Investigation of Serious Incidents, Incidents, Complaints and Claims Policy

Transcription

1 Investigation of Serious Incidents, Incidents, Complaints and Claims Policy Document Reference No. Replacing document Target audience KMPT.CorG KMPT.CorG Trust wide Author Trust Risk Manager Group responsible for development Health, Safety and Risk Committee of this policy Status Approved Version No 4.0 Authorised/Ratified By Health Safety & Risk Committee Authorised/Ratified On January 2017 Date of Implementation January 2017 Review Date December 2019 Distribution date January 2017 Number of Pages 28 Contact Point for Queries Copyright Kent and Medway NHS and Social Care Partnership Trust 2017

2 DOCUMENT TRACKING SHEET Investigation of Serious Incidents, Incidents, Complaints and Claims Policy Version Status Date Issued to/approved by V0.1 Draft 11 th October 2007 Risk Management Group Comments V1.0 Approved 11 th October 2007 Risk Management Group V2.0 Approved October 2009 Health & Safety and Risk Committee V3.0 Approved October 2011 Health & Safety and Risk Committee V3.1 Draft March 2016 Patient Safety Group Absorbed into Management of SI policy but felt to be too large, so separated out again V4.0 Approved January 2017 Trust Wide Health Safety and Risk Group Updated flow charts on p10 and 11. Ratified REFERENCES The Data Protection Act 1998 Freedom of Information Act 2000 Incident decision tree. Online tool. National Framework for Reporting and Learning from Serious Incidents Requiring Investigation. (2009) National Reporting and Learning Service (NRLS) Data Quality Standards: Guidance for Organisations Reporting to the Reporting and Learning System (RLS). (2009) Never Events: Framework Update for 2010/11: Process and action for Primary Care Trusts. (2010) Seven Steps to Patient Safety in Primary Care Trusts. (2006) Medical Error: What to do if things go wrong: A guide for junior doctors. (2010) Patient Safety Alert: Update. WHO Surgical Safety Checklist. (2009) Being open: Saying sorry when things go wrong. (2009) Patient Safety Alert. Being Open: Communicating with patients, their families and carers following a patient safety incident. (2009) Root Cause Analysis (RCA) report-writing tools and templates. NPSA list of resources Department of Health. (2004). Memorandum of understanding: Investigating patient safety incidents involving unexpected death or serious untoward harm: A protocol for liaison and effective communications between the National Health Service, Association of Chief Police Officers and Health and Safety Executive. London: Department of Health. Available at: and Healthcare Commission (HCC). (2008). Learning from investigations. London: Commission for Healthcare Audit and Inspection. Available at: Healthcare Commission (HCC). (2009). Safe in the knowledge: How do NHS trust boards ensure safe care for their patients. London: Commission for Healthcare Audit and Inspection. Available at: House of Commons. (2009). House of Commons Health Committee: Patient Safety: Sixth Report of Session , Volume I. London: The Stationery Office Limited. Available at: National Patient Safety Agency (NPSA) and NHS Confederation. (2009). Questions are the answer! Seven questions every board member should ask about patient safety. London: NPSA and NHS Confederation. Available at:

3 NPSA and NHS Confederation. (2008). Briefing 161: Act on reporting. London: NPSA and NHS Confederation. Available at: Patient Safety First. (2009). The How to Guide for Implementing Human Factors in Healthcare. London: Patient Safety First. Available at: RELATED POLICIES/PROCEDURES/PROTOCOLS/FORMS/LEAFLETS Reference Complaints Handling Policy and Procedure KMPT.CorG.019 Whistleblowing Policy KMPT.HR.002 Claims Management Policy and Process KMPT.CorG.014 Management of Incidents Policy, including Management of Serious Incidents KMPT.CorG.017 Health and Safety Policy KMPT.CorG.005 Being Open Policy KMPT.CorG.018 Risk Management Strategy KMPT.CorG.012 Disciplinary Procedure KMPT.HR.007 Learning from Experience Policy KMPT.CorG.011 SUMMARY OF CHANGES Appendix D Classification of incidents and accidents added Updated flow charts on p10 and 11 Updated committee titles and responsibilities

4 CONTENTS 1 INTRODUCTION PURPOSE DEFINITIONS DUTIES KEY ISSUES INVESTIGATION AND ROOT CAUSE ANALYSIS ROOT CAUSE ANALYSIS MAPPING EVENTS PROCEDURE FOR THE MANAGEMENT AND FOLLOW UP OF SI, RCA AND INQUIRY ACTION PLANS COMPLETING A REPORT LEARNING FROM EXPERIENCE LINKS WITH OTHER PROCEDURES TRAINING TRAINING NEEDS ANALYSIS CONSULTATION EQUALITY IMPACT ASSESSMENT HUMAN RIGHTS MONITORING COMPLIANCE WITH AND EFFECTIVENESS OF THIS DOCUMENT EXCEPTIONS... ERROR! BOOKMARK NOT DEFINED. APPENDIX A EQUALITY ASSESSMENT APPENDIX B ABBREVIATIONS APPENDIX C MANAGEMENT OF ACTION PLANS APPENDIX D CLASSIFICATION OF INCIDENTS/ACCIDENTS

