Incident and Serious Incident Management Policy

Authors Sarah Hemsley Clinical Safety Manager Abi Eaves Patient Safety Manager Quality and Professional Development Leeds Community Healthcare NHS Trust Corporate Lead Angie Clegg Executive (Nurse) Director of Quality Quality and Professional Development Document Version 2.3 Date ratified by Quality Governance and Risk Committee 8 th October 2012 Date amended and issued 19 th November 2014 Review date October 2015 Policy Number PL268

Executive summary The vision of Leeds Community Healthcare (LCH) is to provide the best possible care in every community. The delivery of high quality care is identified as one of the ways of achieving this vision. Key to the provision of high quality care is ensuring that when things go wrong, events are reported and investigated and that learning and action takes place. This policy sets out to outline the processes for Incident and Serious Incident (SI) Management so that all staff are aware of their responsibilities and understand their contribution to patient safety. Implementation of this policy supports and contributes to the LCH Risk Management Strategy and the governance framework within which risk is managed. Implementation of this policy demonstrates compliance with NHS Litigation Authority (NHSLA) risk management standards (2012/13). The policy also contributes to the compliance of the following Care Quality Commission (CQC) Outcomes: 4: Care and Welfare of people who use services 18: Notification of death of a person who uses services 19: Notification of death or unauthorised absence of a person who is detained or liable to be detained under the Mental Health Act 1983. Equality Analysis Leeds Community Healthcare NHS Trust s vision is to provide the best possible care to every community. In support of the vision, with due regard to the Equality Act 2010 General Duty aims, Equality Analysis has been undertaken on this policy (see Appendix 1). Page 2 of 61

Contents Section Page 1 Introduction 6 2 Aims and Objectives 6 3 Definitions 6 4 Responsibilities 8 5 Mental Capacity Act 15 6 Incident Management 16 6.1 Reporting process 16 6.2 Investigating incidents 16 6.3 Internal inquires and other investigations 17 6.4 Professional issues and criminal Acts 17 6.5 Tools to investigate an Incident / Serious Incident (SI) 18 6.5.1 The Root Cause Analysis Process 18 6.5.2 Mapping of events - Time Line/Chronology 19 6.5.3 Analysing the information Fishbone diagram 19 6.5.4 Analysing the information - Five Whys 19 6.6 Formulation of Action Plans 19 6.7 Process for Acting on the Findings of SI Investigations 20 7 Learning and Improvements 20 7.1 Establishing Improvement and Lessons Learnt from Incidents 22 8 Controlled Drugs 22 9 Safeguarding 22 9.1 Serious case reviews 23 10 Communication 23 10.1 Being Open 23 10.2 Duty of Candour 10.3 Support for Staff Involved in Traumatic/Stressful Incidents 24 24 11 Record Keeping 25 12 External Reporting 25 13 Monitoring Compliance and Effectiveness 26 14 Training 28 Page 3 of 61

Section Page 15 Risk Assessment 28 16 Ratification and approval process 28 17 Dissemination and implementation 28 18 Review arrangements 29 References 30 Associated documents 31 Appendices 1 Equality Analysis Relevance Screening Form 32 2 Risk Matrix 33 3 Time Line & Responsibilities for Managing Incidents 35 4 Time Line & Responsibilities for Managing Serious Incidents 37 5 Serious Incidents (SI) 45 6 Decision making for level of investigation 47 7 Time Line & Responsibilities for Managing RCA s 48 8 Categorisation of Incidents 50 9 Tabular Timeline Template 52 10 Fishbone 53 11 Reporting processes for SIs 54 12 Time Line & Responsibilities for Managing SUDIC 55 13 List of staff involved template 56 14 Reference System for Evidence Gathering 57 15 Witness Statement Template 58 Page 4 of 61

Abbreviations Care Quality Commission Central Alerting System Chief Executive Electronic Staff Record System Health and Safety Health and Safety Executive Human Resources Incident Decision Tree Incident Report form Information Technology Leeds Community Healthcare NHS Trust Medicines and Healthcare Products Regulation Authority National Health Service NHS Litigation Authority National Patient Safety Agency National Reporting Learning System Quality Governance and Risk Committee Quality and Professional Development Root cause analysis Safety, Experience Governance Group Serious Adverse Blood Reactions & Events Serious Case Review Serious Incident Specific, measurable, achievable, realistic and timely Strategic Executive Information System Sudden Unexpected Death In Childhood CQC CAS CE ESR H&S HSE HR IDT IR1 IT LCH MHRA NHS NHSLA NPSA NRLS QGRC QPD RCA SEGG SABRE SCR SI SMART STEIS SUDIC Page 5 of 61

1 Introduction Leeds Community Healthcare (LCH) is committed to the delivery of a safety culture in which all LCH employees proactively identify, assess, report and manage risk. LCH acknowledges that incident reporting is a vital part of minimising risk to patient, staff, visitors, contractors or LCH. Any incident, whether resulting in an unintended or unexpected event that could have led to or did lead to harm or damage, must be reported. This enables the organisation to learn from near misses, incidents and serious incidents (SI), to control risks and improve safety. LCH has a systematic approach to incident reporting, which enables the organisation to investigate incidents effectively; to review practice; and to identify trends and patterns. It enables the quick detection and resolution of any problems resulting from inadequate procedures, lack of training, or pressure of work. There are two separate processes to follow depending on the degree of harm caused by the incident and this is determined by using by the Likelihood Consequence Scores (Appendices 2 and 3). The outcome of these assessments will identify the need to follow the Incident Management, or the Serious Incident Management Process as outlined in Appendices 4 and 5. 2 Aims and Objectives Aim To create a safety culture in which all LCH employees proactively identify, report and manage incidents through the implementation of this policy. Objectives To ensure that all staff know how to report an incident all staff are aware of their individual responsibilities in incident and SI management all incidents are thoroughly investigated and any learning shared all incidents are assessed in terms of risk to patients and staff all staff receive appropriate support and advice throughout the incident management process managers feedback findings of investigations, sharing lessons learnt to reduce risk of reoccurrence the Trust complies with regulatory, legislative and statutory requirements 3 Definitions The document will refer to both incidents and Serious Incidents, these are defined as; 3.1 Incident An unintended or unexpected occurrence or event that could have led to, or did lead to, harm or damage. 3.2 Serious Incident (SI) For the purposes of interpretation of this policy an SI is defined as any incident or potential incident where the consequence is or could be assessed to be major or catastrophic. Page 6 of 61

Serious incidents requiring investigation were defined by the NPSA s 2010 National Framework for Reporting and Learning from Serious Incidents requiring Investigation, for catastrophic in accordance with LCH Likelihood and Consequence Scores (Appendices 2 and 3). In summary, this definition describes a serious incident as an incident that occurred during NHS funded healthcare (including in the community), which resulted in one or more of the following; unexpected or avoidable death or severe harm of one or more patients, staff or members of the public; a never event - all never events are defined as serious incidents although not all never events necessarily result in severe harm or death.); a scenario that prevents, or threatens to prevent, an organisation s ability to continue to deliver healthcare services, including data loss, property damage or incidents in population programmes like screening and immunisation where harm potentially may extend to a large population; allegations, or incidents, of physical abuse and sexual assault or abuse; and/or loss of confidence in the service, adverse media coverage or public concern about healthcare or an organisation. Further examples of SIs are available in Appendix 6 3.3 Audit: Any activity which has the overall purpose of improvement and involves the systematic collection and analysis of information and production of recommendations based on the conclusions of that analysis. 3.4 Contributing factors The underlying reasons behind the occurrence of an event. These tell us why events occurred in each instance and signpost the lessons to emerge. 3.5 Grade A measurement of the risk useful for assessing the priority for control measures for the treatment of different risks. 3.6 Investigation A formal process of analysing an event and recording the outcomes. 3.7 Likelihood The chance of a given event occurring (or recurring). 3.8 Quality Report This report forms part of the Governance structure and Board Assurance Framework. The format of the quality report underpins the performance dashboard, strategic objectives and vision which is; to provide the best possible care in every community. This incorporates safety, complaints, patient experience. 3.9 Risk The possibility of suffering harm, loss or damage. Risk is the combination of likelihood and consequence of a risk/harm materialising. Page 7 of 61

