed policies/processes followed? Be specific. Published August 2017 Page 47 of 60

Why didn t staff apply their training? Consider: Patient factors Individual (staff) factors Task factors Communication factors Team and social factors Education and training factors Equipment and resources Working conditions Organisational and strategic factors How were these thing analysed? How was this conclusion reached? The fishbone diagram investigation tool, 5 whys or contributory factors classification/framework may help investigators to determine which are applicable. One diagram should be completed per care/service delivery problem. NPSA tools for each can be found at http://www.nrls.npsa.nhs.uk/resources/?entryid45=75605 Tools used to support/assist the investigation As part of this investigation the following root cause analysis tools/techniques have been applied (the report will contain the tools used): Root cause analysis tabular timeline Time person grid Change analysis Contributory factors classification framework Fishbone diagram Barrier analysis Options appraisal tool 9. Safeguarding concerns Were there any findings from this investigation which triggered safeguarding concerns? Were the appropriate referrals made? 10. Incident Decision Tree This should be completed for staff members, not the incident itself. If more than one employee is involved, it is essential to work through the Incident Decision Tree separately for each person. A flowchart of the incident decision tree questions can be found at appendix six and guidance regarding completion of the incident decision tree can be found here http://www.suspension-nhs.org/resources/safety%20- %20IDT%20(info%20and%20advice%20on%20use).pdf As part of this investigation the Root Cause Analysis has indicated it to be appropriate to apply the incident decision tree. Published August 2017 Page 48 of 60

The outcome of this for each individual involved is confidential, however overall it has been deemed that no members of staff need to be managed through the HR processes OR xx (number) member(s) of staff are/have been managed through the trust s HR processes. 10.1. Deliberate Harm Test 10.2. Incapacity Health Test 10.3. Foresight Test 10.4. Substitution Test 11. Root Causes What factors directly caused which care/service delivery problem/s that resulted in the incident occurring and/or the specific outcome for the patient? 12. Lessons Learned Key safety and practice issues identified which did not materially contribute to the incident. They may be related to the: Incident itself Investigation process Implementation of recommendations/actions plan 13. Actions taken to prevent future incident What actions took place immediately after the incident to ensure the safety of patients and staff? What actions have already taken place to prevent future incident? 14. Recommendations for further action Based on their findings, what does the investigator/investigating team recommend to prevent future incident? To prevent future failings in care? To mitigate against the risk of reoccurrence? In the case of a joint investigation, have all responsible providers agreed to their respective actions, timescale and have nominated a lead? This should be noted within the report. 15. Conclusion Summary of what the investigation found. Have the key questions set out by the terms of reference been answered? Have all providers identified as being involved in the patient s pathway relating to the incident been involved or offered involvement, had adequate opportunity to review and respond to the draft report and have agreement to any actions relating to them? If not, a rationale is to be provided. Published August 2017 Page 49 of 60

16. Statement from the SI meeting/group or clinical lead What were the findings/opinions, in relation to this investigation and its findings, of the SI group or SI lead within the investigating organisation/s who commissioned the investigation and/or who was approved the final version of this report? 17. Arrangements for shared learning How will learning be disseminated to the staff directly involved in the incident? How will learning be shared with the team/s involved in the care of the patient? How will learning be shared with other teams? How will learning be shared with other organisations? 18. Distribution List Who will the report be circulated to once signed off? Appendix two of the NPSA Guide to Investigation Report Writing Following Root Cause Analysis of Patient Safety Incidents provides a list of possible people and organisations for consideration in the distribution list. 19. References Have any published documents be quoted/referenced throughout the report? What was the title? Who was the author? Where was it published What are the relevant sections? Published August 2017 Page 50 of 60

