Note: Yeovil District Hospital NHS Foundation Trusts Incident Reporting Policy refers to this SIRI policy

Transcription

1 PROCESS FOR REPORTING AND LEARNING FROM SERIOUS INCIDENTS REQUIRING INVESTIGATION Note: Yeovil District Hospital NHS Foundation Trusts Incident Reporting Policy refers to this SIRI policy Version: Ratified by: Final Governance Committee Date Ratified: 15 May 2013 Name of Originator/Author: Name of Responsible Committee/Individual: Date issued: May 2013 Review date: May 2016 Target audience: Liz Jagelman, Assistant Risk Manager Patient Safety and Quality Assurance Committee All staff employed by the commissioner and all Services Commissioned by the commissioner

2 PROCESS FOR REPORTING AND LEARNING FROM SERIOUS INCIDENTS REQUIRING INVESTIGATION CONTENTS CONTENTS Page VERSION CONTROL... IMPACT ASSESSMENT... i ii 1 INTRODUCTION DEFINITION OF A SERIOUS INCIDENT REQUIRING INVESTIGATION (SIRI) REPORTING OF SERIOUS INCIDENTS COMMUNICATING WITH PATIENTS, CARERS AND FAMILIES SAFEGUARDING INCIDENTS ROLES AND RESPONSIBILITIES RESPONSIBILITIES OF THE COMMISSIONER... 8 Investigating Serious Incidents Management of Investigations for Grade 2 Incident and Never 10 Events. Standards for Management of Serious incidents BLACK ALERT STATUS - ESCALATION FRAMEWORK 11 9 CATEGORIES AND INCIDENTS THAT SHOULD BE NOTIFIED Abuse of Adults Blood Transfusion Emergency Plan Invoked Health Protection Serious Incidents Occurring in Independent Provider Organisations 14 Regulation... Information Governance Information Technology Major Incidents Maternity Serious Incidents - Maternity, Infant and Child Incidents. 15 Media Issues Medical Devices Adverse Drug Reactions Medico-Legal Incidents/Litigation... 16

3 Mental Health, Substance Misuse and Incidents Involving Learning Disabilities Mortality/Morbidity/Care Incidents Never Events Nursing Home SIRI / Patient Safety Incidents 19 Premises/Equipment Incidents Prison Healthcare Professional Misconduct Radiology Screening Programmes 20 Staff-Related Incidents Terrorism and Chemical, Biological, Radiological or Nuclear (CBRN) Incidents Unexpected Death, Serious Harm or Injury Violence towards Health Care Staff MONITORING AND COMPLIANCE Rapid Responsive Review.. 23 Risk Summits DISSEMINATION OF LEARNING COMMUNICATION BETWEEN ORGANISATIONS MEMORANDUM OF UNDERSTANDING: INVESTIGATING PATIENT SAFETY INCIDENTS INCLUDING UNEXPECTED DEATH OR SERIOUS UNTOWARD HARM ACKNOWLEDGMENTS APPENDICES APPENDIX 1 Out of Hours Reporting and Media Relations APPENDIX 2 Flowchart for Provider Organisations and Lead Commissioners on the Management of Grade 2 Serious Incidents APPENDIX 3 Serious Incident Requiring Investigation (SIRI) 72 Hour Report APPENDIX 4 Guidance for Maternity reportable incidents on STEIS 33 APPENDIX 4a Guidance for Infant and Child Incidents reportable on STEIS. 34 APPENDIX 5 Flowchart for the Management of Mental Health Homicide Incidents APPENDIX 6 Root Cause Analysis Template APPENDIX 7 Adult Safeguarding Flow Chart APPENDIX 8 Child Deaths and Child Safeguarding Flowchart APPENDIX 9 Incident and Risk Rating APPENDIX 10 Pressure Ulcer Investigation Template APPENDIX 11 Protected Groups Form 49 APPENDIX 12 Independent Contractors Pathway. 50

4 APPENDIX 13 NHS III SIRI Flowchart 51 APPENDIX 14 SIRI Communication Template APPENDIX 15 Serious Incidents / Patient Safety Incidents reportable for Nursing Homes... 53

5 REPORTING AND LEARNING FROM SERIOUS INCIDENTS REQUIRING INVESTIGATION VERSION CONTROL Number assigned to document: Document Status: Final Version: 2.0 DOCUMENT CHANGE HISTORY Version Date Comments June 2010 First Draft October 2010 Amendments following publication of the revised South West Strategic Health Authority Process for Serious Untoward Incidents in September November 2010 Amendments following the Patient Safety and Quality Assurance Committee January 2011 Ratified by the Patient Safety and Quality Assurance Committee March 2011 Policy further updated in light of revised Never Events from Department of Health October 2012 Revised following comments from Associate Director of Nursing and Patient Safety October 2012 Revised following comments from Director of Nursing and Patient Safety November 2012 Revised following update from Deputy Director of Nursing and Patient Safety and Designated Nurse for Safeguarding Children January 2013 Ratified by the Patient Safety and Quality Assurance Committee March 2013 Revised to reflect the NHS reforms and policy amended to reflect the responsibilities of Somerset Clinical Commissioning Group March 2013 Revised to reflect updated guidance from the NHS Commissioning Board i

