Procedure for the Management of Incidents and Serious Incidents

Procedure for the Management of Incidents and Serious Incidents This Procedure outlines the key actions staff should undertake in the management of incident and Serious Incidents occurring in NHS Lambeth CCG. Version: 1.2 Approved by: Effective from: Document Control Integrated Governance Committee agreed approval by Chair s action 7 Feb 2018 Chair s action 6 March 2018 March Date last reviewed: Nov 2017 Date of next view: Nov 2018 Owner: Responsible Lead: Supersedes: Stakeholder Group: Related documents: Location: Una Dalton, Director of Governance and Development Anne Middleton, Assistant Director for Governance and Quality Lambeth CCG Incident Management Policy and Guidance NHS Lambeth CCG Serious Incident Review Group NHS Lambeth CCG Incidents and Serious Incidents Policy; National Serious Incident Framework S:\Lam\CCG\Lambeth CCG Shared Documents\Policies Document History Date Author Comments Approved by: 10/06/16 Pippa Pritchard Changes to Responsible Lead details. SIRG Dec 2017 Reviewed by NEL CSU Reviewed and updated for re-approval by IGSG members IGSG 1

1. Incident reporting procedure 1.1 Notification of an incident (See Appendix 1 for summary) 1.1.1 All incidents involving actual or prevented harm/injury (near miss) should be reported verbally immediately to the reporters line manager, or senior manager if other is not available. 1.1.2 All incidents should be notified using the Datix on-line reporting form (QUIC). The member of staff involved or their team leader will normally complete this within 24 hours of the incident or the next working day if the incident occurred at the weekend or on a bank holiday. 1.1.3 Where an individual thinks that an incident should be reported as a Serious Incident (SI) they should immediately inform their Director, or in the absence of their Director, the on-call Director. The Director then determines whether the incident should be reported as an SI. 1.2. Notification of a CCG Internal Serious Incident: (See Appendix 1 for SI summary) 1.2.1 All Serious Incidents (or potential Serious Incidents) and major incidents must be reported immediately to the Director responsible for the service by the fastest possible means of direct contact. It is the responsibility of the most senior member of staff at the scene to ensure that this is done. 1.2.2 It is the responsibility of the Director responsible for the service to confirm if this is a Serious Incident, ensure that the following are informed within 24 hours and keep a written note including the time of those contacted: Accountable Officer Director of Governance and Development Assistant Director Governance and Quality Governance Manager NHS England (LCCG AD Governance will submit onto STEIS) The Police (if appropriate) NHS Lambeth CCG Communications and NHS England Communications Lead on call for London (if appropriate) Local Authority (if appropriate) Local Safeguarding Lead (adults and children) NHSLA (if appropriate) 1.2.3 The relevant Director will also identify other external agencies that need to be informed of the incident e.g. Medicines and Health Products Regulatory Agency; Health and Safety Executive; Department of Health; Professional Bodies e.g. GMC, NMC (if appropriate). See Appendix 2 for detailed list. 2

1.2.4 The relevant Director should complete an initial briefing including a factual account of events within three working days of the incident occurring. This should be submitted to the Governance and Quality Team. An initial briefing template is found at Appendix 3. 1.2.5 Once this initial report has been reviewed, the Director of Governance and Development will appoint a Lead Director and agree the level of investigation required (see Appendix 4 & 5 and the Serious Incident Framework), Lead Investigator and an investigation team. 1.2.6 Depending on the severity or number of people affected by the incident an SI panel may convened. An SI panel should include the Lead Director, if possible the Accountable Officer, the Director of Governance and Development, the Assistant Director of Governance and Quality and any other relevant person involved in the incident. Consideration should be given to the need for legal advice and whether media interest is likely. 1.2.7 Notification of a Safeguarding Incident (children & adults) A safeguarding concern which may or does progress to a single agency review / serious case review should always be reported as a Serious Incident. In many cases this will be completed by the commissioned provider, but this may not always be the case. Child deaths and serious injuries that have elements of child abuse or neglect (from carers or professionals) should be reported to the local Executive Lead for Child Safeguarding and the local Designated Safeguarding Children professionals. The Local Safeguarding Children Board will make a decision as to whether the case meets the criteria for a serious case review or single agency review. The local designated professional will also report the incident to the Child Safeguarding Lead at NHS London. Adult safeguarding Serious Incidents should be reported to the relevant local Executive Lead for Adult Safeguarding and the local authority Adult Safeguarding Lead (ASL). Advice may be sought from the Designated Professionals for Safeguarding in the case of children or the relevant local authority Adult Safeguarding Lead (ASL) in the case of adults at risk. The Safeguarding through Commissioning Policy for children and Local Safeguarding Adults Multi Agency Procedures should be followed. 2. Actions to be taken following all incidents 2.1 Any member of staff witnessing an incident or being first on the scene following an incident, before doing anything else, must manage the immediate situation: o Contact emergency services (fire, police, ambulance) if necessary; o Take appropriate emergency action in the case of fire, explosion, toxic or electrical hazard; o Ensure that any casualties receive immediate medical attention; 3

