Policy for the Investigation of Complaints, Claims and Incidents

Policy for the Investigation of Complaints, Claims and Incidents Executive or Associate Director lead Policy author/ lead Feedback on implementation to Clive Clarke Wendy Hedland Wendy Hedland Date of draft January 2012 Dates of consultation period April 2012 November 2012 Date of ratification March 2013 Ratified by Executive Director Group Date of issue April 2013 Date for review January 2014 Target audience Sheffield Health and Social Care NHS Foundation Trust Staff The policy will be made available to all staff via the Sheffield Health and Social Care NHS Foundation Trust intranet. Hard copies will be distributed to each Directorate and also to central services. An e-mail will be sent to all staff informing them that the policy is available. Version control is the responsibility of the Complaints & Litigation Lead. This is Version 1 of the Policy. Policy for the Investigation of Complaints, Claims and Incidents Page 1 of 55

Contents: Section Page Flowchart 3 1 Introduction 4 2 Scope of these Guidelines 4 3 Definitions 4 4 Purpose of these Guidelines 5 5 Duties 6 6 Process 8 6.1 Deciding on level of investigation required 8 6.2 Level 1: Concise Investigation 8 6.3 Level 2: Comprehensive Investigation 8 6.4 Level 3: Independent Investigation 9 6.5 Why investigate? 9 6.6 The purpose of any investigation 9 6.7 The investigation process 10 6.8 Nominating a lead investigator/investigation team 10 6.9 Gathering the information 10 6.10 Mapping the events 13 6.11 Analysing the information 13 6.12 Completing a report 13 6.13 Developing solutions and an action plan for implementation 14 6.14 Action plan monitoring 17 6.15 Sharing the learning 16 7 Dissemination, storage and archiving 21 8 Training and other resource implications for this policy 21 9 Audit, monitoring and review 21 10 Implementation plan 23 11 Links to other policies, standards and legislation 23 Appendix A Supplementary Equality impact assessment form 24 Appendix B Human rights act assessment checklist 27 Appendix C Development and consultation process 29 Appendix D Version Control 30 Appendix E Dissemination Record 31 Appendix F Risk Grading 32 Appendix G NPSA Contributory Factors Framework 37 Appendix H Mapping Tools 40 Appendix I Analysis Tools 47 Appendix J Guidelines for writing a statement 53 Appendix K Guidelines on conducting interviews with staff involved in investigations 55 Policy for the Investigation of Complaints, Claims and Incidents Page 2 of 55

Flowchart Complaint, Claim or Incident Reported Identify the event to be investigated Decide on the level of the investigation necessary Identify a lead/form an investigation team, if necessary Gather the documentary and other evidence Map the information: suggested methods Narrative Chronology Timeline Tabular Timeline Time Person Grids Explore problems and identify quality improvements: suggested methods Brainstorming Brainwriting The Five Whys Fishbone Diagrams Barrier Analysis Generate recommendations, an action plan and report Policy for the Investigation of Complaints, Claims and Incidents Page 3 of 55

1. Introduction 1.1 Sheffield Health & Social Care NHS Foundation Trust (the Trust) recognises that in a service as large and as complex as the NHS, complaints, claims and incidents will occur. However, the Trust recognises its responsibility to investigate these events in order to understand their root causes and to recommend actions and sustainable solutions to help minimise the chance of the same or a similar event recurring in the future. 1.2 The Trust recognises that most complaints, claims and incidents occur as a result of problems with systems rather than individuals. Therefore, the Trust supports the view that the response to a complaint, claim or incident should not be one of blame and retribution, but of organisational learning with the aim of encouraging participation in the overall process and supporting staff, rather than exposing them to recrimination. Therefore, the Trust is committed to developing a just culture in which staff are encouraged to admit mistakes without fear of punitive measures. 1.3 This document sets out the process for the investigation of complaints, claims and incidents looking at the underlying causes and identifying actions to prevent a recurrence and to understand how loss can be minimised. Analysis of complaints and claims, when examined in conjunction with incidents, allows trends and themes to be identified at both a local and strategic level. The changes which are then implemented support both the prevention of future complaints, claims and incidents and also service improvements. 1.4 For ease of reference, complaints, claims and incidents will all be referred to as events for the remainder of this policy document. 2. Scope of this Policy 2.1 This policy applies to all permanent, locum, agency, bank and voluntary staff but does not replace the personal responsibilities of all staff with regard to issues of professional accountability for governance. 3. Definitions 3.1 Complaint: an expression of dissatisfaction by one or more members of the public about the Trust s action or lack of action, or about the standard of service, whether that action was taken by the Trust itself or by someone acting on behalf of the Trust. 3.2 Claim: allegations of negligence and/or demand for compensation made following an untoward event resulting in personal injury (to a member of staff, a service user or a member of the public), or damage to property. 3.3 Adverse incident: an event or omission which caused physical or psychological injury to a service user, visitor or staff member or any event or circumstances arising during NHS care that could have, or did lead to unintended or unexpected harm, loss or damage. 3.4 Serious Incident: those incidents where serious actual harm or serious near miss has occurred. Incidents assessed as Major or above using the Trust Risk Grading Matrix. Policy for the Investigation of Complaints, Claims and Incidents Page 4 of 55