6 Sponsoring Director: Author(s): Lucy Watson, Director of Quality and Patient Safety Liz Jagelman, Assistant Risk Manager Jo, Howarth, Head of Patient Safety and Risk Management Document Reference: ii

7 CONFIRMATION OF EQUALITY IMPACT ASSESSMENT FOR THE COMMISSIONER DOCUMENTS/POLICIES/STRATEGIES AND SERVICE REVIEWS Main aim of the document: This document sets out the commissioner s policy for the Reporting and Learning from Serious Incidents Requiring Investigation (SIRI s). Outcome of the Equality Impact Assessment Process: Neutral impact identified If relevant, outcome of the full impact assessment: Actions taken and planned as a result of the equality impact assessment, with details of action plan with timescales/review dates as applicable: Review of Policy in Three years (2016) Groups/individuals consulted with as part of the impact assessment: The commissioner staff iii

8 PROCESS FOR REPORTING AND LEARNING FROM SERIOUS INCIDENTS REQUIRING INVESTIGATION 1 INTRODUCTION 1.1 This policy sets out the arrangements by which organisations provide NHS Funded care as commissioned by Somerset Clinical Commissioning Group (CCG) will report, investigation and evidence learning from Serious Incidents Requiring Investigation (SIRI s). 1.2 This Policy for Reporting and Learning from Serious Incidents Requiring Investigation (SIRI) follows the National Framework for Reporting and Learning from Serious Incidents, published by the National Patient Safety Agency, in March The approach encourages openness, trust and continuous learning, and provides a consistent approach to the management of serious incidents, and sets clear standards for investigation and partnership working with relevant bodies. 1.3 Promoting Patient Safety by reducing harm or error is a key priority for the NHS, particularly since the publication of An Organisation with a Memory (Department of Health, 2000) which emphasises the need for learning from adverse events and sets out a series of recommendations. Building a Safer NHS for Patients (Department of Health, 2001) describes the implementation of these recommendations, including plans to establish a national reporting system to record, analyse, and learn from adverse incidents, ensuring that lessons learnt in one part of the NHS are properly shared across the whole health community. 1.4 The Area Team for the NHS Commissioning Board is required to receive notification of all serious incidents from all NHS Trusts and commissioned services within its boundary. In addition the reporting of SIRI s is a requirement of the national contract for acute, community and mental health providers together with a statutory Duty of Candour 1.5 Grade 1 SIRI s - As lead commissioner, Somerset Clinical Commissioning Group is responsible for the management, on-going review and monitoring of serious incidents from organisations providing NHS funded Care in Somerset. All Grade 2 incidents as defined in the National Framework for Reporting and Learning from Serious Incidents 2010, Never Events and incidents requiring independent investigation are monitored jointly by the commissioners and the Area Team for the NHS Commissioning Board. 1.6 This policy should be read in conjunction with the following Somerset Clinical Commissioning Group policy documents: Incident Reporting Policy Major Incident Plan Trust Risk Management Strategy 1

9 Complaints Procedure Raising a Concern policy Safeguarding Children and Adults Policies Checklist for Reporting, Managing and Investigating Information Governance Serious incidents (DH Gateway Ref: 13177) Department of Health Never Events List 2012/2013 NHS South of England Process for reporting and learning from serious incidents requiring investigation National Patient Safety Agency Information resource to support the reporting of Serious Incidents Serious Incident Framework - an update to the 2010 National Framework for Reporting and Learning from Serious Incidents Requiring Investigation 2 DEFINITION OF A SERIOUS INCIDENT REQUIRING INVESTIGATION (SIRI) 2.1 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 or severe harm of one or more patients, staff, visitors or members of the public 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/organisational information, damage to property, reputation or the environment, or IT failure allegations or incidents of abuse loss of confidence in a service as a result of adverse media coverage or public concern about healthcare or an organisation a never event - all never events are defined as SIRIs although not all never events necessarily result in severe harm or death 2.2 Reporting serious incident near misses may also be necessary, due to potential media attention, or to facilitate the dissemination of lessons learnt. Within the severity grading used by the National Patient Safety Agency, near misses are split into two categories, rather than one, as previously, and are referred to as: prevented incidents; (previously classed as a near miss ) such as those that did not impact on the patient because of factors other than intervention, an example of which could be where a patient was given a prescription for the wrong dose of a medication, but the error was noticed and corrected by the pharmacy 2

