Serious Incident Management CCG Policy Reference: SIM 001

Transcription

1 Serious Incident Management CCG Policy Reference: SIM 001 This policy replaces or supersedes Policy Ref: THIS POLICY WILL BE APPROVED BY THE POLICY REVIEW GROUP OF THE CLINICAL COMMISSIONING GROUP (CCG) GOVERNING BODY, AND WILL HAVE EFFECT AS IF INCORPORATED INTO THE CONSTITUTION AS PART OF THE SCHEME OF DELEGATION. Target Audience Brief Description (max 50 words) Action Required Governing Body members, sub-committee members and all staff working for, or on behalf of, the CCG This policy sets out the principles by which the CCG will develop, manage and review all Serious incidents It is the duty of NWS CCG to establish and maintain robust arrangements for monitoring and performance managing SIs reported by services commissioned by NHS North West Surrey CCG. NHS North West Surrey CCG is committed to this policy through the implementation of a robust consistent approach for the management of SIs. This policy is a living document and will be reviewed in line with specified review dates or when a national or local change occurs. As the system learns and matures, relevant changes will be considered and made where appropriate. The Corporate Service Manager will establish and maintain a corporate register of all policies and their status, and will ensure that these are appropriately reflected on the website. Document Title: Serious Incident Management V3 Issue date: April 2014 Document Status: Final Review date: October 2015 Page 1 of 63

2 Reader Information Title Policy Register Number Rights of Access Type of formal paper Category Format Language Document purpose and description Serious Incident Management SIM001 Private Policy & Procedure Word Document English This document provides a framework for the management of serious incidents Name & Title of Author(s) Initial policy written by the Quality Team at South London Clinical Commissioning Support Unit (SLCSU). Revised in October 2013 by Caroline Simonds, Quality and Patient Safety Manager NHS North West Surrey CCG Publication Date 14 March 2013 Dissemination and Implementation details This policy will be disseminated and implemented as outlined below: NHS North West Surrey CCG Quality Team will disseminate the contents of the policy within the CCG and to its commissioned services. Responsibility for NHS North West Surrey CCG Quality Team implementation Review Date October 2015 Disposal Date As per CCG processs Target Audience NWS CCG and Providers Circulation List Consultation Refer to version control Process References National Patient Safety Agency. (NPSA) National Framework for Reporting and Learning from SIs, NPSA 2010, available at National Patient Safety Agency (NPSA) Seven Steps to Patient Safety. The full reference guide. Available at March 2010 Department of Health DH (2004) Memorandum of Understanding: investigating Patient Safety Incidents National Patient Safety Agency (2009) Being Open communicating patient safety incidents with patients, their families and carers. Document Title: Serious Incident Management V3 Issue date: April 2014 Document Status: Final Review date: October 2015 Page 2 of 63

3 DH The never events lists 2011/12: Policy framework for use in the NHS, February 2011 Information resource to support the reporting of serious incidents: NHS London reporting serious incidents: NPSA Three Levels of Root Cause Analysis (RCA) investigation guidance: Root Cause Analysis (RCA) investigation guidance: Root Cause Analysis (RCA) investigation reporting writing templates: Patient safety resources: Checklist for reporting, managing and investigating information governance serious untoward incidents: ons/publicationspolicyandguidance/dh_ National Reporting and Learning Service (NRLS): National Patient Safety Agency: Safeguarding children serious case review policy: Ministry of Justice: Guidance for coroners on changes to Rule 43: Coroner reports to prevent future deaths National Patient Safety Agency, The Never Event Policy Framework, An update to the never events policy: 2012: -events-policy-framework-update-to-policy.pdfnational Patient Safety Agency (NPSA 2009). Being open: communicating patient safety incidents with patients, their families and care. Available at: Department of Health. Independent investigation of adverse events in mental health services.5. Department of Health Available at: ons/publicationspolicyandguidance/dh_ National Patient Safety Agency. Good practice guidance Document Title: Serious Incident Management V3 Issue date: April 2014 Document Status: Final Review date: October 2015 Page 3 of 63

4 Independent investigation of serious patient safety incidents in mental health services 2008 NHS Communications Link. Available at: Superseded Document Financial Resource Implications Department of Health Human Factors Group Interim Report (March 2012). Available at: Care Quality Commission. Essential standards of quality and safety. CQC. 2010; Availalbe at: Clinical Governance and Safeguarding Adults An Integrated Process: Clinical%20governance%20and%20adult%20safeguardin g.pdf Surrey Safeguarding Adults Board policies and procedures which can be accessed via the following link: Surrey Safeguarding Children Boards Policies and Procedures, which can be accessed via the following link: New Document Ratification History Version Date Committee/Group Outcome 2 October 2013 Governing Body Approved 3 April 2014 Policy Sub Group Approved Document Review Control Information Version and Status Date of Change Draft Jan 2013 April 2013 April 2013 April 2013 Title of reviewer SLCSU Senior Nurse & Clinical Governance Lead NHS NW Surrey CCG Head of Quality/ Chief Nurse Description of Change First version of this policy Comments reflected in the policy NHS NW Surrey CCG Comments reflected in the Document Title: Serious Incident Management V3 Issue date: April 2014 Document Status: Final Review date: October 2015 Page 4 of 63

5 Director of Quality and Innovation May 2013 NHS North West Surrey CCG Quality and Performance Committee members June 2013 NHS North West SurreyCCGClinical Executive Committee members Version 1 July 2013 NHS North West Surrey CCG Governing Body Version 2 October 2013 NHS North West Surrey Quality Team Version 3 April 2014 NHS North West Surrey Quality Team policy Comments reflected in the policy Addition of reference to Surrey Safeguarding Adults and Children s processes. Policy approved Amendments to reflect the transition of the Quality team from SLCSU to NHS North West Surrey CCG (NWS CCG) Amendment to the policy to reflect the new SI closure process Equality Impact Assessment (EIA) NWS CCG aims to design and implement services, policies and measures that meet the diverse needs of their service and workforce, ensuring that none are placed at a disadvantage over others. The Equality Impact Assessment is designed to help staff consider the needs and assess the impact of the policy. Policy author(s) must undertake this assessment. Initial assessment Yes/No Comments Does this document affect one group less or more Considerations has favourably than another on the basis of: been made to Race Yes presenting the Ethnic origins (including gypsies and travellers) format of this Nationality document to Gender comply with & to Culture provide alternative Religion or belief medians i.e. Large Sexual orientation including lesbian, gay and print and audio, bisexual people Age Disability learning disabilities, physical disability, sensory impairment and mental health problems Is there any evidence that some groups are affected No differently? If you have identified potential discrimination, are there No any exceptions valid, legal and/or justifiable? Is there a need for external or user consultation Yes Document Title: Serious Incident Management V3 Issue date: April 2014 Document Status: Final Review date: October 2015 Page 5 of 63

6 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? 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 NWS CCG Quality Manager 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 Director of Corporate Development and Assurance Was a full impact assessment required? No What is the level of impact? Low Document Title: Serious Incident Management V3 Issue date: April 2014 Document Status: Final Review date: October 2015 Page 6 of 63

7 Contents 1 INTRODUCTION POLICY STATEMENT DEFINITION OF A SI PURPOSE AND AIMS SCOPE ROLES AND ACCOUNTABILITIES PROCEDURE FOR REPORTING AND LEARNING FROM SIS Additional guidance on serious incident reporting and grading is provided in appendix E DISSEMINATION OF LEARNING MONITORING COMPLIANCE AND EFFECTIVENESS Appendix A Definitions Adverse Event/Incident See Patient Safety Incident Hazard: a hazard is something that has the potential to cause harm Neonate: a child aged between 0 to 28 days Appendix B1 Never Events Core List Appendix B2 Cost Recovery Process Algorithm Appendix C Procedure for Reporting and Investigating Sis The serious case review template will be used in the case of safeguarding children SI Appendix D Steps be taken when a serious incident occurs simplified flowchart Red = NWS CCG Responsibility Appendix E Additional Guidance Serious Case Reviews would fall into the Grade 2 / Level 3 category Appendix F NHS NW Surrey Serious Incident Closure Panel Appendix G Grading of Sis Appendix H Serious Incident Requiring Investigation (SIRI) 72 Hour Report Appendix I De escalation Request Form Document Title: Serious Incident Management V3 Issue date: April 2014 Document Status: Final Review date: October 2015 Page 7 of 63

8 Appendix J Notification Form Appendix K Serious Incident Extension Request Form Appendix L Information required by the Department of Health for Category 3+ Information Governance SUIs Appendix M Guidance for Maternity, Infant and Child Sis Appendix N DOH Gateway Letter Definition of a SI in relation to Personal Identifiable Data Immediate response to SI Assessing the Severity of the Incident Informing Patients Appendix O Clinical Governance and Adult Safeguarding Flowchart Document Title: Serious Incident Management V3 Issue date: April 2014 Document Status: Final Review date: October 2015 Page 8 of 63

9 1 INTRODUCTION This policy outlines the systems and processes within which serious incidents will be reported and managed. It applies to serious incidents reported by organisations for which NHS North West Surrey CCG is lead commissioner. NWS CCG will work with other CCGs and Commissioning Support Units in relation to serious incidents reported by other providers for which the CCG is not the lead commissioner ( e.g. Surrey and Borders Partnership Trust, other acute provider Trusts). The vast majority of patients receive high standards of care, however incidents do occur and it is important they are reported and managed effectively. As a provider of Serious Incident (SI) management services to NHS North West Surrey Clinical Commissioning Group (CCG), is committed to promoting patient safety and making an effective contribution to the CCG s vision of no avoidable deaths, injury or illness and no avoidable suffering or pain. SIs in healthcare are uncommon but when they occur the NHS has a responsibility to ensure there are systematic measures in place for safeguarding people, property, NHS resources and reputation. NHS North West Surrey CCG will ensure that appropriate management systems are in place across North West Surrey CCG Commissioned providers to: Meet nationally identified standards; Report all SIs in a timely fashion and without prejudice; Have systematic measures in place to robustly and effectively manage SIs. Ensuring actions are taken to improve quality and safety and to minimise the risk of future reoccurrences; Sharing the learning. Intelligence gained from SIs will be used to influence contract monitoring, quality and safety standards for care pathway development and service specifications. One of the key principles of patient safety improvement is that of incident reporting. Reporting is the first stage in learning the lessons from an incident and ensuring it can never happen again. Failure to report a SI is simply unacceptable and a sign of real cultural and safety failings in an organisation. As has been noted by Sir Liam Donaldson, to err is human, to cover up is unforgivable, and to fail to learn is inexcusable. This policy is based on the National Patient Safety Agency (NPSA) s National Framework for Reporting and Learning from Serious Incidents Requiring Investigation NWS CCG has adopted this framework in full and will be adhering to the guidance contained in the framework. The National Commissioning Board SI framework, published in March 2013 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 Document Title: Serious Incident Management V3 Issue date: April 2014 Document Status: Final Review date: October 2015 Page 9 of 63