3.5 Near Miss: an unplanned event, act or omission, which does not cause injury or damage but has the realistic potential to do so. 3.6 Harm: an injury (physical or psychological), disease, suffering, disability or death. In most instances, harm can be considered to be unexpected if it is not related to the natural course of the individual s illness, treatment or underlying condition, or the natural course of events if harm occurs to other than a service user. 3.7 Root Cause Analysis (RCA): a recognised way of investigating complaints, claims and incidents which offers a framework identifying what, how and why the event happened. Analysis can then be undertaken to identify areas of change, develop recommendations and look for new solutions. 3.8 Investigation: a detailed inquiry or systematic examination, the process of careful search or examination in order to discover the truth 3.9 National Patient Safety Agency (NPSA): an arm s length body of the Department of Health which leads and contributes to improved, safe patient care by informing, supporting and influencing organisations and people working in the health sector. 4. Purpose of this Policy 4.1 The purpose of this policy is to ensure that the appropriate level and quality of investigation takes place as a result of complaints, claims or adverse incidents and results in measurable improvement in practice. The policy has been developed to demonstrate the Trust s commitment to improving patient safety by learning lessons from the investigation and analysis of complaints, claims and incidents. The Trust has individual policies and procedures that cover the reporting and management of complaints, claims and incidents, therefore this policy should be read in conjunction with the Complaints Policy, the Claims Policy, the Incident Reporting and Investigation Policy and the Being Open Policy. 4.2 This policy aims to: minimise the human, organisational and financial impacts of complaints, claims and incidents through effective management; ensure that where appropriate, lesson are learned to reduce risk and improve service user care; identify practices, systems or equipment that are not contributing to the highest standard of service user care and to correct them; maintain public confidence in Trust services; prevent any recurrence by identifying root causes in complaints, claims and incidents and minimise the risks from legal claims which divert funds and staff away from service user care; provide information to relevant managers to facilitate action or further investigation and to enable local records to be kept for inspection and periodic review; enable the compilation of statistics for monitoring risk management performance; Policy for the Investigation of Complaints, Claims and Incidents Page 5 of 55

provide an archive of the essential facts for possible use by the Trust s legal advisors/insurers; ensure compliance with all mandatory reporting schemes. 5. Duties 5.1 The Chief Executive is the Trust Board Member with overall responsibility for complaints and claims and will keep the Executive Directors Group, Quality Assurance Committee and Trust Board informed of major developments. 5.2 The Executive Director of Nursing and Integrated Governance is the Trust Board Member with overall responsibility for incidents and will keep the Executive Directors Group, Quality Assurance Committee and Trust Board informed of major developments. 5.3 The Quality Assurance Committee has responsibility for monitoring events actively throughout the Trust. The Quality Assurance Committee will escalate any issues either to the Trust s Executive Directors Group or escalate directly to the Trust Board as necessary. 5.4 The Service User Safety Group will review events on a monthly basis and will escalate any concerns to the Quality Assurance Committee. 5.5 It is the responsibility of the Service Directors and Clinical Directors to: ensure that staff within their Directorate are aware of, and understand, the Trust s Complaints Policy, Claims Policy, Incident Investigation and Reporting Policy and Being Open Policy and work within local guidelines; ensure the application of the Complaints Policy, Claims Policy and Incident Investigation and Reporting Policy within their Directorate; appoint appropriately trained senior managers and clinicians to investigate events within their Directorate; ensure that action is taken to address issues raised in events and provide evidence of improvements (completed action plans); ensure the timely investigation of events and that reports are sent by the date provided by the Complaints & Litigation Lead or Risk Lead (as appropriate); ensure that issues raised in events and lessons learned/actions taken are discussed at the Directorate s Service Governance meetings; ensure that issues raised in events are discussed in the relevant Team Governance meetings on a regular basis. 5.6 It is the responsibility of the Complaints & Litigation Lead to: manage the complaints and claims procedures within the appropriate timescales and standards ensuring that all complaints are accurately recorded, acknowledged and that the investigation process is agreed with the complainant, including timescales for responding; give advice to any staff involved in the processes; support Directorate staff to facilitate local resolution meetings, chairing and/or facilitating where necessary; ensure that all complaints and claims are risk graded and action plans are developed for high or significant risk complaints; co-ordinate complaint and claims investigations and reports; Policy for the Investigation of Complaints, Claims and Incidents Page 6 of 55

