INCIDENT & NEAR MISS REPORTING POLICY (Clinical & Non-clinical) For All Levels of Incident from No Harm to Serious Incidents

Status: Feb 2015 V6 Draft INCIDENT & NEAR MISS REPORTING POLICY (Clinical & Non-clinical) For All Levels of Incident from No Harm to Serious Incidents This document is uncontrolled once printed. Please check on the Trust s Intranet site for the most up-to-date version. Policy Number LNWHT/CPPE/002/2015 Date Ratified: 6 th February 2015 Name of author: Assistant Director of Risk Management and Head of Patient Safety Name of ratifying committee: Responsible Executive Director: Clinical Performance and Patient Experience Committee Chief Nurse Date issued: February 2014 Review date: December 2016 Target audience: All staff, volunteers and contractors Equality Impact Assessment: Yes, December 2014 t Associated documents/policies: Risk Management Strategy & Policy. Health & Safety Policy. Being Open Policy. Violence & Aggression Policy. Raising Concerns Policy. Management of Medical Devices Policy. Guidance for Performing Risk Assessments. Trust RCA Investigation Guidance for Incidents, Claims and Complaints. Guidance for the investigation of cervical screening incidents. Datix - how to use Datix incident reporting system - reporters guide. Datix - how to use Datix incident reporting system - Managers guide. Capability policy and procedures Relevant legislation: Health and Safety at Work etc., Act 1974 Version Control Version Date Revision from previous issue number 1 29.12.2014 New policy, replacing the Incident Reporting Policies of NWLH and EHT ICO Trusts and it incorporates the investigations aspect from the Incident and Complaints policy. 2 31.12.2014 Provide guidance on management of incidents relating to NHS Bowel Screening Programme. 3 02.01.2015 Guidance on the Duty of Candour 4 30.01.2015 Revision of severity scores to take into account the two Datix 1

Status: Feb 2015 V6 Draft systemscurrently in use.(appendix B) 5 01.02.2015 Final formatting 6 05.02.2015 Amendments to RIDDOR and Health & Safety references Data Protection Act 1998 Data Protection issues have been considered with regards to this policy. Adherence to this policy will therefore ensure compliance with the Data Protection Act 1998 and internal Data Protection Policies. Diversity Policies Equality issues have been considered with regards to this policy. Adherence to this policy will therefore ensure compliance with Equal Opportunity legislation and internal Equal Opportunity policies. Freedom of Information Act 2000 Freedoms of Information issues have been considered with regards to this policy. Adherence to this policy will therefore ensure compliance with the Freedom of Information Act 2000 legislation and internal Freedom of Information policies. Health and Safety at Worketc., Act 1974 Health and Safety issues have been considered with regards to this policy. Adherence to this policy will therefore ensure compliance with Health and Safety legislation and internal Health and Safety policies. Human Rights Act 1998 The Human Rights Act 1998 has been considered with regards to this policy. Proportionally has been identified as the key to Human Rights compliance. This means striking a fair balance between the rights of the individuals and those of the rest of the community. There must be a reasonable relationship between the aim to be achieved and the means used. Race Relations Amendment Act 2000 The Race Relations Amendment Act 2000 has been considered with regards to this policy. Adherence to this policy means that the Trust will eliminate discrimination on the grounds of race and will promote race equality and good race relations. The Mental Capacity Act 2005 Has been considered when developing this policy to ensure the guiding principles of the act are adhered to with reference to testing and assessment of capacity, consulting others and protecting the best interests of the patient. The Mental Capacity Act provides a statutory framework to empower and protect vulnerable people who are not able to make their own decisions. It makes it clear who can take decisions, in which situations, and how they should go about this. It enables people to plan ahead for a time when they may lose capacity. Page 2 of 37

CONTENTS Status: Feb 2015 V6 Draft 1 Introduction 4 2 Raising Concerns/Open Disclosure 4 3 Purpose 4 4 Scope 4 5 Patient, Carers, Staff Support 5 6 Misconduct 5 7 Grading incidents 5 8 Responsibilities / Duties / Processes 6 9 Level of Investigation 11 10 Process for monitoring the effectiveness of this policy 12 11 Training & Education 13 12 Confidentiality 13 13 Policy Review 13 14 References 13 APPENDIX A Definitions & Types of Incidents 14 APPENDIX B Grading Incidents 17 APPENDIX C Process for reporting to External Agencies 21 APPENDIX D Process for reporting Serious Incidents to the National Patient Safety 25 Agency and NHS London APPENDIX E RIDDOR Reportable Injuries/Incidents 26 APPENDIX F NHS London guide to Serious Untoward Incidents 27 APPENDIX G Incident and Near Miss Reporting Process 30 APPENDIX H Duty of Candour 36 Page 3 of 37