10 the framework according to the revised organisation of the NHS as is reflected in the document. From April , as part of the new registration requirements arising from the Health and Social Care Act 2008, commissioned providers are required to notify the Care Quality Commission (CQC) about events that indicate or may indicate risks to ongoing compliance with registration requirements, or may lead to changes in the details about the commissioned provider in the CQC s register. Reports about SIs and deaths are defined in the CQC s guidance, Essential Standards of Quality and Safety. These requirements are met by reporting via the NPSA, and the NPSA will forward relevant information to the CQC. Primary medical services providers, dental providers and independent health care providers must submit all notifications directly to CQC; they cannot submit notifications to the CQC through the former NPSA National Reporting and Learning System (NRLS).Surrey and Sussex area team will be responsible for managing serious incidents reported within primary care however NWS CCG will link with the Surrey and Sussex area team to ensure information on incidents relating to NHS North West Surrey primary care providers can be included in quality reporting within the CCG. 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 the organisational changes within the NHS. Serious incident (including Never Events) reporting requirements are specified in the contracts with all providers. 2 POLICY STATEMENT It is the duty of NWS CCG to establish and maintain robust arrangements for monitoring and performance managing SIs reported by services commissioned by NHS North West Surrey CCG. NHS North West Surrey CCG is committed to this policy through the implementation of a robust consistent approach for the management of SIs. This policy is a living document and will be reviewed in line with specified review dates or when a national or local change occurs. As the system learns and matures, relevant changes will be considered and made where appropriate. 3 DEFINITION OF A SI There is no simple definition of a SI. What may at first appear to be of minor importance may, on further investigation, be found to be serious and vice versa. A serious incident requiring investigation is defined as an incident that occurred in relation to NHS-funded services and care resulting in one of the following outcomes or scenarios outlined in A serious incident requiring investigation is defined as an incident that occurred in relation to NHS-funded services and care resulting in one of the Document Title: Serious Incident Management V3 Issue date: April 2014 Document Status: Final Review date: October 2015 Page 10 of 63

11 following: Unexpected or avoidable death of one or more patients, staff, visitors or members of the public; 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, for example, actual or potential loss of personal/organizational information, damage to property, reputation or the environment, or IT failure; Allegations of abuse Adverse media coverage or public concern about the organisation or the wider NHS One of the core set of Never Events as updated on an annual basis Further information on serious incident guidance is provided in Appendix A, SI Definitions (NPSA 2009). Never Events Never Events are serious, largely preventable patient safety incidents that should not occur if the available preventative measures have been implemented by healthcare provider and guidance on the events classified as never events is outlined appendix B along with the cost recovery algorithm used in relation to these events. 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 commissioned providers ability to deliver ongoing healthcare. 4 PURPOSE AND AIMS The purpose of this policy is to describe the NWS CCG framework for reporting and managing SIs reported by NHS North West Surrey CCG Commissioned Organisations. The policy aims to ensure that North West Surrey CCG complies with current legislation, National Guidance and the NHS Commissioning Board SI Framework (NHSCB) with regard to SI reporting, investigation evaluation of the management process. 5 SCOPE This policy applies to all providers for whom NHS North West Surrey CCG is the lead commissioner. Document Title: Serious Incident Management V3 Issue date: April 2014 Document Status: Final Review date: October 2015 Page 11 of 63

12 6 ROLES AND ACCOUNTABILITIES Both commissioning and commissioned providers, whether in primary, secondary or tertiary care, are accountable for effective governance and learning following a serious incident. The precise split of responsibilities between organisations varies with the type of provider and commissioner, and the particular circumstances of each serious incident. Each Commissioned Provider must ensure compliance to the commissioners instructions of SI reporting. CCG responsibilities with respect to SI management are outlined in Appendix C (previously A). 6.1 NHS North West Surrey CCG Chief Officer: is accountable for ensuring the CCG has the necessary management systems in place to enable the effective implementation of SI management. 6.2 NHS North West Surrey Director of Quality and Innovation: is the CCG appointed Director with responsibility for monitoring the effective management of SIs 6.3 NHS North West Surrey CCG Head of Quality and Chief Nurse is responsible for ensuring there is effective management of SIs. The role is accountable to the Director of Quality and Innovation. The Head of Quality/Chief Nurse is responsible for Providing clinical advice and leadership ensuring through the work that: Commissioned organisations have robust systems and processes for prompt reporting and management systems for SIs, Performance monitoring of commissioned organisations reported SIs, NWS CCG s Governing Body and Quality and Performance Committee are assured on the performance management of SIs within commissioned organisations, NCB and/or relevant professional bodies are informed of the relevant SIs, Informing the Surrey and Sussex Area Team when an SI originates in or involve the actions of the CCG and ensuring a robust investigation is undertaken. 6.4 NHS North West Surrey CCG Clinical Chief will provide expert clinical review of serious incidents and advise Quality and Performance Committee and Governing Body on clinical issues and concerns requiring action. 6.5 Role of Governing Body: is to be assured that there are systems in place within NHS North West Surrey CCG and its commissioned services to provide a robust framework for serious incident management. 6.6 Role of Quality and Performance Committee (QPC): The role of the Quality and Performance Committee to provide assurance to the Governing Body that the organisation has robust incident management and serious incident performance management processes in place. To execute its responsibilities in respect of serious incident management and to enable Document Title: Serious Incident Management V3 Issue date: April 2014 Document Status: Final Review date: October 2015 Page 12 of 63

13 the committee to provide robust assurance to Governing Body, QPC has put in place a serious incident closure panel. This group leads on the review Serious incidents and will report to Quality and Performance Committee on the serious incidents approved for closure, overall performance management, trends and themes through the Quality Report. 6.7 NHS Northwest Surrey CCG SI Closure Panel: has delegated responsibility for the review and closure of commissioned services serious incidents. This group is also responsible for reviewing investigation reports from NHS North West Surrey CCG provider serious incidents that are graded as grade 2 incidents on STEIS prior to their submission to the Surrey and Sussex Area Team for review before closure. The terms of reference for the SI closure panels are outlined in appendix F. 6.8 Clinical Quality Review Groups: Will be provided with serious incident reports providing updates on Provider serious incident management updates. This will provide assurance updates on the implementation and outcomes from SI investigation report action plans. This will also include, where appropriate, assurance from commissioned providers 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) and Safeguarding Children and or Adult interface with the SI process. CCGs will regularly review SIs monitor action plan implementation with Commissioned providers as part of the Clinical Review Process. 6.9 North West Surrey CCG Quality Team: Has delegated responsibility for The management of Commissioned provider SIs, through: Receiving SI notifications via STEIS; Agree grading of SI with the reporting organisation; Ensuring respective CCG is notified of Grade 2 SI s promptly, highlighting those that may be of higher risk and/or media interest; Maintaining an overview of Grade 0, 1 & 2 SIs reported across commissioned providers allowing for identification of trends and patterns; Reviewing and agreeing SI grades, investigation due dates, etc, in conjunction with respective CCG Quality and Safety Leads; Developing: o Close working relationship with commissioned providers identified Quality and Safety Leads; o Providing a consistent approach for the sign-off and closure of commissioned provider SIs by the CCG; o A system of activities for disseminating and sharing lessons to allow for minimisation of risks and improvement of patient safety. Supporting serious incident closures within the North West Surrey serious incident management framework (this involves the sub Group of Quality and Performance Committee attending the Surrey CCGs Patient Safety Assurance Review Group (PSARG) and reporting to Quality and Performance Committee through the quality report). The CCGs Patient Safety Assurance Review Group (PSARG) has delegated responsibility for reviewing, sign-off and closing of all commissioned provider root Document Title: Serious Incident Management V3 Issue date: April 2014 Document Status: Final Review date: October 2015 Page 13 of 63

14 cause analysis (RCA) investigation reports. This group will ensure a robust investigation has been carried out, including the identification of appropriate actions and that lessons are learnt (see Terms of Reference for the Group Appendix F). Provide regular reports on commissioned provider SIs to the CCG; Support & offer guidance to all commissioned providers to ensure they are able to comply with policy requirements. This role will be undertaken by NHS North west Surrey CCG Quality and Patient Safety Manager NWS CCG Communication Lead: has responsibility for working with the CCG communication team to identify a clear communication plan for working with relevant colleagues both internally and externally to support effective management of the SIs. This should include, for example, working with clinical staff, risk management, boards and local safeguarding teams. They will work 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). They will also confirm proposed handling arrangements with, where considered necessary develop communications/media handling strategies with other organisations and liaise with relevant stakeholders as appropriate. The Communications Team will design and implement a strategy for on-going and longer-term management of communications. This should include details of key messaging, sign-off process, spokespeople and effective engagement Subject-Matter Expert Leads: (as and when required). In addition to their own suitably qualified and experienced staff, NWS CCG will ensure access to competent independent investigators and experienced clinical advisers who can be engaged to undertake investigations when required. The role of an expert lead would be to review relevant SI alerts and identify any areas that need to be addressed as part of the investigation. When the SI report is completed, the role is then to support the Root Cause Analysis (RCA) evaluation process in ensuring that commissioned provider SIs are investigated appropriately, identify whether the investigation had addressed all the issues and is suitable for closure. Subject-matter expert leads could provide advice around medicines management, maternity, infection control, mental health, information governance, health and safety, estates etc Commissioned Providers: 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. The commissioned provider should give early consideration 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. The commissioned provider must Document Title: Serious Incident Management V3 Issue date: April 2014 Document Status: Final Review date: October 2015 Page 14 of 63

