Serious Incident: Reporting and Management Policy. September 2017

Transcription

1 Serious Incident: Reporting and Management Policy September 2017 NHS East and North Hertfordshire Clinical Commissioning Group Page 1 of 43

2 DOCUMENT CONTROL SHEET Document Owner: Sheilagh Reavey, Director of Nursing & Quality Document Author(s): Rosie Connolly, Quality Manager Emma Hollingsworth, Quality Lead Version: 0.3 FINAL Directorate: Nursing and Quality Approved By: Quality Committee Date of Approval: 17 th September Date of Review: Reviewed September Next review September 2018 Change History: Version Date Reviewer(s) Revision Description v Emma Hollingsworth/ Rosie Connolly V Emma Hollingsworth/ Rosie Connolly Policy revised following publication of new SI Framework and Never Event. Policy amended following publication of updated HSCIC guidance for reporting IG incidents V Rosie Connolly Minor amendments made to reflect latest policies, Terms of Reference, contact details etc Implementation Plan: Development and Consultation Dissemination Training Monitoring Nursing and Quality Team ENHCCG external website Learning Hour All staff awareness by Nursing and Quality Team N/A Review September 2018 Equality, Diversity and Privacy Associated Documents 31/08/ Equality Impact Assessment 31/08/ Privacy Impact Assessment NHS England Serious Incident Framework 2015 NHS England Revised Never Events Policy and Framework 2015 ENHCCG s Adult Safeguarding Policy 2016 Managing Allegations of Abuse Against Adults who work with Children and Young People 2015 NHS East and North Hertfordshire Clinical Commissioning Group Page 2 of 43

3 ENHCCG s Safeguarding Children At Risk & Looked After Children Policy 2016 ENHCCG s Information Governance Policy 2016 ENHCCG s Records Management Policy 2016 The Caldicott Guardian Manual 2017 Duty of Candour 2014 References See Appendix One ENHCCG s Complaints Policy and Procedure 2017 HSCIC Guidance for Reporting, Managing and Investigating Information Governance and Cyber Security Serious Incidents Requiring Investigation, Version 5.1, May 2015 NHS East and North Hertfordshire Clinical Commissioning Group Page 3 of 43

4 Table of Contents Section No. Section Name Page No. 1.0 Introduction Purpose Definitions Serious Incidents Never Events Roles and Responsibilities CCG Governing Body Quality Committee Director of Nursing and Quality Quality Team Incident Panel All Staff NHS England Provider Organisations Process and Monitoring SI Process Reporting of Serious Incidents Compliance with Data Protection Act CCG Serious Incident Process Extensions Assurance regarding completed actions and embedded learning Duty of Candour Independent Sector Special Circumstances Downgrading Serious Incidents Reporting/Governance Governance in Provider Organisations NHS East and North Hertfordshire Clinical Commissioning Group Page 4 of 43

5 Records Management Retention of Records Equality and Diversity Information Governance Training Policy Process Approval Dissemination and Implementation Monitoring of Compliance APPENDICIES Appendix 1 NHS England Serious Incident Framework 2015 & Never Event Framework 20 Appendix 2 CCG SI Panel Terms of Reference 21 Appendix 3 ENHCCG SI Process Flowchart 24 Appendix 4 Appendix 5 Appendix 6 Appendix 7 Appendix 8 Appendix 9 Appendix 10 Appendix 11 Investigation Templates: 72 Hour and RCA ENHCCG Escalation Process ENHCCG Multiple Commissioner SI Process CCG Extension Request Form STEIS Form Template Interested Bodies Equality Impact Assessment Stage 1 Screening Privacy Impact Assessment Stage 1 Screening NHS East and North Hertfordshire Clinical Commissioning Group Page 5 of 43

6 KEY CONTACTS CCG Central Midlands Area Team In-Hours Telephone: Telephone: / Out of Hours Director on call Senior Manager on call Director on call ACRONYMNS ABO AHP ASMS CCG CEMACE CQC DEQ DH DHR DOLS EIA ENHCCG EU GP HEE HR HSAB HSCA HSCB HSCIC HSE HSWA IG IIRG LSAMO LSMS MCA MHRA NHS NRLS PHE PIA QRM RCA RIDDOR SABRE SAR SCR SHOT SI SIRS SMART STEIS TB TDA ABO Blood Groups Allied Health Professional Area Security Management Specialist Clinical Commissioning Group Confidential Enquiry into Maternity and Child Health Care Quality Commission Directors of Education and Quality Department of Health Domestic Homicide Review Deprivation of Liberty Safeguards Equality Impact Assessment East and North Hertfordshire Clinical Commissioning Group European Union General Practitioner Health Education England Human Resources Hertfordshire Safeguarding Adults Board Health and Social Care Act Hertfordshire Safeguarding Children s Board Health and Social Care Information Centre Health and Safety Executive Health and Safety at Work Act Information Governance Independent Investigations Review Group Local Supervisory Authority Midwifery Officer Local Security Management Specialist Mental Capacity Act Medicines and Healthcare Regulatory Agency National Health Service National Reporting Learning Service Public Health England Privacy Impact Assessment Quality Review Meeting Root Cause Analysis Reporting of Injuries, Diseases and Dangerous Occurrences Regulations Serious Adverse Blood Reactions and Incidents Safeguarding Adult Review Serious Case Review Serious Hazards Of Transfusion Serious Incident Serious Incident Reporting System Specific, Measureable, Assignable, Realistic, Time-Related Strategic Executive Information System Tuberculosis Trust Development Authority NHS East and North Hertfordshire Clinical Commissioning Group Page 6 of 43