Status: Feb 2015 V6 Draft 1. INTRODUCTION The Trust acknowledges that research indicates that the majority of mistakes on investigation are caused as a result of organisational process and systems rather than individuals. The Trust is committed to the promotion of a learning and fair blame culture in which staff feel able to report all incidents. Throughout this policy an incident refers to all accidents, incidents and near misses. Definitions of incidents are detailed in Appendix A. 1. RAISING CONCERNS/OPEN DISCLOSURE/DUTY OF CANDOUR The Trust wants all staff to feel safe to report any incident including near misses, incidents and safety issues. The Trust assures staff through processes such as the whistleblowing policy [Raising Concerns Policy] that the information they share will be treated with respect and acted upon appropriately to improve the safety and quality of the service we provide for our patient/service users and the safety and quality of the work environment for staff and visitors. In line with National Patient Safety Agency guidance Being Open (2009) and the Duty of Candour Requirements (2014) the Trust also has a Being Open policy[ Being Open 2009/PSA003 alert]to ensure that when mistakes are made patients/relatives/carers receive an acknowledgement, apology and a truthful and clear explanation as soon as a patient safety incident has occurred. Saying sorry is not an admission of liability it is the right thing to do. Communication with patients, carers and the public must be fully documented. Staff can also contact the Care Quality Commission CQC with concerns about care; details are available on the CQC website - http://www.cqc.org.uk/ 2. PURPOSE 3. SCOPE This policy details the process for the management of incidents. This includes incidents ranging from No Harm to Serious Incidents. The aim of this policy is to ensure that all incidents, whether clinical or non-clinical are reported using the Trust incident reporting system (Datix), investigated appropriately and action[s] taken to minimise the risk of reoccurrence. This policy is written with reference to Department of Health publications, An Organisation with a Memory,Building a Safer NHSandDoing Less Harm and National Patient Safety Agency [NPSA] publications. NPSA, Building a Memory: Preventing Harm Reducing Risks and Improving Patient Safety, NPSA, Being Open: Communicating Patient Safety Incidents with Patients and their Carers, NPSA, National Framework for Reporting and Learning from Serious Incidents requiring Investigation. The Chief Nurse is accountable to the Chief Executive and Trust Board for the management of clinical risk in the Trust. The Medical Director works in conjunction with the Chief Nurse to ensure effective risk management is in place. The Director of Estates and Facilities is the lead for Health and Safety. The Assistant Director of Risk Management is responsible for ensuring that the process for the management of incidents is in line with statutory and national requirements. However this Policy applies to all employees, including agency and contractual staff, withinthe Trust in all healthcare settings and working environments. Page 4 of 37

Status: Feb 2015 V6 Draft 4. PATIENTS, CARERS, STAFF SUPPORT, & REGULATING BODIES 5.1 PATIENTS, CARERS, STAFF SUPPORT Involvement in an incident can undermine confidence for patients, carers and families. The member of staff who informed the patient/relative/carer about the incident should offer all necessary support. [Trust s Being Open Policy] Managers, supervisors and mentors should be aware that an individual or team, involved in an incident could experience difficulties associated with the event and might require immediate and ongoing support. The manager in discussion with the individual or team will guide them to the appropriate support service. The Occupational Health Department, Human Resources Department, counselling service, chaplaincy service and external agencies such as professional bodies can provide proportionate support for staff involved in an incident. If a staff member is required to prepare a statement, attend a Serious IncidentPanel or is called as a witness for a Coroner sinquest, advice and guidance is available from the Clinical Governance Department. Staff involved in an incident should receive feedback from their manager regarding any investigation, recommendations and actions taken to reduce the risk of reoccurrence. 5.2 Care Quality Commission The Chief Nurse is the Trust s nominated person, with responsibility for supervising the way regulated activity is managed. As such the nominated individual will notify the CQC about events that indicate or may indicate risks to ongoing compliance with the registration requirements, or that lead or may lead to changes in the details about the organisation in the Commission s register. 5. MISCONDUCT Where an incident upon investigation, identifies that an individual[s] acted in a manner, which knowingly placed themselves and others at significant risk or if misconduct or fraudulent behaviour is identified disciplinary action may follow. If a member of staff knowingly fails to report an incident it will be in breach of this policy. Where individual staff repeatedly make the same mistakes, or are persistently closely involved with incidents and fail to learn from the support and training provided by the organisation, then the Trust s Capability policy and procedureswill be followed. 6. GRADING INCIDENTS The severity of an incident, consequences along with the likelihood of reoccurrence is applied to the incident which could involve staff, patients and others to establish a grade e.g. near miss, negligible, minor, moderate, major, catastrophic. A scoring matrix is included in Appendix B to help identify the appropriate score for an incident. All incidents including near misses are graded however a near miss will be graded in relation to the potential harm as opposed to the actual harm. Page 5 of 37 This table is an example of patient safety incidents taken from the National Patient Safety Agency s (NPSA) comparative reports.

Status: Feb 2015 V6 Draft Severity Near Miss Negligible Minor Moderate Major Catastrophic Example The wrong drug was prescribed but this was noticed and the drug was not administered. e.g. wrong dose of aspirin given, but no harm Requiring extra observation or minor treatment e.g. Fall and grazed arm, dressing applied Causing significant but not permanent harm e.g. Fall requiring more than first aid such as sutures to a wound. Causing permanent and significant harm e.g. cardiac arrest after allergic reaction, anoxic brain damage Directly related to the patient safety incident e.g. paracetamol levels not checked in an overdose patient, fatal liver failure 7. RESPONSIBILITIES/DUTIES/PROCESSES 7.1. All Employees/Staff Reporting Incidents If you are involved in or witness an incident, to the best of your ability take all necessary action to ensure that the needs of the person(s) or facilities affected by the event are attended to, to minimising the risk of further harm to the person affected and others. Ensure that any medicines or equipment that has been involved in the incident are quarantined labelled and under the jurisdiction of the senior manager. Report the incident verbally to your line manager/senior manager on duty immediately or immediately following any action in relation to the person/facility affected and complete the Trusts electronic incident reporting form on Datixas soon is reasonably possible (but before going off shift). The line manager or their nominated deputy must review the form within 3 working days. The Trust uses an electronic Incident Reporting System for the reporting and recording of information about all incidents to Patients, Staff, Contractors, Visitors, Agency Staff, whether on or off Trust locations carrying out their work. Trust staff working off site involved in an incident must enter details of the incident onto the Trust s electronic reporting system as well as reporting the incident to the organisation they are working in via their incidents reporting process. The staff s line manager at the Trust will carry out the investigation in conjunction with any investigation conducted by the organisation the member of staff was working in. If the incident is of a particularly sensitive nature and the reporter is unsure as to how to proceed with the logging of the incident they should discuss the matter,in the first instance, with their Line Manager or a member of the Risk Management Team. 7.2. Contractors Contractors involved in an incident should ensure the incident is entered onto the Trust electronic incident reporting system and the incident reporting form of their employer. The contractor s line manager at the Trust, in conjunction with the person s employer, will conduct the investigation. Page 6 of 37

