Serious Incident, Policy for the management of

Serious Incident, Policy for the management of The Trust strives to ensure equality of opportunity for all, both as a major employer and as a provider of health care. This procedural document has been equality impact assessed to ensure fairness and consistency for all those covered by it regardless of their individual differences and the results are shown in Appendix A. Policy Profile Policy Reference: Org 2.10 Version: 6 Author: Christopher Brooks-Daw, Interim Corporate Risk Manager Executive sponsor: Trust Secretary Target audience: All staff Date issued: 24 th March 2011 Review date: 24 th March 2014 Consultation Key individuals and committees consulted Risk Managers Dates February 2011 during drafting PRG Members Dates March 2011 Approval Ratification Ratification Committee: Policy Ratification Group Date: 24 th March 2011 Document History Version Date Review date Reason for change 5.1 August 2007 July 2009 Regular review due. 6 24 th Mar 2011 24 th Mar 2014 Policy Ratified Page 1 of 40

Contents Paragraph Page Executive Summary 3 1 Introduction 5 2 Purpose 5 3 Definitions 6 4 Scope 8 5 Roles and responsibilities 8 6 Serious Incident Identification, Reporting and Grading 13 6.1 What is a Serious Incident? 13 6.2 Mandatory Serious Incidents reportable to NHS London 14 6.3 Never Events 20 6.4 How to report a Serious Incident 27 6.5 Grading of Serious Incidents 28 6.6 External Reporting 28 7 Relationship to complaints, claims and the HR processes 32 8 Investigation Process 33 9 Communicating with and supporting staff 35 10 Learning from Serious Incident Investigations 35 11 Training 36 12 References and associated documentation 36 13 Monitoring compliance 37 Appendices A Equality Impact Assessment 38 B Procedural Document Checklist 40 C SI and HR Investigations flowchart 42 Page 2 of 40

Executive Summary A true safety culture is one in which every person in the organisation recognises their responsibilities to patient safety and works to improve the care that they deliver; this is the essence of clinical governance (National Patient Safety Agency, Build a Safety Culture, 2006) St. George s Healthcare NHS Trust (the Trust) recognises that in the NHS, tens of thousands of patients are treated safely by dedicated healthcare professionals who provide high quality and safe clinical care. For the vast majority of patients, their treatment helps to alleviate or improve their symptoms and is a positive experience. However, when serious incidents occur, the NHS has a responsibility to ensure that there are systematic measures in place for safeguarding people, property, NHS resources and reputation. This includes responsibility to learn from these incidents to minimise the risk of them happening again (National Framework for Reporting and Learning from Serious Incidents Requiring Investigation, (2010). This policy deals with the process of reporting, investigating and management of Serious Incidents once declared in order to improve safety, share lessons learnt and to prevent the recurrence of similar incidents. Identification and investigation are only part of the process to learn from such incidents. The process following the completion of an investigation and the report publication is at least as important as the investigation itself as this is the period in which the Trust must implement the required actions in order to reduce the chances of such an incident happening again. A serious incident may cross the boundaries of a number of internal systems and processes, most notably complaints, claims and human resources. It is imperative that the communication between these systems is robust to ensure that the investigative process is completed as appropriate. It is therefore necessary to be familiar with the other policy framework around complaints, claims and human resources. In the event of such an incident, only one process of investigation should be followed at any one time. This is described in more detail in section 6. If in doubt, the Corporate Risk and Assurance Department must be contacted for advice and guidance. In line with the National Framework for Reporting and Learning from Serious Incidents Requiring Investigation and the NHS London Serious Incident Reporting Policy (NHS London, December 2010), incidents previously referred to as Serious Untoward Incidents will now be known as Serious Incidents (SI). The St George s Healthcare NHS Trust Serious Incident Policy formalises the procedures, roles and responsibilities for the effective and efficient management of SIs in the Trust to ensure that such events are managed effectively and efficiently, lessons are learnt locally, Trust-wide and nationally using a systematic investigation technique that looks beyond the individuals concerned, seeking to understand the underlying and root causes. The aim of this policy is to optimise patient, staff, contractor and visitor safety by establishing the root cause/s of a Serious Incident, identifying organisational learning and making appropriate changes in practice and management to eliminate or mitigate the potential of recurrence. To achieve this aim, it is important that all staff understand that the purpose of adverse incident reporting and investigation is not to apportion blame to individuals or groups but to identify potential problems and remedy them. The focus of any investigation will be on what, why and how an incident occurred with the intended outcomes of: To support a safety culture of openness, learning and fairness. Page 3 of 40

Consistency of approach to managing incident investigations across the Trust. Clarity of roles and responsibilities. Knowledge of and adherence to the associated target times for reporting SIs at local, regional and national levels. That lessons learnt are evidenced and shared. Page 4 of 40

