Incident reporting policy - Homerton University Hospital

1.0 Version ControlVersion Date Author Reason RatificationRequired1.2 Sept 2008 David Bridger, Head ofYesGovernanceGloria Ophar-George, DatixOfficerAnnette Anderson, ActingClinical Risk Manager1.3 Nov 2009 Reviewed and updated byNicola Havutcu, InterimClinical Risk Manager andDavid Bridger, Head ofGovernanceTo reflect currentorganisation structureand functionto ensure compliancewith NHSLA and CQCregistration requirementsYes2.0 SummaryTo demonstrate that the Trust has approved documentation which describes the process for managing therisks associated with the reporting of all internally and externally reportable incidents.To provide comprehensive guidance to all Trust staff for the reporting and management of all adverseevents and near misses. The Trust aims to take an integrated approach to learning from all incidents inorder to improve and assure its services, whether clinical or non-clinical. It recognises that such learningcan only take place in a non-threatening environment and that fear of disciplinary or legal action may deterstaff from reporting an incident.3.0 Introduction and Policy Statement3.1 In accordance with national guidance and legislation, the Trust is required to record all adverse events andnear misses whether they are major / minor, clinical/non-clinical, affecting one or more persons, related topatients, staff, student, contractors or visitors to trust premises; involving equipment, buildings or property.Incidents may be observed and reported by staff, patients or the general public.3.2 Homerton University Hospital NHS Foundation Trust is committed to providing, as far as is reasonablypracticable, an environment that is free from risk to the health, safety and welfare of patients, staff andvisitors to the Trust.In order to minimise risk the Trust has adopted this policy which, together with its associated policies andprocedures, is intended to ensure that:• All adverse events or „near misses‟ which occur on Trust premise or in the course of employees dutiesare recorded.• All adverse events or „near misses‟ are investigated at an appropriate level to identify the root cause ofthe event.• Action is taken to prevent or reduce the risk of recurrence.• A prompt and accurate report of adverse events and „near misses‟ is where appropriate made to theappropriate external agency,• Counselling and support is offered to families, carers and staff involved in an incident3.3 The philosophy of incident reporting and investigation is not to apportion blame, but to use the informationgained to help the Trust to improve working practices and the environment, so as to improve themanagement of risk throughout the Trust.3.4 The prompt and accurate reporting of incidents is also essential so that the Trust may support its staff todeal with the incident itself and with any subsequent developments such as legal action.3.5 The initial recording and investigation of these incidents will follow the process outlined in this policy. Thelevel of internal investigation will be determined by the incident severity.3.6 Some more serious incidents with wider implications are to be reported to various outside agencies,appropriate Senior Managers and the Risk Management Department will make such reports according tothe processes detailed in this document.3.7 All staff work to provide a high standard of patient care to the best of their ability and within availablePage 3 of 47

Ensuring that all junior doctors under their supervision are fully aware of this policy and organisationalarrangements and comply with it at all times.5.4 Assistant General Managers with responsibilities for Quality and RiskDivisional Risk Leads are responsible for:• Ensuring incidents are appropriately investigated within the divisions,• Recording incidents to Datix• Ensuring appropriate feedback mechanisms are in place.• Ensuring statistic incident data is presented at the divisional risk forums.• Holding incident investigations and witness reports on file where the incident scores red.• Providing incident information for the Trust‟s analysis report on the aggregation of Complaints,Litigation, Incidents and Pals (CLIP)5.5 Managers / Department Heads (including Senior Staff on duty)Managers have a duty to:• Ensure that all staff are made aware of this policy and its associated procedures and guidelines andare informed of how to access electronic incident report forms;• Ensure that this policy, and its associated procedures and guidelines, are implemented within theirareas of responsibility;• Ensure that staff understand how to use electronic incident reporting;• Ensure, following an incident that the appropriate sections of the incident report are accuratelycompleted on Datix within the identified timescales and forwarded to the appropriate designatedperson;• Review and take appropriate action to address, all incidents reported to them via Datix.• Ensure that any equipment involved in an incident is removed from use and clearly labeled as unsafewith the appropriate person(s) notified in order for it to be tested;• Ensure full and open communication with those staff who have been directly involved in an incident;• Ensuring directly involved staff have generalized feedback of the preliminary investigation• Are involved in the investigation where appropriate;• Seek appropriate feedback from the final investigation and resultant action plan.5.6 Individual employeesAll Trust employees have a duty to:• Report any incident or near miss to their supervisor as soon as reasonable practicable, manager orperson in charge as soon as possible;• Ensure that the details of the incident are accurately and fully recorded electronically via Datix(available through the Trust Intranet).Where an employee is unable to report the incident, i.e. as a result of injuries sustained, unconsciousnessetc., the responsibility for reporting will rest with their manager.5.7 Contractors, Volunteers, students, work experience placementsContractors, Volunteers, students, work experience placements etc: are to report any incident to a memberof staff who will then have the responsibility for reporting.5.8 Risk ManagementThe Risk Management Department has a duty to:• Develop and maintain procedures and guidelines to facilitate the implementation of this policythroughout the Trust.• Maintain a database of all incidents.• Produce reports for relevant Trust Committees to assist in the identification of risk and trends inincident occurrence.• Report incidents to appropriate external agencies in accordance with procedure.• Provide staff with support and guidance when approached.Page 5 of 47

6.0 Policy Definitions6.1 Adverse Incident: Is defined as an event or circumstance that leads to either unintended or intendedharm, loss or damage to a patient / staff / general public / equipment / building, which may be clinical ornon-clinical (see 4.6 below for further definition and examples of clinical and non-clinical incidents).6.2 Near Miss: Is defined as an event or circumstance, which could have but did not result in harm to patient/staff / general public / equipment / building. This may be clinical or non-clinical where no immediate harm,loss or damage was suffered, but if not detected could have led to an adverse incident. It is important torecord/assess these incidents so they can be investigated and any preventative measures taken.6.3 Harm: Is defined as injury (physical or psychological), disease, disability or death. In the case of incidentsarising during patient care, harm can be considered „unexpected‟ if it is not related to the natural cause ofthe patient‟s illness or underlying condition. Adverse outcomes related to natural course of illness or propertreatment in accordance with accepted clinical standards are therefore NOT classed as clinical incidents.6.4 Consequence: Is defined as the effect, result, or outcome of an incident. This is classified asCatastrophic, Major, Moderate, Minor, Insignificant / None. Refer to Appendix 1 for categorisation,description and scoring. This table is used to assist with the identification of the consequence of anincident.6.5 Clinical and Non-clinical Adverse EventsA clinical incident is any untoward event or near miss that involves a patient e.g. drug errors,patients falling, patient going missing (rather than environmental issues i.e. food, heating etc)The following list demonstrates the range of events the Trust are obliged to record, some of which may beimmediately evident while some may not be. This list should be used as a further guide as to what shouldbe reported:NPSA Never Events 1• Wrong site surgery• Retained instrument post-operation• Wrong route administration of chemotherapy• Misplaced naso or orogastric tube not detected prior to use• Inpatient suicide using non-collapsible rails• Intravenous administration of mis-selected concentrated potassium chlorideA non-clinical incident is an untoward event that involves any person (eg member of staff, visitors, voluntaryworkers, contractors etc). A non-clinical incident may be an accident or a near miss. Please note that there arelegal duties under RIDDOR that require you to report and record some work-related accidents by the quickestmeans possible. Please see Appendix 5 for further details on RIDDOR reportable incidents.For other examples of reportable incidents see Appendix 2.6.6 Serious Untoward Incident: Is defined as:“An accident or incident when a person to whom the organisation owes a duty of care0 2 suffers (or1The National Reporting and Learning System (NRLS) within the National Patient Safety Agency (NPSA) have identified a core list of„Never Events‟ which are serious, largely preventable patient safety incidents that should not occur if the available preventative measureshave been implemented. Implementation of a policy on Never Events was identified in High Quality Care for All: NHS Next Stage ReviewFinal Report as a key priority for the NHS in England.2Patient, member of staff (including those who work in the community), or member of the publicPage 6 of 47

probably has suffered) a serious injury, major permanent harm or unexpected death 3 in hospital,other health service premises or other premises where NHS care is provided”and/orAn accident or incident that is in itself sufficiently serious and could in normal circumstances leadto death, serious injury or major permanent harm even if in the case considered it did not.and/orAccidents or incidents (or series of them that accumulate or build up to form a more seriousproblem) which are likely to cause significant concern to staff or the public or may producesignificant legal or media interest.The process for the management of these events is covered by Serious Untoward Incident (SUI) Procedure at22.0 below.7.0. Incident Reporting Process7.1 This process guide identifies the action that should be taken in the event of an incident. This is designedto ensure that adverse incidents are dealt with promptly and effectively so that the risk of harm to staff,patients and visitors is minimised and appropriate follow-up action is taken. It is recognised that the verynature of adverse incidents will call for a degree of flexibility and initiative by the individuals involved whichcannot be defined in this procedure.7.2 This procedure should be implemented by the senior member of staff on duty in an area when an adverseincident or near miss occurs.7.3 Action to be taken on discovery of an incident or near missThe most senior member of staff on duty is responsible for ensuring, as appropriate.• The immediate safety and care of the people involved• That the area has been made as safe as possible. Staff should only act within their capabilities andshould not jeopardise their own or others safety.• That a senior manager has been informed• That the scene is preserved; the area or equipment involved is isolated and that there is nounauthorised entry to the area or tampering with the equipment if applicable.• The area or equipment is not re-used until authorised by a senior manager.• That, where possible, statements have been taken from witnesses. If this is not possible at the time,then the names and contact details of all witnesses should be recorded so that statements can beobtained later.• That an incident report form is completed electronically on Datix in accordance with these guidelines.7.4 In the event of a serious untoward incident, as defined above, the Trust‟s Serious Untoward Proceduremust be followed at 22.0.8.0 Reporting Adverse Incidents8.1 Adverse events and near misses must be reported as soon as reasonably possible, using the Trusts onlineDatix system which can be accessed via the Trust intranet homepage. This process should be used toreport any incident that takes place on Trust property and to Trust staff at locations outside of the Truste.g. in a patient‟s home. On-line reporting can also be used for any incidents that involve the businessactivities of the Trust in any shape or form.8.2 Completion of the form provides:Formal documentation of all incidentsManagers with the opportunity to investigate and implement remedial action wherever necessary.8.3 The following points should also be noted:3 An event which has resulted in an unanticipated death or harm not related to the natural cause of the patient illness/underlyingcondition/pregnancy/childbirth. To be declared as SUI an incident, as well as the actual harm, must have occurred. A causal link betweenincident and outcome does not need to be demonstrated (e.g. by post-mortem) but must be plausible or suspected.Page 7 of 47

