INCIDENT MANAGEMENT POLICY and PROCEDURES

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1 INCIDENT MANAGEMENT POLICY and PROCEDURES Risk Management Policy Reference: RM 3.0 id1132 Date of Issue: November 2009 Prepared by: Head of Clinical Date of Review: November 2011 Governance & Risk Management Lead Reviewer: Risk Management Version: 2.0 Steering Group Authorised by: Clinical Governance Date: 10 November 2009 EQIA: Yes / No Committee Distribution Executive Directors Associate Directors Clinical Directors General Managers Clinical Leads Assistant General Managers CHP Lead Nurses/Nurse Managers Clinical Governance Committee Risk Management Steering Group Head of Clinical Governance and Risk Management Head of Health and Safety Professional Heads of Service/ AHP Professional Leads Network Managers Head of Public Engagement Head of ehealth Director of Occupational Health Director of Pharmacy Clinical Dental Manager Clinical Governance Support Team Managers Health & Safety Managers Moving & Handling Manager Violence & Aggression Manager Method Paper Intranet Page: 1 of 56 Date of Review: November 2011

2 Contents 1. Introduction 3 2. Aims 4 3. Scope of the Policy 5 4. Definitions 5 5. Roles and Responsibilities 7 6. Incident Management Incident Analysis, Action Planning and Review Counselling and Support for Staff Training and Education Monitoring and Review 12 Procedures 1. Initial Management of an Incident Procedure Reporting of an Incident Procedure Type of Incidents to be Reported Procedure Incident Grading Procedure Carrying out an Incident Review Procedure Timescales and Summary Actions Procedure Learning from Incidents Procedure Involving Patients Procedure Dealing with the Media Procedure Joint Working and Multi-Agency Issues Procedure Serious Untoward Incidents Procedure Protocol for Informing the NHS Board Procedure Appendices Page Appendix 1 RIDDOR 34 Appendix 2 DIF 1 Form 36 Appendix 3 Types of Incidents to be Reported 37 Appendix 4 Incident Grading Tool 40 Appendix 5 NHS Highland Being Open Policy Appendix 6 - A Quick Reference Guide for Staff 42 Protocol for Notification of Death to the Procurator 44 Fiscal Appendix 7 CIR for Mental Health Learning Disabilities Appendix 8 QIS Suicide Reporting System Page: 2 of 56 Date of Review: November 2011

3 1. INTRODUCTION 1.1 NHS Highland is committed to continually and systematically reviewing and improving its healthcare processes and working practices to prevent or reduce the risk of harm. It is also committed to complying with its statutory responsibilities to ensure, so far as is reasonably practicable, the health, safety and welfare of all its employees and other persons on its premises or using its services. 1.2 Incident reporting is one of the key methods for alerting an organisation to issues that, if left unattended, may pose a serious risk to either the patients in its care, the staff it employs or to others for which it has a responsibility e.g. visitors, contractors, volunteers etc. Without an effective system the organisation may be blind to some of this risk exposure, and cannot make the necessary improvements to support safety. 1.3 It is the responsibility of everyone working for NHS Highland to report all occasions where something has happened that has or could have caused harm to a patient, member of the public, staff member or contractor, or affected the day to day running of the organisation. However it is recognised that reporting on occasions where things have gone wrong can be challenging, especially where there are implications for individual staff or healthcare teams. NHS Highland wishes to encourage all staff to have the confidence to report incidents and near misses. 1.4 In addition NHS Highland has a statutory duty under the Reporting of Injuries, Diseases and Dangerous Occurrences Regulations 1995 (RIDDOR) to report certain incidents which occur in the course of work. RIDDOR reports bring to the attention of the Health and Safety Executive serious incidents which they may wish to investigate. Staff and managers have a responsibility to facilitate NHS Highland s Health and Safety staff in meeting our legal responsibility to report RIDDOR related incidents in the appropriate timeframe specified elsewhere in this document. 1.5 In the majority of cases the causes of incidents or near misses go far beyond the actions of individuals immediately involved. In healthcare there are a number of factors at work at any one time that can affect the likelihood of incidents occurring. It is with this in mind that NHS Highland is committed to advocating an 'Open and Fair Culture'. There will, however, be instances where individuals must be held accountable for their actions, particularly if there is evidence of gross negligence, recklessness or criminal behaviour. A culture where errors or service failures can be reported and discussed, lessons learned and necessary changes put in place is essential. 1.6 The reporting and management of incidents and near misses is an essential part of the systems and processes that support clinical governance and risk management, health and safety management and staff governance within NHS Highland. Information and data used for this purpose is captured on the DATIX Risk Management System. Page: 3 of 56 Date of Review: November 2011