3.10 Risk Reduction The strategies and process by which the Trust can seek to reduce risks by the introduction of control measures. 3.11 Root Cause Analysis A structured approach to the analysis and investigation of an incident and the identification of the underlying cause(s) of an incident and the actions necessary to eliminate or reduce its reoccurrence. 3.12 Whistle-Blowing All LCH employees can report incidents without fear of prejudice for doing so as long as the information provided is done so in good faith. Incident reports must be focused on what went wrong and the consequences of the incident. Incident report forms must not be used to directly complain about service provision or performance of individual members of staff. LCH Whistleblowing Policy Formally known as: Hearing the Concerns of Workers Policy must be followed to manage concerns regarding service provision. Where incident investigations give rise to concerns regarding staff performance, Human Resource (HR) advice must be sought to ensure the appropriate policies are followed. 4 Responsibilities All staff employed by LCH must work in accordance with the Leeds Safeguarding Multi-agency Policies and Procedures and local guidelines in relation to any safeguarding concerns they have for children or adults with whom they have contact. 4.1 LCH Board LCH Board has overall responsibility for the quality, health, safety and welfare of patients, staff and members of the public, and to ensure that the Trust complies with its statutory obligations in this regard. LCH Board must be assured by the Audit Committee and Internal and External Auditors that systems are in place to manage Serious Incidents. The Executive (Nurse) Director of Quality has the delegated responsibility for ensuring these processes are implemented effectively. The Board will be supplied with a confidential report of all SIs, incident trends and mitigating action to reduce risks at the private section of every public Board meeting. 4.2 Chief Executive or designated CE in absence The Chief Executive has ultimate responsibility for all aspects of incident management including the implementation and monitoring of this policy. The CE as the accountable officer will, via the governance structures ensure: Remedial action is taken to manage SI s and reduce risk to others External organisations are notified as necessary. Communications and media statements are prepared. Action plans from investigations are implemented and monitored. Page 8 of 61

4.3 Executive (Nurse) Director of Quality The Executive (Nurse) Director of Quality has delegated authority from the Chief Executive to ensure there is a suitable process for the management of all incidents and it is functioning in accordance with this Policy. 4.4 Executive Directors or Second On Call In the Event of an SI Inform the Chief Executive and the Chair at the earliest opportunity Retain overall responsibility and accountability for the investigation and assign a Lead Investigator to conduct the investigation. Inform a member of the Communications Team see 4.9 Ensure that appropriate remedial action is taken and management of action plans are monitored through the committee structure and reported to the Trust Board. Attend Executive Director review panel meeting prior to submission of the final investigation report Inform the QPD Safety Team See the Timeline for responsibilities for managing an SI (Appendix 5) Out of hours Contact the Chief Executive and Chair immediately if the SI is of an exceptional nature e.g. likely to result in catastrophic impact on the reputation of the organisation, or attracts significant media attention 4.5 General Manager or First On Call Responsibilities are to ensure: Implementation of the Risk Management Strategy and this policy Incident reporting procedures are in place Persons throughout the incident reporting process understand their roles and responsibilities and have the capabilities to contribute effectively to the incident reporting process Appropriate delegation of the responsibility for the investigation process, providing support where required. This may involve taking on the role of lead investigator depending on the severity of the incident Investigations are undertaken in a fair and equitable manner The Incident Decision Tree (section 7.5.2) is used to establish if HR advice or consultation is required. LCH Maintaining High Professional Standards in the Modern NHS and/or LCH Disciplinary Policy and Procedure (2011) must be considered if appropriate The quality and effectiveness of the investigation process are monitored All actions identified following investigation are implemented and arrangements agreed for inclusion of risks on the appropriate risk registers if required Relevant timescales, both internal and external, are adhered to Learning is shared across the organisation. Where there is media interest (actual or potential) the affected patients and staff are informed, when appropriate, before the media. Page 9 of 61

In addition out of hours Staff are prompted to complete an Incident Report Form via Datix before their shift is over. In the event of a suspected SI, the second on call must be contacted and follow the timeline for responsibilities for managing an SI (Appendix 5) The incident is handed over to the respective service manager in hours so that they can continue to manage the incident. 4.6 Line Manager It is the responsibility of the line manager to: Act as the first point of contact for staff that have witnessed or been involved in an incident. Through the Datix system: o Review all incident reports submitted by their staff within three working days o Ensure the completion of the investigation of all incidents (unless a SI) within 30 working days (provide final approval via Datix ) o Develop and implement actions plans, monitoring progress and recording outcomes where this is necessary to reduce overall risk. o Run reports to identify and analyse themes and trends Establish if any complaints are linked to the incident Take on the role of lead investigator or delegate the role to a member of the team Assess the situation to determine that the appropriate actions have been taken to ensure ongoing safety for staff and patients. Keep relevant patients, carers, staff and others informed of the progress and outcomes of any investigations Reinforce the value of, and need for, incident reporting and to provide feedback to reporting staff on the outcomes of the reports they have made Ensure all staff involved with traumatic/stressful incidents are offered support following the incident Attend relevant training identified in the training needs analysis Share learning from incidents within team and with the wider organisation as required In the event of a suspected SI, the Line Manager must contact their General Manager / First On call immediately and follow the timeline for responsibilities for managing an SI (Appendix 5). 4.7 All staff All LCH staff have a duty to report all incidents within three days via LCH Datix incident management system in accordance with this policy. Serious incidents must be reported immediately to the appropriate manager to minimise harm and ensure ongoing safety for staff and patients. Following report of the incident this must be recorded in the patient record Page 10 of 61

All employees have a duty to their patients, employer and fellow colleagues to cooperate fully with an investigation. This is to ensure that an incident is thoroughly investigated, with appropriate outcomes. 4.8 Quality and Professional Development (QPD) QPD Safety Team has the responsibility to ensure that: The organisation has robust systems and processes in place to effectively manage incident and serious incidents Compliance with the policy is monitored and developed as necessary Access to incident reporting via Datix is enabled Information from all reported incidents is received and collated Incident data quality is monitored to ensure that correct coding and grading has been applied as per the Trust Risk Matrix Incident data is uploaded to external agencies within given timescales Advice on external reporting is provided All incidents relating to the building structure owned by other NHS Trusts where LCH staff are working will be forwarded to the appropriate risk team Assistance is provided for the reporting and investigation of incidents, including the role as critical friend following an SI. The relevant managers are liaised with to ensure that sufficient investigation has been undertaken and action plans completed. Incident themes and trends are aggregated and reported to the relevant Directorate, Health Safety and Experience Governance Group, Quality Committee and Trust Board via required reporting mechanisms Wider learning is disseminated to appropriate services and committees Serious incidents are escalated to an Executive Director Standard Operating Procedures followed to ensure the SI process is adhered to, within dedicated timeframe Appropriate incidents are reported to the Health & Safety Executive (HSE) under the Reporting of Injuries, Diseases & Dangerous Occurrences Regulations (RIDDOR) Appropriate incidents are reported to the Medicines and Healthcare Products Regulatory Agency (MHRA) Triage and dissemination of relevant Central Alerts (CAS), including NPSA, Pharmacy, and equipment alerts Identifying need for changes in practice as a result of an incident investigation and implementation of National Safety alerts Requesting relevant clinical audit where appropriate Support and identification of RCA investigation (Appendices 7 and 8) In the event of an SI The management of Serious Incidents are co-coordinated including the external reporting, grading and ensure lessons are both learnt and disseminated throughout the organization. The appropriate serious incident procedures are followed in the given timeframes (Appendix 5) Managers undertaking incident investigations are supported and advised as appropriate Advice on root cause analysis (RCA) processes is given. Page 11 of 61