draft responses on behalf of the Chief Executive quality assuring complaint responses; ensure that action plans arising from complaints and claims are written, implemented, monitored and the learning is shared; monitor and report on trends e.g. number of complaints/claims, issues, timeliness of complaints/claims handling, outcome, lessons learned; provide a quarterly and annual report on complaints to the Quality Assurance Committee; provide an annual report on claims to the Quality Assurance Committee; attend the Service User Safety Group on a quarterly basis to discuss themes and trends arising from complaints and claims; formulate and present staff training programmes on complaints and claims; track and monitor performance of complaints and claims handling, ensuring concerns are escalated and action is taken when needed. 5.7 It is the responsibility of the Risk Lead to: manage the incident procedures within the appropriate timescales and standards; give advice to any staff involved in the process; ensure that all incidents are risk graded and action plans are developed for high or significant risk incidents; co-ordinate incident investigations and reports; ensure that action plans arising from incidents are written, implemented, monitored and the learning is shared; monitor and report on trends; provide a quarterly report to the Quality Assurance Committee; attend the Service User Safety Group on a monthly basis to discuss themes and trend arising from incidents; formulate and present staff training programmes on incidents; track and monitor performance of incident handling. 5.8 With regard to the investigation of events, a named investigator(s) (investigating officer) will be identified and have responsibility for facilitating the investigation and preparing an investigation report. The investigating officer will be a senior clinician or manager. 5.9 The investigating officer is responsible for:- notifying the Complaints & Litigation Lead or Risk Lead of any possible conflict of interest they may have in relation to the event; in respect of complaints, disclosing on the complaint resolution plan the working relationship between themselves and any staff named in the complaint; meeting with complainants and/or bereaved families; thoroughly reviewing care records (where appropriate); ensuring that all relevant staff are interviewed (or where appropriate a telephone conversation or correspondence takes place); ensuring that all relevant staff are offered support either from their line manager, Workplace Wellbeing and/or peer support; in respect of complaints, ensuring that the complaint resolution plan is adhered to and that all aspects of the complaint have been addressed; producing a report to be delivered in a timely manner; in respect of complaints, completing the Complaint Record; ensuring that any action plan arising from an event investigation that they have carried out is implemented and monitored. Policy for the Investigation of Complaints, Claims and Incidents Page 7 of 55

5.10 With respect to claims, the investigating officer will be the Complaints & Litigation Lead. A nominated senior manager from the Directorate will, where appropriate, provide assistance and support in relation to information gathering. 6. Process 6.1 Deciding the level of investigation required: 6.1.1 It is unrealistic to suggest that all events should be, or need to be investigated to the same degree or at the same level. The Trust uses the principles of the NPSA guidance (www.npsa.nhs.uk) to ensure the investigation is conducted at a level appropriate and proportionate to the event. While the principles of any investigation remain the same, the level of detail will be determined by the type, severity and potential for learning. 6.2 Level 1: Concise Investigation 6.2.1 This type of investigation is most commonly used for incidents, complaints and claims or concerns that resulted in no, low, or moderate harm to the service user (graded green, yellow, or amber for complaints and green or yellow for incidents). 6.2.2 It will normally: be conducted by one or more people who: o are local to the event o have knowledge of investigative procedures involve completion of a summary or short report(s) include the essentials of a thorough and credible investigation conducted in the briefest of terms involve a select number of RCA tools eg timeline, 5 why s contributory factors include recommendations or changes already made in the light of the event 6.3 Level 2: Comprehensive Investigation 6.3.1 This type of investigation is normally used for incidents, complaints and claims when the outcome has been actual, or the potential for severe harm or death (graded red for complaints and amber or red for incidents). 6.3.2 Serious incidents (see Incident Management Policy for definitions/examples) are generally those incidents deemed to be externally reportable to NHS Sheffield via the StEIS system. Serious incidents require a full and thorough root cause analysis investigation to be carried out by nominated investigators who are trained/experienced in root cause analysis techniques. 6.3.3 There may be certain incidents that the Trust deems to be serious enough to warrant a comprehensive level 2 investigation, but do not meet the criteria for reporting to StEIS. These incidents may be directorate level or executive level. 6.3.4 Incidents warranting a comprehensive (level 2) investigation will be triaged by the Clinical Risk Manager and assigned a case manager from within the Risk Management Department who will support the investigation and investigators through the incident investigation processes. Policy for the Investigation of Complaints, Claims and Incidents Page 8 of 55