o Ensure the area is made safe to avoid further injury occurring; o Immediately contact line manager or alternate out of hours manager if the incident is serious or potentially serious. Consideration should be given to the need to implement site based emergency / contingency plans. 2.2 Once immediate hazards have been removed staff involved with the incident should ensure that the scene of the incident is preserved until the relevant senior manager has inspected it. Important evidence, such as broken equipment, should be taken out of use and retained for inspection. Camera equipment is available from LBSAT, for instances where the scene of the incident needs to be recorded, and the team can be contacted for advice on this aspect. 2.3 Following notification of an incident, the manager from where the incident was reported should carry out the following steps: Review immediate remedial action taken and arrangements made to preserve the scene; ensure the area has been made safe and that the security and safety of all individuals involved has been appropriately addressed. In the event of a violent incident, the relevant line manager should ensure that the police have been called; Ensure that all necessary reporting requirements have been fulfilled and the on line (QUIC) report form is completed within 24 hours; Agree the grading of the incident using the matrix in Appendix 4. Incidents should be graded according to the likelihood of them reoccurring given the current controls and the impact of the incident. Inform the Governance Manager of the grade so the online form can be updated; Ensure that equipment and other substances involved in an incident are removed from service and kept securely in an appropriate environment; For members of staff, liaise with the Occupational Health service (details available from HR) regarding any issues related to the health of an injured person; Send any information to the Assistant Director for Governance and Quality where a staff member has had time off or is not able to do normal work as a result of an accident or incident. NHS Lambeth CCG is legally required to report all such lost time from injuries which exceed 7 days off or inability to work normally; Obtain, where possible, names and contact details of witnesses; Ensure that any relevant health or other records are secured and kept in a safe and confidential environment. These may need to be made available as part of the investigation process and consequently, where they are needed for the continuing care of the patient; a duplicate set should be made up for this purpose; Ensure a contemporaneous record of the incident is prepared, i.e. in chronological order on a day-by-day basis; Inform the NELCSU Information Governance Team if the incident is related to information governance, e.g. breach of confidentiality, data loss or data security; Provide feedback to the person(s) reporting or involved in the incident; 4

Ensure that incidents are appropriately investigated, and where necessary remedial measures taken. If the incident is serious a Lead Director and Lead Investigator will be appointed; Ensure that risk assessments are reviewed or carried out on all significant identified hazards and appropriate action plans put in place to reduce risks to an acceptable level. The results of those risk assessments must be communicated to all those who may be at risk. (Copies also need to be sent to the Governance and QualityTeam). 3. Investigation 3.1 Not all incidents need to be investigated to the same extent or depth. However, in all incidents, unless the fundamental or root causes of incidents are properly understood, lessons will not be learnt and suitable improvements will not be made to secure a reduction in the risk of harm in the future. 3.2 Low / moderate harm incidents All negligible, minor and moderate (not serious) harm incidents must be investigated and QUIC updated with actions taken / lessons learned within 20 working days of being reported. Investigation templates are available at http://www.nrls.npsa.nhs.uk/resources/collections/root-cause-analysis/ or from the Governance and Quality Team. Root cause analysis training is not required for this level of investigation, although the individual undertaking the investigation should be competent enough to investigate and ensure appropriate actions are taken to reduce the occurrence of similar incidents happening again. Support may be sought from the Assistant Director Governance and Quality or the Governance Manager. 5