That communication between the Trust and legal parties takes place as required Coordinate and attend the Executive Director review panel meeting prior to submission of the final investigation report Action plans are implemented as agreed 4.9 The Communication Team It is the responsibility of the Communication Team to: Inform the Commissioner Communications team of the occurrence of an SI and keep them informed of scheduled significant events. Develop a media handling strategy in relation to the incident in conjunction with the Executive Director or CE. This may include the preparation of a press statement depending on the issue. Liaise with the Commissioner Communications team immediately if there is the possibility of adverse media coverage, so that a media handling strategy can be agreed together. Liaise with other organisations regarding a communications strategy as appropriate Out of hours Clinical Commissioning Group (CCG) On-Call will provide out of hours communication support as part of their regional role. LCH 2 nd On-Call managers should advise the CCG On-Call communications team regarding any media contact. (Refer to On Call manual). 4.10 Specialist Reviewers To ensure an appropriate response to particular incidents a number of specialist reviewers have been identified who will receive notification of all incidents within their sphere of responsibility. For example all medication incidents are reviewed by a member of the medicines management team Specialist reviewers are required to review all incidents forwarded to them, and advise on appropriate action where it is necessary. Any actions recommended to the investigator must be completed in the requested timescale and recorded via Datix. Any outstanding actions will be followed up and escalated where necessary to the appropriate line manager. Specific Specialist Reviewers are required to be an identified lead for a quarterly incident action log pertinent to their specialist field. The incident action log ensures the analysis of incident data, trends and actions required to mitigate risk. The QPD Safety Team reviews the incident action logs, seeking further clarity and actions to ensure effectiveness of the incident management process to reduce future risk. These reports are fed into the relevant Governance Committee for review and acceptance. They are also provided to the General Manager as part of the quarterly aggregated quality report (see section 4.12), where deemed appropriate. A list of specialist reviewers and the incident types they are required to review is available from the QPD Safety Team Page 12 of 61

4.11 Critical Friend This role is allocated by the Executive (Nurse) Director Quality (or assigned deputy) following notification that a serious incident has occurred. The Critical Friend will be a member of QPD. The Critical Friend role is to support the Lead Investigator with the process of their investigation and production of the first draft of the serious incident investigation report. Costa, A. and Kallick, B.(1993) defines a critical friend as: A trusted person who asks provocative questions, provides data to be examined through another lens, and offers critiques of a person s work as a friend. A critical friend takes the time to fully understand the context of the work presented and the outcomes that the person or group is working toward. The friend is an advocate for the success of that work. 4.12 Links with Incident Management and Complaints/Claims Management All incidents, complaints and claims are logged on to a shared Datix system which allows linking of, for example, an incident to a complaint. Incidents and Complaints are managed within the QPD Directorate which facilitates the sharing of information within the organisation as appropriate. Monthly Quarterly reports relating to Incidents, Compliments, Comments, Concerns and Complaints, Patient Experience, Clinical Effectiveness and claims trends are triangulated for each General Managers portfolio. These form part of the information reviewed at local General Managers Performance Meetings, Incident and Complaints data is also presented to the Health Safety, Experience and Governance Group. The Quality Committee reviews incident themes and trends aggregated with complaints and claims via the quarterly Quality report. In the Performance meetings Incidents, Compliments, Comments, Concerns and Complaints, Patient Experience Clinical Effectiveness and claims are discussed with representation from members of QPD whose expertise lies in these areas. Aggregated qualitative and quantitative data is analysed, with a view to identifying trends over identified time periods, locations and services. Other aggregated data relating to incidents, complaints and claims to be reviewed will be: Overall degree of harm Top five most common categories/sub-categories Top five most common themes Improvement activity linked to the top five most common categories Actions required for areas not addressed through formally recognised improvement activity. This will include risk assessing themes and citing them on the risk register via the appropriate risk guardian in particular when no improvement activity has been identified or can be initiated. Any emerging trends, improvement activities or learning will be communicated to relevant staff groups through management cascades, Learning for Patient Safety memos and the Quality Newsletter. Page 13 of 61

4.13 Governance Reporting The incident reporting process is governed through LCHs formal committee structure, see below: Quality Committee Health, Safety & Experience Governance Group Patient Experience Group Vulnerable Groups Clinical Governance Steering Group Medical Devices Group Medical Gas Committee Infection Prevention & Control Group 4.14 Quality Committee The Trust Board has delegated responsibility to the Quality Committee to promote good risk management and ensure effective governance, both clinical and nonclinical, across all services. In relation to incidents, key responsibilities are to: Review, monitor and develop the Trust systems and processes for compliments, complaints and incident management to ensure performance targets are achieved and organisational learning takes place Oversee the detailed analysis and performance management and triangulation of operational and clinical risks, complaints, incidents and audit to provide evidence of effective risk management to the Board through the minutes of the meeting Review incidents themes and trends with complaints and claims via the monthly Quality report. Overall rates of incidents as reported by the National Reporting and Learning Service and how the Trust perform in related to other community Trusts (available twice yearly) are also reviewed as the data becomes available Make recommendations for any actions or shared learning to take place as a result of reviewing the Quality report Identify any corporate risks arising from incidents and cite them on the appropriate risk register (as per the LCH Risk Management Strategy) Closely monitor actions following serious incidents and take appropriate action where required. Escalate to LCH Board any issues arising out of the review of incidents or their action plans. 4.15 Health, Safety and Experience Governance Group The Trust Board has delegated responsibility to the Health, Safety and Experience Governance Group to provide assurance to the QC on matters relating to health, safety and experience. In relation to incidents, its key responsibilities are as follows: Page 14 of 61

Develop, implement and monitor improvement strategies for the enhancement of health, safety and experience of patients, staff, partners and other persons in their involvement with LCH; clearly identifying indicators that will demonstrate performance in these areas. These areas will be identified via the Care Quality Commission (CQC) core outcome measures: Outcome 1: respecting and involving people who use the services Outcome 4: care and welfare of people who use services Outcome 8: cleanliness and infection control Outcome 10: safety and suitability of premises Outcome 11: safety, availability and suitability of equipment Outcomes 12, 13 and 14: suitability, appropriate recruitment and support of staff. Outcome 17: complaints Monitor and provide assurance on the effectiveness of structures, systems and processes and lines of accountability for delivering an effective health, safety and experience agenda Ensure compliance with external standards in respect of health and safety, security, fire, transport, waste, catering and food hygiene and buildings, land, plant, non medical equipment and medical devices. Review and scrutinise the individual work plans from each of the HSEGG sub-groups and to ensure compliance with the overarching governance framework Oversee the governance and Terms of Reference of the subgroups that report to it Receive reports from individual members for specific functions and the subgroups that report to it, in line with an agreed annual work 4.16 Other Committees and Groups Other relevant Committees and Groups will review incidents pertinent to their terms of reference. It is their responsibility to facilitate or directly respond to trends or patterns of those incidents and take the necessary action including incorporating them on the relevant risk registers. Competent and appropriate persons should undertake a full risk assessment and action plan and submit this to the appropriate committee / group for approval and monitoring. A list (although not exhaustive) of these Committees/groups are as follows: Infection Prevention and Control Group Medical Device Group Vulnerable Groups Clinical Governance Steering Group LCH Safeguarding Committee 5 Mental Capacity Act (MCA 2005 Code of Practice) This Act applies to all persons over the age of 16 who are judged to lack capacity to consent or withhold consent to acts which are considered by health and social care professionals to be in the best interests of their welfare and health. The Mental Capacity Act 2005 imposes a legal requirement on health and social care professionals to have regard to relevant guidance within the Code of Practice when acting or making decisions on behalf of someone who lacks capacity to make Page 15 of 61

