NHS ROTHERHAM INCIDENT AND NEAR MISS REPORTING POLICY AND PROCEDURE, INCORPORATING SERIOUS INCIDENT PROCEDURE

NHS ROTHERHAM INCIDENT AND NEAR MISS REPORTING POLICY AND PROCEDURE, INCORPORATING SERIOUS INCIDENT PROCEDURE Dissemination and Implementation NHS Rotherham employed staff Approved and Adopted by Trust Board July 2004, August 2005, Jan 2007, Dec 2008 Review Feb 2011 Next Review July 2013 Lead Director Director of Organisational Development, Workforce and Governance, Director of Public Health and Health Policy Lead Officers Head of Patient Support Services & Risk Management Head of Clinical Governance Head of Human Resources c:\documents and settings\harts\local settings\temporary internet files\content.outlook\grmulmnk\revised incident near miss policy incorporating sui procedure - 2011 01 27.doc

CONTENTS - Section One - Incident and Near Miss Reporting Policy 1. Introduction 2. Policy Statement 3. Scope of this Policy 4. Definitions 5. Responsibilities - Trust Board, Chief Executive - Managers, staff - Independent Contractors - Delegated responsibility, Head of Human Resources and Head of Patient Support Services and Risk Management, Head of Clinical Governance - Risk and Complaints Coordinator - Community Pharmacy Adviser, Dental Adviser and Ophthalmic Adviser 6. Training 7. NHS Rotherham Risk Register 8. Sharing the learning 9. Monitoring systems for the effectiveness of this policy 10. Dissemination, implementation and access to the document 11. Policy Review 12. Equality Impact Assessment Section Two - Incident Reporting Procedure 13. Incident Reporting Procedure 13.1 Benefits of Reporting Incidents 13.2 Procedure for Reporting Incidents 14 External Reporting Arrangements Section Three - Serious Incident Reporting 15 Serious Incident Procedure - Check List for Action on Discovering a Serious Incident - (refer to Appendix 7) 15.1 Definition 15.2 Procedure 15.3 Responsibilities Section Four SI Performance Management 16 Delegated Responsibility 16.1 Procedure 16.2 Reporting Arrangements Appendices Appendix 1 Appendix 2 Appendix 3 Appendix 4 Appendix 5 Appendix 6 Appendix 7 Appendix 8 (i) Appendix 8 (ii) Appendix 9 (i) Appendix 9 (ii) Incident Report Form (IR1) and (IR2) Guidance notes for completing Form IR1 Guidance notes for completing Form IR1 and Form IR2 Risk Evaluation - Incident Categorisation matrix RIDDOR - examples of major Injuries, Dangerous Occurrences and Diseases Guidance re Incident investigation and Root Cause Analysis Check List for Action on Discovering a Serious Incident Flow chart for use within NHS Rotherham when incident occurs involving NHS Rotherham employed staff or NHS Rotherham owned premises. Flow chart for use by NHS Rotherham when incident occurs involving Independent Contractors Incident Alert Form (IAF1) for use by GP Practices Incident Alert Form (IAF2) for use by Community Pharmacists 2

Appendix 10 Criteria for a Serious Incident Appendix 11 Reference and further sources of Information Appendix 11 (i) SHA Incident Management Appendix 11 (ii) NHS Yorkshire & the Humber Procedure for the Management of Serious Incidents (SIs) Version 6 October 2010 Appendix 12 Serious Incident Flowchart IF YOU NEED TO REPORT A SERIOUS INCIDENT QUICKLY PHONE 01709 302121 -Or- Out of Hours and line manager not available contact the main Rotherham NHS Foundation Trust Switchboard on 01709 820000 who will have contact details for the on-call NHS Rotherham Manager/Director 3

SECTION ONE 1. INTRODUCTION INCIDENT AND NEAR MISS REPORTING POLICY AND PROCEDURE, INCORPORATING SERIOUS INCIDENT PROCEDURE POLICY NUMBER: 4.3 1.1 The full notification, recording, analysis and feedback of information is an essential requirement to assist NHS Rotherham (NHSR) in accurately identifying and managing all significant risks as required by the Trust s Risk Management Framework and Risk Assurance Strategy. The information produced by effective incident reporting systems will enable NHS Rotherham to correct specific faults and to identify, track and monitor trends of incidents and accidents. If incidents are not properly managed they may result in a loss of public confidence in the organisation and a loss of assets. The term incident, near miss or serious incident should be interpreted in the widest context to include, incidents, accidents, near misses, ill health, hazards, claims and complaints, relating to patients, staff and visitors. This will help facilitate wider organisational learning. NHS Rotherham has a legal duty under the Reporting of Injuries, Diseases and Dangerous Occurrences (RIDDOR) Regulations 1995 to report certain accidents to the Health and Safety Executive (HSE). These include certain deaths, major injury, over three day lost time injury, diseases, certain patient safety incidents and dangerous occurrences. The Department of Health publications An Organisation with a Memory and Building a Safer NHS for Patients, and the National Patient Safety Agency publication Seven Steps to Patient Safety - A Guide for NHS Staff, have all identified the significant opportunities that exist to reduce unintended harm to patients arising during NHS care, and helping to establish a safety culture within NHS Rotherham. 1.2 This policy and procedure should be read in conjunction with NHS Rotherham s policies, procedures and processes on: Risk Management and Risk Assurance Framework, Whistleblowing, Being Open Policy, Health and Safety Policy, Assessing Risks to Health and Safety. Reference should also be made to the NHS Yorkshire and Humber Good Practice Principles for Incident Management and NHS Yorkshire & the Humber Procedure for the Management of Serious Incidents. 1.3 NHS Rotherham has devolved responsibility, from NHS Yorkshire and the Humber for the performance management of Serious Incidents (SIs) reported by the Rotherham NHS Foundation Trust and Rotherham Community Health Services. NHS Doncaster has devolved responsibility for the performance management of SIs reported by Rotherham Doncaster and South Humber, and NHS Rotherham will be informed by NHS Doncaster of SIs, relating to Rotherham residents. NHS Bradford and Airedale has devolved responsibility for the performance management of Serious Incidents reported by Yorkshire and South Humber (Ambulance Service) (YAS). NHS Bradford and Airedale produce an annual report of their performance management activity and this is discussed at bi-monthly clinical quality review meetings with all commissioners. 1.4 NHS Rotherham has a responsibility to ensure that the investigation and management of Serious Incidents in services which they have commissioned in the Independent Sector are robust and reported to the NHS Yorkshire and Humber in the usual way, indicating what actions will have been taken. 4