Incidents are to be signed off by the relevant reporting manager who should inform the Governance Manager to enable the incident to be closed on the system. 3.3 CCG Internal Serious Incidents: Root cause analysis All SI investigations will be carried out using the Root Cause Analysis (RCA) methodology. RCA is a structured investigation that aims to identify the true causes of a problem and the actions necessary to eliminate it or reduce the likelihood of it reoccurring. It is the responsibility of the relevant manager, or Lead Director in the case of SI s, to set up a local process for the investigation of an incident. Managers are responsible for ensuring that all incidents reported to them are fully investigated. Those trained in Root Cause Analysis techniques will lead on Serious Incident investigations. Guidance and best practice for conducting a root cause analysis is available on the Intranet and further information is available in Appendix 5. All investigations must be completed within 60 days in accordance with the Serious Incident Framework. Based on the emerging and/or ultimate findings, a decision will be taken as to whether there is a need to carry out an independent investigation or inquiry. In such cases, the investigation should be completed within 6 months. All investigations should be completed using the report template, which is available at http://www.nrls.npsa.nhs.uk/resources/collections/root-cause-analysis/ or from the Governance and Quality Team. The process for monitoring and closure is outlined below and can be found in summary in Appendix 1. 4. Communications 4.1 Communicating with and supporting staff Being involved in an incident or witnessing an incident can be traumatic even where they may have sustained no apparent physical injury. It is vital that the line manager ensures that those involved get the help and support they need. Prompt, effective and appropriate debriefing, support and counsel should be provided to those directly and indirectly involved in such incidents. The Director taking the lead for a Serious Incident needs to provide an initial debriefing at, or just after, the incident with all of the staff directly involved. The following matters should be considered in dealing with staff involved in an incident: Ensure physical injuries are attended to. Staff should be accompanied where attendance at A&E is required. Staff should be offered accompanied transport home whether from the site or from A&E, if they are unfit to continue working; Staff may need to be provided with an opportunity to discuss the incident in a confidential environment. Given that their line manager may be involved either in the investigation process or in a related managerial process, it is not appropriate 6

for them to undertake such a session. This might be undertaken with the assistance of the staff member's union representative or other nominated colleague; The provision of counselling through Occupational Health should be an option discussed, according to the situation; Where appropriate, the need for other therapeutic interventions should be explored with the staff member; Very occasionally incidents may give rise to the need for disciplinary action. This is dealt with in the NHS Lambeth CCG s disciplinary policy; Staff directly involved in an incident should be kept informed as to the progress and outcome of any incident investigation. 4.2 Communicating the outcome of Serious Incident investigations 4.2.1 The Director and staff directly involved in a Serious Incident should be kept informed about the investigation time scale and any issues arising from the investigation of an incident. Staff directly involved in a Serious Incident must be given access to any final report in order that recommendations can be acted upon. All reports must be anonymised. 4.2.2 When a Serious Incident investigation has been completed, the Director of the service concerned must ensure that there is a formal feedback session with the relevant staff members within 20 working days of the completion of the investigation. The investigation lead must attend and where there has been a full root cause analysis at least one member of the team must attend. The purpose of the session is to consider and agree the investigation report / root cause analysis, discuss the implementation of recommendations, and ensure that lessons are learned. 4.2.3 Confidentiality should be respected at all times and staff should be advised that the session is about providing the help and support they need, from whichever source most appropriate for the staff member concerned. The session should include: A systematic analysis of the incident Consideration of the report and recommendations The formation of an implementation plan with measurable outcomes, time scale for review and/or congratulating staff on their appropriate actions. Following the session it may be necessary for the report to be amended in the light of the feedback received. 4.2.4 It is the responsibility of the Director to ensure that a written action plan is prepared and in place within 20 days and all necessary arrangements put into effect to ensure that the action outlined in the report is implemented and any changes made evaluated. The Governing Body will receive updates on the implementation plans for serious and major incidents and will receive aggregate reports about action on all other incidents. 5. Record Keeping 7

