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