Incident Management Policy Including Serious Incidents Requiring ...

Peninsula Community HealthIncident Management Policy includingSerious Incidents Requiring Investigation (SUI’s)Title: Incident Management Policy IncludingSerious Incidents Requiring Investigation(SUI’s)Procedural Document Type:PolicyReference:COP6CQC Outcome: Outcome 4B, 14A, 16B, 20Version: version 3 March 2011Approved by:CIOS Community Health Services BoardRatified by:CIOS Community Health Services BoardDate ratified: 28th April 2011Freedom of Information:This document can be releasedName of originator/author:Governance ManagerName of responsible team:GovernanceReview Frequency:3 YearsReview Date: 28th April 2014Target Audience:All staffExecutive Signature (Hard Copy Only):Registered in England and Wales No: 7564579Registered office: Peninsula Community Health CIC,Sedgemoor Centre, Priory Road, St Austell PL25 5ASwww.peninsulacommunityhealth.co.ukQuality care, closer to youPeninsula Community Health is a not for profitCommunity Interest Company responsible forproviding NHS adult community healthservicesin Cornwall and the Isles of Scilly

Contents1 Introduction ........................................................................................................ 42 Definitions .......................................................................................................... 43 Duties................................................................................................................. 53.1 Individual Roles............................................................................................ 53.2 Committee Roles ......................................................................................... 84 Reporting an Incident ......................................................................................... 94.1 Violations ..................................................................................................... 94.2 Reporting Incidents Anonymouysly.............................................................. 95 Incident Investigation ......................................................................................... 95.1 Levels of Investigation ................................................................................. 95.2 Records ..................................................................................................... 105.3 Timescales................................................................................................. 105.4 Simple investigations ................................................................................. 106 Root Cause Analysis........................................................................................ 117 External Stakeholder Notification ..................................................................... 128 Reporting to External Agencies........................................................................ 128.1 National Patient Safety Agency (NPSA) .................................................... 128.2 Reporting of Injuries, Diseases and Dangerous Occurrences (RIDDOR) . 128.2.1 To Report a RIDDOR Incident:.......................................................................128.3 NHS Litigation Authority............................................................................. 148.4 Medical Devices Agency............................................................................ 148.5 Serious Hazards of Transfusion (SHOT) reporting. ................................... 148.6 Ionising Radiation (Medical Exposure) Regulations (IRMER) 2000. .......... 148.7 Information Commissioner ......................................................................... 148.8 NHS Counter Fraud & Security Management Service ............................... 149 Incident Grading And Subsequent Actions....................................................... 159.1 Adding risks highlighted by an incident investigation to the Risk Register. 1510 Public Communications.................................................................................... 1511 Recommendations and Action Planning .......................................................... 1612 Support for Patients, Carers, Relatives and others .......................................... 1612.1 Timing................................................................................................. 1612.2 Statements.......................................................................................... 1612.3 Staff support ....................................................................................... 1612.4 Whistleblowing.................................................................................... 1713 Link with Incident Management and Complaints Management ........................ 1714 What to Report as a Serious Incident Requiring Investigation (SUI) ................ 17Major Incidents/Terrorism and Chemical, Biological, Radiological or Nuclear (CBRN)Incidents................................................................................................................... 17Medico-legal incidents/litigation................................................................................ 17Mortality/Morbidity/Care Incidents ............................................................................ 18Safety and Governance Incidents ............................................................................ 19Health Protection (Major Outbreaks/Serious Incidents of Communicable Disease). 20Media Issues. ........................................................................................................... 2114.1 How to Report a Serious Incident (SUI) – Who And How ................... 2114.1.1 Grading Incidents.............................................................................................2114.2 The investigation and final report........................................................ 2515 Never events .................................................................................................... 2516 Management of Serial Incidents....................................................................... 252 of 28

17 Performance Management and Data Collection............................................... 2618 Reports to the Integrated Governance Committee and the Board ................... 2619 Learning from Experience and Sharing Lessons Learnt .................................. 2620 Risk Management Strategy Implementation..................................................... 2620.1 Implementation & Dissemination ........................................................ 2620.2 Training and Support .......................................................................... 2720.3 Document Control & Archiving Arrangements .................................... 2720.4 Equality Impact Assessment............................................................... 2721 Process for Monitoring Effective Implementation ............................................. 2722 Associated Documentation............................................................................... 2723 References....................................................................................................... 28Please Note the Intention of this DocumentThis policy sets out the roles and responsibilities of all staff in Peninsula Community Healthin relation to incidents and the arrangements for reporting and management of all incidents,including near misses and serious incidents requiring investigation.Review and Amendment LogVersion No Type of Change Date Description of change3 of 28

1 IntroductionEvery day more than a million people are treated safely and successfully in the NHS. However theadvances in technology and knowledge in recent decades have created an immensely complexhealthcare system. This complexity brings risks, and evidence shows that things will and do gowrong in the NHS; that patients are sometimes harmed no matter how dedicated and professionalthe staff.Systems not PeopleIncidents are more often than not the result of a system failure and rather than one individual’sactions. Blaming individuals can result in defensive behaviour, resentment, closed communicationand disciplinary problems. This can also prove to be extremely damaging as people becomereluctant to report incidents, or report the true facts, which results in a distorted view of the actualcause. It seldom prevents recurrence of an incident as it changes nothing about the system.Reviewing the way things are done, rather than the individuals involved, assists us in establishingwhat corrective action can be taken in order to modify the systems and processes – as opposed toapportioning blame.Peninsula Community Health is committed to staff and patient safety and will take a proactive and‘fair-blame’ approach to managing incidents to promote risk reduction in an open and fair culture.Peninsula Community Health (PCH) will follow the guidance laid out the National Patient SafetyAgency’s ‘Incident Decision Tree’ (appendix 1) to ensure staff involved in incidents are treatedfairly.Incidents and near misses provide an opportunity for learning and improvement. In order for thislearning to take place it is essential that all incidents and near misses are reported andinvestigated, promptly, accurately and appropriately to identify underlying causes of incidents.PCH will use incident reports to identify opportunities for improving the safety of patients, staff andother visitors to its premises, to learn from them in order to ensure that they are not repeated.This policy sets out the roles and responsibilities of all staff in Peninsula Community Health inrelation to incidents and the arrangements for reporting and management of all incidents, includingnear misses and serious incidents requiring investigation.2 DefinitionsAn incident is any event that has given rise to actual or possible injury/harm to a patient, memberof staff, visitor or contractor or causes/may cause damage to or loss of PCH property. This includesnon-physical harm such as stress or anxiety, breaches of confidentiality and information securityand also discrimination against people on the grounds of religion/belief, gender, race, age, disabilityor sexual orientation.Near misses are incidents which could have resulted in injury or damage but for the intervention ofa third party or ‘luck’. The National Patient Safety Agency also refers to these as “prevented patientsafety incidents”. For example when a nurse spots the wrong drug has been prescribed ordispensed and does not administer it. Reporting a near miss is just as important as reporting anincident which actually happened or caused harm.A Serious Incident Requiring Investigation (SUI) is generally defined as: An adverse incident when a patient, member of staff, or member of the public suffersserious harm (as defined by the healthcare organisation’s own adverse incident reportingpolicy), or unexpected death (or the risk of death or injury) in hospital, other health servicepremises or premises where health care is provided including in a patient’s own home. In4 of 28

the case of those in receipt of mental health care services this may occur anywhere in thecommunity;Where actions of health service staff are likely to cause significant public concern;Any event that might seriously impact upon the delivery of service plans and/or may attractmedia attention and/or result in a settlement following litigation and/or may reflect a seriousbreach of standards or quality of service.More detailed guidance on what constitutes a serious incident requiring investigation requiringreporting to the NHS Cornwall & Isles of Scilly (or to the Strategic Health Authority for NHS CIOSserious incidents requiring investigation) can be found in Section 21 of this policy.A Serial Incident is one where multiple enquiries by patients/public/media are anticipated. Forexample where a member of staff has been found to be carrying an infectious disease which couldhave impacted many patients; in the event of such an incident, it may be necessary to set up anincident room with a ‘hotline’ arrangement for concerned members of staff/public/media to contactthe organisation with their enquiries. (Section 23 gives guidance).Risk is the possibility of harm or loss, for example, an unplanned event which may cause injury, orhave an impact upon, the PCH’ patients, staff, contractors, visitors (including the general public),partner organisations, the organisation’s strategic objectives, assets and/or its reputation.A Risk Register is a document, held electronically and/or on paper, that outlines all the riskscurrently present in Peninsula Community Health/Locality/department etc.Risks and incidents are assessed in terms of Likelihood and Impact. For grading incidents,likelihood is the chance of the event occurring again and the impact is the actual level of harmcaused by the incidents (rather than the potential harm it could have caused). Section 5 givesguidance on assessing likelihood and impact.An Investigation is a process by which an incident is examined to allow the organisation tostop a similar event happening in the future. Investigations establish not just what happened butwhy they happened.Root cause analysis is a method for investigating incidents which focuses on why thingshappened in order to identify actions to prevent recurrence, rather than focussing on “who didwhat”. Actions can then be taken to address the cause or causes of the incident, in a fair blameand learning environment. Further guidance on incident investigation is available in section 10.3 DutiesThis section includes an overview of individual roles, departmental and committee duties includinglevels of responsibility:3.1 Individual RolesStaff affected by or involved in incidents will: Take appropriate immediate action to maintain the safety of patients, staff, members of thepublic and contractors. Report any incidents to their line manager or supervisor as soon as they become aware ofevents. Make a formal report of the incident within 24 hours of becoming aware of events. This canbe done using DATIX, the telephone incident reporting line (01872 253490). Section 5 of this policy includes guidance on what information is needed for an incident tobe investigated.5 of 28