5 1 INTRODUCTION 1.1 Various events may, from time to time give rise to the need for KMPT to conduct a Root Cause Analysis (RCA) investigation. Such events will include things such as serious untoward incidents, complaints against KMPT, claims etc. Where an investigation is required it s essential this is carried out in a manner which is fair, open and impartial and staff involved feel fully supported. Whilst in some exceptional circumstances an investigation may lead to further action the purpose of this investigation is not to gather evidence against those involved. Rather, it is to ascertain what has occurred, to see whether any lessons may be learned, identify strengths and weaknesses and to assist in deciding what, if any further steps are necessary. 1.2 All KMPT staff, agency workers and volunteers are expected to fully participate in any management investigation carried out by KMPT or other agencies such as the Police or social services. 2 PURPOSE 2.1 The purpose of this procedure is to establish a clear framework for conducting investigations and to ensure such investigations are undertaken in a manner consistent both with the rights of those who may be involved and the need to establish the facts accurately and expeditiously. We are an organisation who wants to learn from incidents, complaints and claims and develop safer systems and processes. This is an opportunity for staff to review their peers practice and to evaluate and recommend best practice, so KMPT constantly improves, manages and reduces risk of harm to staff, patients and visitors to our sites. 3 DEFINITIONS Patient Safety Incident Root Cause Analysis Human Error Harm Causal Factors External Agency Adverse Event Serious Adverse Event Clusters Chronology of Events Retrospective record Barrier, defences and controls Any unintended or unexpected incident which could have or did lead to harm for one or more patients receiving NHS funded care. A structured investigation that aims to identify the true cause of a problem, and the actions necessary to reduce or eliminate it Human error occurs when the actions and decisions of individuals result in failures that can immediately or directly impact patient safety Harm is defined as injury, suffering, disability or death. A Causal factor is something which can lead directly to an incident. Removal of these factors will either prevent, or reduce the chances of a similar type of incident from happening in similar circumstances in the future. eg Health Care Commission, National Patients Safety Agency An Incident A Serious Untoward Incident A number of SI s, incidents, complaints and claims that are low risk but are an accumulation in numbers Time lining the process by which information is placed in date and time order An account written at a later date and time. A control measure that is designed to prevent harm to vulnerable or valuable persons, organisations or objects. These measures may be physical, human action, administrative or natural. 1

6 4 DUTIES 4.1 KMPT Board The KMPT Board is responsible for ensuring systems and processes are in place to undertake suitable and sufficient investigations so learning and implementation can be demonstrated. They will receive assurance from the Governance & Risk Committee through Summary and Exception reporting. The KMPT Board will receive monthly SI Reports. They will demonstrate leadership in underpinning a learning culture by supporting staff in taking forward the Being Open Policy, and by ensuring KMPT continues to demonstrate improvements in service delivery and safety. It is KMPT Board s responsibility to ensure staff feel safe to report issues and the information they share will be treated with respect and acted upon appropriately for the improvement of the safety and quality of health services 4.2 The Quality Committee The Quality Committee, on behalf of the KMPT Board, will review the Incident reports and will ensure the investigation procedure is suitable and sufficient to identify the learning. They will ensure lessons learnt have been shared across the organisation and implemented. They will receive assurance that underpins that the change has been systematic and embedded throughout KMPT where it is appropriate to the learning. They will provide leadership and support to Service Line Directors in undertaking their programme in continuous learning, review, implementing and sustaining change and then evaluating the outcomes. 4.3 The Trust Wide Patient Safety and Mortality Review Group The Trust Wide Patient Safety and Mortality Review Group Chaired by the Medical Director is responsible for reviewing all RCA Reports and for ensuring evidence is available to demonstrate the learning and to monitor and support local groups with the implementation of the action plans. They will ensure learning is disseminated across KMPT and actively support the continuous publication of best practice and examples of learning from Serious Incidents in the learning from experience group to ensure all staff have access to information and to ensure there is a continuous re-evaluation of risk reduction measures undertaken in a systematic and sustained process. 4.4 Trust Wide Health Safety and Risk Group (TWHSRG) The TWHSRG will routinely monitor the number and types of incidents arising from health and safety issues, in particular those that are reportable under the RIDDOR regulations. The TWHSRG may also review the numbers of clinical and non-clinical incidents to establish themes and trends and assist with obtaining assurances for the management of risk. 4.5 Service Line Governance/Risk Management Groups These Service Line Groups will retain responsibility for implementing local action plans and ensuring there is a system of evaluation. They will provide evidence on service changes and improvements and evidence of the implementation of best practice. They will review and monitor their Serious, Incidents and will organise any additional investigations. 2

