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Serious Incident, Policy for the management ofThe Trust strives to ensure equality of opportunity for all, both as a major employer and as a providerof health care. This procedural document has been equality impact assessed to ensure fairness andconsistency for all those covered by it regardless of their individual differences and the results areshown in Appendix A.Policy ProfilePolicy Reference:Version:Author:Executive sponsor:Target audience:Date issued:Review date:ConsultationKey individuals andcommittees consultedduring draftingOrg 2.106Christopher Brooks-Daw, Interim Corporate Risk ManagerTrust SecretaryAll staff24th March 201124th March 2014Risk ManagersPRG MembersApprovalRatificationRatification Committee: Policy Ratification GroupDate: 24th March 2011Document HistoryVersionDate5.1August 2007th624 Mar 2011Review dateJuly 2009th24 Mar 2014DatesFebruary 2011DatesMarch 2011Reason for changeRegular review due.Policy RatifiedPage 1 of 40
ContentsParagraphPageExecutive 85Roles and responsibilities86Serious Incident Identification, Reporting and Grading136.1 What is a Serious Incident?136.2 Mandatory Serious Incidents reportable to NHS London146.3 Never Events206.4 How to report a Serious Incident276.5 Grading of Serious Incidents286.6 External Reporting287Relationship to complaints, claims and the HR processes328Investigation Process339Communicating with and supporting staff3510Learning from Serious Incident Investigations3511Training3612References and associated documentation3613Monitoring compliance37AppendicesAEquality Impact Assessment38BProcedural Document Checklist40CSI and HR Investigations flowchart42Page 2 of 40
Executive Summary“A true safety culture is one in which every person in the organisation recognisestheir 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 aSafety Culture, 2006)St. George’s Healthcare NHS Trust (the Trust) recognises that in the NHS, tens ofthousands of patients are treated safely by dedicated healthcare professionals who providehigh quality and safe clinical care. For the vast majority of patients, their treatment helps toalleviate or improve their symptoms and is a positive experience. However, when seriousincidents occur, the NHS has a responsibility to ensure that there are systematic measuresin place for safeguarding people, property, NHS resources and reputation. This includesresponsibility to learn from these incidents to minimise the risk of them happening again(National Framework for Reporting and Learning from Serious Incidents RequiringInvestigation, (2010).This policy deals with the process of reporting, investigating and management of SeriousIncidents once declared in order to improve safety, share lessons learnt and to prevent therecurrence of similar incidents. Identification and investigation are only part of the process tolearn from such incidents. The process following the completion of an investigation and thereport publication is at least as important as the investigation itself as this is the period inwhich the Trust must implement the required actions in order to reduce the chances of suchan 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 thecommunication between these systems is robust to ensure that the investigative process iscompleted as appropriate. It is therefore necessary to be familiar with the other policyframework around complaints, claims and human resources. In the event of such anincident, only one process of investigation should be followed at any one time. This isdescribed in more detail in section 6.If in doubt, the Corporate Risk and Assurance Department must be contacted for advice andguidance.In line with the National Framework for Reporting and Learning from Serious IncidentsRequiring Investigation and the NHS London Serious Incident Reporting Policy (NHSLondon, December 2010), incidents previously referred to as Serious Untoward Incidents willnow be known as Serious Incidents (SI). The St George’s Healthcare NHS Trust SeriousIncident Policy formalises the procedures, roles and responsibilities for the effective andefficient management of SIs in the Trust to ensure that such events are managed effectivelyand efficiently, lessons are learnt locally, Trust-wide and nationally using a systematicinvestigation technique that looks beyond the individuals concerned, seeking to understandthe underlying and root causes.The aim of this policy is to optimise patient, staff, contractor and visitor safety by establishingthe root cause/s of a Serious Incident, identifying organisational learning and makingappropriate changes in practice and management to eliminate or mitigate the potential ofrecurrence. To achieve this aim, it is important that all staff understand that the purpose ofadverse incident reporting and investigation is not to apportion blame to individuals orgroups but to identify potential problems and remedy them. The focus of any investigationwill 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.Introduction1.1The Trust recognises that incidents will occur and that when they