1. Introduction 1.1 The Trust recognises that incidents will occur and that when they do, a systematic process must be used to identify the factors that contributed to the incident, looking beyond the individuals concerned and seeking to understand the underlying causes, the environmental context in which the incident occurred to ensure lessons are learnt and implemented to prevent reoccurrence. 1.2 This policy sets out the reporting arrangements, immediate action and the process to be taken in the event of a serious incident for investigation 1.3 All adverse incidents should be reported via the DATIX Electronic Reporting System; see Adverse Incident Reporting Policy & Procedure. 1.4 This policy describes the link and relationship with other related systems and processes: complaints, claims and human resources. 2. Purpose 2.1 The fundamental purpose of this policy is to ensure that all Serious Incidents are identified, investigated and learned from consistently and robustly in line with national best practise and guidelines, most notably the NPSA National Framework for Reporting and Learning from Serious Incidents Requiring Investigation (NPSA March 2010) and NHS London Serious Incident Policy (NHSL October 2010). 2.2 This policy describes the arrangements for staff involved in an SI to access appropriate counselling and support, this may be through their manager, peers, Human Resources, Occupational Health, Legal Services, Risk Management, or Patient Safety Team. 2.3 This policy fosters organisational learning within the Trust and the Trust s contribution to learning by the wider community through reporting SIs to appropriate external agencies such as the Specialist Commissioners, Acute Commissioning Unit, PCT, SHA, HSE, NPSA, MHRA and others as and when required. 2.4 A clinical or non-clinical error, accident or incident, however serious, is rarely caused wilfully. It is not, in itself, evidence of carelessness, neglect or a failure to carry out a duty of care. Errors are often caused by a number of factors including, process problems, human error, individual behaviour and lack of knowledge or skills. Learning from such incidents can only take place when they are reported and investigated in a positive, open and structured way. 2.5 Determining safe practice is an important part of successful risk management. Moving away from punishing errors to learning from them will promote a fair and open culture and safe practice throughout the organisation. This will enable the organisation to identify trends and take positive action to prevent the error or adverse incident from happening again. 2.6 To promote a fair and open culture and encourage the reporting of incidents, the organisation will take a fair blame and non-punitive approach to those incidents it investigates. Staff remain accountable to users, carers, the organisation and their professional bodies for their actions, but a non-punitive approach means that action Page 5 of 40

(under disciplinary or capability procedures) will not be taken against a member of staff for reporting an incident, except in rare circumstances such as: Professional or gross personal misconduct Repeated breaches of acceptable behaviour or protocol An incident that results in a police investigation. 2.7 Openness when things go wrong is fundamental. 2.8 Although the majority of Serious Incidents are patient safety related, there may be Serious Incidents that do not fall into this category. For example, an incident in a workshop or on a part of the trust that maintenance work is being carried on. These incidents will follow the same process of reporting and discussion as all other Serious Incidents. However, consideration of the appropriate membership of the investigation panel will be conducted by the Serious Incident Declaration Meeting. The Director of Estates and Facilities will be consulted in such cases. 3. Definitions 3.1 Serious Incident 3.1.1 Serious Incident: a serious incident requiring investigation is defined as an incident that has occurred in relation to NHS-funded services and care resulting in: 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-saving intervention, major surgical/medical intervention, permanent harm or will shorten life expectancy, or result in prolonged pain or psychological harm (this 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 for the organisation or the wider NHS One of the core set of Never Events (See section 6.3). If in doubt, it is better to report an incident as a potential SI, as this can then be confirmed by the Serious Incident Declaration and Discussion Meeting which is held every Monday. It is also advisable that an investigation is commenced immediately as opposed to waiting until the incident has been declared as a Serious Incident. 3.1.2 Adverse Incident: an event or circumstance that could have resulted, or did result, in unnecessary damage, loss of harm such as physical or mental injury to a patient, staff, visitors or members of the public (World Health Organisation (2009) 3.1.3 NHS-funded services and care: healthcare that is partially or fully funded by the NHS, regardless of the location (National Patient Safety Agency (2004) Seven Steps to Patient Safety; National Patient Safety Agency (2009) Data Quality Standards, Guidance for organisations to the reporting and learning system) Page 6 of 40

3.1.4 Unexpected Death: Where natural causes are not suspected and an incident may have contributed to the unexpected death 3.1.5 Permanent Harm: Permanent lessening of bodily functions, including sensory, motor, physiological or intellectual and which are directly related to the incident and not to the natural course of the patient s illness or underlying conditions, 3.1.6 Prolonged Pain and/or prolonged Psychological harm: Pain or harm that a patient has experienced or is likely to experience for a continuous period of 28 days 3.1.7 Severe Harm: A patient safety incident that appears to have resulted in permanent harm to one or more patients receiving NHS funded care 3.1.8 Major surgery: A surgical operation within or upon the contents of the abdominal or pelvic, cranial or thoracic cavities or a procedure which, the locality, condition of the patient, level of difficulty, or length of time to perform, constitutes a hazard to life or function of an organ, or tissue (if an extensive orthopaedic procedure is involved, the surgery is considered major ) 3.1.9 Abuse: A violation of a person s human or civil rights by another person or persons, consisting of single or repeated acts. It may be physical, verbal or psychological, neglect or omission to act, a vulnerable person is persuaded to enter into financial or sexual transaction to which he or she has not or cannot consent. 3.1.10 Never Events: Serious, largely preventable patient safety incidents that should not occur if the available preventative measures have been implemented. The NPSA developed the core list of Never Events, included in section 6.3 of this policy. 3.1.11 Safety Culture: A culture where individuals and teams have a constant and active awareness of the potential for things to go wrong. 3.1.12 Root Causes Analysis (RCA): A systematic process to identify the factors that contributed to the incident, looking beyond the individuals concerned and seeking to understand the underlying causes and environmental context in which the incident happened. 3.1.13 Incident Decision Tree (IDT): An aid to improve the consistency of decision making about whether human error or systems failures contributed to an incident. It is designed for use by anyone who has the authority to exclude a member of staff from work following a patient safety incident (including Medical/Nursing Directors, Chief Executives & Human Resources staff) 3.1.14 Contractors and Other Organisations: There are a diverse range of contractors and other organisations working for or within the Trust. They also have a duty to comply with and assist in the requirements of this policy 3.1.15 National Patient Safety Agency (NPSA): An arm s length body of the Department of Health which leads and contributes to improved, safe patient care by informing, supporting and influencing organisations and people working in the health sector 3.1.16 Strategic Executive Information System (STEIS): The electronic database hosted by the Department of Health and onto which all SIs and reports of investigations into those SIs are submitted by a member of the Risk Management Team. Page 7 of 40