the decision for themselves. Furthermore, they should be able to explain how they had regard to the Code when acting or making decisions. Detailed guidance is available in the Mental Capacity Act 2005 Code of Practice (http://www.dca.gov.uk/legal-policy/mental-capacity/mca-cp.pdf ). 6 Incident Management 6.1 Reporting Process All incidents must be completed via the Datix electronic reporting system within three working days of the incident. Complete all mandatory fields and depending on the category of incident, (for additional support with categorisation of incident, see Appendix 9) further information will be requested. Assess the degree of harm using the Likelihood/ Consequence Scores (Appendices 2 and 3). Use Appendix 6 to help determine whether the incident is an SI. The electronic form is automatically forwarded to the chosen Line Manager who is then expected to complete an electronic form for all incidents to demonstrate investigation, review and sign-off of the incident. When completing an incident form provide clear, factual, timely information. Refer to Appendix 4 for onward management of incidents. In the event an incident occurs in a building owned by a third, party e.g. Leeds Teaching Hospital Trust, a Prison site or a LIFT building and where an LCH employee resides, this must also be reported as per local process for that area. 6.2 Investigating incidents All incidents require some level of investigation in order to identify the underlying causes of how and why the incident has occurred. The level of the investigation will depend upon the degree of harm to the patient/carer/relative or staff member. For this reason, all incidents require a likelihood / consequence grading by the team / service manager when completing the incident form (Appendix 2 and 3). All incidents graded causing major harm will require full RCA, in some cases this level of investigation will also be required for an incident of low harm but high frequency where potential for learning is identified (Appendix 7). At this point the requirement for a specific risk assessment may be highlighted to identify the current risk and actions required to minimise the risk. Dependent on the degree of harm of the risk this may need escalating to senior managers to consider logging onto their local risk register via the appropriate risk guardian. Different Levels of Investigation Refer to Appendix 7 for level of investigation required. An investigation must commence immediately once safe and legal to do so. In certain circumstances the scene of the incident may need to be preserved or equipment retained for inspection. Any equipment involved suspected to have precipitated or caused harm must be quarantined and reported to the Medicines and Healthcare Products Regulation Authority (MHRA). The equipment must not be used until it has been checked and certified safe for use by the MHRA. Page 16 of 61

The objective of the investigation is not to apportion blame or liability rather to identify why the incident occurred. When conducting an investigation ensure actions are documented as close to the time occurring as possible, in accordance with the Records Management Policy including Health Records standards and guidance in this document. The investigation report must be anonymised i.e. no patient or staff names or other identifiable information. Additional staff for example Specialist Reviewers, Quality and Professional Development, Health and Safety Adviser, clinical, HR, managerial or technical staff may need to be identified to provide expert advice as part of the investigation team. Where the investigation is complex and involves other organisations, these will be agreed by the Executive Director leading the investigation and they will be approached for their involvement. In very serious cases, particularly where there is likely to be significant public interest and external parties involved, it may be necessary to commission an external review or include an external representative on the panel conducting the internal inquiry. 6.3 Internal Inquiries and Other Investigations Internal inquiries must not interfere with other investigations e.g. police, Health & Safety Executive. Reference must be made to the Memorandum of Understanding between the Department of Health, Health and Safety Executive (HSE) and Association of Chief Police Officers (February 2006). This indicates that careful consideration needs to be given to the conduct of any NHS investigation once a matter has been referred to the police, HSE or other statutory bodies. In such cases immediate patient and staff safety must be assured with further investigation taking place only after discussion with an Executive Officer who may establish an Incident Coordination Group. The primary concern of all agencies is that of public safety. While there is nothing in law that states the police s duty to investigate ranks higher than the NHS duty to ensure patient safety, interference with a police investigation could undermine potential legal proceedings. Any request by the police for the NHS organisation involved not to discuss the incident with others can never override the NHS organisation s obligations to do this. 6.4 Professional Issues and Criminal Acts If, during an investigation, matters relating to professional standards, conduct and performance are identified, the investigating team or individual must refer these matters to the investigating General Manager and a decision made about whether to pursue the issues through alternative LCH policies, for example Managing Concerns about Performance (2011), LCH Disciplinary Policy and Procedure (2011). Consideration must be given in respect of whether members of staff can continue their duties and if suspension with or without prejudice is necessary. Such decisions can only be made by the Executive Director in liaison with other advisors supported by the Incident Decision Tree. Page 17 of 61

Where there are serious concerns about the actions of an individual health professional and they are considered likely to be seeking work with other employers who would be unaware of the concerns, LCH will liaise with commissioners, other providers and regulatory bodies. LCH will report all incidents directly involving trainee doctors to the Executive Medical Director and subsequently the Deanery. If at any time during the investigation Safeguarding Vulnerable Adults or Children concerns arise, it is the responsibility of the lead investigator to refer to the appropriate LCH policies. If there are concerns that a criminal act has taken place then the lead investigator must ensure the scene of the incident is secured and preserved. All investigations must cease and the police notified immediately. 6.5 Tools to investigate an incident / SI The model for all investigations, no matter what level, will be based on the theory and principles of the RCA technique. The underpinning theory behind RCA is that systems and processes are reviewed to identify the potential causes of failure and corrective actions are then taken to prevent reoccurrence. A complete set of investigative tools are available via the LCH QPD Safety webpage. Alternatively, the National Patient Safety Agency (NPSA) website contains information relating to RCA tools. 6.5.1 The Root Cause Analysis Process 1: Information Gathering: Gather all appropriate information required e.g. from staff involved; site of incident; related policies & procedures; patient records. 2: Information Mapping: Complete the time line/ chronology in order to get the full picture of the incident as it unfolded. 3: Identify problems and highlight good practice: Within the chronology identify where things began to go wrong and why. Highlight good practice. 4: Identify the Contributory Factors: Having identified the problems, undertake a fishbone of each problem to identify the contributory factors. 5: Agree the Root Cause/s: Identify which of the above factors most contributed to the incident and which had they been prevented, the incident would not have occurred 6: Generate Solutions: By rectifying the system/ process at this point should prevent the incident from reoccurring. 7: Recommending and Reporting: Ensure the recommendations made will prevent a similar incident in the future. Page 18 of 61

A selection of recommended tools is discussed below. Further advice can be sought from QPD. 6.5.2 Mapping of events - Time Line/Chronology When the investigation team conducts a detailed investigation into the events contributing to a serious incident, a vast array of information can be collected - often from a number of diverse sources. This information will be used to help the investigator or investigation team in identifying what, how and why the incident occurred and to complete an investigation report. The key first step is to determine the chronology of the incident. To use the information collected effectively, the investigation team will need to ensure that their information is complete and validated. It is therefore essential that the information is set out or mapped at an early stage. There are a number of tools that can support the investigator(s) in doing this. This document describes the nature and application of the tabular timeline (Appendix 10). 6.5.3 Analysing the information Fishbone diagram This tool enables each problem to be analysed for its contributory factors and to consider whether contributory factors were influencing or causal. It also ensures consistency of the investigation process. The contributory factors checklist can be used with the fishbone in order to examine fully each contributory factor (Appendix 11). 6.5.4 Analysing the information - Five Whys The main purpose of this technique is to constantly ask the question Why? through the various layers of cause thus progressing towards the true root cause of the identified problem or issue. When to Use Five Whys to question each identified primary cause of a problem and to identify whether it is a symptom, an influencing factor or a root cause to continue the search for true root causes, even after finding a possible cause. 6.6 Formulation of Action Plans Information generated by the incident reporting system must be used to proactively improve patient and staff care. Any contributing factors or root causes identified through the investigation process must be used to form the basis of an action plan with actions focussing on how risk of the incident reoccurring can be reduced. Actions may be identified for individual, team and organisational implementation. They must be specific, measurable, achievable, realistic and timely (SMART) involving the staff who will be required to implement them to ensure ownership. Identified actions can either be attached to the Datix incident or input to the Actions Taken section of the investigation page. Actions should be followed up and monitored via local arrangements to ensure they have been embedded within the organisation. Page 19 of 61