do, a systematicprocess must be used to identify the factors that contributed to the incident, lookingbeyond the individuals concerned and seeking to understand the underlying causes,the environmental context in which the incident occurred to ensure lessons are learntand implemented to prevent reoccurrence.1.2This policy sets out the reporting arrangements, immediate action and the process tobe taken in the event of a serious incident for investigation1.3All adverse incidents should be reported via the DATIX Electronic Reporting System;see Adverse Incident Reporting Policy & Procedure.1.4This policy describes the link and relationship with other related systems andprocesses: complaints, claims and human resources.2.Purpose2.1The fundamental purpose of this policy is to ensure that all Serious Incidents areidentified, investigated and learned from consistently and robustly in line with nationalbest practise and guidelines, most notably the NPSA National Framework forReporting and Learning from Serious Incidents Requiring Investigation (NPSA March2010) and NHS London Serious Incident Policy (NHSL October 2010).2.2This policy describes the arrangements for staff involved in an SI to access appropriatecounselling and support, this may be through their manager, peers, Human Resources,Occupational Health, Legal Services, Risk Management, or Patient Safety Team.2.3This policy fosters organisational learning within the Trust and the Trust’s contributionto learning by the wider community through reporting SIs to appropriate externalagencies such as the Specialist Commissioners, Acute Commissioning Unit, PCT,SHA, HSE, NPSA, MHRA and others as and when required.2.4A clinical or non-clinical error, accident or incident, however serious, is rarely causedwilfully. It is not, in itself, evidence of carelessness, neglect or a failure to carry out aduty of care. Errors are often caused by a number of factors including, processproblems, human error, individual behaviour and lack of knowledge or skills. Learningfrom such incidents can only take place when they are reported and investigated in apositive, open and structured way.2.5Determining safe practice is an important part of successful risk management. Movingaway from punishing errors to learning from them will promote a fair and open cultureand safe practice throughout the organisation. This will enable the organisation toidentify trends and take positive action to prevent the error or adverse incident fromhappening again.2.6To promote a fair and open culture and encourage the reporting of incidents, theorganisation will take a fair blame and non-punitive approach to those incidents itinvestigates. Staff remain accountable to users, carers, the organisation and theirprofessional bodies for their actions, but a non-punitive approach means that actionPage 5 of 40
(under disciplinary or capability procedures) will not be taken against a member of stafffor 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.2.7Openness when things go wrong is fundamental.2.8Although the majority of Serious Incidents are patient safety related, there may beSerious Incidents that do not fall into this category. For example, an incident in aworkshop or on a part of the trust that maintenance work is being carried on. Theseincidents will follow the same process of reporting and discussion as all other SeriousIncidents. However, consideration of the appropriate membership of the investigationpanel will be conducted by the Serious Incident Declaration Meeting. The Director ofEstates and Facilities will be consulted in such cases.3.Definitions3.1Serious Incident3.1.1 Serious Incident: a serious incident requiring investigation is defined as an incidentthat has occurred in relation to NHS-funded services and care resulting in: Unexpected or avoidable death of one or more patients, staff, visitors or membersof the public Serious harm to one or more patients, staff, visitors or members of the public orwhere the outcome requires life-saving intervention, major surgical/medicalintervention, permanent harm or will shorten life expectancy, or result in prolongedpain or psychological harm (this includes incidents graded under the NPSAdefinition of severe harm) A scenario that prevents or threatens to prevent a provider organisation’s ability tocontinue to deliver health care services, for example, actual or potential loss ofpersonal/organisational information, damage to property, reputation or theenvironment, 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 beconfirmed by the Serious Incident Declaration and Discussion Meeting which is heldevery Monday. It is also advisable that an investigation is commenced immediately asopposed 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, inunnecessary 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 theNHS, regardless of the location (National Patient Safety Agency (2004) Seven Steps toPatient 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 mayhave contributed to the unexpected death3.1.5 Permanent Harm: Permanent lessening of bodily functions, including