7 1.0 INTRODUCTION This policy supersedes the CCG s Serious Incidents Requiring Investigation Policy (2013). 1.1 NHS East and North Hertfordshire Clinical Commissioning Group (CCG) is committed to ensuring that we commission services that provide high quality care with patient safety as one of its fundamental principles. It is therefore essential that the CCG and our providers have effective processes in place to allow staff to report incidents when patients have, or could be harmed. Through investigation of incidents and analysing the root cause, there is an opportunity to learn lessons and implement actions to reduce the risk of the incident recurring and ultimately improving patient outcomes. The reporting of incidents, and the subsequent learning, should be regarded as positive by all and NHS England has provided a clear framework about the declaration and management of Serious Incidents (SI). This policy stands alongside NHS England s Serious Incident Framework 2015 and the Revised Never Event Framework (Appendix 1 NHS England Serious Incident Framework: 2015 and Revised Never Event Framework 2015) 2.0 PURPOSE This policy sets out the CCG s process for the reporting and management of SIs and relates to all services commissioned by the CCG and staff employed directly, and working on behalf of the CCG. The CCG expects all commissioned organisations that provide NHS funded healthcare to incorporate the requirements of this policy into their own organisational policies, as per the requirement within the NHS Standard Contract. 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. Furthermore NHS organisations are encouraged to co-operate as fully as possible in investigations by other agencies. 3.0 DEFINITIONS 3.1 Serious Incidents In accordance with the NHS England SI Framework (2015), SIs are events in health care where the potential for learning is so great, or the consequences to patients, families and carers, staff or organisations are so significant, that they warrant using additional resources to mount a comprehensive response. There is no definitive list of events/incidents that constitute a SI. Every incident must be considered on a case-by-case basis using the definitions below which set out the circumstances in which a SI must be declared. Acts and/or omissions occurring as part of NHS-funded healthcare (including in the community) that result in: o Unexpected or avoidable death of one or more people. This includes; - suicide/self-inflicted death; and NHS East and North Hertfordshire Clinical Commissioning Group Page 7 of 43

8 - homicide by a person in receipt of mental health care within the recent past o Unexpected or avoidable injury to one or more people that has resulted in serious harm o Unexpected or avoidable injury to one or more people that requires further treatment by a healthcare professional in order to prevent; - the death of the service user; or - serious harm o Actual or alleged abuse; sexual abuse, physical or psychological illtreatment, or acts of omission which constitute neglect, exploitation, financial or material abuse, discriminative and organisational abuse, self-neglect, domestic abuse, human trafficking and modern day slavery where; - healthcare did not take appropriate action/intervention to safeguarding against such abuse occurring or - where abuse occurred during the provision of NHS-funded care An incident (or series of incidents) that prevents, or threatens to prevent, an organisation s ability to continue to deliver an acceptable quality of healthcare services, including (but not limited to) the following: o Failures in the security, integrity, accuracy or availability of information often described as data loss and/or information governance related issues, including cyber security (See Section 5.1.8) o Property damage o o Serious breach/concern Incidents in population-wide healthcare activities like screening and immunisation programmes where the potential for harm may extend to a large population. o Inappropriate enforcement/care under the Mental Health Act (1983) and the Mental Capacity Act (2005) including Mental Capacity Act Deprivation of Liberty Safeguards (MCA DOLS) o o Systematic failure to provide an acceptable standard of safe care (this may include incidents, or series of incidents, which necessitate ward/unit closure or suspension of services) Activation of Major Incident Plan (by provider, commissioner of relevant agency) Major loss in confidence in the service, including prolonged adverse media coverage or public concern about the quality of healthcare or an organisation. It may be appropriate for a near miss to be classed as a SI because the outcome of an incident does not always reflect the potential severity of harm that could be caused should the incident (or a similar incident) occur again. This does not mean that every near miss should be reported as a SI but any decision should be based on an assessment of risk that considers: o The likelihood of the incident occurring again if the current systems/process remain unchanged and o The potential for harm to staff, patients, and the organisation should the incident occur again. If there is uncertainty about whether an incident meets the SI definition then these should be reported as SIs and an investigation undertaken. Advice can be sought from the CCG s Quality Team on NHS East and North Hertfordshire Clinical Commissioning Group Page 8 of 43