Line Managers will Take appropriate action to maintain the safety of patients, staff, members of the public andcontractors Ensure any staff members affected by or involved in the incident have received appropriatecare and advice; this could include referrals to occupational health. (Section 18) Consider whether the incidents should be classed as a serious incidents requiringinvestigation and if so, contact Senior Manager immediately (Section 21). Ensure the incident has been reported onto DATIX. Report to external agencies as required ( RIDDOR, MHRA etc, see section 12) Instigate an investigation into the incident and identify the causes and any actions requiredto prevent recurrence. (See section 10 on incident investigations.) Record the findings and outcome of this investigation on DATIXSenior Managers will Ensure the DATIX report is accurate and complete, including details of investigationsundertaken and actions planned and implemented. Monitor incidents in their area of responsibility to identify any trends requiring furtherinvestigation or action. Consider any reports of potential serious incidents requiring investigation, contacting theappropriate Director and Head of Governance as appropriate. (See sections 21 and flowchart page 21). Lead on investigation and root cause analysis of serious incidents requiring investigation.(see section 22). Identify any risks highlighted through the incident report and investigation which cannot beimmediately resolved through action. These should be recorded on the Risk Register; referto section 14.1 and also the NHS CIOS/PCH Guide to Risk Assessment.Investigating Manager/TeamWhen an incident is reported, the DATIX system automatically sends a notification email tomanagers of the location where the incident occurred; the investigating manager is determinedby the degree of harm caused.No and low harm incidents are investigated by the Ward managerModerate and severe harm incidents are investigated by the matronSevere harm/incidents resulting in death are investigated by Locality ManagersFor non-ward services, equivalent rationales have been agreed.Role of Clinicians/Specialist AdvisorsSpecialist advisors are also automatically notified by email when incidents are reported whichcontain information pertinent to their area of expertise e.g. all medication incidents are notifiedto the Pharmaceutical Advisors, all incidents marked as Safeguarding Adults/Childrenconcerns are notified to the Named Nurse for Safeguarding Adults/ Children as appropriate.Their role is to provide advice and support to the investigating officer in relation to the breadthof the investigation, external reporting and other action that must be taken. They will alsoensure that learning from individual incidents informs future training and decision makingacross the organisation.Head of Governance Report any PCH serious incidents requiring investigation to STEIS as per PCH’ seriousincident requiring investigation process; refer to Section 21 and also NHS CIOS(Commissioning) Serious incident requiring investigation Reporting and Monitoring Policy atAppendix C) Provide guidance on serious incident requiring investigation identification and reporting. Provide support with the root cause analysis of serious incidents requiring investigation.6 of 28

Director of Finance will Retain overall responsibility for financial risks and financial aspects of organisational risks.Director of Nursing and Professional PracticeIs the director with responsibility for ensuring compliance with the policy. They act as Caldicott Guardian Accountable Officer for Controlled Drugs nominated lead for issues involving Adult Protection nominated Director for Infection Prevention and Control The Clinical Governance Lead, with a role to develop and encourage awareness of clinicalrisk management throughout the PCH.The Non-Executive Directors within Peninsula Community Health will Provide non-executive leadership in areas such as Security, Child and Adult Protection andCounter Fraud. Attend and/or chair appropriate governance committees with a role in incident monitoringwhere appropriate.3.2 Committee RolesThe Peninsula Community Health Board willReceive monthly reports on serious incidents requiring investigation reported by all serviceswithin Peninsula Community Health. This report will be compiled by the Head of Governance.The business of the Clinical Quality and Safety Committee will be reported to the Board toinclude key information relating top staff an patient safety.The Clinical Quality and Safety Committee will Act as the committee with overarching responsibility for safety and risk management Receive bi-monthly reports on Serious incident requiring investigation trends and learningfrom across Peninsula Community Health Receive bi-monthly reports on all reported incidents including trends and learning fromacross the organisationThe Health and Safety sub-committee will Receive quarterly reports on incidents relating to manual handling, fire, security, violenceand aggression and non-patient safety incidents including:o Medical devices/equipment failureo Slips, trips and fallso Pressure Ulcerso Needle-stick and sharpso COSHH incidentso RTA or transport relatedo Stress relatedo Sickness absence relatedThe Information Governance sub-committee willReceive reports on information governance incidents such as breach of confidentiality, dataprotection concerns and inadequate or incorrect documentation.The Controlled Drugs Local Intelligence Network will Share information regarding the management and use of Controlled Drugs in Cornwall. Discuss the quarterly reports received by the PCT Accountable Officer from the PCT’sprovider service and other designated bodies such as NHS Trusts, Independent Hospitals,and Hospices on incidents and actions relating to controlled drugs.8 of 28

4 Reporting an IncidentWherever possible staff should report an incident using the DATIX web browser which is accessiblefrom any computer than can access the Cornwall and Isles of Scilly Health Community intranet.When reporting an incident it is important to remember that all details must be factual and personaidentifiable data should only be entered into the appropriate fields of the form it should NOT beentered into free text areas.Appendix E gives screen shots showing how to access DATIX- webIf it is not possible to access the web-browser for any reason incidents can be reported using thetelephone incident reporting line (01872 253490) or using a paper form where internet/telephoneaccess are unavailable. All relevant details should be recorded including:Incident description including any injuries/harm/lossLocationPeople AffectedStaff InvolvedName of person reporting the incidentDetails of line manager/supervisor and where appropriate, clinician responsibleWitnesses (and statements where applicable)Immediate action taken4.1 ViolationsWhilst encouraging an open reporting culture with a focus on systems analysis whichmoves us from blaming individuals, it is important to recognise there may be cases where itbecomes clear an individual has deliberately violated systems or processes resulting in anadverse incident. In such cases appropriate disciplinary procedures will be followed asappropriate.Staff should refer to PCH “Whistleblowing policy” for guidance on what to do if they haveconcerns regarding a colleague’s behaviour.4.2 Reporting Incidents AnonymouyslyPeninsula Community Health’s Incident Reporting System (DATIX) allows staff to reportincidents anonymously if they wish to and PCH recognises that staff may wish to do this,despite efforts by the PCH to establish and embed a culture of fair blame, openness andhonesty. If a member of staff does report anonymously it is particularly important they giveas much detailed information as possible to allow identification of the location and timing ofthe incident as well as the people involved.5 Incident Investigation5.1 Levels of InvestigationThe following table indicates the levels of action depending on the degree of harm caused:9 of 28

No harm/minimal harmAny immediate actionsnecessary. Ensure DATIXincident report completed.Report to external agencies asrequired.Investigation at local level byimmediate manager/ supervisor.Learning shared acrossorganisation as appropriateModerate/severe harmAny immediate actionsnecessary. Ensure DATIXincident report completed.Consider need to report as SUIReport to external agencies asrequired.Investigation within departmentby manager/ supervisor, possiblywith input from local managersand/or ‘specialists’ from otherteams.DeathAny immediate actions necessary.Report on DATIX immediately,internally and to external agenciesas required, including reporting asa significant untoward incident(section 6) if appropriate.n Investigation and root causeanalysis by Manager involvingspecialists as appropriate.Report outcomes to Directorresponsible for area and learningshared across organisation asappropriate.5.2 RecordsContemporaneous records must be made throughout the incident management processand investigation should take place as soon as possible after the events to ensure recall isas accurate as possible.5.3 TimescalesDATIX has a timeframe built into the system based on blocks of 7 days for any part of theprocess e.g. report to investigation commencing, completion of investigation, approval andclosure. Where the activity goes past 7 days the system will mark the incident as overdue.Realistically all reports should be opened by the investigating manager as soon as possiblepreferably within 48 hours.5.4 Simple investigationsSimple investigations should be completed as near to the 7 day period as possible but it ismore important to have a thorough, proportionate and well conducted investigation eventough it goes over the seven days. Where it is not possible to complete the investigationwithin the 7 day period, the incident report should be update to make it clear why theinvestigation is ongoing and what actions are planned to bring it to conclusion.The collection and analysis of all facts surrounding the incident should be completed beforeany conclusions are made regarding the cause.It is important to focus on the true purpose of the investigation, that of learning andpreventing recurrence, Root Cause Analysis techniques can be used for all incidentinvestigations, and will be used for all amber and red incidents and SUIs, as an effectivemethod of focussing attention on learning.The Incident Decision Tree has been created by the NPSA (see references section) to helpNHS managers and senior clinicians decide whether they need to suspend (exclude) staffinvolved in a serious patient safety incident and to identify appropriate managementaction. The aim is to promote fair and consistent staff treatment within and betweenhealthcare organisations.The Incident Decision Tree is a web-based tool and is simple to use. Depending on thenature of the incident and the amount of information gathered, it usually takes 30 to 6010 of 28

minutes to work through. It can be accessed via the NPSA website in the patient safetysection under “Alerts, directives, tools and guidance”.6 Root Cause AnalysisApplying root cause analysis techniques offers an effective method for understanding the problemsassociated with management systems in order to improve safety within the organisation.It is imperative that the organisation understands the reasons behind the incident occurring so thatsuch events can be reduced or controlled. Simply stating that, for example, a member of staffmade a mistake and sending them on a training course is not sufficient, as while that may preventthat particular staff member making the same mistake again, it does not address the broaderissues. For example, there may have been inadequate initial training, if so why was it inadequateand how many other staff also had inadequate training, was the training quality assessed at thetime, is it mandatory/is attendance checked etc? The identification of root causes is the key toproblem solving and continued quality improvement.Establishing the root cause of such unplanned and undesirable events can be a very simpleprocess and should be used for investigating any incident graded amber or red and all seriousincidents requiring investigation but it may also be useful for yellow and green incidentinvestigations should the manager feel a more thorough investigation is required.By working backwards, starting from the incident itself, a timeline of events should be constructed,highlighting all the potential points when the incident could or should have been prevented andlooking at why it was not prevented.All possible contributory factors relating to this should be examined. For example:environmenttrainingproceduresequipmenthuman and team behaviour (including patient, staff and visitors)organisational processes/cultureThe next step is then to make recommendations and take action to improve the chances of asimilar incident being prevented. This is done by adding additional points at which the incidentcould have been prevented, or by strengthening existing points.The National Patient Safety Agency has developed a Root Cause Analysis (RCA) Toolkit andeLearning Programme (RCA Toolkit) as a tool for guiding NHS staff through the process ofconducting an RCA investigation. The RCA Toolkit is supplied free of charge to NHS staff and canbe accessed via http://www.npsa.nhs.uk/patientsafety/improvingpatientsafetyStaff are advised to use the NPSA toolkit for guidance, particularly if they are yet to undergo rootcause analysis training.Advice on undertaking a root cause analysis is available from the Head of Governance.The National Patient Safety Agency (NPSA) website provides further information and resources inrelation to incident reporting, ‘Being Open’ and root cause analysis: www.npsa.nhs.uk.11 of 28

