Adverse Incidents and Near Misses Management Policy



3810-60642500Policy for the Management of Safety Learning Events and Near MissesVersion4.3Name of responsible (ratifying) committeeSerious Incident Review GroupDate ratified28 June 2016Document Manager (job title)Head of Risk ManagementDate issued21 July 2016Review date31 January 2019 Electronic locationManagement PoliciesRelated Procedural DocumentsRisk Management StrategyManagement of Serious Incidents Requiring InvestigationManagement of Complaints, Concerns, Comments and PlauditsDuty of Candour and Being Open PolicyManagement of Claims, Clinical Negligence Liabilities to Third Parties and Property Expenses Scheme Disclosure of Information to the Police PolicyHow to Report a Safety Learning EventKey Words (to aid with searching)Incident; Serious Incident; Safety Learning EventVersionDate RatifiedBrief Summary of ChangesAuthor4.329/10/2018Extension agreed by the Chair of Q&P pending combination with Serious Incidents Requiring Investigation Policy-4.225/06/2018Extension agreed by the Chair of SIRG as awaiting outcome of external Serious Incident Process review-4.115/05/2018Extension agreed by the Chair of SIRG as awaiting outcome of external Serious Incident Process review-4.0June 2016Change of policy title from ‘Adverse Event and Near Misses Management Policy’Updated processUpdated ResponsibilitiesA Green3.1-Chairs action to extend review date-3January 2014Alignment to NRLS definitionsInclusion of Duty of Candour requirementsAddition of screening incidentsUpdate to responsibilitiesChanges to monitoringRemoval of Guidance on Grading Incidents replaced by NRLS definitionsA GreenCONTENTS TOC \o "1-2" \h \z \t "Appendix,1,Heading,2" QUICK REFERENCE GUIDE PAGEREF _Toc456864849 \h 41.INTRODUCTION PAGEREF _Toc456864850 \h 52.PURPOSE PAGEREF _Toc456864851 \h 53.SCOPE PAGEREF _Toc456864852 \h 54.DEFINITIONS PAGEREF _Toc456864853 \h 55.DUTIES AND RESPONSIBILITIES PAGEREF _Toc456864854 \h 66.PROCESS PAGEREF _Toc456864855 \h 77TRAINING REQUIREMENTS PAGEREF _Toc456864856 \h 108REFERENCES AND ASSOCIATED DOCUMENTATION PAGEREF _Toc456864857 \h 119EQUALITY IMPACT STATEMENT PAGEREF _Toc456864858 \h 1110MONITORING COMPLIANCE PAGEREF _Toc456864859 \h 12As a minimum, the following elements will be monitored PAGEREF _Toc456864860 \h 12Appendix A: Reportable incidents PAGEREF _Toc456864861 \h 13Appendix B: How to Report an Adverse Incident PAGEREF _Toc456864862 \h 15Appendix C: Guidance on grading incidents PAGEREF _Toc456864863 \h 33Appendix D: SIRI Pathway PAGEREF _Toc456864864 \h 34Appendix E: Reporting to External Agencies PAGEREF _Toc456864866 \h 35Appendix F: Informing external agencies: when, why and by whom PAGEREF _Toc456864868 \h 36Appendix G: VTE Reporting and Investigation Process PAGEREF _Toc456864869 \h 38 PAGEREF _Toc456864870 \h 38Title of Procedural Document: Safety Learning Event and Near Miss Management PAGEREF _Toc456864871 \h 39Date of Assessment PAGEREF _Toc456864872 \h 39QUICK REFERENCE GUIDEFor quick reference the guide below is a summary of actions required. This does not negate the need for those involved in the process to be aware of and follow the detail of this policy.PROCESS FOR THE REPORTING AND MANAGEMENT OF A SAFETY LEARNING EVENT (SLE)24701500INCIDENT OCCURS00INCIDENT OCCURSDeath/Severe Harm(including ‘Never Events’)Moderate HarmLow Harm Inform appropriate senior member of staff.Risk Advisors /Governance Leads/ Line Managers will be automatically alerted to the incident and notified via email from ernance Lead reviews to ensure appropriate grading.Will require an initial investigation panel arranged, chaired by a CSC Management representative, or patient safety lead, where the type, level and investigator is determined.Investigation to be completed to the same timescale as a SIRI.Risk management advised of the outcome of the investigation. The event must then be closed on DatixWeb.No HarmIssues reported to/monitored via:CSC Governance Committees/CSC SIRGCSC Performance ReviewsGovernance & Quality Committee as part of CSC reportingCSC BoardsVTE weekly panelIssues reported to / monitored via:CSC Governance Committees/CSC SIRGCSC Performance ReviewsCSC BoardsGovernance & Quality Committee as part of CSC reportingGovernance Lead reviews the incident within 5 days and allocates an investigator.Once completed Governance lead checks details actions identified are appropriate and close the incident on DatixWeb.Must be reported immediately to senior member of staff.Risk Advisors/ Governance Leads/Line Managers will be automatically alerted to the incident and notified via email from Datix.Will require an initial investigation panel arranged and managed in accordance with the Trust Policy on the Management of Serious Incidents Requiring Investigation.No Harm Near MissIssues reported to/ monitored via:CSC Governance TeamsSerious Incident Review GroupGovernance & Quality CommitteeTrust BoardCSC Performance ReviewsCSC BoardsCCGs Address the immediate health needs of the person(s) involvedReport the incident onto DatixWeb using the on-line electronic SLE reporting form (guidance in Appendix B)Grade the incident (ref: NRLS guidance in Appendix C) – Death/Severe Harm/ Moderate Harm/ Low Harm/No Harm/Near miss NB: event may be re-graded following review by your Governance Lead or Manager or the Risk Management Department, following further investigation.Consider the level of required communication with the patientFor any VTE Incident follow the process at appendix GDeath/Severe Harm(including ‘Never Events’)Moderate HarmLow Harm Inform appropriate senior member of staff.Risk Advisors /Governance Leads/ Line Managers will be automatically alerted to the incident and notified via email from ernance Lead reviews to ensure appropriate grading.Will require an initial investigation panel arranged, chaired by a CSC Management representative, or patient safety lead, where the type, level and investigator is determined.Investigation to be completed to the same timescale as a SIRI.Risk management advised of the outcome of the investigation. The event must then be closed on DatixWeb.No HarmIssues reported to/monitored via:CSC Governance Committees/CSC SIRGCSC Performance ReviewsGovernance & Quality Committee as part of CSC reportingCSC BoardsVTE weekly panelIssues reported to / monitored via:CSC Governance Committees/CSC SIRGCSC Performance ReviewsCSC BoardsGovernance & Quality Committee as part of CSC reportingGovernance Lead reviews the incident within 5 days and allocates an investigator.Once completed Governance lead checks details actions identified are appropriate and close the incident on DatixWeb.Must be reported immediately to senior member of staff.Risk Advisors/ Governance Leads/Line Managers will be automatically alerted to the incident and notified via email from Datix.Will require an initial investigation panel arranged and managed in accordance with the Trust Policy on the Management of Serious Incidents Requiring Investigation.No Harm Near MissIssues reported to/ monitored via:CSC Governance TeamsSerious Incident Review GroupGovernance & Quality CommitteeTrust BoardCSC Performance ReviewsCSC BoardsCCGs Address the immediate health needs of the person(s) involvedReport the incident onto DatixWeb using the on-line electronic SLE reporting form (guidance in Appendix B)Grade the incident (ref: NRLS guidance in Appendix C) – Death/Severe Harm/ Moderate Harm/ Low Harm/No Harm/Near miss NB: event may be re-graded following review by your Governance Lead or Manager or the Risk Management Department, following further investigation.Consider the level of required communication with the patientFor any VTE Incident follow the process at appendix G24765099060It is essential that staff receive meaningful feedback on the safety learning event that they have reported and any associated learning/actions taken as a result. This is provided via DatixWeb when the event is closed. 