7 Service Line Groups will utilise the information gained from the analysis of reports and ensure risk management and risk reduction strategies are put into place and share this information and evidence as part of their quarterly report or as an adhoc report should the situation arise where information needs to be disseminated urgently. 4.6 Chief Executive The Chief Executive has overall responsibility for ensuring investigations are appropriate and effective and learning is identified and disseminated across the organisation. The Chief Executive is committed to KMPT demonstrating sustainable effective change based on learning from all incidents. 4.7 Medical Director (Designated Board Member) Lead for Patient Safety Takes responsibility for ensuring all incidents are managed and investigated appropriately according to KMPT Policy and meet all external requirements. The Medical Director takes responsibility for sharing learning, Ensures that the Chief Executive and Trust Board are appraised of incidents that are Level 5 (Red) and reportable to the Clinical Commissioning Groups and other external Stakeholders. Ensures learning is demonstrable and evidenced and good practice is shared across the organisation. Takes responsibility for alerting the Chief Executive and initiating the Memorandum of Understanding protocol 4.8 Lead Investigating Manager/Team They will have received training in RCA investigating either through specific training or through experience Investigations will be determined by the SI Alert form and the SI Immediate Management Investigation Report and the decision will rest with the SI Core Team. The Investigation Policy can be applied to all types of investigations a) reviewing incidents, accidents b) a significant near miss c) clusters of incidents, accidents. 4.9 Role of Clinicians/Specialist Advisors 4.10 All Staff There will be access to staff that are able to provide consultation and support to the process. This will be determined at the onset of the investigation process, setting the parameters. Specific support will be allocated to each team. Where there is insufficient expertise within the organisation KMPT will consider identifying an external Consultant experienced in RCA who will support the Team All staff have a responsibility to highlight any risk issues that would warrant further review or investigation. 3

8 KMPT will expect them to contribute fully to the investigation process openly and honestly. KMPT expects staff to seek to know where risks are occurring so that actions can be taken to reduce or manage the risk (please refer to the Risk Management Policy). 5 KEY ISSUES 5.1 In most cases an incident does not result from one single event, but is more likely to have involved cumulative triggers which in isolation may have no effect, but when they occur in an event chain can be serious or even catastrophic. 5.2 When investigating an incident, complaint or claim, it is important to concentrate on the facts, with a retrospective review of events to establish the underlying causes. Analysis will then identify areas for change, looking at long-term solutions, improving standards and improving patient safety and to minimise reoccurrence in the future or to reduce the level of harm 5.3 The key features of a good investigation are a) Clear terms of reference/parameters b) A thorough identification and analysis of events c) A clear and concise report d) Clear rationales for decisions/actions taken e) A robust audit trail of actions taken. 5.4 Elements of the RCA investigation process can be applied to any situation or circumstance that is being investigated. 5.5 Why are investigations necessary? Incidents occur across KMPT and it s our responsibility to ensure we can learn from these, avoid repeating the same mistakes and introduce safer ways of working, better services to patients and ensure high standards of care are delivered across the organisation. Also where HM Coroner issues a report under Preventing Future Death Reports there is a duty to ensure the matters raised in the report are investigated and a full response is sent to the Coroner as soon as possible. These investigations will be carried out under this policy. In order to do this we need to be able to investigate the underlying root cause. This enables investigations to be undertaken that do not look to blame but instead looks for the underlying root cause as to why complaints, claims and incidents occur and ensures we are always learning and developing better, safer services. 5.6 Why are learning and sharing safety lessons important? KMPT is committed to learning from all incidents so we can deliver safe, effective services to our patients. We can avoid repeating the same mistakes, we can learn and we can continuously improve and change sustaining improvements, 4

9 with all members of KMPT staff committed to learning retrospectively and developing improving standards of practice and improvements in safety. We will achieve this by creating an environment of open and honest review of incidents. This will enable staff and KMPT to review practice and service delivery, learning lessons and enabling the development of safer systems of working, ensuring and supporting improving standards of care. a) Develop safer practice b) Ensure implementation of improving standards. c) Staff have the skills to undertake the task d) Maintaining high standards of care and being clear about the expectations of the Trust are on staff and best practice e) Reducing the impact and severity of incidents occurring f) Increasing the number of incidents reported g) Promoting a safer working environment for staff, patients and visitors to our sites h) Sharing learning across KMPT i) Bringing in lessons learnt from the NHS through External Inquiries, External Reporting Systems in the United Kingdom j) Supporting design innovation to reduce the likelihood of incidents occurring So we become an organisation that improves and reduces the impact of incidents, complaints and claims because our staff are risk and safety aware and continuously listen, review, learn and change practice and then audit the results. 5.7 The Process for effective Internal and External Communication KMPT fully supports the expectation that staff fully participate in the investigation process as our opportunity to learn and develop improving standards and improving safety. Effective communication is necessary to ensure all those who have been involved in the incident, complaint or claim fully understands the time scale their involvement and what they can expect when being interviewed any other role they are being asked to contribute such as a review of the process, a consultation group, or as lead clinicians to comment on an aspect of practice. Staff, patients or any other group may be approached by the Investigating team to take part in the investigating process and their roles will be clearly stated. Communication back to those involved will be made explicit so all are aware when they can expect feed back and the final report. The Service Line Director will identify a Lead Investigator who will ensure all communication is undertaken, recorded and completed. This will include a) To let staff, patients carers/family know immediately if this is likely to attract publicity and the media 5