7 External Stakeholder NotificationThere are some incidents which require reporting to external agencies, such as RIDDOR and theMHRA (see next section). However, it may also be necessary and/or helpful to involve suchagencies in the investigation of some incidents and this should be considered as early on in theinvestigation as possible in order to gain maximum benefit from the process. If anotherorganisation has been involved the incident or in the lead up to or aftermath of the incident thenthey should be approached for at least their own incident report or information, in some cases ajoint investigation may be undertaken, for example an incident involving the transfer of a patientfrom one care provider to another or where the HM Coroner is involved.The decision to involve and contact an external agency should be made by the incident managerusuallythe matron or senior manager – and should follow appropriate discussion with their linemanager or Director when necessary.8 Reporting to External Agencies8.1 National Patient Safety Agency (NPSA)The National Patient Safety Agency is a Special Health Authority with the role to coordinatethe efforts of all those involved in healthcare so we can identify and learn frompatient safety incidents including near misses. The NPSA defines a patient safety incidentas: “any unintended or unexpected incident which could have or did lead to harm for one ormore patients receiving NHS funded healthcare.”As well as making sure incidents are reported, the NPSA is aiming to promote a more openand just culture across the NHS.Peninsula Community Health DATIX Administrator will upload patient incident data to theNPSA’s National Reporting and Learning System (NRLS) on at least a fortnightly basis.8.2 Reporting of Injuries, Diseases and Dangerous Occurrences (RIDDOR)Under the Reporting of Injuries, Diseases and Dangerous Occurrences Regulations 1995,(RIDDOR), Peninsula Community Health has a legal duty to formally notify the Health andSafety Executive (HSE) with details of certain incidents that occur in the course of workactivities.Reporting is undertaken by the Matron/Clinical Manager/Manager, and a copy of theRIDDOR form should be forwarded to the Health & Safety Manager with the DATIXincident reference number clearly annotated at the top of the page. The DATIX recordshould also reflect the fact a RIDDOR report has been instigated.RIDDOR reporting should take place immediately for deaths, serious injuries anddangerous occurrences and within 10 days for over three-day absence from work for staffinjured in a work-related incident.8.2.1 To Report a RIDDOR Incident:Telephone - 0845 3009923Internet - by completing the relevant form on the RIDDOR website (www.riddor.gov.uk)Form - by completing the relevant hard copy form and sending by Fax - 0845 3009924By post to:Incident Contact CentreCaerphilly Business ParkCaerphillyCF83 3GG12 of 28

Should staff be uncertain as to the need for a RIDDOR report, the Health & SafetyManager can provide guidance.Incidents Reportable to the HSE under theReporting of Injuries, Diseases and Dangerous Occurrences Regulations 1995 (RIDDOR)a) Death.b) Major Injury.c) A person not at work suffers an injury/major injury as a result of an accident arising out of or inconnection with work and is taken to hospital for treatment in respect of that injury.d) Any dangerous occurrence (defined below).The following injuries must be reported as soon as practicable, and a report sent to the relevantenforcing authority within 10 days on the approved form;where a person is incapacitated for work of a kind which he might reasonably be expected to do, formore than three consecutive days (excluding the day of the accident but including days which wouldnot have been working days), because of an accident arising out of or in connection with work.Where an employee, as a result of an accident at work, has suffered an injury reportable under 1 (a)-(d) above, which is the cause of his death within one year from the date of the accident, the employershall inform the relevant enforcing authority in writing of the death as soon as it comes to hisknowledge, whether or not it was previously reported.Diseases that are due to physical agents and physical demands of the work, infection due to biologicalagents (e.g. cleaning agents) and conditions due to substances, any case of disease relating to the jobactivity should be referred to the occupational health department. Deaths or injuries, which arise frommedical treatment or examinations, carried out by a registered medical practitioner must be reported tothe Trusts Executive Office.A Major Injury (see above) is defined as:a) Any fracture (not fingers or toes)b) Any amputationc) Dislocation of the shoulder, hip, knee or spined) Loss of sight (whether temporary or permanent)e) A chemical or hot metal burn to the eye, or any penetrating injury to the eyef) Any injury from an electric shock or electric burn leading to unconsciousness or requiringresuscitation or admission to hospital for more than 24 hoursg) Any other injury leading to hypothermia, heat-induced illness, or unconsciousness, or requiringresuscitation, or admission to hospital for more than 24 hoursh) Loss of consciousness caused by asphyxia or by exposure to a harmful substance or biologicalagenti) Acute illness or loss of consciousness caused by the absorption of any substance by inhalation,ingestion or through the skinj) Acute illness resulting from exposure to a biological agent or its toxins or infected material.Dangerous occurrences include incidents involving the collapse or overturning of lifting machinery (orthe failure of any load-bearing part), the failure of pressure systems, electric short circuits or overloadswhich result in the stoppage of plant for more than 24 hours, incidents involving explosives, release orescape of biological agents, malfunctioning of radiation generators, malfunctioning of breathingapparatus while in use or being tested prior to use, the collapse of scaffolding, the collapse of abuilding or structure, an explosion or fire, the escape of flammable substances, and the escape of anysubstances likely to cause injury, death or any other damage to the health of any person13 of 28

8.3 NHS Litigation AuthorityThe National Health Service Litigation Authority (NHSLA) requires notification of any staffincident that results in over 10 days sickness absence period, fatal injuries, amputation toany limb, head injury and likely HSE prosecution. Managers/Supervisors should informthe Head of Governance of any such incidents as the Head of Governance reports to theNHSLA on behalf of Peninsula Community Health.8.4 Medical Devices AgencyThe Medical Devices Agency (MDA) must be notified where medical equipment is involvedin an incident leading to, or potentially leading to:DeathLife threatening illness or injuryDeterioration in healthTemporary or permanent impairment of body function or damageThe necessity for surgical or medical intervention to prevent permanent damage tobody function or structure.Unreliable test results leading to inappropriate diagnosis or therapy.Notification should occur before any repairs/modifications are made to the medical device.Manufacturers should not be allowed to inspect such equipment until permission has beengranted by the MDA. Where circumstances allow, medical devices should be removedfrom the department. If equipment cannot be moved due to size, fixtures etc., it must beclearly labelled and staff notified of the problem.Responsibility for MDA reporting lies with the Manager/Supervisor, who should liaise withCHESS and inform the Head of Governance that this has been done.8.5 Serious Hazards of Transfusion (SHOT) reporting.SHOT is a confidential, voluntary reporting system for serious adverse events followingtransfusion of blood components, these include (and are not limited to) giving the wrongblood to the patient, Transfusion transmitted infections and acute or delayed haemolytictransfusion reaction including anaphylaxis. All transfusion related incidents and nearmisses should be reported following the Peninsula Community Health procedures and alsoreported to the Blood Laboratory of the acute Trust providing the service who will report thecase to SHOT as appropriate.8.6 Ionising Radiation (Medical Exposure) Regulations (IRMER) 2000.As part of the regulation process, hospitals and other users of medical radiation arerequired to notify the Healthcare Commission of incidents where patients are exposed tolevels of radiation “much greater than intended”. For more information on IRMERregulations visit www.cqc.org.uk8.7 Information CommissionerSerious breaches of data protection/information governance, as defined in Section 7.1.4should be reported to the Information Governance Lead (Head of Governance).8.8 NHS Counter Fraud & Security Management ServicePeninsula Community Health will report all instances of violence and aggression against it’sstaff by patients or members of the public to the NHS Counter Fraud & Security14 of 28

Management Service. This will take place through the Peninsula Community Health LocalSecurity Management Specialist.9 Incident Grading And Subsequent ActionsAll incidents are graded by the investigating officer/handler based on actual severity of impact andlikelihood of recurrence using the descriptions below (from PCH Guide to Risk Assessment).DATIX will provide the final risk grading.Appendix 2 gives PCH’ guidance on deciding the impact and likelihood scores and also showshow these scores provide an incident grade of green, yellow, amber or red.The following table indicates the levels of action required for the different grades of incident:No harm/minimal harmAny immediate actionsnecessary. Ensure DATIXincident report completed.Report to external agencies asrequired. Investigation at locallevel by immediatemanager/supervisor. Learningshared across organisation asappropriateModerate/severe harm:Any immediate actions necessary.Ensure DATIX incident reportcompleted.Report to external agencies asrequired. Investigation withindepartment by manager/ supervisor,possibly with input from localmanagers and/or ‘specialists’ fromother teams.Results reported to Directorresponsible for area and learningshared across organisation asappropriate.DeathAny immediate actions necessary.Report immediately, internally andto external agencies as required,including reporting as asignificant untoward incident(section 6) if appropriate.Investigation and root causeanalysis by Manager involvingspecialists as appropriate.Report outcomes to Directorresponsible for area and learningshared across organisation asappropriate.Following investigation, the grading of the incident should be re-visited and amended asappropriate to ensure an accurate representation of the situation.9.1 Adding risks highlighted by an incident investigation to the Risk Register.Incidents and their investigations can often highlight areas of concern which cannotimmediately be addressed. For example there may be a need for additional staffing or achange in a care pathway. While these actions are being considered, there is a risk asimilar incident could occur. This risk should be assessed using PCH Guide to RiskAssessment. The assessment should be shared with the relevant teams and managersand also sent to the Head of Governance.10 Public CommunicationsSometimes Peninsula Community Health may wish to seek the involvement of the media inincident management, for example where there may be a recall, or a public health concern.Peninsula Community Health may also wish to work closely with the media to ensure the incidentevents and PCH actions are accurately reflected.The Communications team in PCH will co-ordinate all media relations as necessary/ appropriate inline with PCH Communications Strategy and will maintain contemporaneous records of all contactand information shared with the media.15 of 28