00It is essential that staff receive meaningful feedback on the safety learning event that they have reported and any associated learning/actions taken as a result. This is provided via DatixWeb when the event is closed. INTRODUCTIONIn a service as large and complex as the NHS, things will sometimes go wrong. When they do, the response should not be one of blame and retribution, but of learning and a drive to reduce risk for future patients, visitors and staff. Therefore, the Trust is committed to developing a just culture and to encouraging a willingness to admit mistakes without fear of punitive measures. In support of this, the Trust accepts that completion of an Safety Learning Event (SLE) form does not constitute an admission of liability and will not result in automatic disciplinary action. There are occasions, of course, when it may be necessary to take action against individuals which will be governed by appropriate HR policies: acts of maliciousness or criminal or gross/repeated professional misconduct.The policy has been formulated in response to the Department of Health publications An Organisation with Memory, Building a Safer NHS, Doing Less Harm and the National Patient Safety Agency publications Building a Memory: preventing harm, reducing risks and improving patient safety, Seven Steps to Patient Safety and Being Open: Communicating Patient Safety Incidents with Patients and their Carers. The policy is also designed to ensure compliance with the requirements of external agencies. However, the ultimate aim is to reduce the risk of harm to patients, staff and other users of Trust premises through improving the safety and quality of services and the environment. PURPOSEThis policy sets out the processes for the appropriate identification and reporting of Safety Learning Events (SLEs) and near misses. SCOPEThis policy applies to all permanent, locum, agency, bank and voluntary staff of Portsmouth Hospitals NHS Trust, the MDHU (Portsmouth) and Carillion, whilst acknowledging that for staff other than those directly employed by the Trust the appropriate line management or chain of command will be taken into account‘In the event of an infection outbreak, flu pandemic or major incident, the Trust recognises that it may not be possible to adhere to all aspects of this document. In such circumstances, staff should take advice from their manager and all possible action must be taken to maintain ongoing patient and staff safety’.DEFINITIONSSafety Learning Event (SLE): an event or omission relating to a patient, visitor or staff member or any event or circumstances arising during NHS care that could have or did lead to unintended or unexpected harm, loss or damage. See Appendix A for more information on incidents that should be reported.Patient safety incident: any unintended or unexpected incident which could have, or did, lead to harm for one or more patients receiving NHS-funded healthcare.Serious incident requiring investigation (SIRI): (commonly classified as an incident causing severe harm or death) an incident that occurred during NHS funded healthcare (including in the community) which resulted in one or more of the following:unexpected or avoidable death or severe harm of one or more patients, staff or members of the public. a ‘never event’ – all never events are defined as a SIRI although not all necessarily result in severe harm or death. a scenario that prevents, or threatens to prevent, an organisation’s ability to continue to deliver healthcare services including; divert of ambulances, breaches of the 12 hour decision to admit (DTA) target, data loss, property damage or incidents in population programmes like screening and immunization where harm potentially may extend to a large population.allegations or incidents of physical abuse and sexual assault or abuse.loss of confidence in the service, adverse media coverage or public concern about healthcare or an organisation.All grade 3 and 4 pressure ulcers, death attributable to either C Diff or MRSA (part 1 of death certificate), death attributable to VTE, falls resulting in fractures requiring surgical intervention or death.If in doubt, it is better to report an incident as a potential SIRI, as this can then be confirmed by the Clinical Service Centre (CSC) or at the Initial Investigation Panel meeting. Once confirmed the incident will be managed according to the Serious Incident Requiring Investigation Policy.Never Event: a largely preventable patient safety incident that should not occur if the available preventative measures have been implemented.Near miss: a situation in which an event or omission, or a sequence of events or omissions, arising during clinical care fails to develop further, whether or not as a result of compensating action, thus preventing injury to a patient.Harm: an injury (physical or psychological), disease, suffering, disability or death to patients, staff or members of the public. In most instances, harm can be considered to be unexpected if it is not related to the natural course of the patient’s illness, treatment or underlying condition.Root Cause Analysis: A well recognised way of investigating incidents, claims and complaints, which offers a framework identifying what, how and why the event happened. Analysis can then be used to identify areas of change, develop recommendations and look for new solutions.DatixWeb: A Patient Safety and Risk Management System that provides a comprehensive picture of our organisation’s risks by collating information from incidents affecting patients, staff & visitors.DUTIES AND RESPONSIBILITIESAssociate Director of Governance and Quality The Associate Director of Governance and Quality has responsibility for the strategic implementation of this policy.The Head of Risk Management The Head of Risk Management has responsibility for the operational and day-to- day implementation of this policy.Associate Director of Infection Control & Patient SafetyThe Associate Director of