6.3.5 For incidents that are externally reportable to NHS Sheffield, an approved report, chronology and action plan must be submitted to them within 12 weeks of the incident being reported to the StEIS system. In exceptional circumstances, an extension request may be submitted to NHS Sheffield outlining the rationale why the report can not be submitted within the given timescales. All extension requests must be authorised by the Head of Integrated Governance, before submission. In all cases, a draft report must be submitted within the initial 12 week deadline. 6.3.6 Level 2 investigations will either be led by a Senior Manager/Clinician within the Directorate wherein the event occurred or will be commissioned by the Executive Directors Group and will be investigated outside of the Directorate within which the event occurred. 6.3.7 They will normally: require input from a multi disciplinary team be led by someone experienced and/or trained in RCA be conducted to a high level of detail, including all the elements of a thorough investigation include the use of appropriate analytical tools eg tabular timeline, contributory factors involve the service user/relative/carer, including the offer of support/independent representation 6.3.8 They must include: a full report with an executive summary and appendices robust recommendations and time targeted action plan process for shared learning: locally/nationally 6.3.9 They may require management of the media via the Trust s communications officer. Directorate Level Incidents For directorate level serious incidents, the relevant service and clinical directors will set the terms of reference for the investigation and nominate investigators. Example terms of reference can be seen at Appendix xx. A report must be produced, using the standard template provided (see Appendix H) and an action plan generated to address any recommendations made within the report. The report and action plan must be approved through directorate governance structures, eg Senior Management Team meetings. Once approved at directorate level, the report and action plan will receive final approval from the Chief Operating Officer/Chief Nurse. The directors of the service where the incident occurred are responsible for ensuring the required actions are implemented and the learning and findings of the incident are fed back to relevant staff. See action plan monitoring (section 7.4) and lessons learned (section 7.5) for further details. Executive Level Incidents Executive level serious incidents will usually be serious incidents that warrant an independent investigation (level 3), commissioned by the NHS North of England. Policy for the Investigation of Complaints, Claims and Incidents Page 9 of 55

Incidents deemed to be at this level will be reported to relevant external stakeholders by the Head of Integrated Governance, eg Care Quality Commission, Monitor, Sheffield City Council. These incidents will be investigated by an investigation team, comprising of two investigators, a case manager and an HR representative. The lead investigators are nominated by the Deputy Chief Executive and the Chief Operating Officer/Chief Nurse and should normally be from outside of the directorate where the incident has occurred. The terms of reference for this level incident are set by the named executive directors above. Incidents at this level require a 48 hour report to be completed by the team/manager where the incident occurred, within 48 hours of the incident, or from the Trust becoming aware of the incident. A template will be provided for this (see Appendix I). Information from this report will be used by the incident case manager to complete the 72 hour report required by NHS North of England. The 48 hour report is cascaded to Board members and other individuals with specialist interest. The Director of Human Resources will nominate the HR representative who will form part of the investigation team. Whilst these incidents are performance managed by NHS Sheffield, the NHS North of England may request periodic updates on progress throughout the 12 week investigation period. Unlike directorate level serious incidents, once the investigation report has been completed and recommendations made, a panel meeting must be held to discuss the findings of the report. The two lead executive directors, service and clinical directors from the relevant directorate(s), Head of Integrated Governance and the investigating officer(s) should attend. Where this is not possible, nominated deputies may be appointed to attend. The panel will discuss the report findings in detail and agree the recommendations. Following the panel meeting, the relevant directors will develop the action plan to address the recommendations. The completed investigation report, chronology and action plan will be presented to the Executive Directors Group for approval, prior to submission to NHS Sheffield and the NHS North of England. An executive summary of the incident, together with the action plan, will be presented to the Board of Directors within the confidential section of the next available Board meeting. The report and action plan will also be sent external stakeholders initially informed of the incident, unless arrangements are made contrary to this by the Head of Integrated Governance. The relevant directors are responsible for implementing the action plan and providing feedback on the findings, lessons learned and support to the staff involved. 6.4 Level 3: Independent Investigation Policy for the Investigation of Complaints, Claims and Incidents Page 10 of 55

6.4.1 This is commonly considered for events of high public interest or attracting considerable media attention. It is similar to Level 2 but will be commissioned and conducted by those independent of the Trust eg the Commissioners or the Strategic Health Authority. 6.5 Why Investigate? 6.5.1 The primary reason for undertaking an investigation is not to set out to find someone to blame. It is to identify what, how and why the event happened and to learn and change where the need for this is identified. While acceptance of accountability for one s actions is an integral part of every employee s life, staff rightly expect to be treated fairly and equitably and will not be used as scapegoats for organisational failures. 6.6 The purpose of any investigation 6.6.1 The purpose of any investigation is to: find out the full facts in relation to the sequence of events that led to the event occurring determine what, if anything, went wrong and identify issues of concern identify the root causes of any error or concern determine what was managed well identify the actions required to prevent a recurrence 6.7 The investigation process 6.7.1 The Trust utilises the Root Cause Analysis methodology and investigation tools developed in line with the recommendations of the National Patient Safety Agency. The methodology and tools do not attempt to supplant clinical expertise; the aim is to utilise that expertise and experience to the fullest extent. The structured, systematic approach means that the ground to be covered in any investigation is, to a significant extent, already mapped out and the methods used are designed to promote a greater climate of openness, moving away from routine assignment of blame. The methodology also enables a process of analysis, investigation and organisational as well as individual learning. More information can be obtained at www.npsa.nhs.uk/nrls. 6.8 Nominating a lead investigator/investigation team 6.8.1 All investigations should have a lead investigator who is trained or experienced in root cause analysis to a level proportionate to the event. Appendix F offers guidance on grading an event. Policy for the Investigation of Complaints, Claims and Incidents Page 11 of 55