2 POLICY STATEMENT It is NHS Rotherham s policy to ensure that incidents at work are reported, recorded and investigated in order to meet the Trust s obligations for Health and Safety at work including RIDDOR. NHS Rotherham will aim, through its incident, near miss and serious incident reporting, investigations, root cause analysis and monitoring procedures, to assist the development of a proactive and positive response to incidents, ensuring that learning from these is identified and shared appropriately. This will be achieved by adopting an open and fair cultural learning approach where mistakes and incidents are identified quickly and acted upon in a positive and constructive manner. The main purpose of any investigation will be to learn lessons and prevent recurrence. All learning identified as a result of an incident occurring will be shared, by various methods: by reports, through Healthworks, Newsround, Newsletters, also included within mandatory training for all staff and through the sharing of the minutes of the Operational Risk, Governance and Quality Management Group. 3 SCOPE OF THIS POLICY This policy covers all incidents, near misses and serious incidents no matter who or what may be involved or how serious or minor the incident. 4 DEFINITIONS This policy applies to everyone employed by NHS Rotherham (wherever they are based) and anyone working on or visiting NHS Rotherham premises or places where NHS Rotherham provides healthcare in whatever capacity. It includes events involving service users, visitors, contractors, and those providing services under service level agreement, volunteers, students, people on work experience or secondment, agency and bank staff etc. This policy also includes Social Services staff seconded to work at NHS Rotherham. This staff group must consider the need to comply with the reporting requirements of Social Services. NHS Rotherham encourages service users, carers, and visitors to report adverse events that occur. Only by having a clear understanding of all events will NHS Rotherham be able to develop an appropriate response to the risks that face the organisation, its staff and the public. This policy covers the delegated responsibilities for the performance management of Serious Incidents reported by providers of Commissioner Services. Any incident, accident, near miss or serious incident that occurs in the workplace, or whilst at work must be reported. A single reporting system is in use that incorporates the reporting of both clinical and non clinical events (including IT). 4.1 An Incident/Accident An incident/accident is defined as an occurrence or unplanned event, where there is injury, loss of life, loss or damage to persons or property. 5

Examples of incidents: patient safety incidents, personal accidents, security, theft, fire, violence, abuse, harassment or vandalism. 4.2 Near Misses Near misses may also constitute SIs and can be defined where the contributory causes are serious and under different circumstances they may have led to serious injury, major permanent harm, or unexpected death, but no actual harm resulted on that occasion. A possible example is that of a system failure, the result of which is incorrect/delayed diagnosis. This may not have any serious consequences for some patients, but for others could lead to the wrong treatment/serious delay in treatment and ultimately to death. 4.3 A Patient Safety Incident A patient safety incident is any unintended or unexpected incident which could have or did lead to harm for one or more patients receiving NHS/funded care. 4.4 What is a SI? A serious incident requiring investigation is defined by the NPSA in the National Framework for Reporting and Learning from Serious Incidents Requiring Investigation as an incident that occurred in relation to NHS-funded services and care resulting in one of the following:- Unexpected or avoidable death of one or more patients, staff, visitors or members of the public; Serious harm to one or more patients, staff, visitors or members of the public or where the outcome requires life-threatening intervention, major surgical/medical intervention, permanent harm or will shorten life expectancy or result in prolonged pain or psychological harm (the includes incidents graded under the NPSA definition of severe harm); A scenario that prevents or threatens to prevent a provider organisation s ability to continue to deliver health care services, for example, actual or potential loss of personal/organisational information, damage to property, reputation or the environment, or IT failure; Allegations of abuse Adverse media coverage or public concern about the organisation or the wider NHS; One of the core set of Never Events. Never Events are serious, largely preventable patient safety incidents that should not occur if the available preventative measures have been implemented by providers. All Never Events should be reported as SIs. The Operating Framework for the NHS in England 2010/11 reaffirms that PCTs should use the national set of eight Never Events as part of their contract arrangements with providers; ensure that patient safety incidents which are Never Events are reported to the NPSA; and publish the numbers and types of events on an annual basis. Examples of other incidents which are reportable as SIs are shown in the Yorkshire & Humber Procedure for the management of Serious Incidents Version 6 October 2010. 6

