Policy for the Investigation of Incidents, Complaints and Claims, including Analysis and Improvement

Policy for the Investigation of Incidents, Complaints and Claims, including Analysis and Improvement DOCUMENT CONTROL Version: 3 Ratified by: Risk Management Sub Group Date Ratified: 15 January 2013 Name of Originator / Author: Head of Patient Safety & Experience Name of Responsible Committee/Individual: Risk Management Sub Group Date Issued: 18 January 2013 Review Date: January 2016 Target Audience All staff

CONTENTS SECTION PAGE 1. INTRODUCTION 4 1.1 Rationale 4 1.2 Incident investigation 4 1.3 Definitions 5 2. PURPOSE 5 3. SCOPE 6 4. RESPONSIBILITIES, ACCOUNTABILITIES AND DUTIES 6 4.1 Board of Directors 6 4.2 Chief Executive 6 4.3 Executive Director Business Assurance 7 4.4 Directors 7 4.5 Deputy Chief Executive/Director of Nursing and Partnerships 7 4.6 Chief Operating Officer 7 4.7 Assistant Directors 7 4.8 Head of Patient Safety & Experience 7 4.9 Head of Learning and Development 8 4.10 Risk Management Sub Group 8 4.11 Organisational Learning Forum 8 4.12 Clinical Governance Group 8 4.13 Health, Safety and Security Forum 9 4.14 Human Resources and Organisational Development Group 9 4.15 Managers 9 4.16 Investigators 10 4.17 Trust Lead Specialists/Other Specialists 11 4.18 All staff 12 5. PROCEDURE / IMPLEMENTATION 13 5.1 Investigation 13 5.2 Analysis 20 5.3 Improvement 20 Page 2 of 55

6. TRAINING IMPLICATIONS 21 7. MONITORING ARRANGEMENTS 22 8. EQUALITY IMPACT ASSESSMENT 23 8.1 Privacy, Dignity and Respect 23 8.2 Mental Capacity Act 23 9. LINKS TO ANY ASSOCIATED DOCUMENTS 23 10. REFERENCES 24 11. APPENDICES Appendix 1 NPSA Risk Matrix 25 Appendix 2 - Terms of Reference Organisational Learning Forum (OLF) 28 Appendix 3 NPSA Root Cause Analysis Investigation Tools - three levels of Root Cause Analysis Investigation Guidance 31 Appendix 4 - NPSA Contributory factor classification framework 34 Appendix 5 Level 1 Concise Investigation Report Template 38 Appendix 6 - Level 2 Comprehensive Investigation Report Template 41 Appendix 7 - Investigation checklist and helpful investigation planning templates 50 Appendix 8 - Guidance on Witness Statements 53 Page 3 of 55

1. INTRODUCTION 1.1 Rationale Assuring the safety of patients, staff and visitors should be a key priority within any healthcare organisation. This requires a collaborative approach to the analysis of incidents, complaints and claims and ensuring that lessons learned from this analysis are shared across the organisation as well as across the local health community. The analysis can provide an opportunity for proactive risk management, learning from what has happened and implementing controls to prevent recurrence. Many serious events have occurred because organisations have ignored the warning signs of incidents, complaints or claims and failed to learn from the lessons of the past. Systematic processes are required that clearly determine when, how and by whom learning should be cascaded and acted upon and that plans for improvement are formulated, acted on and followed up. Organisations should make use of root cause analysis techniques to ensure there is a systematic investigation process that looks beyond the individuals concerned to discover underlying causes. Organisations should value the importance of identifying and learning from the causes of incidents, complaints and claims and implementation of solutions to prevent recurrence (NHSLA, 2012). The process for learning will take place in line with Trust Business Division/Directorate and corporate risk registers using the risk grading matrix (see Appendix 1) and managers authority to treat risk. The Trust has developed ways of determining what the learning points are and how they will be shared internally across the Trust and externally, as set out later in this policy. The sharing of lessons learnt from one service to other areas of the Trust will help ensure that similar incidents do not repeat across Business Divisions/services and that any system failures discovered during investigations are adopted by the Trust as a whole and pockets of good practice are not isolated. 1.2 Incident investigation Incident investigation is an essential element of the Trust s approach to investigating, analysing and learning from experience, in order to improve the safety and quality of services. In most cases an incident does not result from a single event, but it is more likely to have involved cumulative triggers and effects which in isolation may have no noticeable impact, but when they occur in an event chain, the result can be serious or even catastrophic. It is essential when investigating an incident that blame, early judgments and assumptions are avoided. To this end, the Trust is committed to the use of Root Cause Analysis (RCA) as the basis for a chronological, objective and systematic investigation. The use of RCA Page 4 of 55

