POLICY REF NO: SABP/RISK/0002. Incident Management Policy

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1 POLICY REF NO: SABP/RISK/0002 NAME OF POLICY REASON FOR POLICY Incident Management Policy To establish the arrangements for the reporting, recording, investigation and notification of incidents, including those considered to be serious incidents (SI) WHAT THE POLICY WILL ACHIEVE Compliance with statutory and mandatory requirements. WHO NEEDS TO KNOW ABOUT IT? All directorates, clinical and managerial staff DATE APPROVED 21 July 2015 VERSION NUMBER Version 6 APPROVING COMMITTEE Executive Board DATE OF IMPLEMENTATION 21 July 2015 DATE OF FORMAL REVIEW 21 July 2018 AUTHOR / REVIEWER Lead Nurse for Clinical Assurance RESPONSIBLE DIRECTORATE DISTRIBUTION Quality All directorates, clinical and managerial staff Page 1 of 54

2 VERSION CONTROL SHEET Version Date Author Status Comments / 02/2010 Head of Risk Active until The Policy is no longer in line August 2011 with new procedures currently in place in SABP as approved by the Executive Board. The new procedures are in line with the NPSA National Framework for Reporting and Learning from Serious Incidents Requiring Investigation in / 07/2011 Billy Hatifani Active until The Policy has been reviewed 2014 and amended in line with national guidance as set out by the NPSA and new electronic reporting processes /04/2012 Amanda Shaw Active until Revised monitoring table July 2015 added. (after extension) 6 05/03/2015 Ben Chambers Approved Full review of policy and at Exec procedure to align it to current 21/07/15 national guidelines and Trust wide systems. Summary of Changes Page /Paragraph/Appendix Number (select the appropriate action) Whole Policy and Procedure Original / New / Amendment / Deleted Statement (select the appropriate action) Full review of policy and procedure to align it to current national guidelines and Trust wide systems. Page 2 of 54

3 1. Policy Statement The Trust recognises that it has legal, contractual and specific duties to report certain incidents to various statutory and other bodies. It also has a duty to ensure that incidents are not only identified and reported, but that appropriate investigations are carried out to ensure that any actions arising or lessons to be learnt are transposed into the organisational culture to improve practice. To meet those duties, the Trust requires its staff to report all incidents, including near misses that they become aware of, or are involved in. The Trust recognises that in order to achieve its desire to meet its duties and learn lessons from incidents it must adopt an open and honest culture for incident reporting. The intention is not to apportion blame unfairly, but to create an environment that encourages the reporting of incidents that alerts management and other staff to areas of risk potential at an early stage to enable action to be taken. It is not the policy of the Trust to use reported incidents to attribute or apportion unfair blame to any individual. Where necessary, staff and others may wish to raise concerns in the public interest following the Trust s Whistle Blowing Procedure. It should be noted that on occasions it may be necessary to consider further action where there has been an act of maliciousness, criminal or gross/repeated professional misconduct. These matters will be dealt with in accordance with other Trust policies and procedures. To facilitate timely reporting, the Trust s staff will use the procedures set out within this policy, that describe the differing types of incident that are required to be reported and to whom. All Trust staff have a duty to ensure the maintenance and improvement of health, safety and welfare for people who use our services, their carers, themselves and colleagues and the general public or anyone else who may be affected by the Trust s work. This duty also extends to the reporting, recording and investigating of incidents and where appropriate, the carrying out of remedial action. (The Trust's procedures detail this process below). 2. Scope of Policy & Procedure This policy and its attached procedures apply throughout all areas of the Trust s business. Page 3 of 54

4 3. Purpose The Policy incorporates detailed procedural guidance on the arrangements for reporting, recording, investigation, analysis, learning and notification for all types of incident including Serious Incidents (SI s) and other Notifiable Incidents The intention of these procedures is to: Positively encourage the reporting of incidents by staff. Provide clear and easily understood guidance on the reporting of all incidents types within the Trust. Identify the scope / type of incidents that are to be reported, who they should be reported to, the timescale for reporting and how this reporting should be done. Indicate the duties and legal obligations of the Trust in the reporting of incidents. Identify the scope / type of incidents that should be investigated, level of record keeping and who has responsibility for this. Provide guidance for staff on how to manage incidents as they occur and following their end. 4. Associated Trust Policies/ Procedure Anti-Fraud, Bribery and Corruption Policy SABP/AUDIT/0008 Aggression Conflict and Violence Management Procedure SABP/WORKFORCE/0009 Claims Handling SABP/RISK/0034 Complaints PALS Policy and Procedure SABP/SERVICE IMPROVEMENT/0001 Health and Safety Management (Risk Assessment) SABP/RISK/0012 Infection Prevention & Control SABP/RISK/0014 Information Security - Incident Reporting Procedure SABP/IM&T/0003/INCIDENT REPORTING PROCEDURE Records Management: Requests for Access to Health Records SABP/SERVICE IMPROVEMENT0013 Reporting and Learning Arrangements SABP/EXECUTIVE BOARD/0028 Safeguarding Adults SABP/SERVICE IMPROVEMENT/0012 Safeguarding Children and Children Visiting In-Patient Wards / Units SABP / SERVICE IMPROVEMNET / Security within Trust Properties SABP/RISK/0004 Whistle Blowing SABP Procedure/EXECUTIVE BOARD/0023 Page 4 of 54

5 Appendix 1 - Datix incident / near miss reporting flow chart Page 5 of 54

6 PROCEDURE REF NO: SABP/RISK/0002/PROCEDURE01 NAME OF PROCEDURE Incident Management Procedure (including guidance on liaising with bereaved families) REASON FOR PROCEDURE To establish the arrangements for the reporting, recording, management, investigation and notification of incidents, including those considered to be serious incidents (SI). WHAT THE PROCEDURE WILL ACHIEVE: Compliance with statutory and mandatory requirements, through clarification of the incident identification, reporting and management processes. WHO NEEDS TO KNOW All directorates, clinical and managerial staff ABOUT IT? DATE APPROVED 21 July 2015 VERSION NUMBER Version 6 APPROVING COMMITTEE Executive Board DATE OF IMPLEMENTATION 21 July 2015 DATE OF FORMAL REVIEW 21 July 2018 REVIEWER: Lead Nurse for Clinical Assurance RESPONSIBLE DIRECTORATE DISTRIBUTION Quality Directorate All directorates, clinical and managerial staff Page 6 of 54

7 TABLE OF CONTENTS (for Incident Management Procedure) section content Page 1 Introduction 8 2 Roles & responsibilities Trust wide assurance meetings 13 4 SABP incident management reporting structure 14 5 What is an incident? What to do when an incident occurs Immediate post incident actions Duty of Candour Supporting people who have been affected or bereaved by an incident. 10 Support for staff after a traumatic incident Staff Incident Support Team Guidance for reporting incidents on Datix Incidents that require investigation General Principles for SI and HLI investigation Serious Incident (SI) process High Level Incident (HLI) process RIDDOR incident investigation process Confidentiality and litigation Learning from incidents In the event of media interest Compliance Matrix References Equality Analysis Appendix 1 Datix incident reporting flow chart 41 Appendix 2 Trigger List - Examples of incidents to be reported 42 Appendix 3 Examples of Serious Incidents 43 Appendix 4 Registration of a Serious Incident 44 Appendix 5 Serious Incident Investigation Process 45 Appendix 6 Duties and Legal Obligations of the Trust (Notifiable 46 Incidents) Appendix 7 Reporting of Injuries, Diseases and Dangerous 47 Occurrences Regulations (RIDDOR) Appendix 8 RIDDOR Investigation Process 48 Appendix 9 IG SIRI response flow chart 49 Appendix 10 Summary guide to being open Appendix 11 SIST response following a Traumatic Incident 52 Appendix 12 Glossary Page 7 of 54

8 PROCEDURE 1. Introduction The Incident Management Procedures should be read in conjunction with the Incident Management Policy. 2. Roles & Responsibilities The Chief Executive has overall responsibility for Health & Safety (of which incident management is part) and has made the Director of Quality the Board Member specifically responsible for this policy/procedure. The Director of Quality or delegated deputy is responsible for ensuring that both statutory and mandatory requirements are met and that adequate resources are made available for the Trust to meet its duties for incident reporting, recording, investigation, analysis and applying lessons learnt. This will also include: o Ensuring that suitable and sufficient arrangements are in place for the effective aggregation of data analysis (including incidents, complaints and claims) and that the learning from such incidents is appropriately communicated to all relevant staff. o Ensuring appropriate reporting to the Board and the relevant teams within SABP and that arrangements for monitoring and actions regarding identified trends and lessons learnt are undertaken when required. o Ensuring access to health and safety related training with particular reference to incident reporting, to meet the needs of this policy/procedure in line with the Training needs analysis. o Deciding on whether an incident is regarded as a Never Event or Serious Incident (SI) requiring notification as an SI through the Strategic Executive Information System (STEIS) to the Commissioners and Regulators. o For ensuring that the findings of investigations are shared with those involved in accordance with the Being Open guidance and the contractual duty of candour requirements. o Responsibility for reporting upon compliance with this policy/procedure The Chief Finance Officer is the Trust Board Member for information security also designated as the Senior Information Risk Owner (SIRO). Page 8 of 54