4 2. AIMS 2.1 This policy aims to ensure that all incidents are reported and analysed as appropriate and that the knowledge thus gained is regularly disseminated to improve the performance of the organisation. This will encourage and strengthen a learning culture in which the quality of care for patients and working lives for staff will continuously be improved. 2.2 This will be achieved by ensuring that: All individuals are aware of what constitutes an accident, incident or near miss ; There is a clear and reliable system for the management and reporting of all incidents and near misses; All reported incidents are graded according to the actual impact on, and/or the potential future risk to NHS Highland. The grading system complements that of the Risk Assessment Guidance and the overall Risk Management Process; Incidents are subject to analysis including causal analysis according to the category of risk, and where appropriate an improvement strategy is prepared; Aggregate reviews of local incidents are carried out on an ongoing basis by NHS Highland and the significant results communicated to local stakeholders; Lessons are learned from individual incidents, from local aggregate reviews and from wider experiences, including feedback from agencies/bodies, and benchmarking. Improvement strategies aimed at reducing risk to future patients, directly employed staff and others including visitors, contractors and volunteers are implemented and monitored by NHS Highland; Employees are motivated to report incidents by ensuring that they are aware that their concerns are being acted upon and are provided with timely feedback on changes that have taken place as a result of their reporting. 2.3 Support for staff involved in incidents, complaints, claims or inquests is vital and support mechanisms will be reviewed and widely publicised for all groups of staff. NHS Highland recognises that whilst it is important to promote a culture of learning and closing the loop with regards to risk management, the effect on staff directly involved in an incident or enquiry should not be underestimated. 2.4 NHS Highland has a statutory duty to report certain kinds of accidents to the Health and Safety Executive (HSE). This would include deaths, any over 3 day absences, major injuries, violent incidents, dangerous occurrences and occupational ill health under the Health and Safety at Work etc Act 1974 and more specifically in accordance with the Reporting of Injuries, Diseases and Dangerous Occurrences Regulations (RIDDOR) Please refer to Appendix 1. It is also a requirement to report certain incidents to a national body (e.g. Scottish Healthcare Supplies, Scottish Executive Health Department and Procurator Fiscal). 2.5 This Incident Management Policy is supported by Incident Management Procedures. Page: 4 of 56 Date of Review: November 2011

5 3. SCOPE OF THE POLICY 3.1 This Policy applies to all staff employed by NHS Highland and encompasses any incident affecting patients, clients, staff, volunteers, contractors or visitors (including carers, relatives and advocates). 3.2 This policy is not for the purpose of clinical performance monitoring. If anyone is concerned with the performance or professional standard of any individual employee they should refer to the procedures contained within the NHS Highland Dealing with Employee Concerns Policy and the NHS Highland Management of Employee Capability Policy. 3.3 However the DATIX Risk Management system does allow for staff roles within incidents to be recorded. Whilst this information is tightly controlled line managers will be able to request details of incidents relating to their staff for the purposes of the personal development plans / appraisal process / reaccreditation. 3.4 In addition the system will be monitored by the Clinical Governance Support Team and any concerns over a member of staff s performance will be flagged with the direct line manager concerned. NHS Highland Dealing with Employee Concerns Policy and the NHS Highland Management of Employee Capability Policy should then be referred to where necessary. 3.5 This policy and the associated procedures apply to incidents which relate to research activity supported by NHS Highland. In these instances the incident investigation shall be coordinated by the NHS Highland Research Manager. 4. DEFINITIONS 4.1 Accident An accident is defined as an event that results in injury or ill-health. 4.2 Incident An incident is defined as any event or circumstance arising during NHS Highland's care or service provision that could have or did lead to unintended or unexpected harm, loss or damage. 4.3 Near Miss A near miss is where an error or omission occurred which could have caused harm to a patient, member of staff or visitor or others or where a last minute intervention prevented a serious incident from occurring. Reports of near misses are helpful from a risk management perspective as they may help guide changes in procedure to avoid recurrence 4.4 Harm Harm is defined as injury (physical or psychological), disease, suffering, disability or death. In most instances harm can be considered to be unexpected if it is not related to the natural cause of a patient s illness or underlying condition. This includes the death of a patient. Page: 5 of 56 Date of Review: November 2011

6 There may also be harm to NHS Highland as a result of e.g. fraudulent activity, loss of confidential information or other incidents which have an impact on NHS Highland s objectives. 4.5 Serious Untoward Incident A serious untoward incident (SUI) can be broadly described as when an accident or incident involving a patient, member of staff, visitor on NHS property, contractor or other person to whom the organisation owes a duty of care, occurs causing significant loss or damage, serious injury or unexpected death. It includes situations where: Serious damage occurs to NHS property e.g. through fire, criminal activity, etc. A major health risk occurs, e.g. outbreak of notifiable diseases, such as blood borne viruses (Hepatitis B&C etc) or radiation incidents Unexpected death of a child, adult or elderly person Serious drug dispensing or administration errors Systematic screening errors or consistently poor diagnostic performance Major outbreaks of infection Major clinical errors Failures in engineering infrastructure putting patients, staff or visitors at risk (for example electricity, medical gases) Large scale theft or fraud Where litigation is expected A number of service users or staff are affected That attracts adverse media attention or has other ramifications for the Board that may be disproportionate to the actual nature of the incident itself. A serious threat to the health of the community, disruption to the health service, or causes significant public concern. Suicide/attempted suicide. 4.6 Person in Charge Person in charge is defined as the most senior person responsible for the area or work activity at the time of the incident. This may not necessarily be the permanent manager of the ward or department. 4.7 Department Manager Department Manager is defined as the person who is permanently responsible for the area or work activity within which the incident took place. This includes Charge Nurse, Supervisor, Head of Department, Nurse in Charge, Estates Manager or other responsible person and should be interpreted in context of the incident. 4.8 Root Cause Analysis (RCA) Is a quality improvement tool used to help determine the contributory factors or root causes that led to (or nearly resulted in) an unwanted event. The process of undertaking an RCA enables a structured approach to investigating incidents, which supports analysis of effective solutions to problems. It involves all levels of staff in identifying causes and solutions, promoting a positive attitude to the management of incidents and moving towards a fair and learning culture. 4.9 DATIX DATIX is NHS Highland s Risk Management system. All incidents and near misses should Page: 6 of 56 Date of Review: November 2011