6.8.2 The lead investigator should ensure that the investigation is conducted thoroughly and: is in line with the severity and nature of the event follows the principles of root cause analysis is completed within the required timescales and where this is not possible, notify the appropriate responsible manager ie the Complaints and Litigation Lead in respect of complaints and claims and the Clinical Risk Manager in respect of incidents leads to a comprehensive written report, including recommendations for actions to address any identified areas for improvement ensure any areas identified as requiring immediate action, for example, a specific safety issue, or a different or additional investigation process, for example, vulnerable adults, are reported to the appropriate manager will present the report and its findings to the Service User Safety Group if appropriate 6.9 Gathering the information 6.9.1 All material facts relating to the event must be gathered as soon as possible after the event occurred. In determining what information to collect, the investigator must consider the facts leading up to the event as well as the event itself. For complex events it is only by starting at the point that the event occurred and working backwards that the start point can be identified. 6.9.2 Investigators will find it helpful to consider information from a range of sources including: the people involved in or witnessing the event the place or environment in which the event took place the equipment or objects involved in the event the documentation related to the event 6.9.3 The Trust recognises that being involved in a complaint, claim or incident is a stressful situation and a cause of worry for staff. 6.9.4 All staff involved in the event must be identified and informed that an investigation is taking place. Where staff are named in formal complaints, they will receive a copy of the letter of complaint. Staff will be informed that their assistance and co-operation in the investigation process is expected and that the purpose of the investigation is to identify areas where systems failed rather than to focus on human error. 6.9.5 All staff involved in tragic or catastrophic incidents must be advised of the availability of confidential support and counselling (eg Workplace Wellbeing) during what will be a stressful period. They should also be advised that they can have a friend or union representative with them during interviews. 6.9.6 The following support will be available to staff both immediately and on an ongoing basis from the start of the investigation until the file is closed: Immediate medical treatment if required Support from the Complaints & Litigation Lead for claims and complaints (internal) Support from the Risk Lead for incidents (internal) Support from their line manager (internal) Peer support should a member of staff wish to access this, this can be arranged by the Complaints & Litigation Lead (internal) Policy for the Investigation of Complaints, Claims and Incidents Page 12 of 55

Access to the Trust s staff counselling service Workplace Wellbeing (internal) Occupational Health Service (referral by Manager) (internal) Chaplaincy and Spiritual Care Service (internal) Trade Union support (e.g. Unison) if they are a Union member (external) Advice/support from relevant Professional Bodies (e.g. GMC, NMC) (external) Advice from Human Resources (internal) Legal advice (at the discretion of the Trust) (external) Time away from work (nature of leave to be agreed on a case by case basis) Time out to consult with their Union and/or professional body 6.9.7 Line managers must ensure that support is provided to staff during an investigation and offer ongoing support following the completion of an investigation. This may include team debriefing or the use of Workplace Wellbeing. Team and individual debriefing is available from the Complaints & Litigation Lead on request. 6.9.8 Staff will be made aware that investigations of complaints, claims and incidents take place independently of any disciplinary procedure and in the context of the Trust s Being Open policy. 6.9.9 All members of staff who are interviewed as part of the any of the processes will be given the opportunity to be supported by a colleague or staff representative at interview. 6.9.10 Guidance for staff on preparing statements in response to a complaint is available from the Complaints & Litigation Lead. Guidance is also available in Appendix J of this policy 6.9.11 Staff are entitled to seek the advice of a trade union or professional body. If, during the investigation, any human resource or competency issues are highlighted, these will be addressed with line managers and will remain confidential. 6.9.12 Should Managers or individual staff become aware that a staff member is experiencing difficulties associated with the event they should contact the Complaints & Litigation Lead for advice immediately. The member of staff will be offered a face to face meeting with the Complaints & Litigation Lead to talk through any issues and will be encouraged to access the other support mechanisms detailed in 6.18.3. In exceptional or extreme cases, it may be considered appropriate for a member of staff to be temporarily relocated to another team or site. Any such decision will be taken by the relevant Manager and Service and/or Clinical Director with advice and support from the Complaints & Litigation Lead. 6.9.13 Following the conclusion of the investigation, all members of staff named in a complaint will receive a copy of the Trust s response and/or the investigation report. All staff involved in a claim will receive notification of the outcome (although this information may be limited due to service user and/or staff confidentiality). All staff involved in incidents will have access to the investigation report and may receive a de-briefing session upon its completion. This will be arranged and facilitated by the ward/team manager. 6.9.14 All staff involved and any witnesses to the event should be requested to provide a statement (Appendix J) and, if necessary, interviewed as soon as possible after the event. 6.9.15 Should any member of staff be called as a witness in respect of a claim or an inquest, the line manager must ensure that the staff member has access to appropriate support Policy for the Investigation of Complaints, Claims and Incidents Page 13 of 55

