Incident Management Policy and Guidance

Transcription

1 This document is uncontrolled once printed. Please check on the intranet for the most up to date version. Incident Management Policy and Guidance Includes Serious Incident Management Our Mission is to improve the health and reduce health inequalities of Lambeth people and to commission the highest quality health services on their behalf. Version No. 2.0 Page 1

2 Document control Change History Version Date Author Approver Reason Sally Brooks Marion Shipman Updated roles and responsibilities Combined both the serious incident policy and incident policy into a single document Updated flow charts and processes for management of provider serious incidents Investigation templates included Serious incident evaluation template added Filename Incident Policy June 2012 v2.0 Superseded documents: Incident Policy v1.8 Contact details As set out above Version No. 2.0 Page 2

3 Contents DOCUMENT CONTROL... 3 CHANGE HISTORY... 3 INCIDENT REPORTING FLOW CHART...6 SERIOUS INCIDENT REPORTING AND MONITORING PROCESS LCCG INTRODUCTION POLICY STATEMENT & AIM OBJECTIVES SUPPORT REGULATORY REQUIREMENTS SCOPE OF DOCUMENT DEFINITIONS ROLES AND RESPONSIBILITIES ORGANISATIONAL ACCOUNTABILITY: OVERARCHING GOVERNANCE DIRECTOR OF OPERATIONS DIRECTOR LEADERSHIP LOCAL LEVEL RESPONSIBILITY INVESTIGATING OFFICER/INVESTIGATION TEAM (SERIOUS INCIDENT INVESTIGATIONS) NON SERIOUS INCIDENTS SERIOUS INCIDENTS SERIOUS INCIDENTS (SI S) IN COMMISSIONED SERVICES INCIDENT REPORTING PROCEDURE NOTIFICATION OF AN INCIDENT (TIME LIMIT: 24 HOURS) NOTIFICATION OF A SERIOUS INCIDENT: (TIME LIMIT: IMMEDIATE) NOTIFICATION OF A MAJOR INCIDENT NOTIFICATION OF A SAFEGUARDING INCIDENT (CHILDREN & ADULTS) ACTIONS TO BE TAKEN FOLLOWING ALL INCIDENTS INVESTIGATION INVESTIGATION INTRODUCTION LOW /MODERATE HARM INCIDENTS SERIOUS INCIDENTS : ROOT CAUSE ANALYSIS SUMMARY TIME LINE FOR REPORTING AND INVESTIGATING INCIDENTS RECORD KEEPING SAFEGUARDING INCIDENTS Version No. 2.0 Page 3

4 8. MONITORING AND CLOSURE RELATED STRATEGIES NHS LIABILITY COMMUNICATIONS AUDIT AND MONITORING CRITERIA Version No. 2.0 Page 4

5 13. STATEMENT OF EVIDENCE/REFERENCES IMPLEMENTATION AND DISSEMINATION OF DOCUMENT ASSOCIATED DOCUMENTS APPENDICES APPENDIX 1 - KEY EXTERNAL STAKEHOLDERS APPENDIX 2 SERIOUS INCIDENT NOTIFICATION FORM & SIGN OFF CHECKLIST APPENDIX 3 GRADING AN INCIDENT AND DETERMINING LEVEL OF INCIDENT INVESTIGATION...34 APPENDIX 4: IMPACT (CONSEQUENCE) TABLE APPENDIX 5 ROOT CAUSE ANALYSIS APPENDIX 6 - CONCISE INVESTIGATION REPORT TEMPLATE APPENDIX 7 COMPREHENSIVE INVESTIGATION REPORT APPENDIX 8 - BEST PRACTICE FOR INVESTIGATING MANAGERS APPENDIX 9 GSTT/SLAM SI FLOW CHART APPENDIX 10 SI REPORT EVALUATION TOOL APPENDIX 11 - EQUALITY & EQUITY IMPACT ASSESSMENT CHECKLIST APPENDIX 12 - CONSULTATION HISTORY Version No. 2.0 Page 5

6 Incident reporting flow chart An incident or near miss occurs Has the incident/near miss led to/ could have led to moderate or severe harm? (includes safeguarding incidents) No Log the incident on DafixWeb within 24 hours and notify line manager Governance team reviews and risk rates the incident reported on DafixWeb Manager determines level of investigation to be carried out- AD Governance may advise No 1nvest1gat10n completed. Administrator updates DafixWeb with outcome and action pian Administrator closes DafixWeb incident when actions completed Incident data analysed by Governance team and reported to reievant committees Version No. 2.0 Page 6

7 [Type text] Serious Incident Reporting and Monitoring Process LCCG Safeguarding i ssue i dentified- adult or children. Assess if Serious incident (i.e.goiug to a SCRJIMR) or confirmed SCRJIMR Not Serious Incidentmanage through usual safeguarding links Safeguarding incidents are addressed through the relevant safeguarding lead Director ""' -l> ;" (J') '< ;.)> (/J =.., Safeg uarding investi gations led b y LA IMR o r SCR Safeguarding bodies to monitor & sign off reports & action plans. NHS Lambeth Safeguarding Director Leads to ensure reports and action plans are forwarded to NHS London for ciasure.. = s. iii "-' "Action plan completion within 6 months. Themes,trends,learningand long term issues to be shared via LCCCB (part 2) reports. Arrangements for 'closure' may change with development of the Clinical Commissioning Group (CCG)

8 1. Introduction 1.1. Policy Statement & Aim In the course of commissioning health care, incidents can occur, some of which do or may have serious consequences for NHS Lambeth and the users of our services. This policy provides the framework for reporting and managing all incidents, including serious incidents and near misses, which could or did lead to harm to a patient, employee, visitor, contractor, building or equipment or have an impact on the provision of services, the Trust s reputation or its legal duty of care This policy aims to ensure that risks to patients, staff and the public are minimised and that procedures are in place so that lessons arising from the review of incidents are learnt and embedded. All staff have a responsibility to contribute and take part in this process During normal working hours staff are required to report serious incidents to their Line Manager immediately or in their absence the next most senior manager. Out of hours staff should contact the Director on Call The serious incident management should be read in conjunction with the National Patient Safety Agency (NPSA) guidance on serious incident management and the NHS South East London Serious Incidents Reporting Policy and Procedure Objectives Support To support all those responsible for the management and investigation of incidents to minimise the likelihood or impact of harm / damage, whether physical, financial or reputational by: Taking immediate actions as far as reasonably practical Appropriately investigating to establish the root cause(s) Identifying any gaps / deficits from analysis and taking action(s) to reduce risk of recurrence Sharing learning from incidents and actions taken Providing documented evidence if required for litigation purposes Regulatory requirements To meet regulatory requirements e.g. Health and Safety (RIDDOR 1995*), Information Governance, Care Quality Commission To identify any potential concerns over professional conduct which may Version No. 2.0 Page 8 of 63

9 need to be examined in other forum. To ensure that the appropriate level of support is offered to those affected by the incident. Ensure that commissioned provider serious incident investigations are managed in accordance with National Patient Safety Agency (NPSA) guidelines and that learning from recommendations outlined in action plans are implemented and disseminated. *Reporting of Injuries, Diseases and Dangerous Occurrences Regulations 1995 reporting revision effective April Scope of document This policy covers all incidents no matter how serious or minor and applies to everyone employed by NHS Lambeth and anyone working on or visiting NHS Lambeth premises in whatever capacity. This policy also covers NHS Lambeth responsibilities in respect of incident management within its commissioned services including Independent Contractors. 3. Definitions Near miss: An incident that does not result in actual harm loss or damage. These are as important to record and investigate as those incidents where actual harm was caused. Near misses can highlight potential problems and allow the organisation to remedy matters before any harm occurs. All near misses should be reported via the Datix incident system.. Adverse incident: Any event or circumstance arising in the course of providing or supporting the provision of health care services that could have or did lead to unintended or unexpected harm, loss or damage to a patient, visitor, member of staff, the organisation - including its property or the environment. Serious Incident (SI): an event, usually unexpected, which did or had the potential to cause serious harm, and/or likely to attract public and media interest that occurs on NHS premises or in the provision of an NHS or other commissioned service. This may be because it involves a large number of patients, there is a question of poor clinical or management judgement, a service has failed, a patient has died under unusual circumstances, or there is the perception that any of these has occurred. SIs are not exclusively clinical issues; an electrical failure for example may have consequences that make it an SI. Examples include: The occurrence of any major health risk e.g. outbreak of Legionella, infections which produce/could produce unwanted effects involving the safety of patients, Version No. 2.0 Page 9 of 63

10 staff or others Events that affect a number of service users e.g. incorrect screening procedures Serious damage to NHS property, large-scale theft or fraud, or where major litigation is expected. Information governance incident e.g. actual or potential loss of personal information that could lead to identity fraud or have other significant impact on individuals. It includes electronic media and paper records. An incident or multiples of the same incident e.g. the need for revaccination that attracts adverse media attention or has other ramifications for NHS Lambeth that may be disproportionate to the actual nature of the incident itself. Safeguarding incidents (adults or children) which are likely to result in a serious case review or which at a future date it is agreed to undertake a management review / serious case review. See the Safeguarding Adult and Children s policies. In deciding whether or not the incident being dealt with constitutes an SI, staff should consider the possible impact the incident could have, including media coverage. If the incident could be damaging to the NHS it should be reported as an SI. Major incident: any event that presents a serious threat to the health of the community, disruption to the health service, or causes (or is likely to cause) such numbers or types of casualty as to require special arrangements to be implemented. Separate guidance exists for dealing with such incidents see the Major Incident Policy and Business Continuity Plan for NHS Lambeth. These documents can be found with the HR and Corporate Affairs Administration Team. Examples include: train crash large outbreaks of communicable diseases chemical contamination and radioactive release. Root Cause Analysis (RCA): an acknowledged way of investigating incidents which offers a framework that identifies what, how and why the event happened. Analysis can be used to identify areas of changes, look for new solutions and develop recommendations that are presented in an action plan. 4. Roles and responsibilities Organisational Accountability: Overarching Governance The NHS Lambeth Managing Director has overall accountability for ensuring that there are appropriate processes in place for the investigation of incidents. This responsibility can be delegated to the Director of Operations (formerly Director HR & Corporate Affairs). Version No. 2.0 Page 10 of 63

11 4.2. Director of Operations Is the nominated senior officer with overall responsibility for incident management Takes a strategic overview of the incident policy and processes to ensure that appropriate and effective performance management systems are in place. To appoint a Lead Director for NHS Lambeth and Non Foundation Trust Serious Incidents (SI s). To agree an investigating officer for NHS Lambeth SIs as soon as reasonably practicable and depending on the severity or number of people affected by the incident will convene an SI panel. Consider the need for legal advice and whether media interest is likely. Ensure that regular serious incident reports including assurance that agreed actions have been embedded and sustained, are provided to the Board.Ensure that all providers of PCT commissioned services are contractually required to report all SIs to NHS Lambeth. (See Appendix 8) Ensure that NHS London s Serious Incident Reporting Guidance - October 2007 and SEL Serious Incident Policy are followed and that all NHS Lambeth and non Foundation Trust SI s are reported on the Strategic Executive Information System (STEIS) updated for progress on the SI investigation and outcome. Ensure that NHS Lambeth complies with other relevant reporting requirements, including following NHS SEL and NHS London s serious incident policies, the National Patient Safety Agency serious incident guidance and regulatory requirements Director leadership The relevant service Director (relevant Director) advised of a serious incident is responsible for confirming serious incident status and taking appropriate action to ensure the immediate needs of those involved are considered and the incident site, evidence, equipment and documentation are preserved. They are responsible for completing an SI notification form and ensuring that an electronic Datix incident form has been completed after immediate action has been taken. The relevant Director must ensure that the following are informed within 24 hours and keep a written note including the time of those contacted: - Managing Director - Director of Operations - Assistant Director Governance - Head of Issues of Concern (NHS SEL) where the incident involves an Independent Contractor - Assistant Director, Communications NHS SEL (if appropriate) - NHS London (AD Governance will submit onto STEIS from the completed SI notification) - The Police (if appropriate) - NHS London Communications Lead on call for London (if appropriate) - Local Authority (if appropriate) - Local Safeguarding Lead (adults and children) Version No. 2.0 Page 11 of 63

12 - NHSLA (if appropriate) The relevant Director will identify other external agencies that need to be informed upon the nature of the incident e.g. Medicines and Health Products Regulatory Agency; Health and Safety Executive; Department of Health; Coroner; Professional Bodies e.g. GMC, NMC (if appropriate). See Appendix xx for detailed list. Should the SI be de-escalated those contacted should be advised of the changed status. The appointed Lead Director for a particular serious incident is responsible for ensuring serious incident investigations are completed within agreed timescales Local level responsibility The Assistant Director Governance is responsible for the overall operation of the incident and serious incident reporting and management processes. To provide support to Investigation Officers / Lead Investigators in the use of Root Cause Analysis investigation tool and incident report evaluations. Responsible for ensuring a functional Datix incident system within GP Practices to support incident reporting (until transfer of function to NCB 01/04/2013). Inform the Head of Issues of Concern where relevant issues are raised through the serious incident system. Provide incident and SI reports to relevant bodies and internal committees and groups as required. The Datix lead is responsible for the day-to-day management of Datix and the local serious incident database, the administrative processes around these and producing reports. Responsible for providing support to General Practice Datix Administrators. Assistant Directors/Managers (Managers) are responsible within their areas for investigating incidents at the appropriate level set out by this policy, liaising with the AD Governance where necessary and taking actions and sharing lessons learned. Liaise with Datix lead to ensure incidents are updated and closed on the Datix system. Responsible for ensuring that direct line staff understand and follow this procedure. Head of Issues of Concern (NHS SEL) is responsible for informing the Assistant Director Governance, NHS Lambeth, where there are serious incidents involving Independent Contractors for which they receive notification. The Head of Issues of Concern will be responsible for ensuring there are robust processes in place for signing off Issues of Concern which are also serious incidents, involving Independent Contractors. Every member of staff is responsible for verbally reporting all incidents (including near miss incidents) to their manager as soon as possible and ensuring that a Datix electronic incident report is completed (either by themselves or if incapacitated, by a nominee) within 24 hours of the incident (or next working day if prior to a weekend or Bank Holiday). Version No. 2.0 Page 12 of 63

13 Responsible for complying with section 6 Actions to be taken following an incident section of this policy. Independent Contractors should have their own incident systems in place. Serious incidents should be reported during working hours to an individual s Line Manager immediately or in their absence the next most senior manager, who in turn should inform the relevant Director. Out of hours staff should contact the Director on Call. Commissioners are responsible for ensuring that incidents and serious incidents are included within contractual requirements, monitored, signed off and lessons learned throughout the period of the contract contribute to serious incident report evaluations when requested. Ensure arrangements are in place for agreeing the commissioning of independent investigations with provider organisations and NHS London if required for serious incidents. Co-ordinate complex multiagency investigations Investigating Officer/Investigation Team (Serious Incident investigations) Non Serious Incidents The role of the investigating officer is to undertake an investigation according to the level of incident grading and address any identified issues. See Appendix 3. An investigation team will not be required for non serious incidents. The investigating officer may find it helpful to have some knowledge of the Root Cause Analysis approach to investigating incidents. The NPSA Concise report template should be used. See Appendix Serious Incidents A Lead Investigator will be appointed within an Investigation Team and they must ensure that the incident is investigated in a systemic and timely manner, achieving the 45/60 day target set within this policy. The Lead Investigator will be responsible for liaising with the area where the incident occurred in order to identify any requirements necessary to ensure that a thorough investigation is carried out. The Lead Investigator must be knowledgeable of a Root Cause Analysis approach to the investigation of incidents. The Lead Investigator is responsible for the completion of an SI investigation report together with an action plan, which addresses in full the areas of concern highlighted by the investigation. The action plan must be written according to SMART criteria. See concise and comprehensive investigation templates and guidance Appendices 5, 6 and 7. Version No. 2.0 Page 13 of 63

14 Serious Incidents (SI s) in Commissioned services NHS Lambeth SI processes comply with the SEL Cluster serious incident reporting policy and procedure. As host commissioner for Guy s and St Thomas NHS Foundation Trust (GSTT) NHS Lambeth will take the lead for ensuring there is communication to non Lambeth PCTs for relevant GSTT serious incidents. Provide relevant summary information to commissioning PCTs concerning GSTT management of SIs. Monitor the progress of SI investigations within all commissioned services including the implementation of action plans and recommendations, signing off and closing SIs as per the NHS SEL serious incident policy and agreed delegation responsibilities. The Head of Issues of Concern will be responsible for ensuring there are robust processes in place for investigating Independent Contractor Serious Incident Issues of Concern and signing these off. 5. Incident reporting procedure 5.1. Notification of an incident (Time Limit: 24 hours) See Flow chart 1 for summary 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 not available. All incidents should be notified using the Datix on-line reporting form. 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. 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 Notification of a Serious Incident: (Time Limit: Immediate) See Flow Chart 2 for SI summary 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, usually by telephone contact. It is the responsibility of the most senior member of staff at the scene to ensure that this is done. Version No. 2.0 Page 14 of 63

15 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: o Managing Director o Director of HR & Corporate Affairs o Assistant Director Governance o Assistant Director, Communications NHS SEL (if appropriate) o NHS London (AD Governance will submit onto STEIS from the completed SI notification) o The Police (if appropriate) o NHS SEL Communications and NHS London Communications Lead on call for London (if appropriate) o Local Authority (if appropriate) o Local Safeguarding Lead (adults and children) o NHSLA (if appropriate) 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; Coroner; Professional Bodies e.g. GMC, NMC (if appropriate) and ensure they are contacted should be advised of the changed status. See Appendix 1 for detailed list. The relevant Director should complete a notification form including a factual account of events within 24 hours of the incident occurring. A serious incident notification form template appears at Appendix 2. Once this initial report has been reviewed the Director of HR & Corporate Affairs will appoint a Lead Director and agree the level of investigation required, Lead Investigator and an investigation team. 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 Managing Director, the Director of Human Resources and Corporate Affairs, the Assistant Director of Governance and any other relevant person involved in the incident. Where the SI involves an Independent Contractor the Medical Director, as lead for Issues of Concern in NHS SEL will be involved to consider whether there are any apparent suspension/ disciplinary issues. Consideration should be given to the need for legal advice and whether media interest is likely Notification of a Major Incident It is the on-call Director s responsibility to decide whether an incident is a major incident. If he/she declares a major incident, the Director will be responsible for immediately instigating the Major Incident Plan. A copy of the major incident plan is available on the intranet with a hard copy held by the Corporate Affairs Administration Team. Version No. 2.0 Page 15 of 63

16 In the event of a major incident, the major incident team will decide the most appropriate Director to lead the review or be involved in the review if NHS Lambeth is not the lead organisation Notification of a Safeguarding Incident (children & adults) A safeguarding concern which may do or does progress to a single agency review / serious case review should always be reported as a serious incident. 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. 6. Actions to be taken following all incidents 6.1. 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 Contact emergency services (fire, police, ambulance) if necessary. Take appropriate emergency action in the case of fire, explosion, toxic or electrical hazard Ensure that any casualties receive immediate medical attention Ensure the area is made safe to avoid further injury occurring 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 Once immediate hazards have been removed staff involved with the incident Version No. 2.0 Page 16 of 63

17 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 HR and Corporate Affairs for instances where the scene of the incident needs to be recorded and can be contacted for advice on this aspect 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 report form is completed within 24 hours. Ensure that equipment and other substances (e.g. vaccines) 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 (phone kentoh@heales.com ) regarding any health issues related to the health of an injured person Send information to the Assistant Director for Governance in relation to a staff member having time off or not being able to do normal work as a result of an accident or incident. NHS Lambeth is legally required to report all such lost time injuries which exceed 3 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. Provide feedback to the person(s) reporting or involved in the incident 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 Version No. 2.0 Page 17 of 63

18 be communicated to all those who may be at risk. (Copies also need to be sent to the Governance Team). 7. Investigation 7.1. Investigation introduction 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 Low /moderate harm incidents All negligible, minor and moderate (not serious) harm incidents must be investigated and Datix updated with actions taken/lessons learned within 20 working days of being reported. The concise investigation template (Appendix 5) may be used. 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 incidence of similar incidents happening again. Support may be sought from the Assistant Director Governance. Incidents are to be signed off by the relevant reporting manager who should inform the Datix Lead (Governance Team) to enable the incident to be closed on the system. GP practices in Lambeth also use Datix for recording incidents and investigate and Practice Datix Administrators close all incidents except those relating to medicines management issues which are investigated and confirmed by the NHS Lambeth pharmacy team to the NHS Lambeth Datix Administrator for closure. Serious medicines incidents are managed through the serious incident process (see 7.3 below) Serious Incidents : Root cause analysis All SI incident 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 full investigated. Those trained in Root Cause Analysis techniques will lead on serious incident investigations. Guidance for conducting a root cause analysis appears at Appendix 5 and best practice for investigating incidents can be found at Appendix 8. All investigations must be completed within Version No. 2.0 Page 18 of 63

19 agreed timescales: Serious incidents (Grade 1 NPSA) must be reported to NHS London / NHS SEL by 45 working days from incident date. To meet this deadline the report must be completed by 30 working days and sent to the AD Governance. Serious incidents (Grade 2 NPSA) must be reported to NHS London / NHS SEL by 60 working days from incident date. To meet this deadline the report must be completed by 45 working days and sent to the AD Governance. 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. All investigations should be completed using the report template (Appendices 5&6). The process for monitoring and closure is outlined below and can be found in summary on Flow Charts 1& Summary time line for reporting and investigating incidents Description Timescale for reporting Responsibility Method Reporting an Incident/Near Miss/ Major Incident/ SI Within 24 hours All Managers All incidents complete Datix report For Serious incidents contact Director/on call Director /Head of Issues of Concern for Independent Contractors Reporting detail of the incident to NHS London Within 2 working days or as soon as possible Director of Operations Via STEIS Contact the Health & Safety Executive Within 7 days Director of Operations Via HR & Corporate Affairs Produce Report & Action Plan Grade 1 incidents within 30 / 45 days to enable sign off at NHS Lambeth All Managers Using Root Cause Analysis Forward to NHS London Grade 2 incidents within 45/ 60 days Director of Operations Via STEIS 7.5. Record Keeping The relevant senior manager is responsible for ensuring that there is a contemporaneous record of events from the time the incident is reported. This information should be included on the SI notification form. The record must be dated and the author identified. Version No. 2.0 Page 19 of 63

20 Incomplete records will cause confusion in the investigation process and leave NHS Lambeth open to criticism in litigation or other external inquiries. 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 Safeguarding Incidents The investigation of serious safeguarding 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 Governance. 8. Monitoring and Closure Timescales Incidents / Near Misses Organisation Type/ Level of investigation Actions & by whom Report due Sign off/ closure Monitoring NHS Lambeth Low/moderate harm Governance 20 working Reporting Quarterly Team update days from managers to incident report Review incident & address issues to prevent reoccurrence. A Datix with actions taken / lessons learned incident being reported sign off and notify Datix Manager for closure on to LCCCB produced by NHSL Governance concise investigation Datix. report may be appropriate. General Low/moderate harm Practice Internal Provider Quarterly Practice update Datix timescales internal signoff incident report Practice to review incident & address issues to prevent reoccurrence with actions taken / lessons learned for all but medicines incidents which are to LCCCB produced by NHSL Governance. reviewed and signed off by the NHS Lambeth Datix lead following confirmation by pharmacist / Controlled Drug lead. Quarterly review all medicines incidents by Medicines Management Committee. Primary Care Practice reviews. Version No. 2.0 Page 20 of 63

21 All other commissioned providers Low/moderate harm Provider internal investigations Provider internal processes Internal timescales Provider internal signoff Incident reports to Contract / Quality meetings Serious Incidents Organisation Type/ Level of investigation Actions & by whom Report due Sign off/ closure Monitoring NHS Lambeth NHS London notification via STEIS within 2 working days General Practice Notification to NHS Lambeth directly or via Independent Contract Lead who will report to NHS London via STEIS within 2 working days of notification Moderate/ severe harm: comprehensive investigation Grade 1 = 45 working days from notification (30 days to meet sign off times) Grade 2 = 60 working days from notification (45 days to meet sign off time) Rarely independent investigations (external investigator) 26 weeks from notification Internal SI investigation with appointed Lead Director & Investigator To be agreed in discussion with NHS Lambeth 45/60 days Sign off by NHS Lambeth SI Monitoring group Closure by NHS London 45/60 days Sign off by NHS Lambeth SI monitoring group Closure by NHS London Quarterly incident report to LCCCB produced by NHSL Governance Datix Lead review incidents and risk ratings liaising with Practice Mgrs if queries. Quarterly incident report to LCCCB produced by NHSL Governance Primary Care Practice individualised serious incident follow up. Discussed with Issues of Concern Team. Foundation Trusts* Notification to NHS Lambeth within 2 working days of incident identification who forward information to NHS London Provider investigation 45/60 days Sign off commissioner / provider SI review meetings: All residents for GSTT. Lambeth only residents for SLaM. Incidents involving Lambeth residents at Version No. 2.0 Page 21 of 63 Quarterly Quality Report to Integrated Committee (NHS SEL) by relevant commissioners and LCCCB Commissioner / Provider SI review meetings

22 KCH will be signed off by NHS Southwark and vice versa for Southwark patients at GSTT. Closure by NHS SEL. Non Foundation Trusts Initial report to NHS London & NHS SEL via notification report Provider investigation 45/60 days Sign off by NHS Lambeth SI Monitoring group Closure by NHS London Contract / quality meetings Other providers Provider investigation 45/60 days Sign off by NHS Lambeth SI Monitoring group. Brixton Prison SIs are initially signed off by the Partnership Board before consideration by NHS Lambeth. Independent Contractor meetings. Closure by NHS London *Guy s & St Thomas s NHS Foundation Trust (GSTT) / Kings College Hospital NHS Foundation Trust (KCH)/ South London & Maudsley NHS Foundation Trust (SLaM) If the incident is a Major Incident, once the incident has ended a decision will be made by the Major Incident Team as to whether it is the role of NHS Lambeth or another organisation to lead the investigation into the incident. NHS Lambeth will usually nominate a lead Director to either lead the investigation or assist in the case of another organisation leading the investigation. 9. Related Strategies There are a number of other important and related documents that staff should be aware of, all of which are available on the NHS Lambeth intranet. The Risk Management Strategy describes the approach to be adopted by NHS Lambeth towards managing risks and achieving compliance with risk management standards. This is in line with the NHS SEL Assurance Framework and NHS SEL Risk Management and Assurance Toolkit. Version No. 2.0 Page 22 of 63

23 NHS Lambeth has a duty to protect and promote the health of the community, including at times of emergency. It is committed to ensuring it can respond quickly and effectively to any major incident. NHS Lambeth s Major Incident Plan details how it will do this. Sometimes an incident may give rise to a complaint. The timetable for response to such complaints is set out in NHS Lambeth s Complaints Policy and must be adhered to. 10. NHS Liability NHS Lambeth is liable for the actions, omissions and consequences of its employees in the legitimate course of their employment and recognises its responsibility to protect the physical and psychological health and well-being of its staff after a serious incident. It is essential that the HR and Corporate Affairs Director and the AD Governance are given advanced notice of incidents, which are or may become negligence claims. Any member of staff completing an incident form, either on behalf of another or where another is named as the person involved, should ensure, as far as is possible, that the person involved understands and agrees with what has been written on the incident form. This agreement should be confirmed, where possible, with a signature. It is important that the information contained on the form is accurate and complete. This will ensure that the maximum benefit is obtained in responding to the incident and in risk management. It will also help to protect both staff and NHS Lambeth in the event of a complaint or legal claim being made. Incident forms are confidential documents and must be treated as such. Completed reports when printed must not be freely accessible to unauthorised people. Employees, service users and others are entitled to have the confidential information contained in the incident form respected. There may, however, be circumstances in which it is appropriate and helpful to allow the contents of the Incident Form to be seen by the relatives/carers of a patient or others involved in the investigation process. That decision should only be made by the Director bearing in mind the duty to keep patient information confidential and the permitted exceptions to that rule. Once an incident has been investigated, the outcome of that investigation must be signed off by the manager responsible and entered on Datix. Support can be provided through the Governance Team for updating the Datix form. 11. Communications 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 that line management ensures that those involved get the help and support they need. Prompt, effective and appropriate debriefing, support Version No. 2.0 Page 23 of 63

24 and counsel should be provided to those directly and indirectly involved in such incidents. A Director taking the lead for a serious incident needs to provide an initial debriefing at, or just after the incident, with all 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 a related managerial process it is not appropriate 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 disciplinary policy. Staff directly involved in an incident should be kept informed as to the progress and outcome of any incident investigation Communicating with and supporting service users, carers and relatives When an incident has caused harm to a service user one of the biggest concerns for patients, relatives and carers is lack of information. Providing factual information in a sensitive way is helpful and is not an admission of liability for the event itself. When NHS Lambeth is advised of a serious incident involving service users, carers and relatives by Providers they should seek assurance that the organisation s Being Open policy has been instigated including the following: discussion with the service user as soon as possible by the relevant senior manager or by the person delegated by them to do this. Where a clinical incident has occurred, the service user should also be given an opportunity to discuss the case with the relevant health professional. An explanation of how the follow-up to the incident will be managed The need for support or counselling should be discussed Relatives and carers of service users involved in an incident will also need to be given a clear understanding of how the follow-up to an incident will be managed and in the event of a patient death or injury, offered the Version No. 2.0 Page 24 of 63

25 opportunity to discuss the matter with the relevant health professional Media Relations Serious incidents will, on occasion, attract media attention. Any media representatives arriving on the organisation s property must be informed to contact the Director of Operations. Some serious incidents may produce a situation that arouses significant media or public interest. It is essential in those circumstances that the communications team is informed and any communication with the media/public/relatives/staff is dealt with only by the Director of the service in consultation with the Director of Communications? or on-call Director out of hours. The need to inform the Communications Team at NHS London should be considered if the SEL Communications Team are advised. Every effort must be made to ensure that the service user is informed before any information is released to the media. This may not always be possible in instances where many patients have been affected, but it is essential to demonstrate that every effort has been made. Some incidents may affect or potentially affect a number of patients, staff and members of the public. In those circumstances the relevant Director will consider the need to make urgent provision for a telephone hotline (this could potentially be NHS Direct), permanently manned during office hours to deal with enquiries from the public. This should be in discussion with the SEL and NHS London Communications Teams. In some circumstances it may be necessary to arrange extended cover depending on the severity of the incident and number of calls anticipated. Arrangements will also need to be made to ensure that relevant reception staff and all members of the service area are fully aware of the arrangements. The Director will need to devise a strategy for contacting all those potentially affected by the incident as a matter of priority. They will also need to agree a specific strategy for dealing with media interest to be agreed with the Managing Director. Clear records must be kept of all calls received, timed and dated and with details of the advice provided and by whom. Staff may require access to relevant the database where applicable to deal with patient enquiries effectively. It may be necessary to make arrangements for additional telephone lines and post deliveries Communicating the outcome of investigations Where the incident/si involves a service user, he/she and/or the relatives/carers, as relevant, will need to be informed of the outcome of the investigation as appropriate by the relevant Director as a matter of priority. It may also be appropriate to provide interim updates where an investigation process is lengthy. Version No. 2.0 Page 25 of 63

26 Similarly, 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. When the 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. 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: 1. A systematic analysis of the incident 2. Consideration of the report and recommendations 3. 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. 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 Board will receive updates on the implementation plans for serious and major incidents and will receive aggregate reports about action on all incidents Working with other agencies NHS Lambeth recognises the importance of joint working around incident management and it is committed to developing appropriate joint investigation and communication processes with partner agencies. Version No. 2.0 Page 26 of 63

27 It is the joint responsibility of the Director of Operations and Lead Director to ensure that other stakeholders requiring information about the incident have been notified. Southwark Clinical Commissioning Group and Lambeth ClinicalCommissioning Group have agreed that serious incidents at each organisation will lead on serious incidents for all Southwark/Lambeth residents that occur in KCH and GSTT. Reports as per section 12 will go to each Board. 12. Audit and monitoring criteria Document Audit and Monitoring Table Monitoring requirements - what in this document do we have to monitor Monitoring Method: (e.g. statistics, report) a ) Incident reporting and SI notifications by all organisations (including timescales for notification, reports, trends / issues and actions taken) b) Incident and SI information a) Incident and SI report within Integrated Governance and Performance Report b) Report Monitoring prepared by :- (name job titles) Monitoring presented to:- (e.g. Committees) Frequency of presentation:- (e.g. annually, sixmonthly etc) a) LCCG Governance Team b) Providers a) LCCG b) Contract / Quality Commissioner meetings a) Quarterly b) as agreed in contract Version No. 2.0 Page 27 of 63