7 be reported directly into the DATIXweb Incidents module which is accessible through NHS Highland s intranet DIF1 This is DATIX Incident Form 1 which can be accessed by any member of staff with access to a computer with NHS Highland s intranet and is found under Non-Clinical Applications. Datix Internet Site. Anyone can report an incident by completing this form and then selecting a manager to submit the incident to DIF2 This is DATIX Incident Form 2 which can only be accessed by managers and their deputies. A username and password is required to access this form. The DIF2 allows managers to review the information submitted by the person reporting the incident on the DIF1. The manager or deputy can then grade the incident and record details of any relevant investigation Handler Handler is the term used to identify the person responsible for completing the DIF2 on the DATIXweb Incidents Module. The Handler is decided by the person reporting the incident this is the manager to whom they submitted the form. 5. ROLES AND RESPONSIBILITIES 5.1 All staff have a responsibility to: Take care of their own safety and that of others including patients, clients, colleagues, volunteers, contractors or visitors; Eliminate unlawful discrimination and unlawful harassment, promote equality of opportunity and promote good relations between different population groups; Report any incident or near miss to their manager or other responsible person; Complete a DIF1 Form and submit this to the appropriate manager as soon as is practical to do so after the incident has been dealt with, and no later than 24 hours after the incident; Raise / discuss any concerns they may have with a senior member of staff. 5.2 Managers have a responsibility to: Identify and escalate RIDDOR Reportable Incidents to the Health and Safety Team as soon as possible after the incident and within 5 Days to ensure timely reporting to the HSE. Ensure that, as a first priority, any person affected by an incident receives appropriate first aid or medical treatment. The manager must also ensure that action is taken to prevent further danger to others. Equipment involved in the incident must be made safe, removed from use and retained for inspection. Where possible, the surrounding area of the event should be isolated, pending any necessary analysis; Ensure that reporting procedures are complied with in the event of any incident affecting any patients, clients, members of staff, volunteers, contractors, visitors or premises for which they are responsible, including the completion of an initial action plan; Including Page: 7 of 56 Date of Review: November 2011

8 ensuring staff report the incident on the DIF1 form within 24 hours of the incident occurring. Ensure that staff involved in an incident are given the opportunity to access the Occupational Health Service if required; Undertake reviews of incidents and near misses, in liaison with other managers where necessary; Grading and reporting details of investigation regarding the incident on the DIF2 within agreed timescales; To ensure any serious incidents are reported to the General Manager and/or Clinical Director; Provide support to any team or individual who is carrying out a review of the incident; Provide the opportunity for staff to de-brief and feedback on specific incidents and near misses; Use feedback function within DATIX to provide feedback to person reporting the incident. Involve and consult accredited staff side H&S representatives, making information and knowledge of incidents available; Monitor trends within their area of responsibility; use pre-set reports to monitor trends in own area and share this information with staff; Contribute to dissemination of lessons learned and implement any actions identified as their responsibility, or the responsibility of their team. 5.3 General Managers/ Clinical Directors/Heads of Corporate Services Departments have a responsibility, via the Clinical Governance & Risk Management Groups to: Ensure systems are in place / implemented to review all reported incidents and near misses within their areas on a regular basis and agree any necessary actions or improvements required; Ensure systems are in place / implemented to provide feedback on local reviews of incidents and near misses to Clinical Governance & Risk Management Groups as necessary; Initiate a review of serious incidents or near misses in liaison with specialist advisors and staff side H&S representatives where necessary; Ensure systems are in place/ implemented to assess all near misses and incidents, and where appropriate implement action plans to address root causes identified to ensure that learning is disseminated; Monitor implementation of local action plans and where relevant action plans from elsewhere in the organisation; Where relevant ensure that incidents are finally approved within the DATIX system and that all investigations where actions are outstanding are followed up within the agreed timescales. 5.4 The Head of Clinical Governance & Risk Management has a responsibility to: Ensure an effective Incident Reporting System is in place which meets the needs of NHS Highland as set out in this policy; Take the lead role in developing and overseeing systems for disseminating lessons for learning following incidents; Ensure reviews of serious incidents are carried out and reported within the agreed timescales; Ensure that serious immediate concerns are reported directly to the Chief Executive. Page: 8 of 56 Date of Review: November 2011