will lead to the identification of preventative measures to address underlying causes, in order to prevent incidents happening again and to remove or reduce the risk. 1.3 Definitions 1.3.1 Incident For the purposes of this policy the term incident is used to cover incidents, complaints and claims, and is defined as any reportable event which could have or did lead to unintended or unexpected harm, loss or damage (including reputation). 1.3.2 Root Cause Analysis (RCA) A way of conducting an investigation into an identified problem that allows the investigator(s), and other involved parties, to understand better the root, or fundamental, cause of the problem so that it can be put right. 1.3.3 Investigation The work of inquiring into something thoroughly and systematically. 1.3.4 Root Cause Defined as the underlying cause to which the incident can be ultimately attributed and which if corrected, will prevent a recurrence. 1.3.5 Contributory Cause Defined as a cause which contributes to the incident but which by itself, would not cause the incident. 1.3.6 External Agency A body that is recognised as having an interest in the investigation, such as Commissioners, the Coroner, Health and Safety Executive (HSE), National Patient Safety Agency (NPSA), Care Quality Commission (CQC) etc. A comprehensive list of external agencies to which various types of incidents are required to be reported is provided in the Incident Reporting Policy. 1.3.7 Aggregated data Data from incidents, complaints and claims which have been analysed both separately and all together, and in a number of different ways e.g. by service type, location, cause, etc. to determine a comprehensive risk profile of the organisation. 2. PURPOSE The purpose of this policy is to set out the Trust s arrangements for investigation, analysis and learning and improvement from incidents, complaints and claims. Specifically: The investigation of incidents, complaints and claims The aggregation and analysis of incidents, complaints and claims Learning and improvement in practice The Trust aims to achieve this within a progressive, honest and open environment, where risks and incidents are identified quickly and acted upon in a positive and constructive way, and where an ethos of learning and improvement is fostered. Page 5 of 55

3. SCOPE This policy applies to all staff that are required to report incidents and to contribute to investigation, analysis and learning and improvement activities, from a basic to a complex level, depending on their role. The policy provides guidance on investigation, as shown in Appendix 3 - NPSA Root Cause Analysis Investigation Tools - Three Levels of Root Cause Analysis Investigation. The policy supports the arrangements set out in the following Trust procedural documents, which should be referred to in relation to the specific arrangements for each subject: Policy and Procedure Relating to the Handling of Formal Complaints Claims Handling Policy for the Management of Clinical Negligence Claims, Employer Liability Claims and Property Expense Claims Policy for the Management of Serious Incidents (SIs) Incident Reporting Policy 4. RESPONSIBILITIES, ACCOUNTABILITIES AND DUTIES All members of staff have an individual responsibility for the identification of risk and all levels of management must understand and implement the Trust s Risk Management Strategy and supporting policies and procedures. 4.1 Board of Directors The Board of Directors is responsible for ensuring that the Trust consistently follows the principles of good governance applicable to NHS organisations. This includes the development of systems and processes for investigation, analysis, learning and improvement. The Board of Directors is responsibility for ensuring that it receives assurance that this policy is being implemented, that lessons are being learnt and improvements made, and areas of vulnerability are improving. This will be achieved through the arrangements set out in this policy. Where concerns are identified relating to the robustness of learning and improvement or actions planned, the Board will seek assurances that these concerns are being acted upon. 4.2 Chief Executive The Board of Directors delegates to the Chief Executive the overall responsibility for effective risk management in the Trust, meeting all statutory requirements and adhering to guidance issued. The Chief Executive is ultimately accountable for the implementation of this policy. Page 6 of 55

A number of Directors have responsibilities in relation to this policy as detailed below. They are responsible for cooperating with each other to ensure that assurance is gained that this policy is being effectively implemented within the organisation. 4.3 Executive Director Business Assurance The Executive Director Business Assurance is the Director designated with lead responsibility for risk management. 4.4 Directors Directors (both Executive and other Directors) have the delegated authority for ensuring that risk is managed appropriately in their area of responsibility and are responsible for the effective implementation and monitoring of this policy. The Risk Management Strategy identifies Directors with responsibility for specific aspects of risk which may require investigations. All Directors are responsible for providing leadership for the development of a learning organisation that recognises that improvement occurs through people who need support to enable them to improve on the work they do today. For the most serious incidents, Directors will be responsible for the direct appointment of an Investigator, but in most other cases this will be delegated to a next in line Manager. 4.5 Deputy Chief Executive/Director of Nursing and Partnerships The Deputy Chief Executive/Director of Nursing and Partnerships is responsible for the effective management of clinical risk, liaising with the Chief Operating Officer. 4.6 Chief Operating Officer The Chief Operating Officer (COO) is responsible for the effective management of clinical risk within the Trust s Business Divisions. 4.7 Assistant Directors Assistant Directors will be responsible for overseeing the processes in this policy in their Business Division including: appointing an Investigator approving reports/letters acting as the lead for action plans They are responsible for making sure that learning is cascaded and acted upon within theire services and that plans for improvement are formulated, acted on and followed up. 4.8 Head of Patient Safety & Experience The Head of Patient Safety & Experience is responsible for providing support to Directors, Assistant Directors, Managers, Lead Specialists and staff to Page 7 of 55