10 b) Communicating with and coordinating the investigating team c) Contacting, communicating and meeting with patients, families/carers d) Ensuring staff are communicated with prior to any interview. Support is given to staff who may be asked to contribute to the learning process e) Preparing and providing written reports as required but to include a final written report to the service line and the Trust Wide Patient Safety and Mortality Group f) That the investigation is completed within the timescale g) Ensuring feedback at the completion of the final report h) That the Draft final report is shared with staff to comment on factual accuracy i) That the final report is presented by the Lead Investigator or nominated other to the Trust Wide Patient Safety and Mortality Group j) The Trust Wide Patient Safety and Mortality Group will then agree on the release of the report and oversee the reporting schedule. The Lead Investigator will ensure the report is shared with the a) Patient/Families or Carers b) Staff c) The Service Line in which the Serious Incident occurred will take responsibility for writing and monitoring the local implementation of the Action plans. d) Trust Wide Patient Safety and Mortality Group will ensure that the Action plans (where relevant) are shared with the rest of services within the Trust e) Trust Wide Patient Safety and Mortality Group will then oversee the progress on action plans through reports from each Service line. Summaries of learning to share safety lessons and best practice will continue to be publicised in Trust Wide and local learning bulletin If it is necessary for more immediate communication learning will be shared and publicised through the Team Brief process. If the need to communicate to all staff is urgent this will be done through the Communications Team and Administrator e mail out to all staff. This will also be subject to the Trust Being Open Policy. The Trust Wide Patient Safety and Mortality Group will identify when there is a need to involve external agencies following an adverse event or near miss. This will be based on NHS England s Serious Incident Framework a) All homicides b) All inpatient suicides c) Media involvement d) SI s that cross into other provider services e) Death or serious injury through negligence f) Death or serious injury of a member of staff g) Equipment has significant failure causing serious injury or death h) Serious Criminal act 6

11 i) Death in suspicious circumstances (unexplained/unexpected) j) Involvement of other agencies requiring other expertises And will be reported, where necessary and appropriate, to k) Clinical Commissioning Groups l) NHS England m) Health & Safety Executive n) Local Authority Social Services o) Acute Hospitals Trust p) Quality Commission q) Medical Devices Agency r) Medicines Regulatory Authority s) Healthcare Products Regulatory Agency (MHRA) t) Police u) Environmental Health Agency (EHA) v) Counter fraud and Security Management Service 5.8 External reporting of incidents NHS England Clinical Commissioners Groups Local Authorities Coroner Incident Type Suicide of any person on NHS premises or under the care of a specialist team in the community Homicide committed by a patient with mental health problems Serious injury or unexpected death involving a member of staff, visitor, contractor or another person to whom the organisation owes a duty of care Serious damage to NHS property, particularly resulting in injury or disruption of services e.g. through fire, flood or criminal activity. Incidents associated with infection that produce, or have the potential to produce, unwanted effects involving the safety of patients, staff or others Any other Serious Untoward Incidents that may be identified as a cluster of events that lead to something more significant including those that may attract media attention Death from industrial diseases Cot death and postnatal deaths Where death may be linked to an accident (whenever it occurred) Timescale Immediately within working hours or within the first hour of the next working day. STEIS system entered by the SI Administrator within 72 hours Immediate Contact 7

12 National Reporting & Learning System by the Health & Safety Team. Incident Type Death after operation or before full recovery from anaesthetic Cause of death unknown or within 24 hours of admission Any violent, suspicious or unnatural death Drug related deaths Death of anyone currently or recently detained in Police/Prison Custody All patient safety incidents Timescale As soon as possible National Reporting & Learning System by the Health & Safety Team. Health & Safety Executive(HSE) National Health Service Litigation Authority (NHSLA) Professional Regulatory bodies Medicines and Healthcare Products Regulatory Agency (MHRA) Serious Hazards of Transfusion (SHOT) Safeguarding Vulnerable Children Safeguarding Vulnerable Adults Death, major injury or dangerous occurrence. Over seven day injuries Specified injuries (such as fractures, scalping s and some burns) Incidents where the Trust becomes aware that litigation will result Incidents where there appears to have been a breech of the professional code of conduct Incidents involving injury or risk of serious injury involving healthcare products and equipment Any incident involving transfusion of blood products Any incident involving serious harm to a child Any serious incident involving a vulnerable adult Immediate by telephone to the Health & Safety Executive see your Health & Safety files or Health & Safety home page (Trust Intranet) Seven days using a RIDDOR form (see Health & Safety file or go to link on the Health & Safety home page Trust Intranet) Immediate through the Legal Services Team As soon as the breech becomes apparent Through the Human Resources Team Within 24 hours As soon as it is identified Immediate Immediate 8