9 3.2 Never Events Never Events are particular types of SI that meet all of the following criteria; They are wholly preventable, where guidance or safety recommendations that provide strong systemic protective barriers are available at a national level, and should have been implemented by all healthcare providers. Each Never Event type has the potential to cause serious patient harm of death. However serious harm or death is not required to have happened as a result of a specific incident occurrence for that incident to be categorised as a Never Event. There is evidence that the category of Never Event has occurred in the past, for example through reports to the NRLS and a risk of recurrence remains. Occurrence of the Never Event is easily recognised and clearly defined this requirement helps minimised disputes around classification and ensures focus on learning and improving patient safety. The current never event list includes the following; Wrong Site Surgery Wrong implant/prosthesis Retained foreign object post-procedure Mis-selection of a strong potassium containing solution Wrong route administration of medication Overdose of Insulin due to abbreviations or incorrect device Overdose of methotrexate for non-cancer treatment Mis-selection of high strength midazolam during conscious sedation Failure to install functional collapsible shower or curtain rails (mental health) Falls from poorly restricted windows Chest or neck entrapment in bedrails Transfusion or transplantation of ABO-incompatible blood components or organs Scalding of patients For further information regarding the Never Event Policy and Framework 2015, please use the following link (or refer to Appendix One): ROLES AND RESPONSIBILIES 4.1 CCG Governing Body The role of the Governing Body is to ensure it is assured around the quality of commissioned services and holds providers to account in relation to the management of SIs and all associated actions and learning. The CCG s Governing Body will receive an update on key SIs bi-monthly as part of the Part 2 paper; a non-public appendix to the Integrated Performance and Quality Report. An update on numbers, themes and trends is included in the main Integrated, Performance and Quality Report. 4.2 CCG Quality Committee The role of the committee is to work to ensure that commissioned services are being delivered in a high quality and safe manner, ensuring quality sits at the heart of everything the CCG does. NHS East and North Hertfordshire Clinical Commissioning Group Page 9 of 43

10 The committee takes an active role in reviewing and advising on all patient safety issues, and reviewing themes, trends and learning from SIs. The Quality Committee regularly triangulates information from SIs with other intelligence to inform the wider quality agenda. 4.3 Director of Nursing & Quality The CCG s Director of Nursing and Quality has overall responsibility for the management of SIs and will: Delegate responsibility to (or undertake in the absence of) their deputies and/or relevant specialist leads, the review of all SI investigation reports and action plans, ensuring that they are sufficient Liaise with NHS England or any external body as required in relation to the immediate response to the declaration of a SI Lead the CCG s Incident Panel to facilitate discussion and review of key SIs and agree case closure Share intelligence and escalate as determined necessary to NHS England, regulatory bodies and partner organisations 4.4 Quality Team The CCG s Quality Team has responsibility for the management of SIs and for reporting the collective position of such to the CCG Quality Committee and the CCG Governing Body, as required. The Quality Team will: On receipt of notification of a SI, notify the relevant personnel as advised by a locally specified internal distribution list. In addition the Quality Team will inform the affected patient s GP Practice, as requested by the Governing Body. Ensure that where a provider does not have access to STEIS the incident is recorded on the providers behalf. Maintain a robust electronic audit trail for every SI investigation. Be responsible for liaising with the provider organisation to co-ordinate and monitor the progress of the SI; ensuring that all investigation and reporting is undertaken within the agreed timescale. Ensure that, if appropriate, the incident is added to the CCG Risk Register. Co-ordinate the review of all received reports, including those submitted to the CCG s SI Panel, for review and ultimate closure of the SI investigation. Monitor compliance with Duty of Candour. Ensure robust investigations are undertaken and appropriate actions identified. Report and oversee investigations for SIs occurring within the CCG. Be the central point of contact for all provider organisations with regards to Patient Safety. Undertake regular thematic reviews of SIs. Facilitate learning across the health system. To alert the CCG Communications Team to any SI cases which will potentially attract media attention. 4.5 Incident Panel The CCG operates an Incident Panel that will; Review and discuss SI investigations; providing appropriate challenge, ensuring the RCA is robust and meets the terms of reference set. Make recommendation where appropriate for further elements of investigation to be undertaken prior to submission for closure. NHS East and North Hertfordshire Clinical Commissioning Group Page 10 of 43