Infection Control & Patient Safety attends all moderate harm panels, ensuring that lessons are identified and that organisational learning has taken place.Clinical Service Centre (CSC) Governance Leads (or nominated deputy)The Governance Leads are responsible for ensuring that all SLEs or near misses are reported and managed in line with this policy; are discussed at CSC SIRG/Governance meetings and shared with staff.CSC BoardsThe CSC Board reviews events reports, ensuring that recommendations arising from investigations are implemented as required and that any identified local or organisational learning has been shared. Risk Management TeamThe Risk Advisors are responsible for supporting and advising staff at all levels across the Trust, to ensure that this policy is implemented across the Trust and for ensuring external agencies (Appendices D and E) are informed, if required. All ManagersManagers are responsible for ensuring their staff are released for training, are fully assisted and supported throughout the reporting and handling of an adverse incident or near miss and receive feedback on the outcome of any investigation. Where staff experience particular difficulties associated with an adverse incident or near miss, managers should consider referring the staff member or members to the Occupational Health Department or the AQUILIS counseling service, in accordance with the Human Resources Policy for Supporting Staff The Reporter of any incident must:Ensure the immediate safety of those directly affected by the SLE or near missComplete an on-line electronic adverse incident formImmediately inform the appropriate senior member of staff/line managerPROCESS6.1 Near Misses (No harm to patient, impact prevented). The reporter must:Complete an on-line electronic SLE rm the appropriate senior member of staff / line manager.The Governance Lead must:Review the incident within 5 days, and confirm the grading. Allocate the event to an investigator.Note: consideration should be given to the potential severity of the near miss had it actually impacted upon a patient, staff member or visitor and the appropriate level of investigation pursued.Ensure details of any long-term actions necessary and/or learning are appropriate (these will be fed back to the reporter via Datix) and close the incident on DatixWeb.The Risk Management Team:Will check that all actions are appropriate and finally approve the event on DatixWeb.6.2 Incidents graded No Harm or Low Harm to patient. The reporter must:Ensure the immediate safety of those directly affected by the plete an on-line electronic SLE rm the appropriate senior member of staff / line manager.The Governance Lead must:Review the incident within 5 days, and confirm the grading. Allocate the event to an investigator.Ensure details of any long-term actions necessary and/or learning are appropriate (these will be fed back to the reporter via Datix) and close the incident on DatixWeb. The Risk Management Team:Will check that all actions are appropriate and finally approve the event on DatixWeb.6.3 Incidents graded Moderate Harm to patient.The reporter must: Ensure the immediate safety of those directly affected by the plete an on-line electronic SLE rm the appropriate senior member of staff/line manager Governance Leads, Risk Advisors and Line Managers will be automatically notified of the incident via email.The Governance Lead must:Review the incident to confirm the grading and organize an initial panel within 48 hours;Initial panel to be chaired by a member of the CSC Management team and include the Associate Director of Infection and Patient Safety as a panel member.As part of the investigation process, complete a Root Cause Analysis (RCA), ensure a member of staff is identified to communicate with the patient or relatives and ensure compliance with Duty of Candour requirements. Further guidance is available in the Trust’s Duty of Candour & Being Open Policy.In conjunction with the CSC Management Team; ensure an investigation is instigated following the agreed timescales for a SIRI investigation.When the investigation is concluded: ensure details of any long-term actions necessary and/or learning are appropriate (these will be fed back to the reporter via Datix) and close the incident on DatixWeb.In accordance with Duty of Candour; arrange to share the final report with the patient/relatives, where this has been requested, within 10 working days. The Risk Management Team:Will check that all actions are appropriate and finally approve the event on DatixWeb. Incidents graded Severe/permanent Harm or Death.Guidance on grading can be found at Appendix C. Advice can also be sought from the Risk Management Department Incidents graded Severe/permanent Harm or Death should be managed in accordance with the Trust Policy for the Management of Serious Incidents Policy. Pathway-Appendix D All incidents must be documented in the patient’s health records, including a note of the incident numberSafeguardingIf a concern is regarding the welfare of an adult patient and a suspected safeguarding incident, staff should refer to the Adult Safeguarding policy, fill in the adult safeguarding section of the SLE reporting from on Datix and the event will automatically be sent to the central Safeguarding Mailbox. The reporter should also complete the referral form (found on the intranet) and sent to the central Safeguarding mailbox.If a concern is regarding the welfare of a child, and a suspected safeguarding incident, staff should refer to the Child Safeguarding policy, complete the reporting form and contact the named nurse or midwife for safeguarding children. Screening IncidentsIncidents relating to national screening programmes must be discussed with the Regional Quality Assurance Director in line with local and national guidelines and escalated to Commissioners as appropriate.PHT currently participates in the following national screening programmes:Breast CancerBowel CancerCervical CancerDiabetic retinopathy Newborn screening6.9 The InvestigationSafety Learning Events and near misses are subject to an appropriate level of investigation and root cause analysis and where relevant an improvement strategy prepared. Not all events need to be investigated to the same extent or depth and the investigation and analysis should be relative to the seriousness, complexity of the event and/or whether it resulted in actual harm and the potential for learning, such as those which are high frequency but may be of low severity.Severe Harm or Death / Never EventsAny event resulting in actual or potential severe harm or death will be subject to an initial investigation panel. Once confirmed the incident must be managed as set out in the Trust Policy on the Management of Serious Incidents Requiring Investigation and is subject to external reporting requirements. Duty of Candour requirements must be followed to ensure the patient/family are fully aware of the event and subsequent