10 no harm incidents; an example of which could be a patient was supplied a drug by a pharmacist which was meant for a different patient. The drug had no ill effect on the patient 2.3 From the 1 April 2010, as part of the new registration requirements arising from the Health and Social Care Act 2008, NHS 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 that lead, or may lead to changes in the details about the organisation in the CQC register. Reports about serious incidents and deaths are defined in the CQC s guidance, Essential Standards of Quality and Safety. For CQC registered providers most of these requirements are met by reporting via the NRLS who will forward relevant information to the CQC. 2.4 In certain instances, there will also be a need to inform other agencies, in accordance with national guidance, such as the Medicines and Healthcare Products Regulatory Agency (MHRA) in the case of medicines equipment failure, and the Counter Fraud and Security Management Service (CFSMS) in the case of fraud and violence towards staff. NHS Foundation Trusts are also required to report specific incidents to the Health and Safety Executive and Monitor. 2.5 There is in place a protocol for liaison and effective communication between the National Health Service, the Health and Safety Executive, and the Association of Chief Police Officers, with regard to investigating patient safety incidents (unexpected death or serious untoward harm) to agree arrangements for investigations of health services to proceed when a criminal investigation or HSE investigation is being undertaken. This is set out in the Memorandum of Understanding: Investigating Patient Safety Incidents Involving Unexpected Death or Serious Untoward Harm, published by the Department of Health, in February

11 3 REPORTING OF SERIOUS INCIDENTS 3.1 The organisation, where the serious incident requiring investigation occurred, has overall responsibility for reporting the incident and for the investigation and implementation of subsequent action plans. The lead commissioner is responsible for monitoring the management of serious incidents requiring investigation, reported by providers of NHS funded care. Where an incident relates to a patient whose treatment has been commissioned by the Specialist Commissioner, the commissioner has in place a process of communication whereby such incidents are required. Reference - South West Specialist Commissioning Group - Process for Handling and Learning from Serious Incidents. 3.2 When an incident is reported by an organisation, and the Commissioner who is responsible for the care of the patient is not the Lead Commissioner (Associate Commissioner) the Lead Commissioner will liaise with the Associate Commissioner, and involve them in the sign off process. 3.3 A Serious Incident will be identified as an incident through the use of the incident reporting risk management matrix. Incidents that are graded against the consequence and likelihood score which result in a combined risk score of greater than 16, will be classed as a Red Serious Incident, and consideration will be given as to whether these incidents meet the requirements for SIRI reporting, as shown in appendix SIRI s should be reported on the Strategic Executive Information System (STEIS) within two working days of the organisation identifying the Serious Incident. In the majority of cases, the date of the incident occurring is the same as the date in which the reporting organisation identifies the incident. In some cases, the date that the organisation identifies the incident may differ from the actual incident date. An example of this is when an incident comes to light, following a retrospective case note review. In these cases, the date of knowledge the organisation identifies the incident becomes the incident date for monitoring purposes. The commissioner will make the final decision on which date applies in consultation with the reporting organisation. 3.5 When an organisation does not have access to the Strategic Executive Information System (STEIS), for example independent contractors and Treatment Centres, the commissioner will input the details of the SIRI and sign off the report. In these cases, oversight of the reporting and investigation process detailed in this process remains in place. 3.6 Where there is an unavoidable delay in investigating an incident, NHS providers should update STEIS and inform the Patient Safety Team as the commissioner, at the earliest opportunity. 4

12 Grading and Monitoring of Incidents 3.7 Serious incidents are graded as either 0, 1 or 2. Definitions can be found in the National Framework for Reporting and Learning from Serious Incidents Requiring Investigation (page 17). The commissioner will review all incidents reported on STEIS within 2 working days of the report being made and agree the grading for the incident with the NHS provider. 3.8 All Never Events are graded as Grade 2 serious incidents. There may need to be discussion between the NHS provider, commissioner and the Local Area Team for the NHS Commissioning Board, to agree that an incident meets the criteria for a Never Event, and the associated grading. The relevant commissioning manager, quality lead and lead GP will be informed when incidents of this nature are reported. 3.9 The on-going monitoring of Grade 1 incidents will be managed by the Somerset Clinical Commissioning Group) Where serious incidents occur across organisational boundaries, Somerset Clinical Commissioning Group will agree with other relevant commissioners arrangements for leading and coordinating the investigation, and oversee the management of the process When an incident occurs where a number of organisations are involved in the patient pathway e.g. NHS III, Ambulance services and Hospital, the Lead Commissioner will facilitate the investigation, to ensure that all stakeholders are involved. Confidentiality 3.12 It should be noted that, in the interests of confidentiality, all reports should contain anonymised information. The content of any report relating to serious incidents should not contain the names of practitioners, patients or information, which could lead to the identification of practitioners or patients. Investigation reports may be disclosable under the Freedom of Information Act Where Somerset Clinical Commissioning Group or the Local Area Team for the NHS Commissioning Board, consider the serious incident to be of a nature where patient (and practitioner) identifiable information is necessary in order to protect patient safety, the Trust may release this information in line with Caldicott principles and agreement with the relevant Caldicott Guardian 3.14 If a patient is transferred to an organisation and clinical staff report that the patient may have previously been involved in a serious incident in the originating organisation, the incident should be reported by the receiving organisation. The receiving organisation should also advise their Lead Commissioner, who may negotiate transfer of the incident and responsibility for investigation to the originating organisation. An example 5