If a staff member is contacted by the media regarding an incident they should refer them to theCommunications team on 01726 62794211 Recommendations and Action PlanningInvestigations should lead to recommendations and action planning to prevent or minimise thelikelihood of a similar incident occurring in the future. These action plans should include details ofwho is responsible for taking the actions and a date for completion and should be monitored by anappropriate forum. Please see Section 3 for information on which PCH committee or subcommitteemay be appropriate.The ongoing monitoring of incident data by the PCH committees and subcommittees as describedin section 3, will allow the organisation to ensure the recommendations and actions have had theintended affect.12 Support for Patients, Carers, Relatives and othersBeing involved in an incident which is under investigation can be an incredibly stressfulexperience. Communication with the patients and/or relatives, visitors or contractors may need totake place both pre and post investigation of an incident.It is important that patients and/or relatives, visitors or contractors are communicated withregarding an incident before the media become aware.This communication should be undertaken by an appropriate member of staff, which in manycases will be the matron or senior manager. In the case of a serious incident requiringinvestigation it may be agreed that communication should go through the Chief Executive.In all cases communication with patients and/or relatives, visitors or contractors should bedocumented in the incident file and take place as soon as is possible and practicable.Where an investigation is likely to take some time, or is running behind schedule, those involvedshould be contacted to explain this and the reasons for the delay.Please refer to the Peninsula Community Health Being Open Policy for further guidance onPatient/relative/visitor/contractor communication and support.12.1 TimingCommunication with the staff may need to take place both pre and post investigation of anincident. Staff personally involved in the incident, as well as other staff within theorganisation may need to be involved in investigation discussion. This communicationshould be undertaken by an appropriate member of staff, which in many cases will be thematron or senior manager. In the case of a serious incident requiring investigation it maybe agreed that communication should go through the appropriate Director or the ChiefExecutive.12.2 StatementsStatements should be taken as soon as possible after the event to ensure the informationwithin them is as accurate as possible.12.3 Staff supportStaff who have been involved in an incident may require additional support. This couldcome from colleagues, managers and/or possibly from occupational health or anemployment union.16 of 28

Staff should be offered support by their line manager or appropriate manager, withoutprejudice, on an immediate and ongoing basis.Some examples of support for staff include compassionate leave from work, temporarychanges to working hours, responsibilities or location, training opportunities, referral tooccupational health for assessment or counselling.Staff can obtain advice in the event of being called as a witness from the Head ofGovernance who will also liaise with professional advisors as appropriate. In the event thatthe Head of Governance cannot be contacted the Director of Nursing and ProfessionalPractice should be approached.12.4 WhistleblowingPCH has a whistle blowing policy for concerns where the interests of others or of the PCHare at risk. It applies to all staff, whether permanent, agency or bank staff, the staff of oneof the PCH contractors, or a volunteer.13 Link with Incident Management and Complaints ManagementThe PCH Complaints manager will provide the Clinical Quality and Safety Committee withquarterly reports of all PALS contacts and complaints received, analysed in the same way asincidents are analysed. This will allow comparison between PALS contacts, complaints, andincidents to identify ‘hotspots’ for further investigation/support.14 What to Report as a Serious Incident Requiring Investigation (SUI)Some examples of events falling into the above definition include:Please note this is not an exhaustive list and is taken from Section 4 of the Cornwall & Isles ofScilly Serious incident requiring investigation reporting and Monitoring PolicyMajor Incidents/Terrorism and Chemical, Biological, Radiological or Nuclear (CBRN)IncidentsAny circumstance which necessitates the activation of an NHS Trust, Primary CareTrust or wider community Emergency PlanAny act of terrorism is normally covered under the Major Incident Policy and willtherefore have a comprehensive list of definitions. Generally, the following incidentsmust be reported:ooterrorist threats/incidents which include incendiary devices or the use of otherweapons including chemical, biological, radiological or nuclear agents(CBRN)potential or confirmed accidental chemical, biological, radiological or nuclearagents (CBRN) incident.Medico-legal incidents/litigationsuspicion of large scale theft or any incident which might give rise to serious criminalchargeslegal challenges to the hospital or clinic regarding a serious incident requiringinvestigationlegal challenges to the hospital or Department of Health which may affect nationalpolicy17 of 28

impending court hearing or out of court settlement in cases of large scale litigation,including negligence claims (as defined by the NHS Litigation Authority (NHSLA)large scale claims are considered to be those over £250,000);Mortality/Morbidity/Care Incidentsunexpected or unexplained death while in NHS care (including community nursingand health visiting);suspicion of a serious error or errors by a member of staff, primary care contractor orother healthcare contractor;a serious drug error, such as mal-administered spinal injections;the suicide of any person currently in receipt of NHS Mental Health services on or offNHS premises, or who has been discharged from NHS Mental Health Services withinthe last twelve months. Suicide is defined as death:ooowhere there is obvious evidence or strong suspicion of self harm;where the above does not apply initially but emerges later from a clinicalreview of the case, or discussion at the incident monitoring group;where the Coroner’s verdict is suicide (or open verdict);death or injury where foul play is suspected, including abuse or neglect;situations when a patient requires additional intervention(s) as a result of failures inthe diagnosis process;the accidental death of, or serious injury to, a patient, a member of staff, or visitor toNHS or primary care premises, or involving NHS or primary care staff or equipment;significant harm to a vulnerable adult where reported under the Protection ofVulnerable Adults procedures. This could be defined as:oooothe death of a vulnerable adult where abuse or neglect is suspected to be afactor in the death;when a vulnerable adult has suffered significant injuries suspected to be as aresult of abusewhere a vulnerable adult has suffered further harm as a result of a healthcare worker failing to follow procedureswhen a serious case review is to be undertakensignificant harm to a child where reported under the local child protectionprocedures. This could be defined as:ooooa child death where abuse or neglect is suspected to be a factor in the deathwhen a child has suffered significant injuries suspected to be as a result ofchild abusewhere a child has suffered further harm as a result of a health care workerfailing to follow procedureswhen a serious case review is to be undertakenchildren and adults with complex health needs failing to obtain their assessed andagreed packages of health care, thus putting their health at serious riskout of county critical care transfers or any other transfer that could have resulted in aserious incident requiring investigationabuse which has been perpetrated within the remit of the organisation; this may beabuse by a member of staff, visitor or member of the public18 of 28

Safety and Governance Incidentsserious complaints about a member of staff or primary care contractor or any incidentrelating to a staff member where adverse media interest could occurthe exclusion of employed doctors or dentists under the disciplinary procedures thatrefer to ‘High Professional Standards in the Modern NHS: a framework for the initialhandling of concerns about doctors and dentists in the NHS’ (HSC 2003/12)significant disciplinary matters of other staffserious verbal and/or physical aggression, whether involving staff or patients,including that based on ethnicity, gender, sexuality, age, disability or other equalityand diversity issuea serious breach of confidentiality, whether affecting staff or patients; particularlyincidents where personal medical information or data that could lead to identity fraudor have other significant impact on individuals has been lost or has got into the publicdomainserious damage which occurs on the premises of Peninsula Community Health orany incident which results in serious injury to any individual or serious disruption toservices (such as evacuation of patients due to fire)failure of equipment so serious as to endanger life, whether or not injury resultssuspicion of malicious activity, such as tampering with equipmentcircumstances that lead to the provider no longer being able to provide an element ofservice and not reportable through SITREP (such as closure of caseloads to newreferrals)abuse which has been perpetrated within the remit of the organisation; this may beabuse by a member of staff, visitor or member of the publicinformation governance incidents such as the loss or inappropriate release ofsensitive/personal/confidential information which fall into category 3, 4 or 5 below:19 of 28

Category 0 1 2 3 4 5Impact No significantreflection onany individualor body.Media interestvery unlikely.Damage to anindividual’sreputation.Possiblemedia intereste.g. celebrityinvolvedDamage toa team’sreputation.Some localmediainterest thatmay not goDamage to aservicesreputation.Local low keymediacoverage.Damage to anorganisation’sreputation.Local mediacoverage.Damage toNHSreputation.NationalmediacoverageMinor breachofconfidentiality.Only a singleindividualaffected.Potentiallyseriousbreach. Lessthan 5 peopleaffected orrisk assessedas low e.gfiles wereencryptedpublicSeriouspotentialbreach andriskassessedhigh e.g.unencryptedclinicalrecords lost,up to 20peopleaffected.Seriousbreach ofconfidentialitye.g up to 100peopleaffectedSerious breachwith eitherparticularsensitivity e.g.sexual healthdetails, or up to1000 peopleaffected.Seriousbreach withpotential forID theft orover 1000peopleaffected.Health Protection (Major Outbreaks/Serious Incidents of Communicable Disease)Any circumstance which necessitates the action of an NHS Trust, Primary Care Trust orwider community in relation to a major outbreak or serious incident of a communicabledisease. This includes:outbreaks of infection which involve presumed transmission within hospital(acute, community) and:cause significant morbidity/mortality such as salmonella outbreak in a hospitalwardimpact significantly on hospital activity such as outbreak of viralgastroenteritis necessitating ward closures and resulting in restrictions ofhospital activityinfected health care workers/patients - incidents that necessitateconsideration of a look-back exercise. This will involve diseases such asTuberculosis (TB), variant Creutzfeldt-Jacob Disease (vCJD) and blood-borneinfections such as Human Immunodeficiency Virus (HIV), Hepatitis B Virus(HBV), Hepatitis C Virus (HCV);serious breakdown of infection control procedures with actual or potential forcross infection such as failure of sterilisation cycle or hospital-acquiredLegionnaires diseaseThe diagnosis of a single case of an unusual infectious illness, which mightindicate a deliberate release by a terroristFor further guidance please see the Health Protection Agency ‘Plan forDealing with a Major Outbreak/Serious Incidents of Communicable Disease’documentFrom February 2007, the Department of Health requires all Acute Trusts toreport each case of Methicillin-Resistant Staphylococcus Aureus (MRSA)bacteraemia as a serious incident requiring investigation. The mechanism forthis is separate from the STEIS system and requires the completion of an e-20 of 28

mail reporting proforma which is then sent to the designated lead (NurseConsultant Infection Control) for Peninsula Community Health are informedby the Acute Trusts of any Pre-48 hr MRSA Bacteraemia case. PCH willundertake an investigation using Root Cause Analysis techniques.Media Issues.matters likely to attract interest from local, regional or national newspapers,TV or radio;all incidents reported to or involving the police, which are considered seriousor may have adverse media interest;any Health and Safety Improvement Notices or convictions being served uponPeninsula Community Health;matters involving high profile patients likely to attract media interest;any other sudden unexpected incidents: including apparently trivial incidentswhich lead to something more serious including those which could attractmedia attention;cancellation of surgery by Peninsula Community Health, on more than threeoccasions.14.1 How to Report a Serious Incident (SUI) – Who And HowThe flowchart below details how to report a serious incident requiring investigation.It may be necessary to inform all staff and/or patients of a potential incident whichcould affect their safety. This should be done via the Communications Team.14.1.1 Grading IncidentsAll incidents should be graded as 0, 1 or 2 in accordance with grading definitionsstated within the National Framework.Incident grades should be agreed with the Commissioning Primary Care Trust(PCT) for grade 1 incidents and the Commissioning Primary Care Trust andStrategic Health Authority (SHA) for grade 2 incidents. The grading of the incidentshould be entered on the ‘further information’ section of STEIS;21 of 28