facilitate the effective implementation and monitoring of this policy. They will: Oversee the production of the Triangulated Report Provide information in the Quality Account and Trust Annual Report Chair the Organisational Learning Forum to ensure that learning is shared via this forum across complaints, claims, incidents and safety, and that appropriate action is reported via the forum Complete an aggregated analysis of incidents (Triangulated Report) on a quarterly basis 4.9 Head of Learning and Development Investigation training is mandatory. The Head of Learning and Development is responsible for the implementation of the Mandatory Risk Management Training Policy and associated Training Needs Analysis, providing reports on compliance to the Human Resources and Organisational Development Group See Mandatory Risk Management Training Policy and Mandatory Risk Management Training Needs Analysis 4.10 Risk Management Sub Group The Risk Management Sub Group is responsible for approving certain policies and for providing assurance to Policy and Planning Group level around its key responsibilities. It gives delegated responsibility to the Organisational Learning Forum (OLF) for the implementation of its work streams and action plans. 4.11 Organisational Learning Forum (OLF) The Organisational Learning Forum is responsible for developing and managing a structured approach to active organisational learning, where lessons learned are embedded in the Trust s culture and practice. The group will help to facilitate a fair blame (no blame) culture. This will include: the sharing of lessons learnt from incidents, complaints and claims from one service to other areas of the Trust in order that any system failures discovered during investigations are adopted by the Trust as a whole and pockets of good practice are not isolated. The fostering of a learning and improvement culture, where all staff understand the value and benefits of learning from error and feel confident to report incidents. 4.12 Clinical Governance Group The purpose of the Clinical Governance Group is to enable the Board of Directors to obtain assurance that high standards of care are provided by the Trust and, in particular, that adequate and appropriate governance structures, processes and Page 8 of 55

controls are in place throughout the Trust This will include: - monitoring trends in incidents, complaints and claims received by the Trust and commissioning actions in response to adverse trends where appropriate - identifying areas for improvement in respect of incidents, complaint and claim trends and ensuring appropriate action is taken. 4.13 Health, Safety and Security Forum One of the key responsibilities of the Health and Safety Forum is to actively champion health, safety and security, promoting incident reporting, learning from experience and best practice. The Health and Safety Forum monitors incident reporting through the quarterly report produced by the Health and Safety Lead, including any associated learning and improvements fed through by Managers for inclusion in the report. The Health and Safety Forum reports to the Risk Management Sub Group through the monthly standing agenda item. 4.14 Human Resources and Organisational Development (HR&OD)Group The HR&OD Group is responsible for receiving though the Head of Learning and Development reports on Mandatory Risk Management Training compliance and for taking appropriate action as required. 4.15 Managers All levels of management must understand and implement the Trust s Risk Management Strategy and supporting processes. Managers are responsible for: Disseminating, implementing and monitoring this policy within their services. Building a learning and improvement culture within their services where staff understand the value and benefits of learning from error, feel confident to report incidents and know that timely feedback will be provided to them. This will require close working with the Lead Specialists Providing local induction on this and related policies for all new starters appropriate to need. Planning for and monitoring the training of their staff in relation to this policy - see Mandatory Risk Management Training Policy and Training Needs Analysis. All incidents being reported on Safeguard in line with the requirements of the Incident Reporting Policy. The risk grading of incidents using the NPSA Risk Matrix (see Appendix 1) and their recording and monitoring via the Risk Register process as appropriate. Discussing incidents graded as High or Extreme with the relevant Director/Assistant Director. Notifying the Chief Operating Officer if an incident is believed to fall within the definition of a Serious Incident, where the arrangements set out within the Policy for the Management of Serious Incidents will apply. Initiating investigations at an appropriate level in line with this policy and the Page 9 of 55

Policy for the Management of Serious Incidents. Seeking advice on levels of investigation from Directors/Assistant Directors/Lead Specialists as required. Identifying relevant staff to undertake investigations, which may include cross- Business Division/Directorate investigations. Agreeing terms of reference for investigations, which describe the plan and latitude allowed to those conducting the investigation. Applying Being Open principles as set out in Being Open - Communicating Openly and Honestly with Service Users following a Patient Safety Incident or Related Complaint or Claim. Providing advice and support to staff as set out in Supporting Staff involved in an Incident, Complaint or Claim Policy. The completion of investigations within any identified timescales, as set out in the individual policies shown in Section 9. Receiving and acting on requests to investigate incidents, Serious Incidents, complaints and claims as per this policy and the Policy for the Management of Serious Incidents. Monitoring trends and themes identified by incident investigation and analysis, and commissioning investigations where concerns are raised about a specific issue, trend or theme or where concerns are raised about the safety of systems/processes. Investigating and taking action when requested on events referred to the Business Division/Directorate, and feeding back to the relevant Director, Assistant Director and/or Lead Specialist. Monitoring the quality of investigations by commenting on investigation reports. Devising and monitoring action plans and risk reduction measures to reduce the likelihood of repeat incidents, taking steps to address any delays in implementation. Updating action plans on Safeguard and Risk Registers and informing, as appropriate, the relevant Director, Assistant Director and/or Lead Specialist if there are any changes to action plans timescales or actions which cannot be met. Recording any residual risks on the relevant Risk Register. Facilitating full co-operation with investigations undertaken by external stakeholders. Having clear processes in place locally for timely feedback to staff on the results of investigations, lessons learned and areas for improvement. Communicating learning and improvement through the Organisational Learning Forum (OLF) (see Appendix 2) and the learning and improvement sections of relevant reports. 4.16 Investigators Investigators are responsible for: Conducting Level One Concise Investigations and Level Two Comprehensive Investigations based on the risk grading of incidents, using the guidance provided in Appendices 3-8 of this policy, and the Policy for the Management of Serious Incidents as appropriate. Seeking specialist advice, support or assistance where identified as being required. Page 10 of 55