4.5 Never Events These are serious, largely preventable patient safety incidents that should not occur if avoidable preventative measures have been implemented by providers. All never events should be reported as Sis and to the National Patient Safety Agency (NPSA) by the provider. 4.6 Hazard and Risk Hazard is defined as something with the inherent potential to cause harm or injury. Risk is defined as the severity and likelihood of harm or injury arising from a hazard. Definitions: NHS North Yorkshire & Humber Procedure for Reporting, Investigating and Learning from Serious Incidents. 4.7 Medicines and Healthcare Products Regulatory Agency (MHRA) The MHRA is the Executive Agency of the Department of Health protecting and promoting public health and patient safety by ensuring that medicines, healthcare products and medical equipment meet appropriate standards of safety, quality, performance and effectiveness, and are used safely. 4.8 The National Patient Safety Agency (NPSA) The National Reporting and Learning System (NRLS) is a national system of reporting anonymous incidents to the National patient Safety Agency (NPSA). The System is designed to collect information on patient safety errors and systems failures with a view to identifying national patient safety trends and priorities in order to develop practical solutions to these. The overall aim of the NRLS is to support the NHS to learn from things that go wrong. NHS Rotherham reports patient safety incidents anonymously to the National Patient Safety Agency (NPSA) through the electronic extraction of data from the Trust s incident reporting system. Anonymised data will be uploaded to the National Reporting and Learning System (NRLS) on a monthly basis by the Risk Coordinator. Staff are able to report independently to the NRLS should they wish through completing an online electronic reporting form, details of which may be found on the NPSA website: www.npsa.nhs.uk 4.9 (RIDDOR) Reporting of Injuries, Disease and Dangerous Occurrences RIDDOR requires that specified injuries, disease and dangerous occurrences are notified to the Health and Safety Executive through the Incident Reporting Centre in Caerphilly. Failure to comply is a criminal offence and liability lays with the responsible person i.e. the person in charge of the work activity in that area in line with managers responsibilities (see section 7.1, 7.2). 4.10 Data Protection Act To comply with the Data Protection Act 1998 (DPA), personal details entered in accident books and/or incident reports must be kept confidential. Managers responsible for completing and retaining accident and incident records must ensure that they are stored securely and only made available to authorised personnel associated with the incident reporting procedure. 7

5 RESPONSIBILITIES/DUTIES 5.1 Trust Board NHS Rotherham Board has overall responsibility for effective risk management within NHS Rotherham, and to ensure that NHS Rotherham complies with its statutory obligations. The Board will approve and oversee implementation of the policy across NHS Rotherham. 5.2 The Chief Executive The Chief Executive is ultimately responsible for ensuring compliance with the Health and Safety at work Act and associated legislation and that this policy is effective and communicated to all staff. 5.3 Operational Risk, Governance & Quality Management Group The Operational Risk, Governance & Quality Management Group will receive, as a standing agenda item, statistics including trend analysis regarding incidents clinical and non clinical, within NHS Rotherham. The Group will review these statistics and also monitor the progress of action plans agreed following all serious incidents. The SI and Serious Complaint Committee will receive completed investigation reports and undertake the performance management of these. This Committee will recommend that submitted reports show that a robust investigation process has been completed, including progress against identified actions, and outstanding issues, including making appropriate challenges to ensure assurance. This Committee will provide assurance to the Board via the Audit and Quality Assurance Committee. 5.4 The Director of Organisational Development, Workforce and Governance (OD/W/G), and Director of Public Health and Health Policy The Director of Organisational Development, Workforce and Governance (OD, W, G) has overall responsibility at director level for the development and monitoring of the incident reporting system across NHS Rotherham, supported by the Head of Human Resources and Head of Patient Support Services and Risk Management. The Director of OD/W/G is also the Lead Director for the reporting of physical assaults to staff, under the Secretary of States directions for tackling violence. The Director of Public Health and Health Policy, as Clinical Governance Lead has responsibility for Serious Incidents, including Performance Management, supported by the Head of Clinical Governance. 5.5 All Directors All Directors are responsible to the Board for implementing this policy and procedure. The Directors will through their Managers ensure all staff within their sphere of responsibility are aware of the need to report incidents, near misses and patient safety incidents and complete the various formal report forms, Incident Report Form (IR1 s) (Appendix 1) and RIDDOR (F2508) Reporting of Injuries, Disease and Dangerous Occurrence Regulations form. If an incident is identified as a serious incident, the responsible Director will ensure that the check list for action on discovering a serious incident is followed (Appendix 7) and section Three of this document and that full written contemporaneous records are maintained of all actions taken. 8