Until the actions are complete, reporting arrangements should also be set up to provide assurance of this. This could occur through management team meetings at their normal frequency (usually monthly). It should be presented by the senior person who co-coordinated the investigation. It is recognised that not all action plans will be completed at the time of submission for final approval and this must be highlighted on the investigation section of the Datix form. The lead investigator for the incident must take responsibility for ensuring that the actions are implemented. QPD will also operate a central system for following up and checking that action plans are completed, these will be reported via the relevant Governance Committee/s (Appendix 12). For actions that are required and are beyond their control, the relevant manager should be informed, and where applicable, risks to future quality are assessed and cited on the risk register (as per the Trust s risk management strategy). 6.7 Process for Acting on the Findings of SI Investigations Where appropriate, the actions/recommendations from all serious incidents must be formally disseminated to the named leads with a request for their completion by the agreed date. They are subsequently be discussed and monitored bi-monthly by the Trust Board, and in more detail, the Quality Committee. Other groups and Committees may also choose to monitor the recommendations as per the remit of their responsibilities. For actions that are not implemented, the Trust Board or the Quality Committee will request the lead to attend the next meeting to discuss barriers to implementation. Alternative solutions to implementation will be identified by the lead and/or the Committee, and where this is not able to be achieved risks to future quality will be assessed and cited on the appropriate risk register as per the Trust s risk management strategy 7. Learning and Improvements Learning from experience and sharing lessons learnt from incidents is critical to the delivery of safe and effective services by LCH. The analysis of findings from incident investigation must be used to identify areas for change, recommendations and sustainable solutions to help minimise reoccurrence in the future. The relevant persons/team/department where the incident occurred or related to, or the investigating manager for the incident (if different) should take responsibility to disseminate any lessons learnt from the investigation. To ensure that lessons learnt from incidents are communicated and that action plans for improving safety are formulated and acted upon, the following steps will be undertaken: Newsletter Publish articles in Community Talk Weekly bulletin as required Email correspondence Alerts from the NPSA and the Central Alerting System (CAS) will be distributed to all relevant managers for appropriate action and dissemination, with a full audit trail maintained Page 20 of 61

Where either organisational, or discipline specific learning is identified through incident investigation, and this learning needs to be shared immediately to prevent further harm, a Learning for Patient Safety memo will be issued and distributed Intranet site information All Learning for Patient Safety Memos and CAS alerts are available via the intranet Training events Learning with regard to practice and changes in practice is shared with managers, professional leads and Workforce Development If appropriate specific training/ awareness sessions will be organised Specific incidents will be used as examples in relevant training Briefings Individual Serious Incident Reports will be made available to Executive Directors and General Managers so that learning can be disseminated Share key lessons to identified Trust educationalists and the Quality and Professional Development team Meetings Management Teams will ensure that learning is appropriately discussed at team meetings, professional forums etc. Sharing of incidents, action plans resulting from investigation and learning must be a standing item on management team meetings. This is measured via the Care Quality Commission (CQC) LCH Quality evidence document, Section - Personal Care, Treatment and support, Outcome 4: Care and welfare of people who use services Aggregated quarterly trend reports allowing quantitative and qualitative data analysis will be provided to each General Manager and used as part of the information supplied to their performance panel. The Incident Action Logs will also form part of the information provided (where appropriate). These logs will also be submitted to the relevant Committees. Learning shared via the Management Teams Documentation and practice development If appropriate, guidelines and policies will be developed or updated Action Plans will reflect any learning identified as part of an investigation and Management Teams will ensure that action plans are fully implemented Incorporate learning from incidents into audit plans as appropriate to ensure lessons learnt are embedded into practice Teams to use learning from incidents as evidence for Care Quality Commission (CQC) LCH Quality evidence document Outcome 4 Care and Welfare of People who use Service. LCH will also take the opportunity to share lessons learnt across the health economy through professional and care pathway networks and consortiums and Page 21 of 61

cooperation with partner organisations. Sharing with external stakeholders will also take place as outlined in section 13. 7.1 Establishing Improvement and Lessons Learnt from Incidents Where applicable, and to provide assurance that real improvements and lessons have been learnt from investigations, periodic clinical audit should be performed. This should form part of the initial action plan and is encouraged in clinical audit training, as a topic for a clinical audit. The results of the clinical audit should be shared with the relevant team/service or individuals affected by the incident. The sharing can occur in a variety of ways and include regular team or management meetings, educational half days, audit half day, or via written communication. Where audits indicate that improvement has not occurred, the full clinical audit or improvement cycle should be commenced and the clinical audit policy should be followed. Where appropriate, risks to quality should also be assessed and cited on the appropriate risk register as per the Trust risk management strategy. 8. Controlled Drugs All incidents involving a controlled drug (as defined by the Misuse of Drugs Regulations 2001) will be reported to the Executive Medical Director as LCH Accountable Officer by the Specialist Reviewer for Medication. 9. Safeguarding Named safeguarding professionals must link with QPD and Head of Service for Safeguarding who is responsible for reporting the following: (a) (b) Any case where there is prima facie evidence (i.e. initial concerns) that a child or adult has sustained a potentially life-threatening injury which may be through abuse, neglect, serious sexual abuse, or sustained serious permanent impairment of health or development through abuse or neglect. A prima facie case where a child dies (including death by suicide) and abuse or neglect is known or suspected to be a factor in the child s death and there will be a Serious Case Review (SCR). ( Working Together, 2010). These cases must be reported to the Commissioners and Executive Safeguarding Lead for LCH by the Head of Service for Safeguarding using the STEIS system as soon as practically possible and as a maximum the working day after the incident. The Commissioner Policy for the reporting and management of children s and adults safeguarding incidents must be followed. See Appendix 13 for the Time Line and Responsibilities for Managing SUDIC. The STEIS report must then be updated by the Head of Service for Safeguarding within a further ten working days and the Commissioner notified that this has been completed by e-mail, currently to yathsha.yandhincidentreporting@nhs.net. The update must identify whether or not the case will proceed to a Serious Case Review (SCR), whether or not any issues for action have been identified and details of action already taken/to be taken. Page 22 of 61

In cases where it has been decided that a Serious Case Review will not be required and no actions for follow up have been identified, the Commissioner will de-log the SI and inform the reporting organisation s relevant department that this has been done. In all cases which have not been de-logged, a full anonymised report and action plan/details of action already taken must be e-mailed to the Commissioner via yathsha.yandhincidentreporting@nhs.net within twelve weeks of the original notification by the Head of Service for Safeguarding. The report and action plan will be reviewed by the Commissioner and if satisfactory and it is decided that there is no need for on-going monitoring of action, the SI will be closed. In exceptional circumstances, if it is not possible to complete the internal review/investigation report and action plan within twelve weeks, the Commissioner must be notified of this at the twelve week point using the incident reporting e-mail address. 9.1 Serious Case Reviews Where a SCR is undertaken, the SI will remain open with the Commissioner until the final report and an action plan in response to any recommendations has been received. This is likely to be for a significant length of time. These documents should be sent to the Commissioner by the Head of Service for Safeguarding via the yathsha.yandhincidentreporting@nhs.net e-mail address, quoting the SI reference number. It is recognised that the timing of the SCR is not within the control of NHS organisations. However, the NHS does have a duty of care to future patients and should therefore not unduly delay any necessary action pending the outcome of the SCR. The Head of Service for Safeguarding is the lead investigating officer and should update the Commissioner at least every eight weeks and in between if necessary on developments pertaining to health services or health care that may occur during the course of the review. If the action plan/details of action already taken are satisfactory, the SI will be closed. 10. Communication 10.1 Being Open Where a patient is harmed as a result of a mistake or error in their care, LCH must ensure that they, their family or those who care for them; receive an apology, be kept fully informed as to what has happened, have their questions answered and know what is being done in response. The LCH Being Open policy endorses our commitment to: Apologise for the harm and/or mistake. Explain, openly and honestly, what has happened. Describe what will be done in response to the event to ensure the risk of recurrence is minimized. Offer support and counselling services that might be able to help. Provide the name of a person to speak to. Provide updates on the results of any investigation Page 23 of 61