investigationModerate HarmAny event resulting in actual or potential moderate harm will be subject to an initial investigation panel conducted within the CSC, chaired by a CSC management representative and once confirmed subject to an investigation. Whilst these investigations may require less input than investigations into SIRIs it is essential to adhere to the same procedure and timescales of a SIRI investigation, establish the root cause(s), lessons to be learned and to comply with the Duty of Candour requirements.All incidents in this category will be subject to review and monitoring by the relevant CSC Governance Committees, to ensure learning and the implementation of any required changes in practice.Low Harm/No Harm/ Near Miss Events:It is the responsibility of the CSC Governance lead and Management Team to ensure that all incidents in this category are investigated with the appropriate thoroughness and subject to aggregated review and monitoring by the relevant CSC Governance Committees; to ensure learning and the implementation of any required changes in practice. They are unlikely to warrant individual investigation, but root cause analysis of trends should be undertaken, perhaps as part of a working group, and a preventative risk management strategy established to prevent recurrence. 6.10Central recording of Safety Learning Events and near missesAll SLEs and near misses and the outcome of any investigations are automatically inputted onto the electronic database (DatixWeb) which is maintained within the Risk Management Department, to support analysis and feedback, identification of key themes and organisational learning.6.11 Organisational LearningNo Safety Learning Event policy will be effective unless there is organisational learning and feedback on the lessons learned and any required changes in practice implemented. The Trust has introduced a number of processes to enable learning and feedback, which include: InternalA systematic approach to the recording and trending of incidents through the use of an electronic reporting system and database;Monthly Quality Exception reports to the Trust Board;Monthly Business Intelligence reports to the Trust Board;Quarterly Quality Reports go to the Trust Board and Governance and Quality committee. The reports provide an aggregated view of issues concerning patient safety and clinical effectiveness, patient experience is provided in a separate report.Production of reports specifically tailored to the needs of various groups e.g. falls, VTE.Monitoring of incidents at the monthly CSC Governance Committees; andA Risk Management intranet site that can be accessed by all staff and that holds all relevant documents and reports, including: event reports; legal updates from solicitors; NRLS updates.ExternalReporting of all patient safety incidents to the National Reporting and Learning System (NRLS). The reports produced by the NRLS, are then used for both benchmarking and learning across the Trust;Reporting of all patients safety incidents to the Care Quality Commission, via the NRLS;Reporting onto STEISReceipt by the Commissioners of the quarterly Quality Report and the monthly Quality Exception and Business Intelligence reports, used to inform the Commissioner’s quality contract with the Trust;A monthly meeting with the Commissioners at which various aspects of incidents are discussed, to provide assurance on organisational learning;Reporting of any relevant incident to external agencies, as required (Appendix E/F)6.12 Staff are also able to raise concerns in line with the Trust’s Whistleblowing Policy. This policy enables staff to raise concerns about wrongdoing at work in a way which protects their interests, and which ensures at the same time, that instances of wrongdoing, alleged wrongdoing or apparent wrongdoing are properly investigated and dealt with. The policy is designed to:Provide a way for members of staff concerned about the care or safety of patients to speak out in the event of other procedures failing or being exhausted. Provide an effective and confidential process to enable staff to challenge practices or behaviours if they believe others are acting in an unlawful and/or unethical wayEnsure victimisation or retribution against staff will not be toleratedProtect staff if they speak out appropriatelyTRAINING REQUIREMENTS 7.1 Training forms part of the Trust’s Essential Skills and Training Requirements; as identified in the Training Needs Analysis. It is included in mandatory Corporate Induction and in Essential Updates7.2 Staff undertake Essential Update refresher training via the Electronic Staff Record (ESR) system every two yearsAll training is recorded on the ESR from which the Learning and Development Team provide a monthly heat map to each CSC, to enable monitoring of complianceCompliance is further monitored through the CSC performance reviews with the Executive TeamREFERENCES AND ASSOCIATED DOCUMENTATIONExternalNational Patient Safety Agency, July 2005. Building a Memory: preventing harm, reducing risks and improving patient safety npsa.nhs.ukNational Health Service Litigation AuthorityNHS ImprovementHampshire County Council Protecting People from Abuse guide Internal Management of Serious Incidents Requiring Investigation Management of Complaints, Concerns, Comments and Plaudits Management of Claims Clinical Negligence Liabilities to Third Parties and Property Expenses SchemeDuty of Candour and Being Open PolicyRisk Management StrategyMaternity Risk Management StrategyTrust Policy and Protocol on Whistleblowing Policy Health & Safety PolicyDisclosure of Information to the PoliceEQUALITY IMPACT STATEMENTPortsmouth Hospitals NHS Trust is committed to ensuring that, as far as is reasonably practicable, the way we provide services to the public and the way we treat our staff reflects their individual needs and does not discriminate against individuals or groups on any grounds.This policy has been assessed accordinglyOur values?are the core of what Portsmouth Hospitals NHS Trust is and what we cherish. They are beliefs that manifest in the behaviours our employees display in the workplace. Our Values were developed after listening to our staff. They bring the Trust closer to its vision to be the best hospital, providing the best care by the best people and ensure that our patients are at the centre of all we do.We are committed to promoting a culture founded on these values which form the ‘heart’ of our Trust:Respect and dignityQuality of careWorking togetherEfficiencyThis policy should be read and implemented with the Trust Values in mind at all timesMONITORING COMPLIANCE As a minimum, the following elements will be monitoredMinimum requirement to be monitoredLeadToolFrequency of Report of ComplianceReporting arrangementsLead(s) for acting on Recommendations95% of incidents/ near misses are reported in accordance with this policyInternal AuditAudit of random selection of 50 DatixWeb