13 of this may be the identification of a suspected safeguarding incident, or where a pressure ulcer is deemed to have been present on admission. 4 COMMUNICATING WITH PATIENTS, CARERS AND FAMILIES 4.1 In November 2009, the National Patient Safety Agency issued an alert strengthening its 2005 Being Open safer practice notice. The alert requires all organisations to adopt the Being Open principles of transparency, involvement and engagement with patients and their families. The detail of the approach and involvement with the patients, family and/or carers should be included in all investigation reports as set out in the Somerset Clinical Commissioning Group Being Open Policy. 4.2 Where statutory instruments deem contact with the patient / relatives is not indicated for example in safeguarding incidents or where a criminal investigation is in progress, the statutory instrument should be adhered to following discussion with the relevant agencies within the framework of the memorandum of agreement. 4.3 In accordance with the Duty of Candour providers must within 10 operational days after reporting a reportable patient safety incident notify the Relevant Person that the reportable patient safety incident has occurred or is suspected to have occurred. 5 SAFEGUARDING INCIDENTS Adults No Secrets (Department of Health 2000) 5.1 The No Secrets guidance (Department of Health, 2000) forms the basis for multi-agency activity to protect adults who are at risk of harm. No Secrets is not legislation itself but rather statutory guidance issued under Section 7 of the Local Authority Social Services Act Councils are thus obliged to follow such guidance. 5.2 Under the No Secrets guidance, local authorities have the lead role in coordinating work to safeguard adults at risk; however, the main focus of the guidance is the need for effective multi-agency working arrangements to protect vulnerable people. Safeguarding Adults: the role of Commissioners (DH, 2011) 5.3 The Department of Health published Safeguarding Adults; the role of Commissioners in March 2011highlighting the need to ensure that responsibilities for safeguarding adults are safely managed and maintained through the transition period and into the new organisational commissioning arrangements by Clinical Commissioning Groups, the NHS Commissioning Board and the Local Authority and 6

14 5.4 This guide sets out that safeguarding adults is integral to safeguarding care or patients using health services as follows: Patient Care: Achieving high quality care for patients. Safeguarding is particularly relevant to domains 4 and 5 of the NHS Outcomes Framework patient experience and protecting people from avoidable harm Regulation: Safeguarding is a fundamental requirement for registration and complying with the Care Quality Commission, Essential Standards for Quality and Safety Legislation: Commissioners duty to comply with legislation including the Human Rights Act; Equality Act; Mental Capacity Act and Safeguarding Vulnerable Groups Act Cost effectiveness: Quality Innovation Productivity and Prevention harm neglect and abuse cost the NHS millions each year in avoidable admissions and care Safeguarding thresholds in health 5.5 The commissioner, in liaison with Somerset County Council, continues to work to strengthen reporting of safeguarding incidents in health settings. 5.6 As part of monitoring arrangements the commissioner will review all SIRIs and consider if there are safeguarding concerns and whether a referral should be made to the Safeguarding Adults Board if this has not been actioned by the reporting organisation or service. 5.7 The SIRI investigation will contribute to any serious case review instigated as a result of a safeguarding concern. 5.8 Details of the Adult Safeguarding process can be found at Appendix 7 of this document. Children 5.9 Health Commissioners and NHS Trusts have a statutory duty to safeguard and promote the welfare of children (Children Act 2004). As part of that duty they must have arrangements in place to identify, report, investigate, as well as implement and manage any remedial action required in situations where it is believed that an incident has occurred that could have adversely affected the health or welfare of a child. This also includes near misses A small subset of adverse incidents will fall into the category of safeguarding 7