15 comply with the duty of candour with the principles of being open and have an approved Being Open Policy. Commissioned providers also have the following responsibilities: Ensuring there are structured risk management systems and processes for collecting, collating and analysis of data on all SIs and lessons learned, including reporting SIs via STEIS. Those commissioned providers without access to STEIS should contact the NWS CCG Quality Team directly. Grading SIs in accordance with the national framework. Re-establishing a safe environment where all equipment or medication involved in the SI are retained and isolated, relevant documentation copied and secured to preserve evidence and facilitate investigation and learning, Contacting the police if there is a suggestion that a criminal offence has been committed, Ensuring all SIs defined by this policy, are investigated as per national guidance, using root cause analysis (RCA) methodologies. Manage the reporting to HSE as appropriate of Health and Safety Incidents, CQC and to the NPSA through the National Reporting and Learning System (NRLS) for Patient Safety Incidents, Informing NWS CCG if they are considering commissioning services (or parts of) through other commissioned providers and must assure NWS CCG that any commissioned services are compliant with this policy. Ensuring appropriate representatives attend the Surrey CCGs Patient Safety Assurance Review Group to support their organisations serious incidents for closure. This policy does not interfere with existing lines of accountability and does not replace the duty to inform the police, Safeguarding Teams and/or other organisations or agencies where appropriate and required. Further guidance can be obtained from the DH publication Memorandum of Understanding - Investigating Patient Safety Incidents, June 004, and accompanying NHS guidance of December 2006 should be followed in conjunction with the relevant guidance. Providers must be compliant with the requirements identified within the National Commissioning Board SI Framework document, published in March Involvement of more than one Commissioned Provider: When more than one commissioned provider is involved in an SI, it is the responsibility of the organisation identifying the SI to liaise with the other commissioned provider involved to agree which organisation will report on STEIS, undertake the investigation, present the findings & agree action implementation. The commissioned provider with the most significant involvement in the SI will take the lead in investigating the SI. This involves collaboration with other commissioned providers involved in the SI and/or managing the outcome. All organisations are required to contribute to the RCA investigation in a timely, responsive and cooperative manner. The Document Title: Serious Incident Management V3 Issue date: April 2014 Document Status: Final Review date: October 2015 Page 15 of 63

16 NWS CCG Quality Team may be contacted to provide support, advice or assistance in brokering an agreement to identify the lead commissioned provider if this is either unclear or is disputed Quality Surveillance Groups (QSG): The National Commissioning Board have developed Quality Surveillance Groups where data, incident reports and the quality of responses to SIs that give cause for concern will be shared. This will assist in the triangulation of other quality-related information and the formulation appropriate responses, such as triggering a Risk Summit or keeping the provider under regular review. The NCB, CCGs, and the NTDA should fully exploit the opportunities for sharing information about SIs in relevant providers with partner organisations who make up the relevant local and regional Quality Surveillance Groups 6.15 National Commissioning Board (NHS England): will have responsibility for: Commissioning independent investigations/inquiries into serious incident cases which meet nationally agreed criteria. Working with NHS England & the Area and Regional Teams to identify relevant intelligence and learning to be shared at national level and to facilitate such learning and sharing at a national level. The NHS England will keep the SI management system under review, particularly to mitigate risks during transition and the bedding down of the new system. High level oversight of SI reporting and responses, including reviewing trends, quality analysis and early warnings via Quality Surveillance Groups will be proportionate to requirements. Provide support to contract management for primary and specialised care providers responses to SIs and, where appropriate, commissioning and co-ordinating primary and specialised care SI investigations. Have oversight of SI investigations undertaken in acute, community, mental health and ambulance care including reviewing trends, quality analysis and early warnings via Quality Surveillance Groups. Management of SIs in services directly commissioned by the NHS England will be the responsibility of the NHS England to comply with National Standards & requirements SI investigation National Trust Development Authority (NTDA): will continue to perform the function currently delivered by what was known as Strategic Health Authorities with respect to NHS Trusts in the context of the ongoing transition of those organisations to Foundation Trust Status. It will also, from the 1 st April 2013 be responsible for the performance management of NHS Trusts. The Trust Development Authority will ensure that NHS trusts have appropriate systems and processes in place to report, investigate and respond to SIs, be able to credibly investigate and follow through on action plans in line with national policy and best practice. It will work in partnership Document Title: Serious Incident Management V3 Issue date: April 2014 Document Status: Final Review date: October 2015 Page 16 of 63

17 with the relevant commissioner and /or NCB to support them in their management of SIs. In this regard, the accountability for the management of SIs rests with commissioners facilitated by the NTDA. The NTDA will use information about SIs as a component of the overall surveillance of quality, sharing information and liaising with the CQC, professional regulators, and other stakeholders especially those associated with quality surveillance groups. Have oversight of all SI investigations in NHS Trusts, coordinating responses where necessary alongside commissioners. Use relevant intelligence and information to inform their performance management of NHS Trusts and the Foundation Trust pipeline. 7 PROCEDURE FOR REPORTING AND LEARNING FROM SIS The procedure for reporting and learning from SIs is outlined in Appendix C. All commissioned services are required to comply with this process. A one page SI reporting algorithm is provided in appendix D. along with a summary of the process for managing commissioned services SIs. Additional guidance on serious incident reporting and grading is provided in appendix E. Serious incidents reported by organisations for which NHS North West Surrey is lead commissioner will be approved for closure by the Sub Group of NHS North West Surrey CCG Quality and Performance Committee within the Surrey CCGs Patient Safety Assurance Review Group. Organisations that do not have access to the Strategic Executive Information System (STEIS) for example independent contractors and providers must use the NWS CCG incident reporting form available in appendix I The incident will be logged on STEIS by NWS CCG using the NHS North West Surrey CCG Independent Provider access code. The serious incident will be managed using the procedure outlined in appendix C. 8 DISSEMINATION OF LEARNING One of the key aims of the serious incident reporting and learning process is to reduce the risk of recurrence, both where the original incident occurred and elsewhere in the NHS. The timely and appropriate dissemination of learning following a serious incident is core to achieving this and to ensure that these lessons are embedded in practice. Learning can be demonstrated at organisational level by sustainable changes and improvements in process, policy, systems and procedures relating to patient safety within healthcare organisations. Key learning points that may be shared more widely may fall into the following areas: understanding and identification of the influence of Human Factors; Document Title: Serious Incident Management V3 Issue date: April 2014 Document Status: Final Review date: October 2015 Page 17 of 63

18 solutions to address incident root causes that may be relevant to other teams, services and provider organisations; Identification of the components of good practice that reduced the potential impact of the incident, and how they were developed and supported. systems and processes that allow early detection or intervention that will reduce the potential impact of the incident; o lessons from conducting the investigation that may improve the management of investigations in future; Documentation of identification of the risks, the extent to which they have been reduced, and how this is measured and monitored. Reporting organisations and NHS North West Surrey CCG will work together to plan how learning from serious incidents can be shared. 9 MONITORING COMPLIANCE AND EFFECTIVENESS In order to comply with the requirements of the National Framework for the reporting and Learning from Serious Incidents, Commissioned organisations and NHS North West Surrey CCG must monitor trends in serious incident reporting. This trend analysis must include not only a quantitative report but also a qualitative analysis of those incidents where root causes and lessons learned have been identified. Ongoing compliance with the requirements of the National Reporting and Learning Framework for Reporting and Learning from Serious Incidents by using the following measures: Standard Detail Data source Incidents will be reported within two working days of identification of the incident Grade 1 incidents will be investigated and reported on within 45 working days (exclude agreed extensions) Time from date of knowledge (see section 2.2) to incident reported on Strategic Executive Information System (STEIS) date Time from incident reported date to investigation completed date. The reporting organisation should have at least a draft investigation report available for first review. Strategic Executive Information System (STEIS) Strategic Executive Information System (STEIS) Document Title: Serious Incident Management V3 Issue date: April 2014 Document Status: Final Review date: October 2015 Page 18 of 63

19 Grade 2 incidents will be investigated and reported on within 60 working days (exclude agreed extensions) Incident investigations will follow the structure and process of Root Cause Analysis methodology. Understanding and analysis within the investigation should include a thorough analysis of key contributory factors to include description against these and identification and understanding of any Human Factors that may lead to wider learning. The Strategic Executive Information System (STEIS) must be kept up to date and incidents closed according to national timescales. Time from incident reported date to investigation completed date. The reporting organisation should have at least a draft investigation report available for first review. Investigation structure to follow the National Patient Safety Agency Root Cause Analysis Guidance and Template or similar robust framework determined at local level Strategic Executive Information System (STEIS) will reflect the current status of the investigation. Strategic Executive Information System (STEIS) Investigation reports Strategic Executive Information System (STEIS) 9.1 Key Performance Indicators Key performance indicators to be used to review the effectiveness of the incident reporting process are; Monitoring of the level of incident reporting via provider organisation s quarterly incident and Serious Incident reports Monitoring the numbers of incidents reported within 24 hours of the incident occurring Monitoring the number of incident investigation completed within 1 month / and SIRI investigations completed within 45 & 60 days Monitoring the incidents formally closed within 6 months of date of reporting. A review of compliance against the above standards will form part of contractual requirements all organisations for whom North West Surrey CCG is the lead commissioner. Document Title: Serious Incident Management V3 Issue date: April 2014 Document Status: Final Review date: October 2015 Page 19 of 63

20 Appendix A Definitions Serious Incidents: A serious incident 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 commissioned provider 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; Abuse A violation of an individual s human and civil rights by any other person or persons. Abuse may consist of single or repeated acts. It may be physical, verbal or psychological, it may be an act of neglect or an omission to act, or it may occur when a vulnerable person is persuaded to enter into a financial or sexual transaction to which he or she has not consented, or cannot consent. Abuse can occur in any relationship and may result in significant harm, or exploitation, of the person subjected to it. As defined by No Secrets for adults. In Working together to safeguard children (2006)6 abuses is defined as follows: abuse and neglect are forms of maltreatment of a child. Somebody may abuse or neglect a child by inflicting harm or by failing to act to prevent harm. NHS North West Surrey CCG complies with the requirements of Surrey Safeguarding Adult and Safeguarding Children multi agency processes. Further information on these processes is available through the Surrey County Council website (see reference section) Adverse Event/Incident See Patient Safety Incident Being Open communication of patient safety incidents that result in harm or the death of a patient while receiving healthcare. Carers Family, friends or those who care for the patient. The patient has consented to their being informed of their confidential information and to their involvement in any decisions about their care. Document Title: Serious Incident Management V3 Issue date: April 2014 Document Status: Final Review date: October 2015 Page 20 of 63