4. Scope This policy applies to all staff (temporary or permanent) working in all the locations registered by St George s Healthcare NHS Trust with the Care Quality Commission, to provide its regulated activities (including working remotely). This includes volunteers, contractors, students and/or trainees. 5. Roles and Responsibilities 5.1 The Trust Board 5.1.1 The Trust Board accepts its responsibilities to ensure that there are structures, processes and procedures for reporting, investigating, monitoring and learning from SIs. The Chief Executive is responsible to the Board for meeting these responsibilities and is accountable for the SI policy. 5.1.2 The Board will ensure that it receives assurance from the Risk, Assurance and Compliance Committee that action is taken to make sure that every step possible is taken to prevent a similar SI occurring. 5.2 The Patient Safety Committee 5.2.1 Receive a briefing on all patient related Serious Incident Investigations Reports and action plans. The PSC will receive a report from each division on all SI Investigations that have been completed and finalised since the previous PSC. This is the case even if the report has not been presented at its respective divisional governance committee. This report will give an overview of the main findings and lessons as well as identifying trust-wide learning that can be shared. 5.2.2 The Patient Safety Committee has overall responsibility to oversee the establishment of effective risk management, governance and quality for the management of investigations arising from incidents. To commission risk related audits across the Trust and collate results to give internal assurance of compliance with risk and safety requirements. Provide reports on assurance/areas of concern identified in the audits to the Executive Risk Committee. 5.3 Organisational Risk Committee: 5.3.1 The ORC will fulfil the roles and responsibilities for all SIs as described above that are not patient safety related. 5.4 Chief Executive 5.4.1 As Accountable Officer, the Chief Executive is responsible for ensuring that the Trust meets its legal (including CQC Essential Standards of Quality and Safety), NPSA, NHS London and NHSLA requirements on behalf of the Trust Board for the management of SIs. 5.4.2 The Chief Executive will: Ensure that there are structures, systems, processes and resources in place for the effective management of SIs. Page 8 of 40

Ensure performance targets on the management of SIs are set and reported at regular intervals to the Risk, Assurance and Compliance Committee (RAC) and to the Trust Board. Delegate these executive functions to the Medical Directors, Director of Nursing & Patient Safety or any other Executive Director as appropriate for an SI as deemed necessary. 5.5 Medical Directors/Director of Nursing & Patient Safety/Trust Secretary 5.5.1 On behalf of the Chief Executive the Medical Directors/Director of Nursing & Patient Safety/Trust Secretary will: Ensure that there are robust arrangements to discuss adverse incidents that are potential Serious Incidents. Partake in the decision making process to determine whether an adverse incident meets the definition of a SI. Ensure that the Director of Communication is briefed on any SI which could result in adverse media coverage or public concern about the Trust or the wider NHS. Ensure that the investigation is completed in line with the SI policy and timeframes. Ensure that a Root Cause Analysis (RCA) is performed and a report, including an action plan with timeframes and responsibilities identified, is developed as a result of the investigation. Ensure learning from the incident is disseminated. 5.6 Deputy Director for Governance & Performance 5.6.1 The Deputy Director for Governance & Performance will ensure the implementation of this policy, and processes across the organisation for the identification, reporting, investigation, performance management and evidencing of SI management. 5.7 Clinical Directors/Divisional Directors of Operations/Divisional Directors of Nursing, and Senior Managers 5.7.1 Are responsible to ensure that: Incidents likely to be SIs are brought to the attention of the Medical Directors, Director of Nursing & Patient Safety, Deputy Director of Governance & Performance, Risk Management department and/or Health and Safety Manager immediately. The incident is reported on Datix (as described in the Adverse Incident Reporting Policy & Procedure) If the incident is a clinical incident, an appropriate senior member of staff is assigned to liaise with the patient/relative directly following the incident until the SI Investigation Panel Chair nominates a Liaison Person. Please refer to the Being Open Policy for a more detailed description and guidance on this process. Statements are collected from those involved as soon as possible after the incident. Preferably prior to the staff member going off duty. Lessons learnt from SIs are disseminated and appropriate actions are taken within their area of responsibility within set or agreed timeframes. Recommendations and action plans resulting from SIs are implemented as required within their area of responsibility. Page 9 of 40