and advice in this regard. For a claim, individual support will be provided by the Complaints & Litigation Lead. Where appropriate, the Complaints & Litigation Lead will meet with individual staff along with representatives from the Trust s solicitors to prepare statements, provide advice and support. For inquests, the Risk Management Department will provide support and guidance to all witnesses with regard to preparing for and attending court. This involves advice and guidance on preparing written reports to HM Coroner, pre-inquest preparation and support during the inquest. (See Appendix H for inquest processes). Line managers are responsible for supporting their staff through the investigation processes, including any resulting inquests. They must also escalate any concerns in this regard to the appropriate service and clinical directorate, who may consider additional/alternative support is necessary. In some instances, the Trust may require legal representation at court (eg Coroners Court). Where this is deemed necessary and appropriate, following discussion with the relevant directors, Complaints and Litigation Lead, Head of Integrated Governance and Director of Performance, Planning and Governance, the Complaints and Litigation Lead will organise and instruct a solicitor to work with the Trust for the case. The Risk Lead for the inquest will liaise with and facilitate the support and preparation for and attending court, in conjunction with the legal representative(s). 6.9.16 In addition to the support described above, staff called as witness can also receive support from the support mechanisms outlined in 6.9.6. 6.9.17 During the discussions with staff, it is important for the investigating officer to determine custom and practice in the workplace in which the event occurred. The information obtained can help identify the context in which risk factors exist. Where applicable, the investigator should visit the environment where the event took place, preferably before any changes are made, noting the layout and the conditions, for example, space, flooring, lighting, noise, staffing levels etc. 6.9.18 Any piece of equipment involved in the event should be immediately removed and preserved as evidence. 6.9.19 Other information sources include evidence of: guidelines, policies and procedures clinical records incident reports risk assessments maintenance records clinical audits training records 6.9.20 It is considered good practice to involve the relevant service user(s) and/or carers in complaint and incident investigations. Where a complaint has been made, the complainant will be contacted by the investigating officer and offered the opportunity to have a face to face meeting or a telephone discussion. Where an incident has taken place, the investigating officer and/or investigation team should make contact with the service user and/or their family as part of the investigation process where deemed appropriate. In cases of unexpected deaths or incidents graded moderate and above, this should be a matter of routine, unless the service user s current status indicates that this is inappropriate (i.e. they are assessed as lacking capacity or are considered to Policy for the Investigation of Complaints, Claims and Incidents Page 14 of 55

pose a significant risk to the investigation team). Advice should be sought on an individual basis from either the Complaints & Litigation Lead or the Risk Lead. 6.9.21 Any meetings held with service users and/or their family should take place within the context of the Trust s Being Open policy. 6.10 Mapping the events 6.10.1 Once all the information has been gathered and collated, the investigating officer will have to make sense of it all by ordering it in some way. This is particularly important when the event is complex and a large amount of notes and records have been gathered or when a full root cause analysis is being carried out. The chronology of events is of the utmost importance and should be mapped to allow the investigating officer to identify problems and good practice in the sequence of events. 6.10.2 There are four common methods of mapping: narrative chronology timeline tabular timeline time person grid 6.10.3 See Appendix H for full information in respect of the methods of mapping. 6.11 Analysing the information 6.11.1 Mapping the chronology of events will start to identify gaps in knowledge and/or systems. Gaps and problems can arise in the process of care usually actions or omissions by staff, for example, care deviated beyond safe limits of practice, failure to monitor, observe, act. Gaps and problems can also be associated with procedures and systems that are part of the process of service delivery and not direct, for example, training process, maintenance systems, environmental conditions and communication strategies. For each gap or problem identified there will be a number of contributory/influencing factors and root causes. 6.11.2 There are a number of analysis tools which can be used including: Fishbone and spider diagrams Five why s Brainstorming Brainwriting 6.11.3 See Appendix I for full information regarding analysis tools. Policy for the Investigation of Complaints, Claims and Incidents Page 15 of 55