10.2 Duty of Candour Implementation of this policy supports and recognises the importance of being transparent about mistakes so that they can be addressed and lessons learnt. The organisation has a statutory duty of candour and staff have a professional duty of candour. In practice this includes: Informing your line manager when mistakes have occurred and reporting them as an incident on datix. Informing patients and carers when mistakes have occurred, what happened and why. The Being Open Policy provides guidance as to the processes that must be followed when an incident is reported. Transparent reporting of incident data and other safety measures. This can occur at team/service level and throughout the governance reporting structures within the organisation. 10.3 Support for Staff Involved in Traumatic/Stressful Incidents Line Managers must ensure all staff involved with traumatic/stressful incidents are offered support following the incident. In the first instance a debrief session must be held as soon after the event as possible to allow staff an opportunity to reflect on the situation and explore their feelings and concerns with regards to the incident, the manager will usually lead with this. The exact nature of the support mechanisms used will be partly dependent on the type and severity of the incident and the needs of the individuals involved and will always follow the principles of being open as detailed in the Being Open Policy and Procedure. The manager may consider actions to protect the individual s well-being at this time. As appropriate, staff will be offered access to: Immediate medical treatment if required Advice from Human Resources Occupational Health Services Independent and confidential counselling Legal advice (at the discretion of LCH) Time away from work (nature of leave to be agreed on a case by case basis) Time to consult with their Staff Side representative and/or professional body Subsequently managers must ensure staff have access to ongoing peer support and Clinical Supervision within and/or external to the team. Further debrief sessions may be required for particular incidents/staff. Any discussions that take place must be documented and retained with the personal staff records. In the event of staff being called as a witness by the police or coroner in relation to an incident, the line manager must ensure that the staff member has access to appropriate advice. The QPD team can be contacted and legal advice or representation considered for the member of staff, this will need to be funded by the service. QPD can provide relevant resource documents to support the process. Page 24 of 61

11. Record Keeping Details of incidents will be entered on LCH Datix system, which is a secure database. All records are kept in line with the LCH Records Management Policy including Health Records Standards. 12. External Reporting In addition to internal reporting certain categories of incident require reporting to external agencies. The following table describes the incident types and the receiving agency. External Reporting Incident Type Reportable to Responsibility Information Governance Information Commissioners Office Head of Information Governance or Safety Team in their absence Medical Device Incidents Medication suspected adverse drug reactions (yellow card scheme) Medicines and Healthcare Products Regulatory Agency (MHRA) http://www.mhra.gov.uk/index.htm Medicines and Healthcare Products Regulatory Agency (MHRA) http://www.mhra.gov.uk/index.htm Investigating Manager link available via Datix A copy of the externally filed report should be linked to the Datix incident Investigating Manager A copy of the externally filed report should be linked to the Datix incident Patient Incidents Safety Physical Assault on Staff RIDDOR Injuries to staff sustained in the course of work NB Some patient safety incidents which result in hospital treatment are also reportable. Contact QPD for guidance National Patient Safety Agency NHS Security Management Service (automatically sent to LSMS if correct category chosen) Health & Safety Executive To report use the link via the HSE website http://www.hse.gov.uk/riddor/ QPD reports all patient safety incidents to the NPSA via a dedicated web link between the Datix database and the NRLS Local Security Management Specialist (LSMS) Investigating Manager link available via Datix A copy of the externally filed report should be linked to the Datix incident NB: if the HSE make contact with the Service to visit, ensure QPD are informed immediately to provide support Section 17 returning after 12MN Serious Adverse Blood Reactions & Events (SABRE) Care Quality Commission Investigating manager in discussion with QPD Medicines and Healthcare Investigating Manager Products Regulatory Agency A copy of the externally filed report (MHRA) should be linked to the Datix http://www.mhra.gov.uk/index.htm incident Serious Incidents Strategic Health Authority QPD via STEIS Page 25 of 61

13. Monitoring Compliance and Effectiveness Incident and Serious Incident Management Policy Minimum requirement to be monitored / audited Duties Process for: Reporting all incidents/near misses involving staff, patients and others including reporting to external agencies Different levels of investigation appropriate to the severity of the event(s) following up relevant action plans organisation ensures that lessons are learnt from analysis result in a change in organisational culture and practice and the organisation ensures both local and organisational learning from incidents, complaints and claims risk reduction measures are implemented Immediate and ongoing support offered to staff Advice available to staff in the event of their being called as a witness Process for monitoring / audit Annual audit taking a sample of reported incidents to assess compliance and effectiveness of incident and serious incident management processes Lead for the monitoring/ audit process Patient Safety Manager Frequency of monitoring / auditing Annual Lead for reviewing results Patient Safety Manager Lead for developing / reviewing action plan Patient Safety Manager Lead for monitoring action plan HSEGG Page 26 of 61

Organisations expectations in relation to staff training, as identified in the training needs analysis Process for involving and communicating with internal and external stakeholders to share safety lessons Refer to the Statutory and Mandatory Policy (including Training Needs Analysis) for the monitoring of training and the non attendance of staff training Update STEIS with lessons learnt from SI investigations Commissioners As SI occurs Patient Safety Manager Patient Safety Manager QC Coordinated approach to the aggregation of incidents, complaints and claims Frequency with which an aggregated analysis of incidents, complaints and claims is to be completed Minimum content required within the analysis report, including qualitative and quantitative analysis Quarterly safety, patient experience and effectiveness meeting with the production of a quarterly report and meeting with senior managers to communicate the information Executive Director of Quality quarterly QPD QPD QC Page 27 of 61

In Addition QPD is responsible for monitoring the implementation of this policy and will determine the following: Data quality of inputting on to the Datix system Action plans are produced and objectives are specific, measurable, achievable, realistic and timely and implemented with outcomes monitored Those bases or groups of individuals who under report comparable to similar teams are identified and highlighted to the General Manager to identify potential causes and strategies to address Relevant time tables both internal and external are adhered to Monitoring of SIs is performed on a continuous basis via the SI monitoring database. All SIs are measured against the timescales detailed in this policy and reported to the private session at every LCH Board meeting That the reports provided to the relevant governance groups containing information on aggregated number of incidents by categories and type of incident and staff groups are analysed to identify themes, emerging trends and contributing factors 14. Training Staff are directed to the LCH Statutory and Mandatory Training Policy (including Training Needs Analysis) and up to date information is available on the ELSIE for course details and for the monitoring of training and the non attendance of staff at raining. In addition, two separate Datix drop in sessions are provided to support staff in the correct use of the system for incident reporting and incident investigation. Risk Management workshops will be delivered by QPD for all Directors, Board Members, Senior and Middle Managers to provide training on the application of the Risk Management Process as outlined in the LCH Risk Management Strategy. 15. Risk assessment Reference is made to risk assessment throughout the document. Escalation of high risk or high frequency incidents will be discussed with the appropriate Senior Managers and entered onto the risk register. Incident action logs are used to identify themes and action required to reduce risk. 16. Ratification and approval process This document will be approved by the Clinical and Corporate Policy Group and ratified by the QC on behalf of LCH Board. 17. Dissemination and Implementation Dissemination of this policy will be via the Clinical and Corporate Policy Group to services and made available to staff via the Intranet. Page 28 of 61

Implementation will require: Executive Operational Directors / General Managers to ensure staff are informed of, and have access to this policy and understand their responsibilities for incident management QPD to provide appropriate support and advice to staff on the implementation of this policy, this maybe on a o one to one basis, o attendance at staff meetings o or a part of the feedback process. 18. Review arrangements This policy will be reviewed in three years by the members of the Safety Team within QPD or sooner if there is a local or national requirement. Page 29 of 61

References Care Quality Commission http://www.cqc.org.uk/ Costa, A. and Kallick, B.(1993) "Through the Lens of a Critical Friend".Educational Leadership 51(2) 49-51 Department of Health the never events list 2011/12 Policy framework for use in the NHS Department of Health, Association of Chief Police Officers and Health &Safety Executive, Memorandum of Understanding - February 2006 Equality Act 2010 http://www.legislation.gov.uk/ukpga/2010/15/pdfs/ukpga_20100015_en.pdf Health & Safety Executive, Reporting of Injuries, Diseases and Dangerous Occurrences Regulations (RIDDOR) http://www.hse.gov.uk/riddor/ HM Government Working Together Working Together to Safeguard Children A guide to inter-agency working to safeguard and promote the welfare of children 2010 LCH Risk Management Strategy 2011-2013 Medicines and Healthcare products Regulatory Agency website (MHRA) http://www.mhra.gov.uk/ The Misuse of Drugs Regulations 2001 http://www.legislation.gov.uk/uksi/2001/3998/contents/made National Framework for Reporting and Learning from Serious Incidents Requiring Investigation (NPSA 2010) NHS Litigation Authority Risk Management Standards 2012/13, January 2012: http://www.nhsla.com/riskmanagement/ Yorkshire & Humber Strategic Health Authority Procedure for the Management of Serious Incidents (SUIs) Version 6 October 2010 Page 30 of 61