21 Child The Children Act 1989 and the Children Act 2004 define a child as being a person up to the age of 18 years. The Children Act 2004 states that safeguarding, protection and cooperation between services may, in certain circumstances, are continued through to a young person s 19th birthday or beyond. Clinical Governance A framework through which NHS organisations are accountable for continuously improving the quality of their services and safeguarding high standards of care by creating an environment in which excellence in clinical care will flourish. Commissioner A person with responsibility for buying services from service providers in either the public, private or voluntary sectors. Clinical Commissioning Group Clinically-led organisation, created by the Health and Social Care Act 2012 that commissions NHS-funded healthcare on behalf of its relevant population. CCGs will not commission primary care or specialised services. Culture Learned attitudes, beliefs and values that define a group or groups of people. Equipment Machines and medical devices used to help, prevent, treat or monitor a person s condition or illness. The term may also be used to refer to aids that may support a person s care, treatment, support, mobility or independence, for example, a walking frame, hoist, or furniture and fittings. It excludes machinery or engineering systems that are physically affixed and integrated into the premises. General Practitioner A medical practitioner who provides primary care and specialises in family medicine. General practitioners treat acute and chronic illnesses and provide preventative care and health education for all ages and gender. Hazard: a hazard is something that has the potential to cause harm. Healthcare The preservation of mental and physical health by preventing or treating illness through services offered by the health professions, including those working in social care settings. Healthcare Professional Doctor, dentist, nurse, pharmacist, optometrist, allied healthcare professional or registered alternative healthcare practitioner. Incident an event or circumstance which could have resulted, or did result in unnecessary damage, loss or harm such as physical or mental injury, to a patient, staff, visitors or members of the public. Independent Healthcare Private, voluntary and not-for-profit healthcare organisations that are not part of the NHS. Independent Providers: Independent providers include Independent Hospitals, Nursing Homes and Hospice Care, as well as provider contracts with the Document Title: Serious Incident Management V3 Issue date: April 2014 Document Status: Final Review date: October 2015 Page 21 of 63

22 voluntary sector providers. Where there will be an expectation that this policy will be interpreted and inclusive of their operations. Investigation The act or process of investigating a detailed enquiry or systematic examination. Major Incident: A major incident can be defined as any occurrence which presents a serious threat to the health of the community, disruption to service, or causes (or is likely to cause) such numbers or types of casualty as to require special arrangements to be implemented. Major surgery - a surgical operation within or upon the contents of the abdominal or pelvic, cranial or thoracic cavities or a procedure which, given the locality, condition of patient, level of difficulty, or length of time to perform, constitutes a hazard to life or function of an organ, tissue or (if an extensive orthopaedic procedure is involved, the surgery is considered major ). Medical Device Any instrument, apparatus, appliance, software, material or other article (whether used alone or in combination) (including software intended by its manufacturer to be used for diagnostic and/or therapeutic purposes and necessary for its proper application), intended by the manufacturer to be used for the purpose of: diagnosis, prevention, monitoring, treatment or alleviation of disease, diagnosis, monitoring, alleviation of or compensation for an injury or disability, investigation, replacement or modification of the anatomy of a physiological process, and/or control of conception, and which does not achieve its physical intended action on the human body by pharmacological, immunological or metabolic means, but may be assisted in its function by such means. Near Miss: A near miss is an incident that had the potential to cause harm but was prevented. Neonate: a child aged between 0 to 28 days. Never Events Serious, largely preventable patient safety incidents that should not occur if the available preventative measures have been implemented by healthcare provider. NHS-Funded Healthcare that is partially or fully funded by the NHS, regardless of the location. Notification The act of notifying to one or more organisations/bodies Patient Safety The process by which an organisation makes patient care safer. This should involve risk assessment, the identification and management of patient-related risks, the reporting and analysis of incidents, and the capacity to learn from and follow-up on incidents and implement solutions to minimise the risk of them recurring. The term patient safety is replacing clinical risk, nonclinical risk and the health and safety of patients. Document Title: Serious Incident Management V3 Issue date: April 2014 Document Status: Final Review date: October 2015 Page 22 of 63

23 Patient Safety Incident Any unintended or unexpected incident that could have or did lead to harm for one or more patients receiving NHS-funded healthcare. The terms patient safety incident and prevented patient safety incident will be used to describe adverse events / clinical errors and near misses respectively. Permanent Harm Permanent lessening of bodily functions; including sensory, motor, physiological or intellectual. Primary Care refers to services provided by GP practices, dental practices, community pharmacies and high street optometrists and commissioned by the NHS Commissioning Board from April 2013 Professional Body An organisation that exists to further a profession and to protect both the public interest, by maintaining and enforcing standards of training and ethics in their profession, and the interest of its professional members. Prolonged pain and/or prolonged psychological harm pain or harm that a service user has experienced or is likely to experience, for a continuous period of 28 days. Commissioned provider: Commissioned providers include community health services, mental health services, learning disabilities, acute services and other health services providing services to residents in CCG areas. Provider (or Healthcare provider) Organisation that provides healthcare including NHS Trusts, NHS Foundation Trusts, general practitioners, pharmacists, optometrists, dentists and non-nhs provider Quality Surveillance Groups Virtual teams established across a health economy either at the level of the relevant area team or the relevant regional team, bringing together organisations and their respective information and intelligence gathered through performance monitoring, commissioning, and regulatory activities. By collectively considering and triangulating information and intelligence, QSGs will work to safeguard the quality of care that people receive. Risk The chance of something happening that will have an impact on individuals and/or organisations. It is measured in terms of likelihood and consequences. Risk Management Identifying, assessing, analysing, understanding and acting on risk issues in order to reach an optimal balance of risk, benefit and cost. Risk Summit A meeting of high-level leaders called to shape a programme of action, which is focussed on sharing information willingly to help achieve a consensus about the situation under scrutiny and the actions required to mitigate the identified risks. Root Cause Analysis (RCA) A systematic process whereby the factors that contributed to an incident are identified. As an investigation technique for patient safety incidents, it looks beyond the individuals concerned and seeks to understand the underlying causes and environmental context in which an incident happened. Document Title: Serious Incident Management V3 Issue date: April 2014 Document Status: Final Review date: October 2015 Page 23 of 63

24 Safety A state in which risk has been reduced to an acceptable level. Safeguarding Ensuring that people live free from harm, abuse and neglect and, in doing so, protecting their health, wellbeing and human rights. Children, and adults in vulnerable situations, need to be safeguarded. For children, safeguarding work focuses more on care and development; for adults, on empowerment, independence and choice. Secondary care Defined as a service provided by medical specialists who generally do not have first contact with patients. Secondary care is usually delivered in hospitals or clinics and patients have usually been referred to secondary care by their primary care provider (usually their GP). Secondary care services will be commissioned by CCGs from April Severe Harm A patient safety incident that appears to have resulted in permanent harm to one or more persons receiving NHS-funded care. Significant Event Audit An audit process where data is collected on specific types of incidents that are considered important to learn about to improve patient safety. Specialised services Defined as those services with a planning population of more than one million people. This means that a specialised service would not be provided by every hospital in England. Specialised services will be commissioned by the NHS Commissioning Board from April Strategic Executive Information System (STEIS): a means of reporting SIs to CCGs, Area Teams and NHS England. Tertiary Care Specialised consultative health care, usually for inpatients and on referral from a primary or secondary health professional, in a facility that has personnel and facilities for advanced medical investigation and treatment, such as a tertiary referral hospital. Treatment Broadly, the management and care of a patient to prevent or cure disease or reduce suffering and disability. Unexpected Death Where natural causes are not suspected. Local organisations should investigate these to determine if the incident contributed to the unexpected death. Unexplained circumstances: factors in the environment, history or examination which may give rise to concern about the circumstances surrounding the death. Examples: non-accidental injury, environment which highlights issues of neglect. Working Day Days that exclude weekends and bank holidays Document Title: Serious Incident Management V3 Issue date: April 2014 Document Status: Final Review date: October 2015 Page 24 of 63

25 Appendix B1 Never Events Core List Incidents are considered to be never events if: The incident either resulted in severe harm or death or had the potential to cause severe harm or death 2. There is evidence that the never event has occurred in the past and is a known source of risk (for example through reports to the National Reporting and Learning System or other serious incident reporting system). There are existing national guidance or safety recommendations, which if followed, would have prevented the incident from occurring. Occurrence of the never event can be easily identified, defined and measured on an ongoing basis. The term should not be used for incidents that do not meet these criteria. The twenty-five types of incident that currently meet these criteria are: 1. Wrong site surgery 2. Wrong implant/ prosthesis 3. Retained foreign object post-operation 4. Wrongly prepared high-risk injectable medication 5. Maladministration of potassium-containing solutions 6. Wrong route administration of chemotherapy 7. Wrong route administration of oral/enteral treatment 8. Intravenous administration of epidural medication 9. Maladministration of insulin 10. Overdose of midazolam during conscious sedation 11. Opioid overdose of an opioid-naïve patient 12. Inappropriate administration of daily oral methotrexate 13. Suicide using non-collapsible rails 14. Escape of a transferred prisoner 15. Falls from unrestricted windows 16. Entrapment in bedrails 17. Transfusion of ABO-incompatible blood components 18. Transplantation of ABO or HLA-incompatible organs 19. Misplaced naso- or oro-gastric tubes 20. Wrong gas administered 21. Failure to monitor and respond to oxygen saturation 22. Air embolism 23. Misidentification of patients 24. Severe scalding of patients 25. Maternal death due to post partum haemorrhage after elective Caesarean section Document Title: Serious Incident Management V3 Issue date: April 2014 Document Status: Final Review date: October 2015 Page 25 of 63

26 Appendix B2 Cost Recovery Process Algorithm Cost Recovery Process Algorithm Responsibility Blue: Provider Organisation Yellow: NWS CCG Never Event occurs Provider records Never Event on STEIS NWS CCG Contract Manager notified of Never Event NWS CCG Contract Manager confirms Never Event and obtains additional info. (as outlined in the SI Policy). Contracts Manager passes relevant information onto Finance Department to recover the cost of the episode of care as per the national contract. 26

27 Appendix C Procedure for Reporting and Investigating Sis Reporting a SI All Commissioned providers must use STEIS to report SIs. See Appendix D for the SI Reporting algorithm. 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. In accordance with the Caldecott principles of confidentiality, the report on STEIS must not contain any patient or staff identifiable data and 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 NWS CCG. For the purposes of determining the investigation and monitoring approach the SI grade identified by the commissioned provider should be agreed with NWS CCG. NWS CCG will carry out this function in conjunction with the respective CCGs and specialist sources where appropriate. This will be done on an individual case-by-case basis within 3 working days of receiving SI alert notification. Appendix G provides a reference guide developed by the NPSA to support the grading of SIs. STEIS record must be updated within 3 working days if the situation changes after the initial report. If it is agreed that the incident does not fall within the definition of a SI, the incident can be removed from STEIS rather than simply closed. This should be done by the Area team following a request from a relevant organisation and the provision of relevant evidence. If it does continue to be considered a patient safety incident despite being downgraded, it must be reported on the provider organisation s local incident management system and investigated accordingly. A clear audit trail must be kept. Where reporting of a SI is not within the expected 2 working days, commissioned providers 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 is of particular gravity in terms of clinical, managerial, reputation issues, public concern or potentially attracts media attention, it should be highlighted by selecting the Media interest option and be reported to the NWS CCG by telephone. If the SI has already attracted adverse media attention, this should be identified clearly and details should be included in the commentary. Where identified necessary, the CCG will agree jointly whether the situation requires escalation to the NHSCB directly and agreeing any action that needs to be taken with the relevant commissioned provider. The NWS CCG Communications Team will be informed of high risk Sis. 27