N.B. Level Three Independent Investigations are conducted by those independent to the Trust. Level Two Comprehensive Investigations require investigators to: Conduct to a high level of detail, a thorough investigation. Bring together an investigation team (as and when required) comprising multi-disciplinary staff. Agree timescales for feedback to interested parties. Involve patients and carers as appropriate (see Being Open Policy). Develop an action plan to address the recommendations from the investigation. Develop robust recommendations for shared learning both internally to the Trust and externally as appropriate. Investigators are responsible for, and have authority to: Collect evidence by direct observation, documentation reviews and interviews. Assemble and consider evidence to determine causation. Compare findings with relevant standards. Draw up action plans, including timescales. Debrief staff. Assist in the implementation of the improvement strategy and help track progress. Provide reports to Directors/Managers/Lead Specialists and others as and when required. Where a particular need is identified to access Specialist advice (see Section 4.17) internal to the Trust, prior approval is required from the relevant Manager who the Investigator is reporting to for the investigation. Where a need is identified to access Specialist advice external to the Trust, prior approval is required from the relevant Director. 4.17 Trust Lead Specialists/Other Specialists 4.17.1 Trust Lead Specialists Investigators may need to involve Trust Lead Specialists to advise, support and/or assist in the investigation. Investigators are responsible for determining when specialist advice is required and Lead Specialists have a duty to provide support and advice as and when required. This may be in the form of: reviewing investigation findings to date; attendance at multi-disciplinary investigation meetings; provision of a written report/opinion or review of recommendations; or, acting as a facilitator so that all those involved can make a full and honest contribution in a non-threatening environment. 4.17.2 Health and Safety Lead, Patient Safety Lead, Complaints Manager, Claims Manager, Local Security Management Specialist The above officers are responsible for: Page 11 of 55

Providing advice, support and assistance in relation to the implementation of this policy and with the requirements of the subject specific policies set out in Section 9. Providing advice on the appropriate risk grading and required level of investigation of incidents. Contacting the relevant Business Division/Directorate to request that an investigation is commissioned where an incident report is received with an incorrect risk grading, or where an investigation has not been commissioned but should have been. Monitoring the timeliness, quantity, quality and effectiveness of investigations, as well as learning and improvement and the embedding of actions within the Trust. This will be achieved through the normal course of their day to day work - with the facility for any concerns to be escalated to the Executive Director Business Assurance - and through the relevant groups identified in Section 4.. Following up and monitoring action plans through to completion via the Safeguard system and/or via other systems specific to the incident subject i.e. Incident, Serious Incident, Complaint or Claim. The production of a quarterly Incident Report for the Health and Safety Forum by the Health and Safety Lead. 4.17.3 Other Specialists It may be necessary at times to seek advice and/or involvement of other Specialists with particular expertise which will be helpful to the investigation. These individuals may be internal or external to the Trust. Reasons for doing this might include insufficient expertise within the Trust, or the need to eliminate bias etc. A clear rationale and parameters for advice and/or involvement should be agreed by the Investigator prior to seeking involvement. Where a particular need is identified to access Specialist advice internal to the Trust, prior approval is required from the relevant Manager who appointed the Investigator. Where a need is identified to access Specialist Advice external to the Trust, prior approval is required from the relevant Director. 4.18 All Staff All members of staff have an individual responsibility for the identification of risk and all levels of management must understand and implement the Trust s Risk Management Strategy and supporting processes. All staff are required to be aware of and comply with this policy, and are responsible for: Highlighting any risk issues which would warrant further investigation. Being open and co-operative with any investigation process. Page 12 of 55

Contributing to learning and improvement activity 5. PROCEDURE / IMPLEMENTATION Some of the procedures which support implementation of this policy are set out in Section 4, and will therefore not be duplicated in this section. 5.1 Investigation The specific techniques and tools of Root Cause Analysis (RCA) are not described in detail in this policy. Guidance is provided in Appendices 3-8. The use of RCA provides analysis through systematic investigation techniques that look past the immediate causes or active failures and seek to understand the underlying or latent failures to clearly identify causal factors and remedial actions. 5.1.1 Different levels of investigation appropriate to the severity of the event(s)-concise, comprehensive, independent The level of investigation undertaken will dictate the degree of leadership, overview and strategic review required. Not all incidents need to be investigated to the same extent or depth. The risk matrix shown in Appendix 1 will be used by Managers to assess the impact of an incident, which provides a grading on the consequence and likelihood of recurrence. The level of investigation to be undertaken will be determined by the risk grading of the incident, and will be conducted at a level appropriate and proportionate to the incident under review. Appendix 4 provides guidance on what might be considered appropriate and proportionate. There are three main considerations when making this decision: The level of severity of harm. The likelihood of the event recurring. The potential for learning (which can result in the investigation of those incidents which are high in frequency but of low severity). Where an incident is believed to fall within the definition of a Serious Incident, Managers will notify the Chief Operating Officer immediately in line with the requirements of the Policy for the Management of Serious Incidents. All incidents require some level of local review and it is a requirement for Managers to document this on the IR1 incident report form on Safeguard as per the requirements of the Incident Reporting Policy. The time spent on investigation will normally, but not exclusively, be in direct relation to the risk grading of the incident. 5.1.2 Low Risk Incidents Although these incidents represent relatively low risk, this does not mean they can be ignored. They represent small failures and vulnerabilities that may signal action to avoid escalation of a situation. Where it is determined that further local investigation is required, this will be initiated Page 13 of 55