5.7 All Managers 5.8 Staff All Managers are responsible for the safety of their workforce and will ensure that systems of incident reporting are implemented within their area of responsibility. They will maintain records and monitor the occurrence of all incidents, accidents and near misses, affecting and involving their workforce, patients, service users, volunteers and members of the public and be responsible for reporting their findings as appropriate. Managers should also record the immediate actions taken, which might include, making the area safe, wearing protective clothing, removal of similar equipment and undertake risk assessments. Each NHS Rotherham Manager is responsible for receiving all incident reports, scoring the severity of the incident and carrying out incident investigations, as soon as possible after the event, which occur within their sphere of responsibility. An incident investigation must be carried out for all incidents graded amber or red, even when no injury resulted (i.e. near miss). Completed incident forms must be forwarded to the Risk and Complaints Coordinator as per the reporting timescales. (Section 6.2.4). Reviews of incidents will be routinely carried out by managers to ensure that agreed/proposed actions have been carried out. All staff have a legal responsibility to report all incidents, near misses or hazards to their Line Manager as soon as is reasonably practicable but within the timescales detailed (see action appendix 4). Should any situation pose imminent danger to others, all staff should attempt to reduce the risk of occurrence by their direct action, i.e. removing obstacles on pathways/roads, having temporary barriers placed around holes, spillages etc. They will ensure that the incident is reported as soon as practicable to their line manager and an Incident Record Form (IR1) (Appendix 1) is completed. 5.9 Independent Contractors Independent Contractors are strongly recommended to report all incidents to NHS Rotherham. Incidents should be reported using the Incident Alert Forms (IAF1 and IAF2) (Appendix 9i for GP Practices, 9ii for Community Pharmacists). NHS Rotherham would expect Independent Contractors, as part of their professional duty, to report all serious and dangerous events and those which are initially coded as moderate or high risk, we would expect them to investigate and to share their findings with NHS Rotherham. 5.10 Delegated Responsibility 5.10.1 The Head of Human Resources and the Head of Patient Support Services and Risk Management will, ensure on behalf of the Director of HR/OD/CG, that the following action is taken: Ensure in conjunction with the Health and Safety Advisor and Risk and Complaints Coordinator, that training/familiarisation of the incident reporting module is provided for all staff, including documentation and procedures. Ensure in conjunction with the Risk and Complaints Coordinator, that a reporting system for the receipt of Incident Record Form (Form IR1) and Incident Alert Form (IAF1) is maintained and that all incidents are entered onto the Incident Reporting Module. The system will keep a record of the incident and will produce records, identify trends in frequency and causation of accidents and incidents, and reports will be provided for the Operational Risk, Governance & Quality Management Group. Ensure that regular monitoring and, as necessary, audit of the operation of this policy and procedure will be carried out to ensure its effective implementation. 9

Ensure that completion of appropriate documentation for all physical assaults to staff is undertaken and reported to the Security Management Service by the Health and Safety Advisor. Ensure, in conjunction with the Health and Safety Advisor and Risk and Complaints Coordinator, that training/familiarisation on the requirements of the RIDDOR regulations is provided in order that managers can fulfil their responsibilities. Ensure that regular monitoring and, as necessary, audit of actions taken by managers in response to accidents and incidents reportable under RIDDOR is undertaken. 5.10.2 The Risk and Complaints Coordinator will support the Head of Patient Support Services and Risk Management by taking the following action: Act as a resource providing assistance to managers in carrying out their responsibilities for the reporting and investigation of accidents/incidents and ensuring suitable follow up actions are taken. Ensure the adaptation and implementation of the incident reporting module contained in SENTINEL, (a computer based system developed for the NHS). Prepare integrated incident, complaints/pal s and claims reports as necessary for Board, Directors and Committees as required by procedures. Provide necessary training/familiarisation to personnel on the accident/incident and RIDDOR reporting systems. Conduct monitoring, review and audit of accidents/incidents and RIDDOR reporting systems as required. Report as appropriate patient safety incidents through the NPSA via the National Reporting and Learning System and for all Serious Incidents, report these to the Strategic Health Authority, via the electronic reporting system - UNIFY (previously STEIS - Strategic Executive Information System). 5.10.3 The Head of Clinical Governance has responsibility for ensuring that performance management processes are undertaken in a timely and appropriate manner, and the Head of Clinical Governance will ensure on behalf of the Department of Public Health & Health Policy that the following actions are taken:- Act as a resource for providers regarding the reporting and investigation of SIs. Maintaining accurate records of SIs reported by NHSR, RCHS, and RFT. Liaising with the identified performance management PCT regarding SIs concerning Rotherham residents receiving care either out of area or from other NHS organisations within Rotherham e.g. RDaSH, YAS, and Sheffield Teaching Hospitals. Ensuring that the performance management of SIs reported by RCHS and RFT is undertaken in a timely and appropriate manner, including the management of appropriate challenges and ensuring the appropriate attendance at the SI committee. Monthly reports are submitted by the NHSR Board, regarding SI statistics. Bi-monthly reports including SI statistics, performance management and action plan monitoring are submitted to Audit and Quality Assurance Committee. 5.10.4 The Clinical Governance Manager for Independent Contractors will take responsibility for ensuring regular communication with GP practices where incidents/serious Incidents have taken place within a GP practice, or involve NHS Rotherham employed staff whilst working on GP premises. 10

5.10.5 The Community Pharmacy Adviser, Dental Adviser and Optometric Adviser will take responsibility for ensuring regular communication with Community Pharmacies, Dental practices and Optometrics respectively where incidents/serious Incidents have taken place involving Community Pharmacists, General Dentists or Opticians or on their premises. 5.10.6 The Associate Director of External Communications/Head of Communications should be informed where there could be media interest involving staff, patients, relatives and adverse publicity relating to NHS Rotherham. This person will be responsible for dealing with the media in all circumstances. 6. Training NHS Rotherham is committed to educating and training staff in order to minimise risk. Each NHS Rotherham manager shall ensure that all members of their staff receive appropriate training so that they fulfil their individual responsibility under the regulations. Training will be provided at the induction stage, and at mandatory training sessions on Health and Safety as per NHS Rotherham Training Duration. A number of staff will be registered to be trained in the NPSA Root Cause Analysis techniques, and this will be dependent on their role in incident investigation. 7. NHS Rotherham s Risk Register To ensure there is a clear and developed link between incidents and the NHS Rotherham s Risk Register. Incidents categorised as red will be placed in the Risk Register and reviewed quarterly. Major risks identified from other sources including the Corporate Risk Assurance Framework Analysis of Risks document, and Directorate Analysis of Risks will also be placed into the Risk Register. 8. Sharing the Learning The investigation into any incident should include an analysis regarding the lessons learnt, to prevent recurrence. All learning identified will be shared throughout the Health Community and with independent contractors. Mechanisms for achieving this dissemination will include Team Briefings, Staff newsletter, external newsletters, mandatory training for staff and through reports taken at Operational Risk, Governance and Quality Management Group and Board (see Risk Management Framework section 7 for further information relating to Communicating with external stakeholders). 9. Monitoring Systems for the effectiveness of this Policy NHS Rotherham s Performance in the Management of Incidents will be monitored by qualitative and quantitative indicators as detailed below and through regular integrated reports to the Operational Risk, Governance and Quality Management Group, Quantitative The number of incident reports completed. The number of serious incident reports completed. Attendees for awareness sessions and managing people Qualitative Actions taken. Recommendations made. Sharing all learning. Improvement in final report completion. The Operational Risk, Governance and Quality Management Group will review/monitor the indicators at their regular meetings through the integrated reports produced for meetings and Annual report for the Serious Incident and Serious Complaints Committee. Individual managers have responsibility for ensuring that actions/recommendations are implemented in full. 11