13 Care Quality Commissioner Environmental Health/Food Standards Agency/Health Protection Agency Incident Type Any serious incident Incident involving contaminated food products resulting in illness Timescale Reported by the Medical Director/Director of Corporate Services Immediate Contact the Director of Infection, Prevention and Control or Clinical Lead Nurse NHS Protect Local Community All physical assaults against NHS staff and professionals Any incident that is likely to impact on the local community Immediate See contact details on the Risk Management page on the Staff web page intranet As soon as possible 5.9 Support for patients/carers/relatives and staff Identified Lead Investigator will ascertain from the patient/family/carer a) To contact them immediately if the incident, complaint or claim is likely to attract publicity and the media. b) Involvement in the RCA Investigation and any immediate learning identified through the Immediate Management investigation c) Methods of communication with them d) Timescales for reporting e) How to contact the investigating team f) Any other support the patient/family/carer would find beneficial g) Receipt of the final Report Summary and Action plans 6 INVESTIGATION AND ROOT CAUSE ANALYSIS 6.1 Identifying which incidents, complaints or claims need to be investigated. 6.2 Elements of the RCAt framework/toolkit can be applied to any investigation. All incidents complaints and claims will be subject to investigation and the level of the investigation will be determined by the level of the incident, complaint or claim. See flow charts for levels 1-3 and levels 4-5 below. 6.3 Investigation of incidents at different levels would be undertaken by the appropriate staff. See classification of incidents/accidents (Appendix D). 9

14 Level 1: Incidents involving Clients, Staff or property which result in no injury, damage or loss but with the potential to cause injury loss or damage eg verbal aggression without intent to harm, accidents with no injury, minimal damage or loss to property. Level 2: Incidents involving clients, staff or property which result in minor injury, damage or loss, but no serious consequences eg self-harm or assault causing minor injury, or financial loss or cost to the Trust of up to 500. Level 3: Incidents involving clients, staff or property which result in moderately serious injury, damage or loss requiring formal investigation by a senior manager eg needlestick injury, allegation of sexual assault, attacks needing medical attention in the ward or department, or financial cost to the Trust of ,000. Incident or near miss occurs, complete relevant paper work and follow reporting process IMMEDIATELY OR AS SOON AS PRACTICAL Inform person in charge Review client s care plan & assess persons medical care needs. If staff member involved, refer to Incident Policy & action as required BEFORE OF SHIFT END Person in charge Ensures the Datix alert Dif 1 form is completed with relevant risk rating of severity Completes the investigation Signs & sends form to service manager Ensures a full written account of the incident is documented in the relevant records With client permission Informs clients & relatives If appropriate inform RC/ Lead Clinician as soon as is practically possible If member of staff involved in incident is injured send copy to Occupational Health within 72 hours. Each staff member should retain a copy. WITHIN 2 WORKING DAYS Reviews the incident, investigation and re-assesses risk rating in light of the learning from the investigation. Completes the manager report on Datix Next Health & Safety Meeting Ensures implementation of any service or environmental changes. Reviews all incidents, identify themes and trends and share learning at the Health & Safety meetings or if urgent share learning with Service Director who will share it across other service lines Service Manager Ensures appropriate action has been taken to manage risk If staff incident, follow reporting process Ensure immediate health & safety concerns are addressed Review Risk Assessments & Risk Register & ensure they are updated as appropriate 10

15 Serious Incident Reporting (Level 4 & 5). IMMEDIATELY inform manager/ shift lead/service manager/on call manager BEFORE END OF DAY Qualified staff member completes SI ALERT FORM (online Datix) Inform the service user / relatives Tell them an investigation will be taking place & investigator will contact them confirm in writing (As per Duty of Candour) Review risk assessment/care plan/observation levels/leave etc Consider adult/child protection alert and/or police involvement Urgent learning shared WITHIN 72 HOURS Manager (with support from Quality Team) completes SI MANAGERS REPORT (on line Datix) & DRAFTS ACTION PLAN Where disturbed/violent behaviour Clinical team carry out a Clinical Review meeting using NICE format (within 72 hours) Assesses medical needs of people involved Takes URGENT action as relevant * Where staff member injured or traumatized, manager considers referral to Occupational Health * Informs Ministry of Justice (Forensic services) * SI Dept communicates with other external agencies/media (e.g. CQC) * Considers RIDDOR * Where patient/staff is potentially traumatized, Clinical Team OFFER initial support. Manager/psychology to monitor wellbeing of staff/service user and offer access to further support / counselling if signs of trauma still evident in long term WITHIN 10 WORKING DAYS: Clinical Team carry out a Clinical Review to highlight: To share and reflect upon current practice (actions before, during and after the incident) To highlight ways of improving practice (learning) To support staff & service users and encourage the therapeutic relationship between staff, service users & their carers To ensure best practice is followed To provide an opportunity to highlight issues with trust systems & trust/local policies, procedures and protocols. WITHIN 45 WORKING DAYS Quality Team co-ordinate a LEARNING REVIEW INVESTIGATION to highlight root cause / contributory factors / learning / recommendations. Where appropriate, this includes a Learning Review meeting with the Clinical Team Investigators add learning points to the SI action plan for local ownership/implementation Learning Review approval at * Local Governance meeting * Service Line Governance meeting * Trust Patient Safety meeting When action plan completed SI closed by Service Line Governance meeting/chair. Serious incidents Serious incidents involving clients, staff or property which result in grievous or substantial damage or loss, requiring further investigation overseen by a director e.g. attempted suicide or homicide with serious injuries, sudden unexpected death to natural causes, absconds of violent or suicidal clients, incidents involving property which result in financial loss or cost to the Trust of 10,000 to 40,000. Incidents involving clients, staff or property which result in death or severe service disruption e.g. suicide or homicide or rape, or incidents involving property which result in financial loss or cost to the Trust 11