Associated documents Related Policies Incident and Serious Incident Management Policy LCH Disciplinary Policy and Procedure LCH Whistleblowing Policy Formally known as: Hearing the Concerns of Workers Policy LCH Managing Concerns with Performance LCH Acceptable Standards of Behaviour Policy and Procedure(Incorporating bullying, harassment and other behaviours which affect people s dignity at work LCH Maintaining High Professional Standards in the Modern NHS LCH Statutory & Mandatory Training Policy LCH Handling Comments, Concerns, Compliments and Complaints Policy and Procedure LCH Claims Handling Policy and Procedure for Clinical Negligence, Liability to Third Parties and Property Expense Claims Scheme LCH Being Open Policy and Procedures LCH Records Management Policy including Health Record Keeping Standards Guidance LCH Safeguarding Adults Operational Policy Leeds Multi Agency Safeguarding Adults Partnership Policy Part 1 Leeds Safeguarding Adults Partnership - Part 2 Multi Agency Procedures Leeds Child Protection Manual - Safeguarding Children LCH Infection Prevention and Control Manual LCH Out of Hours Management On-Call Manual NHS Leeds Controlled Drugs Policy LCH Counter fraud and anti-bribery Policy and Procedure Related documents - External Department of Health (2010) Checklist for reporting, managing and investigating Information Governance Serious Untoward Incidents. The Health Act 2006 National Patient Safety Agency (2009). Data Quality Standards. Guidance for organisations reporting to the reporting and learning system. http://www.nrls.npsa.nhs.uk/ NPSA, Seven steps to patient safety for primary care, full reference guide, May 2006: http://www.npsa.nhs.uk/health/resources/7steps NHS Commissioning Board (2013) Serious Incident Framework Page 31 of 61

Appendix 1: Equality Analysis (EA) Relevance Screening Form 1. Name of the document Incident and Serious Incident Management Policy 2. What are the main aims and objectives of the document To create a safety culture in which all LCH employees proactively identify, report and manage incidents through the implementation of: The Incident Management process The Serious Incident (SI) Management process 3. Is this a key strategic document? Yes No No 4. What impact will this document have on the public or staff? High Medium Low Don t know Low Explain: The policy is to provide information and support to staff when dealing with incidents. It will provide clarity to build on and improve existing practice. The impact it will have on patients will be positive in terms of facilitating the learning from incidents to reduce the risk of them re-occurring, therefore improving patient safety 5. Is there any evidence, or reasons that different groups have different needs, experiences, issues and priorities in respect of this particular document? Yes No Don t know Explain: The policy is applicable to all clinical teams within Leeds Community Healthcare NHS Trust If you have answered Yes to question 3, you should move straight onto EA. If, for question 4 you have answered Low, there is no need to continue to conduct an EA. If for question 4 you have answered Medium and No for question 5, there is no need to conduct an EA. If, for question 4 you have answered Medium or Don t Know, and have answered Yes or Don t Know for question 5 you should move on to a Stage One EA. If, for question 4 you have answered High, you need to conduct an EA. Equality Analysis None No 6. Based on the result of the screening, is an EA required? None Sarah Hemsley, Clinical Safety Manager Abi Eaves, Patient Safety Manager August 2012 Page 32 of 61

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Appendix 3: Leeds Community Healthcare NHS Trust Time Line & Responsibilities for Managing Incidents Time line Staff member Line Manager / Investigation Lead General Manager* QPD Specialist Reviewer Wk 1 Day 1 WK1 Day 1-3 Day 1-30 Verbally report incident to line manager Complete Datix web or paper IR1 only if web unavailable) SUBMIT FORM WITHIN 3 DAYS (MANDATORY) Incident number generated NB: Electronic forms are automatically sent to the chosen manager who will become the investigator or delegate this duty. The form is available via LCH inet, located under favourites. Escalate immediately if this is a Serious SI following SI Flow chart (Appendix 5) Review level of harm using the Decision making for level of investigation Flowchart (appendix 7) and Escalate to General Manager Provide support to staff Investigator receives the notification from LCH safety account via email with a link to the incident Review incident Being reviewed Is the incident RIDDOR reportable? http://www.hse.gov.uk/riddor/ Investigator to review the incident form via Datix, moving the incident from the holding area, into being reviewed Decide level of investigation Complete date investigation started (i.e. incident date) Click Save to complete later Investigator must review all Incident components. Investigation underway. Investigating lead will review progress via the Investigation section of Incidents module. 30 working days are allowed for the investigation to be completed Upon completion of the investigation, Investigating Lead will Approve the incident, link any contacts and press save Escalate to Executive Director as potential serious incident following SI Flow chart Following RCA Flowchart if it meets the RCA Criteria General Manager can review the incident investigation at anytime All incidents are viewed by the Governance Systems Manager Support and advice can be provided by QPD Where the incident is deemed to have caused major harm an RCA will be undertaken see appendix 8 Appropriate Specialist Reviewers will be notified of incident via email and provide guidance/support Incident Management Policy and Guidance 35 of 61

Time line Staff member Line Manager / Investigation Lead General Manager* QPD Specialist Reviewer Final Approval To be given by the approved individual who will review the incident information. If all details are complete, the status is changed to final approval and click save Feedback to staff Trends can be identified by running Reports General Manager to performance manage overdue incidents QPD upload the patient safety incidents to the National Reporting Learning System QPD provide over due incident information as follows Weekly emails to the Handler / Investigator of the incident Quarterly Aggregated Report, which include overdue incidents * General Manager responsibility may be replaced by Business Unit Clinical Lead Incident Management Policy and Guidance 36 of 61

Appendix 4: Leeds Community Healthcare NHS Trust Time Line & Responsibilities for Managing Serious Incidents INCIDENT GRADE 1 Day / Week Day 1 Wk 1 Staff member Line Manager date Verbally report Escalate to to line manager General or first On Call Manager / first manager as On Call as soon as potential SI incident occurs. Complete Datix form Review Datix form move from holding area to being reviewed Provide support to staff members involved Give permission via Datix to the Lead Investigator (if not the Line Manager to view the incident) Advise staff that Witness statements may be required General Manager* Executive Director Lead Investigator date Escalate to Executive Director / second on call as potential serious incident If not SI manage incident via managing incident flowchart end of SI pathway. Consider if this requires a RCA investigation If SI, commence SI Investigation process and inform QPD Agree and appoint Lead Investigator with Executive Director and inform QPD Consider who else needs to be informed, including the patient and or family / next of kin identify a contact person for the family / Decide whether incident meets criteria for SI. Inform General Manager that it does or does not meet the criteria for an SI Inform Chair, Chief Exec and Comms Agree and appoint Lead Investigator with General Manager Critical Friend QPD Follow the Detailed SI Process for QPD, depending on the Service this will be the general, death in custody or Little Woodhouse Hall process Incident Management Policy and Guidance 37 of 61

Day / Week Day 2-3 Staff member Line Manager date Support & contribute to investigation as required Support & contribute to investigation as required Debrief with staff members involved, offering further support if required, consider Clinical Supervision Staff counselling Support & contribute to investigation as required General Manager* Executive Director Lead Investigator date next of kin. Agree with the nominated person Review need for Provide / decline Start investigation supported by involvement of permission to be Critical Friend as required external agencies. sought from External Use SI template as a guide to the Seek permission from Agencies (if process of completing the the Executive Director requested) investigation if information is required from External Agencies Commence 72 hour review, identifying relevant participants once complete forward to QPD unless a Death in Custody Support & contribute to investigation as required Participate in the 72 hour review unless a Death in Custody Use the Agree Terms of Reference from the 72 hour review for the investigation unless a Death in Custody Compile a list of staff involved use the List of staff involved template (Appendix 14) Start to populate the evidence required / collected template (Appendix 15) for timeline Review the need for / begin to collect statements from LCH Critical Friend Support Lead Investigator as required QPD Support to Services as required Incident Management Policy and Guidance 38 of 61