5.1 The relevant senior manager is responsible for ensuring that there is a contemporaneous record of events from the time the incident is reported. Incomplete records will cause confusion in the investigation process and leave NHS Lambeth CCG open to criticism in litigation or other external inquiries. 5.2 The legibility and clarity of all documents related to an incident is vital. All documents are liable to be disclosed in the event of legal proceedings. Ambiguous and/or illegible records are not good evidence as far as the Court is concerned. 6. Safeguarding Incidents 6.1 The investigations of safeguarding Serious Incidents are co-ordinated by the identified adult and children s safeguarding Executive Leads with review and sign off via the LSCB and adult equivalent Board. Timescales are agreed by the lead Director. Details about the progress of these reviews should be recorded on the STEIS system via the AD for Governance and Quality. 7. Monitoring and Closure of Lambeth CCG incidents 7.1 The process for monitoring and closure of incidents is summarised in the table below. Type/ Level of investigation Actions & by whom Report due Sign off/ closure Monitoring Low/moderate harm. Review incident and address issues to prevent reoccurrence. A concise investigation may be appropriate Governance Team update Datix with actions taken / lessons learned 20 working days from incident being reported Reporting managers to sign off and notify Governance Manager for closure on Datix. Quarterly Serious Incidents. Full RCA investigation Internal SI investigation 60 working days Sign off by Regional Team/another CCG Quarterly report to IGC 7.2 If the incident is a Major Incident, the CCG Director notified of the incident should inform NHSE (NHS01) who are Category 1 responders. Once the incident has ended the NHSE Emergency Preparedness, Resilience and Response (EPRR) team will decide whether it is the role of NHS Lambeth CCG or another organisation to lead 8

the investigation. A lead Director will be nominated to either lead the investigation or to assist in the case of another organisation leading the investigation. 7.3 Once an incident has been investigated, the outcome of that investigation must be signed off by the manager responsible and entered on QUIC or STEIS systems by the Governance and Quality Team. 9

Appendix 1 - LCCG Incident and Serious Incident Reporting Process Incident or near miss occurs Serious Incident Manage the immediate situation Notify Manager Immediately Manager to inform Director of Governance and Development Yes Does the incident meet the definition of a Serious Incident, (including Safeguarding incidents)?* AD for Governance and Quality to report on STEIS within 2 working days Investigator and team appointed Notify NHS England (London) Comms Lead potentially high profile No Report the incident online (QUIC) within 24 hours and inform line manager Initial review completed within 3 working days Governance Team reviews and risk rates incident on QUIC Investigation undertaken within 60 working days Manager determines level of investigation to be carried out Investigation report evaluated by peer reviewer within 20 calendar days and feedback given to author Investigation completed in 20 working days. Governance Manager updates QUIC with outcome and action plan Author reviews evaluation response and returns feedback within 10 working days Governance Manager closes incident when actions completed SI signed off at Provider SI Review Group when satisfactory investigation, action plan and recommendations are effective Incident data analysed by Governance and Quality Team and reported to relevant committees 10

Appendix 2 - Key external stakeholders It is the joint responsibility of the Director of Governance and Development and the relevant Director to ensure that other stakeholders requiring information about the incident have been notified. Reporting to External Stakeholders must be completed within the respective organisations required time frames. External reporting framework for all incidents must be agreed by a Director from the following list: Adverse drug action (yellow card) scheme Centre for Communicable Disease Control Care Quality Commission Confidential Inquiries Department of Health Defective medicines reporting Environmental Health Fire code reporting of fire incidents Food Standards Agency Health and Safety Executive Local Counter Fraud Medicines and Healthcare products Regulatory Agency (MHRA) Monitor NHS Litigation Authority including: Losses to Third Parties (LTPS) and Property Expenses (PES) schemes NHS Estates - buildings and non-medical equipment defect and failure reporting Police Professional regulatory bodies (e.g. GMC, UKCC, etc) Public Health Laboratory Service Reporting of Injuries, Diseases and Dangerous Occurrences Regulations 1995 (RIDDOR) Fraud Incidents Where an incident involves suspected fraud these should be reported to the Local Counter Fraud Specialist for Lambeth: Melanie Alflatt, melanie.alflatt@nhs.net, 07899981415 Reportable Injuries, diseases or dangerous occurrences (RIDDOR) The Reporting of Injuries, Diseases and Dangerous Occurrences Regulations (RIDDOR) 1995 (SI 1995/3163) sets out how various incidents relating to staff or members of the public should be reported to the Health & Safety Executive (HSE). These incidents include: death or major injury following an accident or a dangerous occurrence that could have caused these; a reportable work related disease; or an injury where a member of staff is away from work for seven days or more. All injuries should be reported locally but since 6 April 2012 only where a member of staff is away for 7 or more days (not counting the day of injury) should it be reported as a RIDDOR incident. 11