5.8 All Staff 5.8.1 All Trust employees have a responsibility to: Read all policies related to incident reporting and investigation. Report adverse incidents. Be familiar with arrangements for the reporting of adverse incidents and report any adverse incident they witness or are involved in. Cooperate with any relating investigation process including the timely provision of written witness statements. 5.9 Corporate Risk and Assurance Department 5.9.1 The Corporate Risk and Assurance Department has responsibility to: Ensure that all relevant external agencies have been notified through the appropriate channels Provide advice to any internal/external investigations on the SI process. Provide specialist expertise to the panel in relation to the SI investigation process, Root Cause Analysis, Incident Decision Tree (IDT) To monitor the SI investigation progress against the set deadline and send reminders to the chairs when required. Retain original files of all SI investigation reports. Record/monitor SI audit progress. Provide performance reports to all relevant committees, in line with their respective terms of reference. Conduct a quarterly audit on all ongoing action plan relating to completed SIs. Ensure Trust wide awareness of this policy. 5.10 Serious Incident Declaration Meeting (SIDM) 5.10.1 The SIDM meets to discuss all potential SIs to ensure that the decision making process when considering and declaring an SI is robust. Its members are: Core Members: Medical Directors Director of Nursing & Patient Safety Trust Secretary Deputy Director for Governance & Performance Corporate Risk Manager Head of Patient Safety In regular attendance: Obstetric Risk Manager SI Coordinator 5.10.2 As the SIDM is not a formal committee it does not require a quorum to make a decision. However, only any one of the Executive Director members and/or the Deputy Director for Governance and Performance can make a decision as to whether or not an SI should be declared. In the event that this decision is made outside of the Page 10 of 40

SIDM, the Core Members will be informed as soon as possible with an explanation of the rationale for its declaration. 5.10.3 The purpose of the SIDM is to: Lead the process of decision-making when determining whether an adverse incident is an SI. To do this, it will consider the initial evidence regarding particular adverse incidents that have been identified as potential Serious Incidents. Decide upon the Grade of the SI and the Level of investigation required Advise the Chief Executive Officer (CEO) and Trust Board (TB) of SIs declared. The Trust Secretary, acting on behalf of this group, will advise the CEO and Trust Board. Monitor the progress of SI investigations. Monitor the quality of final reports. This may be done either prior to or after the final report is sent to NHS London. If a report is amended following being submitted to NHS London, the updated report will be sent to NHS London with a description of the changes and the rationale for amending the report. The SIDM may instruct a particular course of action to investigate a Serious Incident that does not follow the prescribed process described in this policy. This process must meet the minimum requirements of the report as set down by NHS London. 5.10.4 The SIDM meets weekly but where necessary urgent decisions may be taken by key members of the group outside of the weekly meeting. 5.10.5 Although the SIDM is not an investigatory panel, it may call any member of staff to attend to offer witness or information that will assist it in its decision making process. 5.11 SI Panels and alternative investigatory arrangements 5.11.1 Each Division must have established standing panels or an effective alternative arrangement to investigate declared SIs. Where a standing panel does not sit, the division is expected to convene a panel to investigate as and when required. 5.11.2 For Serious Incident Investigations that do not fall within the responsibility of a Division, for example SI that occurred in a non-clinical area such as a workshop, an appropriate investigation chair will be determined by the Serious Incident Declaration Meeting. 5.11.3 The Panel/s will be responsible for: Having a nominated Chair and Deputy. The panel chair is responsible for identifying which sections of the patients medical records should be copied for the investigation panel packs. Panel packs are issued pending location of the medical records and review by the panel Chair. These should be prepared by each Division; assistance can be sought from the Corporate Risk and Assurance Department if necessary. Nominating a person to liaise with the patient, their family and/or carers. Undertaking a full investigation of the SI using root cause analysis. Providing a final report to the Chief Executive or their nominated deputy for sign off, including briefing the Chief Executive on the report prior to sign off. Page 11 of 40

The Panel Chair is responsible for informing any staff identified as leading on an action or recommendation as a result of a SI Investigation.. Ensuring that the final report is presented at the relevant Care Group meeting/s for discussion and at the Divisional Governance Committee. 5.12 Divisional Chair/s 5.12.1 Divisional Chair/s are responsible for ensuring that: The SI is completed within the set time frame. Final SI reports are discussed at the Divisional Governance Committee or equivalent Divisional Committee and summary reports presented at the relevant committee: Patient Safety incident at the Patient Safety Committee (PSC) and Nonclinical at the Organisational Risk Committee (ORC). For reports that are relevant to both non-clinical and patient safety, a summary report must be presented to both the PSC and ORC. The action-plans are implemented and audited. Lessons learnt are disseminated and implemented within the Division and Care Group. Analysis of trends/themes is provided to the PSC/ORC to ensure organisational learning. An audit of the actions is commissioned 4 months after the completion of an SI report for presentation at the Divisional Governance Committee. A summary of this audit is presented at the PSC/ORC and Risk, Assurance & Compliance Committee (RAC). 5.13 Divisional Governance Manager 5.13.1 The Divisional Governance Managers support the Divisional Directors of Nursing and Governance in their roles and responsibilities. 5.13.2 The Divisional Governance Managers liaise closely with the Corporate Risk and Assurance Department to ensure that the requirements of the Serious Incident investigation process are met. 5.14 Divisional Governance Committee 5.14.1 The committee s responsibilities are to: Review all SIs for the Division. Ensure dissemination of learning to the relevant Care Group/groups. Ensure the action plan is implemented. Provide analytical reports on SIs monthly to PSC/ORC to ensure organisational learning. Ensure Divisional performance i.e. completing reports within the set timeframe. Ensure effective patient or family liaison during the SI investigation and sharing of the final reports, etc. Page 12 of 40