The person in charge at the time of the incident, involving; a patient, member of staff, visitor andcontractor; will ensure an on-line incident form is completed even if there is no apparent injury.The form should be completed at the time of the incident the free text should contain facts, notopinions.The free text must not contain any patients or staff identifiable information.The employee‟s manager/supervisor, and in-patients ward manager, if different from that department,or manager for the area where the incident occurred will be informed by receipt of an e-mail notificationthat provides them with a link to access the incident once it has been submitted.The designated person should ensure the form is accurately completed and coded; and as themanager, needs to complete the “Action taken” section of the form, grade the incident in the “RiskGrading” section and give final approval to the incident.Completing the incident form does not constitute an admission of liability of any kind on any person.Details on how to complete an on-line incident report can be found on the Risk Management TrustIntranet site under Electronic Incident Forms - Guidance on Reporting Incidents Electronically viaDatixWeb and How to Investigate Incidents.If the patient is taking part in a research project or trial this should be indicated on the incident form.The Assistant General Manager or Governance Facilitator will automatically receive a copy of anyincident relevant to their Directorate.8.4 An incident report will be completed at the employee‟s base if the incident occurs:In the community.Public places within the Trust‟s boundaries.Public places outside the Trust‟s boundaries, but occurring in the course ofauthorised duties on behalf of the Trust.8.5 If a member of staff is injured at work the employee‟s manager must inform the Risk ManagementDepartment and the Employee Health Management Services (EHMS) if any sick leave is taken relating toan alleged industrial injury.8.6 For incidents involving:Patients. The person in charge should ensure that the incident form on Datix is completed immediately. Thenurse in charge must ensure that the patient is seen by a Doctor who will record this in the patient‟s notes.The remedial action taken is recorded on the form. The ward/departmental manager checks, assesses,provides additional information and approves the incident.Visitor/Contractor If necessary the individual will be escorted to the A&E department. The form will becompleted by the nurse in charge, with assistance from those involved and any witnesses. If the individualrefuses to attend A&E the incident should be reported immediately to the Clinical Site Manager (bleep 118).9.0 Grading of Adverse Incidents9.1 All adverse events should be graded according to their severity by the manager they are reported to usingthe matrix detailed in Appendix 1.9.2 Incidents are graded so that the Trust can identify the overall impact of incidents and to allow for theidentification of performance improvement opportunities.9.3 All incidents are saved on the Risk Management Database maintained by the Risk ManagementDepartment.9.4 Any incident classified as a “Serious Untoward Incident” will be processed in accordance with the TrustsSerious Untoward Incident Policy (See Section 22.0)10.0 Follow Up10.1 Incident InvestigationIt is important that where appropriate incidents are investigated in order to:identify the cause (direct and indirect);identify the necessary actions required to prevent a recurrence;Identify a named person for ensuring that the necessary actions are taken, with an agreed deadline.Page 8 of 47

Use the incident for learning from in order to educate others to help prevent recurrences.10.2 In all circumstances, staff involved in an incident must be advised of the progress of any investigationand/or action plan resulting from the incident. Following an incident consideration should be given to theneed to provide a de-briefing meeting for staff, to ensure that appropriate support is provided.10.3 Incident Review Group (IRG)All incidents are reviewed by the IRG which meet 3 times a month (see Appendix 3 for Terms ofReference). At this meeting, chaired by the Chief Nurse and Director of Governance, a decision is madefor individual incidents to be followed-up (investigated further) or not. Results of these investigations areentered onto Datix by the Assistant General Managers for Quality & Risk, and are fed back at subsequentmeetings. Through the Assistant General Managers learning is then disseminated back to theDirectorates.Further details regarding incident investigation can be found in the Trust document „Incident InvestigationGuidance‟ which details the Root Cause Analysis tools to be used for incident investigations.11.0 Staff SupportDuring or immediately after an incident has occurred it may be necessary to provide support for any staffinvolved.It will be the role of manager, including on-call managers, to be alert to those factors, which maynecessitate and provide the necessary resources for this to take place. The welfare of any staff involved ina serious incident must be considered particularly in relation to psychological trauma or stress. Thissupport may be immediate or ongoing in nature depending upon the circumstances and individual needsof that member of staff. Employee Health Management Service may be used for counselling and stressmanagement if required.Any support offered must remain confidential to the individual. It is also important for staff to be kept fullyinformed of the progress of an investigation with which they have had clear associations. This will be theresponsibility of the manager undertaking the review or chair of any investigation team. In particular staffmust be kept aware of progress and when the report has been completed, the findings, recommendationsand action to be taken should be relayed to them, giving them the opportunity to ask questions.Importantly, support should also be given to patients and carers or members of the public involved in anincident. It will be for the manager in whose area the incident occurred, to provide that support and toensure than any inquiry teams are made aware of any areas of concern or information not previouslymade available.11.1 Responsibilities of ManagersAfter any incident, the manager or appropriate colleagues should take appropriate steps to address anyimmediate concerns, which may include contacting senior PCT Managers or addressing any immediatemedical concerns. After the immediate incident has been dealt with, post-traumatic incident support caninclude the following:• Assess the situation e.g. get main details of the incident, send the member of staff home if necessary.• Personal debrief and support for staff member involved. A personal debrief should always take placebefore the member of staff returns to work, even if they return to work shortly after the incident.• Team debrief to learn wider lessons of incident.• Return to work plan negotiated with staff member involved. It is recommended this be in writing.• Access to Occupational Health service and counselling service – immediate and ongoing.• Possible involvement with others such as HR, Health & Safety Manager, Trade Unions, othermanagers.• Immediate managers being sensitive to possible delayed reactions in trauma.• Access to information and PCT policies / procedures.Page 9 of 47

• Review sessions throughout the above so staff member involved (and their manager) is kept up todate, understands what is going on and reviews action plan as necessary.11.2 Personal DebriefThe personal debrief is where the manager and the staff member involved sit in private and discuss theincident in an uncritical atmosphere. The location of this debrief should be discussed and could include aprivate office, at the staff member‟s home or in a neutral location.It is a good idea (with the permission of the staff member) to write some notes e.g. on the incident andhow this has affected staff and what assistance has been offered by the manager.11.3 Leave ArrangementsIn some incidences, staff may wish to return to work e.g. after a couple of hours. A personal debriefshould always take place before the member of staff returns to work, even if they return to work shortlyafter the incident. This will ensure that both the member of staff and manager are in agreement they canreturn and make any necessary changes to their duties.When the member of staff is not ready to return to work, they should be allowed to go home. Due toHealth & Safety Executive reporting requirements regarding incidents at work, all subsequent leave willneed to be taken as sick leave and this incident will then become RIDDOR reportable, if it has not beendeclared already.If the member of staff and manager disagree as to whether the member of staff is ready to return to work,advice should be sought from the Human Resources Department as a matter of urgency.11.4 Access to CounsellingThe Line Manager or his/her nominated Deputy can request for formal counselling to be arranged throughEmployee Health Management Service. Individuals may however wish to organise this themselves. Thisshould be arranged within 5 days of the incident. No one should be forced into counselling but it should bemade available and offered to all those involved and/or affected by the incident.11.5 Useful ContactsEmployee Health Management Service (previously known as the Occupational health department) issituated on the ground floor in Chatsworth House towards the back of the hospital, past Clifden House.Hours of opening: Mondays to Fridays from 9am to 5pm.For needlestick injuries outside these hours, staff should contact the A&E department.Tel: 020 8510 7259Fax: 020 8510 7528External ContactsVictim Support National Office - Tel: 020 7735 9166Health and Safety Executive - Tel: 020 7717 600012.0 Anonymous ReportingPlease also refer to the Raising Concerns at Work Policy & Procedure (Whistle blowing policy) for furtherguidance.Staff who report an incident may not want their identity to be disclosed, if staff want to raise a concernanonymously they can do.Under the Public Interest Disclosure Act 1998, employees who have an honest and reasonable suspicionthat corruption or malpractice has occurred and/or is likely to occur at work, and speak out against it, havestatutory protection against victimisation and dismissal.Page 10 of 47

13.0 Reporting to external agenciesSenior Managers and Assistant General Managers for Quality and Risk will be responsible for ensuringescalation of incidents to the Clinical and Non-Clinical Risk Managers where they are graded as major /catastrophic (Red – Refer to Trust Matrix at Appendix 1) that may require notification to the NationalPatient Safety Agency (NPSA). These incidents will however, be normally reviewed through the IncidentReview Group (See Appendix 3)The Clinical and Non-Clinical Risk Manager(s) will then escalate this requirement to the Head ofGovernance and/or Chief Nurse who will then make the final decision as to the level of investigationrequired and whether the incident requires a Serious Incident Investigation or should be onward reportedas a Serious Untoward Incident.Local Supervising Authority Midwifery Officer should be informed of all incidents graded as major /catastrophic (Red) midwifery incidents and / or maternal deaths.In addition, there will be a requirement to report incidents to other external bodies within prescribedtimescales as outlined in Appendix 4.13.1 Other External Agencies13.1.1 National Patient Safety Agency (NPSA)The NPSA is a special Health Authority established to ensure that the National Health Service learns fromAdverse Patient Incidents involving patients so that improvements to the delivery of healthcare and thesystems supporting care can be made for the benefit of patients in the future.To support this the NPSA has established the National Reporting and Learning Service (NRLS).Thefunction of the NRLS is to collect and analyse patient safety incidents, including prevented patient safetyincidents (near misses) and provide feedback to healthcare organisations in a way that promotes learningand risk reduction through environmental and / or system changes in organisational, management orclinical practice.Reporting to the NPSA / NRLS is conducted by the Risk Management team.The Trust, through the Risk Management Dept, will upload all clinical patient safety incidents to the NPSAon a bi-weekly / monthly basis.Any incident that involves the unexpected death of a patient must be reported to the NPSA13.1.2 Strategic Health Authority (SHA)In line with the NHS London Serious Untoward Incident Reporting Policy including the procedure to befollowed for Safeguarding Children (2009) and the Contract for NHS Services with the commissioningPCT, the Trust will report all SUI‟s to City & Hackney Teaching PCT. The trust will ensure that the PCT isinformed via upload of all SUI incidents to the STEISS database managed by NHS London.Though it is not compulsory for Foundation Trusts to report SUIs to NHS London as there is no direct lineof accountability, the trust will aim to participate in the established reporting system in order to contribute tothe learning from the wider reporting of SUIs. Where there is a concern that other organisations could beat risk of a similar incident occurring (such as an equipment malfunction) the trust will inform NHS Londonat the earliest opportunity as well as other appropriate bodies (e.g. the MHRA).14.0 Escalation of Reported Incidents14.1 All reported incidents are systematically analysed to identify trends and produce information formanagement review and action. Details of reported accidents are provided to the following groups:14.2 Patient Safety CommitteeMeest on a monthly basis and receives an update of all current serious incidents. The committee receivescompleted serious incident investigation reports, ratifies, or otherwise, the report recommendations andensures that appropriate action plans are put in place.Page 11 of 47

They refer serious incident investigation reports to the Clinical Board when their findings may beconsidered to have significant trust wide implications, have significant resource implications, thefindings/recommendations may be deemed controversial or when there are serious behavioural problems.Clinical incidents, trends or concerns are escalated to the Clinical Governance Committee.14.3 Clinical Governance CommitteeThe role of the Clinical Governance Committee is to assure the Board of Directors that the Hospital iscontinually monitoring the safety and quality of clinical care, implementing appropriate controls to ensurethat this is maintained and addressing significant clinical risks. The committee will receive and review amonthly running summary of reported clinical incidents. This will focus primarily on numbers and trends,but will highlight significant incidents, for example where a patient has come to harm.The Clinical Governance Committee will report on a quarterly basis to the Risk Committee and whennecessary to Clinical Board.14.4 Health & Safety CommitteeMeets Quarterly. A Trust wide summary of reported non-clinical incidents is provided for perusal by thisCommittee to assess trends and make appropriate recommendations for further action or more detailedmonitoring.14.5 Risk CommitteeIt is the role of the Risk Committee to review all risks to the Organisation, Clinical / Non Clinical / Financial.The group receives regular reports from each of this „Risk areas‟ and reviews both the Risk Register andthe Board Assurance Framework.14.6 Trust Board of DirectorsA summary report of incidents is produced for the Board on an annual basis for information. This issupplemented by quarterly reports to the Risk Committee and Clinical Governance and ModernisationCommittee, the minutes of which are provided to as information to the Board of Directors.15.0 Incident Grading & Investigation Procedures15.1 Grading of IncidentsIncidents are graded according to the actual impact on the safety of person involved, and the potentialfuture risk to the Trust after corrective action has been put in place using the Trust‟s Risk Scoring Matrix(See Appendix 1).The severity level of an incident must be decided on the actual harm to the person affected as a resultof the incident.Incident severity is ranked from 1 to 5 as follows:Level 1Level 2Level 3Level 4Level 5Incident is considered Insignificant or Negligible requiring no intervention or treatment, ortime off from workMinor intervention requiring time off work for >3 days, increase in hospital stay by 1-3 daysModerate requiring professional intervention, time off work for 4-14 days, length of stay inhospital increase by 4-15 days, RIDDOR reportable or impacts on a small number ofpatientsMajor leading to long-term disability or incapacity, time off work >14 days, increasedhospital stay >15 days, or mis-management of patient care with long term effectsCatastrophic incident leading to death, permanent injuries or health effects and whichimpacts on a large number of patients. Thresholds depend on the circumstances andnature of the type of incident or hazard.(See Guide on Reporting Incidents)With the support of the appropriate Assistant General Manager for Quality and Risk or Divisional ClinicalPage 12 of 47