Information governance related Serious Incidents For Information Governance Serious Incidents also inform: The local Information Governance lead who will inform the Information Commissioner The local Data Protection Officer and the local Caldicott Guardian Information Governance Serious Incidents will be reviewed at the IG Steering Group HSCIC guidance should be followed: Checklist for Reporting, Managing and Investigating Information Governance and Cyber Security Serious Incidents Requiring Investigation (HSCIC Feb 2015). https://www.igt.hscic.gov.uk/knowledgebasenew/hscic%20siri%20reporting%20and%2 0Checklist%20Guidance.pdf Medicines and Healthcare products Regulatory Agency (MHRA) The following incidents should be reported to the Medicines and Healthcare products Regulatory Agency (MHRA): Incidents involving an adverse blood reaction / event Incidents involving a suspected counterfeit product Incidents involving a suspected defective medicine The Assistant Director for Governance and Quality will ensure these are reported to the MHRA 12

APPENDIX 3 Initial Review Template Serious Incident Reference Number: STEIS Identification Number: Date/Time/Location of Incident including hospital / ward / team level information Incident type Type of investigation expected to be required: Level 1, 2 or 3 Description of incident including reason for admission and diagnosis (for mental health please include Mental Health Act status and date of referral and last contact) Details of any police or media involvement/interest Details of contact with or planned contact patient/family or carers Immediate actions taken including actions to mitigate any further risk Details of other organisations/individuals notified Lead Commissioner Report completed by Designation Date / time report completed A brief chronology of key events (to be inserted) if required 13

Appendix 4 Grading an Incident and determining level of incident investigation 1. Rationale Grading incidents according to the actual impact on those involved and the potential future risk of the incident recurring establishes the level of local investigation and analysis that should be carried out. All incidents require grading. The most senior member of staff at the scene initially grades incidents at the point that the incident occurred. The purpose of this initial decision around the seriousness of the incident is to ensure that for frontline staff and managers there is a simple process for making sure that incidents that require the most urgent response are reported quickly. It is not necessary for the assessor to be possession of all the facts at the time of grading the incident. There is always scope for re-grading the incident as the facts and issues emerge. The Director of Governance and Development in consultation with the relevant manager/director will grade Serious Incidents. The grading of Serious Incidents may be reviewed by the Accountable Officer. Advice may be sought from the NHS London Patient Safety Team or other national body. 2. Procedure Incidents are graded against a matrix that plots the impact of the incident in terms of harm (negligible, minor, moderate, major, catastrophic) against the likelihood of recurrence (almost certain, likely, possible, unlikely, rare) and thereby assigns a risk level in accordance with the following three steps. Step 1 - What is the apparent impact / consequence of the incident in terms of harm? Level Descriptor Description 1 Negligible First aid treatment. Moderate financial loss. 2 Minor Medical treatment required. Moderate environmental implications. High financial loss. Moderate loss of reputation. Serious business interruption. 3 Moderate 4 Major Serious injuries. Serious environmental implications. Serious financial loss. Serious loss of reputation. Serious business interruption. Excessive injuries. High environmental implications. Major financial loss. Major loss of reputation. Major business interruption. 5 Catastrophic Single or multiple deaths of any persons. 14

Step 2 - What is the potential future risk (likelihood) to patients and to the organisation? Likelihood (Probability) 1 2 3 4 5 Score Descriptor Rare Unlikely Possible Likely Almost certain Frequency How often might it/does it happen This will probably never happen/recur Do not expect it to happen/recur but it is possible it may do so Might happen or recur occasionally Will probably happen/recur but it is not a persisting issue Will undoubtedly happen/recur, possibly frequently Frequency Time-frame Not expected to occur for years Expected to occur at least annually Expected to occur at least monthly Expected to occur at least weekly Expected to occur at least daily Frequency Will it happen or not? <0.1% 0.1 to 1% 1 to 10% 10 to 50% >50% Step 3 - Plot the Impact (most likely outcome) against the likelihood of recurrence on the table Risk Scoring Matrix Impact Negligible Minor Moderate Major Catastrophic Likelihood 1 2 3 4 5 Rare 1 1 2 3 4 5 Unlikely 2 2 4 6 8 10 Possible 3 3 6 9 12 15 Likely 4 4 8 12 16 20 Almost Certain 5 5 10 15 20 25 Step 4 - Action Required The level of investigation and analysis required for individual events depends on the incident grading 15