9 5.5 The Head of Clinical Governance & Risk Management and the Head of Health & Safety, jointly or separately and according to circumstances, have a responsibility to: Provide relevant support to ensure incidents are reviewed and analysed in accordance with the Incident Management Procedures; Provide support to service leads in monitoring improvement actions; Ensure that the relevant Directors and Senior Managers are kept informed of specific incidents and near misses; Produce regular analysis of trends and outcomes of incidents and near misses, and report to relevant groups and departments; Co-ordinate a root cause analysis training programme; Co-ordinate a risk management training programme; Co-ordinate external reporting as required; Produce an annual report on incidents and near misses. 5.6 Specialist Advisors / Managers (e.g. Health & Safety Managers / Advisors, Moving and Handling Manager, Management of Violence & Aggression Manager / Advisors, Clinical Governance Managers etc.) have a responsibility to: Provide advice, guidance and support within their areas of competence to managers and other employees if requested; Assist in incident analysis as required. To provide expert advice on root cause analysis of incidents as necessary and appropriate assistance to ensure incident reports are prepared within the agreed timescale; Make recommendations to reduce risk based on incident analysis; Offer practical support and guidance to Managers to implement remedial actions and to monitor progress with such plans; Encourage staff reporting of incidents and near misses; Keep their knowledge and skills up to date within their areas of competence; Make recommendations to reduce risk based on changes to legislation, Scottish Executive Health Department (SEHD) and NHS Quality Improvement Scotland (NHS QIS) guidelines, and other relevant information; Assist in the provision of staff training where appropriate; Ensure that all incidents are final approved within 5 working days of being approved by the relevant local manager, and that all investigations where actions are outstanding are followed up within 1 month; Incidents graded high and very high will have outstanding actions tabled for discussion at the Clinical Governance and Risk Management Groups. 5.7 The Risk Management Steering Group has a responsibility to: Encourage a culture of learning from incidents and near misses; Encourage a culture of fairness, ensuring that the root causes of incidents and near misses are addressed; Receive regular reports on trends and outcomes of incidents and near misses from the Clinical Governance Support Team and Health & Safety Team; Receive reports on specific serious incidents; Monitor that appropriate action and learning has taken place following the identification and reporting of incidents and near misses. Page: 9 of 56 Date of Review: November 2011

10 5.8 The Clinical Governance Committee, Staff Governance Committee and Health & Safety Committee have a responsibility to: Ensure that the organisation develops a fair, open and risk aware culture; Ensure that the organisation develops a culture of reporting and learning from incidents and near misses; Monitor the implementation of the Incident Management Policy and Procedures; Receive regular reports on trends and outcomes of incidents and near misses from the Clinical Governance Support Team and Health & Safety Team; Receive reports on specific serious incidents; Monitor that appropriate action and learning has taken place following the identification and reporting of incidents and near misses. 6. INCIDENT MANAGEMENT 6.1 To support Managers detailed procedures have been developed which cover: Initial management of an Incident Procedure 1 Reporting of an Incident Procedure 2 Type of Incidents to be Reported Procedure 3 Incident Grading Procedure 4 Carrying Out an Incident Review Procedure 5 Timescales, and Summary Actions Procedure 6 Learning from Incidents Procedure 7 Involving Patients Procedure 8 Dealing with the Media Procedure 9 Joint Working and Multi-Agency Issues Procedure 10 Serious Untoward Incidents Procedure 11 Protocol for Informing the NHS Board Procedure INCIDENT ANALYSIS, ACTION PLANNING AND REVIEW 7.1 All incidents and near misses require basic initial analysis. Following this the incident must be assessed for actual or potential severity using the risk assessment tool (Appendix X). The extent of further incident analysis will depend on the grade assigned through this process. 7.2 Where it is appropriate, root cause analysis should be undertaken, in order to understand why the incident occurred, how the incident could have been prevented and ensure wider learning about any underlying problems with NHS Highland s systems or processes. 7.3 An action plan must be developed to address the concerns identified following the root cause analysis. The action plan must detail a timetable for action, responsible individuals and/or teams, and a schedule for review. 7.4 A summary of the actions taken following an incident review will be provided by the Local Manager to the individual who reported the incident and to those who were involved in the incident analysis. The summary will be prepared taking full account of duties with regard to confidentiality. Page: 10 of 56 Date of Review: November 2011

11 7.5 Debriefing and encouraging informal and formal discussion about incidents will assist individuals, services and the organisation to learn from incidents. This must be usual practice following the occurrence of serious incidents and near misses with potentially serious consequences. Accredited staff side representatives should be involved in this process at the earliest possible stage. 8. COUNSELLING & SUPPORT FOR STAFF 8.1 Managers are responsible for ensuring that staff are given the opportunity to be de-briefed following an incident with serious or potentially serious consequences. 8.2 Managers will ensure that staff are informed of how to access Occupational Health Services and Psychology Services if appropriate and other counselling / therapy services. 8.3 Managers should ensure that staff are encouraged to seek support from accredited staff side representatives where appropriate. 8.4 NHS Highland will provide support to any member of staff identified as a witness in court proceedings: in preparing statements, including guidelines and support from the line manager with additional advice as required from the Legal/Claims Officer; in preparing for a court appearance, including advice from the line manager and/or the Legal/Claims Officer; with debriefing. The line manager should arrange an informal meeting with the staff member subsequent to the court proceedings. 9. TRAINING AND EDUCATION 9.1 In order to facilitate an open and transparent incident reporting culture and to support the implementation of this policy throughout NHS Highland, the Clinical Governance Support Team and the Health and Safety Team will provide training to staff across the organisation. 9.2 All new staff will be trained in how to log an incident using DATIXweb. 9.3 The Clinical Governance Support Team and Health and Safety Team will provide training on any aspect of incident management including root cause analysis as required 9.4 Training on Incident Management forms part of the training provided by the Clinical Governance Team for the ILM Management Development Programme and the Leading Better Care Programme All training provided by the Clinical Governance Support Team and Health and Safety Team is evaluated and changes are made as appropriate Page: 11 of 56 Date of Review: November 2011