11 Determine whether sufficient assurance has been provided, including confirmation of completed actions, to agree closure of the SI. For SI Panel Terms of Reference please refer to Appendix All Staff All CCG members of staff have a responsibility to familiarise themselves with the content of the Serious Incident: Reporting and Management Policy. All members of staff have a duty to work within the standards and guidelines as specified in the Policy. All members of staff will review their practice as a result of any learning identified from a SI investigation. 4.7 NHS England NHS England has a responsibility to ensure that CCGs have appropriate systems in place to manage SIs in commissioned services. As part of this role, NHS has oversight of SI management and is responsible for reviewing trends and identifying areas of concern across the wider healthcare system. NHS England has a duty to provide the healthcare system with intelligence gained through this oversight role and to maintain mechanisms to support this function including local Quality Surveillance Groups. 4.8 Provider organisations The CCG expects provider organisations to have a robust process and clear governance in place for the reporting and management of SIs which is in line with this policy and the NHS England SI Framework. As part of this the CCG expects all providers to; Have a clear process for the identification and reporting of SIs which should include open communication with the CCG if there is indecision about whether an incident meets the SI criteria. Report all SIs to the CCG within 2 working days of the incident occurring, or being identified. Ensure all SIs meet the full requirements of Duty of Candour which involves early and open engagement with affected patients and/or their families. Ensure investigations are robust and identify the root cause, as well as the contributory factors, and meet the terms of reference set. Investigations to be undertaken by appropriately trained staff that are sufficiently removed from the incident to be able to provide an objective view. A multi-disciplinary approach should occur as appropriate. Have clear processes in place to ensure reports are submitted to the CCG within agreed timescales, following appropriate sign off at Director level. Mechanisms to ensure that appropriate SMART actions are identified; implemented and embedded within the organisation and learning is shared within their organisation and more widely as required. 5.0 PROCESS AND MANAGEMENT 5.1 SI Process Reporting of Serious Incidents SIs must be reported to the CCG s Quality Team and onto STEIS without delay and within two working days of the incident occurring or being identified. If there is a delay in reporting the incident, the provider must provide a rationale for the delay. For those organisations without access to STEIS a copy of the STEIS incident form should be completed and forwarded to the CCG s Quality Team who will record on STEIS. If all NHS East and North Hertfordshire Clinical Commissioning Group Page 11 of 43

12 of this information is not available at the time of reporting it should be updated as soon as possible thereafter. All SIs involving patient safety incidents must be reported to the National Reporting and Learning Service (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. If an organisation becomes aware of a SI which occurred at another provider it is expected they will send all relevant information to enhccg.quality@nhs.net. The CCG s Quality Team will subsequently contact the relevant provider who will be expected to complete the STEIS form. If a SI requiring immediate escalation and reporting to the CCG occurs out of hours, the CCG on call management procedures must be followed. The SI should then be reported on STEIS within 2 working days. In addition to reporting the SI on STEIS providers should ensure they have reported the incident to any external organisation where relevant Hertfordshire Safeguarding Children s Board: if the serious incident involves a child Hertfordshire Safeguarding Adult s Board: if the serious incident involves allegations of abuse or mistreatment of a vulnerable adult. Health and Safety Executive (HSE): If the incident is reportable under RIDDOR Medicines and Healthcare Products Regulatory Agency: If the incident involves a medical device or adverse drug reaction is suspected Coroner: If a death has occurred within 24 hours of patient admission or any sudden unexplained death Counter Fraud and Security Management Service: If the incident involves physical violence against a member of staff Public Health England: If the incident raises severe widespread threats to public health. The local Public Health Team within Hertfordshire are based within Health and Community Services If an external inquiry is required, this will need to be agreed in line with relevant national guidance. The responsibility for commissioning an external inquiry depends on the nature of the incident COMPLIANCE WITH DATA PROTECTION ACT The CCG, and its provider organisations, must comply with the Data Protection Act. When reporting a SI, investigation reports must not contain names or patient identifiable information and any such reports will be returned to the provider to anonymise before the CCG will accept the document. It is the responsibility of the investigating organisation to securely retain the investigation for 30 years. Any information shared between provider and commissioner needs to be sent securely CCG SERIOUS INCIDENT PROCESS CCG Process Following the declaration of the SI, the provider should undertake an initial review of the incident and provide the CCG with a report within 72 hours of the incident being reported. This report as a minimum should: NHS East and North Hertfordshire Clinical Commissioning Group Page 12 of 43

13 - Identify and provide assurance that any necessary immediate action to ensure the safety of staff, patients and the public is in place - Assess the incident in more detail (and to confirm if the incident does still meet the criteria for a serious incident and therefore does require full investigation) The CCG will review the report and provide feedback to the provider within 5 working days. Unless immediate assurance is required, clarifications should be incorporated into the final investigation report. The level of investigation will be determined by the nature of the incident and the should be adapted accordingly. 1. Concise Internal Investigation: Less complex incidents should be managed by individuals or a small group at a local level. The investigation outcome should be submitted in a concise report to the CCG within 60 working days of the incident being reported. 2. Comprehensive Internal Investigation: Complex incidents should be conducted by an investigation team or multi-disciplinary team with the potential to include specialist investigators. The investigation outcome should be submitted in a comprehensive report to the CCG within 60 working days of the incident being reported. 3. Independent Investigation: Such an investigation may be commissioned if the potential causes of the incident warrant independent scrutiny in order to ensure the root cause is identified and appropriate action taken. If an independent investigation has been commissioned then the case deadline is 6 months from the date the investigation commenced. All provider RCA reports should include confirmation of the Director who authorised the report. The investigation report will be reviewed by the CCG s Quality Team and feedback provided within 10 working days. Once an investigation has been completed the provider organisation will update the root causes and lessons learnt section of STEIS. This information should include key details of the investigation including an overview of the incident, findings, contributory factors, root causes, recommendations and actions. Please refer to Appendix 3 for further details of the CCG s process and Appendix 4 for investigation templates. Special dispensation may be given enabling NHS providers to undertake more detailed RCA or Panel Review investigative processes. Deadlines for these investigations will be agreed at the start of each process and must be adhered to. For any overdue provider reports and action plans, the CCG will implement the internal escalation process. Please see Appendix 5 for further details. Failure to meet CCG agreed timeframes may result in a performance related penalty being applied in line with the NHS Standard Contract. NHS East and North Hertfordshire Clinical Commissioning Group Page 13 of 43