20. ACTION PLAN Actions should be developed by, or in conjunction with, the individuals/teams expected to implement them. They will have a better insight into why it may or may not work, the barriers they may come across and the time it will take to implement. Involvement in this process will increase the likelihood of individuals/teams taking ownership of the action and taking it forward; it will increase the chance that staff will feel the plan contributes to their work, their service, their patients. Action Plan 1. 2. 3. Recommendation Recommendations as detailed in section 14. Action required What action/s can be taken to achieve this recommendation? More than one action may be required to achieve a recommendation. Actions are not restricted to recommendations made by the investigation. The completion of the duty of candour process or the Monitoring Arrangements Once complete, how will the organisation/ team ensure that it is working, that practice continues, that it is effective etc Individual/ Team/ Organisational Action Is this action for an individual/s, team/s or organisation/s? Lead Deadline RAG rating Who is responsible for completing this action When will this action be completed by? Green = completed Amber = In progress Red = Overdue Published August 2017 Page 51 of 60

4. 5. 6. 7. Recommendation Action required sharing of learning may also be included to ensure completion. Extend the table as required Monitoring Arrangements Individual/ Team/ Organisational Action Lead Deadline RAG rating Acknowledgement of responsibility Action Lead - Name Action Lead Job title/role Relevant actions Signature Date To ensure acknowledgement of responsibility for an action/s, list each of the leads as detailed in the above table and request their signature to demonstrate agreement. Published August 2017 Page 52 of 60

ANNEXE 1 Glossary: A description of acronyms and technical/clinical terms Consider any terms or acronyms that have been used in the report that may not be familiar to those outside of the organisation, who have not been clinically trained, and provide a brief description here e.g. for the patient and/or their family. Published August 2017 Page 53 of 60

ANNEXE 2 Duty of Candour Tool designed around the CQC regulation 20 requirements to help track the duty of candour lead s progress. Yes No Details Initial Notification As soon as reasonably practicable after becoming aware of the incident, was the relevant person informed of the incident? As soon as reasonably practicable, was support provided to the relevant person in relation to the incident? Was this notification given in person? Did the notification provide an account, which to the best of the Provider s knowledge is true, of all the facts the Provider knew about the incident as at the date of the notification? Was the relevant person informed at notification of the further enquiries and investigations into the incident the Provider believed to be appropriate? Did the initial notification include an apology? Was a written record kept of the notification and held securely by the provider? Follow up written notification Was the notification followed by one or more written notifications given or sent to the relevant person containing: An account of all the facts the Provider knew about the incident as at the date of the notification Details of any enquiries and investigations to be undertaken Details of any enquiries and investigations that have been carried out into the incident, and any causes of that incident, or other findings, that have been identified as a result of those enquiries investigations; any steps that have been taken to prevent the recurrence of such an incident An apology Unable to contact or declined by relevant person If the Relevant Person cannot be contacted or declines to speak to the representative of the Provider was a written record of attempts to contact or speak to the Relevant Person kept? Published August 2017 Page 54 of 60

Yes No Details Record keeping Have copies of all correspondence and full written records of any meeting or other contact with the relevant person in relation to the incident been kept by the provider? Sharing findings Within 10 Operational Days following the investigation being signed off as complete by the Provider, did the Provider provide the Relevant Person with a copy of the investigation report? Was the relevant person informed the report may be subject to amendment following review by the Commissioner? If, following review, the relevant Commissioner required substantial changes to the investigation report, was a copy of the final amended report shared with the relevant person? Published August 2017 Page 55 of 60

ANNEXE 3 Investigation tool - Chronology A chronology is a useful investigation tool which helps to map the incident and the events that led to it using all information gathered. From this, the investigator can compare what happened with what should have happened and highlight any areas of good practice or where there are care/service delivery problems that warrant further investigation. Date Time Description of Event Good Practice Care/Service Delivery Problems Published August 2017 Page 56 of 60

ANNEXE 4 Investigation tool - Care Management/Service Delivery Problem Analysis Care Management/Service Delivery Contributory Factors to CDP Problems (CDP) Recommendations Published August 2017 Page 57 of 60

ANNEXE 5 Investigation tool - Fishbone Diagrams (One per care/service delivery problems) Place one of the care/service delivery problems and then consider what contributed to that occurring. Complete a fish for each problem.

ANNEXE 6 Incident Decision Tree