10. Dissemination, Implementation and Access to this Document The main points of the Incident and Near Miss Reporting Policy will be highlighted in the mandatory Risk Management awareness sessions which all staff attend. Managers are responsible for the dissemination and implementation of this policy to the staff that they manage, they should also monitor that their staff adhere to the policy and procedure in its entirety. The policy can be found on the NHS Rotherham intranet in the directorate headed: - Directorate of Human Resources, Organisational Development and Corporate Governance - click on Patient Support Services and Risk Management - click on Risk Management and incidents 11. Policy Review This policy will be reviewed every 3 years or whenever national policy, legislation, or guidance changes are required to be considered, by the Integrated Governance and Assurance Group and by the Board. 12. Equality Impact Assessment As part of its development, this policy and its impact on equality, have been reviewed in consultation with the Trust Equality Scheme and Equal Opportunities Policy, and no detriment was identified. The purpose of the assessment is to minimise, and if possible, remove any disproportionate impact on the grounds of race, sex, disability, age, sexual orientation or religious beliefs. 12

SECTION TWO-INCIDENT REPORTING PROCEDURE 13. INCIDENT REPORTING PROCEDURE 13.1 Benefits of reporting incidents Staff will normally recognise where there are problems which may cause risk in their work environment. All members of staff do therefore have an important role to play by identifying and minimising inherent risks using the incident reporting procedure. The main purpose of any investigation will be to identify causes of incidents/accidents, using root cause analysis where appropriate (see Appendix 6, Guidance on Incident Investigation and Root Cause Analysis) to learn lessons and prevent recurrence. NHS Rotherham supports an open, fair and a positive learning culture. Staff are positively encouraged to report all incidents and near misses. However, in rare circumstances, where there has been maliciousness, criminal or gross misconduct this could lead to disciplinary action being taken e.g. Repeat occurrences of incidents involving the same individual Deliberate failure to report incidents Failure to co-operate fully in subsequent investigations. This approach will enable NHS Rotherham to: Prevent recurrences Review existing practices and make adjustments to policies, procedures and processes Improve the working environment Identify training / retraining needs Respond appropriately to any complaints arising subsequently Prepare defence or settlement of legal claims against NHS Rotherham 13.2 Procedure for Reporting Incidents 13.2.1 An Incident Record book including the Incident Record Form (IR1 and Incident investigation Form (Form IR2) (as in Appendix 1) is available in all Primary Care Trust Directorates/ Departments. To assist in its completion, each book has definitions and guidance notes for completion on the front inside cover (as in Appendices 2 & 3). 13.2.2 Independent Contractors are to report incidents using the Incident Alert Form (IAF) (Appendix 9i; 9ii, 9iii), formerly known as the Serious Adverse Event or SAE form. The completed form should then be emailed on the dedicated IAF e-mail address, or faxed to the Risk and Complaints Coordinator on 01709 302041. These forms are available from the Risk and Complaints Coordinator. The Clinical Governance Manager for Independent Contractors, the Community Pharmacist Adviser, the Dental Adviser or the Optical Adviser are then responsible for the completion of the Incident Record form (IR1) where appropriate. 13.2.3 NHS Rotherham staff will record all incidents on an Incident Record Form (IR1) as per guidance notes (Appendix 2) and pass to their Line Manager in line with timescales detailed on page 13, for signature and risk grading. NHS Rotherham staff will when an incident occurs, assess immediately the severity of the incident, and if considered a Serious Incident they will follow the procedure for reporting SI s see section 3 of this procedure, and Appendix 7 - Checklist for Action on Discovering a Serious Incident. In all incidents, staff will first ensure that any injured person(s) including, staff, patients and any other receives the most appropriate treatment or medical advice. Any assistance should be obtained from Line Manager or by telephoning the Risk Management Team on (01709) 302117. If the incident occurs out of hours and the Line Manager is unavailable, contact the main Rotherham NHS Foundation Trust switchboard on (01709) 820000 who will have details of the on-call manager. 13

13.2.4 Directors, Heads of Departments, Line Managers and Team Leaders, will upon receipt of the IR1 form score the severity of the incident by completing the Incident Categorisation Matrix chart at the bottom of the IR1 form. Guidance for completing the risk evaluation chart is shown in Appendix 4. If an incident is identified as a Serious Incident (see Appendix 10 criteria) they will immediately ensure that the step by step process included in Check List of Action on Discovering a Serious Incident, as detailed in Appendix 7 of this policy has been followed and implemented. Dependent on the incident grade, the following timescales for the reporting of incidents must be strictly adhered to by staff and managers as per the flow chart, detailed in Appendix 8i. Red within 24 hours All red incidents involving physical assault or patient death and those deemed as SIs (faxed to Risk and Complaints Coordinator on 01709 302041 or telephone 01709 302117) who will then inform the relevant Director and Chief Executive of the details of the incident. Amber within 72 hours - (fax to the Risk and Complaints Coordinator on 01709 302041) who will then inform the relevant Director of the details of the incident. Yellow Green the incident report must be lodged with the Risk and Complaints Coordinator within 7 days. the incident report must be lodged with the Risk and Complaints Coordinator within 28 days. The Line Manager should forward the top copy of the IR1 Form in line with the timescales detailed above, where appropriate, IR2, to the Data Input Clerk @ NHS Rotherham headquarters. Where appropriate, the form may also be copied to other parties, e.g. Moving and Handling Coordinator, Security Officer and if appropriate, details of repair work required as a result of the incident/accident should be forwarded separately to the Estates Department. Where an incident involves suspected fraud, the Director of Finance or Local Counter Fraud Specialist should be informed, in line with the PCT Fraud Policy and Response Plan. Line Manager/Team Leaders/Heads of Service/Directors will ensure that all incidents, within their area of responsibility, which are categorised as red and amber incidents (using the incident categorisation matrix - Appendix 4) are reported to the Risk Management Coordinator within the above timescales and undertake an investigation to identify the root cause. Details of the investigation and actions taken to be completed on the IR2 which is on the reverse side of the IR1. If an incident is categorised as a Serious Incident (see section 3 and Appendix 10 criteria), then the responsible Director will ensure that the Checklist for Action on Discovering a Serious Incident has been followed and implemented. Investigating Managers can assign a small team of staff to assist them in carrying out a more complex investigation (see Appendix 6 - Guidance re: Incident Investigation and Root Cause Analysis). It is important that communication with staff involved in the incident itself is carried out both pre and post investigation. The Investigating Officer will be responsible for maintaining communication links and records relating to the investigation. A record of the investigation should be maintained (using form IR2) and actions should include: 1 Reviewing risk assessments 2 Removing equipment from service - notify MHRA 3 Amend policies, procedures and processes 4 Re-assess training requirements 5 Making the area safe 6 Wearing protective clothing 7 On completion of investigation, rescore the severity of incident to determine the reduction in risk 8 An action plan should be developed with realistic timescales, managers should then monitor the action plan to ensure that all actions have been implemented 14

9 On implementing the full action plan the incident should be regraded to evidence a reduction in the risk of similar type and incidents occurring again. Consideration should be given whether to report amber/red incidents to the NPSA using the National Reporting and Learning System (NRLS). If appropriate it should be reported within 3 working days of the occurrence by the Risk and Complaints Coordinator. The Line Manager has the responsibility to determine whether an investigation should commence for incidents categorised either green or yellow. Where the decision is made to conduct an investigation, they will decide on the most appropriate person in their team to carry out the investigation, and this should commence immediately. 13.2.5 Flow charts (Appendix 8i) demonstrates the process for incident reporting and investigating for incidents involving PCT staff and premises and (8.ii) the process for incident reporting by Independent Contractors. 14. EXTERNAL REPORTING ARRANGEMENTS 14.1 Report of Injuries, Disease and Dangerous Occurrence Regulations (RIDDOR) 1995. In addition to the Trust s internal IR1 form there are some incidents which by nature of their seriousness have to be reported under RIDDOR to the Health and Safety Executive. Managers must notify the HSE without delay, if there is an incident connected with work and: - An employee or a self employed person working on NHS Rotherham s premises is killed or suffers a major injury (including as a result of physical violence) or; - A member of the public is killed or taken to hospital or; - There is a dangerous occurrence listed in the regulations (see Appendix 5) Managers must also report to the HSE any notifiable incident (See Appendix 5) or; - Any other injury to an employee (including an act of physical violence) which results in their absence from work or being unable to do their normal work for more than three days (including days which would not normally be working days); - Any other cases of ill health listed in the regulations (see Appendix 5) 14.2 Reports to the HSE may take the following format: Form F2508 to be used for reporting injuries and dangerous occurrences Form F2508A to be used for cases of diseases Forms F2508 and F2508A are available on the internet at www.riddor.gov.uk The F2508 and F2508A, not submitted online, must be forward to: The Incident Contact Centre Caerphilly Business Park Caerphilly CF83 3GG Details can also be phoned in on 084 300 9923 Or faxed on 0845 300 9924 Or sent by e-mail on riddor@nalbrit.com 14.3 Managers must record any injury, dangerous occurrence or case of infectious disease on the reverse side of the Form IR1. A copy of the RIDDOR form should be attached to the blue copy of the Incident Report including any RIDDOR Report Numbers provided by the Incident Contact Centre to designated input clerk. 15

14.4 NHS Estates Heads of Estates are required to report incidents relating to fire, buildings, plant and nonmedical equipment to NHS Estates at the following address: NHS Estates Department of Health 1 Trevelyan Square Boar Lane Leeds. LS1 6AE Tel: 0113 254 7000 Fax: 0113 254 7299 Managers having such an incident should contact the Head of Estates and Facilities with all the relevant information to enable the Head of Estates and Facilities to complete an appropriate report form. 14.5 Medicines and Healthcare Products Regulatory Agency (MHRA) Any incident relating to medical equipment should be notified formally to NHS Rotherham s MDA Liaison Officer who is currently the Head of Patient Support Services and Risk Management on (01709) 302108) who will then notify the MHRA through the Central Alert System (CAS). 14.6 National Health Service Litigation Authority Incidents where there are likely to be civil claims require, where practicable, to be notified to the National Health Service Litigation Authority as early as possible. Managers should inform the Head of Patient Support Services and Risk Management of such incidents supported by the IR1 form to enable as much information to be gathered prior to reporting. The Head of Patient Support Services & Risk Management will contact the Litigation Authority as appropriate: The NHS Litigation Authority 1 st Floor 151 Buckingham Palace Road London SW1W 9SZ Telephone: 020 7811 2700 Fax: 020 7821 0029 14.7 Medicine Controls Agency (MCA) Incidents relating to adverse drug reactions are reportable to the MCA via NHS Rotherham s Pharmaceutical Advisor on (01709 302047). 14.8 Environmental Health Officer Incidents relating to food will, in addition to being notified internally using the IR1, be notified to the Local Environmental Office of the Local Authority and in future to the Food Standards Agency by the Hotel Services Manager. 16

14.9 Police Particular incidents will, by their nature, be reported to the police. These will normally be assaults actual or threat, vandalism, suspicious activity of deaths, thefts etc, and in accordance with the Department of Health Memorandum of Understanding - Investigating patient safety incidents involving unexpected death or serious harm! 14.10 Reporting to Strategic Health Authority See Appendix 7 4.5 14.11 Care Quality Commission (CQC) Care Quality Commission National Correspondence Citygate Gallowgate Newcastle upon Tyne NE1 4PA Contact by telephone on 03000 616161 Contact by email on enquiries@cqc.org.uk SECTION THREE - SERIOUS INCIDENT REPORTING 15. Serious Incident Procedure - Check List for Action on Discovering a Serious Incident (Refer to Appendix 7) 15.1 Serious Incident (SI) - definition Is defined as an incident where a patient, member of staff, or member of the public has suffered serious injury, major permanent harm, or unexpected death or where there is cluster/pattern of incidents or actions by NHS staff which have caused or are likely to cause significant public concern. Where a patient/member of staff makes a complaint about an NHS organisation direct to the media, it will be for the Trust/PCT to determine in conjunction with the Integrated Governance team at the SHA whether this has substance and should therefore be reported as a SI. See the Yorkshire & Humber Procedure for the management of Serious Incidents Version 6 October 2010. 15.2 Responsibilities 1) All staff must be aware of what constitutes a Serious Incident and the process to be followed when one occurs. Once a Serious Incident has been identified, the step by step process outlined in Check list for Action on Discovering a Serious Incident - Appendix 7, should be followed. NB - The responsible Director/Investigating Officer will report the SI to the Risk Management team who will report this to the Strategic Health Authority electronically via the UNIFY system in accordance with 4.5 of the checklist - appendix 7. 2) All employees and healthcare professional associated with the PCT, including Independent Contractors, have a duty to ensure that all potential and actual SI s are reported - be they clinical or non-clinical. This can be done through adequate and timely reporting, using this policy and the other relevant reporting procedures of: whistleblowing, complaints, accidents, health and safety issues, security issues, alleged clinical negligence or malpractice and alleged abuse of patients, staff, property and equipment. 17

3) It is the responsibility of managers to initiate an appropriate investigation in accordance with assigned responsibilities within this procedure and to ensure that all remedial steps are taken. NHS Rotherham departments and/or Independent Contractors will be expected to cooperate in any investigation and/or inquiry whether carried out by NHS Rotherham or an independent body. 4) The Head of Patient Support Services and Risk Management to maintain a register of NHS Rotherham staff trained in Root Cause Analysis and that there are sufficient staff trained to maintain capacity for involvement in appropriate investigations. 5) The responsible Director/investigating officer will decide if Root Cause Analysis techniques should be used in the investigation but it is expected that it will be normal practice in investigating all Serious Incidents. Root Cause Analysis should always be undertaken if the incident has led to permanent harm or death. The responsible Director should ensure that the investigating team includes a senior member of staff with the appropriate training. 6) The responsible Director/investigating officer must identify incidents which are in any way related to research activity, inform the Research Governance Lead and make reports and subsequent action plans available to the Research Governance Committee. 7) NHS Rotherham will collate local data and report to the National Patient Safety Agency (NPSA) using the National Reporting and Learning System (NRLS). Lessons learned from Serious Incidents will be shared locally through the PCT and nationally through the NPSA. 8) When the investigation is complete, the Responsible Director/Investigating Officer should prepare a final report including an action plan, with recommendations for learning arising from the incident. If a decision is reached that no further action is to be taken, this should be explicitly documented, giving the reason for that decision. 9) A repeat of the Risk Evaluation Process should be carried out. 10) A summary of SI s, together with any subsequent action plans, will be collated on a monthly basis by the Head of Clinical Governance presented to the Board. 11) Lessons to be learned from the Root Cause Analysis of events and outcome of Internal Reviews should be identified and an action plan for disseminating the learning agreed by the SI and Complaints Committee. 12) Six-monthly review of all action plans arising from the investigation of SI s to be carried out by the SI and Complaints Committee. 13) Where SI s have taken place within a GP Practice, or involve NHS Rotherham employed staff whilst working on GP Premises, regular communication should be maintained with the practice. 14) Performance management refers to Appendix 11 NHS Rotherham SI Process. The performance management of SIs reported by the Rotherham NHS Foundation Trust and Rotherham Community Health Services is delegated to NHS Rotherham by Yorkshire & Humber Strategic Health Authority. It is NHS Rotherham s responsibility to ensure that they are satisfied that the investigation, report and action plan are adequate and that actions are complete. 18

Reference Documents Yorkshire and Humber Strategic Health Authority - Procedure for the Management of Serious Incidents (SI s). Yorkshire and Humber Strategic Health Authority - Good Practice Principles for Incident Management 19

GUIDANCE NOTES FOR COMPLETING FORM IR1 Appendix 1 General Use the IR1 form to record ALL incidents. Record only known facts - not opinions. Please complete a separate form for each person directly affected by the incident, i.e. any person who suffers or potentially suffered injury, ill health, or loss. Completing the IR1 form does not constitute an admission of liability of any kind on any person. Any equipment involved in the incident should be retained untouched and in safe keeping for examination. The IR1 form should be completed where the incident happened by the member of staff who is responsible for recording the incident. The form should be passed to the person with designated responsibility for incident investigation (i.e. the line manager). Please use a black ball point pen to write clearly, using block capitals where possible. Please take care always to ensure that the correct boxes are ticked and, where a text entry is required, that the correct choice is made by carefully choosing from the pick lists' provided. No deviation from the pick lists should be made. WHERE DEATH OR SERIOUS INJURY HAS OCCURRED THIS MUST BE REPORTED IMMEDIATELY Section A Only one box should be ticked to define the incident type. The following definitions apply: Personal accident: any accident, no matter how small, which did or could have adversely affected any person. This does not include any incident caused deliberately (e.g. by act of violence or by fire). Violence, abuse or harassment: any incident where staff are abused, threatened or assaulted in circumstances related to their work, involving an explicit or implicit challenge to their safety, well -being or health. Ill health: any cause of known o r suspected work or environment related ill health (e.g. infection, headaches, dermatitis, etc.) Clinical Incident: Any incident directly related to patient treatment or care, which did or could have resulted in adverse outcome (e.g. treatment error, medical equipment failure, etc.) Fire incident: any incident, no matter how small, involving fire or fire warning systems (including false alarms). Security incident: any incident involving theft, loss or other damage to organisation or personal property, intrusions, false alarms (but not fire alarms, absconded patients and other security incidents). Vehicle incident: Any incident involving a vehicle, e.g. road traffic accident, excluding vandalism or theft which would be classified as a security incident. Complaint: Oral comments from any person or organisation, which may reduce risk and improve service quality. Note: formal complaints should be managed in accordance with the Trust s complaints procedure. Near Miss: An incident which has the potential for serious consequences. Other: This type of incident should be marginal in number and might include accidental property damage or loss, environmental incidents (e.g. accidental discharge to drains or the atmosphere), food safety/hygiene incidents, etc. 20

Section B The individual affected by the incident is the person who suffers or potentially suffers injury, ill health, or loss, including theft and any other property damage or loss. Complete separate IR1 forms for each person directly involved. If the person is a member of staff, student/trainee, specify their occupation, grade, directorate, whether they are full or part time employed, and whether they were or will be absent from duties. If absence is unknown, tick the Query' box. Please indicate the address and telephone number of the person affected. Resident individuals who may be titled as residents or clients by the Trust should be classified as 'inpatients'. Section C Tick one or more boxes to identify any attention received by the person directly involved in the incident. For example, the person may be seen by a resident doctor and sent to Occupational Health or advised to see their own GP Where possible, give brief details of any first aid or other treatment/attention received. Note that the IR1 form should not be used as the prime entry for clinical information, which should be held in the patient's clinical notes. Section D If the person did not apparently suffer physical injury, ill health or other adverse effect, tick the No box and go to Section E. Otherwise, specify the details requested with reference to the pick lists. Be clear about the part of the body affected. State left or right side or both e.g. left hand, right foot, both eyes, etc., and if fingers or toes are injured specify which one(s). Note that for ill health incidents involving infection the type of infection should be specified. Section E Enter the appropriate details of the primary and secondary locations and the management unit, (e.g. directorate) within which the incident occurred. The exact location box can be used to describe where the incident happened in some detail, e.g. toilet by lift in main corridor, middle stairs, etc. For an Incident occurring in a patient's home, specify 'Patient Home' i n the primary location field and give the full address, including postcode, in the secondary and exact location boxes. Section F Give brief details on the circumstances of the incident. Indicate the events leading up to the incident and the part played by any person(s) in the sequence of events. If any property/equipment is involved in the incident, give details including serial numbers as applicable. If the incident involves theft of personal property, give full details including an estimate of financial value. In the case of personal injury or ill health, indicate what the person was doing at the time and whether environmental factors (e.g. temperature, lighting, etc.) might be involved. Specify the name of any substance(s) involved. Section G Briefly describe any remedial or other action taken or proposed. This might include removal of faulty equipment from use, calling the police, or informing a patient's relatives of any incident, etc. Section H Specify the names and addresses, or designations if members of staff, for any witnesses to the Incident. Please note that "6 patients in ward" is not acceptable. State NONE if there were no witnesses to the incident. Administrative details The person completing the IR1 form should enter all details in BLOCK CAPITALS. Note that the person to whom the incident is reported would, normally be the person with designated responsibility for incident investigation (i.e. the line manager). 21