28 STEIS will be monitored on a daily basis for new SI reports. Respective CCGs will be notified of their commissioned providers SI instantaneously as part of the STEIS cascade alert system. Once reported, commissioned providers must update the SI record on STEIS as the situation changes, which could be weeks or months after the original SI. Following Notification of SI The Quality Team will: Within 3 working days: o Acknowledge receipt of STEIS notification; o Agree the grading of the SI; o Confirm SI investigation timescale and ascertain whether further information or clarification is required. o Request 72 hour update reports for all grade 2 serious incidents. The template for the 72 hr report is available in appendix H Meet weekly to: o Ensure contact has been made with the reporting commissioned provider, that the SI grade has been agreed and acknowledged receipt of alert notification; o Review requests for de-escalation or extension of deadlines. Report Format As a minimum SI investigation Tool. NWS CCG requires all Providers to use the NPSA root cause analysis template 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 investigation aids are available at The serious case review template will be used in the case of safeguarding children SI. Action Plans Format Following the investigation of a SI an agreed action plan be drawn up that sets out how each recommendation from the investigation will be implemented. The action plan must define the following minimum requirements: Recommendations based on the contributing factors: these should be the analysis and findings of the investigation the recommendations from the report and every recommendation must have clearly articulated action(s); Action agreed: this should be the actions the organisation needs to take to resolve the contributory factor; Document Title: Serious Incident Management V3 Issue date: April 2014 Document Status: Final Review date: October 2015 Page 28 of 63

29 Level of recommendations: this identifies whether the action need to be taken at: - Unique: specific to the area, - Common: organisation specific, - Universal: have regional/national significance; By Whom: identifies who in the commissioned provider 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; recognised committee with responsibility for ensuring action plan delivered and monitoring closing action plan; 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: Date when the action has been completed. A SMART approach to action planning is recommended. That is, the actions should be: Specific, Measurable, Attainable, Relevant and Time-bound. Submission of Final Report Unless otherwise agreed with NWS CCG Quality Team, the final RCA investigation report must be submitted within: Grade 0: 3 Working Days to remove as an SI or escalate to a Grade 1 SI. Grade 1: 45 working days of the SI being notified (requiring Investigation Level 2 (comprehensive RCA for incidents involving moderate and severe harm or death). Grade 2: 60 working days of the SI being notified requiring Investigation Level 2 (comprehensive RCA for incidents involving moderate and severe harm or death). Grade 2: 6 months of the SI being notified (Grade 3): requiring Investigation Level 3 (Independent RCA). All final RCA investigation report must be submitted to the [email protected] inbox within the timeframe stipulated. Evaluation of SI RCA Investigation Report On receipt of a completed investigation report and action plan, a review using the Quality Assurance Tool will be carried out by NHS North West Surrey CCG Quality team to assess the content and structure of the report using the criteria identified within the SI Quality Assurance Tool. Clinical and/or other 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. The PSARG (see Appendix F: Terms of Reference) requires 100% compliance and will use the completed quality assurance tool to determine whether the SI: Document Title: Serious Incident Management V3 Issue date: April 2014 Document Status: Final Review date: October 2015 Page 29 of 63

30 Meets the criteria, therefore should be closed as the report clearly identifies learning including findings, contributory factors, root causes, conclusions and recommendations, or Does not meet the criteria: therefore requires further action and a manageable agreed timeframe for completion of those actions. Reasons for non-acceptance will be given and no extension will be granted to account for the period of revision and it will be recorded as overdue. The PSARG will not close a SI until it is satisfied that an appropriate investigation has been undertaken, clear contributory (or causal) factors have been identified, any relevant patient safety alerts (such as Central Alert System [CAS] or NPSA Rapid Response Reports [RRR]) have been referenced and considered, lessons to be learned have been identified and a robust action plan developed. Serious Case Reviews: SIs involving Serious Case Reviews should not be closed on STEIS until the Serious Case Review has been completed and published by the Local Safeguarding Children Board. On occasions this will mean waiting until any 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. In addition the NWS CCG Quality Team may draw on professional advice from when closing SIs on STEIS. The Team will ensure that the relevant CCG contracting leads are advised regarding SI reporting and actions on lessons learned. Contacting NWS CCG Quality Team The NWS CCG Quality Team can provide advice on the management of SIs and can be contacted: In Hours: correspondences: [email protected] Minimum Reporting Standards SI should be notified via STEIS within 2 working days. Contact will be made with the commissioned provider to identify any additional relevant information that may have emerged during the immediate investigation. RCA investigation reports with accompanying action plan should be submitted to NWS CCG within the timescales stipulated in Section 7.5: Submission of Final Report. This may be extended on a case-by-case basis with mutual agreement with the commissioned provider (see section 7.14: Extension of Submission Period). Investigation reports must not contain patient or staff identifiable information, apart from the name of the reporter and names of the investigation panel members. Electronic reports should be saved by STEIS number rather than any person identifiable Document Title: Serious Incident Management V3 Issue date: April 2014 Document Status: Final Review date: October 2015 Page 30 of 63

31 information. It is the responsibility of the commissioned provider that generated the investigative report to retain the document for a period of 30 years. Copies shared with other commissioned providers may be destroyed in accordance with the local confidentiality procedure once the report is no longer of use. Monitoring of Action Plans Action plans should be completely implemented within 6 months with extensions by agreement with the NWS CCG. In relation to Never Events and SIs involving an independent investigation or inquiry, NHS Commissioning Board on behalf of NWS CCG, will continue to monitor action plans until evidence is provided that each action point has been implemented. In addition, there may be other Grade 2 SIs where Surrey and Sussex Area Team will monitor action plans such as SIs of high public interest. For other categories of SIs the responsibility for monitoring the implementation of action plans following SIs, rests with the reporting commissioned provider and the respective CCGs via CQRGs and managed via the local performance management system. Monitoring Commissioned providers SI Policy Compliance All contracts for services commissioned by Northwest Surrey CCG will identify SI reporting requirements. NWS CCG will monitor commissioned providers compliance with this policy through the provision of regular reports and completion of an annual checklist development of performance metrics which will measure the following points. The NWS CCG will meet on a regular basis with the commissioned provider with the view to reviewing: SI trends, patterns and themes; Challenge SI process; Receiving assurance around implementation of good practice; Action plans implementation: should be completely implemented within 6 months. Learning from SIs All organisations with a responsibility for notifying or receiving details of SIs have a responsibility for the dissemination of learning. They should consider disseminating relevant learning where, in their opinion, there are novel or important learning points, or the learning is likely to be of use to other organisations in preventing harm to patients, staff of the public. NHS Organisations should be prepared to share Root Cause Analysis (RCA) investigation or Serious Event Audits (SEA) findings with the NRLS and/or NHS Commissioning Board routinely and via dedicated routes and mechanisms as requested. NWS Quality Team is responsible for ensuring arrangements: Document Title: Serious Incident Management V3 Issue date: April 2014 Document Status: Final Review date: October 2015 Page 31 of 63

32 Exist for the dissemination of learning and recommendations from SI investigations across CCG and more widely as appropriate. For carrying out regular thematic reviews of SIs to identify trends and patterns and wider implications of key learning points are disseminated. Information Sharing The reporting commissioned provider must ensure that any reports (SI preliminary analysis investigation reports or STEIS reports and/or correspondence) should be sent using secure NHS.net account. NWS CCG 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. De-escalation Process NWS CCG recognises that SIs may be reported based on limited information which on further investigation does not meet criteria for an SI. In such cases, the commissioned provider should request de-escalation from NWS CCG using the form in Appendix I. Requests for SIs to be de-escalated should be sent to [email protected]. NWS CCG will review and discuss the proposed de-escalation request and will inform the commissioned provider of the decision. Extension of Submission Period It is recognised that in certain circumstances commissioned providers will find it impossible to complete a final report within the national framework timescales. In such cases an extension can be requested from NWS CCG by the commissioned provider using the form in Appendix J. Requests for extensions should be sent to [email protected]. The commissioned provider can only request one extension of time in exceptional circumstances or any other exceptional circumstances agreed by NWS CCG. Following review by CCG and the Head of Quality/Chief Nurse an extension may be granted. This will start from the day on which the SI report was due for submission. The commissioned provider will be informed of the decision once it has been made. 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 for submission. (See appendix K) Document Title: Serious Incident Management V3 Issue date: April 2014 Document Status: Final Review date: October 2015 Page 32 of 63

33 Appendix D Steps be taken when a serious incident occurs simplified flowchart Incident occurs Report to local reporting systems- STEIS Inform patient Report to commissioner, Area team, NTDA (as appropriate) and other relevant organisations if not already Grade incident Ensure recorded on STEIS Review grading & next steps Undertake investigation, keeping patient / their family and relevant organisations involved Establish appropriate investigation Develop action plan Submit incident investigation report and action plan to commissioner, Area team and NTDA (as NWS CCG signs off as closed the grade1 incidents once they have been too reviewed through the SI closure review process. Grade 2 incidents will require a coordinated sign off with the CCG &the Area Team Depending on incident grade Implement Action Plan Share learning & evidence Review implementation of actions through the CQRG Red = NWS CCG Responsibility Blue = CCG Commissioned Provider Responsibility Green = Incident report management cycle completed. Document Title: Serious Incident Management V3 Issue date: April 2014 Document Status: Final Review date: October 2015 Page 33 of 63

34 Appendix E Additional Guidance CCG Commissioned Providers Each commissioned provider 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 commissioned provider. All commissioned providers should report SIs via the STEIS system with the exception to any independent or any qualified providers where there is no access to STEIS. In such cases, any qualified providers should report a SI via the dedicated NHS net account [email protected] and using the report form identified in Appendix J Commissioned provider 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. Under the Data Protection Act (1988) commissioned provider will need to be open and transparent with regards to investigation processes, unless there are specific exceptions. 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. The commissioned provider will forward their RCA investigation report to the NWS CCG as soon as it is completed and/or within the nationally identified timescale in Section7.5: Submission of Final Report. An example of the contents for a report and action plan has been identified within Sections 7.3 Report Format and 7.4 Action Plan Format. If a SI spans organisational boundaries, it is the responsibility of the commissioned provider where the SI took place to formally report the SI through STEIS. All other commissioned providers involved must contribute and fully cooperate with the process in line with agreed timescales. If more than one organisation is involved in a SI, the commissioner or lead commissioner must take a decision on who will act as the lead organisation for the purposes of investigation and incident management, and be responsible for reporting the SI. Such reporting should adhere to national time frames as set out in Appendix E. The information within this policy must 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. CCGs expect commissioned provider to utilise guidance from the Department of Health Publication Memorandum of Understanding: Investigating Patient Safety Incidents (June 2004) and the NPSA guidance for Serious Incidents (March 2010). The need to involve outside agencies should not impede the retrieval of immediate learning. 34 Governing Body 22 nd July 2013