6. Serious Incident Identification, Reporting and Grading 6.1 What is a Serious Incident? 6.1.1 There is no exhaustive list of serious incidents. Whether an incident meets the definition of a Serious Incident as written at the beginning of this policy takes consideration and discussion. This section gives some examples of incidents that should be considered as to whether they meet the definition of a SI. 6.1.2 Section 6.2 identifies the range of incidents that must be reported to NHS London as serious incidents and investigated accordingly. 6.1.3 Examples of potential Serious Incidents are as follows: 6.1.4 Patient related 6.1.5 Staff Unexpected death, serious or life threatening injury Falls related death Grade 3 and 4 pressure ulcers VTE resulting in serious/prolonged harm or death Major clinical incidents such as a failure to diagnose a serious illness e.g. meningitis Medication errors which result in serious/prolonged harm or death Absconding or escape of a detained patient which may pose a significant risk to the patient, the public or generate media interest Death related to Clostridium Difficile (C Diff) Methicillin Resistant Staphylococcus Aureus (MRSA) Breach of confidentiality of patient identifiable data An assault on a member of staff which results in death or serious actual bodily harm 6.1.6 Organisational Significant damage to Trust assets or reputation. For example: an incident that may create adverse regional or national media publicity Failure to follow procedures resulting in harm or death. For example: equipment not serviced as per protocol 6.1.7 Major Health Risks Significant health care associated infections. For example: an outbreak of infection, failure in decontamination or an infected health worker Significant toxic contamination or radiation hazard 6.1.8 Child/Vulnerable Adult Any incident reported to the Local Safeguarding Board for follow up. Examples include death or injuries where abuse or neglect is suspected or where a child has Page 13 of 40

suffered further harm as a result of a health care worker failing to follow procedures or where a Serious Case Review is to be undertaken. Significant cases involving children or vulnerable adults 6.1.9 Cluster A number of low level incidents which aggregate to suggest a potentially more serious problem. A cluster of unexpected/unexplained deaths or serious adverse outcomes. 6.1.10 Infection/HCAI Known, or suspected, cases of health care associated infection, which are deemed a significant outbreak or involve failure of systems, such as decontamination or hospital acquired legionellosis. Death in which MRSA bacteraemia or C difficile are recorded on part one of the death certificate (parts 1a, 1b or 1c). Two or more cases of C. difficile in the same ward within the same week and/or third case within the same ward and month. 6.1.11 Equipment Where a death occurred, an injury took place, or where someone was seriously put at risk as a result of a lack of, or faulty procedures, instructions or faulty equipment or drugs Failure or misuse of equipment or plant which either caused or could have constituted a risk of injury, harm or danger to the life of a patient, member of the public/member of staff 6.1.12 Procedures The failure of clinical or non-clinical procedures or their application so serious as to endanger life of a patient, member of the public or member of staff, or to pose a serious security risk or situations when a patient requires additional intervention(s) as a result of failures in the diagnosis/treatment process. 6.2 Mandatory Serious Incidents reportable to NHS London: 6.2.1 Maternity: 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 have contributed. Page 14 of 40

Intra partum death (during labour): Unexpected intra partum death during labour regardless of gestational age where service or clinical factors might have contributed. Unexpected Neonatal Death: Unexpected death of a baby aged 0-28 days. The requirement is to report unexpected death where 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 responsible for unexpected deaths should be consulted. In such cases, the incident should be reported until the available 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 following delivery or in the early postnatal period of a previously well infant requiring intensive care (positive pressure 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 not possible. The Local Supervisory Authority expects to be informed when any part of a maternity service is suspended. Post partum haemorrhage (PPH): 1. In hospital maternal death from post partum haemorrhage after elective caesarean section (Never Event) 2. Unplanned admission to HDU/ITU following post partum haemorrhage 3. Unplanned hysterectomy/uterine artery embolisation If significant care or service issues were identified which contributed to the PPH. 6.2.2 Pressure Ulcers: All grade 3 and/or 4 pressure ulcers discovered by a member of staff whilst delivering services to a patient/client is a Serious Incident. When reporting this, context is very important as the incident may need to be investigated elsewhere if the pressure ulcer is discovered following transfer of the patient/client from elsewhere. The following diagrams gives guidance on the process for reporting pressure ulcer related Serious Incidents. The flow charts on pages 17 and 18 demonstrate the steps in reporting a pressure ulcer as a Serious Incident. Page 15 of 40