reportsAnnuallyPolicy audit report to:Patient Safety Steering GroupHead of Risk Management95% of relevant incidents will be appropriately reported to external agenciesHead of Risk ManagementAudit of random selection of 20 SIRIsAnnuallyPolicy audit report to:Patient Safety Steering GroupHead of Risk ManagementAppendix A: Reportable incidentsReportable IncidentsWhilst it is not possible to cover every eventuality, the following incidents must always be reported: some of which will be considered to be Serious Incidents Requiring Investigation (SIRIs) and investigated in accordance with that policy. For ease of reference the incidents have been loosely grouped into: clinical care; information governance; accident/damage/theft/loss; other; and never eventsClinical CareAbsence of consent form / incomplete consent formUnmarked / incorrectly marked surgical siteInappropriate surgery performedUnexpected outcomesUnexpected deathAny major clinical incident e.g. failure to diagnose a serious illnessMedication incidentsPatient slips/trips/fallsPressure ulcersUnexpected patient moves (more than 4 moves)Any incident involving multiple patients e.g. cervical screening incidentsAbsconding patientSuicide / serious self-harm Incidents relating to radiology regulations (IRMER)Death related to Clostridium Difficile (C Diff)Death related to Methicillin Resistant Staphylococcus Aureus (MRSA)VTE/PEInformation GovernanceBreach of confidentialityLoss of person identifiable dataIncidents relating to health records, including unavailabilityBreach of securityAccidents / Damage / Theft / LossInvolving any person on Trust premisesIncidents involving any vehicle on Trust premises Theft of property: Trust, staff or patientLoss of property: Trust, staff or patientDamage to Trust property: premises; fixtures; equipment etcInjury or ill-health suffered as a result of handling patients or inanimate objectContact with bodily fluids – needlesticksContact with harmful chemicals or spillagesFire: actual or false alarmOtherExpression or act of violence or aggression“Rogue” staffProcedure or protocol related incidents, including failure to followNever Events (as defined by the DoH) Wrong site surgery. Wrong implant/prosthesis.Retained foreign object post-operation. Mis-selection of a strong potassium containing solution.Wrong route administration of medicationOverdose of insulin due to abbreviations or incorrect deviceOverdose of methotrexate for non-cancer treatment Mis-selection of high strength Midazolam during conscious sedation.Fall from poorly restricted windows.Chest or Neck entrapment in bedrails Transfusion of ABO-incompatible blood components or organs Misplaced naso or oro-gastric tube Scalding of patients as a result of water used for washing/bathingIf in doubt, it is always better to report than not, but advice can be obtained from your line manager or the Risk Management DepartmentAppendix B: How to Report an Adverse Incident How to complete a Safety Learning Event Reporting FormIf you witness or are involved in any safety event, or see or witness a ‘near miss’ (that is something that didn’t happen because someone did something to prevent it) you should report this event using a Safety Learning Event Reporting Form. This enables the Trust to review all such events and to learn from them, making sure our patients and staff are protected from harm.Reporting an event is straightforward and should take no more than 5 minutes.Section 1: How to access the formStep 1Log on to a computer; any Trust computer will do.4635542989500Step 2 Click on the ‘Safety Learning Event’ Link180975436435500180975-63500Step 313652530416500You can fill in the form from here or, if you know your Datix login, login first.21463071628000If you are logged in your details will automatically be completed on the form. This can make it quicker for you (especially if you have more than one event to report) and ensures that your details are correct.Step 4Now you can start to complete the form.Section 2: Event date and timeThe date and time the event happened.Click on the calendar icon to open the calendar, or type in the date in dd/mm/yyyy format. If you do not know the time that the incident occurred enter the time that you are reporting it.Section 3: Event locationThe next step is to fill out the location of the event 2087880212915500-417703016954500Choose the site from the list. If you type in the first few letters of the location the list of options will reduce making it easier to find the right one – please see below:Now choose the Ward, Department or Unit where the event was first identified.Again, if you type the first few letters of the ward or department this will make it much easier to find the correct one.Datix will now automatically populate the Clinical Service Centre information for the Ward/Department/Unit that you have selected:The Specialty relates to the specialty that the patient is being cared for by, e.g. respiratory or colorectal surgery. This box is not mandatory so please complete it if you know but leave it blank if you don’t.86233068199000For some wards/ departments an additional option – Section- will now appear, this is only for areas where there are distinct areas caring for different groups of patients, see below for an example:For some areas there is then a further sub-section option but for most this is not required.The final box to complete is the location exact, which identifies where in the ward, department or unit the event occurred. Again, typing the first few letters will help you to find the correct option quickly.This is most important for events such as patient falls where the exact location is required, for all other events the general location is sufficient.Section 4: Event codingThis section provides information about what happened.First choose the type of event- who was affected by what happened? 232664032004000If you are not sure, please choose ‘Event affecting Patient’, don’t worry, if this is incorrect the reviewer will put it right.121602528892500If you are reporting a patient event you will see the following message -11239552133500The People affected section will open up further down the screen and you will see the following four questions. These are all yes/no answers. Next, complete the Event type.Choose from the options listed. If none of these apply, choose either ‘Clinical Event not listed above’ or ‘Non-Clinical Event not listed above’Don’t worry if your event type is not listed, those that are on the list are there because additional information is needed about these events.229235051244500Some Event types are only available for patient events, for example VTE and Tissue Damage. Only events which are relevant for the person affected will appear as options; RememberDepending on the event type chosen certain additional questions will appear, these will relate specifically to the type of event and will all be mandatory fields so you must complete these.Some examples are shown