Risk Manager the Ward / Department Manager in charge of the incident location will review and grade allincidents. The Clinical and Non-Clinical Risk Manager(s) are also available to advice and support with thisincident grading.Incidents relating to relating to actual or potential breaches of confidentiality involving person identifiabledata (P.I.D), including data loss should have grading adjusted as per the scoring matrix in Appendix 1 todetermine the impact on the organisation and whether the incident constitutes reporting as a SeriousUntoward Incident.15.2 Investigation ProceduresIt is unrealistic to suggest that all incidents should be investigated to the same degree, or at the same levelwithin the Trust. Furthermore the outcome of an incident, including a "near miss", is often a poor indicatorof the level of investigation required.For all investigation levels described in the next section, the following should be followed / included withinthe investigation process:• The Trust Accountable Officer for Controlled Drugs, who is the Consultant Nurse for MedicinesManagement, must be involved and be part of the investigation team for all incidents involvingControlled Drugs. This is a statutory requirement for such incidents. The scoring matrix todetermine level of investigation for Drug Administration Errors should be used for all such incidents• The Chief Pharmacists must be involved in the investigation of incidents graded as Red or SeriousUntoward Incidents that involve drugs (including Controlled Drugs).• A Root Cause Analysis must be undertaken on all hospital acquired full thickness pressure ulcers(Grade 3 & 4's) incidents.• A Root Cause Analysis must be undertaken on all inpatient falls resulting in a fracture/other seriousinjury.• A Root Cause Analysis must always be carried out in all cases where the patient (adult or child)was treated in any way at the Trust (inpatient, outpatients, A&E) and subsequently diesunexpectedly within the next 7 days. If the patient dies after 7 days there must be a discussion withthe relevant clinicians and Trust executive team to determine whether an RCA is required.• All identified infections of hospital acquired Methicillin-resistant Staphylococcus Aureus (MRSA)and Colostrium Difficile (C. Diff) should be investigated using a specific MRSA or C. Diff RootCause Analysis approach. These are usually escalated as a Serious Untoward Incident. Furtherdetail can be provided by the Trust Nurse Consultant for Infection Control.• Midwifery Incidents – A supervisor of midwives should be involved in midwifery incidents with aconsequence score of 3 and above.15.3 Levels of InvestigationThe Clinical Risk and Non-Clinical Risk Managers(s) are available to advise and support with the processof investigation. This should be used as a guide only, only an executive director can make the finaldecision as to whether an incident is declared as an SUI.All SUIs should be investigated using Root Cause Analysis (RCA) methodology. For further information ofthe different level of investigation for SUIs please see 22.0. Root Cause Analysis e-learning programme isavailable on National Patient Safety Agency‟s website atwww.npsa.nhs.uk/health/resources/root_cause_analysis.Level of Incident Process Investigation Investigation TeamLeadRed IncidentsMajor / CatastrophicIncidents with a consequence score • of 4 or 5 Executive • Director Executive Director(Red) should be escalated to be consideredas a serious untoward incident and ifdeclared Serious Untoward Incidents (SUIs),should be escalated via the SUI proceduredetailed at Section 8.0. If a decision is taken• Senior / Service Manager .• A member of staff trained inRoot Cause Analysis (RCA)[ideally should not be fromthe service / departmentPage 13 of 47

Level of Incident Process Investigation Investigation TeamLeadthat it is not an SUI, then a decision may bemade to conduct a Serious IncidentInvestigation (SII) that mirrors that of an SUI.Both SUIs and SIIs should be categorised assuch on Datix.•where the incident occurred]Two members of staff – fromthe staff group involved in theincidentAll Red SUI‟s and SII‟s should beinvestigated using Root Cause Analysis(RCA) methodology. Root Cause Analysis e-learning programme is available on NationalPatient Safety Agency‟s website atwww.npsa.nhs.uk/health/resources/root_cause_analysis for guidance on how to conduct aRCA.It is the responsibility of the relevant service /senior manager where the incident occurredto ensure that all learning points and safetyimprovements are appropriately identifiedand action plans drawn up, implemented,monitored and reviewed.Amber Incidents -ModerateConsideration should be given for conducting • Executive • Director Senior Managera root cause analysis investigation. It is theresponsibility of the relevant service managerwhere the incident occurred to ensure that all• Department / ServiceManager (from where theincident occurred)learning points and safety improvements areappropriately identified and action plansdrawn up, implemented, monitored andreviewed• A member of staff trained inRoot Cause Analysis (RCA)[ideally should not be fromthe service where theincident occurred]• Two members of staff – fromthe staff group involved inthe incidentYellow Incidents –MinorThe local team should identify learning pointsor safety improvements and implementcontrol measures.Any controls identified which are not withinthe local team's control should becommunicated to more senior managers forconsideration.GeneralManager/AssistantGeneralManager/Departmental ManagerHead ofNursing/LeadNurseDepartment / Ward / LineManager (from where theincident occurred)Two – three members of staff– from within the departmentGreen Incidents -Insignificant Harm orNegligibleThese should normally be investigated andreviewed locally in the ward or department inwhich the event occurred.Ward / department / linemanager.The local team should identify learning pointsor safety improvements and implementcontrol measures.Any controls identified which are not withinthe local team's control should becommunicated to more senior managers forconsideration.15.4 Time ScalesPage 14 of 47

It is important that investigations are carried out expeditiously as delay can lead to a reduction in reliabilityof the memories of those concerned, anxiety on the part of those being investigated and dissatisfaction forthose who have raised the matter for investigation (see 22.0 for SUI/SII investigation timescales) .16.0 Support during InvestigationIncidents can be very distressing for all concerned. All those involved in the incident should be givensupport. Managers should ensure that staff feel supported throughout the incident investigation process,as being involved too may have traumatised them. This support may be immediate or ongoing in naturedepending upon the circumstances and individual needs of that member of staff. Employee HealthManagement Service may be used for counselling and stress management if required.16.1 Support for those involved in an investigationIt is essential that all investigations are conducted in a manner that is demonstrably supportive to thoseinvolved and in a fair blame atmosphere. The process should be seen as being about listening, learningand improving. This will include providing those who are being investigated with a full account of thereasons for the investigation, giving them a proper opportunity to talk to the Lead Investigating Officer andensuring that they are kept informed of progress. Also any findings of the investigation and response tothird parties must be shared with those whose actions are being investigated.Where the investigation arises from a clinical issue the findings and response must be shared with theclinician to ensure factual accuracy. For midwives, their own Supervisor of midwives should be informed.Those involved must also be informed of support services that are available to them. An employee of theTrust being asked to submit a written statement (See Policy on Writing a Witness Statement) has the rightto consult their own union or other representative prior to submitting a statement or being called in as awitness, but this should not delay the process by more than 5 working days.16.2 Support for the Investigating OfficerWhere an investigation is likely to be time consuming the appointing Executive Director should assist theInvestigating Officer in reprioritising his/her existing workload while the investigation is taking place. Wherethe Investigating Officer feels that the investigation might result in a recommendation for disciplinary actionhe/she should contact their HR Manager as soon as possible for advice and support. Investigating Officersshould seek the support of the Clinical Director for the locality if medical/staffing issues have beenidentified. If there are any reasonable concerns about the objectivity of the Clinical Director, such supportshould be sought from the Medical Director or nominated clinical representative.17.0 Communication17.1 Communication with the affected individual (including patients)Every effort must be made to inform the individual involved as soon as possible before any media contactis made and in line with the Trust‟s Being Open Policy.The individual will receive treatment, care and support, and be given full information on the incident,including the outcome of the investigation. If the individual is incapacitated then next of kin and orsignificant other, must be informed in lieu of the patient. Where the incident has led to death or seriousinjury, the individual‟s next of kin must be informed before any media contact is made. The Lead Directorwill be responsible for delegating these tasks where appropriate.17.2 Communication with many affected individualsIt is acknowledged that on occasion, particularly where many patients have been involved or the incidenthas come to light some months later, it may not be possible to inform the individuals affected prior to themedia becoming aware, although it will be the responsibility of the Lead Director to ensure every effort todo has been demonstrated.There may be circumstances where there are multiple enquiries needing to be responded to, or a complex,high profile incident needing well co-ordinated action planning and implementation. In these events hotlinearrangements will be implemented. Please see Procedural Guidance for the Establishing and Running of aInformation Helpline for further details on the Trust strategy for hotline arrangements.Page 15 of 47

17.3 Communication with StaffIt will be the responsibility of the manager in charge of the area where the incident occurred (investigatingofficer, in the case of an SUI) to ensure that relevant senior clinical and management staff are involvedand informed. In the case of an SUI involving a patient, their Responsible Medical Officer should becontacted.It will be the responsibility of the Lead Investigating Officer to ensure full feedback on completion of theinvestigation.17.4 Communications with other interested partiesAt any stage during the investigation, the Chief Executive, Chief Nurse or Medical Director will considerwhether or not it is appropriate to report the incident to the relevant professional or statutory body e.g.NMC, GMC.It will also be the responsibility of the Chief Executive (or Lead Director) to determine whether otherexternal bodies are to be involved in the investigation, based on the detail of the incident itself. It will be theresponsibility of the Lead Director to inform and involve any organisation as appropriate; this may includeone or more of the following:• GPs (particularly if the incident involves many patients)• The Strategic Health Authority (Via STEIS database), PCT‟s, other Trusts (particularly ELMHT),Mental Health Commission and Home Office where applicable.• Patient Advice and Liaison Services (PALS)• NHS Litigation Authority via the Complaints and Legal services Manager• Care Quality Commission• IRMER – radiation incidents – reported via CQC• Monitor• Police• Coroner• Social Services• London Deanery (medical education)• Medicines and Healthcare products Regulatory Agency• Health and Safety Executive (via the Non Clinical Risk Manager)• Public Health Bodies (e.g. SHOT, MHRA)• Trust legal Advisors• Local Supervising Authorities for a maternal death• Area Child protection advisers• Any incident that involves a cancer screening process must include and follow the relevant guidelinesfor the Quality Assurance related to that screening programme. QA must be contacted as soon as theincident is known.N.B: This list is not exhaustiveFor investigations where there is either Police or HSE involvement, there is a Memorandum ofUnderstanding for liaison and effective communications between the National Health Service, Associationof Chief Police Officers and the HSE. See Appendix 6 for a basic explanation of the actions required.This protocol sets out the general principles for the NHS, police and HSE to observe when liaising with oneanother. It focuses on investigations in NHS Trusts, although the principles and practices it promotesshould apply to other locations where healthcare is provided and the NHS is required to investigate underits performance management and other duties.The NHS has produced guidelines in support of the Memorandum of Understanding that provide practicaladvice about what to do when faced with a patient safety incident that may require investigation by thePage 16 of 47