Status: Feb 2015 V6 Draft 7.3. Line Managers/Staff Managing Incidents/Handlers Ensure any Serious Incident is immediately reported to your Manager who will escalate in line with Trust policy. If for any reason your manager is not available the incident must be reported to the On-Call Duty Managerwho will escalate as above. Ensure, to the best of your ability, that action has been taken to address any immediate risk to patients, carers, staff and visitors. Ensure that any medicines or equipment that has been involved in the incident are quarantined labelled and under the jurisdiction of the senior manager. Where appropriate refer staff involved in an incident to the Occupational Health or out of hours to the Accident & Emergency department. Investigate any incident reported to you referring to the Trust s root cause analysis investigation guidance and grade accordingly. Line Managers, Supervisors and Mentors should be aware that an individual or team, involved in allegations of negligence or experiencing difficulties associated with the event, might require immediate and ongoing support during any investigation. In discussion with them, you should help guide them,if necessary with the involvement of the clinical governance team and professional bodies to the appropriate support service. The Occupational Health Department, Human Resources Department, counselling service, chaplaincy service and external agencies can provide proportionate support for staff involved in serious incidents, which will continue throughout the event to conclusion and may include preparation to be a witness. In certain instances individual staff members will require legal or other advice and support, which if deemed necessary, will be supported by the Trust. If it is suspected that the cause of the incident was the unacceptable performance or conduct of a member of staff the Executive Director and Chief Executive may be required to consider suspension of the member of staff to ensure the safety of patients or the service. Ensure that with regard to any patient safety incident the patient/carer/relatives are informed of the incident in line with the Trust s Being Open Policy, and requirements on the Duty of Candour - please see Appendix H. Report to the Risk Management any member of staff who is off sick for seven days or more as a result of an incident. [The Reporting of Injuries, Diseases and Dangerous Occurrences Regulations 2013 [RIDDOR] Undertake an investigation of the incident using the Trust s investigation guidance. If indicated carry out a risk assessment using the Trust s Guidance for Performing a Risk Assessment to establish areas of risk and required controls. The incident must be recorded on Datix on the day on the event. The line manager or their nominated deputy must review the Datix entry within 3 working days.10 days are allowed for investigation into the incident and completion ofall mandatory fields on the Datix system, this must be forwarded to the risk management team no later than day 10. The Risk Management team have 5 days to ensure investigation and data entry complete before final sign off. Page 7 of 37

Status: Feb 2015 V6 Draft Page 8 of 37 Where appropriate communication with relevant services/external companies/contractors should be undertakenetc. Grade the incident referencing the grading matrix Appendix B. 7.4. Matrons, Heads of Nursing, Consultants, Clinical/Non-Clinical Department Heads, Service Managers Ensure that all Serious Incidents are reported to the Divisional Clinical Directors, Divisional Heads of Nursing, Divisional General Managers, Chief Nurse and Medical Director. Ensure that with regard to any patient safety incident the patient/carer/relatives are informed of the incident in line with the Trust s Being Open Policy, and requirements on the Duty of Candour - please see Appendix H. Ensure that any medicines or equipment that has been involved in the incident is kept under quarantined and labelled appropriately to support/ inform the investigation process. Support line managers in undertaking the root cause analysis and writing the report. 7.5. On-Call Duty Manager You must report all major and catastrophic incidents, that have the potential to be declared as an Internal Critical Incident [ICI] or a Serious Incident (SI), to the Chief Nurse or Medical Director or their deputies as required. These Executive Directors will inform the Chief Executive and other relevant parties. 7.6. Divisional Clinical Directors, Divisional Heads of Nursing, and Divisional General Managers Ensure that this policy is implemented across your Division. You must report all major and catastrophic incidents, that have the potential to be declared as an Internal Critical Incident [ICI] or a Serious Incident (SI), to the Chief Nurse or Medical Director or their deputies as required. These Executive Directors will inform the Chief Executive and other relevant parties. Ensure that with regard to any patient safety incident the patient/carer/relatives are informed of the incident in line with the Trust s Being Open Policy, and requirements on the Duty of Candour - please see Appendix H. Also ensure all immediate actions have been taken to avoid reoccurrence, any equipment has been isolated and ensure that staff involved understands the investigation process and are appropriately supported. 7.7. Assistant Director of Risk Management/Deputy Risk Manager Will provide expertise advice on the Trust s risk management reporting system and processes. Ensure all relevant incidents are reported to the relevant agencies. e.g. National Patient Safety Agency (NPSA), Medicine & Healthcare Products Regulatory Authority (MHRA), Health & Safety Executive (HSE), Local Security Management Service (LSMS), Counter Fraud Management Service (CFMS) [Appendix C] Oversee the production of regular incident reports, including frequency and severity of incidents and an overview of any trends to enable Divisionsto evaluate what action(s) are in place and the effectiveness of these in reducing the likelihood of incidents reoccurring.