6.2.3 Delay of Ambulance handover in an Emergency Department of One Hour or More: A serious incident will be triggered where patient handover time, which is defined as the time of arrival to the time of transfer to hospital trolley, is in excess of one hour. Handover delays of over one hour should not be occurring in Emergency Departments (EDs). Patients who have not received a clinical handover for this period of time can be at major clinical risk. There is also a major clinical risk for patients waiting for ambulances that cannot be attended to in an appropriate time period because the ambulances are delayed at EDs. For these clinical reasons, as well as that of appropriate governance procedures, it is important that the trust Board is made aware (and ultimately can be held accountable) of such occurrences through a formal reporting process. Classifying these delays as SIs ensures that they are captured, investigated and reported to the Board under an established governance procedure. This provides the opportunity for Board level scrutiny and oversight, as well as the instigation of actions to ensure these occurrences are eliminated, leading to an improved quality of care for NHS users. 6.2.4 Death in Custody (DIC) All DICs are reportable SIs to NHS London. Death in Custody relates to an individual detained in prison. In the event of a DIC, the Corporate Risk and Assurance Department must be informed immediately. Unexpected DICs must be investigated as a Serious Incident. In the case of an expected death in custody, a full RCA is not required. A brief summary of the case and care received is required by NHS London. This should be entered onto STEIS with a request to NHS London for the SI to be closed. There is no requirement for a separate report to be submitted. All DICs are subject to investigation by the Prison and Probation Ombudsman (PPO). 6.2.5 Information Governance Loss of health records or documentation containing person identifiable data (PID) The requirement for reporting information governance (IG) SIs in London will be consistent with the guidance in the National Framework for Reporting and Learning from Serious Incidents Requiring Investigation. NHS London has a duty to escalate to the Department of Health Business Unit, details of all IG SIs graded as level 3 (please refer to table below) or above. To enable this to happen, when a level 3 or above IG SI is reported, a checklist for completion will be emailed to the trust SI lead. This must be completed and retuned to the email address on the form within 72 hours of the SI being reported on STEIS. The form can be found on the NHS London website. Page 16 of 40

0 1 2 3 4 5 No significant reflection on any individual or body Media interest very unlikely Damage to an individuals reputation. Possible media interest, e.g. celebrity involved Damage to a team s reputation. Some local media interest that may not go public Damage to a services reputation/ Low key local media coverage. Damage to an organisation s reputation/ Local media coverage. Damage to NHS reputation/ National media coverage. Minor breach of confidentiality. Only a single individual affected Potentially serious breach. Less than 5 people affected or risk assessed as low, e.g. files were encrypted Serious potential breach & risk assessed high e.g. unencrypted clinical records lost. Up to 20 people affected Serious breach of confidentiality e.g. up to 100 people affected Serious breach with either particular sensitivity e.g. sexual health details, or up to 1000 people affected Serious breach with potential for ID theft or over 1000 people affected Page 17 of 40

Reporting Framework for Grade 3 & 4 Pressure Ulcers detected in the community Grade 3 or 4 Pressure Ulcer Identified by community staff Grade 3 or 4 pressure ulcer identified on first visit. Report on Datixas an adverse incident Patient has acquired grade 3 / 4 pressure ulcer whilst on caseload Evaluate and adjust the pressure ulcer prevention and wound care plans accordingly Grade 3 or 4 pressure ulcer identified on first visit. Patient discharged from St. George s Healthcare NHS Trust inpatient care Report on Datix as an adverse incident Patient discharged from non St. George s Healthcare NHS Trust inpatient care in the last 72 hours. Note date and time of discharge and date and time of assessment of ulcer. Report on Datix as an adverse incident Risk department will record on STEIS if determined to be a Serious Incident. (first alert) Risk department will record on STEIS if determined to be a Serious Incident. (first alert) Risk department will record on STEIS if determined to be a Serious Incident. (first alert) If not in receipt of any care, complete STEIS record with circumstances leading to ulcer development and request closure. Patient in receipt of care commissioned by health and/or social care either at home or in a care home Undertake investigation and ensure sign off by Executive Team Member If the patient was discharged from a non-st. George s Healthcare NHS Trust inpatient service the Risk Department will coordinate contact with the discharging organisation and request they record incident on STEIS and undertake investigation. Acute organisation and community provider disagree as to origins of ulcer. Acute organisation agrees, records on STEIS and requests de-escalation of first alert. Report to Commissioner of care and ensure incident is referred to Safeguarding Adults Team Refer to Commissioner Commissioner records on STEIS and requests deescalation of first alert. Acute Organisation investigates incident etc Complete STEIS record, inform NHS London of actions and request closure of incident of STEIS Commissioner informs both organisations Directors of Nursing ofoutcome, completes STEIS record and requests closure of incident with NHS London. Page 18 of 40

Reporting Framework for Grade 3 & 4 Pressure Ulcers detected in hospital Grade 3 or 4 Pressure Ulcer Identified by hospital staff Evaluate and adjust the pressure ulcer prevention and wound care plans accordingly Grade 3 or 4 pressure ulcer identified on admission. Patient has acquired grade 3 / 4 pressure ulcer whilst an inpatient Grade 3 or 4 pressure ulcer develops within 72 hours of transfer from another acute Trust or community services provider. Report on Datix as an adverse incident Report on Datix as an adverse incident Report on Datix as an adverse incident Risk department will record on STEIS if determined to be a Serious Incident. (first alert) If not in receipt of any care, inform NHS London of circumstances leading to ulcer development and request closure. Patient has commissioned health and/or social care either at home or in a care home Risk department will record on STEIS if determined to be a Serious Incident. (first alert) Undertake investigation and ensure sign off by Executive Team Member Neither organisation agree as to origins of ulcer. Risk Department will coordinate contact with the discharging organisation and request they report the incident on STEIS and undertake investigation. Transferring organisation agrees, records on STEIS and requests deescalation of first alert. Report to Commissioner and ensure incident is referred to Safeguarding Adults Team Refer to commissioner who records on STEIS and informs NHS London who de-escalate first alert. Transferring Organisation investigates incident etc Complete STEIS record, inform NHS London of actions and request closure of incident of STEIS Commissioner informs both organisations Directors of Nursing ofoutcome, completes STEIS record and requests closure of incident with NHS London. Page 19 of 40