12 10. MONITORING AND REVIEW 10.1 This Policy will be reviewed in two years in accordance with NHS Highland Revised Policy for the Management of Policies and Procedures and NHS Highland Health and Safety Policy. Page: 12 of 56 Date of Review: November 2011

13 1. INITIAL MANAGEMENT OF AN INCIDENT - PROCEDURE On discovery of an incident the priority is that any person affected by the incident should receive appropriate first aid or medical treatment. The Person in Charge must ensure that this is done, and that action is taken to prevent any further injuries / damage to the affected person or to others. 1.2 Equipment involved in the incident must be made safe, removed from use and retained or isolated for inspection. Where possible, the surrounding area of the event should be isolated, pending any necessary investigation. 1.3 Once a safe situation has been assured the detailed NHS Highland Incident Management Procedures must be followed. 1.4 If the incident is serious or if an emergency situation arises, the appropriate staff should be contacted as per the Serious Untoward Incident Procedure 6. The NHS Highland Emergency Plan should be followed when handling any major incident or emergency. 1.5 If the incident is a RIDDOR-reportable incident (see Appendix 1) the necessary report should be made on the DIF1, which when submitted will automatically alert the Health and Safety Team who will contact the Health and Safety Executive (HSE) within the necessary timescales. Whether the incident is RIDDOR reportable should be checked by the Manager approving the incident on the DIF2 as this could have changed between the time the incident was reported and when the Manager reviews the incident. It is the Manager s responsibility to inform the Health and Safety Team if the status has changed. 1.6 In all cases where a patient has been involved in an incident, where possible the patient must be informed before informing relatives, carers, the media or other parties. If there is the possibility that an incident may lead to media interest the communications department should be contacted for advice. Staff should not talk to the media about an incident without obtaining advice. Further guidance can be obtained from NHS Highlands Being Open Policy, A Quick Reference Guide for Staff, Appendix 5 and Dealing with the Media Procedure 9. Page: 13 of 56 Date of Review: November 2011

14 2. REPORTING AN INCIDENT PROCEDURE All incidents, including near misses, must be reported. Until an initial analysis of the circumstances of the incident takes place an informed decision cannot be made about the implications. Whilst it is acknowledged that some patients may be involved in several incidents in one day, i.e. slips, trips and falls or disruptive, violent and aggressive behaviour, staff are encouraged to record all incidents individually and not report one incident detailing several occurrences, as this will under-report the level of incidents taking place in NHS Highland. However, staff can contact Clinical Governance to discuss this if they have any concerns. 2.2 NHS Highland uses the DATIX Risk Management System s DATIXweb Incident Module to record details of incidents and near misses. 2.3 Incidents and near misses should be reported on the DIF1 form of the DATIXweb Incident Module which is accessible via NHS Highland s intranet site. No username or password is required however staff will need access to a computer. NHS Highland recognises that not all staff will have easy access to a computer, accordingly it is the responsibility of each department which envisages a problem with access to ensure that they nominate an administrative person who can assist staff to report incidents via the DIF1, or who can input the information from a paper-based version, a copy of which is appended to this procedure (Appendix 2) 2.4 A DIF1 must be completed by the person(s) involved in the incident. The Person in Charge may help with this if necessary. If it is not possible for the person(s) involved to complete their form, it should be completed by the Person in Charge with help from witnesses where required. If a patient, members of the public or contractors are involved, then the form should be completed by the relevant employee. In any case, the form(s) should be completed and submitted as soon as is practical after the incident has been discovered and no later than 24 hours after the incident. 2.5 The person completing the DIF1 should take particular care to record only known facts rather than opinion and should not assign fault or blame, as the form is a legally discloseable document. 2.6 The person completing the DIF1 will select a manager to submit the incident to. This Manager is deemed the Handler of the incident and accordingly is responsible for reviewing the information submitted on the DIF2 and grading the incident (see Procedure 4) the outcome of which will determine what further action is required and how much of the investigation screen requires completion. Page: 14 of 56 Date of Review: November 2011