9 Directors/Associate Directors/Professional Leads are responsible for: o Ensuring that all staff are made aware of both the organisation s policy on Incident management and where appropriate any subsidiary directorate or departmental policy. o Ensuring that suitable and sufficient risk assessments of the areas under their control are undertaken and reviewed on a regular and planned basis, particularly following incidents. o Ensuring that robust arrangements are in place for the timely reporting of all incident types, including those which may attract public or media interest categorised as a Serious Incidents (SI) and other Notifiable Incidents. o Supporting their staff by making adequate resources available to fulfil the requirements of this policy. o Making provision for their staff to undertake appropriate training in line with the training needs analysis. o Supporting the Quality Directorate in reviewing aggregated data on incidents, complaints and claims in the preparation of reports. Operational / Service Managers and Heads of Departments are responsible for ensuring that: o Staff in their area of managerial control are fully aware of the content of this policy and its associated procedures o All incidents, including near misses, are promptly reported through Datix (the Trust s incident reporting system) o Reviewing completed Datix incident report forms to ensure that they have been accurately and fully completed within the time scales detailed below. o Any necessary immediate local reviews and / or investigations have been carried out and that the outcomes, together with any remedial action(s) have been accurately recorded in the action taken and lessons learnt sections of the Dif 2 Datix forms (automatically sent to managers on completion of the initial Dif 1 incident reporting form). o Staff are released to attend training / information sessions related to this policy. o For ensuring that all their staff are aware of their contractual duty of candour requirements and follow the principles of the Being Open guidance appropriately. o Information regarding incident trends data is used to identify and resolve weaknesses in systems, processes and practices and actions taken to address these needs. Page 9 of 54

10 Local Managers are responsible for ensuring that: o Staff in their area of managerial control are fully aware of the content of this policy and associated procedures. o All incidents, including near misses, are promptly reported through Datix (the Trust s Incident Reporting System) before the end of shift during which they have been identified. The forms must be a factual, accurate and complete account of the incident as it is known at that time. o For ensuring that all their staff are aware of their contractual duty of candour requirements and follow the principles of the Being Open guidance when appropriate. o Information regarding incident trends data is used to identify and resolve weaknesses in systems, processes and practices and actions taken to address these needs. o All RIDDOR reportable incidents are investigated using the guidelines and template available from the Health and Safety Team and on TrustWeb. The Head of Clinical Risk & Safety is responsible for ensuring that: o Reports are produced and presented regarding the aggregation of incidents, for use at operational meetings (from team reviews to directorate Quality Action Groups) and to advice the Trust Board of recent incident activity. These reports will include but not be limited to contributions to the monthly Quality Management Report and the Integrated Quality and Performance Report. o The national and local time frames for reporting, investigating and delivering for review the reports on incidents that have been identified as requiring formal investigation (including SIs) are adhered to. o All serious incidents (and other incidents that are formally investigated) reports are disclosed to those affected in a timely manner, appropriately reported and investigated, with the findings being shared with those involved in accordance with the Being Open guidance and the contractual duty of candour requirements. ; The reporting of incidents on the Datix system is monitored and analysed and action taken to improve the reporting culture of the Trust. o The Clinical Risk and Safety Team complete their responsibilities as detailed below. Page 10 of 54

11 The Clinical, Risk & Safety Team (CRS Team) are responsible for: o Reviewing all the completed Datix incident reports to ensure that the data is recorded correctly and the appropriate immediate actions have taken place. This includes the appropriate notification of other internal or external agencies that need to be advised. o Identifying the need for and initiating further investigation of incidents where appropriate and bringing to the attention of those responsible the findings and or recommendations from the investigation for action. To enable them to update local procedures, safe methods of working etc. o Reporting the incident to the relevant commissioner using the Strategic Executive Information System (STEIS). They will also notify the Chief Executive, Medical Director, and other relevant Directors / senior managers, Communications Lead and the Staff Incident Support team of reported SIs. o Supporting operational management through the production of reports identifying trends in incidents reported. o Ensuring that the any incidents that may possibly attract media interest are shared with the communications team in a timely fashion. o Ensuring all Serious Incident (and other incidents that are formally investigated) reports are robust in their conclusions and disclosed to those affected (including any victims and their families) in a timely manner in accordance with the Being Open guidance and the contractual duty of candour requirements. The Complaints and PALS Manager is responsible for managing the complaints process and for recording and maintaining complaints information for analysis and reporting. The Legal Services and Reporting Manager is responsible for: o Coordinating claims resulting from incidents that have occurred within the scope of the Trust s care o Liaising directly with the Coroner s office. All communication from the coroner including notification of a person s death, requests made by the Coroner for a statement and attendance at an inquest should be made communicated to staff through the Legal Services and Reporting Manager. If any staff member is contacted directly by a person reporting to be from the Coroner s office, they should be directed to the Legal Services Manager (who can be reached via Switchboard). Page 11 of 54

12 o Coordinating (requesting, sense-checking, collating and sending through) information / evidence requested by either the Coroner s office or insurance companies in cases that involve the Trust. o Supporting staff prior to Court appearances including advice on writing statements and preparation for attending inquests. o Supporting staff when giving statements to the Police following incidents. o Requesting legal representation on behalf of the Trust. The Occupational Health Manager is responsible for following up on incident referrals and initiating appropriate action with management as appropriate to ensure health promotion, health protection and surveillance. The Head of Health, Safety and Wellbeing is responsible for ensuring that RIDDOR incidents are investigated appropriately by local managers and reported to the Health and Safety Executive within the timeframes specified in the (HSE) RIDDOR regulations. The Information Governance Manager / Security Manager is responsible for: o Following up Information Governance incident referrals and initiating appropriate action with management. o Liaising with the Chief Finance Officer who is the Senior Information Risk Owner where there are information security incident referrals. o Liaising with the Health and Social Care Information Centre (HSCIC) with regards to incidents involving people s information. The Communications Team is responsible for liaising with the Quality Directorate on any incidents, complaints, claims, and coroner s cases that may become subject to public interest to ensure that prompt and proactive media management action is taken. Staff are responsible for: o Ensuring that they understand the content of this policy and its associated procedure. o Taking care of their own health and safety and that of others who may be affected by their acts or omissions at work. o Managing all information (both personal identifiable, clinical, staffing, financial and corporate information, held either electronically or on paper or by way of Page 12 of 54

13 any other means) legally and securely and only sharing it appropriately and securely. o Cooperating with the employer and promptly reporting ALL incidents (including near misses on the Trust s Datix incident form, in an accurate and timely manner (before the end of the shift in which the incident occurred). The forms must be a factual, accurate and complete account of the incident as it is known at that time. o Co-operating with and supporting the process of investigation and developing learning from incidents / complaints and claims they may be involved with. 3. Trust-wide Assurance meetings The Quality Committee as a sub-committee of the Trust Board meets on a quarterly basis and reviews assurance reports concerning the aggregation of incidents, complaints and claims. Further assurance that concerns highlighted in the reports have been addressed can be requested by this group. The Quality Committee is responsible for assuring itself that the arrangements for the effective aggregation of data analysis and dissemination of learning are adequate. The Quality Management Board (QMB) meets monthly and is responsible for reviewing monthly analysis reports from Quality Directorate. The Directors of each directorate are present or represented and actions are allocated to the responsible Director (or their nominated deputy) as necessary to provide assurance of improvements to practice. The Scrutiny Panel meets on a monthly basis and is chaired by the Director of Quality or nominated deputy. The purpose of the meeting is to review all the Serious Incident, High Level Incident and Serious Case Review investigation reports to ensure that they are accurate, identify the root cause and provide appropriate recommendations to reduce the likelihood of a re-occurrence of similar incidents. If the Scrutiny Panel decides the report requires further work, they will be resubmitted with amendments until approved. The Scrutiny Panel also monitors the completion of the SI report action plans. The CCG Serious Incident Learning and Review Panel meets on a monthly basis with representatives from each Surrey CCG SABP are commissioned by and the Head of Clinical Risk and Safety, the SABP Director of Risk and Safety, Medical Director and the Director of Quality. The purpose of the meeting is to review and approve SI reports that have been approved by the internal Scrutiny Panel. Once approved by the SI learning and review Panel the CCGs close the incident on STEIS (or when required recommend closure for the Area Team to action). Page 13 of 54