police and/or HSE. These guidelines should be followed by the Lead Investigator/Executive Directorwhere incidents involving Police and/or HSE are involved and the Model Terms of Reference and trackingform at Appendix G should also be completed.17.5 Communications with Next of KinThe primary concern of staff following a patient safety incident should be focused on ensuring the patientreceives appropriate and corrective treatment. However when an incident occurs patients / relatives /carers should receive an explanation as soon as possible after the event has occurred.In the event of a serious death or a serious injury a person to person meeting may be the most appropriatein the circumstances. For a patient: notification should be carried out by the patients Consultant or by theSenior Nurse on the ward the patient was on. For a member of staff, visitor or contractor: notificationshould be carried out by the Director of Nursing and Quality or the Director on call. Telephone contactshould be made as soon as possible after the incident rather than waiting for a relative to attend the ward.When mistakes happen it is important to express regret that the patient has had this experience within ourTrust. Saying sorry is not in itself an admission of liability, but an important part of acknowledging thatsomething has happened that should not have. A patient has a right to openness in their healthcare. In allcases the patient or next of kin must be informed before the media becomes involved.For further information regarding informing Patients and their Next of Kin, please refer to the Being OpenPolicy.17.6 Communications with other people involved in the incidentIncidents may involve anyone, visitors, the general public or staff from other agencies. All those involved inthe incident should be offered support.17.7 Communications with MediaIn circumstances where there is actual or anticipated media interest in an incident, then the ChiefExecutive is responsible for dealing with the Trusts response to the media, in conjunction with theCommunications Officer. It will be the responsibility of the Communications Officer to make every effort toensure staff are briefed on how to deal with the media should they be approached.Depending on the nature and severity of the incident, there may be immediate media interest. Outside normalworking hours, the CSM will contact the Senior Manager on-call and Head of Corporate Affairs for a statementto be prepared and refer all media enquiries to the Senior Manager On-Call. If within working hours, the TrustPress Officer will prepare a statement and the switchboard will be advised to direct all media enquiries to thePress Office.The Trust's wish to be as open as possible with the media should be balanced by the need for protection ofpatient / staff details under the Trust's duty of confidentiality.18.0 Incident Analysis & Sharing of LessonsThe identification of any lessons learnt will form part of all Serious Incident Investigations (SII) andUntoward Incident investigations (SUI). These will be presented to the Patient Safety Committee afterlocal approval has been gained.The Patient Safety Committee will monitor and ensure the completion of all action plans as a result of SIIand SUI investigations on a monthly basis.The Incident Review Group will be responsible for seeking assurance that local action has taken place forall other incidents. This will be validated by ongoing quality audit checks on Datix.19.0 Process by which to raise concernsWhere an incident investigated raises concerns about the performance of a particular member of staff, thePage 17 of 47

Trust‟s Raising Concerns at Work (Whistleblowing) Policy and Procedure should be followed.20.0 Disciplinary ActionThe Trust recognises that the most serious incidents occur as a result of an accumulation of a number offactors and events all conspiring together. Staff should be encouraged to report incidents without fear ofdisciplinary action in a culture of learning and fair blame. Fear of disciplinary action may deter staff fromreporting a serious incident.The view of the Trust is that disciplinary action should not form part of a response to an incident except incases where one or more of the following apply:• Where in the view of the Trust, and / or any professional registration body, the actions causing theincident / arising from the incident were far removed from acceptable practice• Where there was intent to harm and / or criminal offence has taken place• Where there is failure to report an incident in which the member of staff was either involved or aboutwhich they were awareIf, prior to or during the investigation, the matter to be investigated is considered to involve grossmisconduct or if it is considered that allowing the employee to continue working will jeopardise patient careand safety whilst the investigation is conducted, the employee may be suspended from work for as short aperiod as possible.Suspension is a neutral action and does not imply guilt. The employee will receive full pay and will lose norights whilst the investigation proceeds apart from in exceptional circumstances. Suspension processesoutlined in the Trust‟s Disciplinary Policy & Procedures should be followed.No disciplinary process will be commenced as a result of an incident until at least the initial report of theinvestigation has been completed and agreed by the Head of Governance / Chief Nurse / Director of HR.To ensure a robust and consistent approach to incident investigation, the Trust must use the NPSA‟sIncident Decision Tree (IDT) which can be found athttp://www.msnpsa.nhs.uk/idt2/(d5vvderjryty2f552oxkrr55)/index.aspxThe Incident Decision Tree helps NHS managers and senior clinicians decide initial action to take withstaff involved in a patient safety incident. It is intended to promote a consistent and fair approach, avoidingunnecessary and costly suspensions and exclusions.This process can be facilitated by the Clinical Governance and Risk Manager(s) in conjunction with theLead Investigation Officer and Head of Nursing / Divisional Director.All RCA reports will be reviewed by the Clinical Risk Manager, prior to being forwarded to the LeadDirector or PCT.21.0 Training and AwarenessAll new members of staff will be introduced to the principles of risk management, including incidentreporting procedures (incident grading), during Corporate Induction and all staff will receive mandatoryupdate training on incident reporting as part of risk management training (See Trust Training NeedsAnalysis)Root Cause Analysis training will be provided to identified staff on a necessity basis (i.e. when asked tolead an investigation or form part of an investigation team). Training will be provided on a cascaded basisby someone already experienced in undertaking Root Cause Analysis.22.0 Serious Untoward Incident (SUI) Procedure22.1 IntroductionThis procedure outlines the reporting, recording and investigation procedures which are to be followedwhen a serious untoward incident occurs (or is suspected of occurring) involving; an employee, patient,Page 18 of 47

contractor, or visitor during the course of their work and/or whilst on Trust premises and/or receivingservices from the Trust (See Appendix 7 for overview of SUI process).The responsibility for reporting serious untoward incidents in line with this policy applies to all Trust staff.Related and supporting Trust Policies include:Risk Management Policy and StrategyRaising Concerns at Work (Whistle-blowing) Policy and ProcedureMedia PolicyProcedure for the Establishment and Running of a Patient Information HotlineBeing open policyAlso See Guide for Reporting Incidents ElectronicallyThe Trust promotes an open and fair culture across all of its services in order for staff to feel able to reportincidents. The emphasis of the Trust is on learning lessons from system failures and reducing the risk ofrecurrence of a similar incident.This procedure is in line with the National Patient Safety Agency guidance on root cause analysis 2008and is in line with the expectations of the Primary Care Trust and the Strategic Health authority.22.3 Definition of a serious untoward incident (SUI)For the purpose of declaring an SUI the definition of a serious untoward incident is:“An accident or incident when a person to whom the organisation owes a duty of care 4 suffers (orprobably has suffered) a serious injury, major permanent harm or unexpected death 5 in hospital, otherhealth service premises or other premises where NHS care is provided”and/ orAn accident or incident that is in itself sufficiently serious and could in normal circumstances lead to death,serious injury or major permanent harm even if in the case considered it did not.and/orAccidents or incidents (or series of them that accumulate or build up to form a more serious problem),which are likely to cause significant concern to staff, the public or may produce significant legal or mediainterest.22.4 Types of incidents that may be declaredSerious (or potentially serious) injury or unexpected death involving patients, a member of staff, visitor,contractor or another person to whom the organisation owes a duty of care; As a guide this will include:• Where it is suspected that a person has died, been seriously injured or put at serious risk as a result of;o faulty procedures or instructionso lack of proper procedures or a failure to follow proper procedures or instructionso faulty equipmento drugs or unsafe environmento self harm, attempted or actual suicide whilst in the Trust care4 patient, member of staff (including those working in the community), or member of the public.5 an event which has resulted in an unanticipated death or harm not related to the natural cause of the patient illness/underlyingcondition/pregnancy/childbirth. To be declared as SUI an incident, as well as the actual harm, must have occurred. A causal link betweenincident and outcome does not need to be demonstrated (e.g. by post-mortem) but must be plausible or suspected.Page 19 of 47

o action or lack of action by a member of the Trust‟s staff, employees of other agencies orcontractorso Trust responsible Meticillin Resistant Staphylococcus aureaus (MRSA) bacteraemias(regardless of outcome) and Clostridium difficile related deaths (pt 1 of death certificate)• Serious damage to NHS property e.g. through fire, flood or criminal activity etc;• Major public health risk occurs e.g. outbreak of infection such as salmonella or legionella, radiationincidents;• Large scale theft, confidentiality breach or fraud has occurred, or major litigation is expected• Incidents affecting large numbers of people;• Any event likely to lead to significant legal, media or other interests if not properly managed and/ormay result in loss of the Trust's reputation, services or assets.• Child deaths or serious injuries that have elements of child abuse or neglect or are press-worthy, orwhere there is poor clinical management would constitute an SUI. Investigation of such incidentsshould be carried out in line with this policy but with specific reference to the Trust SafeguardingChildren Policy and Trust procedure for the management of child deaths.Specific definitions have been defined for incidents related to infection control see Appendix 8.22.5 The following 4 types of incidents should be referred to alternative investigation processes for resolutione.g. Human Resources, professional regulatory body, police etc• Events thought to be the result of a criminal act by care provider/staff• Purposeful (malicious) unsafe acts by care provider /staff intending to cause harm• Acts related to substance abuse by care provider/staff• Events involving suspected patient abuse of any kind.22.6 SUI Accountability, responsibility and compliance22.6.1 Chief ExecutiveThe Chief Executive must ensure that the Trust has a robust system in place to manage serious untowardincidents and that staff are skilled to carry out their responsibilities.22.6.2 Medical Director and the Chief Nurse and Director Governance (referred to as the Chief Nurse inthe remainder of this document)The Medical Director and Chief Nurse have joint responsibility for Clinical Governance within the Trust.The Chief Executive has delegated responsibility for the strategic development and implementation ofpolicies and procedures relating to serious untoward incident and near miss reporting to the Chief Nurse,as outlined in the policy, namely:• The Chief Nurse is responsible for confirming action or giving further advice to the senior/servicemanager following identification or suspicion of a serious untoward incident.• The Chief Nurse will ensure that the senior/service managers are fully prepared to initiate incidentreports, to establish facts, revise systems and procedures and take other action that may bedeemed necessary, including the audit of action plans.• The Chief Nurse will liaise with the Executive team to determine whether other parties should beinformed, and will undertake further action as agreed.• The Chief Nurse will report to the Clinical Board and the Board of Directors monthly to reviewserious untoward incidents and progress of the action taken.• The Chief Nurse will discuss with the Chief Executive and the Clinical Board matters immediatelyarising from the incident and follow-up action to be taken both without delay and when theinvestigation is concluded.22.6.3 Executive DirectorsExecutive Directors are responsible for implementing/overseeing the following key aspects of the reportingand investigation of SUIs. They must;Page 20 of 47

• Assess the environment and risks to patients and staff following an SUI ensuring appropriateimmediate action to minimize risk is taken.• Immediately notify the Risk Management Department when an SUI is suspected.• Ensure staff involved complete statements within 1 week of the incident (See Policy on Writing aWitness Statement).• Submit formal reports, including progress reports to the Chief Nurse in respect of the factssurrounding any untoward incident as requested.• Implement the agreed action plan to minimize the risk of recurrence.22.6.4 Clinical Risk/Non Clinical Risk ManagerThe risk managers‟ responsibility is the updating of this policy at a minimum every 3 years or sooner ifnecessary. To train staff in root cause analysis in order that they can undertake SUI investigations. Tosupport staff undertaking SUI investigations, particularly in relation to report writing and to ensure thereports are presented at the Patient Safety Committee and action plans followed up.The Clinical Risk Manager will maintain a database of all SUIs in order to monitor progress of theinvestigation and action plans.22.6.5 Managers trained in Root Cause AnalysisThese managers have a responsibility to undertake a full investigation of the incident (either alone or aspart of a team) using root cause analysis, if requested to do so by the Chief Nurse.22.6.6 The Press OfficerThe Press Officer is responsible for handling any likely media interest resulting from any SUI liaisingclosely with the Chief Executive and, where necessary, the Strategic Health Authority and the PrimaryCare Trust (Section 17.7 of Incident Reporting Policy and Media Reporting Policy).22.6.7 ManagersManagers, including Ward managers, Departmental Managers and Team Leaders are responsible for:• Providing the supportive environment required to facilitate untoward incident reporting.• Ensuring staff are aware of this policy and that new staff are made aware of the policy on induction.• Keeping staff up to date about any changes within the policy.• Ensuring staff adhere to the reporting procedures outlined in this policy.• Ensuring staff report any untoward incident immediately to the most senior person in thedepartment.• Supporting staff, patients and carers/relatives through any investigation and arrangingcounselling/on-going support for any members of staff who may be suffering emotional trauma as aresult of being involved in an SUI.• Undertaking local risk assessments.22.6.8 All EmployeesAll employees have a responsibility to report untoward incidents and near misses to their line manager,Senior Manager or Clinical Site Manager immediately to ensure that the SUI policy is initiated.All employees are responsible for co-operating in the investigation process. It is expected that uponrequest to attend an interview or to submit a statement staff will fully co-operate and provide a full accountof events. Requests for statements should be responded to within 7 days from the date of initial request.(See Policy for Writing a Witness Statement).22.7 Organisational arrangements for the reporting serious untoward incidentsPage 21 of 47