15 3. THE TYPES OF INCIDENTS TO BE REPORTED PROCEDURE Staff should report anything that causes them concern but the overlying principle which should be followed is that any event or circumstance arising during NHS Highland's care or service provision that could have or did lead to unintended or unexpected harm, loss or damage to the individual (i.e. patients, staff or others) or to the organisation must be reported. This definition includes near misses: any incident which did not result in injury / ill health or property damage / loss but had the potential to do so Examples of the types of incidents which should be recorded on a DIF1 form are shown in Appendix If unsure about the category of the incident, please contact the Clinical Governance Support Team for advice - during normal working hours. Page: 15 of 56 Date of Review: November 2011

16 4. INCIDENT GRADING PROCEDURE All incidents and near misses require basic initial analysis. The extent of further review and the subsequent actions required will vary according to the risk rating derived from the incident analysis. 4.2 The risk grading process developed by NHS Highland is based on the Australian/New Zealand Risk Management Standard (AS/NZS 4360:2004) and the NHS Quality Improvement Scotland Core Risk Assessment Matrices (October 2005). This includes the use of a 5x5 risk matrix. 4.3 The manager to whom the incident is submitted, the Handler should grade the incident on the DIF2 using the process described below. This process should be completed as soon as the manager is made aware of the incident. 4.4 The grading of any incident is determined by two factors: The severity of consequence or outcome of the incident; or for near misses the potential The probability or likelihood of the incident occurring/reoccurring. 4.5 Both of these factors can be assigned to one of five categories. A detailed description of the categories is given in Appendix Each incident should be assessed and scored for likelihood and severity and the results plotted on the risk matrix. 4.7 Grading incidents in this way will then establish: The level of local review and causal analysis that should be carried out The internal reporting requirements These are described in more detail in Procedure There is the facility to re-grade incidents following the completion of the incident form. If, following initial review of the incident, the initial risk grading is found to be either too high or too low, the incident must be re-graded accordingly. DATIX will record any change to the grading, along with the details of the manager who made this change. However the rationale for re-grading must be included on the investigation screen of the DIF2 or attached in a word document to the incident in the system. Page: 16 of 56 Date of Review: November 2011

17 5. CARRYING OUT AN INCIDENT REVIEW PROCEDURE 5 The Risk Grading process has been adopted to provide guidance to managers on what action should be taken following an incident. Managers should however use their experience and judgment on what level of investigation needs to be undertaken. In some cases it may be more helpful just to consider the impact / consequence of the incident. 5.1 All incidents have risk potential and should be reviewed by the Department Manager. In some instances a more detailed analysis may be necessary i.e. those incidents that are graded as MEDIUM (depending on the circumstances) and all graded as HIGH or VERY HIGH on the grading matrix (but not necessarily all). Other parties may need to be involved, e.g. Health & Safety Manager, Clinical Governance Managers, other Specialist Advisors, especially where an outside impartial viewpoint is essential. 5.2 Every incident will require an assessment to establish the cause. This will range from a minimal review where the root cause is well known and is already being addressed through other means, or the incident has been risk assessed and is as low as it can be, to a serious untoward incident which will give rise to a full and immediate analysis. This is called Root Cause Analysis and this term is used to describe the process necessary to establish the true cause of a problem and the actions necessary to eliminate it. 5.3 Training on root cause analysis has been provided to nominated staff within the Clinical Governance Support Team and the Health & Safety Team and they can provide additional advice, support and facilitation as required. 5.4 Who should carry out the incident review will depend on the nature of the incident but will certainly involve the Department Manager and may involve more senior personnel. Outside experts should be consulted as necessary. In the event of an incident of a criminal nature the police will be informed at the earliest opportunity, for immediate investigation, if necessary, before the completion of an incident report. 5.5 The following is a list of factors, which are recommended to be included in an analysis of the incident, dependent on the nature of the incident and the work area involved: The precise location The precise time and date Who was involved in the incident The normal occupation of the person involved if an employee Exactly what happened including: o Exactly what the person was doing at the time o The conditions at the time (e.g. lighting, weather, housekeeping) o The causes of the incident o Which standards were not met or deviated from The nature of any injuries or damage which occurred including: o What inflicted the injury or damage Description of any equipment involved in the incident An assessment of the grading of the incident including the potential severity and the chance of recurrence The causes (contributory factors) of the incident Page: 17 of 56 Date of Review: November 2011

18 The measures to prevent a recurrence - immediate and future Details of any witnesses to the incident 5.6 The Critical Incident Resource Pack for Managers should be referred to and is available on the Clinical Governance and Risk Management webpage on the intranet, as well as on the DATIXweb Homepage 5.7 The Department Manager should make an assessment as to whether written statements are required and make arrangements for these to be obtained as necessary. 5.8 Incidents which are graded LOW These will be LOW risk, simple incidents, dealt with by the Department Manager Managers will be required to login to review the information submitted about the incident and grade the incident on the investigation screen. The remainder of the investigation screen does not need to be completed however it can be used if managers would find this helpful The frequency of this type of incident should be given careful scrutiny and consideration given to carrying out a risk assessment, which should be undertaken as part of a proactive approach Consideration should be given to how this incident might be prevented bearing in mind that inadequate control measures could result in a more serious incident in the future This type of event will be reviewed using quarterly incident trend reports via the Clinical Governance & Risk Management Groups. 5.9 Incidents which are graded MEDIUM These incidents require some investigation as to what happened and why did it happen Managers will require to login to review the information submitted and grade the incident on the investigation screen. Whilst this may be sufficient for many MEDIUM graded incidents, more detail will be required than for LOW graded incidents. The Department Manager should read any analysis and determine what actions are required to reduce or remove the risks, and any underlying causes, organisational, environmental, team or individual However for those MEDIUM graded incidents where the severity is noted to be major or extreme the incident should be investigated further and all parts of the investigation screen on the DIF2 should be completed The outcome of the analysis together with any recommended actions should be reported to the Directorate / Locality General Manager who have a responsibility to ensure that they monitor these incidents accordingly and ensure that remedial actions recommended have been acted upon and are working This type of incident will be reviewed using quarterly incident reports via the Clinical Governance & Risk Management Groups. Page: 18 of 56 Date of Review: November 2011