by the Manager responsible for signing off the IR1 form. Appendix 4 provides guidance for Level One Concise Investigations which can be used as required as a prompt. However, it is accepted that many local incidents will not require a formal investigation report. The process may involve for example, the multi-disciplinary team exploring ways to minimise a recurrence, or a review of a care plan. The Contributory Factor Classification Framework shown in Appendix 5 also provides a useful prompt. The outcome will be clearly documented on the IR1 in the Management Action section along with details of any further action planned. The Manager will identify improvement measures which are within their control, and they will notify any that are not within their control to the relevant Director/ Manager for consideration/action. Lessons learned will be documented on the IR1. The Manager will sign off the IR1 and record the final risk grading. The Manager and their team will monitor trends/themes associated with this grade of incident, and identify where the underlying causes are common to the service area, taking appropriate action to address any local system weaknesses identified. Where incidents appear to be occurring with increasing frequency and a trend/theme is identified, Businesses Divisions/Directorates or Lead Specialists may request a root cause analysis exercise to be undertaken in line with a Level One Concise Investigation to provide further causal analysis and actions to prevent the frequency of recurrence. 5.1.3 Moderate Risk Incidents As a guide, the Manager will take immediate action to try to reduce the risk of a recurrence, record this on the IR1 and sign off the IR1 with the risk grading, indicating that a Level One Concise Investigation is to be undertaken see Appendix 4. Local investigation will normally be carried out by one or two key staff only e.g. local manager with assistance from another member of staff, but should be led by a person who has undertaken RCA training. An attempt should be made to establish root cause(s), but this will be a smaller scale investigation than for higher risk incidents. Lead Specialists may be requested to support these investigations as required. A Level One Concise Investigation report template is provided in Appendix 6. 5.1.4 High Risk Incidents These incidents may or may not fall within the scope of the Policy for the Management of Serious Incidents, and Managers will seek advice from the relevant Director/Lead Specialist based on their initial risk grading of the incident. Based on the outcome of the above, a Level I Concise Investigation may be adequate for some High Risk Incidents and others will require a Level 2 Comprehensive Investigation. Page 14 of 55

High risk incidents require an investigation employing RCA techniques and the investigation will be led by a person who has undertaken RCA training. These investigations will normally be led by a person from the Business Division/Directorate where the incident occurred. On occasions they may be led by an investigator outside of the Business Division/Directorate, as agreed between relevant Managers/Directors as appropriate. When an incident is declared not to fall within the scope of the Policy for the Management of Serious Incidents, the Manager will sign off the IR1 detailing the completion of the immediate actions taken to try and reduce the risk of recurrence, indicating what level of investigation is to be undertaken and will record the risk grading allocated to the incident. Where a Level 2 Comprehensive Investigation is required, it will require the full cooperation of the teams/departments involved. A report template for a Level 2 Comprehensive Investigation is provided in Appendix 7. 5.1.5 Extreme Risk Incidents These incidents will fall within the scope of the Policy for the Management of Serious Incidents, and should be notified immediately to the Chief Operating Officer. Depending on the nature of the incident, it may be investigated internally though a Level 2 Comprehensive Investigation or it may be required to be investigated externally as a Level 3 Independent Investigation. Further guidance is provided in the Policy for the Management of Serious Incidents. 5.1.6 Terms of Reference Managers will agree terms of reference for investigations which describe the plan and latitude allowed to those conducting the investigation. These will have regard for previous investigation findings and identify: Specific problems or issues to be addressed. Who commissioned the investigation (and at which level in the Trust). Investigation lead (and team where relevant). Aims and objectives of the investigation and desired outputs. Scope and boundaries beyond which the investigation should not go e.g. disciplinary process. Timescales for the report and for reviewing progress on the action plan. Administration arrangements (including accountability, meetings, resources, reporting and monitoring arrangements). Actual or potential for involvement of the police, Health and Safety Executive etc and plans for this to be addressed and managed effectively at the earliest point. Page 15 of 55