16 A full RCA investigation may be held in any situation where there is a need to formally establish the facts surrounding any particular incident or occurrence. This may be following a Serious Incident, or a cluster of Serious Incidents. Levels of Investigation All Serious Incidents will be subject to an Immediate 72 hour Management Investigation and a further RCA investigation. Such incident would include the following: a) Where an Inpatient death has occurred b) Homicide c) Suspected Suicide d) Specialist Teams where suspected suicide has occurred i ii iii iv Crisis Assessment & Treatment Teams Early Intervention in Psychosis Community Mental Health Teams Forensic e) Incidents of violence and injury to staff requiring hospital A&E care f) Incidents where serious property damage has occurred and business continuity plans have been invoked g) Any other incident that is likely to be highly publicised h) Service Line Directors or other members of staff have raised serious concerns i) Where there is an opportunity to gather facts and identify learning that will help to reduce or manage risk and develop safer services j) Clusters of incidents that may not be risk rated at red or amber k) This list however is not exhaustive and an investigation may be required in other situations where is deemed necessary to make a formal inquiry into the circumstances and to record the findings thereof. 6.3 Investigation Process Appointment of an Investigating lead/team a) It is considered good practice for the RCA investigation to be undertaken by more than one person to enable greater objectivity. b) The Investigating lead or team may be drawn from local manager/senior manager responsible for the service or a local manager/ senior manager from another part of KMPT and supported by other clinical and non clinical staff. The appointment of the Investigating lead will be made by the Service Line Director and they will have received some training in incident investigation and RCA. c) Where it is felt necessary the Investigating lead should be a Director, the appointment will be made by the Executive Medical Director and Chief Executive and will be approved at the earliest opportunity by the Executive Management Team. In such cases the Director concerned will be from a different service to that under investigation. 12

17 d) Where the SI is a homicide, inpatient suicide or likely to attract a lot of public interest, it may be necessary to appoint an external Investigator to support the internal investigating team. This will be approved by the Executive Medical Director and the Chief Executive e) The team will receive the full support and authorisation of the KMPT Board. 6.4 Identification of people to be interviewed Information must be collected from all available sources, both in terms of the specific event factors and those underlying factors. During this scoping exercise, consideration will be given to those staff, visitors, patients that the team wish to interview, this will vary on a case by case basis. People involved or witnessed the event The Place or Environment in which the event or events take place The Equipment involved The paper work related to the event The widely held beliefs about the normal working processes, team relationships, and adequacy of leadership in the work place i.e. the normal paradigm of work. Possible Identification of staff to be interviewed Those staff, patients, visitors or anyone else who was involved in the Serious Incident, complaint or claim Anyone who witnessed the event but was not directly involved The wider teams Other staff, patients, visitors who use the space Medical Devices Manager Medical devices Hoists Moving and Handling Trainer Resuscitation Officer Records Manager. Information Rights Manager Caldicott Guardian Consultation group Experts Director of Nursing Executive Medical Director Clinical Leads Senior Practitioners Trust Managers/Associate Directors Another similar team External Experts/other Trusts (This list is not exhaustive) 13

18 All Staff/Patients/Families/Carers or Visitors will be asked to write a full record including events leading up to and post event as soon as possible. For assistance with writing statements please contact the Trust Legal Services Department, Human Resources Managers or Trade Union Officer. It is recognised that the Trust may have to involve other organisations in the investigation or that other organisations may take the lead on the investigation process such as a Police investigation. However since the introduction of the Memorandum of Understanding this enables Trusts, Police, NHS organisations and the Health & Safety Executive to meet post incidence and identify roles, processes and information sharing. 6.5 Conducting the Interviews At all stages sensitivity and tact will be practiced with appropriate support available for anyone providing information into the Investigation process All those identified for interview will be informed by letter, including the purpose of the investigation. a) To find out what happened? b) To identify areas of good practice c) Areas where systems failed d) Implement safety improvements All staff involved must have access to confidential support and counselling for support during a potentially stressful period and that they can bring a staff side representative or workplace colleague with them at any interview Patients/families/carers may wish to have a friend or relative with them or wish to bring an Advocate or support from PALS. Patients/families/carers and visitors to sites will be offered further support and given access to counselling. All Investigations are conducted in a manner a) Demonstrably supportive b) Blame free atmosphere c) Listening, learning and improving. d) Information on progress Any findings of the investigation and response to third parties must be shared with those whose actions are being investigated. Where the investigation arises from a clinical issue the findings and response must be shared with the clinician to ensure factual accuracy. Those involved must also be informed of support services that are available to them. 6.6 Support for the Investigating lead The team members will also be available to anyone undertaking an investigation who requires support or the opportunity to discuss process and progress or who just wants the opportunity to reflect on the investigation so far. 14

19 6.7 Timescales for feedback to interested parties Time scales: It is important investigations are carried out expeditiously as delay can lead to a reduction in reliability of the memories of those concerned, anxiety on the part of those being investigated and dissatisfaction for those who have raised the matter for investigation. Timescales for completion of the investigation will be agreed at the beginning of the process. Feedback will be the responsibility of the Lead Investigator 6.8 Involvement of any external agencies Other agencies or organisations are or may become involved depending on the nature of the SI, incident, complaint and/or claim. a) Police Force, b) Coroners Officer, c) Local Authority, d) Clinical Commissioning Groups, e) Primary Care Trusts. f) National Health Service Litigation Authority g) Health & Safety Executive h) NHS England i) Care Quality Commission j) Audit Commission k) Social Services 6.9 Development of Action Plans including timescales Once the investigation has been completed it becomes the responsibility of the Service Manager in the main location to complete an action plan. The Service Line Director has overall responsibility to ensure the action plan is workable, realistic and cost effective and reduces risk. This is then shared following KMPT processes. 7 ROOT CAUSE ANALYSIS 7.1 The Process of Investigation 7.2 Information This may be subject to a Police Investigation, or involved the Health & Safety Executive, Healthcare Commission, NHS England, the Medical Devices Agency, the Clinical Commission Group, Local Authority, or Acute Hospitals Trust. This list is not exhaustive and there may be occasions when investigations are undertaken with the private sector provider. Remember the impact this may have on staff and ensure there is support in place and access to Staff support services and counselling services or through individual supervision Lead up to the incident as well as the incident it self Witness statements 15

20 Information from the family/carers Records and Notes taken during the event Case notes/patient records Incident forms Any other paper work available Equipment involved Policies and procedures Widely held beliefs about the normal working processes, the team relationships and adequacy of leadership in the work place 7.3 Paper or Electronic Evidence - Evidence will be available through both paper and electronic copy however wherever possible information and evidence will be collected electronically and action plans stored on the central data base. Incident reports Policy & Procedures Audits 7.4 Interviews 7.5 Statements 7.6 Paradigms Risk Assessments Letters of concern written previously Maintenance records Training records Service Level Agreements Interagency agreements Shifts, rotas, working arrangements All witnesses, including the person who was central to the event should be interviewed if at all possible and other staff will also be expected to support the investigation by providing information on custom and practice. Visits to the site of the event Observations about layout, possible photographic evidence Physical location of individuals involved Equipment Any equipment failure or any weapon that was used be removed and preserved Gaining an understanding of the custom and practice, prevailing attitudes of the teams 7.7 This list is not exhaustive and there may be information available specific to the event. 16

21 8 MAPPING EVENTS 8.1 Maintain an orderly approach to document management and maintain a log of information gathered. 8.2 Chronology of Events Mapping a time line should also enable the identification of good practice and key problem areas in the sequence of events. The National Patient Safety Agency 6 Steps Root Cause Analysis described 4 main time lines Narrative Time Line a number of different sources of information collected into one account Time Line chronology of information linked by arrows to identify the direction of time Tabular Time this table allows more detail to be recorded as well as identifying key problem areas and good practice Time Person Grid enables a closer analysis of concentrated time periods. Once completed this may be shared with staff involved to ensure factual accuracy. This is often an opportunity for staff who may recall further information (and provide a retrospective record) to assist in the development of the investigation Identifying issues to explore During the chronology mapping further why questions will be raised. The fact based and clarification questions will be answered by going back to persons involved in the event and key witnesses. The why questions may require involved parties to get together with the support of the investigation team to explore the unanswered questions as part of the causal analysis process. 8.3 Analysing the Information 8.4 Brainstorming Determining the underlying causes and lessons that can be learnt Structured: each individual in turn contributes a suggestion or idea Unstructured: a free flow of information 8.5 Nominal Group Technique Consensus building tool, a) prioritise the problems or issues that are significant in contributing to the event. b) If consensus is hard to reach it enables agreement on the most basic causal factors. c) Agree priority improvement strategies 17

22 8.6 Process 8.7 Five Whys Using brain writing technique, the group are asked to identify the problems or issues arising from the chronology All suggestions on to flip chart and remove duplicate issues and group similar issues together The group are asked to select a number of issues that they believe are the most significant and then rank them in order of priority All cards are collected and the issues with the lowest scores will be subject to causal analysis The Five Whys is a technique to help you to drill down into a particular issue through the various layers of cause to find the fundamental cause of the problem (6 Steps to RCA, NPSA). 8.8 Fishbone Diagrams 8.9 Barrier Analysis A tool to be able to continuously view the incident as a whole, including the timeline, influencing and causal factors. Enables the charting of relationships of events, conditions, changes, barriers and causal factors on a timeline using standard symbols for each If the event is large or complex it is a useful tool to start early in the process, however you need a large wall space. A control measure designed to prevent harm, may be known as a control. When an Serious Incident has occurred usually means that a barrier or barriers have failed Barriers may be a) Physical b) Natural c) Human d) Administrative Physical barriers are usually the most reliable followed by barriers of time and place Human Action and Administrative barriers are usually the most unreliable as humans are fallible. Barrier analysis is a critical analysis of the control measures in place at the time of the event. Use of the whys process is a useful tool in identifying the barriers and why they failed Change Analysis Change is a necessary requirement for progress to take place. However during change this increases the likelihood of error occurring. It is therefore necessary 18