35 If there is evidence to indicate that an SI could be part of a cluster or trend, or where the circumstances or consequences of the SI are of particular concern, NWS CCG may instigate a wider review. It is difficult to be prescriptive, as the extent of that case review will depend upon the nature of the SI. The commissioned provider may be required to undertake further enquiries or suggest a particular course of action. SIs which have impacted on or have potential to impact on children and/or adults at risk must be reported and investigated in line with the Surrey Safeguarding Adult or Children s processes and in conjunction with the Safeguarding Lead. National Reporting and Learning System: NRLS commissioned providers must have agreed processes for reporting serious patient safety incidents to the National Patient Safety Agency. 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 should not be closed by NWS CCG. The commissioned provider must send the verdict (a summary, not the coroner s report) to [email protected]. If the report meets all the reporting requirements and there are no outstanding organisational actions pending the feedback from the Coroner s inquest, Stop the Clock will be applied. 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 commissioned provider will be required to revise the SI report in order to incorporate these issues and to re-submit it Never Events Given the seriousness of these events, there will be a greater level of scrutiny. NHSCB and locally Surrey and Sussex area team will be ultimately responsible for closure of Never Event SIs. Closure of the SI will only be achieved where a commissioned provider is able to demonstrate evidence of implementation of all actions points in the action plan within 6 months with extensions by agreement with NWS CCG. See Appendix B for list of Never Events. There is a requirement to report never events to the following: STEIS; NRLS; NHS Trust Development Authority (NTDA): Non-Foundation Trust organisations; Monitor: Foundation Trust organisations. 35

36 In cases where there is uncertainty around the status of a SI as a never event, Commissioned providers with NWS CCG input must come to a conclusion as a matter of urgency. It is important that where there is a doubt about the status of a SI, NWS CCG and Commissioned providers discuss this and agree the categorisation according to the details set out in the never events list. Prevented never events provide a vital warning signs to commissioned providers that the potential for actual never events exists in their organisation. In that respect they are possibly the most powerful signal that action needs to be taken and can be the most important factor in preventing the devastating consequences of an actual never event. Prevented never events are defined as SI that may have been never events had action not been taken to avoid a SI meeting the never event criteria and where such action is not part of the specified preventative action detailed in the relevant guidance or safety recommendations. For example, it is a prevented never event where an opioid naive patient receives an opioid overdose, but the error is rescued and severe harm or death is prevented through rapid naloxone administration. This is also an actual patient safety incident and should be reported as such, but it is not an actual never event and so is not subject to cost recovery, for example. 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. The cost recovery process algorithm is identified in Appendix B. Once the Contract Manager receives notification of a never event occurring. The notifying commissioned provider will be contacted by the contract manager to confirm the never event and obtain the following information: Month never event occurred; Type and number of never event; Confirmation of the CCG covering the patient s area of resident; Patient s NHS number; Spell number (treatment number); Charge: includes market forces factor (cost of patient s care). Information obtained will be passed onto the Finance Department to recover the cost of the episode of care as per the national contract Delay of Ambulance Handover in an Emergency Department of 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 Emergency Departments. For these clinical reasons, as well as that of appropriate governance procedures, it is important that the commissioned providers Board are made aware (and ultimately can be held accountable) of such occurrences through a formal 36

37 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 Maternity Under the current legislation governing midwifery practice rule 10 of the Midwives Rules and Standards (NMC 2012) states: Ensure that the South of England Local Supervising Authority Midwifery Officer 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 LSAMO. The LSAMO for South of England Region is based in the Regional offices in Newbury. 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 incident being identified. The aforesaid categories are not exhaustive. If in doubt, A Surrey and Sussex Area Team Patient Safety lead for Maternity should be contacted for advice. Where the criteria stipulate SI reporting where care or service factors might have contributed to the outcome, it is expected that as a minimum all commissioned provider Maternity services will undertake a prompt detailed initial case review to determine SI status in each case. The 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 7.3: 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. Commissioned providers 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 The reporting of maternity, infant and child related incidents is a complex area involving a number of agencies coupled with parallel statutory responsibilities. This guidance is intended to clarify the reporting requirements England. See Appendix M for the types of maternity, infant and child incidents that should be reported onto STEIS. This is in line with the NPSA Framework Reporting Maternity, Infant and Child, Adult at Risk Related SIs In all cases, the safety of the child/siblings and/or adult at risk is paramount. Children and/or adult at risk should be made safe before reporting the SI. However, it is important that reports are timely and consistent. When reporting a 37

38 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. Deciding on which organisation reports the SI may be complex and differs depending on the circumstances. Organisations should contact NWS CCG for advice if there is any doubt on who should report a specific SI. A reportable SI should be reported no later than 2 working days from the time the SI is known. However, safeguarding SI is an exception to this as the full extent of the SI is sometimes not clear until after the initial strategy meeting. Therefore, unless there is media attention, 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 7. 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 linked with 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: 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 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 commissioned providers are responsible for highlighting their local SIs to other people/networks outside the organisation in which the 38

39 SI took place in the health system who may be impacted by their local SI. These experts can help the commissioned providers make contact with the relevant; 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 commissioned provider through these e.g. Breast and cervical. 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. For SIs, the CCG should be informed immediately and updated on the next working day by telephone or to ensure assurance and involvement in the investigation. Further details on the management of incidents within the breast screening programme are available in Guidelines for Managing Incidents in the Breast Screening Programme 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 Information Governance (Breach of Confidentiality 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. NHSCB has a duty to escalate to the DoH Business Unit, details of all IG SIs graded as level 3 or above when a level 3 or above IG SI is reported, the notification must be submitted to the CCG SI box: [email protected] within 72 hours of the SI being reported on STEIS. 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 damage to the reputation of the NWS CCG should be considered as serious. The reporting of SIs relating to breaches of confidentiality involving person identifiable data and data losses should be reported in accordance with DoH Gateway letter 9571 dated 29 February 2008 and refer to the definitions and risk assessment methods (See Appendix N). The CCG will utilise the risk assessment matrix in the DoH guidance to determine the level of seriousness applied to the IG SI. A quarterly report of such incidents 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 commissioned providers in accordance with DoH Gateway letter 9912 of 20 May 2008 utilising the format at Annex A of the gateway letter. 39

40 This type of SI must be reported to the CCG Senior Information Risk Officer (SIRO)/Caldicott Guardian and the Information Governance Manager. The Information Governance Lead at Surrey and Sussex Area 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 identifiable information about them has been lost or inappropriately placed in the public domain. When reporting to NWS CCG Quality Team, the reporting commissioned provider 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 damage the reputation of NWS CCG; 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; 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 SIs Involving Children and/or Adult at Risk SIs involving children and/or adult at risk will be managed in accordance with this policy (see Appendix O: Adult Safeguarding Flowchart). In addition, those SIs impacting on children s and/or adult at risk safeguarding will be overseen by the designated nurse for Safeguarding Children and the Lead for safeguarding Adult and in line with Working Together to Safeguard Children and the relevant safeguarding adult guidance. The Provider must liaise with NWS CCG Executive Lead for adult at risk or child protection to ensure that local safeguarding procedures are followed. SIs raised in relation to children will be discussed with the Surrey CCGs safeguarding designated nurse or lead in order to confirm and ensure safeguarding elements are being identified and managed appropriately. Surrey Safeguarding Children s resource for Surrey is hosted by Guildford and Waverley CCG. Adults safeguarding resource is hosted by Surrey Downs CCG 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 root cause analysis and other documents), could be subject to a request for disclosure under the Freedom of Information Act. A request for information 40

41 regarding a SIs should follow Freedom of Information Act policies of the respective CCG/organisation that received the request. Legally CCGs are obliged to consider the disclosure of this information when it is requested. Since it is information that concerns individual commissioned provider, it is important that commissioned providers have the opportunity to comment on what is intended to be provided to requestors. Commissioned providers 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, commissioned providers are advised to ensure that reports are suitably anonymised. SI FOI requests will most commonly be requests for the number of SIs reported by commissioned providers and the types of SIs. Commissioned providers 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 commissioned provider 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 commissioned provider does not have to complete the Line taken box immediately. In the event of a FOI request NWS CCG will make a decision regarding how to proceed with meeting the SIs FOI request within a given period may be subject to release. Therefore, it is important that commissioned providers 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 commissioned provider to update STEIS accordingly Handling Media Interest SIs can be triggers for media coverage and increased public scrutiny. A wellplanned, structured media management protocol is vital in managing SIs effectively. Every SI has potential for adverse media interest and for this reason the NHSCB/ Surrey and Sussex Area Team and other relevant parties must be notified. If out of hours NWS CCG on call manager and communications on call lead who will then liaise with the Surrey and Sussex Area Team Communications Team to ensure the appropriate action, is taken. Outside normal office times, the on-call Communications Manager will advise the CCG on the appropriate action required. The respective CCG will seek guidance from the CCG s solicitors as necessary Where the CCG is Significant but not Host Commissioner In accordance with the NHSCB s SI Framework, the key organisational accountability for SI management is from the provider to the commissioner of the care in which the SI took place. This may for example be from an acute or community hospital to their CCG or lead CCG, from a specialist tertiary centre to 41

42 the NHSCB (for specialised service), from a mental health trust to their CCG or lead CCG. During an SI investigation, where there is more than one lead commissioner for the various commissioned providers involved the NHSCB in London and the Surrey and Sussex Area Team should make the decision. If more than one organisation is involved in a SI, the commissioner or lead commissioner must take a decision on who will act as the lead organisation for the purposes of investigation and incident management, and be responsible for reporting the SI. Such reporting should adhere to national time frames as set out in Appendix G. When a SI crosses the boundary of two or more commissioners, NWS CCG will liaise with other commissioners to ensure that all relevant parties are notified, that a lead commissioner is identified and a timescale agreed NHS Funded Providers (Independent Sector, Private, Any Qualified Providers, etc) 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. As part of the contractual requirements, all NHS funded providers are expected to have procedures for identifying and handling SIs Each such provider will notify the respective CCG immediately using the SI reporting form in Appendix J and by telephone within 2 working days of the SI happening, i.e. any serious incident that, in the reasonable opinion of the Contractor, affects or is likely to affect the Contractor s performance of its obligations under the agreement. NWS CCG will then log the SI on the STEIS system on behalf of that commissioned provider. The independent provider must ensure that the investigation is completed and submitted within the framework identified. NHSCB/ Area Teams 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 8.2 NRLS All serious patient safety incidents must be reported to the National Reporting and Learning System (NRLS) 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. 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. 42

43 All Independent sector healthcare providers should report the 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. 8.3 Good Governance Principles Regardless of the individual circumstances, both commissioner and commissioned providers should; work in an open and transparent manner with each other when a serious incident has happened; ensure that a board director, in both commissioner and commissioned providers, is formally designated to lead on, and be responsible for, patient safety and the management of serious incidents, including responsibility for the appropriate closure of serious incident files; have a relevant committee identified to consider and monitor serious incident 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 serious incidents. This information should be tailored to the appropriate level of detail for the board concerned provider boards should review every serious incident individually. Commissioner boards may only review a selection of serious incidents in detail. Both boards should receive summary information including the number of serious incident 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 Quality Assurance 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 serious incidents are undertaken in a timely manner and that they enable shared learning at local, and / or regional, national levels as appropriate; ensure that all serious incidents 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 ; ensure that the local safeguarding adult boards/local safeguarding children boards have been notified of relevant incidents and agree arrangements 43

44 for the management of serious case reviews including action planning and learning from incidents. This should include robust communication between safeguarding boards, commissioners, regulators and providers (see appendix B); 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 incidents are reported to the appropriate bodies, including the CQC, and, for patient safety incidents, the National Reporting and Learning System; 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 NTDA should also be informed in the case of nonfoundation 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 serious incident information. Apply human factors principles to serious incident 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? 44

45 Appendix F NHS NW Surrey Serious Incident Closure Panel Terms of Reference 1. CONSTITUTION 1.1 The Governing Body of NHS North West Surrey Clinical Commissioning Group (The CCG) is responsible for performance management and closure on the national reporting system (STEIS) of each investigation report into serious incidents that occur within organisations to which they are the host commissioner or they have commissioned the services of independent providers. 1.2 The process for closure must be robust and auditable so that assurance around closures decisions is evident. This responsibility is under the auspices of the CCG Quality and Performance Committee, a - Committee of the Governing Body, which hereby resolves to establish a s u b C o m m i t t e e t o be known as the Serious Incident Scrutiny Panel. 1.3 The purpose of the scrutiny panel is to provide assurance to the Governing Body on the robustness of investigation and action-planning as a result of serious incidents, and that learning from serious incidents has been identified and shared. 1.4 The Serious incident scrutiny panel will work closely with the Clinical Quality Review Meetings (CQRM), provider focused multistakeholder groups, which monitors the quality of service provision within the commissioned services, to ensure an integrated, coordinated approach to the management of serious incidents, and strengthen the assurance provided to the Quality and Performance Committee and Governing Body. 1.5 The s c r u t i n y p a n e l has no executive powers, other than those specifically delegated in these terms of reference. 2. SCOPE 1.6 All procedural matters in respect of conduct of meetings shall follow the Governing Body Standing Orders. 2.1 Serious incidents declared and investigated by the provider organisations (including Independent Providers) 2.2 A separate scrutiny panel will be convened when required to review serious incidents declared by the CCG. 45

46 3. ACCOUNTABILITY 3.1 The scrutiny panel is accountable to the CCG Governing Body via the Quality and Performance Committee. 3.2 Any risks associated with the incidence of serious incidents and/or identified during the investigation will be shared, immediately where prompt action is required, and via the Clinical Quality Review Meeting and the Quality and Performance Committee. 3.3 The scrutiny panel is responsible for sharing information with other CCGs as appropriate for providers/ services where they are the lead commissioner 4. MEMBERSHIP 4.1 The scrutiny panel will be appointed by the Quality and Performance Committee. 4.2 The members shall be: CCG Members JoAnne Alner (Chair) Director of Quality and Innovation Clare Stone(Deputy Chair) Head of Quality / Chief Nurse Richard Barnett? GP Lead Caroline Simonds Lay Person/Persons Clinical Lead for Quality, Innovation and Medicines Management Quality and Patient Safety Manager NB Confirmation required as to whether the CCG would like lay members on the panel. This is not a model recommended by NHS England but is the historical model from the Surrey system where patient representation was found to make positive contribution to the SI panel. CCG Supporting Officers Quality Facilitator Note taker, Feedback to providers, national and local database updates. Subject Matter Experts Depending on the incident, this might include leads for information governance, infection prevention and control, safeguarding children and adults, or other senior managers or specialist staff as deemed appropriate and able to provide an independent perspective. This can be done prior to the meeting and the outcome feedback at the meeting itself. 46

47 Quality Lead from Other CCGs Where an SI involves a patient residing in their locality or involves a service of whom they are Host Commissioners. Provider Representation Provider Representative Attendance for the discussion. This must be a senior Clinical role such as Director of Nursing/ Medical Director/Head of Quality or Governance. Other leads involved in SI investigations e.g. Risk Manager/ Patient Safety Manager, Clinical Lead or Lead Investigating Managers 5. QUORUM The SI scrutiny panel will be quorate when the following are present Director of Quality and Innovation or Head of Quality/ Chief Nurse Clinical Lead for innovation, Quality and Medicines Management or GP lead Quality and Patient Safety Manager or deputy Lay Person x1 (* this will be dependent on QPC decision regarding Lay member involvement in the panel) The quorum shall be at least two CCG members of which one must be a clinician and one must be a member of the Governing Body. 6. ATTENDANCE AND FREQUENCY OF MEETINGS 6.1 All members (or agreed nominated representatives) are expected to attend each meeting. 6.2 Meetings shall be held at both CCG and Provider sites on a rotational basis. 6.3 Meetings shall be administered by the CCG 6.4 Minutes of meetings will be circulated within two weeks of the meeting been held. 6.5 Decisions made at the meetings shall be updated onto the Strategic Executive Information System (STEIS) by the Quality facilitator within two working days of the meeting 6.6 Progress to decisions made at the meetings will be reviewed at the Clinical 47

48 Quality Review Meeting with the organisation or via subsequent meetings 7. AUTHORITY 7.1 The scrutiny panel is authorised by the CCG Governing Body via the Quality and Performance Committee to investigate any activity within its terms of reference. It is authorised to seek any information it requires from any employee and all employees are directed to co-operate with any requests made by the scrutiny panel. 8. DUTIES 8.1 To review all serious incident investigation reports from the organisation/ trust to assess the quality of the investigation, report and action plan, in line with national best practice guidelines and local Serious Incident policies, and to identify opportunities for wider learning. 8.2 To use a standard checklist or evaluation tool as in accordance with NHS England guidance. 8.3 To agree that recommendations arising from investigations are robust, feasible and meet the patient safety and quality requirements of the CCG as a commissioner. 8.4 To assess the processes in place to implement the action plan, follow up on any outstanding matters and disseminate of organisational learning (internally and in the wider health economy). 8.5 To provide challenge where appropriate and request re-submission of reports deemed unsatisfactory within an agreed timescale. 8.6 Provide a forum for reviewing and scrutinising any joint investigations for which the organisation/ trust may not be the lead organisation/ trust. 9. REPORTING 9.1 The scrutiny panel will report a summary of t h e o u t c o m e s from the meeting and monitor action plans through provider Clinical Quality Review meetings in order to highlight any significant areas or issues for concern and also to the Quality and Performance Committee through the SI paper. 48

49 9.2 The scrutiny panel will circulate monthly position statements of provider open, closed and overdue SIs to each CCG monthly to ensure timely sharing of learning and themes and updates for CCG Quality Reports 9.3 The Committee is responsible for immediate sharing of risk issues or learning that require prompt action or awareness 9.4 The Committee will report to the Quality and Performance as part of the serious incident report received at each meeting. The report will include a summary of the reports reviewed in the period, and opportunities for wider learning that require further discussion and action, as well as progress on implementation of action plans. 9.5 The Chair of the Committee shall draw to the attention of the Clinical Quality Review Meeting, Quality and Performance Committee and Governing Body to any issue that requires immediate disclosure to those bodies. 49

50 Appendix G Grading of Sis This table provides a guide to the grading of SIs fro investigation purposes: Example Incidents Investigation Timeframe Incident (these are suggestions, not Grade and action i Grade definitive) 1 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 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 Following initial reporting within 2 working days, the commissioned provider must submit a completed investigation within 45 working days 2 Grade 2 incident examples: Inpatient suicides (including following absconsion) Maternal deaths Child protection incidents Never events Accusation of physical misconduct or harm Investigation Level 2 Comprehensive RCA Following initial reporting within 3 working days, the commissioned provider must submit a 72 hour update report and a completed investigation. within 60 working days 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 Commissioning Board. Homicides following recent contact with mental health services require an independent investigation. For example a major system failure with multiple stakeholders Investigation Level 3 Independent RCA Following initial reporting within 3 working days, a 72 hour update report is required. independent investigators should be commissioned to complete an investigation within 6 months 50

51 Appendix H Serious Incident Requiring Investigation (SIRI) 72 Hour Report SIRI Reference Number: STEIS Identification Number: Report completed by: Designation: Date / Time report completed: Date of Birth: Date/Time/ Place of Incident: Incident Type: Diagnosis (currently being treated for) Description of Incident: Details of any police or media involvement/interest: Immediate Actions Taken including actions to mitigate any further risk: Details of other organisations/individuals notified: Commissioning PCT 51

52 Appendix I De escalation Request Form Some SI s may be reported based on limited information which, on further investigation, do not meet the criteria for an SI. In such cases, the de-escalation request form must be completed. NWS CCG will review and discuss the proposed de-escalation request and will inform the commissioned provider of the decision. NWS CCG may decide that the SI should not be de-escalated and a full SI report will be required. Please complete Section 1 of the form below: SECTION 1 Commissioned provider to complete Commissioned provider Name Contact Number Date of request for deescalation Requesting Officer STEIS Reference Number Current Grade of SI Reason for de-escalation: SECTION 2 NWS CCG to complete CCG Review By (10 days from request) Actions: Outcome Please return the completed form by to [email protected]. 52

53 Appendix J Notification Form NHS North West Surrey CCG This is a confidential document NOTIFICATION FORM SERIOUS INCIDENT REQUIRING INVESTIGATIONS (SIRIs) and NOTIFIABLE INCIDENTS (NIs) Reporting Organisation Date: dd/mm/yyyy Health Authority - South East Coast When, Where & Your Details Date of Incident: Time of Incident: Site of Incident: Reporter Name: Reporter Job Title: Reporter Tel. No: Location of Incident: Accident and Emergency Reporter Who Care Sector: Acute Typ e of Pati ent: A&E Patient Clinical Area: Surgical - General Surgery Gen der Male Female None Date of Birth (N/A or Ethn ic Gro White - British 53