sensory, motor,physiological or intellectual and which are directly related to the incident and not to thenatural course of the patient’s illness or underlying conditions,3.1.6 Prolonged Pain and/or prolonged Psychological harm: Pain or harm that a patienthas experienced or is likely to experience for a continuous period of 28 days3.1.7 Severe Harm: A patient safety incident that appears to have resulted in permanentharm to one or more patients receiving NHS funded care3.1.8 Major surgery: A surgical operation within or upon the contents of the abdominal orpelvic, cranial or thoracic cavities or a procedure which, the locality, condition of thepatient, level of difficulty, or length of time to perform, constitutes a hazard to life orfunction of an organ, or tissue (if an extensive orthopaedic procedure is involved, thesurgery 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 orsexual transaction to which he or she has not or cannot consent.3.1.10 Never Events: Serious, largely preventable patient safety incidents that should notoccur if the available preventative measures have been implemented. The NPSAdeveloped 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 activeawareness of the potential for things to go wrong.3.1.12 Root Causes Analysis (RCA):– A systematic process to identify the factors thatcontributed to the incident, looking beyond the individuals concerned and seeking tounderstand the underlying causes and environmental context in which the incidenthappened.3.1.13 Incident Decision Tree (IDT):– An aid to improve the consistency of decision makingabout whether human error or systems failures contributed to an incident. It isdesigned for use by anyone who has the authority to exclude a member of staff fromwork following a patient safety incident (including Medical/Nursing Directors, ChiefExecutives & Human Resources staff)3.1.14 Contractors and Other Organisations: There are a diverse range of contractors andother organisations working for or within the Trust. They also have a duty to complywith and assist in the requirements of this policy3.1.15 National Patient Safety Agency (NPSA): An arm’s length body of the Department ofHealth which leads and contributes to improved, safe patient care by informing,supporting and influencing organisations and people working in the health sector3.1.16 Strategic Executive Information System (STEIS): The electronic database ‘hosted’by the Department of Health and onto which all SIs and reports of investigations intothose SIs are submitted by a member of the Risk Management Team.Page 7 of 40
4.ScopeThis policy applies to all staff (temporary or permanent) working in all the locationsregistered by St George’s Healthcare NHS Trust with the Care QualityCommission, to provide its regulated activities (including working remotely). Thisincludes volunteers, contractors, students and/or trainees.5.Roles and Responsibilities5.1The Trust Board5.1.1The Trust Board accepts its responsibilities to ensure that there are structures,processes and procedures for reporting, investigating, monitoring and learning fromSIs. The Chief Executive is responsible to the Board for meeting theseresponsibilities and is accountable for the SI policy.5.1.2The Board will ensure that it receives assurance from the Risk, Assurance andCompliance Committee that action is taken to make sure that every step possible istaken to prevent a similar SI occurring.5.2The Patient Safety Committee5.2.1Receive a briefing on all patient related Serious Incident Investigations Reports andaction plans. The PSC will receive a report from each division on all SI Investigationsthat have been completed and finalised since the previous PSC. This is the caseeven if the report has not been presented at its respective divisional governancecommittee. This report will give an overview of the main findings and lessons as wellas identifying trust-wide learning that can be shared.5.2.2The Patient Safety Committee has overall responsibility to oversee the establishmentof effective risk management, governance and quality for the management ofinvestigations arising from incidents. To commission risk related audits across theTrust and collate results to give internal assurance of compliance with risk and safetyrequirements. Provide reports on assurance/areas of concern identified in the auditsto the Executive Risk Committee.5.3Organisational Risk Committee:5.3.1The ORC will fulfil the roles and responsibilities for all SIs as described above thatare not patient safety related.5.4Chief Executive5.4.1As Accountable Officer, the Chief Executive is responsible for ensuring that the Trustmeets its legal (including CQC Essential Standards of Quality and Safety), NPSA,NHS London and NHSLA requirements on behalf of the Trust Board for themanagement of SIs.5.4.2The Chief Executive will: Ensure that there are structures, systems, processes and resources in place for theeffective management of SIs.Page 8 of 40