Status: Feb 2015 V6 Draft Oversee the provision of reports to groups or committees, with a remit for risk management. This will include quarterly reports to the Trust Patient Quality and Safety Committee, Clinical Performance and Patient Experience Committee (CP&PE) and external agencies as part of their governance and assurance process. Oversee all aspects risk management training to include Incident reporting training on staff induction. Incident reporting to update staff in post. Provide tools, advice and guidance on incident investigations [RCA] Provide guidance and support for any SI investigation. 7.8. Head of Health & Safety To providing advice and guidance on all matters of Health and Safety Law, Regulations, Approved Codes of Practice and The Reporting of Injuries, Diseases & Dangerous Occurrences Regulations [2013] (RIDDOR). Ensure RIDDOR reportable incidents are reported to the Health & Safety Executive Ensuring the provision of suitable Induction and Refresher training; Health and Safety Workshops, Governance Training Days and Tool box talks, on a planned schedule. Liaising with the Health and Safety Executive and other Enforcing Authorities as necessary. Undertaking Health and Safety monitoring, inspections and audits, in any Trust premises; of any work equipment; working environment / ward or department; work procedure / Safe Systems of Work. Liaising closely with Governance and Risk Managers, Occupational Health, Estates and Facilities, Unions and Safety Representatives, Infection Control, Community Services and all other clinical specialties and Contractors. 7.9. Head of Clinical Governance To ensure the Trust s seriousincident investigation processes reflect and comply with current Clinical Commissioning Group (CCG) and National guidance. Maintain a Trust wide database of SI s. Liaise with NHS England and Commissioners to monitor timescales for SI reports Provide an updated SI tracker to go to the Patient Quality and Safety Committee. Provide a serious incident summary report to commissioners and other stakeholders as required. To maintain a database of Divisional ICI/SI trackers. Provide a quarterly report to the Clinical Performance and Patient Experience Committee on the monitoring of the key standards within this policy. Page 9 of 37

Status: Feb 2015 V6 Draft 7.10. Chief Nurse and Medical Director Review the incident and determine the appropriate investigation process e.g. Serious Incident (SI) or Internal Critical Incident ( ICI ) [Appendix G] Determine whether the incident is reportable to the NHS England, Commissioners, Social Services and Local Borough safeguarding leads and Care Quality Commission (CQC).By definition SI reporting requires only the most serious of incidents to be reported. If the incident is deemed to reportable as an SI to follow the process for in or out of hours reporting and ensure the incident is entered onto the STEIS system [if circumstances dictate report the incident directly to the Commissioners] [Appendix F] Page 10 of 37

Status: Feb 2015 V6 Draft 8. LEVEL OF INVESTIGATION The lead for the investigation of any incident or near miss will be dependent on the severity score. The Trust s root cause analysis investigation guidance will indicate the best approach to investigate the incident and guidance is available from the risk management team. The process for investigating serious incidents deemed to be an SI or ICI is detailed in Root Cause Analysis Investigation Guidance for, Serious Incidents, Clinical Negligence Claims and Complaints Policy. Incident Investigation Investigation Lead by Negligible /minor Moderate Major to Catastrophic Infection Control Incidents Pressure Ulcer Maternity reportable SI LAS/A&E Such incidents will have very little impact on individual or facilities and will not require detailed investigation the reason or root cause of the incident will be clear and there may be very few if any contributory factors Such incidents can cause significant but not permanent harm. These events will require a more in depth investigation i.e. RCA as there may be underlying reasons why the event occurred - a number of factors occurring at the same time may have contributed to the event occurring. A critical incident, where it is suspected that all Trust policies and procedures where adhered to but serious injury still occurred will require an in-depth internal investigation i.e. RCA and/or panel investigation Where it is suspected that Trust s policies and procedures were deviated from or not adhered will require an in-depth and in the majority of cases a panel investigation Confirmed infection control incidents such as MRSA bacteraemia / C.Diff will be investigated using the NPSA Action tool. Grade 3 /4 pressure ulcer investigated using the Pressure Ulcer RCAinvestigation tool. See Appendix A Delayed handover of more than 60 minutes between LAS and A&E Line manager Matrons/Heads of Service/General Managers/Senior Consultants Divisional Clinical Directors, Divisional Heads of Nursing, and Divisional General Managers Infection control team supported by the risk management team Matrons/Heads of Service/General Managers/Senior Consultants Head of Midwifery A & E General Manager Data Loss or confidentiality breaches DoH score 1 to 5 Safeguarding incident All confidential information leaks and breaches of person identifiable data incidents are now required to have the severity of the incident assessed and a risk rating allocated from 1 to 5 as new guidance from the DoH, May 2008 table below Local safeguarding procedures for adults and children must be followed and safeguarding alerts made whenever appropriate. The LSAB/LSCB and Independent Safeguarding Authority (ISA) and professional bodies. Divisional Clinical Directors, Divisional Heads of Nursing, and Divisional General Managers Chief Nurseor Deputy Chief Nurse[Children] Chief Nurseor Deputy Chief Nurse[Adults] Page 11 of 37