14 Clock Stop For cases which are subject to an external investigation a clock stop can be requested by the provider. A clock stop will need to subsequently be requested by the CCG and agreed by the Area Team. This would include investigations such as: - Independent homicide investigations - Domestic Homicide Reviews - Coroner s investigation - Safeguarding investigation - Child death review - Police investigation - Prison Ombudsman - HSE investigation Action Plans Actions plans must be SMART: specific, measurable, attainable, relevant and timebound and should be relevant to the investigation report and target identified areas in order to significantly reduce the risk of incident recurrence. A responsible person must assigned responsibility for the implementation of each action with a clear deadline for completion. Review of RCA Reports/ SI Panel Submitted investigation reports will be reviewed by the CCG s Quality Team, and appropriate individuals as required. Investigation reports for key SIs will be discussed and reviewed by the CCG s Incident Panel. Both processes of review will determine whether further investigation is required or the case can be closed. Please see Appendix 2 for more information regarding the CCG s SI Panel. Where concerns are identified regarding the quality of RCAs, these will be fed back to the provider and escalated to the relevant Director where required. Closure Once a completed action plan is received with any relevant evidence of implementation, and no further investigation is required, the CCG will complete a closure form which will be signed by the CCG s Director of Nursing and Quality or designated Lead. Confirmation will be sent to the provider once the case has been closed on STEIS. Multiple agency SIs If there are multiple organisations involved in a SI it is expected that the organisation who first became aware of the SI reports on STEIS. Where required the CCG will assist with ensuring all relevant organisations are involved and agree who will lead the SI, and who will be responsible for ensuring Duty of Candour requirements have been adhered to. For incidents involving multiple agencies, the CCG may decide to facilitate and coordinate a joint investigation and if required, Chair a SI co-ordination meeting at the beginning of the process to agree Terms of Reference. All organisations will be expected to contribute to the process and subsequent investigation. The CCG will be responsible for monitoring the completion of the action plan. If the incident is less complex and input is required from an additional provider, the CCG expects for the investigating provider to lead the investigation with support from the CCG. NHS East and North Hertfordshire Clinical Commissioning Group Page 14 of 43

15 In situations related to unexpected deaths or GP contact, GP reports may be requested by the CCG via the Area Team and shared with provider organisations involved. Where a SI crosses the boundary of two or more CCGs, the CCGs concerned will liaise to ensure all are notified; a lead CCG is identified and a timescale is locally agreed. The lead CCG will be identified based on the main geographical location and service area where the SI occurred or in certain circumstances the residential original of the person(s) involved. Associate Commissioner SIs Where an SI relates to non-enhccg patient, details of the SI will be forwarded to the relevant commissioner. Please see Appendix 6 for the CCG s multiple commissioner SI process Extensions Timescales for report submission and review will be in accordance with the NHS England Serious Incident Framework 2015 and will be monitored by the CCG. If required extensions for investigations should be requested in a timely manner as soon as the requirement is known; they must be agreed on a case-by-case basis. Unless there are very exceptional circumstances, extensions will not be granted where; There is a failure by the provider to co-ordinate internal discussions. There is an inability to obtain an executive sign off. The request is submitted 72 hours prior to the submission deadline. Extension requests must be completed using the extension request form (Appendix 7) and must be made by the provider organisation s Patient Safety Team no less than three working days before the deadline. The request will be reviewed by a Senior member of staff from the CCG s Quality Team to make review the request and make a decision Assurance regarding completion of actions and embedded learning The CCG will monitor performance in relation to the SI process and seek assurance through the following means: Provider Quality Review Meetings: The CCG monitors progress made, implementation of action plans and review outcomes with the provider. Themes and trends of SIs will also be discussed at this forum for commissioner assurance and any further action required. Quality Assurance Visits: The CCG will use intelligence from SI investigations to inform provider Quality Assurance Visits and use this opportunity to seek assurance that specific actions have been implemented and embedded within the organisation. The Quality Lead and Quality Manager will meet with provider Patient Safety Teams to review processes and seek assurance in relation to actions and learning Duty of Candour Any SI investigation should adhere to the Being Open principle whereby affected patients and/or their families and carers should expect openness and honesty from the investigating organisation. Effective communication with those affected should commence as soon as the incident is identified. The NHS Standard Contract requires that the notification must be within 10 working days of the incident being reported to NHS East and North Hertfordshire Clinical Commissioning Group Page 15 of 43