19 5.9.6 Outstanding actions will be followed-up by final approvers within 1 month Incidents which are graded HIGH These incidents are likely to have, or could have, a significant outcome and may require significant analysis. A DIF2 form will require to be completed for these incidents The Department Manager should report all such incidents to the Directorate / Locality General Manager who will be responsible for ensuring that a detailed analysis of the incident is carried out. This may be done by an individual or a small team. Advice and/or support will be provided by a member of the Clinical Governance Support Team or Health and Safety Team as appropriate Managers will require to login to review the information submitted and grade the incident on the investigation screen. All HIGH graded incidents require all the details on the investigation screen of the DIF2 to be completed in order to reflect why the incident happened, what has been learned and what action has been taken as a result of the incident A critical incident review using Root Cause Analysis should be considered for these incidents. Any such review should be attached to the incident on DATIXweb The Directorate / Locality General Manager will be responsible for providing a report of the investigation, including recommended actions, to the Operational Unit General Manager and Clinical Director and to the Head of Clinical Governance & Risk Management Summarised reports and action plans should be presented to the relevant Clinical Governance and Risk Management Groups. These groups are responsible for monitoring the progress with the action plans Incidents which are graded VERY HIGH These will be the most serious incidents and the measures detailed in procedure 11 should be followed. Page: 19 of 56 Date of Review: November 2011

20 6. TIMESCALES AND SUMMARY ACTIONS PROCEDURE Time is important, if there is a significant lapse then conditions may change and memories will become clouded. It is therefore important to assemble the relevant people as quickly as possible. For this reason timeframes are applied to any incident review. 6.2 It should be noted that there is a statutory duty to report certain types of incidents within a defined timescale and it is important that incidents are reported timely to enable us to comply with these requirements. Refer Appendix 1 Incident Grading DIF1 completed DIF2 review DIF2 Completion & Approval / Investigation Action Plan Monitoring LOW DIF1 to be completed within 24 hours of incident DIF2 review and grading within 3 working days of incident being submitted. Manager to undertake review and approve within 10 working days of incident. Any learning points/ Improvement measures communicated and monitored at ward/ Department meetings Monitored at ward/ department level Quarterly trend report to CG&RM Groups MEDIUM DIF1 to be completed within 24 hours of incident DIF2 review and grading within 3 working days of incident being submitted. Manager to undertake review/ Investigation and approve within 20 working days. Any learning points/ Improvement measures communicated and monitored at ward/ Department meetings and where relevant shared with other areas Directorate/Locality General Manager responsible for monitoring and ensuring action is taken. Quarterly trend report to CG&RM Groups. Outstanding actions to be followed up by final approvers within 1 month. HIGH DIF1 to be completed within 24 hours of incident DIF2 review and grading completed within 30 working days of incident being submitted. This incident will include a root cause analysis. DGM/AGM or Team to carry out a critical incident review. Manager to complete review and attach investigation and action plan within 30 working days. Action Plan to prepared following critical incident review Any learning points/ Improvement measures should be shared across the operational unit and other units where applicable. Actions Monitored through the CG&RM groups and completed within 3 months Page: 20 of 56 Date of Review: November 2011

21 Incident Grading DIF1 completed DIF2 review DIF2 Completion & Approval / Investigation Action plan Monitoring VERY HIGH DIF1 to be completed within 24 hours of incident DIF2 review and grading within 40 working days of incident being submitted. This incident will require root cause analysis. SUI Review Team convened within 3 working days. Interim report within 14 days. If SUI Investigation Team set up full report within 40 working days. Manager to complete review and attach investigation and action plan within 40 working days. Action Plan to be prepared following SUl incident review Any learning points/ Improvement measures should be shared across the operational unit and other units where applicable. Safety Alert Briefing to be completed Action monitored through the CG&RM groups and completed within 6 months Page: 21 of 56 Date of Review: November 2011