Peninsula Community HealthSERIOUS INCIDENT REQUIRING INVESTIGATION REPORTING FLOWCHARTIncident Occurs which could be a Serious incident requiring investigation according toguidance in Section 7 of the Incident Management Policy including Serious incident requiringinvestigationsTake immediate action asappropriate such as contactingambulance, police etcReport immediately to LineManager/Person in Charge.Follow usual incidentreporting route of recordingon DATIXLine Manager/Person in Charge reports immediately to Service Manager/SeniorManager (using on call arrangements if out of hours)Service Manager/Senior Manager assesses situationNot a SUI Confirms SUI status Remains uncertain regardingSUI statusManage as perIncidentManagementPolicyDirectorconfirmsthis isnot an SUIContacts Director/Deputy Director(or Director on call if out of hours)Director/Deputy Director confirms SUI statusInformsCommunicationsTeamAppointsInvestigatingOfficerInformsChiefExecutiveInforms Head ofGovernanceCo-ordinate allmedia relations asnecessary in linewith the PeninsulaCommunity HealthCommunicationsStrategy.Undertakesinvestigation, usingRoot CauseAnalysis techniques.Provides updatesand final report toDirector/DeputyDirector and toHead ofGovernanceWill providereports andsummaries toand ClinicalQuality andSafetyCommitteeand, asrequested, tothe BoardReports SUI to thecommissioner (viaSTEIS system, in linewith PCT SUI reporting& monitoring policy)within 24 hours ofincident being confirmedas a SUI.Maintains overview ofinvestigation andoutcomes and updatesSTEIS as required.NB. Clear, contemporaneous records should be kept of all actions taken. Reporting an incident as a SUI doesnot replace ‘normal’ incident reporting systems in place within the PCT, and does not replace the duty to informthe Police and other authorities, such as Social Services, where appropriate.22 of 28

Incidents should be graded and managed in accordance with the NPSA Framework 2010 asshown in the table below:Grade 0Action requiredNotification only - it is unclear if a serious incident has occurred.The provider organisation must update the PCT/SHA with further information within three working daysof a grade 0 incident being notified.If within three working days it is found not to be a serious incident, it can be downgraded with theagreement of the accountable SHA/PCT.If a serious incident has occurred it will be regraded as a grade 1 or 2Action requiredMonitoring requiredExamples of casesGrade 1Commissioning PCT’s willmonitor the case and reportfindings, recommendationsand associated action plans tothe SHA.SHA will monitor progress on aquarterly basis with PCTunless earlier discussion isrequired or the serious incidentis regraded.Comprehensive InvestigationRoot Cause Analysis (RCA)required (level 2 Investigation)Local monitoring The PCT and/or SHA will closethe incident when it is satisfiedthe investigation,recommendations and actionplan are satisfactory, and localmonitoring arrangements are inplace and working efficiently. Publish incident details withinAnnual ReportsTimescales: Up to 45 workingdays/9 weeks from the datethe incident is notified to thePCT/SHA.Mental Health – deaths inthe community*HCAI outbreaksAvoidable/unexplaineddeath Mental health –attempted suicides asinpatients*Ambulance servicesmissing target for arrivalresulting in death/severeharm to patientData loss and informationsecurityGrade 3 pressure ulcerdevelopsPoor discharge planningcauses harm to patient23 of 28

Action requiredMonitoring requiredExamples of casesGrade 2Case will be monitored by theSHA/PCT/LA in conjunctionwith the provider organisation.The SHA will review findings,recommendations andassociated action plans.For Never Events, thecommissioning PCT will beobliged to monitor overallnumbers and actions andreport these in its annualreporting arrangementsComprehensiveInvestigation (RCA level 2investigation)(as above) or IndependentInvestigation (RCA level 3Investigation)*SHA/PCT monitoring Incidents leading to anindependent investigation orinquiry or those considered highrisk will continue to bemonitored by the SHA/PCT orLocal Authority until evidence isprovided that each action pointhas been implemented.Incidents involving adult or childabuse are referred to localsafeguarding arrangements Publish quarterly reportsTimescales: For IndependentInvestigations allow up to 26weeks/6 months for completion ofinvestigation. Extensions can begranted on an individual case-bycasebasis by the SHA/PCT.Maternal deathsInpatient suicides (includingfollowing absconsion)*Child protectionData loss and informationsecurity (DH Criteria level3-5)Never EventsAccusation of physicalmisconduct or harm ismadeHomicides following recentcontact with mental healthservices** Mental Health incidentsshould refer to DH guidance:Independent investigation ofadverse events in mental healthservices24 of 28

14.2 The investigation and final reportThe investigation and final report with recommendations for a serious incidentrequiring investigation should be completed as soon as possible and there is anexpectation that completion will be within 60 days of the incident. All final reportsfrom SUI’s are to be sent to the Head of Governance and there is a requirement toprovide an update every fourteen days until the completion of the investigation. TheHead of Governance will provide support and guidance in regard to the investigationprocess if requiredSerious incidents should only be closed on STEIS following the receipt of a robustinvestigation report that has been generated following a full root cause analysis. Asa minimum, reports should include:root cause(s);lessons learned;have a time-bound action plan.15 Never eventsThe National Patient Safety Agency define Never events as:"Never events" are very serious, largely preventable patient safety incidents thatshould not occur if the relevant preventative measures have been put in place. To bea “never event”, an incident must fulfil the following criteria;The incident has clear potential for or has caused severe harm/death.There is evidence of occurrence in the past (i.e. it is a known source of risk).There is existing national guidance and/or national safety recommendationson how the event can be prevented and support for implementation.The event is largely preventable if the guidance is implemented.Occurrence can be easily defined, identified and continually measured.”The 2011 list of events considered Never Events is shown at Appendix D. All reportableNever Events are Serious Incidents Requiring Investigation and should one occur, the SUIprocedure outlined in the flowchart above must be followed.16 Management of Serial IncidentsA serial incident is one where multiple enquiries by patients/public/media are anticipated forexample where a member of staff has been found to be carrying an infectious disease whichcould have impacted many patients. Guidance on managing such incidents can be found inthe Major Incident Policy.25 of 28

17 Performance Management and Data CollectionReported incidents will be formally analysed quarterly considering incidence by category,location and severity and comparisons made to preceding quarters and years. Analysis willbe both qualitative and quantitative in nature, and discuss any trends that have beenidentified as a result of investigations and any themes/trends relating to causal factors.Changes in practice as a result of incidents will be includedSerious incidents requiring investigation will be analysed and learning and changes made asa result of the investigation will be identified.18 Reports to Committees and the BoardThe Clinical Quality and Safety Committee will receive the analysis of incidents on aquarterly basis, bi-monthly for SUIs. It will monitor progress towards achievement of actionsplanned following severe and Serious incidents requiring investigation (action plans for lesssevere incidents will be monitored through the Locality structure) and the impact these haveon incident reduction/trends.The Committee will also receive a Complaints report analysed in the same manner to allowconsideration, comparison and aggregation of incidents and complaints.Through shared membership and notes of meeting, the Clinical Quality and SafetyCommittee will report key incident information to the Board to ensure this informs thecorporate decision making and strategy formulation19 Learning from Experience and Sharing Lessons LearntSharing the lessons learnt through an incident and its investigation is a critical part ofincident management.As set out in Section 25, anonymised incident data, both quantitative and qualitative, such asnumbers, themes and trends, as well as the outcomes of investigations including causes andrecommendations will be analysed and reported to the Clinical Quality and SafetyCommittee by the Head of Governance to highlight any patterns and uncover any need forfurther intervention. Serious incident requiring investigation themes and learning will also bereported to the PCH Board.Learning will, as indicated in the NPSA National Framework 2010, be shared by managersthrough team meetings, staff briefings, newsletters and all user emails where appropriate, toensure the lessons are communicated not just to those directly affected by the actions, but toother groups who may be able to adapt the learning to suit their own services and needs.20 Risk Management Strategy Implementation20.1 Implementation & DisseminationRegular briefings will be provided by the Datix Administrator and circulated byCommunications reminding staff to report incidents using the datix system. Allstaff should be informed of incident reporting at induction or at their firstappraisal.26 of 28

20.2 Training and SupportReporting Guides have been developed to assist staff and are available from theDatix Administrator or from the internet site. Those required to investigateincidents using the DATIX System will be provided with training by the DATIXAdministrator. Training needs in relation to specific investigation techniques willbe identified through appraisal and provided by the organisation.20.3 Document Control & Archiving ArrangementsOnce ratified, this policy will be loaded to the documents library. Any previousversions will be electronically archived by the Policy Administrator in theelectronic Policy Drive Archive Folder.A signed hard copy of the policy will be forwarded to the Policy Administrator andan electronic copy will be saved by the Policy Administrator in the electronicPolicy Drive. Further copies of current and archived policies can be obtainedfrom the Policy Administrator including versions in large print, Braille and otherlanguages.20.4 Equality Impact AssessmentPeninsula Community Health aims to design and implement services, policies andmeasures that meet the diverse needs of our service, population and workforce,ensuring that none are placed at a disadvantage over others.As part of its development, this strategy and its impact on equality have beenassessed. The assessment is to minimise and if possible remove anydisproportionate impact on employees on the grounds of race sex, disability, age,sexual orientation or religious belief. No detriment was identified.21 Process for Monitoring Effective ImplementationCompliance with the processes outlined in this document will be identified by comparison ofcomplaints and incident data, completion of DATIX and by notes of meetings.All SUI investigations will be reviewed by the Head of Governance.The Head of Governance will also randomly select incidents from DATIX to review thequality of the investigation, documentation and action planning.22 Associated DocumentationThis policy should be read in conjunction with the following polices and guidance pertainingto:ooooooooRisk management strategyComplaints managementClaims managementInvestigation and root cause analysisMajor incidentBeing openSupport for staffTraining needs analysis27 of 28