Who the audience is for the final report (distribution list). 5.1.7 Key Components of the Investigation Process Preservation of an incident scene should occur where relevant and practical. A number of tools have been provided in this policy to support the investigation process: Appendix 4 - NPSA Contributory Factor Classification Framework Appendix 5 and 6 - Report templates Appendix 7 - Investigation Checklist and useful investigation planning templates Appendix 8 - Guidance on Witness Statements. All investigations have four key components: a) What happened? Establish the chronology of events and state the immediate action taken. Identify who was involved in the event, when the event took place and where the event occurred. Identify people to be interviewed - those directly involved or who have an expert knowledge. Obtain written statements from those involved and obtain, preserve and examine any evidence (e.g. equipment). Conduct interviews in private with staff representation as appropriate ensuring adequate staff support. b) How did it happen? Identify the problems or events that led to the occurrence. Identify good practice. Establish a chronology or sequence of events for these details and facts. c) Why did it happen? Compare the evidence with relevant standards, policies, protocols, guidelines or professional practice (local or national) to identify care management problems or system weaknesses. Consider possible and known causal and risk factors. Identify the contributing factors and root cause(s) that led to the incident occurring. Page 16 of 55

Remember it is unusual for an incident to occur as a direct result of any one factor but more usually due to a combination of several factors. d) What does all this tell us and what next? Review all the information gathered and draw conclusions. From the results of the root cause analysis it should be clear where the problems lie. Develop recommendations to address the root causes. Agree timescale for feedback of findings and draft recommendations to stakeholders. RCA concludes with an investigation report (see report templates at Appendices 8 and 9) dealing with all aspects of the investigation, the recommendations made as a result of the investigation, lessons learnt and actions required to reduce any highlighted risks(s) and to avoid recurrence. Any changes recommended need to be incorporated into the way staff work at all levels of the Trust. Investigations leads will propose risk reduction measures which are: - realistic - sustainable - cost effective These measures should be reviewed by staff and where possible and relevant by service users and carers to make sure that they will be achievable in practice, before implementation. Any risks which cannot be immediately rectified resulting from an incident investigation will be risk assessed and recorded on the relevant Risk Register. Debrief staff ensuring that lessons are learnt and shared. N.B. It is important that lessons learned should be identified, numbered and addressed by the recommendations, including any root causes. 5.1.8 Involvement and support for service users, carers and staff Being involved in an incident which is under investigation can be an incredibly stressful experience. The Trust will endeavour to support service users, carers and staff during this difficult time. The arrangements for supporting and involving service users, carers and staff are set out fully in: Being Open and Communicating Openly and Honestly with Service Users following a Patient Safety Incident or Related Complaint or Claim; and, in the Policy on Supporting Staff involved in an Incident, Complaint or Claim. 5.1.8.1 Service users and carers Page 17 of 55

In line with Being Open, the investigation report should demonstrate the extent to which those affected have: Been given an accurate, open, timely and clear explanation of what has happened, regardless of, but with sensitivity to, the distressing nature of the event. Received an apology in the form of a sincere expression of sorrow or regret for the harm that has resulted from the incident. Been informed of what can be done in terms of care and treatment to repair or redress the harm done. Been given a clear statement of what is going to happen regarding any investigation. The report should also explain to what extent the service user and/or carers were involved in the investigation. This might include detail on whether they were: Asked how much involvement they want. Interviewed to establish the questions they hope the investigation will address and to hear their recollection of events. Asked how they would like their involvement and/or their names referred to in the report. Offered a point of contact (Family liaison person) with regard to the investigation. Given information on sources of independent support/advocacy. Informed and kept up to date with the investigation process, including agreeing the frequency with which they wanted to be updated. Advised that the report and/or findings will be shared with them as they wish, and that it will be written in plain English. Advised of whom they can contact in the future (job title), should they want information on implementation of recommendations. 5.1.8.2 Staff It is important to keep staff informed at all times, and to provide advice, support and opportunities for involvement in the process. In the investigation report, the help received from staff should be acknowledged. Names of staff should not feature in the RCA investigation other than in the archived master, and staff should be advised that the report will be made anonymous before any circulation or publication. The report should outline any support given or offered to staff after the incident and during the investigation, such as counselling, support during interviews or debriefing. Refer to local support from colleagues, as well as formal support, written materials Page 18 of 55

or access to support networks. Good practice in this regard will include debriefing sessions. Support should be considered for all involved in the process, including for example, students, contractors and investigators. 5.1.9 Process for involving and communicating with internal and external stakeholders to share lessons learned The process for involving and communicating with internal stakeholders to share lessons is through: The use of the aggregated analysis within the Triangulated Report and the themes and trends which are identified from this for inclusion in the Quality Improvement Report. The information is discussed and disseminated at the relevant Trust Committees and Group identified at the next available meeting after the report is produced. The Trust Committees/Groups with responsibilities in relation to this policy, who are expected to disseminate key information through their membership. Established Business Division/Directorate management arrangements, where Managers have a defined responsibility to involve and feedback to relevant staff in a timely and appropriate way. The report is shared at the next round of Divisional meetings following its production by the Assistant Directors. Practice Development Bulletins. The Mandatory Risk Management Training Programme whose content is updated to reflect the outcomes of investigations and lessons learned. The process for involving and communicating with external stakeholders to share lessons is through: Reports provided to Commissioners. Joint investigations e.g. Complaints, where there is an opportunity to share lessons across the whole care pathway. Reports to the National Reporting and Learning Service (NRLS) at the NPSA. As requested by an external agency e.g. Coroner, Heath and Safety Executive etc The inclusion of an annual trend and theme update through the Trust Annual Report and Quality Account - which is published on the trust website and is presented to external stakeholders and widely disseminated - will facilitate the sharing of learning actions with the wider public. 5.1.10 Process for following up relevant action plans Managers, in conjunction with the Lead Specialists will follow up and monitor action Page 19 of 55

plans through to completion via the Safeguard system and/or via other systems specific to the incident subject and in accordance with individual policies e.g. Policy and Procedure Relating to the Handling of Formal Complaints. The Organisational Learning Forum has responsibility for overseeing completion of action plans as part of the sharing of lessons learnt (see Appendix 2), monitoring this on a monthly basis. 5.2 Analysis 5.2.1 Coordinated approach to the aggregation of incidents, complaints and claims The purpose of a coordinated approach to the aggregation of incidents, complaints and claims is to determine a comprehensive risk profile of the Trust. A Triangulated Report is produced on a quarterly basis of incidents, complaints and claims or the Risk Management Sub Group and Commissioners. 5.2.2 Frequency with which an aggregated analysis of incidents is to be completed An aggregated analysis is completed on a quarterly basis. 5.2.3 Minimum content required within the analysis report, including qualitative and quantitative analysis The analysis report will include as a minimum: Separate quantitative and qualitative analysis summaries of incidents, complaints and claims. Aggregated quantitative and qualitative analysis summaries of incidents, complaints and claims. Summary of trends, themes, causal factors and any subsequent changes in practice. Data will be analysed by service type, location, cause, etc. Summary review of outcomes of investigations and performance against action plans. Summary of actions taken to disseminate lessons. Summary of risk reduction measures implemented. Summary of improvements made. Areas identified for action with timescales - Actions will be identified to a particular area where relevant in order to focus improvement and learning 5.2.4 Process for communicating this information to relevant individuals or groups The process for communicating this information to relevant individuals or groups is as set out in Section 5.1.9 above. 5.3 Improvement 5.3.1 Process by which the Trust ensures local and organisational learning from incidents and that lessons learned from analysis result in a change in organisational culture and practice To be an active learning organisation requires the Trust to embed lessons learned in its culture and practice, rather than identifying lessons but not putting them into practice. This will require more than following up the implementation of action plans, but also the ongoing monitoring of trends, themes and causal factors and the use of methods Page 20 of 55

such as clinical audit to check that improvements have been sustained over time. There may be occasions when nothing could have prevented an incident and no root causes are identified. However, there are always lessons to learn and key safer practice issues may be identified which did not materially contribute to the incident. Organisational learning will be monitored through the ongoing processes for the analysis of incidents and for following up relevant action plans. The Trust Lead Specialists will monitor the timeliness, quantity, quality and effectiveness of investigations, as well as learning and improvement and the embedding of actions within the Trust. This will be achieved through the normal course of their day to day work and through the Trust Committees/Groups with responsibilities in relation to this policy. 5.3.2 Opportunities for sharing lessons learnt from incidents across the local health community Opportunities for sharing lessons learnt across the local health community will be afforded by: Discussions with, and reports provided for, Commissioners on a quarterly and annual basis Participation in multiagency investigations and reviews e.g. safeguarding. Participation in multiagency events with an emphasis on learning and improving. The Trust s Annual Report/Quality Account Joint investigations which provide wider opportunities for sharing lessons across for example, a whole pathway of care. 5.3.3 Process for implementing risk reduction measures The use of RCA should result in preventative measures to ensure that similar incidents do not happen again and that the risk is removed or reduced. Risk reduction measures will be implemented in line with Trust Business Division/Directorate and corporate risk registers using the risk grading matrix (see Appendix 1) and managers authority to treat risk. The sustainability of risk reduction measures will be measured over time as described above in order to illustrate that they have not led to the transfer of risk, or that they are becoming unsustainable. 6. TRAINING IMPLICATIONS The Training Needs Analysis (TNA) for this policy can be found in the Training Needs Analysis document which is part of the Trust s Mandatory Risk Management Training Policy located under policy section of the Trust website. Page 21 of 55

7. MONITORING ARRANGEMENTS Area for Monitoring How Who by Reported to Frequency Investigations: Duties Different levels of investigation appropriate to the severity of the event Report Lead Specialists/ Head of Patient Safety and Experience Organisational Learning Forum Monthly How the trust shares safety lessons with internal and external stakeholders How action plans are followed up Triangulated Report Risk Management Sub Group Commissioners Quarterly How the Trust trains staff in line with the training needs analysis Report Head of Learning and development Human Resources and Organisational Development Group Quarterly Analysis and improvement: a)duties b) How incidents, complaints and claims are analysed c) How this information is combined to provide a risk profile for the Trust Triangulated report Quality Improvement Report Lead Specialists/ Head of Patient Safety and Experience Organisational Learning Forum Risk Management Sub Group Commissioners Quarterly d) A report template which includes qualitative and quantitative analysis Clinical Governance Group e) How this information will be shared with relevant individuals or groups Page 22 of 55