14 Quality Risk & Safety Team trend analysis 4. SABP Incident Management reporting Structure Trust Board Audit Committee Quality Committee QMB Quality Action Groups All organisational incidents, complaints and claims 5. What is an Incident? 5.1. Definitions Incident term Incident Serious Incident (SI) Never event definition Any unexpected or unplanned event or circumstance that has given rise to or could give rise to actual or potential loss, damage, injury or ill health or other unwanted effect. An incident that occurred during NHS funded healthcare (including in the community), which resulted in one or more of the following: Unexpected or avoidable death (including suicides) or severe harm of one or more patients, staff or members of the public. A never event (see below) regardless of whether it is resultant in severe harm or death. A scenario that prevents, or threatens to prevent an organisations ability to deliver healthcare services including data loss, significant property damage. Allegations or incidents of significant physical or sexual abuse. Significant adverse media coverage or public concern about health care provision in an organisation Examples of typical SIs reportable by SABP can be found in Appendix 3 Nationally defined incidents that should never occur. These incidents are serious and largely preventable such as inpatient suicide using non-collapsible rails or whilst being on 1:1 observations. The current never event list is available on NHS England s website. Page 14 of 54

15 High Level Incident (HLI) RIDDOR incident Near miss Locally defined by SABP as incidents require formal investigation to understand the root cause of the incident, but do not meet the criteria for registration as an SI. They may arise from a single incident or result from observation of a cluster or trend of incidents. Are adverse incidents that result in an injury to a member of staff whilst at work, and must be reported to the Health & Safety Executive. Accidents to members of the public or others who are not at work must also be reported if they result in an injury and the person is taken directly from the scene of the accident to hospital for treatment to that injury (see Appendix 7 for RIDDOR incident types). Incidents that did not but could have led to harm, loss or damage Examples of incidents to be reported (trigger list) Incidents that should be reported are those that involve: o People who use our services o Visitors (Inc. non Trust staff e.g. contractors and members of the public) o Yourself o Your colleagues o Damage to or faults with Trust property o Your own property (when carrying out Trust Business). Incidents will therefore include but are not limited to: o Abuse towards anyone; Physical including actual violence against a person Sexual Mental / psychological including verbal threats or abuse Financial Neglect Institutional Discriminatory o Injuries (whether caused deliberately or by accident) o Death (expected or otherwise including suicides). o Breaches of confidentiality (IG Breaches). o Outbreaks of infectious diseases o Safeguarding incidents (children or adult concerns) o People who have absconded, gone AWOL or failed to return from agreed periods off the ward. o Dangerous occurrences, including working in environments without the required numbers of staff to safely deliver the care / service expected (this includes situations when the safe staffing levels are met, but the acuity demands more). o Medical aids and equipment faults or design defects. o Accidental or intentional loss and damage to Trust or personal property Page 15 of 54

16 o o o o o Vehicle incidents whether a Trust Vehicle or your own whilst carrying out Trust business IT system failures Fires: smoking in unlawful areas Unplanned activation of the fire alarm systems Events with a fire risk potential. Any other incidents with the potential to attract significant media/public interest (an SI). RIDDOR incidents (see Appendix 7 for further guidance) Remember near misses of any of the above should also be reported on the Datix incident management form to help understand the level of risks being managed by the teams. This will support the early identification of areas where additional intervention could help to prevent an actual incident. 6. What to do when an incident has occurred? General practice principles: NB the term senior person present refers to the person who is most appropriate person to coordinate the management of the situation i.e. has leadership responsibility for the area where the incident has occurred and knows the local processes / people well enough to effectively managed the incident e.g. the team / shift leader or manager. It is not necessarily the person with the most senior position as they may not have the local knowledge. As some incidents progress a more appropriate person may attend to help that should take on the coordinator role (e.g. the ward manager returns from a meeting off the ward). In such cases the person initially coordinating the management of the incident should hand over what has been done and the new person continues in the role of senior person present Most incidents are and should be competently managed at the local level through effective, timely and sincere efforts to resolve the situation Begin any required interventions to maintain life In the event of a Serious Incident or an incident that is rapidly escalating, the senior person present in that team must assume a coordinators role, i.e. must ensure that the incident is managed in an appropriate manner, both immediately and until the situation has been concluded. The responsibility for this role will include ensuring that: Appropriate actions are taken by appropriate people. Advice is sought as required including from emergency services. Where necessary That key information is collated as the incident progresses, e.g. critical timings, a complete list of the people involved in the incident and the rationale for decisions made during the management of the incident. That any source of information that could help to objectively understand what Page 16 of 54

17 has occurred is secured (e.g. CCTV footage) Staff supporting people who use our services and their family members who may be present should: Direct people away from the incident (both visually and audibly) so that they are not exposed to unnecessary trauma and the people managing the incident have the space they need to support the person affected. Support family members / visitors in private area without other people who use services to reduce additional distress caused by other people s reactions to the incident and to allow them to communicate information that may be pertinent to resolving the incident. Assure them that staff are dealing with the incident and that information will be shared with them as soon as it is appropriate and safe to do so Should the incident require the immediate attention of the Emergency Services (Fire, Police, Ambulance), a doctor or duty engineer the senior person present must ensure they are contacted by a member of staff who can competently articulate and communicate the specific needs of the situation. When this is likely to require clinical information, the person must, whenever possible, have appropriate access to the person s clinical record The Senior Manager/On-call Manager should be immediately contacted by telephone if the incident regards significant harm to a person (including a potentially life changing or threatening degree of harm), an actual fire or an event that may attract adverse media attention (e.g. an AWOL of a person who is at high risk to either themselves or others, or a person accessing a roof) The Senior Manager/On-call Manager will consider the impact of the incident and support the Senior Person present to resolve the situation. They will also determine what other key people within the Trust require immediate notification such as the communication team and appropriate Director(s) The scene of an extreme incident (one where an actual or near fatality occurred or where serious sexual assault is alleged) must remain undisturbed until permission to do otherwise is given by an appropriate authorised person (usually the police or fire brigade), unless there is a significant risk of further danger or injury. If there is any doubt consult the Clinical Risk and Safety (CRS) team or on call manager for advice. The area should be immediately secured from use and made safe or if this not possible the item causing the risk immobilised or removed and stored safely for inspection Every effort must be made to ensure that the details recorded on the Datix incident form are factual, accurate and a complete account of the incident as it is known at that time. Page 17 of 54

18 7. Immediate post incident actions The immediate management of some incidents can be complex and initially feel chaotic. Once the situation has been resolved there should be an opportunity for the team to have a brief, informal reflective conversation shortly after the incident to check how everyone is both physically and emotionally to help plan the continuing delivery of care required. The senior person present should coordinate this when it is safe to do this (with support from the wider team to help enable this to happen if necessary) Following this conversation care must be taken to support colleagues who are showing signs of distress or shock. If required the senior person present should work with senior staff / management from the wider team to ensure that appropriate measures are taken that will enable the care required from that area to continue safely In situations where such a brief conversation is not possible a manager (the team lead, manager or in their absence a service manager) must ensure that all those involved or affected by the incident are given the opportunity to discuss the incident as soon as is appropriate and action taken by the manager as required to support the staff Throughout the incident and immediately following its resolution, staff members will have been supporting any people who have been using services and or family members / visitors present. Part of the brief, informal reflective conversation will be planning on how their care can be best continued. In the events of a Serious Incident especially where significant harm was caused, consideration needs to be given by the senior person on duty, a senior manager and a senior clinician as to what, when, how and by whom information about the incident is communicated to the people using the service. Considerations will include: Ensuring that where appropriate critical information is given to the family of the person involved first. Information shared with the people who use the services and their family who were present is concise, factual and includes where people can come to if they require more support immediately and how the ongoing care will be provided at this time. Social media communication consider asking people not to disclose information on Social Media such as face book or twitter as it may reach peoples friends and family who have yet to be notified of the incident officially. This could cause significant distress and upset and provide misleading, inaccurate or personal information that could have a detrimental effect on the person or their family Following incidents where the family or carers of the person involved need to be informed about what has happened, careful consideration must be given as to whom would be the most appropriate person to contact the family or carers. Whilst it is considered good practice that the consultant or senior practitioner involved in the care Page 18 of 54