Status: Feb 2015 V6 Draft All confidential information leaks and breaches of person identifiable data incidents are required to have the severity of the incident assessed and a risk rating allocated as per the categorisation below as referenced in the DoH Checklist for reporting, managing and investigating Information Governance SUIs. Gateway Ref: 13177 Jan 2010. 0 1 2 3 4 5 No significant reflection on any individual or body Media interest very unlikely Minor breach of confidentiality. Only a single individual affected. Damage to an individual s reputation. Possible media interest. E.g. celebrity involved Potentially serious breach. Less than 5 people affected or risk assessed as low e.g. files were encrypted Damage to a team s reputation. Some local media interest that may not go public. Serious potential breach & risk assessed high e.g. unencrypted clinical records lost. Up to 20 people affected. Damage to services reputation. Low key local media coverage. Serious breach of confidentia lity e.g. up to 100 people affected Damage to an organisations reputation. Local media coverage. Serious breach with either particular sensitivity e.g. sexual health details or up to 1000 people affected. Damage to NHS reputation. National media coverage. Serious breach with potential for ID theft or over 1000 people affected. 9. PROCESS FOR MONITORING THE EFFECTIVENESS OF THIS POLICY Monitoring will occur using the risk management system and processes to inform a quarterly exception report to the Health and Safety Group and Patient Quality and Safety Committee, which in turn report to the Clinical Performance and Patient Experience Committee. Frequency of monitoring all or specific aspects of this policy can be increased if there is an area of concern e.g. untimely closure of incident reporting. Divisions will monitor compliance with this policy through the DivisionalClinical Governance processes. Divisionswill provide Exception reports to the Health and Safety Groupand Patient Quality and Safety Committee. The Assistant Director of Risk Management will monitor the timeliness of patient safety incidents by reviewing monthly downloads to the NPSA NRLS and the subsequent NPSA six monthly comparative reports. Divisionswill receive copies of the NPSA comparative report. A copy of the NPSA comparative report and a summary will go to the CP&PE bi-annually. All ICI and SI s are reported to the Incident, Review and Analysis Group, Patient Quality and Safety Committee and/or the Trust Board who monitor recommendations and progress against action plans Page 12 of 37

Status: Feb 2015 V6 Draft 10. TRAINING AND EDUCATION Training in incident reporting procedures, guidance on how to complete the Trust s incident reporting form, how to investigate and apply a grade, and identify action[s] required to reduce the risk of reoccurrence will form part of all staff induction to the Trust and the annual mandatory training for all staff. Training will be provided to update staff in post and the Risk Management team will on request provide advice and guidance on incident investigations. Use of the Datix Incident Reporting System can be sought via the appropriate intranet guides in respect of reporting or investigating an incident. If a staff member requires further assistance they can contact the Risk Management Team. Members of staff who may be called on to take part in an ICI/SI investigation Panel should access the root cause analysis training or seek advice and guidance from the Clinical Governance Team. The communications department will advise on any press / media interest. Training, support and supervision to enable staff to implement the lessons learnt from investigations will be dependent on the findings of the investigation and will be available from professional leads and the clinical governance team. 11. CONFIDENTIALITY All incident reports are to be treated as confidential information and patient, visitors or staff are not identified on reports produced by the Risk Management Team nor are any patients, visitors or staff details submitted to the NPSA [NHS Confidentiality Code 2003]. Reports from any investigations are disclosable and as such must not identify an individual patient, member of staff, relative, carer, friend or member of the public. If the incident is of a particularly sensitive nature and the reporter is unsure as to how to proceed with the logging of the incident they should discuss the matter with their Line Manager, in the first instance, or a member of the Risk Management Team. 12. POLICY REVIEW This policy will be reviewed every two years or when circumstances dictate by external agencies or regulatory bodies. 14. REFERENCES Care Quality Commission (2014), Information and services for organisations regulated by the Care Quality Commission. Available from: http://www.cqc.org.uk/organisationswe-regulate[11march 2014]. Department of Health: An organisation with a Memory, Department of Health: Building a Safer NHS, Department of Health: Doing Less Harm National Patient Safety Agency [NPSA] National framework for Reporting and Learning from Serious Incidents Requiring Investigation. March 2010 National Patient Safety Agency [NPSA]: Building a Memory: Preventing Harm, Reducing Risks and Improving Patient Safety NPSA Being Open: Communicating patient safety incidents with patients and their carers Reporting of Injuries, Diseases and Dangerous Occurrences Regulation 2013 NHS England, Serious Incident Framework, March 2013 Health and Safety at Work, etc., Act 1974 Page 13 of 37

Incident Harm APPENDIX A DEFINITIONS & TYPES OF INCIDENTS Status: Feb 2015 V6 Draft An adverse incident is defined as Any event or circumstance arising during NHS care that could have or did lead to unintended or unexpected harm, loss or damage (Doing Less Harm, NPSA 2001). Harm is defined as injury (physical or psychological), disease, suffering, disability or death (Doing Less Harm, NPSA 2001). Loss A Near Miss Can be injury, damage, financial, managerial, morale etc whilst a hazard is something with the potential to cause harm e.g. unacceptable method of working. Is an unplanned event that could have resulted, but by chance ordesigndid not result in loss or injury. A Near Miss is defined by the NPSA as any patient safety incident that had the potential to cause harm but was prevented. Internal Critical Incident Serious Incident Is an incident when: A patient, member of staff or member of the public, suffers serious injury, major permanent harm or unexpected death (or the risk of death or injury) on hospital, other health service premises or other premises where NHS care is provided, where it is suspected that all Trust policies and procedures where adhered to but serious injury still occurred. Is an incident when: A patient, member of staff or member of the public, suffers serious injury, major permanent harm or unexpected death (or the risk of death or injury) on hospital, other health service premises or other premises where NHS care is provided. Where it is suspected that Trust policies and procedures were deviated from or not adhered to. Where actions of health service staff are likely to cause significant public concern. Where an event occurs which involves serious damage to, or loss of NHS property. Incidents affecting large numbers of patients and/or are likely to attract media attention. A Near Miss that has the potential for any of the above could be deemed to be an SI. 14