16 local systems, and sooner where possible. The CCG expects all communication to be open, honest, compassionate and prompt. The needs and expectations of the person(s) affected should be the fundamental basis of the investigation Terms of Reference and the investigation should seek to address all areas of concern. Patients and/or their families should be provided with a single point of contact and be kept updated throughout the investigation process. The investigation report should fully detail the efforts the organisation has taken to ensure Duty of Candour has been adhered to Independent Sector Any SI involving a patient in receipt of NHS-funded care provided by an independent sector healthcare provider must be reported by that provider to the commissioning organisation with responsibility for the contract. The provider should use the electronic version of the STEIS form (Appendix 8). The CCG will then report the SI on the STEIS system on behalf of that organisation and monitor the investigation as per the normal process. Independent sector healthcare providers should report the incident to the NRLS and are also responsible for reporting the incident directly to the CQC Special Circumstances The following more specific incident types should generally be regarded as SIs and be rapidly escalated under the SI process. In addition the incidents may require further attention in respect of other processes applied. These incidents are likely to be closely scrutinised by CCGs and Area Teams due to the nature of their severity and sensitivity. Maternal Deaths In order to comply with Nursing and Midwifery Council Midwives Rules and Standards 2004, all maternal deaths are to be reported to the Local Supervising Authority Midwifery Officer (LSAMO). CEMACE (Confidential Enquiry into Maternal and Child Health) reporting will continue in the normal way. Whilst not all maternal deaths are classified as SIs the STEIS initial report form or internal incident reporting form should be utilised in all cases being notified to the LSAMO. All maternity SIs will be reported by the Area Team to LSAMO. Information Governance Incidents Where incidents relate to information governance (IG) issues they should be reported within the IG toolkit, in line with the Health and Social Care Information Centre guidance HSCIC Checklist Guidance for Reporting, Managing and Investigating Information Governance Serious Incidents Requiring Investigation and subsequent guidance. The severity of the incident must be assessed using the scale and severity factors outlined within the HSCIC guidance. All incidents which reach the threshold for a level 2 IG related serious incidents are reported publicly via the IG toolkit and should be reported and investigated as serious incidents. NHS East and North Hertfordshire Clinical Commissioning Group Page 16 of 43

17 Mental Health Services Incidents Including Homicides Involving Service Users An independent investigation may also be commissioned in the event of a homicide by a patient in receipt of mental health care. The reporting/investigation process for these incidents is defined in 3 stages: 1. Providers report an incident onto STEIS and conduct an initial review and produce a 72 hour report 2. Provider conducts an internal investigation and produce an investigation report within 60 days 3. The NHS England Regional Investigation Teams, in conjunction with the Independent Investigations Review Group (IIRG) review these reports and consider commissioning an independent investigation. Further guidance regarding independent investigations can be found in Appendix 1 of the NHS England Framework Domestic Homicide Reviews When there is a domestic homicide which involves Hertfordshire residents a multiagency DHR will be undertaken. Providers will be expected by law to contribute to this review where required. Suicides Suspected or actual suicide of any person currently in receipt of NHS services on or off NHS premises must be reported as a SI. This includes patients who are currently in receipt of mental health services or who have been discharged within the last 12 months. Serious Case Reviews and Safeguarding Adult Reviews The Local Authority, via the Hertfordshire Safeguarding Children Board or Hertfordshire Safeguarding Adult Board, has a statutory duty to investigate certain types of safeguarding incidents/concerns. In circumstances set out in Working Together to Safeguard Children (2013) the HSCB will commission Serious Case Reviews and in circumstances set out in the Care Act for adult safeguarding concerns the HSAB will commission Safeguarding Adult Reviews. Healthcare providers must contribute towards safeguarding reviews and are required to do so by the HSCB and HSAB. Where it is indicated that a SI within healthcare has occurred, the necessary declaration must be made. Whilst the Local Authority will lead SCR and SARs, healthcare must be able to gain assurance that, if a problem is identified, appropriate measures will be undertaken to protect individuals that remain at risk and ultimately to identify the contributory factors and the fundamental issues to minimise the risk of further harm and/or recurrence. The interface between the SI process and safeguarding procedures must therefore be articulated in the local multi-agency safeguarding policies and protocols. Death In Custody People in custody, including either those detained under the Mental Health Act (1983) or those detained within the police and justice system, are owed a particular duty of care by relevant authorities. In NHS mental health services providers must ensure that any death of a patient detained under the Mental Health Act (1983) is reported to the CQC without delay. Providers are responsible for ensuring there is an appropriate investigation into the NHS East and North Hertfordshire Clinical Commissioning Group Page 17 of 43

18 death of a patient detained under the Mental Health Act (1983) or where Mental Capacity Act (2005) applies. In circumstances where the cause of death is unknown and/or where there is reason to believe the death may have been avoidable or unexpected, i.e. not caused by the natural course of the patient s illness or underlying medical condition when managed in accordance with best practice, including suicide and self inflicted death, then the death must be reported to the CCG as a SI and investigated appropriately. Consideration should be given to commissioning an independent investigation. While the CCG will offer support, the provider is ultimately responsible for undertaking and managing the investigations and consequently incur the cost for this process. This includes paying for independent investigations of the care the provider delivered and for undertaking its own internal investigations. SIs related to National Screening Programmes SIs in the NHS National Screening Programmes must be managed in line with the guidance; Managing Safety Incidents in National Screening Programmes, which is aligned with the principles and processes set out in the Framework. The guidance providers further clarity with regards to the accountabilities, roles and processes for managing screening safety incidents and SIs in national screening programmes. These are often very complex, multi-faceted incidents that require robust coordination and oversight by Screening and Immunisation Teams working within Sub-regions and specialist input from Public Health England s Screening Quality Assurance Service Downgrading of Serious Incidents At any stage during the investigation process evidence may come to light that proves an incident no longer meets the criteria of a serious incident. In this instance the provider must provide the CCG s Quality Team with a clear rationale as to why the incident no longer requires a SI investigation. The rationale will be reviewed by the CCG and if agreed, a request will be made to remove the incident from STEIS. 6. REPORTING/GOVERNANCE 6.1 Governance in Provider Organisations SIs will form an integral part of clinical governance, contract monitoring and performance management processes. This will be achieved through the CCG Quality Team s regular review of SI s logged with the CCG by providers. Providers are expected to maintain robust governance arrangements for the management of SIs within their organisations in accordance with Part 2; 3.1 of NHS England Serious Incident Framework (2015). 6.2 RECORDS MANAGEMENT Retention of Records Files relating to the investigation of SIs received by the CCG will be retained in an electronic format in a secure location for a minimum of 30 years, as per Records Management NHS Code of Practice Part 2 (2 nd Edition) policy Department of Health/Digital Information Policy (2009). 6.3 EQUALITY AND DIVERSITY The CCG is committed to being an organisation within which diversity, equality and human rights are valued. We will not discriminate either directly or indirectly and will not tolerate harassment or victimisation in relation to gender, marital status, gender reassignment, disability, race, age, sexual orientation, religion or belief, trade union membership, status as a fixed-term or part-time worker, socio-economic status and pregnancy or maternity. NHS East and North Hertfordshire Clinical Commissioning Group Page 18 of 43

19 6.4 INFORMATION GOVERNANCE ENHCCG works to a framework for handling personal information in a confidential and secure manner to meet ethical and quality standards. This enables NHS organisations in England and individuals working within them to ensure personal information is dealt with legally, securely, effectively and efficiently to deliver the best possible care to patients and clients. ENHCCG via the Information Governance Toolkit provides the means by which NHS England can assess the organisation s compliance with current legislation, Government and National Guidance. 6.5 TRAINING Managers, and staff referred to within the Policy are responsible for ensuring they and their staff, are adequately training to carry out the roles and responsibilities described. The Quality Team will provide training within the CCG and provide advice to providers as required. 6.6 POLICY PROCESS Approval The policy and subsequent amendments will be approved and ratified by the CCG Quality Committee as the designated body of the CCG Board. The Policy will be reviewed in September Dissemination and Implementation The CCG s policy will be communicated via the CCG website and CCG staff will be made aware of the revised Policy via a staff learning session Monitoring of Compliance The Policy Owner is responsible for monitoring compliance with the process and the effectiveness of actions taken, overseen by the CCG Quality Committee. NHS East and North Hertfordshire Clinical Commissioning Group Page 19 of 43

20 Appendix 1: NHS England Serious Incident Framework 2015 NHSE Serious Incident Framework 2 Never Events Policy and Framework FINA NHS East and North Hertfordshire Clinical Commissioning Group Page 20 of 43

21 APPENDIX 2: CCG Incident Panel Terms of Reference 1. Purpose NHS England s Serious Incident Framework (2015) states that commissioners are accountable for quality assuring the robustness of their providers Serious Incident investigations and the development and implementation of effective actions, by the provider, to prevent recurrence of similar incidents. East and North Hertfordshire Clinical Commissioning Group s (ENHCCG) Incident Panel is responsible for ensuring a robust quality assurance process is in place for the review and closure of Serious Incidents on behalf of the CCG s Governing Body as well as providing a senior clinical view on harm review outcomes and offering guidance on complex complaints. The Incident Panel is responsible for reviewing and scrutinising all investigations and action plans received from providers following Serious Incidents which meet, but not exclusive to, the following definitions: Never Event Multi-Agency Serious Incident Diagnostic Delay/Incident Unexpected Death Deteriorating Patient Maternity/Obstetric Medication Error Homicide Mental Health Absconsion Death of a Service User Any Incident investigation outside of the above definition list will be reviewed by appropriate members of the Nursing and Quality Team, and additional Leads as required, as specified by the Serious Incident Review guidance. In addition to Serious Incident investigations the panel will review all formal harm reviews submitted to the Nursing and Quality Team for review by providers, including acute trust RTT and cancer harm reviews. Complex complaints will also be reviewed where additional clinical input is required. This will be determined on an ad hoc basis in discussion with the Director of Nursing. 2. Remit The responsibility of the Incident Panel is to: Review root cause analysis investigation reports and harm reviews in any provider where CCG has a commissioning responsibility Consider whether the investigation has been fully investigated to identify the root causes using established assurance frameworks Consider whether the recommendations and actions are appropriate Monitor the quality of the investigation report received Support timeliness of responses to investigations Authorise the closure of Serious Incidents if satisfied that the investigation report and action plan meets the required standard Link themes and trends to performance within providers and any on-going quality concerns NHS East and North Hertfordshire Clinical Commissioning Group Page 21 of 43

22 Consider whether enhanced quality surveillance or other action is required on the part of the commissioner, e.g. notification to the CQC Consider whether there is any important learning that should be shared with other providers/agencies or more widely across the local health economy 3. Membership The membership of the Serious Incident Panel will compromise: Quality Lead, ENHCCG (Chair) Patient Experience and Safety Facilitator, ENHCCG (co-chair) Director of Nursing and Quality, ENHCCG Senior Medical representation ie Medical Director or Clinical Fellow, ENHCCG Associate Director of Quality & Patient Experience, ENHCCG Lead Nurse, ENHCCG Quality Manager, ENHCCG In addition to the above members, other key staff will be invited to attend as required to meetings, for example Safeguarding Leads, Infection Control Lead Nurse, Pharmacy and Medicines Optimisation Team, Integrated Health & Care Commissioning Team. Quorum: For an Incident Panel to be quorate, there will need to be at least three representatives including a member of the Senior Management Team, two clinicians and administrative support (minimum of three representatives would require the member of the SMT to be clinical). 4. Responsibilities The Incident Panel will be expected to undertake the following: Review the circulated reports/information prior to the Panel If a member is unable to attend the meeting their comments should be shared electronically in advance of the Panel Should the panel agree that further input into a case is required from a person not present at the meeting, the panel will seek this further advice prior to a decision being made Adhere to ENHCCG s Serious Incident Policy (2015) which is aligned to NHS England s Serious Incident Framework (2015) The Patient Experience and Safety Facilitator will be responsible for the administration of the Panel and will be present at the meeting to record the discussions and actions The Patient Experience and Safety Facilitator will ensure any feedback as a result of the Panel is sent to the provider within timescale The Director of Nursing and Quality will be responsible for authorising the closure of Serious Incidents. In the absence of the Director of Nursing and Quality, the closure of Serious Incidents can be authorised by ENHCCG s Associate Director of Quality and Patient Experience or Lead Nurse. 5. Frequency of Meetings The Incident Panel will be held on a weekly basis as required. The papers for each meeting will be circulated no less than 4 days ahead of each meeting to allow the attendees to prepare for the meeting discussion. 6. Review The Terms of Reference will be reviewed in 12 months or before if necessary to maintain the effectiveness of the group. NHS East and North Hertfordshire Clinical Commissioning Group Page 22 of 43

23 Version 2 Date Agreed Review Date December 2017 NHS East and North Hertfordshire Clinical Commissioning Group Page 23 of 43

24 APPENDIX 3: ENHCCG SI Process Flowchart NHS East and North Hertfordshire Clinical Commissioning Group Page 24 of 43

25 APPENDIX 4.1: 72 Hour Report Template CCG Area Reporting Organisation Reporter Details Reporter Name 72 Hour Report Reporter Job Title Reporter Tel. no Reporter Incident Details Date of Incident Incident Site (if other than reporting org) Date Incident Identified Incident Location Incident Details Type of Patient GP Practice Gender Male Female Date of Birth (dd/mm/yyy or N/A) Ethnic Group Persons Notified Patient Family Carer Degree of Harm None Low Severe Death Junior Doctor Involvement Include Specialty and Grade What Happened Type of Incident Actual/Near Miss NHS East and North Hertfordshire Clinical Commissioning Group Page 25 of 43

26 Never Event Yes Expected level of investigation Description of Incident Immediate Action Taken Media Interest Yes No Comms Informed Yes No Externally reportable Yes No Externally reported to Any Other Comments: e.g. multiagency incident, police and/or HSE investigation, Coroner s inquest, CQC involvement. NHS East and North Hertfordshire Clinical Commissioning Group Page 26 of 43

27 APPENDIX 4.2: RCA Report Requirements A Serious Incident Investigation report should address the following areas: 1. Executive Summary Brief Incident Description Recommendations 2. Terms of Reference Purpose Objectives Key Issues and Scope Key Deliverables 3. Background Description of Patient Description of Service Clinical Services Provided to Patient Additional Information such as: Did the patient die as a result of the incident? Were Safeguarding procedures considered/required? Was a Mental Capacity Act assessment considered? Is the incident being reported or investigated externally? 4. Duty of Candour Description of Support for Patient Description of Support for Family/Carers/Guardians Description of Support for Staff 5. Investigation Report Investigation Team List of Data Sources Timeline/Chronology RCA Fishbone detailing Contributory Factors, including: Patient Factors Individual Staff Factors Task Factors Communication Factors Team and Social Factors Education and Training Factors Equipment and Resource Factors Working Condition Factors Organisational and Strategic Factors Root Cause NHS East and North Hertfordshire Clinical Commissioning Group Page 27 of 43