below.473710156845004743452711450047371020066000Section 5: People affected1460538481000This is the section which opens if you choose a patient, staff or member of the public event.Choose from the drop down list.37846074866500If you are reporting a patient event, choose patient from this list; a ‘sub-type’ box will now appear. If the event involved a single patient choose patient again, however, if the event involved multiple patients choose ‘all patients on ward/department’.25844532766000On choosing ‘Patient’ you will be asked to complete the boxes shown below. The NHS number is mandatory and is the only number required as this is the unique identifier for all patients. Use of this number enables us to link events relating to the same patient so this being accurate is essential.If you are reporting a staff incident, where a member of staff has been injured or affected, choose the employee type from this list: again, a sub-type box will appear.You must provide the name of the person affected. Section 6: Event detailsThis section is where you should describe what happened. Please keep the following prompts in mind when completing this sectionIt is important that the reason for you completing the form is clear, so make sure you say what the event is, or the nature of the near miss, within the first sentence, e.g.Incorrect dose of medication given, prescription unclear.Additional x-ray required, incorrect arm x-rayed on initial film.Patient fell whilst walking from bathroom- unwitnessed fall.Provide any relevant details but don’t feel that you need to write an essay, keep it brief and to the point e.g.500mg given, actual prescription for 300mg.Patient stated L arm should be x-rayed, request stated R. Patient was confused but this was not apparent at time. Patient has diagnosis of dementia, not mentioned on request form.Patient states felt lightheaded prior to fall, did not have walking stick with him as “it was only a short distance”Provide only facts, not opinions.Do NOT put any patient or staff identifiable information into this box. i.e. do not use any names, date of birth details or other identifying information. This section is sent out of the Trust. Use ‘Patient’ ‘Staff Nurse A’ ‘Doctor B’ or initials if necessary Patient handed over to ward staff. When looked at wristband, it stated another patient's name (Alfred Harper). Patient unable to clarify name. Contacted Sister Emma Smithers on previous ward to clarify which patient had been brought to us, she was positive it is Donald Heathson. Patient handed over to ward staff. When looked at wristband, it stated another patient's name (Patient A- AH). Patient unable to clarify name. Contacted Sister ES on previous ward to clarify which patient had been brought to us, she was positive it is Patient B -DH. The details of the patients and staff involved will be available in the ‘People involved’ section.The action taken box is next. The same principles apply; this is where you should state what you did to make the situation safe.e.g.This could be in a list formNurse in charge informedFY2 informed and came to assess the patientPharmacy contacted and confirmed dose within safe limits, advised to monitor BP and pulse Additional obs completed hourly for 4 hoursMedical notes updated.Or as a narrativePatient was returned to bed and commenced on hourly neuro obs. Post falls checklist completed and falls pathway commenced (not on this previously). Doctor informed and attended at 19:30, plan to continue neuro obs hourly until 00:00. Patient advised to call for assistance prior to mobilising until reviewed by physio tomorrow.But, keep it simple, brief and factual.Section 7: Additional information2476545339000This section is where any other information, in particular the details of staff involved or witnesses, is recorded. As the reporter, you do not need to enter your own details into any of these sections as these will be recorded separately. You should complete these sections for other staff who witnessed or were involved in the event, for exampleWitness:the security guard who witnessed an assault or Employee involved:the Doctor who prescribed an incorrect dose of medication.If you don’t know the persons details please provide as much information as you can, e.g.-152406985000 You will also be asked for the role that this member of staff had in the event, choose the closest description from the drop down list-2540025971500You can add other members of staff by clicking the ‘Add another’ box, please include all staff involved.Section 8: Event result and severityThis section is split into two, the first is the result of the event on the person affected and is eitherHarmThe event happened and the person affected suffered physical or psychological harm as a direct result.No HarmThe event happened but the person affected suffered NO physical or psychological harm as a direct result.Near MissThe event did not happen but, if it had, someone could have been harmed.The second section is the Severity, this is the level of harm that was caused to the person affected. The options are:None; Low; Moderate; Severe or Death SeverityMeaningNoneNo harm causedLowAn event that caused minimal harm requiring extra observation or minor treatment ModerateAn event that resulted in further treatment, possible surgical intervention, cancelling of treatment, or transfer to another area, and which caused short-term harm SevereAn event that caused permanent or long term harmDeathAn event that caused the death of the person The examples below may help to clarify the difference EventResultSeverityPrior to bowel surgery a malfunction of the laparoscopic stack is noticed. The stack is replaced before the surgery commences. Near MissNoneDuring bowel surgery a malfunction of the laparoscopic stack occurs leading to a temporary loss of vision for the surgeon. The surgery is halted for 10 minutes and the stack replaced, There is no harm suffered by the patient. No HarmNonePerforation of the bowel during surgery that was repaired at the time and the area was appropriately washed out. Only antibiotic treatment is requiredHarmLowPerforation of the bowel during surgery was not picked up at the time. It results in septicaemia and a return to theatre for repairHarmModeratePerforation of the bowel during surgery, requiring a temporary colostomy and subsequent major operationsHarmSevereDeath as a direct consequence of perforation of the bowel during surgery.HarmDeathA patient is prescribed someone else’s medication in error, the nurse on the drug round realises and does not give the medicationNear MissNoneA patient is given someone else’s medication. The medication is an ‘over the counter’ pain killer and there is no effect on the patient.No HarmNoneA patient is given someone else's medication. The medication is the same as they normally take but at a slightly higher dose. They need to go to bed earlier due to drowsiness.HarmLowA patient is given someone else's medication. The