Status: Feb 2015 V6 Draft DEFINITIONS & TYPES OF INCIDENTS Never Events Never Events are serious, largely preventable patient safety incidentsthat should not occur if the available preventative measures have beenimplemented by healthcare providers. [High Quality Care for All proposed that a policy on Never Events should be introduced into the NHS in England from April 2009]. Commissioners will be expected to seek recovery of the cost of the procedure/ treatment where one of the following Never Events occurs: Wrong site surgery. Wrong implant/prosthesis. Retained foreign object post-operation. Wrongly prepared high-risk injectable medication. Maladministration of potassium-containing solutions. Wrong route administration of chemotherapy. Wrong route administration of oral/enteral treatment. Intravenous administration of epidural medication. Maladministration of Insulin. Overdose of midazolam during conscious sedation. Opioid overdose of an opioid-naïve Patient. Inappropriate administration of daily oral methotrexate. Suicide using non-collapsible rails. Escape of a transferred prisoner. Falls from unrestricted windows. Entrapment in bedrails. Transfusion of ABO-incompatible blood components. Transplantation of ABO or HLA-incompatible organs. Misplaced naso- or oro-gastric tubes. Wrong gas administered. Failure to monitor and respond to oxygen saturation. Air embolism. Misidentification of Patients. Severe scalding of Patients. Maternal death due to post-partum haemorrhage after elective caesarean section. Where a Never Event is related to a commissioned procedure/operation, the consequence of this breach would be the recovery of the cost of the procedure/operation and for there to be no charge to the commissioner for any corrective procedure/operation. Where there is in-hospital death, the consequence of the breach would be recovery of the cost of care to date (within the financial year) for the ongoing patient episode based on the provider s average daily rate costs. NPSA Never Events Framework updated 2011/2012 Never Events list 2012/2013 15

Maternity Status: Feb 2015 V6 Draft The following incidents should be reported as SIs and these STEIS codes used: Maternal death A maternal death is defined as any death which occurs during or within one year of pregnancy, ectopic pregnancy or abortion which is directly or indirectly related to these conditions. Intrauterine death (antenatal) Any intrauterine death at 24 weeks and above where service or clinical factors might havecontributed. Intra partum death (during labour) Unexpected intra partum death during labour regardless of gestational age where service or clinicalfactors might have contributed. Unexpected Neonatal Death Unexpected death of a baby aged 0-28 days. The requirement is to report unexpected deathwhere the death of a neonate was not anticipated as a significant possibility 24 hours before the death or where there was a similarly unexpected collapse leading to or precipitating the events that led to the death. If in doubt about whether or not the death is unexpected, the designated paediatrician responsiblefor unexpected deaths should be consulted. In such cases, the incident should be reported until theavailable evidence enables a decision to be made. Unexpected admission to NICU (Neonatal Intensive Care Unit) Infants > 37 completed weeks of gestation that have a sudden and unexpected collapse followingdelivery or in the early postnatal period of a previously well infant requiring intensive care (positivepressure ventilatory support). Maternal unplanned admission to ITU An unexpected admission to ITU during pregnancy or within 28 days of delivery. Suspension of maternity services Any time a decision is made to suspend the full service even if suspension is subsequently notpossible. The Local Supervisory Authority expects to be informed when any part of a maternityservice is suspended. Post-partum haemorrhage (PPH) 1. In hospital maternal death from postpartum haemorrhage after elective caesarean section(never Event) 2. Unplanned admission to HDU/ITU following postpartum haemorrhage 3. Unplanned hysterectomy/uterine artery embolization 4. If significant care or service issues were identified which contributed to the PPH. 16

Status: Feb 2015 V6 Draft APPENDIX B RISK QUANTIFICATION 1. * Consequence score (severity levels) and examples of descriptors Domains Impact on the safety of patients, staff or public (physical/ psychological harm) Quality/ complaints/audit Organisational development/ staffing/ competence Statutory duty/inspections 1 2 3 4 5 Negligible/Insi gnificant No injury requiring no intervention or treatment. No injury requiring no intervention or treatment. No time off work required. Peripheral element of treatment or service suboptimal. Informal complaint/inqui ry. Low staffing levels that do not impact on quality of service. No impact or breech of guidance/ statutory duty. Minor Moderate Major Catastrophic Minor injury or illness requiring minor intervention. Increase in length of hospital stay by 1 3 days. Minor injury or illness requiring minor intervention. May require time off work for <7 days. Overall treatment or service suboptimal. Formal complaint (stage 1) Local resolution. Single failure to meet internal standards. Minor implications for patient safety if unresolved. Reduced performance rating if unresolved. Low staffing level that reduces service quality. Breech of statutory Legislation. Reduced performance rating if unresolved. Moderate injury requiring further intervention. Increase in length of hospital stay by 4 15 days. RIDDOR/agency reportable incident. An event which impacts on a small number of patients. Moderate injury requiring further intervention. Requiring time off work for >7 days. RIDDOR/agency reportable incident. Treatment or service has significantly reduced effectiveness. Formal complaint (stage 2) Local resolution (with potential to go to independent review). Repeated failure to meet internal standards. Major patient safety implications if findings are not acted on. Unsafe staffing level or competence of staff affecting service delivery. Low staff morale. Poor staff attendance for mandatory/key training. Late delivery of key objective/service due to lack of staff. Single breech in statutory duty. Challenging external recommendations/ improvement notice. Major injury leading to long-term incapacity/ disability. Increase in length of hospital stay by >15 days. Mismanagement of patient care with long-term effects. Major injury leading to long-term incapacity/ disability. Admission to hospital for more than 24 hours (HSE) Non-compliance with national standards with significant risk to patients if unresolved. Multiple complaints/ independent review. Low performance rating. Critical report. Unsafe staffing level or competence of staff significantly affecting service delivery. Loss of key staff. Very low staff morale. No staff attendance for mandatory/key training. Uncertain delivery of key objective/service due to lack of staff. Enforcement action. Multiple breeches in statutory duty. Improvement notices. Low performance rating. Incident leading to death. Multiple permanent injuries or irreversible health effects. An event which has a significant impact on a large number of patients. Incident leading to death of individual or several people. Multiple permanent injuries or irreversible health effects. Incident leading to totally unacceptable level or quality of treatment/service. Gross failure of patient safety if findings not acted on. Inquest/ ombudsman inquiry. Gross failure to meet national standards. Unsafe staffing levels or competence of staff severely affecting service delivery. Loss of several key staff. No staff attending mandatory training/key training resulting in harm to staff or patients. Non-delivery of key objective/service due to lack of staff. Multiple breeches in statutory duty. Prosecution. Complete systems change required. Zero performance rating. 17