6.3 Never Events 6.3.1 Never Events are serious, largely preventable patient safety incidents that should not occur if the available preventative measures have been implemented. 6.3.2 As of April 1 st 2011 an expanded list of Never Events will be in place. This has increased from eight categories to 25. 6.3.3 The following table describes the 25 Never Events that will be in effect from April 1 st 2011. Detailed guidance on Never Event categories is available on the intranet alongside this policy. When deciding on whether an incident meets the definition for a particular Never Event it is essential that you refer to the detailed guidance as many of the incidents are context/location sensitive. For example, No. 14, Escape of a transferred prisoner is only a Never event if the escape is from a secure (Forensic) mental health facility. Never Event 1. Wrong site Surgery Relevant safety notices and alerts - Safer Practice Notice Standardising Wristbands improves patient safety, 2007, available at http://www.nrls.npsa.nhs.uk/resources/?entryid45=59824 - Patient Safety Alert WHO Surgical Safety Checklist, 2009, available at http://www.nrls.npsa.nhs.uk/resources/clinicalspecialty/surgery/ 2. Wrong implant/prosthe sis - Safer Practice Notice Standardising Wristbands improves patient safety, 2007, available at http://www.nrls.npsa.nhs.uk/resources/?entryid45=59824 - Patient Safety Alert WHO Surgical Safety Checklist, 2009, available at http://www.nrls.npsa.nhs.uk/resources/clinicalspecialty/surgery/ - Safer Surgery Checklist for Cataract Surgery, 2009, available at http://www.rcophth.ac.uk/core/core_picker/download.asp?id= 375 3. Retained foreign object post-operation - Standards and recommendations for safe perioperative practice, 2007, available at http://www.afpp.org.uk/news/safe-practice-highlighted-innew-afpp-publication - Swab, instrument and needle counts: Managing the risk, 2005, available at http://www.afpp.org.uk/filegrab/07swabandinstrumentcount.p Page 20 of 40

df?ref=1040 - Patient Safety Alert WHO Surgical Safety Checklist, 2009, available at http://www.nrls.npsa.nhs.uk/resources/clinicalspecialty/surgery/ 4. Wrongly prepared highrisk injectable medicine - Patient Safety Alert - Promoting safer use of injectable medicines, 2007, available at http://www.nrls.npsa.nhs.uk/resources/patient-safetytopics/medication-safety/?entryid45=59812&p=4 5. Maladministrati on of potassiumcontaining solutions - Patient safety alert Potassium chloride concentrate solutions, 2002 (updated 2003), available at http://www.nrls.npsa.nhs.uk/resources/?entryid45=59882 - Standard Operating Protocol fact sheet; Managing Concentrated Injectable Medicines, part of the WHO High 5 s project, available at https://www.high5s.org/bin/view/main/webhome 6. Wrong administration of chemotherapy - HSC2008/001: Updated national guidance on the safe administration of intrathecal chemotherapy, available at http://www.dh.gov.uk/en/publicationsandstatistics/lettersandc irculars/healthservicecirculars/dh_086870 - Rapid Response Report NPSA/2008/RRR004 using vinca alkaloid minibags (adult/adolescent units), available at http://www.nrls.npsa.nhs.uk/resources/?entryid45=59890 7. Wrong route administration of oral/enteral treatment - Patient Safety Alert NPSA/2007/19 - Promoting safer measurement and administration of liquid medicines via oral and other enteral routes, 2007, available at http://www.nrls.npsa.nhs.uk/resources/?entryid45=59808 8. Intravenous administration of epidural medication - Patient Safety Alert NPSA/2007/21, Safer practice with epidural injections and infusions, available at http://www.nrls.npsa.nhs.uk/resources/?entryid45=59807 - Safer spinal (intrathecal), epidural and regional devices - Parts A and B, available at http://www.nrls.npsa.nhs.uk/resources/?entryid45=94529 9. Maladministrati on of insulin - Rapid response report Safer administration of insulin, 2010, available at http://www.nrls.npsa.nhs.uk/alerts/?entryid45=74287 Page 21 of 40