medication is stronger than their own and they suffer prolonged drowsiness for a week. The patient needs frequent observation of their respiratory rate.HarmModerateA patient is given someone else's medication. They have an allergic reaction to it, have a cardiac arrest and suffer brain damage as a result of receiving the medication.HarmSevereA patient is given someone else's medication. They have an allergic reaction to it, have a cardiac arrest and die as a result of receiving the medication.HarmDeathSection 9: Details of person reporting the eventPlease complete this section with your own details. Remember that if you have logged in to Datix this section will complete automatically. Please ensure that you complete this section accurately- in particular that you type your email address correctly- so that you can receive feedback on what has happened as a result of the event you reported. You must use your work email here- i.e. the porthosp address.Appendix C: Guidance on grading incidentsNRLS Definitions of Levels of HarmNear Miss:Impact prevented – any patient safety incident that had the potential to cause harm but was prevented, resulting in no harm to people receiving NHS-funded careNo Harm :Impact not prevented – any patient safety that ran to completion but no harm occurred to people receiving NHS-funded care.Low Harm:Any patient safety incident that required extra observation, or minor treatment and caused minimal harm to one or more persons receiving NHS-funded care.Moderate Harm:Any patient safety incident that resulted in a moderate increase in treatment and which caused significant but not permanent harm, to one or more persons receiving NHS-funded careSevere Harm:Any patient safety incident that appears to have resulted in permanent harm to one or more persons receiving NHS-funded careDeath:Any patient safety incident that directly resulted in the death of one or more persons receiving NHS-funded care.Appendix D: SIRI Pathway4699006159500Appendix E: Reporting to External Agencies45720074930incident that may require external reporting including those relating to a suspicion of crime/arrestable/serious offence 00incident that may require external reporting including those relating to a suspicion of crime/arrestable/serious offence 41148003985260OTHER AGENCIES00OTHER AGENCIES-2286003985260POLICE00POLICEIMMEDIATELYREPORT THE INCIDENT/ISSUE TO YOUR LINE MANAGER / SENIOR PERSON IN THE DEPARTMENT / WARDLINE MANAGER / SENIOR PERSON ESCALATES INFORMATIONCLINICAL SERVICE CENTRE MANAGEMENT TEAMHOSPITAL DUTY MANAGERDUTY EXECUTIVERISK MANAGEMENT DEPARTMENT ext 3476/8Any of the above will be able provide further advice on who needs to be notifiedRecord that you have reported it / to whom / when. Complete on-line electronic SLE formLine manager / senior to record to whom escalated / whenIMMEDIATELYREPORT THE INCIDENT/ISSUE TO YOUR LINE MANAGER / SENIOR PERSON IN THE DEPARTMENT / WARDLINE MANAGER / SENIOR PERSON ESCALATES INFORMATIONCLINICAL SERVICE CENTRE MANAGEMENT TEAMHOSPITAL DUTY MANAGERDUTY EXECUTIVERISK MANAGEMENT DEPARTMENT ext 3476/8Any of the above will be able provide further advice on who needs to be notifiedRecord that you have reported it / to whom / when. Complete on-line electronic SLE formLine manager / senior to record to whom escalated / when4914900927100057150092710003543300116840These include but are not limited to:Care Quality CommissionCoroner Counter-fraud AgencyDisclosure and Baring ServiceEnvironment AgencyEnvironmental Health AgencyHealth and Safety ExecutiveInformation CommissionerMedicines and Healthcare Products Regulatory Agency (MHRA)NPSAProfessional Regulatory Bodies.Safeguarding Adults Team in Adult Social CareSouth Central Neonatal NetworkNHS England00These include but are not limited to:Care Quality CommissionCoroner Counter-fraud AgencyDisclosure and Baring ServiceEnvironment AgencyEnvironmental Health AgencyHealth and Safety ExecutiveInformation CommissionerMedicines and Healthcare Products Regulatory Agency (MHRA)NPSAProfessional Regulatory Bodies.Safeguarding Adults Team in Adult Social CareSouth Central Neonatal NetworkNHS England-342900116840If there is a suspicion that a crime or arrestable offence may have been committed or you have been requested by the person affected to call the police on their behalf(Details of what constitutes a crime or arrestable offence can be found in the ‘Disclosure of Information to the Police Policy’ V5 2015 which can be found on the Trust intranet under: policies and guidelines→ management polices→ Disclosure of Information to the Police 00If there is a suspicion that a crime or arrestable offence may have been committed or you have been requested by the person affected to call the police on their behalf(Details of what constitutes a crime or arrestable offence can be found in the ‘Disclosure of Information to the Police Policy’ V5 2015 which can be found on the Trust intranet under: policies and guidelines→ management polices→ Disclosure of Information to the Police 44577006032500-22860021590IF IN ANY DOUBT PLEASE TAKE ADVICE – DON’T IGNORE ANY POTENTIALLY REPORTABLE ISSUE00IF IN ANY DOUBT PLEASE TAKE ADVICE – DON’T IGNORE ANY POTENTIALLY REPORTABLE ISSUEAppendix F: Informing external agencies: when, why and by whomThe following are examples of the external agencies that may need to be informed in the event of a SLE. If you need any advice in this regard please do not hesitate to contact the Risk Management DepartmentAgencyCircumstancesReporterCare Quality CommissionSIRIs related to breach of radiology regulations e.g. IRMERRadiation Protection AdviserCoronerSudden unexpected death of a patient.Death following an in-patient fall.Suicide.Death as a result of an accident at work.Healthcare professional responsible for care of the patientSenior ManagerCounter-fraud AgencyActual or suspected fraudAssociate Director of Governance & Quality/Director of FinanceEnvironment AgencyMajor contamination of the environmentDirector of Human Resources and WorkforceEnvironmental Health AgencySIRI involving food poisoning originating in, or being transferred through the TrustHead of Hotel Services-CarillionDirector of Corporate AffairsHealth and Safety ExecutiveThe Reporting of Injuries, Diseases and Dangerous Occurrences Regulations 1995 (RIDDOR), place a legal duty on employers to report work-related deaths, major injuries, over-three days injuries, work related diseases and dangerous occurrencesHealth and Safety ManagerDisclosure and Baring ServiceWhen the Trust Dismisses or withdraws permission for a member of staff to engage in a regulated or controlled activity, or would have done so had that individual not resigned, retired, been made redundant or been transferred to a position which is not a regulated or controlled activitybecausethey think that the individual has:engaged in relevant conductsatisfied the Harm Test; orreceived a caution or conviction for a relevant offenceCSC Management Team / Head of Human ResourcesInformation CommissionerAll level 3 information governance SIRIsInformation Governance ManagerMedicines and Healthcare Products Regulatory Agency (MHRA)Suspected safety problems with medicines, medical devices, blood and blood components.Member of staff who discovers the problem – guidance available on Pharmacy intranet web siteNational Patient Safety Agency (NPSA)All patient safety incidentsRisk Management TeamPoliceDeath or injury where it is considered there are unusual or suspicious circumstancesTheft of / malicious damage to, Trust propertyViolent or aggressive incidents where it is considered police involvement is requiredArsonMedical Director / Director of NursingSecurity ManagerMedical Director/Director of Nursing / Senior ManagerDeputy Director of EstatesProfessional Regulatory Bodies. Where there are concerns about the practice of a healthcare professional.Medical Director / Director of Nursing / specific professional lead, depending on healthcare professional involved.Portsmouth or Hampshire Council Safeguarding TeamWhen any safeguarding issue is suspectedAny staff memberRegional Quality Assurance DirectorScreening incidentsAssociate Director of Governance & Quality/Head of Risk ManagementSouth Central Neonatal NetworkNeonatal SIRIMedical Governance Lead W&C CSCNHS Improvement Never EventDirector of Nursing/Medical Director/Associate Director of Governance & Quality/Head of Risk ManagementAppendix G: VTE Reporting and Investigation Process13754097843520001425574673989000698507185660IMR completed and sent to VTE in-box in time for scheduled Weekly VTE panelVTE@porthosp.nhs.uk 00IMR completed and sent to VTE in-box in time for scheduled Weekly VTE panelVTE@porthosp.nhs.uk 2190758147685CSC present IMR at Weekly VTE Panel 00CSC present IMR at Weekly VTE Panel 33991554236720YES00YES2889250423671900142557555841900011207753680460NO00NO1047750353758400-3206753204210Incident closed/rejected and logged asCOMMUNITYNo further PHT investigation00Incident closed/rejected and logged asCOMMUNITYNo further PHT investigation291846030911790036982406880860IMR must include:If patient had been an inpatient, had surgery or attended ED with POP application within previous 90 days.If patient risk assessed and assessment documented on admission to hospital. If any thrombosis risk factor is identified, that thromboprophylaxis (mechanical or chemical) was prescribed in accordance with NICE guidelines Whether any prescribed prophylaxis was delayed or omitted00IMR must include:If patient had been an inpatient, had surgery or attended ED with POP application within previous 90 days.If patient risk assessed and assessment documented on admission to hospital. If any thrombosis risk factor is identified, that thromboprophylaxis (mechanical or chemical) was prescribed in accordance with NICE guidelines Whether any prescribed prophylaxis was delayed or omitted-3200406023610CSC arranges for completion of Initial Management Report (IMR ) and CSC representative to attend VTE panel00CSC arranges for completion of Initial Management Report (IMR ) and CSC representative to attend VTE panel14255754728210VTE Admin Support email CSC Management Team- to inform of event, request IMR, give details of panel date / time of attendance00VTE Admin Support email CSC Management Team- to inform of event, request IMR, give details of panel date / time of attendance17430753413760Risk / VTE Admin Support review – Relevant hospital attendance within 90 days?00Risk / VTE Admin Support review – Relevant hospital attendance within 90 days?18421352578735Department / ward complete DATIX form00Department / ward complete DATIX form3328034640334000155066959937650029375095328920006038845050155006038843957320002937509395732000288988422809200035052006927215Learning fed back to CSC / Trust wide via Governance structureCSC presents feedback of action plan outcome to Thrombosis Committee00Learning fed back to CSC / Trust wide via Governance structureCSC presents feedback of action plan outcome to Thrombosis Committee-1866906870065Definition of MAJOR HARM:Patient requiring ThrombolysisDCCQ admissionResuscitation00Definition of MAJOR HARM:Patient requiring ThrombolysisDCCQ admissionResuscitation27470105727065CSC rep presents completed reports to VTE Incident Review Group for sign off00CSC rep presents completed reports to VTE Incident Review Group for sign off-1866905507990Investigator appointed to complete RCA. Submit to VTE@porthosp.nhs.uk within 28 days00Investigator appointed to complete RCA. Submit to VTE@porthosp.nhs.uk within 28 days21717004355465Investigator appointed to complete RCA. Submit to VTE@porthosp.nhs.uk within 28 days00Investigator appointed to complete RCA. Submit to VTE@porthosp.nhs.uk within 28 days-1295404307840SIRI process instigated and reported to CCG by Risk Dept00SIRI process instigated and reported to CCG by Risk Dept20574002679065AMBERPHT/NICE assessment and prophylaxis guidelines not followed but no DEATH OR MAJOR HARM00AMBERPHT/NICE assessment and prophylaxis guidelines not followed but no DEATH OR MAJOR HARM-2520952679065REDPHT/NICE assessment and prophylaxis guidelines not followed and DEATH OR MAJOR HARM00REDPHT/NICE assessment and prophylaxis guidelines not followed and DEATH OR MAJOR HARMEquality Impact Screening ToolTo be completed and attached to any procedural document when submitted to the appropriate committee for consideration and approval for service and policy changes/amendments.Stage 1 - Screening Title of Procedural Document: Safety Learning Event and Near Miss ManagementDate of Assessment30.06.16Responsible DepartmentRisk ManagementName of person completing assessmentAnnie GreenJob TitleActing Head of Risk ManagementDoes the policy/function affect one group less or more favourably than another on the basis of :Yes/NoCommentsAgeNoDisabilityLearning disability; physical disability; sensory impairment and/or mental health problems e.g. dementiaNoEthnic Origin (including gypsies and travellers)NoGender reassignmentNoPregnancy or MaternityNoRaceNoSexNoReligion and BeliefNoSexual OrientationNoIf the answer to all of the above questions is NO, the EIA is complete. If YES, a full impact assessment is required: go on to stage 2, page 2More Information can be found be following the link below.uk/ukpga/2010/15/contentsStage 2 – Full Impact AssessmentWhat is the impactLevel of ImpactMitigating Actions(what needs to be done to minimise / remove the impact)Responsible Officer Monitoring of ActionsThe monitoring of actions to mitigate any impact will be undertaken at the appropriate levelSpecialty Procedural Document: Specialty Governance CommitteeClinical Service Centre Procedural Document:Clinical Service Centre Governance CommitteeCorporate Procedural Document:Relevant Corporate CommitteeAll actions will be further monitored as part of reporting schedule to the Equality and Diversity Committee ................
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