In the event of a suspected SUI it is vital that there is no delay in notifying the relevant managers so that thenecessary action can be taken and documentedWorking hours 09:00 -17:00During standard working hours it is the responsibility of the most senior person present at the incidentto inform the local manager, normally the ward sister/Department manager, who will inform theappropriate person in the Directorate management team (e.g. Head of Nursing, General Manager,Clinical Director). The Senior Manager on call, Risk Management and an executive Director must alsobe informed.An incident report must be completed on Datix. Details of the incident should then be discussed assoon as possible with the Risk Management Department staff, who will notify the appropriateExecutive Director. In cases where there is doubt as to whether an incident is an SUI notification muststill take place.Out of Hours 17:00 – 09:00The most senior person present at the event must contact the Clinical Site Manger (CSM). It is theresponsibility of the CSM to notify the relevant Senior Manager on-call and for making sure that anincident report is completed on Datix.The Senior Manager On-Call is responsible for contacting the Executive Director On-Call as soon aspossible to notify them; of the incident, what action has been already been taken and to discuss theneed for any further action.The Senior Manager (or Senior Manager On-Call if out of hours) must prepare a written summary of theprecise timings of events, including any immediate action taken and any instructions given. This briefing mustbe emailed to the Risk Management Department the following day.22.8 Actions and documentationAll staff involved in the incident in whatever capacity (including staff called for help after the incidentoccurred both on Trust premises and those on call) must write a statement of their involvement. (SeePolicy for Writing a Witness Statement)The person in charge of the department where the incident happened/Clinical Site Manager must ensurethat:• Where applicable, the incident is documented in the patient‟s healthcare record.• An incident report is completed on Datix.• Any equipment involved is isolated from use, the settings and recordings to remain unaltered.• All documentation is secured (Case notes, X-Rays, ECGs, CTGs…)• Arrange for the health care records to be copied if they are required for ongoing care.• Any relevant photographic evidence is collected and diagrams drawn.• Make a list of all those involved, including witnesses, and ensure they write statements.22.8.1 24 Hour MeetingThe Executive in charge (whether on call or in hours) that has been informed of the incident is responsiblefor arranging a meeting of the relevant staff within 24 hours of the incident being reported.This meeting is to establish known facts, establish whether the incident is an SUI or not and what actionsneed to be taken.If investigation is required the level of investigation and the terms of reference will be established at the 24hour meeting.22.8.2 The agenda for the 24 hour meeting and standard terms of reference are at Appendix 1022.8.3 The following staff must be invited to attend the 24 hour meeting:Chair – one of the Trust executive directorsPage 22 of 47

Senior staff (Ward/Department Manager or similar) from the clinical/non clinical area where theincident happened – with a chronology of events as they are currently known.Head of Service/Clinical Lead/MatronSenior NurseClinical DirectorGeneral ManagerClinical Risk Manager/Non Clinical Risk Manager - will take notes of meetingStaff involved in the incident can be invited to attend.22.9 Declaration of a Serious Untoward IncidentAny incident that has the potential to be classed as an SUI should be escalated to an Executive Director inhours and to the on-call Director out of hours. In all cases the final decision whether to classify an incident asa SUI rests with an Executive Director. In case of clinical incidents the decision will be taken in consultationwith at least one of the following: Chief Executive, Deputy Chief Executive, Medical Director, Chief Nurse.The decision will be made at the 24 hour meeting and confirmed in the notes of the meeting which will be sentto the Head of Governance to ensure the Strategic Executive Information System (STEIS) database isupdated with the correct information. The PCT will be informed of the SUI via STEIS.Once an SUI had been reported to STEIS the Head of Governance must inform (by e-mail) the ChiefExecutive, Chief Nurse, Medical Director, Clinical Risk Manager and relevant Clinical Director, GeneralManager and Head of Nursing in the Division.22.10 Serious Incidents not reported outside the TrustSerious incidents that are not declared as SUIs and reported to the Strategic Health Authority and the PCTmay still require root cause analysis investigation. The actions listed below must be taken for any seriousincident investigation (SII) whether reported to the SHA or not.22.11 Role of the Executive Director with responsibility for risk or designated Executive DirectorFor SUIs of a clinical nature the relevant Executive Director will normally be the Medical Director or the ChiefNurse.Following the declaration of an SUI the relevant Executive Director is responsible for:- ensuring the patient(s)/ relative(s) have been/are informed of the incident and that an investigationis underway- ensuring that other parties and external organisations are informed where necessary. Wheremedical trainees are involved, the Director of Medical Education must be advised immediately.- deciding, in discussion with the Executive Team, whether a rapid response help line needs to beset up- arranging for the incident to be investigated via the 24 hour meeting- reviewing the SUI report and ensuring that this is presented to the Patient Safety Committee- Ensuring staff involved receive feedback once the investigation is complete- Ensuring that the patient/relatives receive feedback once the investigation is complete and thereport ratified by the Patient Safety Committee22.12 Support for staff involved in SUIsMembers of staff involved in an SUI can suffer significant emotional trauma and distress particularly if apatient has been harmed. Staff must be appropriately supported by their line manager and Employee HealthManagement Services. To prevent unnecessary and potentially damaging removal of staff from the workplace, the National Patient Safety Agency (NPSA) incident decision tree has been developed to helpPage 23 of 47

managers determine how staff can best be supported. The tool is designed to encourage a consistent andfair approach and to avoid unnecessary suspensions.Managers must use the incident decision tree before contemplating any disciplinary procedures andcontact Human Resources to ensure that any decisions taken comply with Trust policies and procedures.Staff can sometimes be reluctant to report or come forward in the event of a serious incident for fear ofdisciplinary action. Managers must encourage individuals to report serious incidents and to co-operate in anysubsequent investigation.Staff may need time off work and/or counselling this should be explored immediately following the incidentby the line manager as part if the Trusts duty of care to staff. It is essential that any time staff are given offwork to recover from the emotional impact of an incident is viewed as a supportive measure not asdisciplinary action.The Trust has a professional confidential counselling service that can provide support – the service can becontacted on ext 7162.22.13 Subsequent action and incident investigationFollowing declaration of an SUI the Executive Director will arrange for the incident to be investigated. Theinvestigation will be carried out using root cause analysis and can be done in one of the following ways:The Executive Director will appoint an investigator/investigators (Lead Investigator) to provide adetailed investigation of the incidentA facilitated root cause analysis meeting can be carried out by the Clinical RiskManager/Directorate Risk facilitator and the report written from this meetingAn internal inquiry panel can be set upInvestigation by an investigator external to the organisation.22.14 InvestigationThe Lead Investigator(s) must be Band 7 or above or if a doctor an SPR or Consultant and have had rootcause analysis training. They may, at the discretion of the Executive Director, be from outside the directorate/department where the incident occurred.The investigation (root cause analysis) must be carried out at the level specified by the Executive Director andwithin the agreed terms of reference.The patient and their family should be involved in the investigation wherever possible.If the Lead investigator experiences any difficulties with staff cooperation during the investigation process theyshould immediately notify the Executive Director.Assistance, guidance and support in the investigation and report writing will be provided by the RiskManagement department. (Guidance is available on the intranet via the Clinical Governance web page)22.15 Writing the reportThe investigation report must be completed and returned to the Clinical Risk Manager within 30 working daysfrom the date of the incident or the decision that the incident will be investigated as an SUI. Any extensions tothe time scale must be negotiated with the Clinical Risk Manager as early as possible.The report must be completed using the template agreed by the Trust - the template will be available via theTrust intranet and from the Risk Management Department.A final draft will be sent to the Executive Director by the Clinical Risk Manager for approval.Following review by the Executive Director and Clinical Risk Manager the report should be circulated byPage 24 of 47

the Clinical Risk Manager to the relevant senior management team for the appropriateDivisions/Directorates for formal agreement with the recommendations. As a minimum the report shouldbe circulated to the relevant Clinical Director, General Manager and Head of Nursing.Following review by the Division/Directorate the Executive Director must:• Confirm the report is ready to go to the Patient Safety Committee• Confirm how feedback will be given to staff/patients/relative involved• Lead on any urgent actions if not already actioned.Reports from level 3 investigations must be reviewed by the Chief Executive and the Executive Directorprior to Division/Directorate review and presentation to the PSC in case additional action is required22.16 SUI Report and recommendation ratification and follow-up action2.16.1 Patient Safety CommitteeThe findings of the report, including recommendations and a proposed action plan will be presented to thePatient Safety Committee for ratification by the Lead Investigator or, where appropriate, by the ExecutiveDirector.The ratified report and the action plan must be stored on the Datix database as a document relating to theoriginal incident report form.22.16.2 Follow up actionThe ratified report and action plan will be sent to the relevant Directorates Clinical Director, Head of Nursing,General Manager and Governance Lead by the Clinical Risk Manager.The Divisional Clinical Director, General Manager and Head of Nursing must identify a lead person and a timescale for completion for each recommendation in the action plan, then return the populated action plan to theClinical Risk Manager.The Clinical Risk Manager will maintain a spread sheet of all open recommendations.The Patient Safety Committee will follow up all outstanding actions from all open SUI‟s at each meeting.SUI‟s should not be closed on Datix until all actions have been completed.The final report, including all appendices and related documentation (e.g. statements collected) must beforwarded to the Risk Management Department for central filling.22.16.3 Clinical Governance CommitteeA summary of all SUIs and progress against action plans must go to each meeting of the Clinical GovernanceCommittee.22.16.4 Clinical and Trust BoardThe Clinical Board and the Board of Directors will receive formal updates every 6 months on progress of all“open” recommendations.22.16.5 Patient/RelativesOnce the report has been ratified by the Patient Safety Committee either; a meeting must be arranged by theExecutive Director must determine and record how the report and outcome of the investigation should with thepatient/relatives. If the patient/relative do not wish to meet with Trust staff a letter summarising the outcome ofthe investigation must be sent to them (unless they have previously refused this).22.15.7 Staff involved/affected by the incidentOnce the report has been ratified by the Patient Safety Committee the Executive Director must arrange for thestaff involved/affected to receive feedback about the investigation and the root cause analysis.Page 25 of 47