Management Actions The level of investigation and analysis required for individual events depends on the incident grading. Incidents should also be graded after the implementation of an incident action plan to determine the potential reduction in risk. 1-3 Low Risk 4-6 Moderate Risk To be brought to the attention of the department team leader. Manage by routine procedures. Line Manager immediate control measures in place review risk assessment inform Heads of Department and Nominated Professional Lead. Specific responsibility for risk assessment and action planning must be allocated to a named person. 8-12 Significant Risk Deadline for completion will usually be within 8 to 12 months and will depend on the availability of resources. Urgent attention required. To be brought to the attention of the responsible Director / Heads of Department / Nominated Professional Lead/ Line Manager immediate control measures in place review risk assessment action plan devised Within one month of identification appropriate action must be agreed. The deadline for implementation and reassessment will normally be no later than 6 months from identification. Immediate action required by Executive Director / Heads of Department or Nominated Professional Leads. 15-25 High Risk To be brought to the attention of the Board and Integrated Governance Committee. Carry out root cause analysis review risk assessment. A Director must be informed and he/she will take responsibility for immediately planning action. 16

Type Impact Negligible Minor Moderate Major Catastrophic Injury / Harm (physical / psychological) Minimal injury requiring no / minimal intervention or treatment. No time off work Minor injury or illness, first aid treatment / minor intervention required Requiring time off work for <=3 days Increase in length of hospital stay by 1-3 days Significant injury requiring professional intervention (medical treatment and/or counselling) Requiring time off work for 4-14 days Increase in length of hospital stay by 4 15 days Major injury leading to long term incapacity or disability (e.g. loss of limb) Requiring time off work for >14 days Increase in length of hospital stay by >15 days Incident leading to death Multiple permanent injuries or irreversible health effects An event which impacts on a large number of patients RIDDOR reportable (absence more than 7 days) Mismanagement of patient care with long-term effects An event which impacts on a small number of patients Adverse publicity / reputation [Reputational Risks] Rumours Potential for public concern Local media coverage short term reduction in public confidence Elements of public expectation not being met Local media coverage moderate loss of public confidence in the organisation National media coverage with <3 days service well below reasonable public expectation. Long term reduction in public confidence. National media coverage with >3 days service well below reasonable public expectation. MP concerned (questions in House). Total loss of public confidence in the organisation. 17

Type Impact Negligible Minor Moderate Major Catastrophic Business objectives / projects Insignificant cost increase / schedule slippage Barely noticeable reduction in scope or quality <5% over project budget Schedule slippage or minor reduction in quality / scope 5-10% over project budget Schedule slippage or reduction in quality / scope Non-compliance with national target 10-25% over project budget Schedule slippage Key objective not met Incident leading to >25% over project budget Schedule slippage Key objectives not met Service Business Interruption Loss interruption of 1-8 hours Minimal or no impact on the environment /ability to continue to provide service Loss interruption of 8-24 hours Minor impact on environment / ability to continue to provide service Loss of interruption 1-7 days Moderate impact on the environment / some disruption in service provision Loss interruption of >1 week (not permanent) Major impact on environment / sustained loss of service which has serious impact on delivery of patient care resulting in major contingency plans being invoked Permanent loss of service or facility Catastrophic impact on environment / disruption to service / facility leading to significant knock on effect 18