- NHS Diabetes Safe use of insulin, 2010, available at http://www.diabetes.nhs.uk/safe_use_of_insulin/ - NHSIII Toolkit Think Glucose, 2008, available at www.institute.nhs.uk/thinkglucose - NHS Diabetes guidance - The Hospital Management of Hypoglycaemia in Adults with Diabetes Mellitus, 2010, available at http://www.diabetes.org.uk/about_us/our_views/care_reco mmendations/the-hospital-management-of-hypoglycaemiain-adults-with-diabetes-mellitus/ 10. Overdose of midazolam during conscious sedation - Rapid Response Report - Reducing risk of overdose with midazolam injection in adults, 2008, available at http://www.nrls.npsa.nhs.uk/resources/patient-safetytopics/medication-safety/?entryid45=59896&p=2 - Guidelines for nursing care in interventional radiology, 2006, available at http://www.rcr.ac.uk/docs/radiology/pdf/guidelinesfornursing. pdf - Safe sedation, analgesia and anaesthesia with the radiology department, 2003, available at http://www.rcr.ac.uk/publications.aspx?pageid=310&publica tionid=186 11. Opioid overdose of an opioid-naïve patient 12. Inappropriate administration of daily oral methotrexate - Rapid Response Report Reducing dosing errors with opioid medicines, 2008, available at http://www.nrls.npsa.nhs.uk/resources/?entryid45=59888 - Patient safety alert - Improving compliance with oral methotrexate guidelines, 2006, available at http://www.nrls.npsa.nhs.uk/resources/?entryid45=59800 13. Suicide using non-collapsible rails - NHSE SN (2002) 01: Cubicle rail suspension system with load release support systems, available at http://www.dh.gov.uk/en/publicationsandstatistics/lettersandc irculars/estatesalerts/dh_4122863 Page 22 of 40

- NHSE (2004) 10: Bed cubicle rails, shower curtain rails and curtain rails in psychiatric in-patients settings, available at www.dh.gov.uk/en/publicationsandstatistics/lettersandcircula rs/estatesalerts/dh_4119476 - Clinical guideline 16 self-harm: the short term physical and psychological management and prevention of self-harm in primary and secondary care, 2004, available at www.nice.org.uk/guidance/cg16 - DH (2007)08: Cubicle curtain track rails (anti-ligature), available at http://www.dh.gov.uk/en/publicationsandstatistics/lettersandc irculars/estatesalerts/dh_076400 14. Escape of a transferred prisoner - Standards for medium secure units, 2007, available at www.rcpsych.ac.uk/pdf/final%20standards%20for%20medi um%20secure%20units%20pdf.pdf - Best Practice Guidance: Specification for adult mediumsecure services, 2007, available at http://www.dh.gov.uk/en/publicationsandstatistics/publication s/publicationspolicyandguidance/dh_078744 15. Falls from unrestricted windows - Health Technical Memorandum (HTM) 55: Windows, available via http://www.spaceforhealth.nhs.uk/england/space-health - DH(2007)09 Window restrictors, 2007, available at http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalass ets/@dh/@en/documents/digitalasset/dh_080164.pdf 16. Entrapment in bedrails - Safer practice notice Using bedrails safely and effectively, 2007, available at http://www.nrls.npsa.nhs.uk/resources/?entryid45=59815 - DB 2006(06) Safe use of bed rails, 2006, available at http://www.mhra.gov.uk/publications/safetyguidance/device Bulletins/CON2025348 - Local Authority Circular - Bed Rail Risk Management, 2003, available at http://www.hse.gov.uk/lau/lacs/79-8.htm 17. Transfusion of ABOincompatible blood components - Safer Practice Notice Right Patient, Right Blood, 2006, available at http://www.nrls.npsa.nhs.uk/resources/?entryid45=59805 Page 23 of 40

- SHOT Lessons for clinical staff, 2007, available at http://www.shotuk.org/wp-content/uploads/2010/03/shotlessons-for-clinical-staff-website.pdf - SHOT Lessons for Clinical Staff 2009, available at http://www.shotuk.org/wp-content/uploads/2010/12/lessonsfor-clinical-staff-dec-2010.pdf 18. Transplantation of ABO or HLAincompatible organs - BSHI and BTS Guidelines for the Detection and Characterisation of Clinically Relevant Antibodies in Allotransplantation, 2010, available at http://bts.demo.eibs.co.uk/transplantation/standards-andguidelines/ - Antibody incompatible transplant guidelines, 2006, available at http://bts.demo.eibs.co.uk/transplantation/standards-andguidelines/ - Patient Safety Alert WHO Surgical Safety Checklist, 2009, available at http://www.nrls.npsa.nhs.uk/resources/clinicalspecialty/surgery/ 19. Misplaced naso-gastric tubes - Patient safety alert Reducing harm caused by misplaced nasogastric feeding tubes, 2005, available at http://www.nrls.npsa.nhs.uk/resources/?entryid45=59794 - Patient safety alert Reducing harm caused by misplaced naso and orogastric feeding tubes in babies under the care of neonatal units, 2005, available at http://www.nrls.npsa.nhs.uk/resources/?entryid45=59798&q= 0%c2%acnasogastric%c2%ac 20. Wrong gas administered - Health Technical Memorandum 02-01 parts A & B, 2006, available at https://publications.spaceforhealth.nhs.uk/?option=com_docu ments&task=new_pubs&itemid=1&region=england - Rapid Response Report - Oxygen Safety in Hospitals, 2009, available at http://www.nrls.npsa.nhs.uk/resources/type/alerts/?entryid45 =62811 - NHSE SN (2003) 02: Medical liquid oxygen supply systems, 2003, available at http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalass ets/@dh/@en/documents/digitalasset/dh_4121320.pdf Page 24 of 40