15 children SIRIs, see attached appendix 4 for the reporting guidance on Maternity, Infant and Child SIRIs 5.11 A number of Safeguarding Serious Incidents may also meet the criteria, outlined within Working Together (2010) statutory guidance for a Serious Case Review (SCR). It is the decision of the Local Safeguarding Children Board as to whether or not an SCR will be commissioned. Any child protected in care subject to an SCR will meet the threshold for reporting as a safeguarding Serious Incident. 6 ROLES AND RESPONSIBILITES 6.1 The NHS has a responsibility to ensure that when a serious incident does happen, there are systematic measures in place for: safeguarding people, property, the service s resources and its reputation understanding why the event occurred ensuring that steps are taken to reduce the chance of a similar incident happening again reporting to other bodies, where necessary, and sharing the learning with other NHS organisations and providers of NHS-funded care 7 RESPONSIBILITIES OF THE COMMISSIONER 7.1 The commissioner is responsible for ensuring that the following are in place: processes for reporting the event to other local agencies, such as the police, local authority and other NHS Trusts clear requirements for responding to serious incidents are specified and agreed within contracts with all providers procedures and relevant skills and resources, to receive and appropriately manage and monitor follow up of serious incidents requiring investigation mechanisms in place to ensure that necessary follow-up action is taken including monitoring of actions plans that have a clear trajectory with named responsibility leads. access to independent investigators and experienced clinical advisors, in addition to suitably qualified and experienced commissioning staff, to undertaken investigations when required 8

16 local procedures agreed with LSAB/LSCB, that set out the arrangements for notification and management of serious case reviews, including action planning and learning from incidents arrangements are in place to be satisfied that providers are operating an open and just culture were staff are encouraged to report incidents without fear of inappropriate or unjust blame and where patients are informed and involved in investigations when they have been affected by an incident. quality assure investigations, including internal investigations, to ensure they are robust and demonstrate use of recognised principles such as root cause analysis or Significant Event Audit. ensure timely and transparent closure of serious incidents underpinned by effective communication with providers. 7.2 Somerset Clinical Commissioning Group is responsible for ensuring prompt reporting of adverse incidents and reactions, and defective products relating to medical and non-medical equipment and supplies, food, buildings and plant (Health Service Guidance 93, 13). 7.3 Somerset Clinical Commissioning Group is responsible for ensuring that there are effective arrangements in place, for dealing with major incidents (Health Service Guidance 93, 24) and infection control (Health Service Guidance 93, 56). The commissioner has the responsibility of assuring the quality of commissioned services. 7.4 The responsibility for ensuring that major outbreaks and incidents are appropriately managed, lies with Public Health England and NHS England respectively. These organisations will be responsible for notifying national, regional and the local health and multi-agency partners, where appropriate. 7.5 In the event of an actual, or possible, terrorist threat, the Ambulance Service will be notified by Police and will act as the gateway to health. They will notify Public Health England and NHS England who will activate locally agreed major incident notification cascades. Public Health England will also work closely with the police and fire and rescue service, on any health risks posed by suspect packages that might contain a biological or chemical substance/hazard. 7.6 All serious incidents that involve controlled drugs must be reported to the Somerset Clinical Commissioning Group Accountable Officer, who will oversee the arrangements for investigation of the incident, and manage the shared learning through the Local Network for Accountable Officers for controlled drugs. 9

17 Investigating Serious Incidents 7.7 If a Serious Incident has occurred within a commissioned service the Somerset Clinical Commissioning Group Patient Safety Team will ensure that an appropriate process is followed to ensure that a full investigation is undertaken using root cause analysis techniques, lessons learned are identified and recommendations for improvement made. This will ensure that the necessary action has been taken and lessons learned are shared across the Somerset Health Community. The commissioner will review and monitor action plans from commissioned services through the Patient Safety and Quality Assurance Committee. 7.8 If a Serious Incident occurs within a service commissioned from an Independent Care Contractor, a full investigation will be undertaken led by the appropriate professional lead for the service, and supported by the Patient Safety Team. Investigations involving General Practice will be led by a GP Patient Safety Lead. The pathway for the investigation process for independent care contractors can be found at appendix 12. Management of Investigations for Grade 2 Incidents and Never Events 7.9 The arrangements for monitoring and managing Grade 2 Incidents and Never Events will involve Somerset Clinical Commissioning Group agreeing Terms of Reference for the investigation with the Trust and regular telephone monitoring calls will be held to oversee the management of the investigation and to ensure immediate and on-going assurance of patient safety. Standards for Management of Serious Incidents 7.10 The commissioner will monitor the time taken to close a Serious Incident on the STEIS system from the date the incident is notified, in line with the National Framework as follows: within 45 days, for a Grade 0 or 1 incident (RCA level 2 Investigation) within 60 days, for a Grade 2 incident (RCA Level 2 Investigation within 60 days the internal investigation should be completed for Grade 2 incident. Where an independent investigation must be conducted for mental health homicides (where there has been recent contact with mental health services) that meet Department of Health guidance, 26 weeks will be given a 72 hour management report should be made to the commissioner, and the Local Area Team for the NHS Commissioning Board, for all Grade 2 incidents, and can be found at appendix 3. 10

18 7.11 On rare occasions exceptions to the above timescales can be agreed with the commissioner for Grade 1 incidents, and with the agreement of the Local Area Team for the NHS Commissioning Board for Grade 2 incidents. The circumstances for an extension will be outside of the usual working arrangements, for example where the outcome of an inquest is still awaited or where the family have not been available for interview but wish to participate in the investigation process. The reason for the extension must be recorded on STEIS in the further information section A request can be made to the commissioner to stop the clock on investigations involving the Police where this prevents the SIRI investigation proceeding, incidents incident which are subject to an external review, where it is known that the investigation will exceed the reporting timeframes. These requests must be made to the commissioner for approval In order to close a serious incident on STEIS, the commissioner will require a robust investigation report, generated following a full root cause analysis, to include root causes, lessons learned and a time bounded action plan. The action points need to address each root cause and the timescales and named lead for implementation. This will provide assurance to the commissioner of actions to learn to improve patient safety and enable sharing of lessons learned, and identify key themes across the health community of the improvements made within Trusts, as result of the investigation The commissioner will report Serious Incidents and Never Events, to the Somerset Clinical Commissioning Group Governing Body and in the annual report The commissioner will publish quarterly reports on Grade 2 incidents, Never events and incidents that have led to an independent investigation, or that are considered to be high risk The Patient Safety and Quality Assurance Committee for Somerset Clinical Commissioning Group has responsibility for monitoring the management and follow up of serious incidents, implementation of action plans and identification of themes and trends and reports to the Governance Committee. 8 BLACK ALERT STATUS ESCALATION FRAMEWORK 8.1 A framework has been designed for managers and clinicians involved in managing capacity and patient throughput at a time of excess demand on NHS emergency and acute care services. The document provides a practical working reference tool for all parties, thereby aiding coordination, communication and implementation of the appropriate duties in each organisation. Reference - the NHS South of England, Escalation Framework, August

19 9 CATEGORIES AND INCIDENTS THAT SHOULD BE NOTIFIED 9.1 The following are potential criteria for reporting serious incidents requiring investigation. It is not an exhaustive list and is intended as a guide only. However, in deciding whether or not you are dealing with a serious incident requiring investigation, consider the possible impact the incident could have, including what lessons might be learned from it. Even if the initial judgement is that the issue is/was unavoidable, or had no adverse impact, it is important that the public perception is considered. If it could be damaging to an organisation, or the wider NHS, the incident needs to be reported. 9.2 Where a director of the commissioner has any doubts about the reporting of a serious incident requiring investigation, the Director of Quality and Patient Safety, their Deputy or the Head of Patient Safety and Risk Management can be contacted for advice, during working hours. 9.3 Potential criteria for reporting serious incidents requiring investigation include: Abuse of Adults 9.4 The abuse of adult described in No Secrets. This includes: death or injury to a vulnerable adult, where abuse or neglect is suspected to be a factor where a vulnerable adult has suffered harm, as a result of staff failing to follow agreed procedures, or acceptable practice when a vulnerable adult has suffered significant injuries, suspected to be as a result of abuse Blood Transfusion 9.5 Serious incident involving blood transfusions: serious adverse reaction: any unintended response in a donor, or in a patient that is associated with the collection, or transfusion of blood, or blood components that is fatal, life-threatening, disabling or incapacitating, or results in or prolongs hospitalisation or morbidity serious adverse events: any untoward occurrence associated with the collection, testing, processing, storage and distribution, of blood or blood components, that might lead to death or life-threatening, disabling, or incapacitating conditions for patients, or which results in or prolongs hospitalisation or morbidity 12

20 microbiological contamination of transfusion, leading to major morbidity or death incorrect blood component transfused leading to serious incident or death Emergency Plan Invoked 9.6 Adverse incident that would invoke an emergency plan (affecting business continuity including multiple ward closure due to infection, serious damage to occupied NHS property through fire, flood or criminal damage, IT failure (for terrorist activity see separate section). wilful damage to property, destruction and vandalism Health Protection 9.7 Major outbreaks, serious incidents of communicable disease, or exposure to environmental hazards caused by healthcare failures, or other NHS system failures that have put patients/staff at harm/risk of harm, or restrict service delivery e.g: outbreaks of infection that involve presumed transmission within healthcare settings (acute, community) e.g. Norovirus, Clostridium difficile, Panton-valentine leukociden (PVL) positive, Methicillin resistant staphylococcus aureus (MRSA) etc cases/outbreaks of infection with an NHS-attributable food, water or environmental source e.g. nosocomial legionnaires' disease, salmonella outbreak etc case of blood borne virus (hepatitis B, C, HIV), TB etc. infection in a healthcare worker that necessitates consideration of a look-back exercise case of infection in a patient to whom others have been exposed that necessitates consideration of a look-back exercise failed vaccination cold chain failed sterilisation of instruments an outbreak e.g. of viral gastroenteritis, necessitating ward closures to new patients and resulting in significant restrictions of hospital activity a confirmed death of a patient due to hospital acquired infection including MRSA and C. difficile 13

21 exposure to chemical agents or radiation caused by failures in healthcare settings an outbreak/health protection incident that is poorly managed, resulting in harm 9.8 From February 2007, the Department of Health has required mandatory reporting by Acute Trusts of each case of Methicillin-Resistant Staphylococcus Aureus (MRSA) bacteraemia as a serious incident. The mechanism for this is separate from STEIS. Serious Incidents Occurring in Independent Provider Organisations Regulation 9.9 Under Regulation 28 of the Care Standards Act (2000), independent provider organisations registered with the Care Quality Commission (CQC) must report the following to the Commission: the death of a patient and the circumstances of death in an establishment during treatment provided by an establishment or agency, or as a consequence of treatment provided by an establishment or within the period of seven days prior to the date of death any serious injury to a patient the outbreak in an establishment of any infectious disease, which in the opinion of any medical practitioner employed in the establishment, is sufficiently serious to be so notified any allegation of misconduct resulting in actual or potential harm to a patient by the registered person, any person employed by the establishment or by an agency on behalf of the employer, or any medical practitioner with practising privileges Information Governance 9.10 Serious incident involving Information Governance: major breaches of confidentiality, such as the loss or theft of personal identifiable records, or information, (including missing notes) an incident involving the actual, or potential loss of personal information, that could lead to identity fraud, or have other significant impact on individuals, should be considered as serious 14

22 Information Technology 9.11 Serious incident involving Information Technology: systems failure leading to serious outcomes data loss resulting in severe breach of confidentiality Major Incidents 9.12 Serious incident involving major incidents: any circumstance which necessitates the activation of an NHS Trust, Primary Care Trust or wider community Emergency Plan Maternity Serious Incidents 9.13 See attached appendix 4 for the reporting guidance on Maternity SIR s and appendix 4a for reporting and guidance on infant and child SIRI s. Media Issues 9.14 Serious incident involving media issues: matters likely to attract interest from local, regional or national newspapers, TV or radio all incidents reported to or involving the police, which are considered serious or may have adverse media interest any Health and Safety Improvement Notices or convictions being served upon an NHS or Primary Care Trust matters involving high profile patients likely to attract media interest any other sudden unexpected incidents: including apparently trivial incidents which lead to something more serious including those which could attract media attention cancellation of surgery by the Trust for a patient, on more than three occasions serious fraud or security-related media matters (to be reported to NHS SMS) 15

23 Medical Devices 9.15 Serious incident involving blood transfusions: any serious harm to staff or patients involving medical equipment, whether due to human error, or due to equipment found to be, or suspected of being faulty, or to have failed e.g. hoist collapsing, defibrillator failing any medical device-related incident that causes, or has the potential to cause, unexpected or unwanted effects, involving the safety of device users (including patients) or other persons Medicines and Serious Adverse Drug Reactions 9.16 Suspected or actual serious side effects or adverse drug reactions (ADRs) from a medicine, be it: prescription medicines herbal remedies over-the-counter (OTC) medicines Medico-Legal Incidents/Litigation 9.17 Serious incident involving medico-legal issues: suspicion of large scale theft or any incident which might give rise to serious criminal charges potential legal claims against the hospital regarding a serious incident potential legal claims against the hospital or Department of Health that may affect national policy impending court hearing, or out of court settlement, in cases of large scale litigation, including negligence claims (as defined by the NHS Litigation Authority (NHSLA) large scale claims are considered to be those over 250,000) Mental Health, Substance Misuse and Incidents Involving Learning Disabilities 9.18 Serious incident involving mental health, substance misuse and incidents involving learning disabilities: 16

24 a serious offence including homicide committed by an individual in receipt of mental health and/or learning disability services patients detained under the Mental Health Act 1983, who are absent without leave from health services, and who present a serious risk to themselves and/or others. Specific national guidance governs incidents, such as homicides and other serious incidents, involving mentally ill people (Health Service Guidance 94, 27). Arrangements for dealing with major incidents (Health Service Circular 98, 197) the criteria set out below will at times duplicate the criteria already stated but they are included to remind those delivering mental health services of the need to report them: the absence without leave of a patient detained under the Mental Health Act 1983, where there is serious cause for concern patient/s receiving inpatient care in secure accommodation, who go missing (but not detained under the Mental Health Act 1983) homicide, or suspected homicide, by a patient who has received mental health services. NB if it occurs within six months of receiving treatment, this triggers the setting up of an independent inquiry, as described in Chapter 3.4: Investigation all deaths within secure settings (to be dealt with as a death in custody) all deaths of persons who are subject to the Mental Health Act 1983, or equivalent legal restriction who has, or is receiving care and treatment from the mental health services - any serious criminal acts involving patients - an incident that causes serious harm, or injury, or places life in jeopardy, whether by a patient, staff or visitor in mental health and learning disability services - admission of a child under 18 to an adult mental health ward - an inpatient who is missing from the ward, who is considered a risk to themselves or others - an episode of restraint that does not comply with national or local trust policy Mortality/Morbidity/Care Incidents 9.19 Serious incident involving mortality/morbidity/care incidents: 17