In cases where there may be legal implications for the Trust, the Risk Manager must forward a copy of thefinal report to the Legal Services Officer for safe-keeping as a `potential claim'.Copies of investigation reports must not be released outside the Trust until ratified by the Patient SafetyCommittee and then only with the permission of the Chief Nurse or the Medical Director.22.17 LiabilityThe Homerton University Hospital NHS Foundation Trust is vicariously liable for the acts/ omissions of itsemployees and so will take full responsibility in the event of legal action taken against the Trust which arisesfrom a Serious Untoward Incident.In situations where staff behaviour is considered to be malicious, criminal or gross professional misconductand/or where action is taken by the police or other external agency the Trust may not be vicariously liablefor the acts or omissions in question.23.0 Monitoring & Review of Incident Reporting & Investigation Policy23.1 This policy should be kept under review in the light of changing circumstances and requirements. As aminimum it should be reviewed routinely every three years. If there are significant changes this should bereturned to the ratifying body for approval.The processes for monitoring compliance with this procedure are outlined in the table below:Measurable Policy Objective Monitoring/Audit Frequency ofmonitoringReview of all incidents toinclude validation ofappropriate scoringLessons learnt sharedReport to IncidentReview GroupReview of allongoing andcompletedSerious Incidentand SeriousUntowardIncidentInvestigationsUpdatesThree times amonthMonthlyResponsibilityfor performingthe monitoringRiskManagementDepartmentRiskManagementDepartmentMonitoring reported to whichgroups/committees, incresponsibility for reviewingaction plansIncident Review GroupPatient Safety CommitteeClinical BoardRiskManagementNewsletterQuarterlyRiskManagementDepartmentTrust WideReview of ActionsIncident ReviewMeetingThree times amonthRiskManagementDepartmentIncident Review GroupQuality Audit of Datix RiskManagement SystemSummary Reportof ActionsOutstanding fromSIIs and SUIsIncidentReportingPerformanceMonthlyQuarterlyRiskManagementDepartmentRiskManagementDepartmentPatient Safety CommitteeIncident Reporting GroupPage 26 of 47

ReportQuality Audit ensuring that allindividuals who are affected byviolence and aggression orwho have suffered personalinjury have received a letter offormal support from the TrustReview of Datix(all formalnotificationsshould beappended toincident)QuarterlyRiskManagementDepartmentPatient Safety Committee.24.0 Associated Policies and Procedures• Being open Policy• Child protection / Vulnerable Adults• Disciplinary Policy• Health & Safety Policy• Incident Investigation Guidelines• Serious Untoward Incident Policy• Strategy and Policy for Managing Risk• Whistle Blowing Policy25.0 References• Department of Health, (2006) Guidelines for the NHS: In support of the Memorandum ofUnderstanding - Investigating patient safety incidents involving unexpected death or serious untowardharm• Department of Health, Association of Chief Police Officers, Health & Safety Executive (2006)Memorandum of understanding• Health & Safety Executive (1995) Reporting of Injuries, Diseases & Dangerous OccurrencesRegulations• Memorandum of Understanding• National Patient Safety Agency (2002) Building a safer NHS.• National Patient Safety Agency (2003) Seven steps to patient safety.• National Patient Safety Agency (2004) Root cause analysis toolkit.• National Patient Safety Agency (2005) Communicating patient safety incidents with patients an theircarers.• NPSA RCA Toolkit: www.msnpsa.nhs.uk/rcatoolkit/resources/ resource_glossary.htm#• NPSA‟ RCA Investigation Report Template‟ and „RCA Investigation Evaluation - thoroughness andcredibility checklist‟Page 27 of 47

Appendix 1: Incident Risk AssessmentManagement must review incidents to determine the best course of action to eliminate, reduce and control risks.There will always be some degree of risk. However, when the level of risk is controlled and the level of injury islow, the impact on the Trust will also be low, so the level of risk is acceptable. Risk assessment is the process forassessing and prioritising clinical and non-clinical risks. It can also help managers recognise the incidents theyshould report to senior managers and when they need specialist help to prevent incidents recurring.Table 1 Consequence scoresChoose the most appropriate domain for the identified risk from the left hand side of the table Then work along thecolumns in same row to assess the severity of the risk on the scale of 1 to 5 to determine the consequence score,which is the number given at the top of the column.Consequence score (severity levels) and examples of descriptorsDomainsImpact on thesafety ofpatients, staffor public(physical/psychologicalharm)1 2 3 4 5None/InsignificantNegligibleMinimal injuryrequiring no/minimalintervention ortreatment.No time off workMinor Moderate Major CatastrophicMinor injury orillness, requiringminor interventionRequiring time offwork for >3 daysIncrease in length ofhospital stay by 1-3daysModeraterequiringprofessionalinterventioninjuryRequiring time offwork for 4-14 daysIncrease in length ofhospital stay by 4-15daysRIDDOR/agencyreportable incidentMajor injury leadingto long-termincapacity/disabilityRequiring time offwork for >14 daysIncrease in length ofhospital stay by >15daysMismanagement ofpatient care withlong-term effectsIncident leadingdeathtoMultiple permanentinjuriesorirreversible healtheffectsAn event whichimpacts on a largenumber of patientsAn event whichimpacts on a smallnumber of patientsQuality/complaints/auditPeripheral elementof treatment orservice suboptimalInformalcomplaint/inquiryOverall treatment orservice suboptimalFormal(stage 1)Local resolutioncomplaintSingle failure tomeet internalstandardsMinor implicationsfor patient safety ifunresolvedReducedperformance rating ifunresolvedTreatment or servicehas significantlyreducedeffectivenessFormal complaint(stage 2) complaintLocal resolution(with potential to goto independentreview)Repeated failure tomeet internalstandardsMajor patient safetyimplications iffindings are notacted onNon-compliancewith nationalstandards withsignificant risk topatientsifunresolvedMultiple complaints/independent reviewLowratingCritical reportperformanceTotally unacceptablelevel or quality oftreatment/serviceGross failure ofpatient safety iffindings not actedonInquest/ombudsmaninquiryGross failure tomeet nationalstandardsPage 28 of 47

Humanresources/organisationaldevelopment/staffing/competenceStatutory duty/inspectionsShort-term lowstaffing level thattemporarily reducesservice quality (< 1day)No or minimalimpact or breech ofguidance/ statutorydutyLow staffing levelthat reduces theservice qualityBreech of statutorylegislationReducedperformance rating ifunresolvedLate delivery of keyobjective/ servicedue to lack of staffUnsafe staffing levelor competence (>1day)Low staff moralePoorstaffattendance formandatory/keytrainingSingle breech instatutory dutyChallenging externalrecommendations/improvement noticeUncertain delivery ofkeyobjective/servicedue to lack of staffUnsafe staffing levelor competence (>5days)Loss of key staffVery low staffmoraleNo staff attendingmandatory/ keytrainingEnforcement actionMultiple breeches instatutory dutyImprovementnoticesNon-delivery of keyobjective/servicedue to lack of staffOngoing unsafestaffing levels orcompetenceLoss of several keystaffNo staff attendingmandatory training/key training on anongoing basisMultiple breeches instatutory dutyProsecutionComplete systemschange requiredLowratingperformanceZeroratingperformanceAdversepublicity/reputationRumoursPotential for publicconcernLocal mediacoverage –short-term reductionin public confidenceElements of publicexpectation notbeing metLocal mediacoverage –long-term reductionin public confidenceCritical reportNational mediacoverage with 3days service wellbelow reasonablepublic expectation.MP concerned(questions in theHouse)Businessobjectives/projectsFinanceincludingclaimsService/business interruptionEnvironmentalimpactInsignificant costincrease/ scheduleslippageSmall loss Risk ofclaim remoteLoss/interruption of>1 hourMinimal or noimpact on theenvironment8 hoursMinor impact onenvironment5–10 per cent overproject budgetSchedule slippageLoss of 0.25–0.5 percent of budgetClaim(s) between£10,000 and£100,000Loss/interruption of>1 dayModerate impact onenvironmentNon-compliancewith national 10–25per cent over projectbudgetSchedule slippageKey objectives notmetUncertain delivery ofkey objective/Lossof 0.5–1.0 per centof budgetClaim(s) between£100,000 and £1millionPurchasers failing topay on timeLoss/interruption of>1 weekMajor impact onenvironmentTotal loss of publicconfidenceIncident leading >25per cent over projectbudgetSchedule slippageKey objectives notmetNon-delivery of keyobjective/ Loss of >1per cent of budgetFailure to meetspecification/slippageLoss of contract /payment by resultsClaim(s) >£1 millionPermanent loss ofservice or facilityCatastrophic impacton environmentPage 29 of 47

Table 2 Likelihood score (L)What is the likelihood of the consequence occurring?The frequency-based score is appropriate in most circumstances and is easier to identify. It should be usedwhenever it is possible to identify a frequency.Likelihood score 1 2 3 4 5Descriptor Rare Unlikely Possible Likely Almost certainProbabilityHow often mightit/does it happenThis will probablyneverhappen/recurDo not expect it tohappen/recur butit is possible itmay do soMight happen orrecur occasionally Will probablyhappen/recur butit is not apersisting issueWillundoubtedlyhappen/recur,possiblyfrequentlyFrequencyNot expected tooccur for yearsExpected to occurat least annuallyExpected to occurat least monthlyExpected to occurat least weeklyExpected tooccur at leastdailyTable 3 Risk scoring = consequence x likelihood (C x L )LikelihoodscoreLikelihood1 2 3 4 5Rare Unlikely Possible Likely5 Catastrophic 5 10 15 20 254 Major 4 8 12 16 203 Moderate 3 6 9 12 152 Minor 2 4 6 8 101 Negligible 1 2 3 4 5For grading risk, the scores obtained from the risk matrix are assigned grades as follows1 - 3 Low Risk4 - 6 Moderate Risk8 - 12 High Risk15 - 25 Extreme RiskAlmostcertainInstructions for use1. Use table 1 to determine the consequence score(s) (C) for the potential adverse outcome(s) relevant tothe risk being evaluated.2. Use table 2 to determine the likelihood score(s) (L) for those adverse outcomes. If possible, score thelikelihood by assigning a predicted frequency of occurrence of the adverse outcome. If this is not possible,assign a probability to the adverse outcome occurring within a given time frame, such as the lifetime of aproject or a patient care episode. If it is not possible to determine a numerical probability then use theprobability descriptions to determine the most appropriate score.3. Calculate the risk score the risk multiplying the consequence by the likelihood: C (consequence) x L(likelihood) = R (risk score)Page 30 of 47

Appendix 2: Examples of Reportable IncidentsClinical Incidents• Intra operative problems• Diathermy burns• Reaction to preparation agent• Hospital identified outbreak• Hospital identified significant breech of relevant infection control policy e.g. chickenpox case on openward• Hospital acquired pressure ulcers• Performance of operation that is not indicated on the consent form• Failure to obtain informed consent• Failure to act on abnormal test results• Medication errors• Infusion problems• Blood transfusion problems• Problems with medical records• Clinical equipment malfunction• Self-harm• Unexpected death• Patient fallsObstetric OnlyExamples Include:Antenatal and Postnatal• Readmission of mother and baby following delivery• Transfer to delivery suite post delivery• Eclamptic fit (antenatal/postnatal)• Maternal collapse• Unanticipated admission to NICU• Neonatal death• Discharge from hospital concernsDelivery• Unanticipated admission to NICU• Stillbirth/Neonatal Death• Postpartum haemorrhage > 2 litres or Haemaglobin < 8• Neonatal seizures within 24 hours of what?• Meconium aspiration• Maternal convulsions/eclampsia• Low Apgar score of

Community• Unplanned homebirth• BBA (Born Before Arrival)• Maternal or newborn readmission to hospital• Lost results• Lost specimens• Failure/delay in receiving results• EPR inaccurate/incorrect information• Postnatal discharge problemsNon-clinical IncidentThe following is a non-exhaustive list of non-clinical incidents and examples:• Any physical assault and/or verbal aggression on any person by any person• Any slip trip or fall to staff, visitor or member of the public. Where a patient trips over damaged paving,flooring, over cables, down the stairs or a hole• Needlestick or sharps injury to any person (other than a patient) inflicted by any person.• Any work related ill health including stress• Any burn or scald to staff, visitor or member of the public. Where a patient is injured due to spills of hotgravy or a hot beverage / liquid by themselves or others. Where patient is burnt due to a fire, contactwith a heater• Accidental exposure to electrical source to any person other than a patient• Accidental exposure to chemical agents to any person other than a patient• Accidental exposure to biological agents to any person other than a patient• Accidental exposure to radiation to any person other than a patient• Manual handling injuries to staff• Upper limb disorders/repetitive strain to staff• Any injury to any person other than a patient resulting from trapped limbs etc, or being struck bymoving, flying or falling object• Failure of a passenger lift, a ladder, a crane etc• The theft, loss or damage to property belonging to any personPage 32 of 47