Type Impact Negligible Minor Moderate Major Catastrophic Personal Identifiable Data [Information Management Risks] Damage to an individual s reputation. Possible media interest e.g. celebrity involved Potentially serious breach Damage to a team s reputation. Some local media interest that may not go public. Serious potential breach and risk assessed high e.g. unencrypted clinical records lost. Up to 20 people affected. Damage to a service reputation. Low key local media coverage. Serious breach of confidentiality e.g. up to 100 people affected. Damage to an organisations reputation. Local media coverage. Serious breach with either particular sensitivity e.g. sexual health details or up to 1000 people affected. Damage to NHS reputation. National media coverage. Serious breach with potential for ID theft or over 1000 people affected. Less than 5 people affected or risk assessed as low e.g. files were encrypted Complaints / Claims Locally resolved complaint Risk of claim remote Justified complaint peripheral to clinical care e.g. civil action with or without defence. Claim(s) less than 10k Below excess claim. Justified complaint involving lack of appropriate care. Claim(s) between 10k and 100k Claim above excess level. Claim(s) between 100k and 1 million. Multiple justified complaints Multiple claims or single major claim > 1 million. Significant financial loss > 1 million 19

Type Impact Negligible Minor Moderate Major Catastrophic HR / Organisational Development Staffing and Competence Short term low staffing level temporarily reduces service quality (< 1 day) On-going low staffing level that reduces service quality. Late delivery of key objectives/service due to lack of staff. Unsafe staffing level or competence (>1 day) Low staff morale Poor staff attendance for mandatory / key training. Uncertain delivery of key objective / service due to lack of staff Unsafe staffing level or competence (>5 days) Loss of key staff Very low staff morale No staff attending mandatory / key training Non-delivery of key objectives / service due to lack of staff On-going unsafe staffing levels or incompetence Loss of several key staff No staff attending mandatory training / key training on an ongoing basis Financial (damage / loss / fraud) [Financial Risks] Negligible organisational / financial loss ( < 1000 Negligible organisational / financial loss ( 1000-10000) Organisational / financial loss ( 10000-100000) Organisational / financial loss ( 100000-1m) Organisational / financial loss ( >1million) Inspection / Audit Minor recommendations Minor noncompliance with standards Recommendations given Non-compliance with standards Reduced performance rating if unresolved Reduced rating Challenging recommendations Non-compliance with core standards Prohibition notice served. Enforcement action Low rating Critical report. Major noncompliance with core standards. Improvement notice Prosecution. Zero rating. Severely critical report. Complete systems change required. 20

Appendix 5 Investigating and analysing incidents Not all incidents need to be investigated to the same extent or depth. It is recommended that incidents with negligible, minor or even moderate harm could be investigated using the concise report template. Root cause analysis training is not required to undertake an investigation using this template. Support is available from the Assistant Director Governance and Quality if required. The greatest effort should be concentrated on incidents which have been graded as high risk events. More details of the Levels of Investigation for Serious Incidents are found in the Serious Incident Framework. Level 1 Concise Investigation Most commonly used for Negligible, Minor or Moderate Harm outcomes Includes the essentials of a thorough and credible investigation - conducted in the briefest terms and involving a select number of RCA tools (e.g. Timeline, 5 why s, Contributory Factors framework) Conducted by one or more people (with a multidisciplinary approach if more than one investigator) Often conducted by staff local to the incident Should include person(s) with knowledge of root cause analysis, human error and effective solutions development Includes plans for shared learning - locally / nationally as appropriate Level 2 Comprehensive Investigation Commonly conducted for actual or potential Major or Catastrophic outcomes Conducted to a high level of detail, including all elements of a thorough and credible investigation and involving use of analytical tools ( Tabular Timeline, Contributory' Factors Framework, 'Change analysis, 'Barrier analysis ) Normally conducted by a multidisciplinary team, or involves experts / expert opinion independent advice or specialist investigator(s) Overseen by a director level chair or facilitator Led by person(s) experienced and/or trained in root cause analysis, human error and effective solutions development May require management of the media via the Organization s Communications Department Includes robust recommendations for shared learning locally/nationally as appropriate Includes a full report with an executive summary and appendices Level 3 Independent Investigation 21

As per the above Level 2 - Comprehensive investigation, but also: Must be commissioned and conducted by those independent to the provider service and organisation involved Commonly considered for incidents, claims, complaints or concerns of high public interest or attracting media attention Should be conducted where Article 2 of the European Convention on Human Rights is, or is likely to be, engaged Further details and definitions are available in NHS England s RCA Resource Centre. http://www.nrls.npsa.nhs.uk/resources/collections/root-cause-analysis/ 22