22 7. LEARNING FROM INCIDENTS PROCEDURE The comprehensive system of reporting and analysing incidents and near misses will result in the collection of considerable quantities of useful data. This information can be used to show trends, acting as an early warning system for both potential and realised problems. It can also provide timely information on possible future liabilities. 7.2 A summary of the actions taken following an incident review will be provided to the individual who reported the incident and to those who were involved in the incident analysis. The summary will be prepared taking full account of duties with regard to confidentiality. 7.3 The reporting of incidents and near misses will enable trends to be identified and reported throughout the organisation in order that appropriate action may be taken, learning disseminated and better quality services delivered. 7.4 The Clinical Governance Support Team and/or the Health & Safety Team will provide formal reports on incidents, including near misses to: NHS Highland Board Performance Committee and CHP/Raigmore Governance Committees; The Clinical Governance Committee; Staff Governance Committee; The Health & Safety Committee; The Risk Management Steering Group; CHP/Raigmore/Service Specific Clinical Governance & Risk Management Groups; Area Drug & Therapeutic Committee and/or its sub-groups. Area Nursing and Midwifery Committee 7.5 All managers who have a username and password for DATIXweb Incident also have access to their own data via the My Reports section. This can allow regular local monitoring of trends at ward level and managers should share this information with their staff on a regular basis. 7.6 Information will be disseminated across the organisation according to the Clinical Governance Support Team s communications plan. This will include Safety Alert Briefings, case studies on the Clinical Governance Support Team intranet page and articles in Team Update Page: 22 of 56 Date of Review: November 2011

23 8. INVOLVING PATIENTS PROCEURE Communicating effectively with patients and/or their carers is a vital part of the process of dealing with errors or problems in their treatment. In doing so, NHS Highland can hopefully reduce the trauma suffered by patients and potentially reduce complaints. 8.2 NHS Highland expects that patients should be provided with the following information about patient safety incidents which affect them: acknowledgement of the distress that the incident caused; a sincere and compassionate statement of regret for the distress that they are experiencing; a factual explanation of what happened; a clear statement of what is going to happen from then onwards; a plan about what can be done medically to repair or redress the harm done. 8.3 If a more detailed analysis of the incident is to be carried out then patients and/or their carers should be involved as follows: Being informed that a detailed review is taking place Being invited to discuss whether and if so, how the patient and or carers will be involved Being made aware of the process and the purpose and logic which underpins it Being kept up to date with the progress of the review Being informed of the outcome and the actions which NHS Highland will take following the outcome. 8.4 For further guidance refer to NHS Highland s Being Open Policy and the Quick Reference Guide for Staff, Appendix 5. Page: 23 of 56 Date of Review: November 2011

24 9.0 DEALING WITH THE MEDIA PROCEDURE Managers should expect media interest in any serious incident within the organisation, and prepare for it. The NHS is particularly at risk where a child or vulnerable elderly patient is involved, for example, if wrong treatment is given or where groups of people are put at risk as a result of failures in a diagnostic reporting process or where there has been an outbreak of food poisoning. 9.2 At all times patients and their relatives and staff must be notified before the media. 9.3 Patient confidentiality must be maintained at all times and consent to share patient information must be obtained prior to sharing with the media or other bodies. 9.4 Communications with media will only be via the Chief Executive, Chief Operating Officer, Head of Public Engagement or other senior manager identified for the purpose. Contact can be achieved through a variety of means including a press conference, the releasing of press statements or being available for ad hoc press enquiries. Page: 24 of 56 Date of Review: November 2011

25 10. JOINT WORKING AND MULTI AGENCY ISSUES PROCEDURE Every effort should be made to work with other NHS bodies and external agencies to investigate incidents that cross organisational boundaries. This might involve staff from each organisation working on a joint investigation, or people from different organisations working together to create an Incident Team. This will be overseen by the Chief Operating Officer or the Director of Community Care Local Management must take account of the Adult Protection and Support Good Practice Guidelines and the Child Protection Policy Guidelines as one of these procedures may require to be initiated depending on the incident reported. Nominated Officers are listed in each of the guidelines and should be contacted for support in determining appropriateness Child Protection All agencies which work with children have a shared responsibility for protecting children and safeguarding their welfare. Each has a different contribution to make to this common task Inter-agency review of critical incidents is an important way to identify and improve all interagency practice. Such reviews allow inter-agency guidelines and agreements to be evaluated and changed if necessary, and are an important source of learning for the improvement of practice. NHS Highland is fully committed to this process The Highland Child Protection Committee has issued Child Protection Guidelines, which include a detailed Critical Incident Review Protocol. The Highland Child Protection Committee will always consider whether a review is necessary when: a child dies who was registered on the Child Protection Register; a child has sustained a potentially life threatening injury through abuse or neglect, sexual abuse, or sustained serious and permanent impairment of health or development through abuse or neglect and the case gives rise to concerns about the way in which local professionals and services worked together to protect the child The Child Protection Committee may also consider whether to undertake a case review where there has been significant inter-agency planning and working in a case. New protocols, procedures or guidance may be required to ensure dissemination of any good or new practice undertaken The Child Protection Guidelines recognise that individual agencies may conduct internal management reviews of cases independently of any inter-agency review. Such reviews will inform interagency review. Within NHS Highland any such review will follow the procedures set out in the Serious Untoward Incident Policy Mental Health and Learning Disabilities There is an agreed joint Significant Incident Review protocol that should be followed for these investigations. The reports are signed off by the Chief Officers Group. Page: 25 of 56 Date of Review: November 2011

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