Ensure performance targets on the management of SIs are set and reported atregular intervals to the Risk, Assurance and Compliance Committee (RAC) and tothe 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 deemednecessary.5.5Medical Directors/Director of Nursing & Patient Safety/Trust Secretary5.5.1On behalf of the Chief Executive the Medical Directors/Director of Nursing & PatientSafety/Trust Secretary will: Ensure that there are robust arrangements to discuss adverse incidents that arepotential Serious Incidents. Partake in the decision making process to determine whether an adverse incidentmeets the definition of a SI. Ensure that the Director of Communication is briefed on any SI which could resultin 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 anaction plan with timeframes and responsibilities identified, is developed as a resultof the investigation. Ensure learning from the incident is disseminated.5.6Deputy Director for Governance & Performance5.6.1The Deputy Director for Governance & Performance will ensure the implementationof this policy, and processes across the organisation for the identification, reporting,investigation, performance management and evidencing of SI management.5.7Clinical Directors/Divisional Directors of Operations/Divisional Directors ofNursing, and Senior Managers5.7.1Are 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 Managerimmediately. The incident is reported on Datix (as described in the Adverse Incident ReportingPolicy & Procedure) If the incident is a clinical incident, an appropriate senior member of staff isassigned to liaise with the patient/relative directly following the incident until the SIInvestigation Panel Chair nominates a Liaison Person. Please refer to the BeingOpen Policy for a more detailed description and guidance on this process. Statements are collected from those involved as soon as possible after theincident. Preferably prior to the staff member going off duty. Lessons learnt from SIs are disseminated and appropriate actions are taken withintheir area of responsibility within set or agreed timeframes. Recommendations and action plans resulting from SIs are implemented asrequired within their area of responsibility.Page 9 of 40
5.8All Staff5.8.1All 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 anyadverse incident they witness or are involved in. Cooperate with any relating investigation process including the timely provision ofwritten witness statements.5.9Corporate Risk and Assurance Department5.9.1The Corporate Risk and Assurance Department has responsibility to: Ensure that all relevant external agencies have been notified through theappropriate 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 sendreminders 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 respectiveterms of reference. Conduct a quarterly audit on all ongoing action plan relating to completed SIs. Ensure Trust wide awareness of this policy.5.10Serious Incident Declaration Meeting (SIDM)5.10.1 The SIDM meets to discuss all potential SIs to ensure that the decision makingprocess 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 SafetyIn regular attendance: Obstetric Risk Manager SI Coordinator5.10.2 As the SIDM is not a formal committee it does not require a quorum to make adecision. However, only any one of the Executive Director members and/or theDeputy Director for Governance and Performance can make a decision as to whetheror not an SI should be declared. In the event that this decision is made outside of thePage 10 of 40
SIDM, the Core Members will be informed as soon as possible with an explanation ofthe rationale for its declaration.5.10.3 The purpose of the SIDM is to: Lead the process of decision-making when determining whether an adverseincident is an SI. To do this, it will consider the initial evidence regarding particular adverse incidentsthat 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 TrustBoard. Monitor the progress of SI investigations. Monitor the quality of final reports. This may be done either prior to or after the finalreport is sent to NHS London. If a report is amended following being submitted toNHS London, the updated report will be sent to NHS London with a description ofthe changes and the rationale for amending the report. The SIDM may instruct a particular course of action to investigate a SeriousIncident that does not follow the prescribed process described in this policy. Thisprocess must meet the minimum requirements of the report as set down by NHSLondon.5.10.4 The SIDM meets weekly but where necessary urgent decisions may be taken by keymembers 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 toattend to offer witness or information that will assist it in its decision making process.5.11SI Panels and alternative investigatory arrangements5.11.1 Each Division must have established standing panels or an effective alternativearrangement to investigate declared SIs. Where a standing panel does not sit, thedivision 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 aDivision, for example SI that occurred in a non-clinical area such as a workshop, anappropriate investigation chair will be determined by the Serious Incident DeclarationMeeting.