23 when implementing change to consider the barriers to prevent or reduce the impact of this. a) Nature of the problem b) Map out normal procedure without errors c) What was different on this occasion d) Compare two processes e) Identify where differences have occurred f) Did the change have a direct causative impact on the incident g) Why did these differences occur (Barrier analysis) 8.11 Developing Solutions and an action plan for implementation When the work has been completed and the RCA analysis report has been prepared, it is the role of the Investigator or Investigating Team to make recommendations that will bring about change at all levels of the organisation and that are sustainable and reduce risk. They should be :- SPECIFIC Specific: they say exactly what you mean. MEASURABLE Measurable: you can prove that you've reached them. ACHIEVABLE REALISTIC Achievable: you can reach them in the next few weeks/months Realistic: they are about action you can take. TIME-RELATED Time-related: they have deadlines. It is important to remember that they must be cost effective 9 PROCEDURE FOR THE MANAGEMENT AND FOLLOW UP OF SERIOUS INCIDENTS, RCA AND INQUIRY ACTION PLANS 9.1 The service line via their local governance arrangements are responsible for the implementation of any actions plan following a serious incident. These action plans may be monitored by The Trust Wide Patient Safety and Mortality review group 9.2 External Inquiry Recommendations will be received within KMPT by the Medical Director. The report will be reviewed by the Suicide and Homicide group and an Action Plan developed 9.3 The agreed procedure for management of action plans is as follows: The manager of the team where the incident occurred will be asked to produce the action plan with their team this is usually within 2 months. Completed action plans will be received by the Service Line Governance Groups who are responsible for monitoring the implementations of actions by the Service Line Director 19

24 Service Line Directors agree and monitor the action plans through their local Service Line Governance meetings and are responsible for the follow up of action plans and overseeing the dissemination of learning. Directors must ensure an audit trail is available for the action plans they are responsible for i.e. minutes of meetings where discussed, evidence of implementation of actions etc. 10 COMPLETING A REPORT 10.1 The report of the investigation should be prepared and submitted to the Service Line Serious Incident Lead within 45 working days from the date of the incident. The final report must be submitted to the relevant Clinical Commissioning Group within 60 working days 10.2 A copy of the draft report will be shared with those involved in the incident or who provided additional information. They will have two weeks in which to review the factual accuracy and ask for any factual changes Findings of the investigation will be reviewed by each service line and the Trust Wide Patient Safety and Mortality Review Group in the case of suspected suicides Once they have received approval the Investigating Lead will be responsible for ensuring a Copy of the report is shared with the patient, family and/or carers. They will leave them with a copy of the summary report and actions. Copy of the report is shared with the Team involved in the incident Copy of the report is sent to the Service Line Director of the area involved in the incident. They will ensure t the recommendations are written into an action plan. 11 LEARNING FROM EXPERIENCE 11.1 Following an investigation, recommendations will be made and from this will be the development of a smart action plan. The action plans will be reported into the Trust Wide Patient Safety and Mortality Review Group who will ensure the lessons learnt and the action plans are shared in all KMPT Service lines. The service line leads will complete the learning through experience template and share with the group 11.2 A KMPT wide action plan of themes and lessons learned is put together and information shared and disseminated via the Learning from Experience Group. The Group will also ensure articles go into Team Brief and through the Learning through Experience Newsletters identifying learning from investigations and how this has changed service delivery or practice. Learning will be shared with the wider community through the KMPT website. 12 LINKS WITH OTHER PROCEDURES 12.1 This Procedure does not stand alone. It must, where appropriate be read with the following: - The Disciplinary Procedure Being Open Policy and Duty of Candour 20

25 For those staff who undertake Investigations as part of the SI process within the Trust Incident and Serious Untoward Incident reporting policy and procedure Stakeholder, Carer and User Involvement Learning from Experience Policy Implementing Best Practice and Managing External Agency Visits, Inspections and Accreditations Policy and Process 12.2 This policy will be used by all KMPT staff and will be available on the KMPT web site for access by the Public and Stakeholders Staff will be informed on the policy and any changes via the Policy Manager using the KMPT web site. This will be published on the internet for access by the public. 13 TRAINING 13.1 Training for the identification and reporting of incidents is described in the Incident Reporting Training. Investigation Training using RCA Methodology will be undertaken by all Managers as described in the attached Training Needs Analysis Set out below is the training needs analysis for all staff groups identifying which members of staff require training and the level they require The aim of the training is to: Ensure all staff are aware of their duties/roles and responsibilities to enable them to implement the policy and undertake RCA training in line with the Policy. 14 TRAINING NEEDS ANALYSIS Staff Group Policy Awareness/Roles & Responsibilities Team Briefings, Local Induction Root Cause Analysis Training Medical Staff/Inpatient Adult Community/Consultants Junior Doctor Locums Clinical Staff Based in Adult Wards/Learning Disability Units/Specialist Units Registered Nurses/ HCA s/ OT s/psychologists Clinical Staff Based Older Adult Units Registered Nurses/HCA s/ot s Clinical Staff Based in Rehab. Services Registered Nurses/HCA s/ OT s, Psychologists 21