54 Not Known) up: dd/mm/ yyyy What Happened? Type of Incident: Abscond Actual / Near miss: Actual Near Miss Incident Grade: Grade 0 Never Event: Yes No Description of what happened: Immediate action taken: 54

55 Further Information: Media Interest: Yes No Line being taken by Trust/PCT: Externally reportable: Yes No Externally reportable to: Centre for Communic Report to Health Protection Agency: Yes No When completed, this form should be sent by to NHS Surrey Should you require any advice on reporting please call (tel. no ) N.B. If you do not have all of the details regarding the SIRI do not delay, complete the form with existing information with reference to the fact that additional information may follow. 55

56 Appendix K Serious Incident Extension Request Form In certain circumstances it may be impossible to complete a final report within the national framework timescales. In such cases, an extension of time may be requested from NWS CCG by complete of this form. Following review by the NWS CCG Quality and Safety Manager, an extension may be granted, which will start from the day on which the SI report was due for submission. The commissioned provider will be informed of the decision once it has been made. Requests must be made prior to the due date of the final report, otherwise an extension cannot be granted and the report will be recorded as overdue for submission. Please complete Section 1 of the form below: SECTION 1 Commissioned provider to complete Commissioned provider Name Contact Number Requesting Officer STEIS Reference Number Length of extension required (number of working days) Reason for extension (i.e. short-term sickness/absence, multi-agency involvement etc): SECTION 2 NWS CCG to complete SI Report due date: Date request received: Extension Granted: Yes/No Number of days requesting: Date Commissioned provider informed: B/F on STEIS: Reason for granting/refusing the extension request and actions: Yes/No Please return the completed form by to [email protected]. 56

57 Appendix L Information required by the Department of Health for Category 3+ Information Governance SUIs STEIS Number: Initial assessment of level of SUI (1-5): NHS Organisation Name: SHA Responsible: NHS London Please provide the following: 1 Date of Incident 2 Time of Incident 3 Location of incident 4 Are DH guidelines for incident management are being followed 5 Will disciplinary action will be invoked if appropriate Y/N Y/N 6 Description of what happened: Theft, accidental loss, inappropriate disclosure, procedural failure etc. 7 Number of patients/staff (individual data subjects) data involved and/or the number of records 8 Type of record or data involved and sensitivity 9 The media of the records: paper, electronic, tape 10 If electronic media, whether encrypted or not 11 Is the SUI in the public domain? Y/N 12 Is the media (press etc) involved or is there potential for media Y/N 57

58 interest? 13 Is the reputation of an individual, team, organisation or NHS as a whole at risk (if yes please state which) 14 Are there any legal implications? 15 Has the Information Commissioner been notified? If not why not? 16 Have/will the data subjects be notified? If not why not? Y/N Y/N 17 Have the police been involved? Y/N 18 Immediate action taken, including whether any staff have been suspended pending the results of the investigation 19 Whether there are any consequent risks of the incident (e.g. patient safety, continuity of treatment etc.) and how these will be managed 20 What steps have been or will be taken to recover records/data (if applicable) 21 What lessons have been learned from the incident and how will recurrence be prevented 22 Whether, and to what degree, any member of staff has been disciplined if not appropriate why? Notes: Please complete this form and return it [email protected] within 72 hours of completing the STEIS record. 58

59 Appendix M Guidance for Maternity, Infant and Child Sis Incident Category Child Abuse (family) (Grade 2 incidents) Child Abuse (institutional) (Grade 2 incident) Child Abuse (multiple) Grade 2 incident) Child Abuse (Grade 2 incident) Child Serious Injury Maternity services: Intrapartum death (during labour) Maternity services: Intrauterine death (antenatal) Maternity services: Maternal death (Grade 2 incident) Never Event: Maternal death Description To be reported where a local multi agency /organisational review has identified a failure in the duty of care by a health professional or organisation. To be reported when this has been a factor in a child death or a child has suffered significant injuries either in the past as a missed opportunity or currently Abuse or neglect of one or more children by one or more perpetrators in an institutional setting where there is a health professional linked to the institution (this would include a school, nursery, child minder etc) and children who are looked after in a residential setting or an inpatient in a health care setting Networked abuse of one or more children by one or more perpetrators and where multiple complex and abuse procedures are initiated, e.g. paedophile ring, child trafficking, etc All unexpected and/or unexplained child deaths up to the age 4 years and 364 days. Unexpected death of a child aged 5 to 17 years and 364 days (where natural causes are not suspected) should be reviewed within 48 hours if: they are known to additional health care providers; or where it has been agreed, following the initiation of the rapid response process, that further exploration of the circumstances is required urgently. This includes all children in an institutional setting, e.g. school, youth offenders setting, respite care or secure unit. The death of any child on a child protection plan or looked after child must be reported. Where there is permanent harm or injury that occurs in a healthcare setting or where healthcare is delivered and the injury is related to the healthcare delivery that does not involve safeguarding or abuse Unexpected Intrapartum death during labour regardless of gestational age where service or clinical factors may have contributed Any intrauterine death at 24 weeks and above where service or clinical factors may have contributed to the outcome. Any death which occurs during pregnancy or within one year of pregnancy or within 42 days of birth, ectopic pregnancy or abortion which is directly or indirectly related to these conditions Maternal death due to post partum haemorrhage after elective Caesarean section 59

60 (Grade 2 incident) Maternity services: Unexpected neonatal death Maternal unplanned admission to ITU Post partum haemorrhage (PPH) Suspension of maternity services Unexpected admission to NICU (Neonatal Intensive Care Unit) Admission of all under 16s to adult mental health ward Admission of under 18s to adult mental health wards Safeguarding Vulnerable Child (Grade 2 incident) Serious Case Reviews (Grade 2 incident) Unexpected death of a baby aged 0-28 days. The requirement is to report unexpected death as the death of a neonate that was not anticipated as a significant possibility 24 hours before the death or where there was a similarly unexpected collapse leading to or precipitating the events that led to the death. If there is any doubt about whether or not the death is unexpected, the designated paediatrician responsible for unexpected deaths should be consulted. In such cases, the incident should be reported until evidence enables a decision to be made or suggest otherwise. An unexpected admission to an Intensive Care Unit during pregnancy or within 28 days following birth (either flu or pregnancy related) where service or clinical factors may have contributed 1. In hospital maternal death from post partum haemorrhage after elective caesarean section (Never Event) 2. Unplanned admission to HDU/ITU following post partum haemorrhage 3. Unplanned hysterectomy/uterine artery embolisation 4. If significant care or service issues were identified which contributed to the PPH Any time a decision is made to suspend maternity services regardless of outcome or when the maternity services tries to suspend services and is unable to due to no other units being able to accept transfers Infants > 37 completed weeks of gestation that have a sudden and unexpected collapse following delivery or in the early postnatal period of a previously well infant requiring intensive care (positive pressure ventilator support). Any such admission should be reported To be reported when such an admission is not in accordance with the Mental Health Act and makes no specific provision for the needs of the young person Any such incident should be reported The initiation of a Serious Case Review is to be reported. An existing STEIS record may be used if this was a health incident and has already been reported. If a case is discussed at the Local Safeguarding Children s Board and does not reach the threshold for a Serious Case Review but a local management review involving one or more healthcare 60

61 A child with complex care needs failing to obtain their assessed and agreed package of care Allegations against a healthcare worker (Grade 2 incident) organisations/imr is agreed then this should be reported on the Strategic Executive Information System To be reported when the health of a child is put at risk All allegations against a health professional or nonprofessional within the NHS or other providers of NHS care are to be reported following the reporting of the allegation to the local authority designated officer. 61

62 Appendix N DOH Gateway Letter 9571 DoH Gateway Letter 9571 (29/2/08): Reporting SIs relating to actual or potential breaches of confidentiality involving person identifiable data including data loss It is essential that all SI that occurs in commissioned providers of respective CCGs are reported appropriately and handled effectively. This document covers the reporting arrangements and describes the actions that need to be taken in terms of communication and follow up when an SI occurs. Commissioned providers should ensure that any existing policies for dealing with SIs are updated to reflect these arrangements. Definition of a SI in relation to Personal Identifiable Data There is no simple definition of a SI. What may at first appear to be of minor importance may, on further investigation, be found to be serious and vice versa. As a guide, 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. Immediate response to SI Commissioned providers should have robust policies in place to ensure that appropriate senior staffs are notified immediately of all SIs involving data loss or breaches of confidentiality. Where SIs occur out of hours, the commissioned provider should have arrangements in place to ensure on-call Directors or other nominated individuals are informed of the SI and take action to inform the appropriate contacts Assessing the Severity of the Incident The immediate response to the SI and the escalation process for reporting and investigating this will vary according to the severity of the SI. Risk assessment methods commonly categorise SIs according to the likely consequences, with the most serious being categorised as a 5, e.g. a SI should be categorised at the highest level that applies when considering the characteristics and risks of the SI. Informing Patients Consideration should always be given to informing patients when person identifiable information about them has been lost or inappropriately placed in the public domain. Where there is any risk of identity theft it is strongly recommended that this is done. 62

63 Appendix O Clinical Governance and Adult Safeguarding Flowchart Step 1: EVENT Any incident of concern involving people, interventions, equipment, and the environment Step 2: REPORT *This could be an incident form, complaint, verbal report etc. Any member of staff from any agency witnessing the event should complete a report immediately *Step 3: REVIEW Organisations should have a locally agreed review process for all types of reports that is consistent, comprehensive, and timely and linked to adult safeguarding and governance processes. Key question: IS THIS A SAFEGUARDING CONCERN? Reports should be reviewed within 24 hours in order to progress to step 3. Local arrangements for this will involve partnership between health and social care professionals and the Clinical Governance team. Integrated process for CG NHS and Adult Safeguarding NHS CG processes only YES NO Complete and send Safeguarding Alert to local safeguarding team, an incident report should also still have been made (Re-consider referral to Police if a crime has occurred) AND Consider level and type of investigation(s) required and agree these, response methods and timescales Follow Trust Policies and Procedures to progress type of report as above Safeguarding process initiated by safeguarding team Local investigation initiated as agreed above Regular communication is maintained YES Has a safeguarding concern been identified following further investigation? NO Report(s)/response produced & actions identified Actions implemented, lessons learnt and shared Refer to Regulator/ Independent Safeguarding Authority if appropriate Normal Policy applies 63