Appendix 3: Terms of Reference - Incident Review Group1. AccountabilityThe IRG is will be responsible for reporting to the Patient Safety Committee any Clinical individualincidents or Trends it feels need appropriate escalation. In respect of individual non Clinical Incidents /trends these will be reported to and escalated to the Health and Safety Committee.2. PurposeThe aims of Incident Review Group are:• To ensure a systematic, holistic, multi-disciplinary and proactive approach to the identification andmanagement of risks through the review of incidents that have occurred at the Trust• To ensure that Incident trends and areas for concern are escalated to the appropriate Committeeas described in the Risk Strategy for the Trust. Clinical incidents to Patient Safety Committee (orClinical Governance if appropriate) and Non clinical incidents to the Health and Safety Committee.• To ensure that the Medical Director, the Director of Governance and the relevant directorate staffcan be appropriately briefed on areas of actual and potential risk. To provide a forum for thedirectorates to come together to discuss cross directorate working issues.3. Duties of the GroupThe remit of the group is to:• Review the incidents reported on a weekly basis to ensure that appropriate remedial action hasbeen taken.• Identify incidents which have the potential for reoccurrence that these are suitably investigated.• Identify incidents which have the potential to lead to claims and ensure that these are suitablyinvestigated.• Identify trends and associated risks from serious adverse events, adverse events and triggerevents and ensure that they are being addressed.• Identify clinical risk issues for review by the Clinical Risk Management Lead Clinicians.• Share the lessons learned from serious adverse events.• Review and help progress towards meeting NHSLA level II standards in the first instance, with aview to further progression to attainment of level III standards.• Identify issues that need to be addressed through clinical audit, quality initiatives or clinical riskmanagement.4. Membership• Chief Nurse and Director of Governance (chair)• Head of Governance• Clinical Risk Manager• Maternity Clinical Risk Manager• Assistant General Managers for Quality & Risk• Lead Nurses• Consultant Nurse Specialists• This is an open meeting to which any member of the Trust is welcome although if a sensitive caseis going to be discussed they may be asked to leave for that part of the meeting.5. QuorumDirector of Governance or Clinical Risk Manager.At least one of the Assistant General Manager for Quality & Risk.6. Frequency of meetingsMeetings will be held on a weekly basis (Thursday mornings) with the exception of the first Thursday ofeach month.7. ReviewThe Terms of Reference of this committee shall be reviewed by the Patient Safety Committee and theHealth and Safety Committee annually.Page 33 of 47

Appendix 4: Reporting to External AgenciesThe policies identified in the table should be referred to for details of the appropriate process to befollowed.External Agency Type of Incident Timescale Policy to befollowedCoronerDeath from industrial diseasesCot death and postnatal deathsSuicidesWhere death may be linked to an accident(whenever it occurred).Immediate IncidentInvestigation &Reporting Policyand Litigation andClaims PolicyDeath after operation or before fullrecovery from anaestheticDeath due to abortionCause of death unknown or within 24hours of admissionPossibility of complaint about any medicalcare (Negligence)Neglect or self-neglectAny violent, suspicious or unnatural deathDrug related deathsDeath of anyone currently or recentlydetained in Police / Prison custodyNational Patient Safety Unexpected death of a patient receiving As soon as SUIAgencyHealth & SafetyExecutive (HSE)NHS LitigationAuthority(NHSLA)ProfessionalRegulatoryBodiesMedicines & Healthcareproducts RegulatoryAgency (MHRA)NHS careRIDDOR incidents - death, major injury ordangerous occurrenceOver three day injuries (See alsoAppendix 5)Incidents where Trust becomes awarethat litigation will resultIncidents where there appears to havebeen a breach of the professional code ofconductIncidents involving injury or risk of seriousinjury involving healthcare products andequipmentpossibleImmediateSeven daysImmediateWhen thebreachbecomesapparentWithin 24hoursHealth & SafetyPolicyLitigation & ClaimsPolicyDisciplinary PolicyMedical DevicesPolicy andSafety AlertBroadcasting PolicyArea Child ProtectionCommittee and SocialServicesCare QualityCommissionCare QualityCommissionEnvironmentalHealth/Food StandardsAgency/HealthProtection AgencyAny incident involving transfusion of bloodproducts reportable to Serious Hazards ofTransfusion (SHOT)Serious Adverse Blood Reactions andEvents (SABRE)Any incident involving serious harm to achildAny serious incident deemed necessaryfor escalation by Executive DirectorRadiation Incidents as defined under theIRMER regulations and specified by theRadiation Protection AdviserIncident involving contaminated foodproducts resulting in illnessAs soon as itis identifiedImmediateAs soon aspossibleAs soon aspossibleImmediateBlood TransfusionPolicyChild ProtectionPolicySUI ProcedureSUI ProcedureFood HygienePolicy andProcedurePage 34 of 47

External Agency Type of Incident Timescale Policy to befollowedCounter Fraud andSecurity ManagementService (CFSMS)24 hours (Liaise with TrustCounter FraudSpecialist)Any incident involving serious assault onsomeone in connection with the provisionof health and social care servicesAll non-serious incidentsAs soon asPossibleMental Health ActCommissionAny serious incident involving a detainedpatientAs soon asPossibleLocal Supervising Any serious incidents involving any As soon asAuthority Midwifery midwives or for maternal deathsPossibleOfficerNHS Executive Data Protection Issues As soon aspossibleHealth Protection Requirement of an infection control As soon asAgencyrelated extensive contact tracing exercise possibleQuality Assurance Errors in screening for cancer; breast, As soon as(related to cancer cervical etc etc. Missed slides, results not possiblescreening)given to patients etcMCA PolicyIncidentInvestigation &Reporting PolicyData ProtectionPolicyInfection ControlOperational PolicyIncident reportingand SUI policyPage 35 of 47

Appendix 5: Reportable injuries or events to the Health & Safety Executive (HSE) under RIDDORRIDDOR Reporting of Injuries, Diseases & Dangerous Occurrences Regulations (1995) Under RIDDOR, it is anoffence to fail to report a „reportable‟ event or to fail to report within the specified periods.IMMEDIATELY REPORTABLE EVENTSThe following accidents are to be notified, by Risk Management to the Health & Safety Executive (HSE) by thefastest practicable means i.e. by telephone and confirmed within ten days on Form F2508.• The death of any person as a result of an accident arising out of or in connection with work• Any person suffering any of the following injuries or conditions as a result of an accident arising out ofor in connection with work:• Fracture of any bone (other than fingers, thumbs or toes)• Amputation (including a finger, thumb or toe, or any part thereof if the joint or bone is completelysevered)• Dislocation of the shoulder, hip, knee or spine• Loss of sight (temporary or permanent)• Penetrating injury to an eye, or a chemical or hot metal burn to an eye• Injury resulting from an electric shock from any electrical circuit or equipment, whether or not due todirect contact (including burns) leading to loss of consciousness or requiring resuscitation orhospitalisation for more than 24 hours• Any other injury leading to hypothermia, heat-induced illness or unconsciousness, or requiringresuscitation or hospitalisation for more than 24 hours• The loss of consciousness caused by asphyxia or exposure to a harmful substance(s) or biologicalagent(s)• Acute illness requiring medical treatment or loss of consciousness arising from absorption of anysubstance by inhalation, ingestion or through the skin• Acute illness requiring medical treatment where there is reason to believe that this resulted fromexposure to a biological agent or its toxins or infected material.ANY OF THE FOLLOWING DANGEROUS OCCURRENCES AT WORK (these occurrences may not directlyrelated to injuries sustained by staff, but they require reporting)• Needlestick injury from high risk patients (e.g. HIV, HEP A, B & C)• Collapse or the overturning or the failure of any load bearing part of any lift or lifting equipment• Explosion, collapse or bursting of any closed vessel or associated pipe work• Plant or equipment coming into contact with overhead power lines• Electrical short circuit or overload causing fire or explosion• Any unintentional explosion, misfire, failure of demolition to cause the intended collapse, projection ofmaterial beyond a site boundary, injury caused by an explosion• Accidental release of a biological agent likely to cause severe human illness• Failure of industrial radiography or irradiation equipment to de-energise or return to its safe positionafter the intended exposure period• Failure of any breathing apparatus while in use or during testing immediately prior to use• Collapse or partial collapse of any scaffold over five metres high, or erected near water where therecould be a risk of drowning after a fall• Sudden, uncontrolled release in a building of: 100kg or more of flammable liquid; 10kg of flammableliquid above its boiling point; or of 500kg of these substances if the release is in open air• Explosion or fire causing suspension of normal work for over 24 hours• Accidental release of any substance which may damage health• Unintended collapse of: any building or structure under construction, alteration or demolition whereover five tonnes of materials fall; any floor or wall in a place of work; any false-workREPORTABLE EVENTSThe following incidents are to be notified, by Risk Management, to the Health & Safety Executive (HSE) within tendays on Form F2508: Where a person is incapacitated for work of a kind which they might be reasonablyexpected to do under their contract of employment for more than three consecutive days, (excluding the day of thePage 36 of 47

accident but including any days which would not be normal working days) as a result of an accident at work Anoccurrence of certain occupation related diseases are to be notified, by Risk Management to the Health & SafetyExecutive (HSE) within ten days on Form F2508A.The Trust MUST notify the Health & Safety Executive (HSE) by forwarding the completed F2508A as soon aspossible, but not more than seven days after notification of the occurrence.The list of reportable diseases is lengthy and is not reproduced in its entirety here. The following are the mostcommon. If there is an occurrence of ANY occupation related disease, please contact Risk Management forguidance regarding reporting.• Certain poisonings• Some skin diseases such as: occupational dermatitis, skin cancer, chrome ulcer, oil folliculitis/acne• Lung diseases including: occupational asthma, farmer‟s lung, pneumoconiosis, asbestosis,mesothelioma• Infections such as: leptospirosis (wiels disease); hepatitis; tuberculosis; anthrax; legionellosis andtetanus• Other conditions such as: occupational cancer; certain musculoskeletal disorders; decompression illnessand hand-arm vibration syndrome (vibration white finger)Full details and advice on these regulations is obtainable from the Risk Management Department.Page 37 of 47

Appendix 6MEMORANDUM OF UNDERSTANDINGThe Department of Health, in collaboration with the Police and Health & Safety Executive (HSE), issued aMemorandum of Understanding together with Guidelines covering its operation, in February 2006. ThisMemorandum of Understanding concerns Investigating Patient Safety Incidents involving unexpected death orserious harm.It may be necessary on occasions to contact the Police and HSE following a safety incident where there isevidence or suspicion that the adverse consequences were intended or gross negligence/recklessness in aserious safety incident occurred, including as a result of failure to follow safe practice or procedure or protocol.The decision to contact the Police and HSE under this memorandum must be made at a sufficiently senior level,meaning either the Chief Executive or another Executive DirectorIf any of these are suspected, within 5 working days an Incident Co-ordination Group (ICG) should be set up anda meeting arranged. This should consist of senior members from each agency and with other interested partiessuch as Social Services and the Coroner.Evidence must be secured and preserved promptly following such incidents and receipts for the transfer ofevidence must be maintained by all parties. It is important that information is shared and exchanged betweenagencies but this must be in accordance with the Data Protection Act 1998.The ICG is responsible for agreeing a liaison strategy at the first meeting for keeping those involved (includingpatients, relatives, injured parties and NHS staff) supported throughout the process and for agreeing a strategy todeal with the media.With thanks to Barts and The London NHS Trust Incident reporting policy 2007Page 38 of 47