6.12 Completing a Report 6.12.1 Root cause analysis concludes with an investigation report. The purpose of the report is to provide a: formal record of the investigation means of sharing the investigation 6.12.2 The report should explain: what happened who it happened to when it happened how it happened why it happened the root causes actions to be taken to significantly reduce the likelihood of recurrence 6.12.3 All root cause analysis reports and recommendations will be monitored by either the local governance group, the Risk Department, or the Quality and Assurance Committee depending on its severity. 6.12.4 Any unresolved risks should be discussed at the relevant local governance group and issues placed on the Risk Register as appropriate. Progress against risks and action plans on the Risk Register should be monitored by the Risk Register lead within the Risk Department. 6.13 Developing solutions and an action plan for implementation 6.13.1 For all root cause analysis investigations a final report should be completed and an action plan identified to reduce any highlighted risk(s). 6.13.2 It is the responsibility of the lead manager/clinical lead for the area to ensure action plans are completed. Recommendations should be designed to address root causes ie the conclusions of the investigation. For shorter, less complex investigations, recommendations and solutions may be developed at the same time. For more detailed investigations, recommendations may inform action planning and solutions development carried out at a later date by a different team. 6.13.3 However they are developed, recommendations and action plans should: be clearly linked to identified root causes or key learning points to address the problems rather than the symptoms address all of the root causes and key learning points be designed to significantly reduce the likelihood of recurrence and/or severity of outcome be Specific, Measurable, Achievable, Realistic and Timed (SMART) be prioritised wherever possible be categorised as those: specific to the area where the event occurred that are common only to the Trust that are universal to all and, as such, have national significance Policy for the Investigation of Complaints, Claims and Incidents Page 16 of 55

include the ongoing support of patients and staff affected by the event, if appropriate 6.13.4 Action plans will set out how each of the recommendations will be implemented and follow the same principles as set out above for recommendations. A named lead will be nominated for the implementation of each action point. 6.13.5 In many cases, it will be necessary to involve frontline staff to ensure the solutions are realistic, accepted and owned by the service or services involved. 6.13.9 Performance issues in relation to complaints and claims handling, investigation and timescales will be reported by the Complaints & Litigation Lead to the relevant Clinical and Service Directors. The Risk Lead will do the same for incidents. 6.14 Action Plan Monitoring The implementation of action plans resulting from events is the responsibility of the directorate within which the incident occurred. Sometimes another directorate may have to do something to enable the other directorate to resolve the issue, eg an incident occurs on an acute ward, that requires an IT solution to solve the problem. Whilst the action on the action plan will be directed at the IT Manager, is remains the responsibility of the acute director to ensure it is actioned. 6.14.1 Negligible and Minor (Green) Rated Incidents Action plans resulting from this level of event must be monitored at local/team level. Issues arising from events should be recorded in local risk registers, where necessary. Teams may wish to record details of actions taken following events within their team governance reports, particularly where improvements to quality/safety have been made. Where risks have been recorded in risk registers, implemented actions should be recorded, which should mitigate/remove the risk. 6.14.2 Moderate (Yellow) Rated Incidents Action plans resulting from this level of event should be monitored at directorate/ management team level. Issues arising from events should be recorded in local or directorate risk registers, where necessary. Directorates may wish to record details of actions taken following events within their team governance reports, particularly where improvements to quality/safety have been made. Where risks have been recorded in risk registers, implemented actions should be recorded, which should mitigate/remove the risk. 6.14.3 Major or Catastrophic (Orange and Red) Rated Incidents 6.14.3.1 Directorate Level Action plans resulting from directorate level serious incidents must be monitored through directorate governance processes, eg Senior Management Team meetings. Issues arising from incidents should be recorded in either directorate or corporate risk registers, where necessary. Directorates may wish to record details of actions taken following incidents within their team governance reports, particularly where improvements to quality/safety have been made. Where risks Policy for the Investigation of Complaints, Claims and Incidents Page 17 of 55

have been recorded in risk registers, implemented actions should be recorded, which should mitigate/remove the risk. The Service User Safety (SUS) Group also monitors actions arising from serious events, looking at one directorate s outstanding actions at each monthly meeting. Directorate representatives are called to provide progress updates/evidence of implementation. 6.14.3.2 Executive Level 6.15 Sharing the Learning Action plans resulting from executive level serious incidents must also be monitored through directorate governance processes, eg Senior Management Team meetings. Issues arising from incidents should be recorded in the corporate risk register, where necessary. Actions taken following this level of incident may be recorded within the Trust s Annual Report, particularly where significant improvements to quality/safety have been made. Where risks have been recorded in risk registers, implemented actions should be recorded, which should mitigate/remove the risk. As with directorate level serious incidents, actions will be monitored monthly, by directorate by the SUS Group. Due to the seriousness of this level of incidents, progress on action plans will also be monitored by the Executive Director of Operational Delivery and Executive Director of Nursing and Integrated Governance, in conjunction with the relevant service and clinical directors. Regular meetings will take place, until full implementation, to discuss progress and agree where additional resources may be required to ensure implementation. The Board will also be kept informed of action plan implementation progress for these incidents. The sharing of the lessons learned post investigation is a critical part of incident management. Learning from service user safety incidents is a collaborative, decentralised and reflective process that draws on experience, knowledge and evidence from a variety of sources. The learning process is a process of change evidenced by demonstrable, measurable and sustainable change in knowledge, skills, behaviour and attitude. Learning can be demonstrated at organisational level by changes and improvements in process, policy, systems and procedures relating to service user safety. Individual learning can be demonstrated by changes and improvements in behaviour, beliefs, attitudes and knowledge of staff at the front line. What Constitutes Learning Learning following an incident should be linked to safety related policy, practice and process issues raised by the incident. Examples of learning are given below: solutions to address incident root causes which may be relevant to other teams, services and provider organisations; Policy for the Investigation of Complaints, Claims and Incidents Page 18 of 55