19 of the person involved, liaises directly with their family or carers in some situations such as following the unexpected death of a person, external agencies such as the Police may decide that they wish to notify the family. In such circumstances the following must be considered by the Senior Person present and the external agency: What information the external agency is planning to share, with whom and when? What information should be shared with the family if they make contact with the team before they are officially notified? How will the team be advised by the external agency that the family have been notified? The senior person present must also ensure that all staff are aware that should the family make contact with the team, who should they be initially signposted to? 7.6. In the event of an incident involving people who use services always ensure the responsible medical officer is informed as soon as possible. 8. Duty of Candour 8.1. From November 2014, NHS provider bodies registered with the Care Quality Commission (CQC) have been required to comply with the new Statutory Duty of Candour (DOC). This involves giving the people who use our services and (when appropriate their families / carers) accurate, truthful, prompt information when mistakes are made and treatment does not go to plan What is candour? Recognising when an incident occurs that impacts on a person using services in terms of harm. Notifying that person that something has occurred. Apologising to them Supporting the person further. Following up with the person as your investigations evolve. Documenting the above discussions and steps What triggers the statutory duty of candour? The death of a person due to treatment received or not received (not just their underlying condition). Severe harm - in essence permanent serious injury as a result of care provided. Moderate harm - in essence non-permanent serious injury or prolonged psychological harm. Although the legislation does not include near misses there is a professional duty for healthcare practitioners to be candid with the people using services. Page 19 of 54

20 8.4. What does candour look like? Open discussions between the person affected and the healthcare provider when things go wrong. Acceptance by healthcare staff that open conversations will take place at an early stage. Reduction in overly defensive approaches to information sharing about incidents in relation to the person in question. Engaging the person with the outcome of investigations; and An apology in relation to the incident. 9. Supporting people who have been affected or bereaved by an incident Other people using services Following traumatic incidents it is important to remember that other people who use services may have been distressed if they witnessed the incident or were close to the person. In such circumstances staff should Ensure that they are given the opportunity to discuss their reactions and given the ongoing support required to help them recover. Ensure that they are aware of the potential for people to recreate similar incidents (copycat behaviours etc.) and that support is in place to provide alternative coping strategies for these people The person and their family After the immediate responses to an incident have been progressed (i.e. no later than on the following working day) a specific person should be confirmed by senior staff in the clinical team as responsible for communicating with the person and or their family. The selection of this person should take into account the family s feelings and any communication needs they may have and should be of appropriate seniority and possess the skills to enable them to act with openness and empathy When first speaking with a person or family following an incident especially following a death it can feel uncomfortable. Often these feelings stem from the empathy we feel towards the person and their family for their suffering combined with a fear of how they may respond to us as a representative of the Trust. During this initial conversation it is essential that we sincerely express our sorrow and regret for the harm that has occurred. Saying sorry is not an admission of liability; it is the right thing to do. (Saying Sorry, NHSLA 2014) If the initial or further contact is declined by the person or their family, further attempts at contact should be made. It may be appropriate for a follow up written letter to be sent advising them of how and with whom they could make contact. In some Page 20 of 54

21 situations further liaison may be most accepted through another party, such as the police family liaison officer or the commissioning Area Team When staff communicate with the person and or their family sensitivity should always be shown to the amount, type and regularity of information people want as this will vary between individuals and, for any given individual, may vary over time For incidents where a formal investigation is being conducted, the lead investigator will also make contact with the person and or their family and offer them the opportunity to contribute to the investigation report and keep them up to date with how the progress of the investigation. Support will be given to them regarding accessing the completed report once it has been approved by the Scrutiny Panel During communication with the person and or their family it may become evident that they require additional types of support which they should be signposted to such as: Advocacy services mental health support e.g. counselling or bereavement services other services, such as social care Cruse (bereavement care, counselling & support), Tel: or Samaritans (24hr helpline for those in crisis), Tel: or , Victims (and their families) of serious incidents committed by people who use services. As well as being rare, such incidents are often complex. At the time that an incident occurs the person s mental health history will be one of the factors that may have contributed to the incident occurring. Following such incidents the following points should be considered. The Serious Incident Framework 2015 (NHS England) gives specific guidance on the importance of involving and supporting victims and their families/carers through the investigation process including what information about the investigation process should be shared with them. Contact with the victim (or their family) following a serious incident should be approached using the principles described above and expressed in the Being Open guidance. Involvement begins with a genuine apology, assurance that the Trust will be reviewing the care delivered to the person and advice on how they could contribute to the investigation. A discussion as to the appropriateness of SABP making direct contact with the family should be held as part of the multiagency safeguarding process (if Page 21 of 54

22 applicable), where a collective decision can be made by the agencies present as to which agency could provide the most beneficial support to the family and coordinate contact with others. Where the safeguarding process is not applied, the decision as to who should contact the victim (or their family) and in what capacity will be made within the Quality Directorate Further guidance for staff when communicating with a person who has been involved in an incident, their family or the victims of serious crimes committed by people using services can be found in the following documents. Being Open, communicating patient safety incidents with patients their families and carers is available at A quick reference guide is attached as Appendix 10. Saying Sorry is available at NHS Litigation Authority Guidance on Candour is available at Help is at Hand A resource for people bereaved by suicide and other sudden, traumatic death is available at Independent investigation of serious patient safety incidents in mental health services: Good practice guidance February 2008 available at Serious Incident Framework 2015 available at Support for staff after a Traumatic incident Immediate support: At the time of the incident the Senior Person present will be responsible for identifying any immediate support needs that the staff may have including first aid / medical intervention and emotional support. The resources required to provide the staff involved time to have their immediate needs met should be coordinated by the senior person present and may involve seeking support from colleagues from nearby teams, asking staff to come in early to relieve staff or seeking additional resource from senior managers Later support: People respond to traumatic experiences in different ways. Some staff may experience distress from strong emotional reactions sometime after the incident has occurred. Managers may notice staff exhibiting symptoms such as prolonged sadness, tearfulness, increased sensitivity, anger, restlessness, avoidance of aspects of their role previously done, impaired concentration, reported sleep disturbance and feelings of guilt. Managers must be alert to such possibilities and support their staff to access Page 22 of 54

23 help should it be appropriate or necessary through encouraging staff to: o Discuss their situation with their GP o Advise them to contact the Confidential Care Independent Support and Counselling Service And/or the manager can o Refer them to Occupational Health. o Discuss their needs with the Staff Incident Support Team (SIST). 11. Staff Incident Support Team The Staff Incident Support Team (SIST) consists of a group of clinicians and managers who have completed the staff support training and have volunteered to provide staff incident support. They are notified of incidents in the following ways: By automatic when a Serious Incident is reported on the Datix system. The team manager can contact the SIST Lead directly if an incident has occurred that doesn t meet the criteria for an SI but they feel that staff may require support Following notification of a significant incident the rostered member of staff from the SIST will approach the team manager to gather more information about the incident and the impact it has had on staff If staff support is required, a support session (either individual or group as required) will be organised in conjunction with the manager(s) around 72 hours after the incident The invitation will be to all involved staff and may include members of other teams involved with the individual. Staff will be advised that attendance at the support meeting is voluntary, confidential (unless information is shared that would indicate serious negligence or professional misconduct) and separate from any investigation process The staff who attend the support session will be offered follow-up after one month and the SIST will make themselves available to offer telephone follow-up if required. Staff will be sign posted to additional support if necessary The process is summarized in Appendix 11. Page 23 of 54

24 12. Guidance for reporting incidents on Datix For the purpose of this procedure near misses are also classified as incidents All incidents should be reported through the Datix incident reporting system as soon as possible after the incident has occurred so that key information can be captured accurately The incident reporting form can be completed by any staff members working for the Trust (including NHSP and Agency staff) who have access to a Trust computer. The Datix reporting form can be found on TrustWeb in the Systems and Applications section by clicking on the Datix Incident Management folder. No password or smart card is required to register an incident There is detailed guidance on how to complete the Datix incident form on TrustWeb in the Systems and Applications section on the Datix Risk and Incident Management page Further specific advice and prompts are embedded on the Datix form itself. This information can be accessed by clicking on the icons Every effort must be made to ensure that the details recorded on the Datix incident form are factual, accurate and a complete account of the incident as it is known at that time The following information can be critical when reviewing what lessons can be learnt both at a local and Trust wide level: Critical timings (e.g. when did the incident occur, when was it discovered and at what times did significant people arrive e.g. emergency services or interventions begin and end such as resuscitation) these times can be written into the What happened section on Datix. A complete list of the people involved in the incident e.g. people who may be useful as witnesses such as the person / people directly involved in the incident, people who were with the person before the incident occurred and those who responded to the incident including people external to the Trust. Their names, role in the incident and their contact details can be entered onto the Datix form by selecting Yes to the question Was any other person involved in the incident? Page 24 of 54