Status: Feb 2015 V6 Draft Critical report. Severely critical report. Adverse publicity/ reputation Business objectives/ projects Finance/claims Service/business interruption Environmental impact. Information, Security, Confidentiality Rumours. Insignificant cost increase/sched ule slippage. Small loss. Risk of claim remote. Loss/interrupti on of >1 hour. No impact on the environment. Breach of confidentiality. Less than 5 people affected. Local media coverage short-term reduction in public confidence. Elements of public expectation not being met. <5% over project budget. Schedule slippage. Loss of 0.1 0.25% of budget. Claim less than 10,000. Loss/interruption of >8 hours. Minor impact on environment. Breach of confidentiality. Up to 20 people affected. Local media coverage long-term reduction in public confidence. 5 10% over project budget. Schedule slippage. Loss of 0.25 0.5% of budget. Claim(s) between 10,000 and < 100,000. Loss/interruption of >1 day. Moderate impact on Environment. Breach of confidentiality. Over 20 an up to 100 people affected. National media coverage with service well below reasonable public expectation. Non-compliance with national 10 25% over project budget. Schedule slippage. Key objectives not met. Uncertain delivery of key objective/loss of 0.5 1.0% of budget. Claim(s) between > 100,000 and 1 million. Purchasers failing to pay on time. Loss/interruption of >1 week. Major impact on Environment. Breach of confidentiality. Over 100 and up to 1000 people affected. Or with 1 or more people affected with either particular sensitivity details e.g. sexual health. National media coverage with service well below reasonable public expectation. MP concerned (questions in the House). Total loss of public confidence. Incident leading >25% over project budget. Schedule slippage Key objectives not met. Non-delivery of key objective/loss of >1% of budget. Failure to meet specification/ slippage. Loss of contract/ payment by results. Claim(s) > 1 million. Permanent loss of service or facility. Catastrophic impact on environment. Breach of confidentiality. Over 1000 people affected. Or with 1 or more people affected with the potential for ID theft. Page 18 of 37

Status: Feb 2015 V6 Draft Measures of Consequence (continued with working examples) Consequence score (severity levels) and examples of descriptors 1 2 3 4 5 Domains Negligible Minor Moderate Major Catastrophic Additional examples Incorrect medication dispensed but not taken. Delay in routine transport for patient. Physical attack such as pushing, shoving or pinching, causing minor injury. Self-harm resulting in minor injuries. Grade 1 pressure ulcer. Incident resulting in a bruise/graze, laceration, anxiety requiring occupational health counselling (no time off work required). Physical attack causing moderate injury. Self-harm requiring medical attention. Grade 2/3 pressure ulcer. Healthcare-acquired infection (HCAI) short-term. Incorrect or inadequate information /communication on transfer of care. Vehicle carrying patient involved in a road traffic accident. Slip/fall resulting in injury such as a sprain. Physical attack resulting in serious injury. Grade 4 pressure ulcer. Long-term HCAI. Retained instruments/material after surgery requiring further intervention. Slip/fall resulting in injury such as dislocation/ blow to the head. Loss of a limb. Failure to follow up and administer vaccine to baby born to a mother with hepatitis B. Unexpected death. Suicide of a patient known to the service in the past 12 months. Homicide committed by a mental health patient. Large-scale cervical screening errors. Removal of wrong body part leading to death or permanent incapacity. Incident leading to paralysis. Incident leading to long-term mental health problem. Measures of Likelihood Likelihood score 1 2 3 4 5 Descriptor Rare Unlikely Possible Likely Almost certain Frequency How often might it/does it happen This will probably never happen/reocc ur. i.e. (Not expected to occur for years) Do not expect it to happen/reoccur but it is possible it may do so. i.e. (Expected to occur at least or has occurred annually) Might happen or reoccur occasionally. i.e. (Expected to occur at least or has occurred monthly) Will probably happen/reoccur, but it is not a persisting issue/ circumstances. i.e. (Expected to occur at least or has occurred weekly) Will undoubtedly happen/reoccur, possibly frequently. i.e. (Expected to occur at least or has occurred daily) Page 19 of 37

Status: Feb 2015 V6 Draft 3 Quantitative Level of Risk = Consequences x Likelihood Consequence Negligible Rare 1 Unlikely 2 Possible 3 Likelihood Likely 4 Almost certain 5 1 1 2 3 4 5 Minor 2 2 4 6 8 10 Moderate 3 3 6 9 12 15 Major Catastrophi c 4 4 8 12 16 20 5 5 10 15 20 25 4 and under Low Risk 5-6 Moderate Risk 8-12 Significant Risk 15 and above High Risk 4. Risk Quantification Conclusion/Action Matrix 4 & under Low Risk 5-6 Moderate Risk 8-12 Significant Risk 15 & above High Risk Risks Scores and Actions to be Taken Adding to a Risk Register = Accept risk no further action required. Does not need adding to a Risk Register. = Risk to be managed and monitored locally. Add to Directorate Risk Register. = Risk to be managed and monitored locally, however where local resolution cannot satisfactorily be achieved these risks are to be brought to the Health & Safety or Clinical Risk Management Group (as appropriate) and the Strategic Risk Management and Clinical Governance Committee by the Assistant Director/Clinical Director considered for inclusion in the Trust Risk Register. = Are high risks and are to be brought to the Health & Safety or Clinical Risk Management Group (as appropriate) and the Strategic Risk Management and Clinical Governance Committee by the Assistant Director/Clinical Director for inclusion in the Trust High Risk Register. Add to Directorate Risk Register and consideration by Executive for inclusion in the Trust Risk Register. Add to Directorate Risk Register and inclusion in the Trust Risk Register by an Executive Director. Page 20 of 37