f) How action plans are followed up g) timescales for minimum requirements b) to f) Report Lead Specialists/ Head of Patient Safety and Experience Organisational Learning Forum Monthly 8. EQUALITY IMPACT ASSESSMENT SCREENING The completed Equality Impact Assessment for this Policy has been published on the Equality and Diversity webpage of the RDaSH website click here 8.1 Privacy, Dignity and Respect The NHS Constitution states that all patients should feel that their privacy and dignity are respected while they are in hospital. High Quality Care for All (2008), Lord Darzi s review of the NHS, identifies the need to organise care around the individual, not just clinically but in terms of dignity and respect. As a consequence the Trust is required to articulate its intent to deliver care with privacy and dignity that treats all service users with respect. Therefore, all procedural documents will be considered, if relevant, to reflect the requirement to treat everyone with privacy, dignity and respect, (when appropriate this should also include how same sex accommodation is provided). 8.2 Mental Capacity Act Indicate how this will be met There is no requirement for additional consideration to be given with regard to privacy, dignity or respect. Central to any aspect of care delivered to adults and young people aged 16 years or over will be the consideration of the individuals capacity to participate in the decision making process. Consequently, no intervention should be carried out without either the individuals informed consent, or the powers included in a legal framework, or by order of the Court Therefore, the Trust is required to make sure that all staff working with individuals who use our service are familiar with the provisions within the Mental Capacity Act. For this reason all procedural documents will be considered, if relevant to reflect the provisions of the Mental Capacity Act 2005 to ensure that the interests of an individual whose capacity is in question can continue to make as many decisions for themselves as possible. Indicate How This Will Be Achieved. All individuals involved in the implementation of this policy should do so in accordance with the Guiding Principles of the Mental Capacity Act 2005. (Section 1) Page 23 of 55

9. LINKS TO ANY ASSOCIATED DOCUMENTS Risk Management Strategy Incident Reporting Policy Policy for the Management of Serious Incidents (SIs) Policy and Procedure Relating to the Handling of Formal Complaints Claims Handling Policy for the Management of Clinical Negligence Claims, Employer/Public Liability Claims and Property Expense Scheme Claims Being Open: Communicating Openly and Honestly with Service Users and their Carers following a Patient Safety Incident or Related Complaint or Claim Mandatory Risk Management Training Policy and Training Needs Analysis Policy on Supporting Staff involved in a Traumatic/Stressful Incident, Complaint or Claim Clinical Audit Policy Implementing Best Practice from National Confidential Enquiries/Inquiries 10. REFERENCES NHS Litigation Authority Risk Management Standards NHS Litigation Authority (2011) An Organisation-wide Document for the Investigation of Incidents, Complaints and Claims Department of Health: National Quality Board (2010) Review of early warning systems in the NHS National Framework for Reporting and Learning from Serious Incidents Requiring Investigation (2009) National Patient Safety Agency (2005). Building a Memory: Preventing Harm, Reducing Risks and Protecting Patient Safety. London: National Patient Safety Agency. National Patient Safety Agency (2004). Seven Steps to Patient Safety. London: National Patient Safety Agency. National Patient Safety Agency - Root Cause Analysis Investigation Tools. Guide to investigation report writing following Root Cause Analysis of patient safety incidents. London: National Patient Safety Agency. Available at: http://www.npsa.nhs.uk/nrls/ 11. APPENDICES Page 24 of 55

Appendix 1 NPSA Risk Matrix Table 1 Consequence scores Choose the most appropriate domain for the identified risk from the left hand side of the table Then work along the columns in same row to assess the severity of the risk on the scale of 1 to 5 to determine the consequence score, which is the number given at the top of the column. Consequence score (severity levels) and examples of descriptors 1 2 3 4 5 Domains Negligible Minor Moderate Major Catastrophic Impact on the safety of patients, staff or public (physical/psychological harm) Minimal injury requiring no/minimal intervention or treatment. No time off work Minor injury or illness, requiring minor intervention Requiring time off work for >3 days Increase in length of hospital stay by 1-3 days Moderate injury requiring professional intervention Requiring time off work for 4-14 days Increase in length of hospital stay by 4-15 days RIDDOR/agency reportable incident An event which impacts on a small number of patients Major injury leading to long-term incapacity/disability Requiring time off work for >14 days Increase in length of hospital stay by >15 days Mismanagement of patient care with long-term effects Incident leading to death Multiple permanent injuries or irreversible health effects An event which impacts on a large number of patients Quality/complaints/audit Peripheral element of treatment or service suboptimal Informal complaint/inquiry Overall treatment or service suboptimal Formal complaint (stage 1) Local resolution Single failure to meet internal standards Minor implications for patient safety if unresolved Reduced performance rating if unresolved Treatment or service has significantly reduced effectiveness Formal complaint (stage 2) complaint Local resolution (with potential to go to independent review) Repeated failure to meet internal standards Major patient safety implications if findings are not acted on Non-compliance with national standards with significant risk to patients if unresolved Multiple complaints/ independent review Low performance rating Critical report Totally unacceptable level or quality of treatment/service Gross failure of patient safety if findings not acted on Inquest/ombudsman inquiry Gross failure to meet national standards Page 25 of 55