25 The rationale for decisions that were made during the management of the incident should be recorded in the What happened?, Immediate action taken and in the Action Taken (Investigation) section completed by the local manager depending on when this information becomes known Once the required information has been entered on to the Datix incident reporting form and submitted, the person completing the form will receive a confirmation which will advise them as to who has been sent the incident form for review The Datix system will automatically the manager of the team identified as being where the incident occurred so that they can review the incident and report on the findings of their local review of the incident including any resulting action they have taken Additional key relevant people who need to know about the incident (e.g. the health and safety team, safeguarding leads or estates etc.) will also be automatically ed the incident by completing the form accurately If you are reporting an incident that you think reaches the criteria for registration as a Serious Incident you must select the answer yes to the question is this a serious Incident to ensure that the Clinical Risk and Safety team, senior managers and the communications team receive immediate notification of the incident If there is any doubt about the severity of the incident, report it as a Serious Incident The final approval of the incident forms submitted is by the Clinical Risk and Safety Team (CRS) who scrutinise the forms to provide assurance that the incidents: Have had appropriate local review / investigation. That appropriate actions have been taken at a local level. That the information on the form has been correctly coded including grading of the incident (to enable accurate analysis and reporting of the incident data). To determine whether any further investigation is required The CRS team have access to the Datix forms at every stage of their completion once they have been initially submitted by the person reporting the incident and can request additional information / actions at any time. Page 25 of 54

26 13. Incidents that require investigation: Local Managers response Following any incident or near miss reported on Datix it is expected that the local manager will conduct a local investigation of the event to establish what happened, what could have been done differently and immediately address any overt issues. The outcome of this local investigation and any actions that were taken are then reported on the same Datix form in the Action taken and Lessons Learned boxes of the Managers section Identifying an incident requiring formal investigation. The Clinical Risk and Safety team (CRS) in partnership with the Director for Risk and Safety and the Director for Quality have overall responsibility for determining whether further investigation is indicated and if so at what level, i.e. as a High Level Incident or as a Serious Incident. The criteria used to determine what level of investigation is required is detailed above in section 5.1. The CRS team are notified of a potential serious incident through the Datix incident system. (NB the CRS team review all the incidents reported on Datix and will re-grade any incidents that are Serious Incidents but were not originally graded as such). Some incidents may not meet the criteria for further investigation in isolation but when viewed in the context of information from other sources such as Human Resources, complaints or claims are determined to require formal investigation. The decision to report an incident as a Serious Incident is the responsibility of the Director of Risk and Safety (or their nominated deputy). The responsibility for registering the Serious Incidents and progressing with the investigation lies with the Clinical Risk and Safety team Information Governance incidents. When an Information Governance (IG) incident occurs (as indicated in the points below) the severity of the incident and the requirement to report the incident externally to the Information Commissioner s Office will be determined by the IG SIRI Committee. This committee comprises of senior members of the IG team and the Risk and Safety Team and reports their decision to the Cauldicott Guardian. When an incident has occurred that requires external reporting, the IG team manage this process using the IG Tool Kit reporting system. Reportable incidents for person identifiable data loss and/or confidentiality breach include: o Loss of patient case notes or portable media containing person identifiable data that could/would give rise to reputational damage or risk to individuals. o Inadvertent or deliberate destruction of patient case notes or deletion of Page 26 of 54

27 computerised person identifiable data that could/would give rise to reputational damage or risk to individuals. o Inadvertent or deliberate amendment of data held on patient case notes or computerised systems that could/would give rise to reputational damage or risk to individuals. o Actual or suspected unauthorised disclosure of person identifiable data regarding people who use services or member of staff through any type of transfer i.e. voice, phone, fax, post, that could/would give rise to reputational damage or risk to individuals. o Inadvertent disclosure of person identifiable data regarding people who use services or member of staff through any type of transfer i.e. voice, phone, fax, post, that could/would give rise to reputational damage or risk to individuals. A flow chart describing the process for responding to significant information Governance incidents is in Appendix General Principles for SI and HLI Incident investigation The purpose of investigating incidents is to create a balanced report of the events and rationale for decisions made that led to the incident in order to analyses them and identify what action could be taken to develop practice that could prevent similar incidents from occurring Investigation reports should demonstrate the application of robust investigative methodologies with resultant recommendations which link back to the findings All serious incidents should be investigated using the Root Cause Analysis methodology as outlined by the NPSA guidelines Whilst the responsibility for authoring the investigation report will typically lie with the Clinical Risk and Safety Manger, the investigation should be contributed to by professionals with experience relevant to the incident under investigation On rare occasions a Serious Incident may be allocated to a senior manager as opposed to a Clinical Risk and safety Manager. In such situations the investigator will be sufficiently removed from the incident to be able to provide an objective view When a Serious Incident raises concerns in relation to individual staff culpability or competence, these concerns should be managed in accordance with Local HR procedures and referred to professional bodies as appropriate. Page 27 of 54

28 14.7. Where the incident involves a junior doctor in training the Director of Medical Education needs to be notified immediately to consider whether additional support and or remedial training is required and to report the incident to Health Education Local Education and Training Board (Kent, Surrey and Sussex) Incidents where concerns about the conduct of doctors who are not in training will be discussed with their Associate Medical Director initially by the medical reviewer. The Associated Medical Director will then determine what further action is required Where the investigation involves more than one organisation, a lead organisation should be agreed to coordinate local investigations and amalgamate findings, or to oversee one joint investigation. 15. Serious Incident (SI) Process Each incident identified as possibly being a Serious Incident is reviewed by the Clinical Risk and Safety team. Initial clarification information is sought from the person s clinical record and the people involved to determine whether the incident meets the criteria for registration as an SI. Current guidance for determining whether an incident meets the criteria for registration as a Serious Incident can be found in the Serious Incident Framework 2015 (NHS England) Registration of an SI Once the decision has been made that an incident meets the criteria for registration as a Serious Incident the clinical risk and Safety team will: o Register the incident immediately on STEIS (no later than 72hrs after the incident was identified). This registration alerts the relevant CCG(s) to the incident. For incidents which are urgent, unusual, likely to attract media attention or are a never event immediate telephone contact should also be made by the Director of Risk and Safety (or their nominated deputy) to the CCGs advising them of the details of the incident as known at that time and actions that have been taken to manage the situation. o Ensure that the Team who were supporting the person who uses services are aware that the incident has been registered as an SI SI Grading The Serious Incident Framework 2015 (NHS England) removed grading of serious incidents to simplify the process of serious incident management Investigation time frames Registration of a Serious Incident on STEIS starts the time frame for completion of the report. An initial incident review (characteristically termed the 72-hour review) will be Page 28 of 54

29 written to confirm whether a serious incident has occurred and if applicable, the level of investigation required and to outline immediate action taken (including where other organisations/partners have been informed) and reported on STEIS. This information may already be known at the time of entering the incident on STEIS and no separate 72hr report required. There is a 60 working day timeframe for the completion of serious incident investigation reports Investigation method Immediately after a Serious Incident has been registered, the Head of Clinical Risk and Safety (or their nominated deputy) will allocate a Clinical risk and Safety Manager to coordinate the incident investigation. All unexpected deaths and complex SI will be investigated by a Root Cause Analysis (RCA) panel investigation consisting of those staff involved in the incident, CRS team and other agencies involved. The CRS investigator will also liaise with the person s GP and where appropriate the person who the incident relates to and / or their family. For SI s that result in no harm such as an AWOL or under 18 years admission a panel investigation will not be required and the CRS manager will undertake the investigation by liaising independently with those involved using RCA investigation methodology. A medical reviewer, independent of the team where the incident occurred may also be allocated to contribute to the investigation (not all Serious Incidents will require a medical review depending on the type of incident and the circumstances the decision not to include a medical reviewer can only be confirmed by the Director of Risk and Safety or their nominated deputy). The investigator will also review the clinical documentation regarding the person who uses services involved in the incident as well as related documents such as incident forms. The length of time reviewed prior to the incident by the investigator will vary depending on the circumstances of the incident but will typically be less than 6 months. The care provided to the person including the rational for decisions made will be reviewed and benchmarked against best practice at the time of the incident as described in National guidelines (e.g. NICE guidelines) or locally approved best practice clinical guidelines as part of the investigation process. The RCA panel is chaired by a senior member of SABP and uses an RCA approach as recommended by NHS England to review the care provided leading up to the incidents in the identified timeframe leading up to the incident. Page 29 of 54

30 Completing the reported within the national timescales as indicated in Section When the report is in a draft form (typically working days post registration), the report is sent to the team manager of the team(s) directly involved in the person s care to ensure accuracy of the report detail, identify any contextual elements that may not have been highlighted by the report and to enable the team manager to report on or determine any actions that could be made at this time to minimise the likelihood of similar events reoccurring. The completed draft is then reviewed by, the SABP Director of Risk and Safety (or their nominated deputy) and the root cause and recommendations uploaded onto STEIS Quality assurance process (Inc. Scrutiny Panel) The completed draft report is submitted to the SABP Scrutiny Panel (SP) chaired by the Director of Quality and the Medical Director. The report is presented to the SP by the senior operational representative at the meeting for the directorate where the incident occurred. The SP reviews each report to ensure that it is accurate and has applied the necessary level of investigation to understand the root cause of the incident and provides appropriate recommendations (and actions) to reduce a re-occurrence of similar incidents. If the scrutiny panel decides the report requires further work, it will be resubmitted until it is approved. The finalised report is submitted to the CCG Serious Incident Learning and Review Panel for closure (or the Area Team should they ask to review the report) within the timescales as indicated in Section Any requested amendments from the CCGs are reported back through the SABP Scrutiny Panel process. Following the approval of the Scrutiny Panel and the CCGs the report is deemed to be finalised and can then be shared with external agencies such as the Coroners or NHSLA etc. if required and appropriate. Such sharing of reports will be coordinated by the appropriate leads within the Risk and Safety Division. The Scrutiny Panel also monitors the completion of the SI report action plans and is responsible for determining when the actions have been completed and the Action plan can be closed. Page 30 of 54

31 16. High Level Incident (HLI) Process Investigation time frames HLI are usually carried out by senior operation managers within the Trust and should be completed for presentation at the Trust s Scrutiny Panel within 60 working days Investigation method High Level Incidents are investigated using a brief investigation template developed by the Clinical Risk and Safety team from their RCA template. The purpose of High Level incident investigations are to provide a concise report of the events and rational for decisions made that led to the incident with analyses that leads to improved practice that could prevent similar incidents from occurring. The investigator will review the clinical record of the person(s) involved in the incident (and if appropriate speak to them) and interview staff Quality assurance process (Inc. Scrutiny Panel) The review of a HLI is required by the directorate most relevant to the incident before going to the SABP Scrutiny Panel as described in Section As HLIs are not registered externally on STEIS they do not require closure to be agreed by the CCG Serious Incident Learning and Review Panel. 17. RIDDOR Incident investigation Process RIDDOR incidents that require investigation are confirmed by the Health, Safety and Wellbeing team: After a person reports the incident as a RIDDOR on the initial Datix form. After the Manager informs the Health, Safety and Wellbeing team should an incident become RIDDOR reportable (see Appendix 7 for a full list of RIDDOR reportable incident types) Once a RIDDOR incident has been confirmed as requiring external reporting to the Health and Safety Executive (HSE), this is actioned by the Health, Safety and Wellbeing team Following the reporting of a RIDDOR incident to the HSE an investigation must be carried out locally within the Trust. Page 31 of 54

32 17.4. The RIDDOR incident investigation report will be written by the local team manager where the incident occurred with advice and support available from the Heath, Safety and Wellbeing team The report must be completed using the RIDDOR investigation report template which can be accessed through the Health, Safety and Wellbeing team and TrustWeb The report must be submitted to the Health, Safety and Wellbeing team for final approval within 20 working days of the incident occurring, so that it is available to the HSE if requested. For further information please refer to the flowchart in Appendix Confidentiality and Litigation Internal inquiry reports and any accompanying documentation are confidential documents, which should not be routinely disclosed The disclosure of any internal enquiry reports must be processed by the Records Management team (in consultation with the Quality Directorate) in accordance with the Freedom of Information Act (2000) and the Data Protection Act (1998) requirements People, including the person involved and their families or carers with legitimate reasons for requesting such reports should be supported by either the author of the report or a member of their clinical team to formally request access to these records from the SABP record s management team The Access to Health Records Leaflet containing the request form can be accessed via TrustWeb under the records management tab If information which is requested is withheld, the reason for that decision must be clearly communicated Where disclosure is sought in contemplation of litigation against the Trust, or where proceedings have already been issued against another party where the Trust is not a defendant, then the requesting party may be entitled to a court order requiring disclosure In such circumstances where the granting of a court order requiring disclosure is likely, voluntary disclosure of reports should be considered and advice from the Trust's solicitors should be sought. Page 32 of 54

33 19. Learning from Incidents Local learning Each local manager has access to the Datix incident reports submitted for their team / area. The Datix system allows them to analyse their local data enabling them to identify themes and patterns within their incidents. Which can help them develop and implement local actions through dissemination to their team to resolve local issues. Where formal investigations have been conducted, the finalised report (HLI or SI report) will document areas of good practice as well as areas where improvements may be required to help the teams improve their service. Each report will include (when required) an action plan developed and approved as described in section which will provide guidance for the teams to improve their service and a timescale to achieve this Trust Wide Learning Emerging themes, lessons learnt and improvement initiatives that have been successful are collated by the Clinical Risk and Safety team through the following ways: o Monitoring of the lessons learnt from each formally investigated incident o Themes identified during the discussion of incidents at the Scrutiny Panel and during the CCG Serious Incident Learning and Review Panel. o Improvements / changes to practice required from Coroner s Inquests including those given to the Trust in the form of a Prevention of Future Death notification. o Learning from neighbouring organisations, shared at the CCG Serious Incident Learning and Review Panel. o Inter-Trust networking at conferences and safety collaborative events (such as the South of England Improving Safety in Mental Health Collaborative) o Review of national publications from Governments and Mental Health Organisations. The Clinical Risk and Safety Team share these themes and improvement ideas with the operational teams through: o Monthly attendance at the operational directorate Quality Action Groups to discuss the Learning Report produced by the CRS team which collates the information collated as described above. o The CRS team facilitate regular Trust wide lessons learnt sessions focusing on the learning and action from recent incidents. Where Actions have been identified that require significant changes to practice or a culture within a service the Clinical Risk and Safety team seek the support of lead clinicians and corporate teams to help embed changes to practice. Page 33 of 54

34 19.3. Aggregation of incidents and claims In order for the Trust and staff to learn from the reporting of incidents, complaints and claims, information is aggregated from a number of sources, analysed for patterns and trends and reviewed by services for the implementation of actions leading to improvement and increased patient safety. The Trust collects data on incidents, complaints and claims and triangulates the information to identify common themes or trends to assess: o The Trust s comparative performance position in respect of adverse incidents, complaints and claims, compared with other Trust s and national data available from the Care Quality Commission (CQC), NPSA, NRLS, National Audit Office, and NHSLA o the need to target resources on risk reduction measures to achieve the best benefit or gain for people who use our services, staff and the Trust as a whole o key performance indicators that are needed to measure safety o the effectiveness of specific safety campaigns or initiatives o how best to target training to manage risk and improve patient safety Individuals charged with aspects of risk management or patient safety e.g. the Heads of Clinical Risk and Safety, Legal Services, Infection Control, Health and Safety, and Safeguarding and the Complaints manager can access reports from the Datix system. This enables them to produce reports following the analysis of patterns and trends along with other available information sources contributing to specific reports on events. These reports will either be made available to services directly or through the reporting structure described in Section In the Event of Media Interest If the media, local or national, express an interest in any Incident that has occurred then: Redirect enquiries immediately to the Head of Communications. Under no circumstances should any comments be made on the Incident to the media The Head of Communications will liaise with the Director of the operational team affected, the Director of Quality and Chief Executive to prepare the Trust s response The appropriate Director or Associate Director of Marketing & Communications will work closely with external agencies where required to agree media responses. At times this will require consideration of joint statements being co-produced with other agencies e.g. the Police. Page 34 of 54

35 21. Compliance Monitoring Table What will be How / Frequency Lead monitored method Reporting to Deficiencies / gaps / recommendations and actions That duties outlined within policy are still relevant. Report Annual Head of Clinical Risk and Safety Quality Management Board or other delegated Trust Committee If duties of nominated people change, policy to be amended to reflect this. Escalation of risk by Services Datix report 6 months Director / Associate Director for Service Quality Management Board or other delegated Trust Committee Non compliance will be reported to the relevant Director / Associate Director for them to take appropriate action to resolve the issue. Reporting system to ensure regular update to NRLS is maintained Review of NRLS submission Incident management Scrutiny process including Panel and investigations (including CCG different levels), follow meeting up of action plans and RCA training Complaint, litigation, incidents and PALS activity 6 month Head of Clinical Risk and Safety monthly Head of Clinical Risk and Safety Report Annual Associate Director for Service Immediate and ongoing SIST report Annual support and advice offered to staff Whistle blowing process to include number of cases reported Associate Director for Service Quality Management Board or other delegated Trust Committee Quality Management Board or other delegated Trust Committee Quality Management Board or other delegated Trust Committee Quality Management Board or other delegated Trust Committee Review Annual Director of HR Quality Management Board or other delegated Trust Committee Non compliance will be reported to the Director of Risk and Safety for them to take appropriate action to resolve the issue. Review of reasons for noncompliance at Scrutiny Panel and CCG meeting any changes required to fulfil contractual obligations to be agreed between the CCG and Trust through Director of Quality or Director of Risk and Safety. Non compliance will be reported to the Director of Quality for them to take appropriate action to resolve the issue. Concerns raised, to be addressed by SIST team through review of their service. Concerns raised, to be discussed by Director of HR and Director of Quality with the relevant operational directors. Page 35 of 54

36 22. References Being Open - communicating patient safety incidents with patients their families and carers (2012) Checklist Guidance for reporting, Managing and Investigating Information Governance Serious Incidents Requiring Investigation (IG SIRI) (Nov 2014) Department of Health CQC Guidance on the Duty of Candour (2014) Care Quality Commission Help is at Hand A resource for people bereaved by suicide and other sudden, traumatic death (2005) - Independent investigation of serious patient safety incidents in mental health services (Feb 2008) NPSA Patient safety division NHS Litigation Authority Guidance on Duty of Candour (Nov 2014) NHSLA Preventing Suicide in England: Two years on (Feb 2015) Reporting injuries, diseases and dangerous occurrences in health and Social care guide for employers (Oct 2013 V3) Health and Safety Exec Saying Sorry - NHLSA, Serious Incident Framework Supporting learning to prevent recurrence. (March 2015) - NHS England. Page 36 of 54

37 23. Equality Analysis The equality analysis guidance notes and template are provided to support you in meeting the requirements of the Public Sector Equality Duty which came into force on 5 April You should use this template to record evidence that equality analysis has been carried out before policy decisions take place. The form is a written record that demonstrates that you have shown due regard to the need to eliminate unlawful discrimination, advance equality of opportunity and foster good relations with respect to the characteristics protected by equality law. 1. About the policy/project/change Title of the policy / project / change: What are the intended outcomes / changes expected as a result of this policy / project / change: Are there links with other existing policies/projects: (if yes provide details) Incident Management Policy and Procedure V 6 Implementation of robust, consistent incident management process Risk Management Strategy Health & Safety Risk Assessment Policy 2. Decide if the policy / project / change is equality relevant Does the policy/project involve, or have consequences for people using services, carers, employees or other people? If yes, please state the groups of people who are likely to be affected. If yes, then the policy/project is equality relevant. If no, you can skip to section 6. However the majority of Trust policies and projects are equality relevant because they affect people in some way. It affects all groups as it deals with how incidents should be identified and managed. Incidents could happen to any group. 3. Gathering evidence to inform the equality analysis What evidence have you gathered to help inform this analysis? This can include evidence from national research, surveys & reports, interviews and focus groups, policy monitoring and evaluations from pilot projects, etc. If there are gaps in the evidence available under any of the characteristics, please explain why this is the case and state what actions will be Page 37 of 54

38 taken to close the gaps as part of the action plan. Please ensure you check Annex C of the guidance notes for sources of evidence. The Protected Characteristics & Evidence Using the relevant available evidence - what is known, understood or assumed about each of the equality groups / protected characteristics identified below that could be relevant to this policy / project / change. Record the sources of the evidence used for all the protected characteristics The Policy and Procedure has been drafted in accordance with the Equality Act Engagement and Involvement Record the names of the people and/or groups involved in gathering evidence and/or testing the evidence against the policy / project / change. Who and how were they involved? Who name of individual / group(s) represented Billy Hatifani (Director of Risk and Safety and deputy Director of Nursing) Ben Chambers (Lead Nurse for Clinical Assurance) How have these people been involved e.g. meeting Discussion & reviews. 5. Analysis of the potential impact of the policy / project / change Based on the evidence you have gathered; describe any actual or likely impacts that may arise as a result of the decision and whether these are likely to be positive or negative. Where actual or likely impacts are identified, you should also state what actions will be taken to promote the likelihood of positive impacts as well as minimise or mitigate against possible or likely negative impacts, i.e. what can the Trust reasonably do to actively manage the consequences of its decision / action Eliminate discrimination, harassment and victimisation: Does the policy / project / change, help eliminate discrimination, harassment and victimisation in any way? If yes, provide details. If no, provide reasons Age Caring responsibilities Disability Gender reassignment Marriage & civil partnerships The policy and procedure mitigate against the risks associated with discriminatory behaviour as it emphasis the need for putting in place processes to eliminate and have a zero tolerance stance of abusive behaviour including that which is discriminatory in nature Page 38 of 54

39 Pregnancy & maternity Race / ethnicity Religion or belief Sex / gender Sexual Orientation Advance equality of opportunity: Does the policy / project / change, help develop equality of opportunity in any way? This could include removing or minimising disadvantages suffered by people due to their protected characteristics, taking steps to meet the needs of people from protected groups where these are different from the needs of other people, or encouraging people from protected groups to participate in activities where their participation is disproportionately low. If yes, provide details. If no, provide reasons Age Caring responsibilities Disability Gender reassignment Yes it will support the advancing of equal opportunity as it will view all people equally and includes steps to mitigate the risks of incidents occurring as well as containing guidance on how to fairly mange and support people following an incident without prejudice. Pregnancy & maternity Race / ethnicity Religion or belief Sex / gender Sexual Orientation Promote good relations between different groups: Does the policy / project / change, help foster good or improved relations between different groups in any way? If yes, provide details. If no, provide reasons. Age It encourage corporation and support across different groups of people regardless of protected characteristic Caring responsibilities Disability Gender reassignment Pregnancy & maternity Race / ethnicity Page 39 of 54

40 Religion or belief Sex / gender Sexual Orientation What do you consider the overall impact: This strategy will have a positive impact on staff and people who use services and other key stakeholders. 6. Action Planning Actions to be taken as a result of this analysis (add additional rows as required): 1. Ensure monitoring as outlined through monitoring table in the strategy takes place to ensure full implementation 7. Authorisation Name of person who will take this action Billy Hatifani Date action due to be completed Name & job title of person completing this analysis: Date of completion: 30/04/15 Name & job title of person responsible for monitoring and reporting on the implementation of the actions arising from this analysis: Name & job title of authorised person: (If there are doubts about the completeness or sufficiency of this equality analysis, seek advice from the Equality and Human Rights Team or the Legal Services & Reporting Manager in the Clinical Risk & Safety Team) Date of authorisation: 30/04/15 Ben Chambers Lead nurse for Clinical Assurance. Billy Hatifani Director of Risk and Safety and Deputy Director of Nursing. Billy Hatifani Director of Risk and Safety and Deputy Director of Nursing. Page 40 of 54

41 Appendix 1 - Datix incident / near miss reporting flow chart Page 41 of 54

42 Appendix 2 Trigger List - Examples of incidents to be reported Incidents that should be reported are those that involve: o People who use our services o Visitors (Inc. non Trust staff e.g. contractors and members of the public) o Yourself o Your staff o Damage to or faults with Trust property o Your own property (when carrying out Trust Business). Incidents will therefore include but are not limited to: o Abuse towards anyone: Physical including actual violence against a person Sexual Mental / psychological including verbal threats or abuse Financial Neglect Institutional Discriminatory o injuries (whether caused deliberately or by accident) o Death (expected or otherwise including suicides). o Breaches of confidentiality (IG Breeches). o outbreaks of infectious diseases o Safeguarding incidents (children or adult concerns) o People who have absconded, gone AWOL or failed to return from agreed periods off the ward. o Dangerous occurrences, including working in environments without the required numbers of staff to safely deliver the care / service expected (this includes situations when the safe staffing levels are met, but the acuity demands more). o Medical aids and equipment faults or design defects. o accidental or intentional loss and damage to Trust or personal property o vehicle incidents whether a Trust Vehicle or your own whilst carrying out Trust business o IT system failures o Fires: smoking in unlawful areas unplanned activation of the fire alarm systems Events with a fire risk potential. o Any other incidents with the potential to attract significant media/public interest (an SI). o RIDDOR incidents (see Appendix 7 for further guidance) Remember near misses of any of the above should also be reported on the Datix incident management form to help understand the level of risks being managed by the teams. This will support the early identification of areas where additional intervention could help to prevent an actual incident. Page 42 of 54

43 Appendix 3 - Examples of Serious Incidents Death/serious injury on Trust premises or under the care of Trust services (current or within 6 months of discharge) Death/serious injury of a child on Trust premises or under the care of Trust services Homicide (current or within 6 months of discharge) Communicable diseases Suicide (current or within 6 months of discharge) Serious error Loss/damage Absent Without Leave (AWOL) Media interest Unexpected death Serious confidentiality breach and/or loss of person identifiable data that is assessed as Category 3 or above (see Appendix 9) Fractured neck of femur Grade 3 or 4 pressure ulcer Where it is known or suspected that a person using services, member of staff, member of the public or contractor died, was seriously injured or was seriously put at risk. A death or serious injury to a child in suspicious circumstances, or where death is sudden or unexpected and the cause is not known or uncertain. Where it is known or suspected that a person using services is involved in a homicide whilst on Trust premises or under the care of Trust services in the community. Significant outbreaks of communicable diseases, radiation or chemical hazards, food contamination, or incidents of infection. Where it is known or suspected that a person using services, member of staff, member of public or contractor committed suicide whilst on Trust premises or under the care of Trust services in the community. Where it is known or suspected that a person using services, member of staff, member of the public or contractor was injured or was seriously put at risk by an error, or series of errors, by a member of staff or contractor. Where it is known or suspected that the Trust, a person using services, member of staff, member of the public or contractor suffered or was at risk of suffering a financial, material or structural loss/damage as a result of large scale theft, fraud or fire/flood/vandalism. Where a patient, who is detained under the Mental Health Act, is absent without leave from inpatient care (and is identified as presenting as a high risk to either themselves or others). Where it is known or suspected that a person using services, member of staff, member of the public or contractor was seriously injured or put at significant risk by an incident which may attract media or political attention. In the case of an unexpected death, which is not suspicious (e.g. a death of a person from liver failure, known to have abused alcohol for a number of years), the Head of Clinical Risk and Safety will liaise with the service that was supporting the person and the Director of Risk and Safety to determine what further investigation would be most appropriate. Advice should be sought from the Director of Quality & Performance in their capacity as Senior Information Risk Owner If a person suffers a fractured neck of femur (or other similar type of injury) following a fall whilst receiving inpatient care. If a person develops a grade 3 or 4 pressure ulcer whilst receiving inpatient care. Page 43 of 54

44 Appendix 4 Registration of a Serious Incident Page 44 of 54

45 Appendix 5 Serious Incident Investigation Process Page 45 of 54

46 Appendix 6 - Duties and Legal Obligations of the Trust (Notifiable Incidents) The Trust is required to report and/or notify various agencies as follows: To report certain incidents and certain work related diseases of staff or dangerous occurrences to the Health & Safety Executive (HSE) under the Reporting of Injuries, Diseases and Dangerous Occurrences Regulations (RIDDOR). To report patient safety incidents to the National Reporting and Learning System (NRLS) To formally notify the relevant commissioners of "Serious Incidents" via the STEIS system. To formally notify the Medicines and Healthcare Products Regulatory Agency (MHRA) of "Adverse Incidents" involving devices or equipment categorised as Medical Devices. To formally notify the Medicines and Healthcare Products Regulatory Agency (MHRA) of certain incidents involving drugs To report serious untoward incidents to the Social Services Dept. where the incident has a social services aspect. To notify the NHS Counter Fraud Service where incidents involve fraud. To report all incidents where criminal charges may arise to the police. To report incidents in relevant care locations to the Care Quality Commission To notify the NHS Security Management Service of incidents involving actual physical assault and threatening behaviour To report certain fire related incidents including those to which the Fire Brigade have attended to the Department of Health Estates Department To report certain plant and plant related equipment or systems failures to Department of Health, Estates Department To report losses, damage and theft of property and vehicles to its insurers. To report incidents incurring financial loss to the Trust's Internal Audit Committee. To report certain diseases in people who use services and staff, including Food Safety related incidents to the Control of Infection Officer, Environmental Health Department and Consultant of Communicable Disease Control (CCDC) To notify the NHS Litigation Authority (NHSLA) of potential and actual claims To notify the Information Commissioner s Office of a loss of person identifiable data and/or confidentiality breach that is assessed as Category 3 or above Page 46 of 54

47 Appendix 7 - Reporting of Injuries, Diseases and Dangerous Occurrences Regulations (RIDDOR) RIDDOR reportable incidents are mainly adverse incidents that result in an injury to a member of staff whilst at work, and must be reported to the Health & Safety Executive. Accidents to members of the public or others who are not at work must also be reported if they result in an injury and the person is taken directly from the scene of the accident to hospital for treatment to that injury. Reportable Major Injuries o Over 7 consecutive day absences of staff from work due to a work related injury (not including the day of the accident but does include weekends and rest days) o Death from a work related accident, with the exception of suicides o Fractures or breaks, other than to fingers, thumbs and toes o Amputations o Any injury likely to lead to permanent loss of sight or reduction in sight o Serious burns o Any loss of consciousness caused by head injury or asphyxia o Any incident that causes the victim to have treatment for that injury at A&E Reportable Occupational Diseases o Carpal tunnel syndrome o Severe cramp of the hand or forearm o Occupational dermatitis o Hand-arm vibration syndrome o Occupational asthma o Tendonitis or tenosynovitis of the hand or forearm; o Any occupational cancer o Any disease attributed to an occupational exposure to a biological agent Reportable Dangerous Occurrences o The collapse, overturning or failure of load-bearing parts of lifts and lifting equipment o Plant or equipment coming into contact with overhead power lines o The accidental release of any substance which could cause injury to any person Page 47 of 54

48 Appendix 8 RIDDOR Investigation Process Page 48 of 54

49 Appendix 9 IG SIRI response flow chart. Page 49 of 54

50 Appendix 10 Summary guide to Being Open. Apologising and explaining when people using services have been harmed can be very difficult. You may have already considered some or all of the recommendations below, but this guide will help ensure that you follow best practice. People using services and/or carers should receive an apology as soon as possible after a patient safety incident has occurred and staff should feel able to apologise on the spot. Saying sorry is not an admission of liability and it is the right thing to do. The documentation of communication should begin with the initial discussion and apology as soon as an issue is identified. People using services have a right to expect openness in their care. Staff should liaise with the communications or the Clinical Risk & Safety Teams or use existing professional networks and Trust Committees to ensure there is open communication with other organizations, healthcare teams, staff, patients and or carers in relation to incidents. This sharing of information should be undertaken in line with the NHS confidentiality code of Practice. Stage 1: preliminary meeting with the individual and/or their carers Duties: Who should attend? A lead staff member who is normally the most senior person responsible for the person s care and/or someone with experience and expertise in the type of incident that has occurred. Ensure that those members of staff who do attend the meetings can continue to do so; continuity is very important in building relationships. The person taking the lead should be supported by at least one other member of staff, such as risk manager, nursing or medical director, or member of the healthcare team treating the patient. Ask the person and/or their carers who they would like to be present. Consider each team member s communication skills; they need to be able to communicate clearly, sympathetically and effectively. Hold a pre-meeting amongst healthcare professionals so that everyone knows the facts and understands the aims of the meeting. When should it be held? As soon after the incident as possible. Consider the patient s and/or their carers home and social circumstances. Check that they are happy with the timing. Offer them a choice of times and confirm the chosen date in writing. Do not cancel the meeting unless absolutely necessary. Page 50 of 54

51 Where should it be held? Use a quiet room where you will not be distracted by work or interrupted. Do not host the meeting near to the place where the incident occurred if this may be difficult for the patient and/or their careers. Stage 2: discussion How should you approach the person and/or their carers? Speak to the person and/or their carers as you would want someone in the same situation to communicate with a member of your own family. The information should be truthful and timely. Do not use jargon or acronyms: use clear, straightforward language. Consider the needs of people with special circumstances, for example, linguistic or cultural needs, and those with learning disabilities. What should be discussed? Introduce and explain the role of everyone present to the person and/or their carer and ask them if they are happy with those present. Acknowledge what happened and apologise on behalf of the team and the organisation. Expressing regret is not an admission of liability. Stick to the facts that are known at the time and assure them that if more information becomes available, it will be shared with them. Do not speculate or attribute blame. Suggest sources of support and counselling. Check they have understood what you have told them and offer to answer any questions. Provide a named contact who they can speak to again. Stage 3: follow-up Clarify in writing the information given, reiterate key points, record action points and assign responsibilities and deadlines. The person s notes should contain a complete, accurate record of the discussion(s) including the date and time of each entry, what the person and/or their carers have been told, and a summary of agreed action points. Maintain a dialogue by addressing any new concerns, share new information once available and provide information on counselling, as appropriate. For more information on the NPSA s Being open work visit: Page 51 of 54

52 Appendix 11 SIST response following a Traumatic Incident Page 52 of 54

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