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 medicalrecords should be copied for the investigation panel packs. Panel packs are issued pending location of the medical records and review by thepanel Chair. These should be prepared by each Division; assistance can be soughtfrom 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 anaction or recommendation as a result of a SI Investigation. . Ensuring that the final report is presented at the relevant Care Group meeting/s fordiscussion and at the Divisional Governance Committee.5.12Divisional Chair/s5.12.1 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 orequivalent Divisional Committee and summary reports presented at the relevantcommittee: Patient Safety incident at the Patient Safety Committee (PSC) and Nonclinical at the Organisational Risk Committee (ORC). For reports that are relevantto both non-clinical and patient safety, a summary report must be presented to boththe PSC and ORC. The action-plans are implemented and audited. Lessons learnt are disseminated and implemented within the Division and CareGroup. Analysis of trends/themes is provided to the PSC/ORC to ensure organisationallearning. An audit of the actions is commissioned 4 months after the completion of an SIreport for presentation at the Divisional Governance Committee. A summary of thisaudit is presented at the PSC/ORC and Risk, Assurance & Compliance Committee(RAC).5.13Divisional Governance Manager5.13.1 The Divisional Governance Managers support the Divisional Directors of Nursing andGovernance in their roles and responsibilities.5.13.2 The Divisional Governance Managers liaise closely with the Corporate Risk andAssurance Department to ensure that the requirements of the Serious Incidentinvestigation process are met.5.14Divisional Governance Committee5.14.1 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 organisationallearning. Ensure Divisional performance i.e. completing reports within the set timeframe. Ensure effective patient or family liaison during the SI investigation and sharing ofthe final reports, etc.Page 12 of 40
6.Serious Incident Identification, Reporting and Grading6.1What is a Serious Incident?6.1.1There is no exhaustive list of serious incidents. Whether an incident meets thedefinition of a Serious Incident as written at the beginning of this policy takesconsideration and discussion. This section gives some examples of incidents thatshould be considered as to whether they meet the definition of a SI.6.1.2Section 6.2 identifies the range of incidents that must be reported to NHSLondon as serious incidents and investigated accordingly.6.1.3Examples of potential Serious Incidents are as follows:6.1.4Patient related 6.1.5Unexpected death, serious or life threatening injuryFalls related deathGrade 3 and 4 pressure ulcersVTE resulting in serious/prolonged harm or deathMajor clinical incidents such as a failure to diagnose a serious illness e.g.meningitisMedication errors which result in serious/prolonged harm or deathAbsconding or escape of a detained patient which may pose a significant risk to thepatient, the public or generate media interestDeath related to Clostridium Difficile (C Diff)Methicillin Resistant Staphylococcus Aureus (MRSA)Staff Breach of confidentiality of patient identifiable data An assault on a member of staff which results in death or serious actual bodilyharm6.1.6Organisational Significant damage to Trust assets or reputation. For example: an incident that maycreate adverse regional or national media publicity Failure to follow procedures resulting in harm or death. For example: equipment notserviced as per protocol6.1.7Major 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 hazard6.1.8Child/Vulnerable Adult Any incident reported to the Local Safeguarding Board for follow up. Examplesinclude death or injuries where abuse or neglect is suspected or where a child hasPage 13 of 40
suffered further harm as a result of a health care worker failing to follow proceduresor where a “Serious Case Review” is to be undertaken. Significant cases involving children or vulnerable adults6.1.9Cluster A number of low level incidents which aggregate to suggest a potentially moreserious problem. A cluster of unexpected/unexplained deaths or serious adverseoutcomes.6.1.10 Infection/HCAI Known, or suspected, cases of health care associated infection, which are deemeda significant outbreak or involve failure of systems, such as decontamination orhospital acquired legionellosis. Death in which MRSA bacteraemia or C difficile are recorded on part one of thedeath certificate (parts 1a, 1b or 1c). Two or more cases of C. difficile in the same ward within the same week and/orthird case within the same ward and month.6.1.11 Equipment Where a death occurred, an injury took place, or where someone was seriously putat risk as a result of a lack of, or faulty procedures, instructions or faulty equipmentor drugs Failure or misuse of equipment or plant which either caused or could haveconstituted a risk of injury, harm
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:
