Serious Incident Management Policy and Procedure

Serious Incident Management Policy and Procedure Version: Final Date Approved: July 2013 Date for Review: July 2014 Policy Author & Lead: Head of Clinical Governance & Lead Nurse NOTE: This is a CONTROLLED Document. Any documents appearing in paper form are not controlled and should be checked against the server file version prior to use Wandsworth Clinical Commissioning Group Serious Incident Policy. July 2013 Page 1

Document Title Reader Information Serious Incident Management Policy Register Number CG001 Rights of Access Private Type of formal paper Policy & Procedure Category Clinical Governance Format Word Document Language English Purpose This policy has been developed by NHS Wandsworth Clinical Commissioning Group (WCCG) Clinical Governance Team to explain the responsibilities and actions for dealing with Serious Incidents (SIs). It applies to WCCG and all WCCG NHS-funded care provider organisations. Scope of Document Corporate (applicable across WCCG) Local (applicable to all WCCG provider organisations) Author Evonne Harding, Head of Clinical Governance & Lead Nurse Approval Date July 2013 This policy was approved by the WCCG Serious Incident Management & Assurance Group on the 25 th June 2013 and the Integrated Governance Committee on the 9 th July 2013. Dissemination and Implementation details The content of this policy will be disseminated to and implemented by WCCG and all WCCG Provider Organisations Review Access & Disposal Target Audience Consultation Process The Head of Clinical Governance & Lead Nurse is responsible for ensuring that the SI policy is disseminated and implemented by all WCCG s provider organisations. This policy will be reviewed no later than 3 years from the date of original circulation, if necessary, more frequently as required by national or local changes. This policy can be found on the WCCG website: Clinical Governance page: http://www.wandsworthccg.nhs.uk/pages/home.aspx A copy will be archived in accordance with the Information Governance Policy, all previous copies will be destroyed WCCG All WCCG Provider Organisations The following interested parties were consulted in the development of this policy: Head of Clinical Governance & Lead Nurse Registered Nurse on the Board Director of Corporate Affairs, Performance & Quality Serious Incident Review Group Members Serious Incident Management & Assurance Group Integrated Governance Committee Members Safeguarding Leads (Children & Adult) Deputy Clinical Lead NHS 111 Clinical Lead NHS 111 GP Lead Clinical Lead Clinical Governance Manager Quality and Patient Safety Manager Information Governance Manager Public Health Lead Nurse Wandsworth Clinical Commissioning Group Serious Incident Policy. July 2013 Page 2

References & Supporting Documents Practice Nurse Development Lead Communication Lead NHS England: London Region: Head of Patient Safety Team & Patient Safety Manager National Patient Safety Agency. National Framework for Reporting and Learning from SIRIs, NPSA 2010, available at http://www.nrls.npsa.nhs.uk/resources/?entryid45=75173 National Patient Safety Agency (NPSA) Seven Steps to Patient Safety. The full reference guide. Available at www.npsa.nhs.uk/sevensteps March 2010 DoH (2004) Memorandum of Understanding: investigating Patient Safety Incidents Information resource to support the reporting of serious incidents: http://www.nrls.npsa.nhs.uk/resources/?entryid45=75173 NPSA Three Levels of Root Cause Analysis (RCA) investigation guidance: http://www.nrls.npsa.nhs.uk/resources/?entryid45=75355 http://www.nrls.npsa.nhs.uk/resources/collections/root-causeanalysis/?entryid45=59901 Checklist for reporting, managing and investigating information governance serious untoward incidents: http://www.dh.gov.uk/en/publicationsandstatistics/publications/publicati onspolicyandguidance/dh_111498 Safeguarding children serious case review policy: http://www.london.nhs.uk/publications/tools-and-resources/reportingserious-incidents Ministry of Justice: Guidance for coroners on changes to Rule 43: Coroner reports to prevent future deaths http://www.justice.gov.uk/downloads/burials-and-coroners/coronersreports-future-deaths.pdf National Patient Safety Agency, The Never Event Policy Framework, An update to the never events policy: 2012: https://www.wp.dh.gov.uk/publications/files/2012/10/never-eventspolicy-framework-update-to-policy.pdf National Patient Safety Agency (NPSA 2009). Being open: communicating patient safety incidents with patients, their families and care. Available at: http://www.nrls.npsa.nhs.uk/resources/collections/beingopen/?entryid45=83726 Department of Health Human Factors Group Interim Report (March 2012). Available at: http://www.chfg.org/news-blog/doh-human-factors-groupinterim-report-and-recommendations-for-the-nhs Care Quality Commission. Essential standards of quality and safety. CQC. 2010; Availalbe at: www.cqc.org.uk Document Control and Amendment Record Version Date of Approval Author/Reviewer Description of Change Draft March 2013 Head of Clinical Governance & First version of this policy Lead Nurse Draft April 2013 NHS England: London Region: Comments reflected within the policy Patient Safety Manager Final May 2013 Consultation Process Parties All comments reflected within the policy Final 25 th June 2013 SI Management & Assurance All comments reflected and signed off Group Final 9 th July 2013 Integrated Governance Sign-off Wandsworth Clinical Commissioning Group Serious Incident Policy. July 2013 Page 3

Committee Final 22 nd July 2013 Head of Clinical Governance & Lead Nurse Identified SI KPIs included Equality Impact Assessment Initial assessment Response Does or could the policy have any influence on any of the equality strands in relation to: Promoting equality Eliminating discrimination Achieving equality Race No Religion or belief No Disability learning, physical, sensory impairment and mental health problems No Gender No Sexual orientation including lesbian, gay and bisexual people No Age No Culture No Nationality No Ethnic origins (including gypsies and travellers) No Could the policy in the way it is planned have a negative impact on any of the equality target groups (i.e. it could disadvantage them) or could it have a positive impact on any of the groups, contribute to promoting equality, equal opportunities or improve relations Ethnic groups Positive impact Faith groups Positive impact Disability groups Positive impact Gender groups Positive impact Sexual orientation groups Positive impact Age groups Positive impact If you have identified potential discrimination, are there any exceptions valid, legal and/or N/A justifiable? Is there a need for external or user consultation N/A Is the impact of the document likely to be negative? No If so, can the impact be avoided What alternatives are there to achieving the document without the impact? Can we reduce the impact by taking different action? Was a full impact assessment required? No What is the level of impact? Low Where an adverse or negative impact on equality groups) has been identified during the initial screening process a full EIA assessment should be conducted. If you have identified a potential discriminatory impact of this procedural document, please refer it to the WCCG Head of Clinical Governance and Lead Nurse together with any suggestions as to the action required to avoid/reduce this impact. For advice in respect of answering the above questions, please contact the WCCG Head of Clinical Governance and Lead Nurse. Wandsworth Clinical Commissioning Group Serious Incident Policy. July 2013 Page 4

Serious Incident Management Policy and Procedure Contents 1. Introduction... 6 2. Policy Statement... 7 3. Definition of SI... 7 4. Scope... 7 5. Being Open...7 6. Roles and Responsibilities... 8 7. Committees and Groups...10 8. SI Management Procedure... 12 9. Additional Guidance... 18 Appendices A. Structural Chart B. SI Management & Assurance Group Terms of Reference C. SI Review Group Terms of Reference D. Process for Management of SI including Never Events E. Grading of SI F. Involvement of Multiple Provider Organisation G. NHS England London Region SI Reporting and Investigation Procedure H. Checklist for the Review and Approval of the SI Policy & Procedure Glossary Wandsworth Clinical Commissioning Group Serious Incident Policy. July 2013 Page 5

Serious Incident Management Policy and Procedure 1. Introduction Wandsworth Clinical Commissioning Group (WCCG) is accountable for effective governance and learning following all Serious Incidents (SIs) and seeks to work closely with all provider organisations as well as commissioning staff members to ensure all SIs are reported and managed appropriately. The Francis Report (February 2013) emphasis that commissioners should have a primary responsibility for ensuring quality, as well as providers. SIs requiring investigation in healthcare are rare, but when they do occur, everyone must make sure that there are systematic measures in place for safeguarding people, property, NHS resources, reputation and in responding to them. These measures must protect patients and ensure that robust investigations are carried out, which result in organisations learning from SIs to minimise the risk of the incident happening again. When a SI occurs it must be reported to all relevant bodies. This policy has been developed by WCCG Clinical Governance Team to explain the responsibilities and actions for dealing with SIs and the tools available to help within the new English NHS structure from April 2013. It applies to all WCCG NHS-funded care provider organisations. Intelligence gained from SIs will be used to influence contract monitoring, quality and safety standards for care pathway development and service specifications. This policy is based on the National Patient Safety Agency (NPSA) s National Framework for Reporting and Learning from Serious Incidents Requiring Investigation 2010 and the Serious Incident Framework an update to the 2010 National Framework for reporting and Learning from Serious Incidents Requiring Investigation Guidance March 2013. WCCG has adopted this framework in full and expects those commissioning on behalf of the CCG or providing NHS funded care commissioned by the CCG to adhere to the guidance contained in the framework. The revised SI framework does not fundamentally alter existing principles set out in the NPSA s 2010 National Framework for reporting and Learning from SIs and elsewhere, but does update the framework according to the revised organisation of the NHS. This means that: - existing provider responsibilities continue to rest with providers; - commissioning responsibilities that sat with Primary Care Trusts (PCTs) have moved to CCGs and Local Area Teams (LATs) commissioners; - Strategic Health Authority (SHA) oversight responsibilities, insofar as they still exist under the new legal framework for the NHS, sit with NHS England (NHSE) regional and LATs; - the NHS Trust Development Authority (NTDA) performs the function that was delivered by SHAs with respect to NHS Trusts in the context of the on-going transition of those organisations to Foundation Trust Status. From the 1st April 2013 it has been responsible for the performance management of NHS Trusts Provider organisations are required to notify the Care Quality Commission (CQC) about events that indicate or may indicate risks to on-going compliance with registration requirements, or may lead to changes in the details about the provider organisation in the CQC s register. Reporting SIs is a legal requirement under CQC regulations. Therefore all SIs, including Never Events must be reported to the CQC, this obligation can be met by reporting the never event to the National Reporting and Learning Service. This requirement continues regardless of organisational changes within the NHS. This is a living document and will be amended in response to any changes to statutory and/or local guidance. Wandsworth Clinical Commissioning Group Serious Incident Policy. July 2013 Page 6

2. Policy Statement WCCG is committed to identifying, managing and minimising all risks to the CCG, its commissioned services, service users, staff and visitors through the Integrated Risk Management framework and Integrated Governance structures. WCCG has established SI management arrangements for the purpose of monitoring its Provider Organisations and CCG specific SIs. 3. Definition of a SI requiring investigation An SI requiring investigation is defined as an incident that occurred in relation to NHS-funded services and care resulting in one of the following: Unexpected or avoidable death of one or more patients, staff, visitors or members of the public; A never event all never events are defined as SIs although not all never events necessarily result in severe harm or death (See Never Events Framework) Serious harm to one or more patients, staff visitors or members of the public or where the outcome requires life-saving intervention, major surgical/medical intervention, permanent harm or will shorten life expectancy or result in prolonged pain or psychological harm (this includes incidents graded under the NPSA definition of severe harm); A scenario that prevents or threatens to prevent a provider organisation s ability to continue to deliver healthcare services; Allegations, or incidents, of abuse; Adverse media coverage or public concern about the organisation or the wider NHS (NPSA 2009). An SI in relation to Personal Confidential Data is defined as any incident involving the actual or potential loss of personal information that could lead to identity fraud or have other significant impact on individuals should be considered as serious. As a minimum, patient safety incidents leading to unexpected death or severe harm should be investigated to identify root causes and enable ameliorating action to be taken to prevent recurrence. The definition of SIs requiring investigation extends beyond those which affect patients directly, and includes SIs which may indirectly impact on patient safety or a provider organisations ability to deliver on-going healthcare. 4. Scope This policy is applicable to WCGG and all NHS-funded services commissioned by WCCG including Continuing Care Team, NHS 111 Provider, Nursing Homes; except where that service is commissioned by a number of CCGs where the lead CCG s policy will be used. 5. Being Open For a common culture to be shared throughout the system, these three characteristics are required: Openness: enabling concerns to be raised and disclosed freely without fear, and for questions to be answered; Transparency: allowing true information about performance and outcomes to be shared with staff, patients and the public; Candour: ensuring that patients harmed by a healthcare service are informed of the fact and that an appropriate remedy is offered, whether or not a complaint has been made or a question asked about it. (The Mid Staffordshire NHS Foundation Trust Public Inquiry (2013) Wandsworth Clinical Commissioning Group Serious Incident Policy. July 2013 Page 7

Patients, families and carers involved in adverse incidents should expect openness, transparency and candour throughout the system about matters of concern from providers and the services commissioned by them, with timely communication essential to this principle. Effective communication with patients begins at the start of and throughout their care and this should be no different when a patient safety incident occurs. Openness about what happened and discussing patient safety incidents promptly, fully and compassionately can help patients cope better with the physical and psychological consequences of what happened. The argument that the existence of a criminal sanction inhibits candour and cooperation is not persuasive. Such sanctions have not prevented improvements in other fields of activity. (The Mid Staffordshire NHS Foundation Trust Public Inquiry (2013) 6. Roles and Accountabilities 6.1. Accountable Officer: The Accountable Officer for WCCG and the Chief Executives of the commissioned services each have responsibility for ensuring that their organisations have the necessary management systems and structures in place to enable the effective management and implementation of all risk management and governance system including SI management (See Appendix A: Structural chart). WCCG will performance monitor the contract in place with each of its provider organisations as required by the Department of Health (DoH) and NHSE. Therefore, WCCG is accountable for: The effective governance of and learning following all SIs, seeking to work closely with all its provider organisations to ensure all SIs are reported and managed appropriately, Receiving timely information on all SIs and their related investigation from all provider organisations from whom they commission NHS services. 6.2. Director of Corporate Affairs, Performance & Quality: The Director of Corporate Affairs, Performance & Quality is the executive lead for quality and safety and is accountable for ensuring effective systems for managing all SIs are in place and the implementation of the WCCG SI Policy. 6.3. Head of Clinical Governance and Lead Nurse: The Head of Clinical Governance & Lead Nurse is responsible for the implementation of the WCCG SI policy. The Lead has responsibility for ensuring and monitoring effective management of SIs within its provider organisations. 6.4. Quality and Patient Safety Manager: The Quality and Patient Safety Manager has delegated responsibility for the day-to-day management and oversight of SIs reported by the Acute and Mental Health Trusts. Maintaining an overview of SIs reported across provider organisations and identifying trends and patterns. The Quality and Patient Safety Manager will develop and maintain close working relationship with provider organisations identified Quality and Safety Leads in improving their processes, activities for disseminating and sharing lessons to allow for minimisation of risks and improvement of patient safety including via bi-monthly action plan implementation assurance visits. 6.5. Clinical Governance Manager: The Clinical Governance Manager has delegated responsibility for the day-to-day management and oversight of SIs reported by WCCG and provider organisations other than the Acute or Mental Health Trust. Maintaining an overview of SIs reported across provider organisations and identifying trends and patterns 6.6. Quality and Patient Safety Facilitator: The Quality and Patient Safety Facilitator is responsible for assisting the Quality and Patient Safety Manager in the day-to-day management and implementation of the WCCG SI policy They will undertake analysis of SI themes and organisational performance. 6.7. NHS England (London Region): Will have responsibility for commissioning independent investigations/inquiries in SI cases which meet nationally agreed criteria. Management of Wandsworth Clinical Commissioning Group Serious Incident Policy. July 2013 Page 8

SIs in directly commissioned services (e.g. Primary Care). Strategic Health Authority (SHA) oversight responsibilities, insofar as they still exist under the new legal framework for the NHS, will sit with NHSE London region. NHSE are responsible for sharing relevant learning including with other area teams through relevant network meetings and sharing SI summary reports. 6.8. NHS Trust Development Authority (NTDA): Will continue to perform the function delivered by SHAs with respect to NHS Trusts in the context of the on-going transition of those organisations to Foundation Trust Status. Since the 1 st April 2013 it has been responsible for the performance management of NHS Trusts. The Trust Development Authority ensures that NHS Trusts have appropriate systems and processes in place to report, investigate and respond to SIs, undertake credible investigations and follow through on action plans in line with national policy and best practice. It works in partnership with WCCG to support the management of SIs. In this regard, the accountability for the management of SIs rests with WCCG as commissioners. 6.9. SLCSU Contract Managers and Commissioning Leads: The role of contract managers and commissioning leads is to make explicit reference to SI reporting in the contracts with all provider commissioned services and organisations (including NHS 111 provider). In particular the expectations regarding SI reporting via STEIS and SI indicators for monitoring purposes and the process for performance management of these indicators. They are also responsible for ensuring that lessons learned from SIs influence the quality and safety standards for care pathway and service development. 6.10. SLCSU Communication Team: has responsibility for identifying a clear communication plan for working with relevant colleagues both internally and externally to support effective management of the SIs. They will work with (the relevant parties) to prepare media statements, ensuring that statements are prepared for the media (N.B. ensuring that patients and staff and other affected parties are informed before release of statements to the media). The SLCSU will also confirm proposed handling arrangements with NHSE, where considered necessary develop communications/media handling strategies with other organisations and liaise with relevant stakeholders as appropriate. The Communication Team will design and implement a strategy for on-going and longer-term management of communications. 6.11. Expert Leads: The role of the expert lead is to review relevant SIs and identify any areas that need to be addressed as part of the investigation. When the SI report is completed, their role is to support the RCA evaluation process in ensuring that provider organisation SIs are investigated appropriately, identify whether the investigation had addressed all the issues and is suitable for closure. They would also support WCCG in ensuring the appropriate SI grade has been allocated. Expert leads could provide advice around medicines management, maternity, infection control, mental health, information governance, health and safety, estates, etc. 6.12. Provider Organisations: Each provider organisation is responsible for identifying SIs and taking effective action in each instance. It is expected that clear procedures are in place for identifying, reporting and investigating all SIs. A single point of contact or lead officer for the management of all SI s must be identified by each provider organisation. All provider organisations have a responsibility to ensure that their first priority when an SI occurs is to ensure the needs of individuals affected by the SI are attended to, including any urgent clinical care and management action that may reduce harmful impact. Internal investigations should be commenced immediately on notification of the SI in line with the individual organisation s SI policies which should incorporate the principles of Being Open. Wandsworth Clinical Commissioning Group Serious Incident Policy. July 2013 Page 9

All provider organisation should ensure that their Being Open policy is followed. Under the Data Protection Act (1988) provider organisations will need to be open and transparent with regards to investigation processes. Arrangements may need to be put in place to support patients and family members through the investigation process and sharing of the outcomes of investigations. Early consideration should be made to the provision of information and support to patients, relatives and carers and staff involved in the SI, including information regarding support systems which are available to patients/relatives/visitor/contractors. All provider organisations have to: Ensure there are structured risk management systems and processes for collecting, collating and analysis of data on all SIs and lessons learned and reporting SIs via STEIS. Those provider organisations without access to STEIS should contact WCCG Clinical Governance Team directly (see section 8.7: Contacting WCCG Clinical governance Team). Agree SI grade within 3 working days and in accordance with the national framework subject to local arrangements. Re-establish a safe environment where all equipment or medication involved in the SI is retained and isolated and relevant documentation copied and secured to preserve evidence and facilitate investigation and learning. Contact the police if there is a suggestion that a criminal offence has been committed. Ensure all SIs defined by this policy, are investigated as per national guidance, using root cause analysis (RCA) methodologies. Manage the reporting of Information Governance, Health and Safety Incidents to Health and Safety Executive (HSE), Patient Safety Incidents to the National Reporting and Learning System (NRLS) and as appropriate to CQC. Inform WCCG Clinical Governance Team if they are considering commissioning services (or parts of) through other provider organisations and assure WCCG that any commissioned services are compliant with this policy. Ensure compliance with the requirements identified within the NHSE SI Framework document. Ensure that this policy does not interfere with existing lines of accountability and does not replace the duty to inform the police and or other organisations or agencies where appropriate. Further guidance can be obtained from the DoH publication Memorandum of Understanding - Investigating Patient Safety Incidents (June 2004), and accompanying NHS guidance (December 2006) and NPSA guidance for Serious Incidents (March 2010). The need to involve outside agencies should not impede the retrieval of immediate learning. Wandsworth Clinical Commissioning Group Serious Incident Policy. July 2013 Page 10

7. Lead Committees and Groups 7.1. Integrated Governance Committee (IGC): The IGC is directly accountable to the CCG Board and provide assurance that the governance systems, processes and behaviours by which the CCG leads, directs and controls functions in order to achieve organisational objectives, and the way in which they relate to patients and carers, the wider community and partner organisations are integrated and effective. The IGC oversee processes and compliance issues concerning SIs, receive notification of Never Events, and inform the CCG Board of any escalation or sensitive issue in good time. 7.2. SI Management & Assurance Group (SIMAG): The SI Management & Assurance Group (see Appendix B: Terms of Reference) will have delegated responsibility for overseeing the management and monitoring of all provider organisations SIs, including CCG SIs, receiving regular updates at its monthly meetings from the SI Review Group. The Group reports to the Integrated Governance Committee and CCG Boards, providing assurance that provider organisation SI management systems and processes are appropriate and lessons have been learned and shared. The Group will meet monthly to 7.3. SI Review Group: The SI Review Group (see Appendix C: Terms of Reference) will have delegated responsibility from the SIMAG. The Group will meet weekly to review all provider organisation and CCG SIs RCA reports to determine the robust nature of the investigations and assure that root causes have been appropriately identified and actions reflect the report and the lessons have been learned and shared. The Group will confirm and challenge the content and structure of provider organisation RCA investigation reports using the SI Evaluation Critiquing Tool. 7.4. Clinical Quality Review Groups (CQRG): WCCG meets monthly with providers at the Clinical Quality Review Group. The CQRGs are responsible for ensuring that all contractual requirements relating to clinical care, quality and outcomes are met. CQRGs will review the provider s performance in relation to clinical care and patient experience against nationally and locally agreed standards, and ensure that services commissioned from the provider deliver the best health outcomes. Should any aspect of service quality not be achieved the CQRG will be responsible for agreeing the actions needed to rectify under-performance under the terms of the contract. SIs are a standing item on the agenda. The CQRG will be provided with monthly assurance updates on the investigation and implementation of, and outcomes from SI investigation report action plans. This may also include, where appropriate, assurance from provider organisations on action plans following Coroner s Rule 43 Reports (Ministry of Justice: Guidance for coroners on changes to Rule 43: Coroner reports to prevent future deaths). The chair of the CQRG will identify SI reports to be discussed at the CQRG at notification stage. 7.5. Quality Surveillance Groups (QSG): Where data, incident reports or the quality of responses to SIs give cause for concern, this information should be shared via QSGs who can assist in triangulating other quality-related information and formulating appropriate responses, such as triggering a Risk Summit or keeping the provider under regular review. 7.6. Clinical Effectiveness and Medicine Management Group: promotes evidence-based clinical practice, medicines management and commissioning across primary care, secondary care and mental health care in the Wandsworth health economy. The Group ensures that commissioned services and Public Health (PH) policies and practice meet local need, are evidence based and are consistent with national guidance; service frameworks and best practice e.g. NICE guidance. This Group will be notified of any SIs which could potentially have care pathway implications. Wandsworth Clinical Commissioning Group Serious Incident Policy. July 2013 Page 11

8. SI Management Procedure 8.1. Reporting a SI: All provider organisations and WCCG must use STEIS to report SIs (see Appendix D: Process for Management of SI including Never Events). Once a SI has occurred it should be reported as soon as possible after the incident is detected and no later than 2 working days of the SI being identified. STEIS will automatically generate a cascade alert notification of the SI to the WCCG SI inbox (WACCG.SI@nhs.net). There is also a box on STEIS to state whether the SI was NHS 111 related. The Designated Nurse Safeguarding Children should be informed of all safeguarding children SI simultaneously as SI is logged on STEIS. Stakeholders: WCCG Quality and Patient Safety Manager and/or the Administrative Assistant will notify the relevant key stakeholders of the SI, for e.g. Safeguarding Leads, Information Governance Leads, Clinical Reference Group, Public Health Lead Nurse, NHS 111 Clinical Lead, etc. For NHS 111 specific SIs, the provider organisation will be expected within the Description of what happened section on STEIS to state the SI is NHS111 specific, e.g. (NHS 111). Explanation of what happened. Confidentiality: The report on STEIS must not contain any confidential data relating to patients or staff. The description should be concise (fewer than 60 words). A patient number or identifier (not an NHS number) should be quoted as a reference on all correspondence. Each SI is allocated a unique number and this is the reference number which should be used in any communication with WCCG Clinical Governance Team. SI Grade: The SI grade of individual SI cases identified by the provider organisation or WCCG for CCG specific SIs should be agreed with the WCCG Clinical Governance Team: Quality and Patient Safety Manager within 3 working days of receiving SI alert notification (see Appendix E: Grading of SIs). Updating Records: Once a SI is reported, the provider organisation or WCCG (for CCG specific SIs) must update the STEIS record as the situation changes, which could be weeks or months after the original SI. An email must be sent to the WCCG Clinical Governance Team (WACCG.SI@nhs.net) with the STEIS number in subject line when the STEIS record is updated. If it is agreed that the SI does not fall within the definition of a SI, the SI can be removed from STEIS rather than simply closed. This would be done as outlined in section 8.11: De-escalation Process. Late Notification: Where reporting of a SI is not within the national requirement of 2 working days, provider organisations or WCCG (for CCG specific SIs) are expected to and must provide a rationale for the delay on the further information section of STEIS. For monitoring processes and provision of regular reporting, the date the SI was entered onto STEIS would be the date used to calculate delay in notification. High Risk SIs: Where the SI has already attracted and/or has the potential of attracting media attention, it should be highlighted by selecting the Media interest option on STEIS including informing the WCCG Clinical Governance Team: Quality and Patient Safety Manager immediately by telephone (See section 8.7: Contacting WCCG Clinical Governance Team includes Out of Hours contact). The expectation is that the provider organisation (where the SI occurred) will contact NHSE out of hours directly with an email sent to the WCCG Clinical Governance Team (See section 8.7: Contacting WCCG Clinical Governance Team includes Out of Hours contact). The notification of any high risk SI will activate the WCCG Major Incident Policy and on-call Wandsworth Clinical Commissioning Group Serious Incident Policy. July 2013 Page 12

system for out of hours. NHSE will expect to be notified by both the provider organisation and the CCG of high risk SIs within 24 hours, with out of hour s notification via their on-call system (See section 8.7: Contacting WCCG Clinical Governance Team, includes Out of Hours contact). CCG & GP Practice of Patient Concerned: using the CCG/CSU drop down list and the Patient s GP Practice section on STEIS, the names of CCG and GP practice of the patient involved in the SI should be documented within this section. This would enable the WCCG Clinical Governance Team to facilitate and ensure all SI management information (alert notifications, reports, etc.) are made available to the respective CCG where the patient s GP practice belong. 8.2. Actions Following Notification of SI; The WCCG Clinical Governance Team will: Within 3 working days: o Review new SIs to; Identify any high risks (any need for immediate contact with the Provider Organisation); Identify any additional and/or further relevant information required; Ensure no patient confidential information included; Agree SI grade; Confirm SI is not a Never Event; Assess whether the SI type needs to be re-categorised; Group notifications (in the case of ambulance delay which should be based on time it was reported by the reporting organisation); o Acknowledge receipt of alert notification (inform the provider organisation of SI re-categorisation. Agree the SI grade, confirm investigation timescale); o Review any draft SIs notified but not submitted. o Notifying Contract Manager of Never Event SI o Ensure STEIS is updated with relevant information Weekly: o Ensure contact has been made with the reporting provider organisation (SI grade has been agreed, alert notification acknowledged); o Review requests for de-escalation and/or removal or extension of deadlines; o Send weekly notification of collated SIs to the Wandsworth SMT; o Evaluate provider organisation s SI investigation report using the SI Evaluation Critiquing Tool. o Commence identification of trends and themes arising from SIs; o SI Review Group meeting (see Appendix C: Terms of Reference) o Expected SI Completion Date section on STEIS updated to reflect when an extension has been granted o Identify SIs that will be discussed at the CQRG 8.3. Report Format As a minimum provider organisations or WCCG s (for CCG specific SIs) SI RCA investigation reports should include the criteria identified within the WCCG SI Evaluation Critiquing Tool; available on the WCCG website (http://www.wandsworthccg.nhs.uk/pages/home.aspx). For some types of SIs there are individual reporting templates and investigation aids which can be used. There is a report template for Grade 3 and 4 pressure ulcers. Various templates and Wandsworth Clinical Commissioning Group Serious Incident Policy. July 2013 Page 13

investigation aids are available at www.nrls.npsa.nhs.uk/rca. In the case of safeguarding children, the serious case review template will be used. In accordance with Caldicott principles, SI RCA investigation reports must not contain patient or staff confidential information. The title of the reporter and titles of the investigation panel members should be used. Electronic reports should be saved by STEIS number rather than any person confidential information. It is the responsibility of the provider organisation that generated the investigative report to retain the document for a period of 30 years. Copies shared with other provider organisations may be destroyed in accordance with the local confidentiality procedure once the report is no longer of use. For NHS 111 specific SIs, the provider organisation will be expected within the Description of what happened section on STEIS to state the SI is NHS 111 specific, e.g. (NHS 111). Explanation of what happened. 8.4. Action Plans Format Following the investigation of a SI, the submitted SI RCA investigation report must include an action plan which sets out how each recommendation from the investigation will be implemented. The action plan must define the following minimum requirements: Recommendations: these should be the analysis and findings of the investigation the recommendations from the report and every recommendation must have clearly articulated action(s); Identified Action: this should be the actions the organisation needs to take to resolve the contributory factors and root causes. This should also identify whether the action needs to be taken at: - Unique: specific to the area, - Common: organisation specific, - Universal: have regional/national significance; By Whom: identifies who in the provider organisation will ensure the action is completed and a responsible person (job title only) must be identified for each action point. Planned action completion date: this is the target dates for proposed completion of actions. Resource requirements: to be able to complete the action, what resources required; this should also identify which provider organisation committee will be responsible for monitoring action plan implementation and completeness. Evidence of completion: description of the form of evidence that will be available to confirm completion; this should include any intended post action plan reviews or audits; measures of success: evidence of changes brought about to improve patient safety (this may include changes to practice, education and training) Sign-off: details (name, date, etc.) of when the action plan was signed off by the provider organisation s Executive level lead. SMART approach to action planning is recommended. That is, the actions should be: Specific, Measurable, Attainable, Relevant and Time-bound. 8.5. Submission of Final Report Final SI RCA investigation reports with accompanying action plan should be submitted to WACCG.SI@nhs.net inbox within the timescales stipulated below: 45 working days of the SI being notified (Grade 1): requiring Investigation Level 2 (comprehensive RCA for incidents involving moderate and severe harm or death), 60 working days of the SI being notified (Grade 2): requiring Investigation Level 2 (comprehensive RCA for incidents involving moderate and severe harm or death), Wandsworth Clinical Commissioning Group Serious Incident Policy. July 2013 Page 14

6 months of the SI being notified (Grade 3): requiring Investigation Level 3 (Independent RCA) (see Appendix E: Grading of SIs). 8.6. SI RCA Investigation Report Evaluation and Sign-off Process Once a SI RCA investigation report is received, the Quality and Patient Safety Manager will coordinate and ensure each individual case is evaluated using the SI Evaluation Critiquing Tool available on the WCCG website http://www.wandsworthccg.nhs.uk/pages/home.aspx and reviewed by the WCCG Serious Incident Review Group (SIRG). The SIRG will review reports, grant extensions, agree that reports are final and agree sign-off in accordance with the SIRG Terms of Reference (see Appendix C: Terms of Reference). Expert advice as appropriate will be taken to determine whether all aspects of the SI have been investigated adequately and whether there are clear action points to address each root cause and contributing factor. Each individual case will be evaluated to determine whether the SI report: Meets the criteria, therefore should support sign off and closure or Does not meet the criteria: therefore requires further actions. Following review by the WCCG SI Review Group an extension may be granted (see section 8.12: Extension of Submission Period). Once WCCG has agreed that the report is final and agrees signoff, STEIS must be updated with the completion of the investigation and the findings of the investigation by the provider organisation. Once the CCG receives confirmation that this had been done the incident will be closed on STEIS by WCCG. MRSA Bacteraemia and Clostridium Difficile (CDiff) deaths (i.e. Part 1a of Death certificate) are classed as SIs and RCAs will be reviewed through the SI Review Group with input from the CSU Infection Control Specialists. Serious Case Reviews (SCR): SIs involving SCRs will not be closed on STEIS until the SCR has been completed and published by the Local Safeguarding Children Board (LSCB) and/or the local Safeguarding Adult Board. On occasions this will mean waiting until other processes such as a court case or Coroner s inquests have also been completed. In these cases the term STOP THE CLOCK should be entered in the comments section of STEIS report to enable it to be recognised as a report where closure will be delayed. 8.7. Contacting WCCG Clinical Governance Team The WCCG Clinical Governance Team can be contacted: In Hours: 020 8871 5162 Out of Hours: 08448 222 888 and quote NHS01. This will put you in touch with an NHS England (London) senior manager on-call who can access the out of hours communication team if necessary. Email correspondences: WACCG.SI@nhs.net 8.8. Monitoring Once a week the Clinical Governance Team will produce a briefing report for the Executive Team of WCCG updating them of all SIs reported and alerting them to any pertinent issues. This report will include a short briefing of all SIs reported in the last week and an update on action plan delivery. Action Plans: All SI RCA investigation report action plans should be completely implemented within 6 months of reporting the SI with extensions by agreement with WCCG Clinical Wandsworth Clinical Commissioning Group Serious Incident Policy. July 2013 Page 15

Governance Team: Quality and Patient Safety Manager. Through quarterly SI Assurance Meetings, the WCCG Quality and Patient Safety Manager will: Ensure implementation of actions agreed as a result of SI investigations Ensure that evidence of demonstrable outcomes from SI action plans is available Agree dissemination of learning from SIs Review any identified action plan trends CQRG will receive regular update report on action plan implementation (new actions, completed actions, outstanding actions, improvement outcomes, themes, actions, exceptions). All contracts for services commissioned by WCCG will identify SI reporting requirements. The WCCG Quality and Patient Safety Manager will monitor provider organisations or WCCG s (for CCG specific SIs) compliance with this policy and national requirements through the provision of regular reports and completion of an annual checklist. Grade 2 SIs: within the National framework there is a further breakdown of the SIs categories which include Grade 1 SIs and Grade 2 SIs. Grade 2 SIs include all Never Events and a small number of other SIs such as Inpatient Suicide (including following absconsion), Maternal Deaths, Child Protection Incidents, Accusation of Physical Misconduct or harm and Data Loss and Information security (DH Criteria level 3 5). It is recognised that for Grade 2 SIs there should be a greater level of scrutiny of the investigation, final report and action plans. Grade 2 SIs will only be closed on STEIS when WCCG Clinical Governance Team and the London NHSE Patient Safety Team are satisfied with the evidence of implementation of all actions on the action plan. On receipt of the final report and action plan from the provider organisation, WCCG will forward the report to the London NHSE Patient Safety Team via the london.sui@nhs.net email address. The report will be then be reviewed by all parties and this process will be monitored and coordinated by WCCG. Key Performance Indicators to be monitored by CCG: SIs notified excluding those deescalated or proposed to be deescalated (includes Never Events) SIs notified within 2 working days of the incident being identified (%): all SIs notified on STEIS Number of Never Events reported in a month SIs closed on SIES within 6 months of incident being reported (rolling %) Number of SI investigation reports submitted to the CCG within the expected timescale (45/60 working days). Narrative and trend analysis which includes themes of types of SIs reported, new recommendations identified, improvement actions and outcomes delivered as a result of the SI by the provider organisation. Number of all Incidents not deemed to be SIs reported in a month (low and moderate risk) Narrative and trend analysis which includes themes of all incidents not deemed to be SIs reported (low and moderate risk), new recommendations identified, improvement actions and outcomes delivered as a result of the all incidents (low and moderate risk) not deemed to be SI by the provider organisation. 8.9. Learning from SIs All organisations with a responsibility for notifying or receiving details of SIs have a responsibility for: Wandsworth Clinical Commissioning Group Serious Incident Policy. July 2013 Page 16

Ensuring arrangements exist for the dissemination of relevant learning and recommendations from SI investigations across the organisation and more widely as appropriate. Carrying out regular thematic reviews of SIs to identify trends and patterns and ensure the wider implications of key learning points are disseminated. The Quality and Patient Safety Manager will produce a quarterly Learning the Lessons Report for the WCCG IGC and CQRG. This report will include action themes identified, an update on all actions implemented, outstanding actions and improvement outcomes as a result of actions; If there is evidence to indicate that a SI could be part of a cluster or trend, or where the circumstances or consequences of the SI are of particular concern, a wider review may be instigated. It is difficult to be prescriptive, as the extent of that case review will depend upon the nature of the SI. In order to facilitate, sharing the lessons from SIs, certain SI investigations will be discussed at CQRGs. 8.10. Information Sharing The reporting provider organisation must ensure that any reports (SI preliminary analysis investigation reports or STEIS reports and/or correspondence) are sent via the recommended and secure NHS email pipeline only such as *NHS.net, *gsi.gov.uk, *gsx.gov.uk, *cjsm.net or *gcsx.gov.uk. WCCG will support the development of processes which allows for sharing of information between organisations and other sectors to ensure lessons are learned. A variety of approaches will be utilised to facilitate this process. 8.11. De-escalation Process SIs can sometimes be reported based on limited information which on further investigation does not meet criteria for an SI. De-escalating a record on STEIS means that it is deleted from the system and no longer viewable although the email alert will still exist. If it is agreed that the SI does not fall within the definition of a SI, the SI can be removed from STEIS rather than simply closed. If a record is closed instead of de-escalated this means it would be included in any data reporting that is done in terms of numbers of cases. Provider organisations or WCCG (for CCG specific SIs) should request for de-escalation from WCCG Clinical Governance Team using the form on the WCCG website (http://www.wandsworthccg.nhs.uk/pages/home.aspx). Completed de-escalated request forms should be sent to WACCG.SI@nhs.net. The request will be reviewed by the SI Review Group and the Quality and Patient Safety Manager will inform the provider organisation or WCCG investigation Lead (for CCG specific SIs) of the decision within 10 working days. Completely de-escalating records from STEIS will be managed by the NHSE London Region Patient Safety Team. WCCG SI Review Group approved SIs for de-escalation will be emailed to the NHSE London Region Patient Safety Team (london.sui@nhs.net) with the STEIS number of the case being de-escalated. The Patient Safety Team will then arrange for this record to be deescalated but this will take up to a week for the system to update. The NHSE London Region Patient Safety Team will arrange for this record to be de-escalated but this will take up to a week for the system to update. Any de-escalation requests sent by provider organisations to the NHSE London Region Patient Safety Team will be forwarded to the WCCG for a decision. WCCG will provide the provider organisation with regular reports on SIs de-escalated by the WCCG SI Review Group. Wandsworth Clinical Commissioning Group Serious Incident Policy. July 2013 Page 17

8.12. Extension of Submission Period It is recognised that in certain circumstances provider organisations will find it impossible to complete a final report within the national framework timescales. In such cases an extension for exceptional circumstances can be requested from WCCG Clinical Governance Team using the form on the WCCG website (http://www.wandsworthccg.nhs.uk/pages/home.aspx). Completed extension of submission period request forms should be sent to WACCG.SI@nhs.net. Any request for an extension must be made at least 5 working days prior to the due date of the final report, otherwise an extension cannot be granted and the report will be recorded as overdue. Extensions will be agreed by WCCG Clinical Governance Team and will start from the day on which the SI report was due for submission. Following review by the WCCG SI Review Group an extension may be required if further information is requested. The provider organisation or WCCG investigation Lead (for CCG specific SIs) will be informed of this decision within 10 working days of the review. The WCCG Quality & Patient Safety Manager will update the Expected SI Completion Date section on STEIS to reflect when an extension has been granted Wandsworth Clinical Commissioning Group Serious Incident Policy. July 2013 Page 18

9. Additional Guidance 9.1. NHS Funded Provider Organisations with no access to STEIS Any SI involving a patient in receipt of NHS-funded care provided by an independent sector healthcare provider must be reported by that provider to the commissioning organisation with responsibility for the contract. As part of the contractual requirements, all NHS funded providers are expected to have procedures for identifying and handling SIs. All provider organisations should report SIs via the STEIS system, where the provider organisation/service has no access to STEIS, they are expected to notify WCCG immediately using the SI report form on the WCCG website (http://www.wandsworthccg.nhs.uk/pages/home.aspx). Completed forms should be sent to WACCG.SI@nhs.net and by telephone (In Hours: 020 8871 5162, Out of Hours: for high risk SIs only: 08448 222 888 and quote NHS01. This will put you in touch with an NHS England (London) senior manager on-call who can access the out of hours communication team if necessary) within 2 working days of the SI happening. The WCCG Quality and Patient Safety Manager will log the SI on the STEIS system on behalf of that provider organisation. The provider organisation/service must ensure that the investigation is completed and submitted within the framework identified within section 8.5: Submission of Final Report. NHSE London Region Patient Safety Team can, if appropriate, provide access to STEIS for non-nhs providers for reporting purposes as long as those providers are on the NHS N3 network. For NHS 111 specific SIs, the provider organisation will be expected within the Description of what happened section on STEIS to state the SI is NHS111 specific, e.g. (NHS 111). Explanation of what happened. 9.2. Coroner s Verdicts Some SIs involving patient deaths need to have a verdict from a coroner. Where this is the case, the SI final report should be submitted within the appropriate timescale, and not delayed in order to incorporate the coroner s verdict. It must be made clear in the report that a coroner s verdict is awaited and as a result the report will not be closed, the provider organisation must send the verdict (a summary, not the coroner s report) to WACCG.SI@nhs.net. If the coroner s verdict does not present any issues not already covered in the SI final report then it will be closed (assuming it satisfies the criteria for closing an SI). If the verdict presents issues not covered in the final report, then the provider organisation will be required to revise the SI report in order to incorporate these issues and to re-submit. 9.3. Never Events Given the seriousness of these events, there will be a greater level of scrutiny. NHSE and WCCG will be ultimately responsible for closure of Never Event SIs. Closure of the SI will only be achieved where a provider organisation is able to demonstrate evidence of implementation of all actions points within 6 months. In cases where there is uncertainty around the status of a SI as a never event, WCCG and the provider organisation must discuss and agree the categorisation to come to a conclusion as a matter of urgency. Where an agreement cannot be reached by WCCG and the provider organisation, NHSE will be contacted for a conclusion. Never Events Cost Recovery Process: In accordance with applicable guidance, recovery of the cost of the procedure and no charge to commissioner for any corrective procedure or care applies. Once the Contract Manager receives notification of a never event occurring, the notifying provider organisation will be contacted by the contract manager to confirm the never event and obtain any additional information. Wandsworth Clinical Commissioning Group Serious Incident Policy. July 2013 Page 19

Information obtained will be passed onto the Finance Department to recover the cost of the episode of care as per the national contract. The contract manager will be invited to contribute the evaluation of the RCA investigative report for Never Events. 9.4. Delay of Ambulance Handover in an Emergency Department (One Hour or More) A SI will be triggered where patient handover time, which is defined as the time of arrival to the time of transfer to hospital trolley, is in excess of one hour. Handover delays of over one hour should not be occurring in Emergency Departments (EDs). Patients who have not received a clinical handover for this period of time can be at major clinical risk. There is also a major clinical risk for patients waiting for ambulances that cannot be attended to in an appropriate time period because the ambulances are delayed at EDs. For these clinical reasons, as well as that of appropriate governance procedures, it is important that the provider organisations Board are made aware (and ultimately can be held accountable) of such occurrences through a formal reporting process. Classifying these delays as SIs ensures that they are captured investigated and reported to the Board under an established governance procedure. This provides the opportunity for Board level scrutiny and oversight, as well as the instigation of actions to ensure these occurrences are eliminated, leading to an improved quality of care for NHS users. 9.5. Maternity Under the current legislation governing midwifery practice rule 10 of the Midwives Rules and Standards (NMC 2012) states: Ensure that the LSAMO is notified of all adverse incidents, complaints or concerns that relate to midwifery practice or allegations of impaired fitness to practice against a Midwife. The LSAMO for London is based at the NHSE London regional office in Victoria. SIs in maternity care need to be reported through STEIS as soon as possible after the SI is detected and no later than 2 working days of the SI being identified. The aforesaid categories found on the WCCG website (http://www.wandsworthccg.nhs.uk/pages/home.aspx) are not exhaustive. If in doubt, the Patient Safety lead for Maternity at NHSE London region should be contacted for advice. Any initial detailed case review should take place as soon as possible within 2 working days in order to comply with STEIS reporting requirements. The result of the review will determine whether the investigation should continue as a SI. Where this initial review cannot be undertaken within 2 working days or there is doubt regarding care or service delivery factors, the SI should be reported on STEIS and continue as a SI investigation. De-escalation can subsequently be requested if the investigation shows that it does not fulfil the Maternity SI reporting criteria (see section 8.11: De-escalation Process). All maternity services should keep accurate and updated information regarding numbers and rates of the event types above, regardless of presence of care or service factors. Provider organisations may be required to submit this information on request and are encouraged to monitor rates of avoidable harm from incidents as an indicator of patient safety 9.6. SIs Involving a Child/Infant and Adult at Risk In all cases, the safety of the child/siblings and/or adult at risk is paramount. Children and/or adults at risk should be made safe before reporting the SI. However, it is important that reports are timely and consistent. When reporting a SI, the premise of right first time should prevail in that the organisation who will undertake the majority of the investigation should be the one to report onto STEIS. SIs involving children and/or adults at risk will be managed in accordance with this policy and the WCCG Safeguarding policy & Procedures. A reportable SI should be reported no later than 2 working days from the time the SI is known. However, a safeguarding SI is an exception to this Wandsworth Clinical Commissioning Group Serious Incident Policy. July 2013 Page 20

as the full extent of the SI is sometimes not clear until after the initial strategy meeting. Therefore, unless there is media attention, a safeguarding SI should be reported no later than 2 working days of the strategy meeting taking place. Where an SI has received media attention, this should be reported immediately as detailed in the section 8.1: High Risk SIs. Those SIs impacting on children and/or adults at risk will be overseen by the Safeguarding Designated Children Nurse and the Safeguarding Adult Lead and in line with Working Together to Safeguard Children and the relevant safeguarding adult guidance. The Quality and Patient Safety Manager will liaise with the Safeguarding Leads to ensure that local safeguarding procedures are followed. If an unexpected child death SI is reported where there are clearly unexplained circumstances/ safeguarding concerns, these should be reported no later than 2 working days from when the death is known. A death which was originally believed not to be suspicious and not therefore reported follows the Child Death Overview Panel (CDOP) process. The Child Death Overview Panel (CDOP), with a fuller picture of the evidence, may decide that there are safeguarding issues and that it should be referred to the Local Safeguarding Children Board Serious Case Review Panel. The panel may then determine that the SI meets the criteria for a Serious Case Review. In this case, the SI should then be reported onto STEIS and the date of knowledge of the SI will be the date of the referral to the serious case review panel of the Local Safeguarding Children Board. Serious Case Reviews would fall into the Grade 2 / Level 3 category. SIs which have impacted on or have potential to impact on children and/or adults at risk must be investigated in conjunction with the identified CCG Safeguarding Leads and in accordance with related guidance. For the types of maternity, infant and child incidents that should be reported onto STEIS and which are in line with the NPSA Framework, please see the WCCG website (http://www.wandsworthccg.nhs.uk/pages/home.aspx). 9.7. SIs linked with Public Health and/or National Screening Programmes There are a number of screening programmes which require a broader approach to handling SIs. Important points to remember with regard to these SIs are: Public Health and/or National screening or immunisation pathways cross several organisations, SIs affect the whole pathway and not just the local department or organisation in which the SI occurred, Local SIs can affect the national reputation and alter public participation in the programme nationally, Potential SIs are relevant to the rest of a national programme for which it may highlight real SIs elsewhere, Lessons need to be learned across in the rest of the National Programme, The volumes involved in screening can give individually minor incidents a major population impact, There are established regional/national networks of experts who can help with the identification and handling of SIs, Local provider organisations are responsible for highlighting their local SIs to other people/networks in the health system outside the organisation in which the SI took place in the health system who may be impacted by their local SI. Some of the National Programmes already have defined protocols and tools for handling SIs which will be of value in the investigation and the experts can help to guide the provider organisation through these e.g. Breast and cervical. Wandsworth Clinical Commissioning Group Serious Incident Policy. July 2013 Page 21

SIs linked to the breast and cervical screening programmes should, in addition to normal reporting, also be reported to the Head of Public Health, Military and Offender Health Commissioning within 5 working days. Further details on the management of incidents within the breast screening programme are available in Guidelines for Managing Incidents in the Breast Screening Programme http://www.cancerscreening.nhs.uk/breastscreen/publications/pm-09.html For SIs linked to other national screening programmes (e.g. ante natal and child health screening, retinal screening etc.) the Head of Public Health, Military and Offender Health Commissioning will provide advice and will inform the national co-ordinating bodies as appropriate. 9.8. Information Governance SIs The requirement for reporting information governance (IG) SIs will be consistent with the National Framework for Reporting and Learning from SIs Requiring Investigation guidance. All IG SIs will be led by the WCCG IG Manager. WCCG has a duty to escalate to the DoH Business Unit, details of all IG SIs graded as level 3 or above. To enable this to happen, when a level 3 or above IG SI is reported, a checklist for completion will be emailed to the provider organisation SI lead. This must be completed and returned to the WCCG email address: WACCG.SI@nhs.net within 72 hours of the SI being reported on STEIS. Checklist can be found on the WCCG website http://www.wandsworthccg.nhs.uk/pages/home.aspx The DoH has provided additional guidance for how SIs relating to breaches of confidentiality should be dealt with. Any SI involving the actual or potential loss of personal information that could lead to identity fraud or have other significant impact on individuals or has the potential to cause reputational damage should be considered as serious. The reporting of SIs relating to breaches of confidentiality involving person confidential data and data losses should be reported in accordance with DoH Gateway letter 9571 dated 29 February 2008 and Gateway Ref 13177 dated January 2010. The risk assessment matrix in the DoH guidance determines the level of seriousness applied to the IG SI. Reports of such SIs will be published on its website in accordance with the Gateway letter. Further to this all SIs involving data losses and breaches in confidentiality should be published in the annual reports of all provider organisations in accordance with DoH Gateway letter 9912 of 20 May 2008 utilising the format at Annex A of the gateway letter. This type of SI will be reported to the WCCG Senior Information Risk Officer (SIRO)/Caldicott Guardian and the Information Governance Manager. The NHSE London Region Patient Safety Team is responsible for notifying the DoH of any category 3-5 incident and will do this as soon as possible after they have been made aware of such a SI (either through STEIS or other means). Consideration should always be given to informing patients when person confidential information about them has been lost or inappropriately placed in the public domain. When reporting IG SIs, reporting provider organisations should provide the following information: Short description of the SI and associated actions; How the information was held (paper, memory stick etc.); Any safeguards to mitigate risk e.g. encryption, including any potential to reputational damage; Number of individuals whose information is at risk; Types of information e.g. demographic, clinical; Whether individuals concerned have been informed, or whether a decision has/is being made whether to inform; Whether the SI is in the public domain and extent of media interest or publication; Wandsworth Clinical Commissioning Group Serious Incident Policy. July 2013 Page 22

Category of SI (1-5). Loss of encrypted media should not be reported as an SI unless the data controller has reason to believe that the encryption did not meet the DoH Standards that the protections had been broken, or were improperly applied. Considerations when assessing information breach: Make sure you know what personal data is held and where and how it is stored. Dealing with a data security breach is much easier if you know which data are involved. Establish where the biggest risk lies. For e.g., how much sensitive personal data do you hold? Do you sort data across the business or it concentrated in one location? Risks will arise when sharing with or disclosing to others. You should make sure not only that the method of transmission is secure but also that you only share or disclose the minimum amount of data necessary. By doing this, even if a breach occurs, the risks are reduced. Identify weak points in your existing security measures such as the use of portable storage devices or access to public networks. Monitor staff awareness of security issues and look to fill any gaps through training or tailored advice 9.9. Handling Freedom of Information (FOI) Requests Information relating to SIs (including information held on national systems such as STEIS, local databases and internal reports, investigation reports and RCA and other documents) could be subject to a request for disclosure under the Freedom of Information Act. A request for information regarding SIs should follow the WCCG Freedom of Information Guidance. Legally WCCG is obliged to consider the disclosure of this information when it is requested. Since it is information that concerns individual provider organisations or WCCG (for CCG specific SIs), it is important that provider organisations or WCCG (for CCG specific SIs) have the opportunity to comment on what is intended to be provided to requestors. Provider organisations or WCCG (for CCG specific SIs) should be aware that all information relating to SIs including investigation reports could be subject to a request for disclosure under the Freedom of Information Act. Therefore, provider organisations and WCCG (for CCG specific SIs) are advised to ensure that reports are suitably anonymised. SI FOI requests will most commonly be requests for the number of SIs reported by provider organisations and the types of SIs. Provider organisations do provide a description of the SI when they report it on STEIS; however, those descriptions may not be appropriate for release due to the clinical or technical terminology. On STEIS the Line being taken by the organisation should be used to provide a brief description of the SI that the provider organisation accept may be released in the event of an FOI request. This should be written so that it is comprehensible to a lay person that is, without acronyms or highly clinical or technical terminology. Providing this description should not delay reporting on STEIS in the event of a SI. The provider organisation does not have to complete the Line taken box immediately. In the event of a FOI request the provider organisation likely to be affected by the request will be contacted and informed the FOI request. WCCG will make a decision regarding how to proceed with meeting the FOI request within a given period. The SI category that is entered onto STEIS will be the category WCCG may have to report in the event of a FOI request. Therefore, it is important that provider organisations ensure they are satisfied that STEIS is accurate and up to date. If, for example, a coroner s verdict has ruled that a suspected suicide was actually due to some other unexpected circumstances it is the responsibility of the provider organisation to update STEIS accordingly. Wandsworth Clinical Commissioning Group Serious Incident Policy. July 2013 Page 23

9.10. Handling Media Interest SIs can be triggers for media coverage and increased public scrutiny. A well-planned, structured media management protocol is vital in managing SIs effectively. Every SI has potential for adverse media interest and for this reason the NHSE and other relevant parties must be notified. The Quality and Patient Safety Manager will: Keep WCCG Communications Lead informed of any SIs reported, visit the intranet for the most up-to-date contacts or call 020 3458 5717 or email media@swlondon.nhs.uk. For out of hours Press Office: 07584 610055), where the Communications Manager will advise on the appropriate actions required. Seek guidance from WCCG s Solicitors as necessary See Section 8.1 for how high risk SIs will be handled. In forensic/criminal cases, all communications with the media should be led by the Police in partnership with the relevant agencies involved with the SI. 9.11. Lead Commissioner Role WCCG does not have automatic access to STEIS for provider organisations where they are not the lead commissioner (e.g. South West London). In circumstances where there are multiple commissioning CCGs the principles for identifying the lead commissioner for the purposes of SI management is key. There is no one-size-fits-all approach for the entire NHS as circumstances will vary from place to place, as will the involvement of other organisations such as CSUs. WCCG is the lead commissioner for St Georges Healthcare NHS Trust. All SI management information and reports will be made available to the commissioner where the patient involved in the SI is a resident. Based on the Memorandum of Agreement between CCGs, the WCCG Quality and Patient Safety Manager will ensure all commissioners are aware that an SI involving their resident has occurred and that even where not directly managing an SI, all commissioners have access to the SI information. Regular reports on WCCG s provider organisation will be made available to the relevant commissioners, including trend and theme. Memorandum of Agreement created with respective CCG around notifying WCCG of SIs involving our residents or where the CCG commissions services (Chelsea & Westminster NHS Foundation Trust, Guys and St Thomas NHS Foundation Trust, Kingston Hospital, Epsom & St Helier s Hospital) 9.12. Reporting to NHS England London (NHSEL) Regional Office: Primary Care All services delivered in London which are directly commissioned by NHSEL (e.g. Primary Care) must report SIs and potential SIs to the NHSEL Patient Safety Team via STEIS or by completing the NHSEL SI Reporting form (http://www.wandsworthccg.nhs.uk/pages/home.aspx). Completed form must be email to london.sui@nhs.net (see Appendix G: NHSEL Primary Care SI Reporting & Investigation Procedure) The words Serious Incident Notification must be used in the subject of the email. The SI should be reported as soon as possible after the incident is detected and no later than 2 working days of the SI being identified. The NHSEL Patient Safety Team (PST) can provide advice on the management of SIs and can be contacted by telephone during normal office hours on 020 7932 2659 and email correspondence should be sent to london.sui@nhs.net. The report must not contain any patient or staff identifiable data (including initials of names) and the description should be concise. The NHSEL Patient Safety Team can provide on the management of SIs and can be contacted by telephone during normal office hours on 020 7932 2659. Wandsworth Clinical Commissioning Group Serious Incident Policy. July 2013 Page 24

Where an SI of particular gravity occurs, it should be reported to the NHSEL regional office immediately by telephone During normal office hours: 020 7932 2659 Out of office hours 0844 822 2888 (Page one bureau) and quote NHS01 If the SI has not been reported on STEIS, the NHSEL Patient Safety Team will create a report on STEIS. Each provider is responsible for investigating the incidents that have occurred. The NHSEL PST endorses the use of the NPSA s RCA framework to investigate all SIs, however it is recognised that some independent contractors may not yet have the capability to fully utilise these investigations tools: http://www.nrls.npsa.nhs.uk/resources/. For some providers and in some circumstances it may be appropriate for the NHSEL PST to coordinate an investigation. Furthermore, in some cases the NHSEL PST may appoint an independent investigator to undertake the investigation. It is recognised that some independent contractors do not have the infrastructure or expertise to undertake investigations and in these cases support can be provided by the NHSEL PST. There are circumstances when a SI may involve a number of providers. If more than one provider is involved in a SI, the relevant commissioners will take a decision on who will act as the lead provider for the purposes of reporting, investigation and incident management. Report format, action plans, submission of final reports, quality assurance of SI final report by the NHSEL PST, extension of submission report and monitoring of action plans will be in accordance with (see NHS England London SI Reporting, April 2013) 9.13. NRLS All serious patient safety incidents must be reported to the NRLS system for the purpose of national learning and to comply with CQC registration requirements regarding the reporting of incidents leading to severe harm or death. This should be done without delay. All provider organisations must have agreed processes for reporting patient safety incidents via the NRLS. The Quality and Patient Safety Manager will have arrangements in place to assure the WCCG SMT that SIs are reported by provider organisations to the NRLS and other bodies as appropriate. Most of the requirements for the CQC as defined in current guidance are met by providing incidents reports about SIs and deaths via the NRLS. The NRLS will forward relevant information to the CQC but if there is any doubt, the CQC can be informed directly. All Independent sector healthcare providers should report patient safety incident to the NRLS (e.g. via the e-form of the NRLS). They are also responsible for reporting the incident directly to the CQC. 9.14. Involvement of Multiple Provider Organisation: Deciding on which organisation reports the SI may be complex and differs depending on the circumstances. When more than one provider organisation is involved in an SI, it is the responsibility of the provider organisation identifying the SI to liaise with the other provider organisation involved to agree which organisation will report on STEIS within 2 working days. WCCG through a facilitated meeting (e.g. NHS 111 Clinical Lead) will determine the provider organisation leading on the investigation. This decision will be made based on the provider organisation with the most significant involvement in the SI. All organisations are required to contribute and fully co-operate to the RCA investigation process in a timely, responsive and cooperative manner. It is the responsibility of the provider organisation leading on the investigation of the SI to coordinate and monitor the investigation process through their own systems, liaising and providing requests for information and/or feedback to any participating provider organisation and WCCG if necessary and appropriate. (see Appendix F: Involvement of Multiple Provider Organisation Algorithm). Wandsworth Clinical Commissioning Group Serious Incident Policy. July 2013 Page 25

The WCCG Quality and Patient Safety Manager will liaise with key stakeholder (e.g. NHS 111 Clinical Lead) and other commissioners to ensure that all relevant parties are notified and involved in the monitoring of the SI. The final RCA investigation report should be submitted to the WACCG.SI@nhs.net within the national timescale of either 45 or 60 working days. Evaluation of the SI will follow the process identified within section 8.6: SI RCA investigation Report Evaluation Process. Following the investigation of a SI, the submitted SI RCA investigation report must include an action plan which sets out how each recommendation from the investigation will be implemented. Each provider organisation allocated actions to be delivered will be responsible and accountable for the delivery. The WCCG Clinical Governance Team may be contacted to provide support and/or advice. Contacting the WCCG Clinical Governance Team: In Hours: 020 8871 5162, Out of Hours: for high risk SIs only: 08448 222 888 pager call sign WAND1, or Phone 020 8870 2032/020 8874 3200 & ask for the on-call Manager, email: WACCG.SI@nhs.net. 9.15. Good Governance Principles Regardless of the individual circumstances, both commissioner and provider organisations should; Work in an open and transparent manner with each other when a SI has happened; Ensure that a board director, in both commissioner and provider organisations, is formally designated to lead on, and be responsible for, patient safety and the management of SIs, including responsibility for the appropriate closure of SI files; Have a relevant committee identified to consider and monitor SI investigations. Such committees should also be responsible for ensuring that regular thematic reviews are undertaken to extract learning and support the development of organisational memory with regard to patient safety; Have systems for commissioner and provider Boards to receive regular briefings on the detail of significant issues, trends and other analysis on SIs. This information should be tailored to the appropriate level of detail for the Board concerned provider Boards should review every SI individually. Commissioner Boards may only review a selection of SIs in detail. Both Boards should receive summary information including the number of SI files open beyond deadlines in order to help gain assurance that appropriate action has, or is, being taken to safeguard patients and staff. In this regard, the impact on individual patients and on staff should be clearly understood. This should be undertaken in accordance with the SI Evaluation Critiquing Tool; Ensure that the contribution of patients and front line staff remains central to improving standards of care, including involving patients in all investigations; Monitor the implementation of action plans including the effectiveness of any changes implemented following an investigation; Have robust processes to ensure that investigations into SIs are undertaken in a timely manner and that they enable shared learning at local, and / or regional, national levels as appropriate; Ensure that all SIs are disclosed to those affected in a timely manner, appropriately reported and investigated, with the findings being shared with those involved in accordance with the Being Open Framework guidance and the contractual duty of candour requirements. Face to face meetings between the staff involved and the patient and their families/carers should be actively considered and supported; Manage any staff related issues identified during the course of an investigation within the principles of an open and just culture ; Wandsworth Clinical Commissioning Group Serious Incident Policy. July 2013 Page 26

Ensure that the local Safeguarding Adult Boards/local Safeguarding Children Boards have been notified of relevant SIs and agree arrangements for the management of SCRs including action planning and learning from SIs. This should include robust communication between safeguarding boards, commissioners, regulators and providers; Understand and apply reporting and liaison requirements with regard to agencies such as the Police, Public Health England, Health and Safety Executive, Coroner, Education Partners, Local Midwifery Supervising Authority or Medicines and Healthcare Products Regulatory Agency (MHRA); Ensure SIs are reported to the appropriate bodies, including the CQC, and, for patient safety incidents, the NRLS; and Ensure that in the case of foundation trusts, or those trusts in the advance stage of making an application for foundation trust status, Monitor must be informed. The TDA should also be informed in the case of non-foundation trusts. Apply relevant information governance principles to all information representing potentially sensitive data. This includes maintaining appropriate access controls around STEIS and local incident management systems and applying appropriate policies to all communications regarding SI information. Apply human factors principles to SI investigations, for example as set out in the Clinical Human Factors Group Interim Report and Recommendations for the NHS and the Clinical Human Factors Group report Never?. Wandsworth Clinical Commissioning Group Serious Incident Policy. July 2013 Page 27

Structural Chart Appendix A Director of Corporate Affair, Performance & Quality Registered Nurse on the Board Head of Clinical Governance & Lead Nurse Quality & Patient Safety Manager Clinical Governance Manager Customer Care Manager Safeguarding Adult Lead Safeguarding Children designated Doctor Safeguarding Children GP Lead Safeguarding Children Designated Nurse Deputy Clinical Governance Lead: NHS 111 Quality & Patient Safety Facilitator Quality Team Administrative Support Wandsworth Clinical Commissioning Group Serious Incident Policy. July 2013 Page 28

Wandsworth CCG Serious Incident Management & Assurance Group (SIMAG) Terms of Reference (ToR) Wandsworth Clinical Commissioning Group Serious Incident Policy. July 2013 Page 29 Appendix B 1. Purpose The SIMAG is a sub-group of the Integrated Governance Committee (IGC) and is the designated forum with responsibility for providing assurance to the Wandsworth CCG Integrated Governance Committee and the Board on the management of SI systems and processes (including CCG SIs). The group will: Identify trends and themes arising from SIs reported by provider organisations. Monitor action plan implementation and improvement outcomes as a result of SI investigation Monitor new and outstanding actions Approve reports to be presented at IGC and provider Clinical Quality Review Group meetings Ensure provider organisations and the CCG is meeting local and national guidelines and learning 2. Scope The Group is responsible for providing the IGC and Board with assurance that SIs occurring within provider organisations and the CCG s SI are robustly investigated and lessons are learnt. 3. Terms of Reference The Group will: Ensure monitoring and implementation of actions agreed as a result of SI investigations Ensure that evidence of demonstrable outcomes from SI action plans is available and monitored Agree dissemination of learning from SIs Review any identified trends Gain assurance that provider organisations systems, process and policies are robust enough to manage SIs and learn the lessons 4. Accountability The SIMAG is accountable to the IGC and the CCG Board to which data analysis will feed into the IGC & CQRG reports. The SIMAG Chair will escalate any concerns to the IGC and/or CCG Board. Ensuring risks have been entered onto the Risk Register. 5. Membership The SIRG consists of the following members: Registered Nurse Member of the Board Chair Head of Clinical Governance and Lead Nurse GP Lead Clinical Lead Director of Corporate Affair, Performance & Quality Quality and Patient Safety Manager Clinical Governance Manager Public Health Lead Nurse

Practice Nurse Development Lead Administrative Assistant Subject Matter Expert: as and when required 6. Quorum The Group will be quorate by the attendance of at least two of the following members Chair or Deputy Chair GP or Clinical Lead Quality and Patient Safety Manager Clinical Governance Manager 7. Reporting Arrangements Data analysis information from the SIMAG will be fed into monthly CQRG and IGC reports. 8. Frequency of Meetings A SIMAG meeting will take place monthly to focus and discuss merging trends and patterns, concerns, risks, action plan monitoring update and approving reports to be presented at CQRGs and IGC. 9. Confidentiality The SIMAG will be held in private due to the confidential nature of SIs. Confidentiality will be maintained to ensure that patient and/or staff confidential information are not included. 10. Support The Group will be supported by the Administrative Assistant and Quality and Patient Safety Manager. Date agreed: 25.June.2013 Wandsworth Clinical Commissioning Group Serious Incident Policy. July 2013 Page 30

Appendix C Wandsworth CCG Serious Incident Review Group (SIRG) Terms of Reference (ToR) 11. Purpose The SIRG is a sub-group of the Serious Incident Management & Assurance Group (SIMAG) and is the designated forum with responsibility for reviewing, evaluating and critiquing all SI (including Never Events) investigation reports (including the CCG s SIs). The purpose of the Group is to: Confirm and challenge each final SI investigation report received to ensure that a thorough investigation has taken place to identify the root causes, appropriate recommendations and actions to minimise reoccurrence. Identify lessons learnt and how the learning have been or will be shared. Agree closure of SI reports on STEIS. A summary outcome detailing SIs closed and the reasons for any that were not closed would be reported to the SIMAG. 12. Scope The Group is responsible for providing the WCCG IGC and Board with assurance that SIs occurring within provider organisations are robustly investigated, lessons are learnt and that national standards are met. 13. Terms of Reference The Group will: Evaluate SI investigation reports submitted by provider organisations and the CCG using the Critiquing and Evaluation Tool. Evaluate, sign-off and close all SI investigations, including CCG SIs, legacy SIs and SIs for provider organisations where WCCG is not the lead commissioner but the SI involves a Wandsworth resident (e.g. South West London and St George s Mental Health Trust, Nursing Home, NHS 111, Safeguarding Children and Adult SIs from Local Authority). Ensure reports deemed to be unsatisfactorily investigated are returned to the provider organisation or the CCG investigation officer to be re-submitted within a newly agreed timescale. The additional information requested by the Group will be identified within the completed evaluation tool. Any joint investigations will be brought to this forum for review and discussion. 14. Accountability The SIRG is accountable to the SIMAG to which SI investigation report update and data analysis will feed. The SIRG Chair will escalate any concerns to the SIMAG and risks will be entered onto the Risk Register. 15. Membership The SIRG consists of the following members: Head of Clinical Governance and Lead Nurse - Chair GP and/or Clinical Lead (Virtual members) Subject Matter Expert: as and when required (i.e. infection control, safeguarding leads, medicines management lead, IG manager) Quality and Patient Safety Manager Deputy Chair Wandsworth Clinical Commissioning Group Serious Incident Policy. July 2013 Page 31

Clinical Governance Manager Administrative Assistant Commissioning/Contract Manager (in the case of Never Events, in order to agree cost recovery) 16. Quorum The Group will be quorate by the attendance of at least two of the following members Chair GP or Clinical Lead Quality and Patient Safety Manager Clinical Governance Manager 17. Reporting Arrangements Data analysis information from the SIRG will be fed into monthly SIMAG. 18. Frequency of Meetings A SIRG meeting will take place weekly to evaluate and critique all SI investigation reports. An extraordinary SIRG meeting may be convened by the Chair at the request of the Head of Clinical Governance and Lead Nurse if deemed appropriate. If urgent action is required a virtual meeting may be convened. 19. Confidentiality The SIRG will be held in private due to the confidential nature of SIs. Confidentiality will be maintained to ensure that patient and/or staff confidential information are not included. 20. Support The Group will be supported by the Administrative Assistant and the Quality and Patient Safety Manager. Date agreed: 25.June.2013 Wandsworth Clinical Commissioning Group Serious Incident Policy. July 2013 Page 32

Process for Management of Serious Incidents (SI) including Never Events Patient Safety Manager notifies WCCG SMT, NHSCB, NTDA ASAP of High risk and/or media interest SI (Major Incident Policy activated) Appendix D High risk SIs notified to Q&S Team immediately via phone: In & Out of Hrs (contact Patient Safety Manager for advice if needed) Patient Safety Manager liaises with SLCSU Comms (if necessary) (If high risk SI, NHSCB, NTDA, DH Media Centre contacted) Red: WCCG Green: Provider Orange: High Risk SI Occurs Contacting WCCG In Hours: 020 8871 5162, Out of Hours: for high risk SIs only: 08448 222 888 pager call sign WAND1, or Phone 020 8870 2032/020 8874 3200 & ask for the on-call Manager SI reported on STEIS within 2 working days (No STEIS access, complete SI report form & submit to WACCG.SI@nhs.net) Patient Safety Manager receive instant SI alert notification via STEIS (including Out of Hours) Patient Safety Manager notifies relevant stakeholders (i.e. Safeguarding Leads, IG Manager, NHS 111 Clinical Lead) Quarterly CQRG & Quality Committee update on action plan implementation (Patient Safety Manager to do report) Patient Safety Manager agrees SI grade, timescale with Provider (with e.g. 111 Clinical Lead) Patient Safety Manager sends weekly SI update to SMT & NHS 111 Clinical Lead & Relevant CCGs (where necessary) Dissemination of lessons learned (Newsletters, workshops, etc) Provider organisation submits completed SI RCA investigation report within 45/60 working days Satisfactory Report (SI RCA investigation report signed off, approval granted for closing on STEIS) SI RCA investigation report feedback given to Provider organisation via completed SI Evaluation Critiquing Tool (Patient Safety Manager to coordinate) Bi-Monthly action plan implementation assurance visits with Provider organisation (HoCG, SIRG member, Patient Safety Manager) Provider organisation SI RCA investigation report reviewed by SIRECG using SI Evaluation Critiquing Tool (includes NHS 111 Clinical Lead) Unsatisfactory Report (reason given, re-submission timescale discussed and agreed) Wandsworth Clinical Commissioning Group Serious Incident Policy. July 2013 Page 33

Incident Grade Grading of SIs This table provides a guide to the grading of SIs for investigation purposes: Example Incidents (these are suggestions, not definitive) Investigation Grade and action Timeframe Appendix E 1 2 Grade 1 incident examples: Apparent suicide of people currently under the care of community Mental Health services Mental health inpatient attempted suicides Avoidable or unexplained death Missed Ambulance service arrival target, resulting in patient death/severe harm HCAI outbreaks Grade 3 and 4 pressure ulcers Data loss & information security (DH Criteria level 2) Adult safeguarding incident Grade 2 incident examples: Inpatient suicides (including following absconsion) Maternal deaths Child protection incidents Never events Accusation of physical misconduct or harm Data loss and information security (DH Criteria level 3-5) Selected Grade 2 incidents: The need for independent investigations is identified and arranged by the Commissioner / commissioning sector(sha cluster) or NHS England. Homicides following recent contact with mental health services require an independent investigation. For example a major system failure with multiple stakeholders Investigation Level 1 Concise Root Cause Analysis (RCA) for incidents involving No Harm and Low Harm. Investigation Level 2 Comprehensive RCA for incidents involving moderate and severe harm or death Investigation Level 2 Comprehensive RCA Investigation Level 3 Independent RCA Following initial reporting within 2 working days, the provider organisation must submit a completed investigation within 45 working days Following initial reporting within 3 working days, the provider organisation must submit a completed investigation within 60 working days Following initial reporting within 3 working days independent investigators should be commissioned to complete an investigation within 6 months Wandsworth Clinical Commissioning Group Serious Incident Policy. July 2013 Page 34

Process for Management of SIs (including Never Events): Involvement of Multiple Provider Organisations Red: WCCG Green: Provider Orange: High Risk Provider organisation identifying SI liaises with other providers involved to agree STEIS reporter within 2 working days SI Occurs High risk SIs notified to CG Team immediately via phone: In & Out of Hrs (contact Patient Safety Manager for advice if needed) Appendix F Identified STEIS reporter reports SI on STEIS within 2 working days (No STEIS access, complete SI report form & submit to WACCG.SI@nhs.net) Patient Safety Manager receive instant SI alert notification via STEIS (including NHS 111 and Out of Hours) Commissioner (e.g. NHS 111 clinical lead) determines which provider organisation leads on the SI investigation Patient Safety Manager notifies WCCG SMT, NHSCB, NTDA ASAP of High risk and/or media interest SI (Major Incident Policy activated) Patient Safety Manager liaises with SLCSU Comms (if necessary) (If high risk SI, NHSCB, NTDA, DH Media Centre contacted) Patient Safety Manager notifies all providers of the investigation lead provider SI Management Algorithm applies All providers are expected to contribute to and cooperate with the investigation. The provider leading the investigation will coordinate and monitor the investigation process The RCA Investigation report submitted must include an action plan setting out how each provider will implement recommendations Contacting WCCG In Hours: 020 8871 5162, Out of Hours: for high risk SIs only: 08448 222 888 pager call sign WAND1, or Phone 020 8870 2032/020 8874 3200 & ask for the on-call Manager Each Provider organisation allocated actions will be accountable and responsible for their delivery Wandsworth Clinical Commissioning Group Serious Incident Policy. July 2013 Page 35

Appendix G NHS England London Region Primary Care SI Reporting and Investigation Procedure Wandsworth Clinical Commissioning Group Serious Incident Policy. July 2013 Page 36