23 Referenceso Data Protection Act 1998o Freedom of Information Act 2000o National Framework for Reporting and Learning from Serious Incidents RequiringInvestigation. (2010)o National Reporting and Learning Service (NRLS) Data Quality Standards: Guidancefor Organisations Reporting to the Reporting and Learning System (RLS). (2009)o Never Events: Framework – Update for 2010/11: Process and action for PrimaryCare Trusts. (2010)o Seven Steps to Patient Safety in Primary Care Trusts. (2006)o Medical Error: What to do if things go wrong: A guide for junior doctors. (2010)o Patient Safety Alert: Update. WHO Surgical Safety Checklist. (2009)o Being open: Saying sorry when things go wrong. (2009)oooooPatient Safety Alert. Being Open: Communicating with patients, their families andcarers following a patient safety incident. (2009)‘Root Cause Analysis (RCA) report-writing tools and templates’. NPSA list ofresourcesDepartment of Health. (2004). Memorandum of understanding: Investigating patientsafety incidents involving unexpected death or serious untoward harm: A protocol forliaison and effective communications between the National Health Service,Association of Chief Police Officers and Health and Safety Executive. London:Department of Health. Available at: www.dh.gov.uk and www.acpo.police.ukHealthcare Commission (HCC). (2008). Learning from investigations. London:Commission for Healthcare Audit and Inspection. Available at: www.cqc.org.ukHealthcare Commission (HCC). (2009). Safe in the knowledge: How do NHS trustboards ensure safe care for their patients. London: Commission for Healthcare Auditand Inspection. Available at: www.cqc.org.uko Patient Safety First. (2009). The ‘How to Guide’ for Implementing Human Factors inHealthcare. London: Patient Safety First. Available at: www.patientsafetyfirst.nhs.uko Department of Health February (2011) The "never events" list 2011/12http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/documents/digitalasset/dh_124580.pdfo National Patient Safety Agency, ‘Never Events – Framework: Update for 2010-11’.http://www.nrls.npsa.nhs.uk/resources/?entryid45=6851828 of 28

Appendix A – Sample Investigation Report TemplateComprehensive and Independent Investigation Report Template (NPSA 2010). A ConciseInvestigation Report Template is also available.The full guide can be found at www.npsa.nhs.uk/nrls alongside the ‘Root Cause Analysis (RCA)toolkit’ Online tool (NPSA).Comprehensive and Independent Investigation Report Template See associated NPSA quick ref. guide, or the more detailed RCA investigation report writingguidance. Save the document with the chosen file name. Always include a version number in thefilename. On completion ensure all guidance (in green) is deleted.[Add trust logo]Root Cause Analysis Investigation ReportIncident Investigation Title:Incident Date:Incident Number:Author(s) and Job TitlesInvestigation Report Date:incident management policy 2011 with SUI v3 FINAL 31/51

ContentsExecutive Summary 33MAIN REPORT: 34Incident description and consequences 34Pre‐investigation risk assessment 34Background and context 34Terms of reference 34Level of investigation 35Involvement and support of patient and relatives 35Involvement and support provided for staff involved 35Information and evidence gathered 35FINDINGS: 36Chronology of events 36Detection of incident 36Notable practice 36Care and service delivery problems 36Contributory factors 36Root causes 36Lessons learned 36Post‐investigation risk assessment 36CONCLUSIONS: 36Recommendations 37Arrangements for Shared Learning 37Distribution List 37Appendices 37Action Plan 37incident management policy 2011 with SUI v3 FINAL 32/51

Executive SummaryComplete this summary AFTER the main report has been written. This forms an important précis of the report.Brief incident description:Incident date:Incident type:Healthcare Specialty:Actual effect on patient and/or service:Actual severity of incident:Level of investigation conductedInvolvement and support of the patient and/or relativesDetection of the incidentCare and service delivery problemsContributory factorsRoot causesLessons learnedRecommendationsArrangements for sharing learningincident management policy 2011 with SUI v3 FINAL 33/51

MAIN REPORT:Incident description and consequencesIncident description:Incident date:Incident type:Specialty:Actual effect on patient:Actual severity of the incident:Pre‐investigation risk assessmentAPotential severity(1-5)BLikelihood of recurrenceat that severity (1-5)CRisk rating(C = A x B)Background and contextAdd text hereTerms of referenceGuide provided below. Amend this to build your own. Add only a summary to the body of thereport.Purposeo identify the root causes and key learning from an incident and use this information to significantlyreduce the likelihood of future harm to patientsObjectivesTo establish the facts i.e. what happened (effect), to whom, when, where, how and why(root causes)To establish whether failings occurred in care or treatmentTo look for improvements rather than to apportion blameTo establish how recurrence may be reduced or eliminatedTo formulate recommendations and an action planincident management policy 2011 with SUI v3 FINAL 34/51

To provide a report and record of the investigation process & outcomeTo provide a means of sharing learning from the incidentTo identify routes of sharing learning from the incidentKey questions/issues to be addressed...specific to this incident or incident typeKey DeliverablesInvestigation report, action plan, implementation of actionsScope (investigation start and end points)Investigation type, process and methods usedSingle or multi-incident investigationGathering information, e.g. InterviewsIncident mapping, e.g. Tabular timelineIdentifying care and service delivery problems, e.g. Change analysisIdentifying contributory factors and root causes, e.g. Fishbone diagramsGenerating solutions, e.g. Barrier analysisArrangements for communication, monitoring, evaluation and actionInvestigation commissionerInvestigation teamNames, roles, qualifications, departmentsResourcesInvolvement of other organisationsStakeholders/audienceInvestigation timescales/scheduleLevel of investigationAdd text hereInvolvement and support of patient and relativesAdd text hereInvolvement and support provided for staff involvedAdd text hereInformation and evidence gatheredAdd text hereincident management policy 2011 with SUI v3 FINAL 35/51

FINDINGS:Chronology of eventsChronology (timeline) of eventsDate & Time EventDetection of incidentAdd text hereNotable practiceAdd text hereCare and service delivery problemsAdd text hereContributory factorsAdd text hereRoot causesAdd text hereLessons learnedAdd text herePost‐investigation risk assessmentAPotential severity(1-5)BLikelihood of recurrenceat that severity (1-5)CRisk rating(C = A x B)incident management policy 2011 with SUI v3 FINAL 36/51

CONCLUSIONS:RecommendationsAdd text hereArrangements for Shared LearningAdd text hereDistribution ListAdd text hereAppendicesAdd text hereAction PlanSee also ‘Types of Preventative Actions Planned’‐ tool at www.npsa.nhs.uk/rcaAction 1 Action 2 Action 3Root CAUSEEFFECT on patientRecommendationAction to address rootcauseLevel for action(Org, direct, team)Implementation by:Target date forimplementationAdditional resourcesrequired (Time,money, other)Evidence of progress andcompletionMonitoring and evaluationArrangementsSign off - actioncompleted date:Sign off by:incident management policy 2011 with SUI v3 FINAL 37/51

Appendix B – Organisational Risk MatrixConsequence score (severity levels) and examples of descriptorsDomains Negligible (1) Minor (2) Moderate (3) Major (4) Catastrophic (5)Impact on thesafety ofpatients, staffor public(physical/ Minimal injuryrequiring no/minimalintervention ortreatment. No time off work Minor injury or illness,requiring minorintervention Requiring time off workfor less than 3 dayspsychological Increase in length ofharm)hospital stay by 1-3daysQuality/complaints/audit Peripheral element oftreatment or servicesuboptimal Informalcomplaint/inquiry Overall treatment orservice suboptimal Formal complaint(stage 1) Local resolution Single failure to meetinternal standards Minor patient safetyimplications ifunresolved Reduced performancerating if unresolved Moderate injuryrequiring professionalintervention Requiring time off workfor 3-14 days Increase in length ofhospital stay by 4-15days RIDDOR/agencyreportable incident Event impacts on asmall number ofpatients Treatment or servicehas significantlyreduced effectiveness Formal complaint(stage 2) Local resolution (withpotential to go toindependent review) Repeated failure tomeet internalstandards Major patient safetyimplications if findingsare not acted on Major injury leading tolong-termincapacity/disability Requiring time off workfor over14 days Increase in length ofhospital stay by over15 days Mismanagement ofpatient care with longtermeffects Non-compliance withnational standards withsignificant risk topatients if unresolved Multiple complaints/independent review Low performance rating Critical report Incident leading todeath Multiple permanentinjuries or irreversiblehealth effects An event which impactson a large number ofpatients Totally unacceptablelevel or quality oftreatment/service Gross failure of patientsafety if findings notacted on Inquest/ombudsmaninquiry Gross failure to meetnational standardsincident management policy 2011 with SUI v3 FINAL 38/51

Consequence score (severity levels) and examples of descriptorsDomains Negligible (1) Minor (2) Moderate (3) Major (4) Catastrophic (5)Humanresources/organisationaldevelopment/staffing/competence Short-term lowstaffing level thattemporarily reducesservice quality (lessthan 1 day) Low staffing level thatreduces the servicequalityStatutory duty/inspectionsAdversepublicity/reputationBusinessobjectives/projects No or minimal impactor breach ofguidance/ statutoryduty Rumours Potential for publicconcern Insignificant costincrease/ scheduleslippage Breach of statutorylegislation Reduced performancerating if unresolved Local media coverage -short-term reduction inpublic confidence Elements of publicexpectation not beingmet Up to 5 per cent overproject budget Schedule slippage Late delivery of keyobjective/ service dueto lack of staff Unsafe staffing level orcompetence (>1 day) Low staff morale Poor staff attendancefor mandatory/keytraining Single breach instatutory duty Challenging externalrecommendations/improvement notice Local media coverage -long-term reduction inpublic confidence 5–10 per cent overproject budget Schedule slippage Uncertain delivery ofkey objective/servicedue to lack of staff Unsafe staffing level orcompetence (>5 days) Loss of key staff Very low staff morale No staff attendingmandatory/ keytraining Enforcement action Multiple breaches instatutory duty Improvement notices Low performance rating Critical report National mediacoverage with 3 daysservice well belowreasonable publicexpectation. MPconcerned (questionsin the House) Total loss of publicconfidence Incident leading to over25 per cent overproject budget Schedule slippage Key objectives not metincident management policy 2011 with SUI v3 FINAL 39/51

Consequence score (severity levels) and examples of descriptorsDomains Negligible (1) Minor (2) Moderate (3) Major (4) Catastrophic (5)Financeincludingclaims Small loss Risk ofclaim remoteService/businessinterruptionEnvironmentalimpact Loss/interruption ofup to 1 hour Minimal or no impacton the environment Loss of 0.1–0.25 percent of budget Claim less than£10,000 Loss/interruption of upto 8 hours Minor impact onenvironment Loss of 0.25–0.5 percent of budget Claim(s) between£10,000 and £100,000 Loss/interruption of upto1 day Moderate impact onenvironment Uncertain delivery ofkey objective/Loss of0.5–1.0 per cent ofbudget Claim(s) between£100,000 and £1million Purchasers failing topay on time Loss/interruption of upto1 week Major impact onenvironment Non-delivery of keyobjective/ Loss of >1per cent of budget Failure to meetspecification/ slippage Loss of contract /payment by results Claim(s) over £1million Permanent loss ofservice or facility Catastrophic impact onenvironmentincident management policy 2011 with SUI v3 FINAL 40/51

Appendix C Process for Reporting and Learning from Serious UntowardIncidents Requiring InvestigationGuidance for Providers of Services Commissionedby NHS Cornwall & Isles of ScillyIn March 2010 the National Patient Safety Agency published the National Framework forReporting and Learning from Serious Incidents Requiring Investigation. This frameworkdetails how organisations should report, investigate and monitor serious incidents.NHS Cornwall & Isles of Scilly (NHS CIOS) in conjunction with NHS South West hasadopted the framework in full and as such the following guidance should be read alongsidethe National Framework and NHS South West’s Process for Reporting and Learning fromSerious Incidents Requiring Investigation.The National Framework provides clear guidance on a number of milestones to be followedfrom the point at which a Serious Incident Requiring Investigation (SIRI) is identified toclosure of the incident. Details of the key milestones and proposed procedures are includedbelow:1. In all cases incidents should be reported on the Strategic Executive InformationSystem (STEIS) within two working days of identification of the event.2. Guidance on the types of incidents that should be reported can be found in theNational Patient Safety Agency document ‘Information Resource to Support theReporting of Serious Incidents’ available from the National Patient Safety Agencywebsite. Please note this guidance is not exhaustive.3. Incidents should be graded as 0, 1 or 2 in accordance with grading definitions statedwithin the National Framework (Page17). Incident grades should be agreed with theCommissioning Primary Care Trust (PCT) for grade 1 incidents and theCommissioning Primary Care Trust and Strategic Health Authority (SHA) for grade 2incidents. The grading of the incident should be entered on the ‘furtherinformation’ section of STEIS;4. The ongoing monitoring of grade 1 incidents will be monitored by the commissioningPCT. Grade 2 incidents will be monitored by the Commissioning PCT in conjunctionwith the SHA.5. Timescales for investigation will be dependent on the grade of the serious incident.The following timescales will apply:Grade 0 Notification only (it is unclear if a serious incident has occurred). Theprovider organisation must update the PCT/SHA with further information within threeworking days. If not a serious incident, it can be downgraded with agreement ofPCT/SHA. If a serious incident it will be re graded accordinglyGrade 1 45 working days from the date the incident is notified.Grade2 (Those incidents not requiring independent investigation)60 working days from the date the incident is notified.incident management policy 2011 with SUI v3 FINAL 41/51

Grade 2 (requiring independent investigation such as Homicide Investigations) –Internal investigation should be completed within 60 working days from the date ofthe incident. Where an independent investigation is commissioned this should becompleted within 26 weeks from the date of commissioning.6. Serious incidents should only be closed on STEIS following the receipt of a robustinvestigation report that has been generated following a full root cause analysis. Asa minimum, reports should include:root cause(s);lessons learned;have a time-bound action plan.7. Serious incidents can be closed by the Commissioning PCT or the SHA before thecompletion of an action plan if assurance is received of ongoing monitoring ofimplementation. The exception to this is grade 2 incidents where an independentinvestigation has taken place. In these cases, the Commissioning PCT and the SHAwill continue to monitor the action plan and only close the incident once assurancehas been received that all action points have been completed.8. Providers are requested to update the PCT by the 10 th of each month on theprogress of the investigation of each SIRI.Process for the management of grade 2 serious incidentsGrade 2 incidents are defined as:a never event as defined by the National Patient Safety Never Event Framework2010 (Page 37 National Framework) a homicide or any incident falling into the definitions as defined by HRG 96 (27)that require or may require an independent investigation (see section 3 of thissection for further guidance);an inpatient suicide (including following absconsion);adult safeguarding incident;maternal death;child safeguarding incident data loss and information security (Department of Health criteria level 3-5);grade 4 pressure ulcer;accusation of physical misconduct or harm is made;significant media interest;serious failure of screening services where there is a mis-diagnosis or clinicalincident e.g. perforation.incident management policy 2011 with SUI v3 FINAL 42/51

The incident should be reported by the provider organisation to STEIS within twoworking days of the organisation becoming aware of the incident.Where possible the incident will be reviewed by the NHS CIOS the next working day.The provider organisation should complete a 72 hour management report fordistribution to the SHA and Commissioning PCT. Such a report should include thefollowing:- date and location of incident and STEIS identification number;- initials, gender and date of birth of client;- incident type; e.g. Never Event;- brief details leading up to the incident to include care and treatment;- immediate actions taken;- chronology of contacts.The internal investigation should be completed within 60 working days following thereporting of the incident. The completed investigation report will be shared with theCommissioning PCT who will forward the report to the SHA. The SHA andCommissioning PCT will provide feedback and report back to the reportingorganisation within 20 working days.Process for the monitoring of grade 2 incidents such as homicidesThe incident should be reported by the provider organisation to the Commissioning PCT andthe SHA as soon as notification is received, such notification may in the first instance bemade by telephone.The incident should be formally reported to STEIS within two working days of theorganisation becoming aware of the incident.All organisations should ensure that the appropriate communication leads have been notifiedand that media handling processes are in place.The provider organisation should complete a 72 hour report for distribution to the SHA andCommissioning PCT. The report should include:- date and location of Incident and STEIS identification number;- initials, gender and date of birth of client;- incident type; e.g. homicide;- date of first referral and last contact with Mental Health Services;- details of treatment type; e.g. CPA or inpatient treatment status;- brief details leading up to the incident to include care and treatment;incident management policy 2011 with SUI v3 FINAL 43/51

- immediate actions taken;- details of contacts with the victim and perpetrators family and carers;- chronology of contacts.The report should also include details of any contact and agreement with police with regardto next stage investigation. It should not contain the full names of patients, clients, staff orfamilies but use initials and staff titles as appropriate.The SHA and the Commissioning PCT will agree with the provider organisation the terms ofreference for the internal investigation.The internal investigation should be completed within 60 working days. During this time theprovider organisation should regularly update STEIS form with progress and provide a draftreport to the SHA and the Commissioning PCT to enable both organisations to evaluate thereport and give feedback before completion of the final version.The final internal investigation report should include a clearly time-framed action plan thatwill be monitored by the Commissioning PCTs to ensure all actions are completed and thatany problems or root causes identified have been resolved through the action plan.The SHA Homicide Review Group will review the internal investigation report and make aformal decision as to whether to commission an independent investigation.Where an incident meets the requirements for an independent investigation, the SHA willadvise the provider organisation and the Commissioning PCT.The SHA will convene a start up meeting with the provider organisation, the CommissioningPCT, the appointed independent investigation organisation, police liaison officer, localauthority representative and any other key stakeholders.The independent investigators will conduct their investigation in accordance with nationalguidance. The independent investigators will provide monthly updates to the SHA.In accordance with the timeframes in the National Framework for Reporting and Learningfrom Serious Incidents Requiring Investigation, the independent investigation report will beconcluded within 26 weeks/ 6 months from the date of commissioning. Such timeframesmay be adjusted by local agreement.An action plan to address any recommendations made by the Independent Investigationshould be put in place, time-framed and monitored by the Commissioning PCT.In March 2010 the National Patient Safety Agency published the National Framework forReporting and Learning from Serious Incidents Requiring Investigation. This frameworkdetails how organisations should report, investigate and monitor serious incidents.NHS Cornwall & Isles of Scilly (NHS CIOS) in conjunction with NHS South West hasadopted the framework in full and as such the following guidance should be read alongsidethe National Framework and NHS South West’s Process for Reporting and Learning fromSerious Incidents Requiring Investigation.The National Framework provides clear guidance on a number of milestones to be followedfrom the point at which a Serious Incident Requiring Investigation (SIRI) is identified toincident management policy 2011 with SUI v3 FINAL 44/51

closure of the incident. Details of the key milestones and proposed procedures are includedbelow:9. In all cases incidents should be reported on the Strategic Executive InformationSystem (STEIS) within two working days of identification of the event.10. Guidance on the types of incidents that should be reported can be found in theNational Patient Safety Agency document ‘Information Resource to Support theReporting of Serious Incidents’ available from the National Patient Safety Agencywebsite. Please note this guidance is not exhaustive.11. Incidents should be graded as 0, 1 or 2 in accordance with grading definitions statedwithin the National Framework (Page17). Incident grades should be agreed with theCommissioning Primary Care Trust (PCT) for grade 1 incidents and theCommissioning Primary Care Trust and Strategic Health Authority (SHA) for grade 2incidents. The grading of the incident should be entered on the ‘furtherinformation’ section of STEIS;12. The ongoing monitoring of grade 1 incidents will be monitored by the commissioningPCT. Grade 2 incidents will be monitored by the Commissioning PCT in conjunctionwith the SHA.13. Timescales for investigation will be dependent on the grade of the serious incident.The following timescales will apply:Grade 0 Notification only (it is unclear if a serious incident has occurred). The providerorganisation must update the PCT/SHA with further information within three workingdays. If not a serious incident, it can be downgraded with agreement of PCT/SHA. Ifa serious incident it will be re graded accordinglyGrade 1 45 working days from the date the incident is notified.Grade2 (Those incidents not requiring independent investigation)60 working days from the date the incident is notified.Grade 2 (requiring independent investigation such as Homicide Investigations) –Internal investigation should be completed within 60 working days from the date ofthe incident. Where an independent investigation is commissioned this should becompleted within 26 weeks from the date of commissioning.14. Serious incidents should only be closed on STEIS following the receipt of a robustinvestigation report that has been generated following a full root cause analysis. Asa minimum, reports should include:root cause(s);lessons learned;have a time-bound action plan.15. Serious incidents can be closed by the Commissioning PCT or the SHA before thecompletion of an action plan if assurance is received of ongoing monitoring ofimplementation. The exception to this is grade 2 incidents where an independentinvestigation has taken place. In these cases, the Commissioning PCT and the SHAincident management policy 2011 with SUI v3 FINAL 45/51

will continue to monitor the action plan and only close the incident once assurancehas been received that all action points have been completed.16. Providers are requested to update the PCT by the 10 th of each month on theprogress of the investigation of each SIRI.Process for the management of grade 2 serious incidentsGrade 2 incidents are defined as:a never event as defined by the National Patient Safety Never Event Framework2010 (Page 37 National Framework)a homicide or any incident falling into the definitions as defined by HRG 96 (27) thatrequire or may require an independent investigation (see section 3 of this section forfurther guidance);an inpatient suicide (including following absconsion);adult safeguarding incident;maternal death;child safeguarding incident data loss and information security (Department of Health criteria level 3-5);grade 4 pressure ulcer;accusation of physical misconduct or harm is made;significant media interest;serious failure of screening services where there is a mis-diagnosis or clinicalincident e.g. perforation.The incident should be reported by the provider organisation to STEIS within two workingdays of the organisation becoming aware of the incident.Where possible the incident will be reviewed by the NHS CIOS the next working day.The provider organisation should complete a 72 hour management report for distribution tothe SHA and Commissioning PCT. Such a report should include the following:- date and location of incident and STEIS identification number;- initials, gender and date of birth of client;- incident type; e.g. Never Event;- brief details leading up to the incident to include care and treatment;- immediate actions taken;- chronology of contacts.incident management policy 2011 with SUI v3 FINAL 46/51

The internal investigation should be completed within 60 working days following the reportingof the incident. The completed investigation report will be shared with the CommissioningPCT who will forward the report to the SHA. The SHA and Commissioning PCT will providefeedback and report back to the reporting organisation within 20 working days.Process for the monitoring of grade 2 incidents such as homicidesThe incident should be reported by the provider organisation to the Commissioning PCT andthe SHA as soon as notification is received, such notification may in the first instance bemade by telephone.The incident should be formally reported to STEIS within two working days of theorganisation becoming aware of the incident.All organisations should ensure that the appropriate communication leads have been notifiedand that media handling processes are in place.The provider organisation should complete a 72 hour report for distribution to the SHA andCommissioning PCT. The report should include:- date and location of Incident and STEIS identification number;- initials, gender and date of birth of client;- incident type; e.g. homicide;- date of first referral and last contact with Mental Health Services;- details of treatment type; e.g. CPA or inpatient treatment status;- brief details leading up to the incident to include care and treatment;- immediate actions taken;- details of contacts with the victim and perpetrators family and carers;- chronology of contacts.The report should also include details of any contact and agreement with police with regardto next stage investigation. It should not contain the full names of patients, clients, staff orfamilies but use initials and staff titles as appropriate.The SHA and the Commissioning PCT will agree with the provider organisation the terms ofreference for the internal investigation.The internal investigation should be completed within 60 working days. During this time theprovider organisation should regularly update STEIS form with progress and provide a draftreport to the SHA and the Commissioning PCT to enable both organisations to evaluate thereport and give feedback before completion of the final version.The final internal investigation report should include a clearly time-framed action plan thatwill be monitored by the Commissioning PCTs to ensure all actions are completed and thatany problems or root causes identified have been resolved through the action plan.The SHA Homicide Review Group will review the internal investigation report and make aformal decision as to whether to commission an independent investigation.incident management policy 2011 with SUI v3 FINAL 47/51

Where an incident meets the requirements for an independent investigation, the SHA willadvise the provider organisation and the Commissioning PCT.The SHA will convene a start up meeting with the provider organisation, the CommissioningPCT, the appointed independent investigation organisation, police liaison officer, localauthority representative and any other key stakeholders.The independent investigators will conduct their investigation in accordance with nationalguidance. The independent investigators will provide monthly updates to the SHA.In accordance with the timeframes in the National Framework for Reporting and Learningfrom Serious Incidents Requiring Investigation, the independent investigation report will beconcluded within 26 weeks/ 6 months from the date of commissioning. Such timeframesmay be adjusted by local agreement.An action plan to address any recommendations made by the Independent Investigationshould be put in place, time-framed and monitored by the Commissioning PCT.incident management policy 2011 with SUI v3 FINAL 48/51

31. Appendix D Department of Health Never Events List 2011“Never event” Threshold Method ofMeasurementWrong site surgery >0 Review of reportssubmitted to NationalPatient Safety Agency(or successorbody)/SeriousIncidents reports andmonthly ServiceQuality PerformanceReportWrongimplant/prosthesisRetained foreignobject post-operationWrongly preparedhigh-risk injectablemedicationMaladministration ofpotassium-containingsolutions>0 Review of reportssubmitted to NationalPatient Safety Agency(or successorbody)/SeriousIncidents reports andmonthly ServiceQuality PerformanceReport>0 Review of reportssubmitted to NationalPatient Safety Agency(or successorbody)/SeriousIncidents reports andmonthly ServiceQuality PerformanceReport>0 Review of reportssubmitted to NationalPatient Safety Agency(or successorbody)/SeriousIncidents reports andmonthly ServiceQuality PerformanceReport>0 Review of reportssubmitted to NationalPatient Safety Agency(or successorbody)/SeriousIncidents reports andmonthly ServiceQuality PerformanceReportNever EventConsequence(per occurrence)In accordance withapplicable Guidance,recovery of the cost ofthe procedure and nocharge toCommissioner for anycorrective procedureor careIn accordance withapplicable Guidance,recovery of the cost ofthe procedure and nocharge toCommissioner for anycorrective procedureor careIn accordance withapplicable Guidance,recovery of the cost ofthe procedure and nocharge toCommissioner for anycorrective procedureor careIn accordance withapplicable Guidance,recovery of the cost ofthe procedure and nocharge toCommissioner for anycorrective procedureor careIn accordance withapplicable Guidance,recovery of the cost ofthe procedure and nocharge toCommissioner for anycorrective procedureor careincident management policy 2011 with SUI v3 FINAL 49/51

Wrong routeadministration ofchemotherapy>0 Review of reportssubmitted to NationalPatient Safety Agency(or successorbody)/SeriousIncidents reports andmonthly ServiceQualityIn accordance withapplicable Guidance,recovery of the cost ofthe procedure and nocharge toCommissioner for anycorrective procedureor careincident management policy 2011 with SUI v3 FINAL 50/51

Appendix E Accessing DATIX to report a incidentOn the CIOSPCT home page, click‘CHS Incident reporting’ and it will takeyou to the report formYou DO NOT need to log in, justcomplete the formincident management policy 2011 with SUI v3 FINAL 51/51

Initial Equality and Human Rights Impact Assessment (EIA)Part One – Initial Assessment Screening ToolWhen completing this form please refer to the form guide and frequently askedquestions document which is available on the Cornwall and Isles of Scilly PrimaryCare Trust, Community Health Services, Equality webpage’s.Name of the policy or methodology:Incident Management Policy includingSerious Incidents Requiring Investigation (SUI’s)Details of person completing the EIANameDebby BleaseJob TitleGovernance ManagerDirectorate/Programme Board Governance TeamTelephone Number 01726 6276261. Identify the policy or methodology aimsWhat are the main aims, purpose and outcomes of the policy or methodology?This policy aims to ensure that all staff have an understanding of what constitutes an incident, their role and that of other individuals and groups roles within in CIOS CommunityHealth Services in relation to incidents the arrangements for reporting and management of all incidents, including nearmisses and serious incidents requiring investigation.Its purpose it to encourage reporting of all incidents and near misses particularly thoserelating to the safety of patients, staff and others who visit our sites or use our services,to provide the opportunity for learning and improvement through prompt, accurate andappropriate investigation .The desired outcome is that the number of incidents and near misses reportedincreases with a corresponding decrease in the severity of those incidents due tolearning and changes in practice resulting from previous investigations.How does it relate to our role as a service provider and/or an employer?It affects the everyday activity of all staff particularly those delivering/responsible forpatient services.incident policy 2011 Initial Equality and Human Rights Impact Assessment 1/4

2. Assess the likely impact on human rights and equalityUse this table to indicate if the policy or methodology: could have a negative impact on human rights and/or on any of the equality groups, or could have a positive impact on human rights, contribute to promoting equality, equal opportunities or improve relations.Leave the box blank if no impact is predicted.Human RightsEquality & Diversity Protected Characteristics Right to life e.g. decisions about life-saving treatment, deaths throughnegligence in hospitals and care homes Right not to be tortured or treated in an inhuman or degrading waye.g. dignity in care, abuse or neglect of older people or people withlearning disabilities. Right to respect for private and family life e.g. respecting lgbrelationships, confidentiality Right to freedom of thought, conscience and religion e.g. respect forcultural and religious requirements Right to freedom of expression e.g. access to appropriatecommunication aids Right to freedom of assembly and association e.g., right torepresentation, to socialise in residential care settings Right to education e.g. access to basic knowledge of hygiene andsanitationGeneral•••••••RaceSexDisabilitySexual OrientationReligion or beliefAgeGenderReassignmentMarriage & CivilPartnershipPregnancy &Maternity Right to liberty e.g. informal detention of patients who do not havecapacity• Other types of discrimination e.g. employment, harassment, differentialhealth outcomes•incident policy 2011 Initial Equality and Human Rights Impact Assessment 2/4

3. How does it impact on people’s equality, diversity and human rights?Using the table above, explain anticipated impacts. If a full EIA is recommended, you cansummarise the impacts at this point and in more detail in the full EIA.Could the policy or methodology result in a negative impact i.e. inequality or discrimination?Please explain.Could this policy or methodology result in positive impacts on people’s equality, diversity, humanrights? Could it present opportunities to promote equality? Please explain.The policy should have a positive impact for all those using our services across all the protectedcharacteristics and Human Rights by encouraging incidents of all sorts to be reported to facilitatelearning and improvement thus reducing harm and distress, and promoting dignity and safe care4. RecommendationsIs a full EIA recommended? If not, give reasonsNo – no negative impact is predicted across any of the protected characteristics or Human RightsDetails of person completing the EIANameDebby BleaseSigned ……………………………………………………… Date:18 March 2011…………………………………AgreementHead of Function/Business ManagerNameEIA sign-off by CHS Equality & DiversitySub Committee prior to publishingNameSigned ……………………………………………………… Date: …………………………………incident policy 2011 Initial Equality and Human Rights Impact Assessment 3/4

incident policy 2011 Initial Equality and Human Rights Impact Assessment 4/4