Day / Week Weeks 1 to 3 Week 4 Week 5 Week 5 Week 7 Week 8 End of Week 8 Week 9 Weeks 10 to 13 Staff member Line Manager date Commence implementation of the action plans General Manager* Executive Director Lead Investigator date witnesses using the Witness statement Template (Appendix 16) Investigation underway supported by Critical Friend as required, seeking advice from QPD Start drafting report using SI template supported by Critical Friend as required Provide update to QPD on progress Continue drafting report Review & revise first draft of report with support from Critical Friend as required Review and revise Continue investigation and final report, seeking advice report from QPD as required Submit final report to QPD by Provide information and clarification to QPD as required Review and revise report, seeking advice from QPD as required Critical Friend end of week seven Meet to review the final report, Lead investigator to amend document following the meeting and forward the amended copy to QPD by the end of week 8 for Executive Director final sign off Submission of Final SI to the Commissioners Commence implementation of the action plans Debrief staff The action plan is submitted to LCH Board Meeting Review and revise report, seeking advice from QPD as required Commence implementation of the action plans and debrief staff QPD Follow the Detailed SI Process Incident Management Policy and Guidance 39 of 61

Day / Week Week 14 onwards Staff member Line Manager date General Manager* Executive Director Lead Investigator date Ensure action plan Ensure action plan implemented implemented and monitored via appropriate Governance Committee(s) Disseminate learning from SI Critical Friend QPD Detailed SI Process for QPD *General Manager responsibility may be replaced by Business Unit Clinical Lead Incident Management Policy and Guidance 40 of 61

Appendix 4: Leeds Community Healthcare NHS Trust Time Line & Responsibilities for Managing Serious Incidents INCIDENT GRADE 2 Day / Week Day 1 Wk 1 Staff member Line Manager date Verbally report Escalate to to line manager General or first On Call Manager / first manager as On Call as soon as potential SI incident occurs. Complete Datix form Review Datix form move from holding area to being reviewed Provide support to staff members involved Give permission via Datix to the Lead Investigator (if not the Line Manager to view the incident) Advise staff that Witness statements may be required General Manager* Executive Director Lead Investigator date Escalate to Executive Director / second on call as potential serious incident If not SI manage incident via managing incident flowchart end of SI pathway. Consider if this requires a RCA investigation If SI commence SI Investigation process and inform QPD Agree and appoint Lead Investigator with Executive Director and inform QPD Consider who else needs to be informed, including the patient and or family / next of kin identify a contact person for the family / next of kin. Agree with Decide whether incident meets criteria for SI. Inform General Manager that it does or does not meet the criteria for an SI Inform Chair, Chief Exec and Comms Agree and appoint Lead Investigator with General Manager Critical Friend QPD Follow the Detailed SI Process for QPD, depending on the Service this will be the general, death in custody or Little Woodhouse Hall process Incident Management Policy and Guidance 41 of 61

Day / Week Day 2-3 Staff member Line Manager date Support & contribute to investigation as required Support & contribute to investigation as required Debrief with staff members involved, offering further support if required, consider Clinical Supervision Staff counselling Support & contribute to investigation as required General Manager* Executive Director Lead Investigator date the nominated person Review need for Provide / decline Start investigation supported by involvement of permission to be Critical Friend as required external agencies. sought from External Use SI template as a guide to the Seek permission from Agencies (if process of completing the the Executive Director requested) investigation if information is required from External Agencies Commence 72 hour review, identifying relevant participants once complete forward to QPD unless a Death in Custody Support & contribute to investigation as required Participate in the 72 hour review, unless a Death in Custody Use the Agree Terms of Reference from the 72 hour review for the investigation unless a Death in Custody Compile a list of staff involved use the List of staff involved template (Appendix 14) Start to populate the evidence required / collected template (Appendix 15) for timeline Review the need for / begin to collect statements from LCH witnesses using the Witness Critical Friend Support Lead Investigator as required QPD Support to Services as required Incident Management Policy and Guidance 42 of 61

Day / Week Weeks 2 to 5 Week 6 Week 7 Week 8 Week 9 Week 10 Week 11 End of Week 11 Week 12 Weeks 13 to 15 Staff member Line Manager date Commence implementation of the action General Manager* Executive Director Lead Investigator date statement Template (Appendix 16) Investigation underway supported by Critical Friend as required, seeking advice from QPD Start drafting report using SI template supported by Critical Friend as required Provide update to QPD on progress Continue drafting report Review & revise first draft of report with support from Critical Friend as required Provide progress report to QPD First draft of report submitted to Head of Service / General Manager by end of week eight Review and revise Continue investigation and final report, seeking advice report from QPD as required Submit final report to QPD by Provide information and clarification to QPD as required Review and revise report, seeking advice from QPD as required Critical Friend QPD end of week ten Meet to review the final report, Lead investigator to amend document following the meeting and forward the amended copy to QPD by the end of week 11 for Executive Director final sign off Submission of Final SI to the Commissioners Commence implementation of the action plans The action plan is submitted to LCH Board Meeting Review and revise report, seeking advice from QPD as required Commence implementation of the action plans and debrief staff Follow the Detailed SI Process for QPD Incident Management Policy and Guidance 43 of 61

Day / Week Staff member Line Manager date plans General Manager* Executive Director Lead Investigator date Debrief staff Critical Friend QPD Week 16 Week 17 onwards Ensure action plan implemented and monitored via appropriate Governance Committee(s) Disseminate learning from SI Ensure action plan implemented Detailed SI Process for QPD * General Manager responsibility may be replaced by Business Unit Clinical Lead Incident Management Policy and Guidance 44 of 61

Appendix 5: Serious Incidents (SI) It is a statutory obligation to fully investigate and report all serious incidents to the Commissioner via STEIS. The following list provides examples of SIs. This list is NOT exhaustive or not in any order of importance. Death or serious injury to a patient or member of the public while on NHS premises Suspected homicide by a person currently in receipt of mental health services (or within the last six months) Suicide/suspected suicide of a person currently in receipt of NHS mental health services (both out-patients and in-patients) or who have received NHS mental health services in the last six months Serious injury of a person currently in receipt of NHS care (or within the last six months) as a result of deliberate self-harm (e.g. attempted suicide) or accidental injury Patients detained under the Mental Health Act who abscond from NHS care and who present a serious risk to themselves and/or others. Death or serious injury to a member of staff (including independent contractors) in the course of their NHS duties Medication incidents resulting in death/serious injury Failure of medical equipment resulting in death/major injury Serious fires or other serious damage, which occurs on NHS/Independent contractor premises. Serious or unexplained outbreaks of infection or disease in hospital or the wider community (e.g. food poisoning, Legionnaire s Disease) or the confirmed transmission of serious infectious disease between an NHS staff member and a patient (e.g. HIV/Hepatitis B) Major system failure e.g. failure of laboratory services to provide accurate screening results; patient referral system failure for further consultation/treatment Major environmental incident (e.g. release of gas/chemicals, inappropriate disposal of clinical waste) which has or could have harmed the public Major service disruption e.g. due to power failure, flooding, etc Incident Management Policy and Guidance 45 of 61

Major breach of patient confidentiality e.g. theft of patient notes or computers/laptops containing patient information; discovery of patient records in public area Incidents/concerns regarding the actions of NHS staff. Examples include fraudulent behaviour, gross misconduct and actions resulting in harm to patients. Death in custody A pattern emerging that is causing concern such as a high number of incidents or complaints that may warrant further investigation and action. Incident Management Policy and Guidance 46 of 61

Appendix 6: Decision making for level of investigation Incident Management Policy and Guidance 47 of 61