Appendix 7: Flowchart SUI processDAY 1Identify IncidentReport incident to Senior Manager on callReport incident to Clinical Risk Manager and ExecutiveDirectorTellpatient/relativesabout incident andoffer an apology –as in Being OpenPolicyComplete Incidentreport form andrequest statementsWithin 24hours ofincidentreportHold 24 hour meeting – Chaired by Executive DirectorIf SUI report to SHA and PCT (Using STEIS)If the patient hasdied as a result ofthe incident report toNPSA via NRLSCarry out Investigation and Root Cause AnalysisInvestigator completes draft report using NPSA/TrusttemplateInformpatient/relativesinvestigation is beingconducted –establish type offeedback theyrequire after theinvestigationDay 30Send draft report to Clinical Risk Manager (CRM) 30days from date investigation commencedCRM and investigator address any queries/issues in thereportSend final draft report to the relevant Executive DirectorSend final draft report to the relevant Division/Directorate teamSend final draft to Patient Safety Committee for ratificationFormal sign offfollowing PSCmeeting – finalreport and sign offsheet will beadded to Datixrecord by CRMReport and action plan sent by CRM to relevant GM, CD,SN and governance lead for actionFeedback topatient/relativesvia meeting/letteras agreedMaximumDay 60Update STEIS with root cause and lessons learnt.Send ratified report to SHA via sui@london.nhs.ukPatient Safety Committee follow up action planPage 39 of 47

Appendix 8: Infection Control Serious Untoward IncidentsSerious untoward incidents associated with infection are those that produce, or have the potential toproduce serious unwanted effects involving the safety of patients, staff or others. Reportable incidents arethose that:• result in significant morbidity or mortality and /or• involve highly virulent organisms and / or• are readily transmissible and / or• require control measures that have an impact on the care of other patients, including limitation ofaccess to healthcare servicesWhen the last point is associated with the first three this will commonly be an SUI. Any of the first threebullet points by themselves may not be an SUI – for example chickenpox is highly transmissible but a singlecase should not be an SUI. Necrotising fasciitis caused by group A streptococci involves a highly virulentorganism but a single case is not an SUI. Recognition of a single case of smallpox or Lassa fever on anopen hospital ward would constitute an SUI.Infection related incidents can be broadly divided into:• Outbreaks - two or more linked cases in a healthcare setting.An outbreak is defined by the Strategic Health Authority as two or more cases of the same pathogenin the same location within a week or three or more cases in the same location within a month.Any infection is considered to be hospital acquired if the patient was admitted without the pathogenand developed symptoms after 48 hours.• Infected healthcare worker or patient incidents necessitating look-back investigationse.g. Tuberculosis, variant Creutzfeldt-Jakob Disease, blood borne infections.• Significant breakdown of infection control procedures with actual or potential for crossinfectionMRSA bacteraemias and cases of hospital acquired Clostridium Difficile – these are all to bedeclared as SUI‟sRelease of products from a failed sterilisation cycle – e.g. instrumentation that has been autoclavedand is thought to be safe to use but remains contaminated.Contaminated blood transfusionIsolation of legionella suggesting an environmental source there is a potential risk to others• Patient deaths related to hospital acquired infectionAny patient that dies and MRSA or C.Diff is put on the death certificate as the primary cause of death(Part 1A of the death certificate) must be investigated as an SUI and reported to the PCT and theStrategic Health Authority.Page 40 of 47

Appendix 9: National Patient Safety Agency Three levels of RCA investigation – guidancePatient safety Root Cause Analysis (RCA) investigations should be conducted at a level appropriate andproportionate to the incident, claim, complaint or concern under review.This document provides guidelines for what might be considered appropriate and proportionate.Level 1 - Concise investigation• Most commonly used for incidents, claims, complaints or concerns that resulted in no, low ormoderate harm to the patient.• Also useful as an executive summary to communicate findings from full, comprehensive orindependent investigation reports, following actual or potential „severe harm or death‟ outcomes.• Commonly involves completion of a summary or one page structured template.• Includes the essentials of a thorough and credible investigation,2 conducted in the briefest terms.• Involves a select number of RCA tools (e.g. timeline, 5 why‟s, contributory factors framework).• Conducted by one or more people (with a multidisciplinary approach if more than one investigator).• Often conducted by staff local to the incident (ward/dept/directorate/GP surgery).• Should include person(s) with knowledge of RCA, human error and effective solutions development.• If a patient is directly affected, they/ relative/carer should be involved.• Includes plans for shared learning – locally and/or nationally as appropriate.Level 2 – Comprehensive investigation• Commonly conducted for actual or potential „severe harm or death‟1 outcomes from incidents,claims, complaints or concerns.• Conducted to a high level of detail, including all elements of a thorough and credible investigation.• Includes use of appropriate analytical tools (e.g. tabular timeline, contributory factors framework,change analysis, barrier analysis).• Normally conducted by a multi-disciplinary team, or involves experts/expert opinion/independentadvice or specialist investigator(s).• Conducted by staff not involved in the incident, locality or directorate in which it occurred.• Overseen by a director level chair or facilitator.• Led by person(s) experienced and/or trained in RCA, human error and effective solutionsdevelopment.• Includes patient/relative/carer involvement and should include an offer to patient/relative/carer oflinks to independent representation or advocacy services.• May require management of the media via the organisation‟s communications department.• Includes robust recommendations for shared learning, locally and/or nationally as appropriate.• Includes a full report 2 with an executive summary and appendices.Level 3 – Independent investigationAs per Level 2 but in addition:• Must be commissioned and conducted by those independent to the provider service and organisationinvolved (level 3 investigations can be commissioned by the provider service).• Commonly considered for incidents, claims, complaints or concerns of high public interest orattracting media attention.• Conducted for mental health homicides which meet Department of Health guidance.3• Should be conducted where Article 2 of the European Convention on Human Rights is, or is likely tobe, engaged.As defined in the NPSA RCA Toolkit: www.msnpsa.nhs.uk/rcatoolkit/resources/ resource_glossary.htm#As detailed in the NPSA‟ RCA Investigation Report Template‟ and „RCA Investigation Evaluation - thoroughness andcredibility checklist‟Independent investigation of adverse events in mental health services.http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/publicationsPolicyAndGuidance/DH_4113575Root Cause Analysis Investigation Tools July 2008Page 41 of 47

Appendix 10 – 24 Hour Meeting Agenda1. Review of incident with outline chronologyAgenda for 24 Hour SUI Meeting2. List people involved (name and position: this information will not be circulated)3. Immediate safety actions taken at time of incident/notable practice4. Status of Patient / information given to patient or relatives5. Service / Care delivery problems immediately apparent/6. Confirm actions, due date and responsible personY/N/N/Ai. 24 Hour Meeting only Named person to lead investigation:Level ofInvestigationRequiredii.iii.iv.Any additions to the standard ToRAgreed scope of investigationConcise (Internal)Comprehensive(report to NHS London)External investigator to beappointedWho will collect staff statements for investigation?NB: see over for Standard T of RWho will retain/arrange for copies of the patient‟shealth care record?Have patient/relatives been givenBeingOpeninformation?What further information needs to begiven?Who will support staff following incident andduring investigation?Is it necessary to isolate equipment?By whom:By whom:If yes, has this been done and whereis equipmentHas a post mortem been requested?Do thefollowingneed to beinformedThe CoronerThe Communications DeptThe Legal Services DeptPOVA / ISAOther agencies i.e. HSE, MHRAIs a helpline or look back going to be required?Is a follow up meeting required?If yes, who will organiseIf yesWhen should this beWho will arrangeWho will be invitedPage 42 of 47

Standard Terms of Reference for SUI investigationThe following are the standard T of R for SUI investigations at Homerton University NHS Foundation Trust. Theseshould be reviewed at the 24 meeting to establish if they address the criteria for the proposed investigation or iffurther objectives need to be added.To establish the sequence of events that led to the above incidentTo establish whether failings occurred in care and/or treatmentTo identify learning opportunities and improvementsTo formulate realistic recommendations for practice that will address the root causes of theincidentTo present the key findings in a report that will serve as a record of the investigationScope of the InvestigationThe scope of the investigation must be established at the 24 hour meeting. This includes:What length of time will be covered by the investigation (e.g. this admission, previous admissions, specificperiod of time)Which services will be included in the investigation (including any external agencies)Will the investigation examine issues other than those immediately referred to at the time of reporting.Created by Clinical Risk Advisors Barts and The London NHS TrustPage 43 of 47

Equalities Impact AssessmentThis checklist should be completed for all new Corporate Policies and procedures to understand their potentialimpact on equalities and assure equality in service delivery and employment.Policy/ServiceName:Incident Reporting PolicyDavid BridgerAuthor:Nicola HavutcuHead of GovernanceRole:Clinical Risk Manager (Interim)Directorate: Risk ManagementDate 1/4/10Equalities Impact AssessmentQuestion1. How does the attachedpolicy/service fit into the trustsoverall aims?Yes No CommentYes2. How will the policy/service beimplemented?3. What outcomes are intended byimplementing the policy/deliveringthe service?Through existing Risk ManagementarrangementsAll incidents are report andinvestigated appropriatelyAll incidents are validated for accuracyand appropriate action4. How will the above outcomes bemeasured? Section Section 23.05. Who are they key stakeholders inrespect of this policy/service andhow have they been involved?6. Does this policy/service impacton other policies or services andis that impact understood?7. Does this policy/service impacton other agencies and is thatimpact understood?PSCIRGYesBeing Open Policy (link made)NoPage 44 of 47

8. Is there any data on the policy orservice that will help inform theEqIA?No9. Are there are information gaps,and how will they beaddressed/what additionalinformation is required?NoEqualities Impact AssessmentQuestion10. Does the policy or servicedevelopment have an adverseimpact on any particular group?Yes No CommentX11. Could the way the policy iscarried out have an adverseimpact on equality of opportunityor good relations betweendifferent groups?X12. Where an adverse impact hasbeen identified can changes bemade to minimise it?N/a13. Is the policy directly or indirectlydiscriminatory, and can the latterbe justified?X14. Is the policy intended to increaseequality of opportunity bypermitting Positive Action orReasonable Adjustment? If so isthis lawful?XEQUALITIES IMPACT ASSESSMENTFOR POLICIES AND PROCEDURES2. If any of the questions are answered „yes‟, then the proposed policy is likely to be relevant to the Trust‟sresponsibilities under the equalities duties. Please provide the ratifying committee with information on why„yes‟ answers were given and whether or not this is justifiable for clinical reasons. The author shouldconsult with the Director of HR & Environment to develop a more detailed assessment of the Policy‟simpact and, where appropriate, design monitoring and reporting systems if there is any uncertainty.3. A copy of the completed form should be submitted to the ratifying committee when submitting thedocument for ratification. The Committee will inform you if they perceive the Impact to be sufficient that amore detailed assessment is required. In this instance, the result of this impact assessment and anyfurther work should be summarised in the body of the Policy and support will be given to ensure that thepolicy promotes equality.Page 45 of 47

Policy Submission FormPolicy Submission FormTo be completed and attached to any policy or procedure submitted to the Trust Policy Group1 Details of policy1.1 Title of Policy: Incident Reporting Policy1.2 Lead Executive Director Pauline Brown, Chief Nurse / Director of1.3 Author/TitleGovernanceDavid Bridger, Head of GovernanceNicola Havutcu, Clinical Risk Manager(Interim)1.4 Lead Sub Committee Patient Safety Committee1.5 Reason for Policy CQC/HSE/NHSLA Requirement1.6 Who does policy affect? All staff1.7 Are national guidelines/codes ofpractice incorporated?1.8 Has an Equality ImpactAssessment been carried out?2 Information Collation2.1 Where was Policy informationobtained from?Yes (NPSA)YesNHSLA / NPSA / previous policy3 Policy Management3.1 Is there a requirement for a new orrevised management structure ifthe policy is implemented?3.2 If YES attach a copy to this form3.3 If NO explain why4 Consultation Process4.1 Was there internal/externalconsultation?NoPSC4.2 List groups/Persons involved PSCPage 46 of 47

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