identification of the components of good practice which reduced the potential impact of the incident, and how they were developed and supported; systems and processes that allowed early detection or intervention which reduced the potential impact of the incident; lessons from conducting the investigation which may improve the management of investigations in future; documentation of identification of the risks, the extent to which the risks have been reduced, identified and how this is measured and monitored. 6.15.1 Disseminating Learning from a Serious Incident Learning from serious incidents is disseminated through various means in the Trust. The Service User Safety Group, which has representatives from across the Trust, discusses all actions arising from serious incidents at each meeting (taking one directorate at a time). This enables the directorate representatives to take the actions and learning from all serious incidents back into their directorates to share with their teams and learn from others experiences. Monthly reports on ongoing serious incidents are produced by the Risk Management Department and disseminated across the Trust. This enables directorates, where the incidents did not occur, to understand the type of incidents that have occurred elsewhere, so they can take proactive, preventative action, where necessary, to avoid recurrence in their areas of responsibility. Learning from executive level serious incidents is shared with the Board, through the reporting of the executive summary and action plan. Quarterly reports are produced by the Risk Management Department which provide an analysis of all incidents reported across the Trust. Serious incidents are recorded within these reports in greater detail and all root causes and lessons learned from them are included. These reports are presented to the Quality Assurance Committee, a Board sub-committee, as well as being published on the Trust s intranet site for all staff to access. A quarterly lessons learned bulletin is sent to all staff and published on the Trust s intranet. Teams/wards also discuss incidents, complaints and claims at their regular team governance meetings, in order to feedback findings, heighten understanding and share the learning. 6.15.2 Disseminating Learning from a Complaint or Claim Lessons learned and actions taken will be fed back to Directorates on a quarterly basis through presentations and reports to Service Governance Committees. The action plans with their target dates and completion dates will provide evidence of implementation of recommendations and ensure lessons are learned. The outcomes of complaints and claims and incidents will be reported to Directorate Service Governance meetings. Lessons learned and recommendations for change will be disseminated throughout the Directorate. The Complaints & Litigation Lead will support the sharing of learning across the Trust and report on the outcome of complaint and claims investigations to the staff and teams involved, Service Directors and Clinical Directors. Policy for the Investigation of Complaints, Claims and Incidents Page 19 of 55

6.15.3 Wider Sharing of Lessons Investigations may identify issues of national significance or where the dissemination of national learning is appropriate. Service user safety incidents are reported to the NPSA through the NRLS. When updates to the incidents are recorded on the Safeguard system, updates are sent to the NPSA. When an incident is closed, the root causes and lessons learned are inputted onto Safeguard, which then shares the findings with the NPSA and the Care Quality Commission. Where relevant, NHS Sheffield receive the investigation report, together with any resulting action plan. For executive level serious incident, the CQC, Monitor and Sheffield City Council receive the investigation report and action plan, thus sharing the learning across organisational boundaries. Where the NHS North of England perceives that lessons learned in one Trust may be relevant to others, this will be communicated through them and assurances sought from individual Trust Boards that necessary measures are either already in place or are being taken to prevent the occurrence of such an incident within their Trust. Level 3 investigation reports and action plans are also published on the NHS North of England s website. Quarterly and annual reports on complaints, claims and incidents are provided to the Trust s Commissioners and Local Authority. Copies of the Complaints Annual Report is also shared with NHS North of England, the Parliamentary & Health Service Ombudsman and the Department of Health. Anonymised information in relation to claims will be shared with relevant stakeholders where deemed appropriate by the Complaints & Litigation Lead or Chief Executive. Learning from serious incidents is also discussed at the Yorkshire and the Humber Chief Executives Forum, where appropriate, to ensure that shared learning take place across the health economy. 6.15.4 Learning from Serious Case Reviews (SCR) The Executive Director of Nursing and Integrated Governance is the Trust s representative on Sheffield s Safeguarding Adults Board (SAB) and Sheffield s Safeguarding Children s Board (SCB). They are responsible for ensuring that communication between both the SAB and SCB and the Trust Board is maintained. Learning lessons is the prime rationale of SCRs, and SABs and SCBs are responsible for commissioning each SCR; sharing the learning across all organisations; and monitoring at agreed review periods whether the lessons have been taken on board. The SAB is responsible for ensuring that they receive regular progress reports on a commissioned SCR and to take action if the delay appears unreasonable. NHS organisations in partnership with the SAB should have local policies for implementing the findings from SCR, a process to report to their own boards, and action plans to implement and monitor changes in practice. Policy for the Investigation of Complaints, Claims and Incidents Page 20 of 55