Status: Feb 2015 V6 Draft APPENDIX C PROCESS FOR REPORTING TO EXTERNAL AGENCIES All identified serious incidents must be notified to relevant bodies within two working days of the incident occurring Type of Incident Agency Responsible Person Reporting Requirements All Patient Safety Incidents NPSA via NRLS Assistant Director of Risk Management All patient safety incidents are downloaded to the NRLS on a monthly basis Any accident or injury at work which results in an employee being unable to return to work or unable to carry out their normal duties for 7 days or more. Health & Safety Executive RIDDOR Head of Health & Safety or in their absence a nominated reporter Staff/Incidents in Ealing Hospital Report to the Health & Safety Advisor and/or the Head of Health Safety. The Health &Safety Advisor /Head of Health & Safety will report to HSE accidents or injury occurring RIDDOR Staff/incidents in Community Services Report to the Health & Safety Advisor and/or the Head of Health Safety. The Health &Safety Advisor /Head of Health & Safety will report to HSE accidents or injury occurring RIDDOR Staff/incidents in Northwick Park, Central Middlesex or St Mark s Hospitals Report to the Health & Safety Advisor and/or the Head of Health Safety. The Health &Safety Advisor /Head of Health & Safety will report to HSE accidents or injury occurring RIDDOR 21

Status: Feb 2015 V6 Draft Type of Incident Agency Responsible Person Reporting Requirements Safeguarding incidents The LSAB/LSCB and Independent Safeguarding Authority (ISA) and professional bodies Children Trust lead Chief Nurse / Designated Doctor Adults Chief Nurse Where appropriate, referrals of incidents and/or individuals to the LSAB/LSCB and Independent Safeguarding Authority (ISA) and professional bodies are made Where the incident involves a child or young person, considerations should be given to raising the alert as a Serious Incident under section 8 of Working Together to Safeguard Children,7 which relates to the Children Acts 1989 and 2004 If the incident involves vulnerable adults, an alert should be raised as described in No SecretsGuidance on developing and implementing multi-agency policies and procedures to protect vulnerable adults from abuse. DH & Home Office 2000 NHS organisations in partnership with the SAB/ SCB should have local policies for implementing the findings from SCR, a process to report to their own boards and action plans to implement and monitor changes in practice. Physical assaults on staff NHS Protect Local Security Management Specialist [LSMS] Major injury and dangerous occurrences Health & Safety Executive RIDDOR reporting Director of Estates and Facilities Staff must report all incidents of assualt on Datix and report to the Local Security Management Specialist who will report all incidents of abuse the via the Security management reporting systems [SIRS] Reported to the Incident Contact Centre on 0845 30009923 Complete relevant RIDDOR form www.riddor.gov.uk Head of Health & Safety/ Health & Safety Advisor must be informed Page 22 of 37

Status: Feb 2015 V6 Draft Type of Incident Agency Responsible Person Reporting Requirements Abuse Local Security Management Specialist [LSMS] Local Security Management Specialist [LSMS] Staff must report all incidents of abuse on Datix and report to the Local Security Management Specialist who will report all incidents of abuse the via the Fire that results in injury to individuals or severe property loss Equipment failure The equipment [including medical devices] should be retained untouched and in safe keeping for examination Blood Transfusion incident NHS Estates Health & Safety Executive MHRA MHRA Serious Hazards of Transfusion Haemovigilance Scheme. Fire Officer EBME Manager Assistant Director of Risk Management Transfusion Practitioner Security management reporting systems [SIRS] Report to NHS Estates Complete relevant form on www.riddor.gov.uk Where immediate action is indicated the sequence of reporting should be made by telephone followed up by a written reports Any incident must be reported to the Risk manager who is responsible for reporting to the MHRA Report must be made to the MHRA www.mhra.gov.uk Telephone reports ONLY for those involving death, serious injury or serious public harm concerns Online reporting system SABRE Voluntary reporting to SHOT Unexpected outcome from a drug MHRA Chief Pharmacist Report must be made to the MHRA www.mhra.gov.uk Telephone reports ONLY for those involving death, serious injury or serious public harm concerns All SI NHS England / Commissioners. If required appropriate information to other relevant bodies e.g. Police Health & Safety Executive, NPSA, GMC, NMC, other NHS agencies / organisations Head of Clinical Governance Incidents reported on The Strategic Executive Information System [STEIS] http://nww.steis.doh.nhs.uk/steis/steis.nsf/steismain?readform Out of hours urgent notification should be made to 08700 555 500 Pager #LON 01 APPENDIXD Flowchart for reporting Page 23 of 37

Status: Feb 2015 V6 Draft Type of Incident Agency Responsible Person Reporting Requirements Serious Incident in Colposcopy As with SI above. Head of Clinical Governance In addition to the SI process, there are specific processes to follow for Serious Incident involving Colposcopy Services. Please see the Trusts policy Guidance on Serious Incidents [SI] in Cervical Bowel Screening NHS Bowel Screening Programme Clinical Director for Gastrointestinal Surgery Screening [NHS CSP No 11] Please use the Interim Guidelines for Managing Incidents in the NHS Bowel Screening Programme, available on the Trust s Intranet. Page 24 of 37

APPENDIX D: Serious Incident Reporting Process Status: Feb 2015 V6 Draft 25