25 clusters of unexpected or unexplained deaths where the death results in adverse comments from a coroner maternity: maternal deaths, neonatal deaths and unexpected stillbirths the suicide of any person currently in receipt of NHS services on or off NHS premises, or who has been discharged within the last twelve months. Suicide is defined as death: - where there is obvious evidence or strong suspicion of self harm - where the above does not apply initially but emerges later from a clinical review of the case, or discussion at the incident monitoring group - where the Coroner s verdict is Suicide (or open verdict) death or injury where foul play is suspected situations when a patient requires additional intervention(s) as a result of failures in the diagnosis process the accidental death of, or serious injury to, a patient, a member of staff, or visitor to NHS or primary care premises, or involving NHS staff or equipment: - out of county critical care transfers or any other transfer that could have resulted in a serious incident - abuse which has been perpetrated within the remit of the organisation; this may be abuse by a member of staff, visitor or member of the public - Grade 3 and above pressure sores - Falls which result in a fractured neck of femur, subdural haematoma or death Never Events 9.20 Never Events are serious, largely preventable patient safety incidents that should not occur if the available preventative measures have been implemented. 18

26 9.21 The list of core Never Events which should be reported are listed below, which are updated on annual basis. For further guidance please refer to the Department of Health, Never Events Framework 2012/2013, published 18 January Wrong site surgery - Wrong implant/prosthesis - Retained foreign object post-operation - Wrongly prepared high-risk injectable medication - Maladministration of potassium-containing solutions - Wrong route administration of chemotherapy - Wrong route administration of oral/enteral treatment - Intravenous administration of epidural medication - Maladministration of Insulin - Overdose of midazolam during conscious sedation - Opioid overdose of an opioid-naïve patient - Inappropriate administration of daily oral methotrexate - Suicide using non-collapsible rails - Escape of a transferred prisoner - Falls from unrestricted windows - Entrapment in bedrails - Transfusion of ABO-incompatible blood components - Transplantation of ABO incompatible organs as a result or error - Misplaced naso- or oro-gastric tubes - Wrong gas administered - Failure to monitor and respond to oxygen saturation - Air embolism - Misidentification of patients - Severe scalding of patients - Maternal death due to post partum haemorrhage after elective caesarean section Nursing Home - SIRI / Patient Safety Incidents 9.22 See attached appendix 15 for the reporting guidance on SIRI/Patient Safety Incidents for Nursing Homes. Premises/Equipment Incidents 9.23 Serious incident involving premises/equipment incidents: serious damage which occurs on the premises of NHS or independent sector premises providing NHS work; serious damage to property belonging to NHS, or any incident which results in serious injury to any individual or serious disruption to services (such as evacuation of patients due to fire) failure of equipment, so serious as to endanger life, whether or not injury results 19

27 suspicion of malicious activity, such as tampering with equipment circumstances that lead to the provider no longer being able to provide an element of service and not reportable through SITREP (such as closure of caseloads to new referrals) Prison Healthcare 9.25 Serious incident involving prison healthcare: death of prisoner in custody, prison, probation hostels and immigration detention accommodation. The local NHS as the provider organisation of prison health care must work closely with the PPO to ensure appropriate investigation of clinical aspects of death in custody Professional Misconduct 9.26 Serious incident involving professional misconduct: allegations of serious professional misconduct. Radiology 9.27 Serious incident involving radiology: severe equipment failure leading to harm or death Screening Programmes 9.28 An actual, or possible, failure of the screening service that has consequences for the clinical management of patients, e.g. loss of test results, failure to detect cancers, incorrect notification of results to a patient or groups of patients The screening programmes which are covered are: breast cancer cervical screening bowel cancer diabetic retinopathy abdominal aortic aneurysm - fetal anomaly infectious diseases in pregnancy sickle cell and thalassaemia newborn blood spot newborn hearing newborn and Infant Physical Examination 20

28 The full guidance on the national screening programme SIRI guidance can be found at Staff-Related Incidents 9.30 Serious incident involving staff related incidents: serious complaints about a member of staff, or primary care contractor, or any incident relating to a staff member, where adverse media interest could occur any serious criminal acts involving patients, or staff suspicion of a serious error, or errors, by a member of staff, primary care contractor, or other healthcare contractor where a member of staff is suspected of harming patients a serious drug error, such as mal-administered spinal injections where professional competence is in questions (see NPSA incident decision tree) a serious breach of confidentiality where a member of staff is suspected of committing serious fraud the exclusion of employed doctors, or dentists, under the NHS Trust disciplinary procedures, that refer to High Professional Standards in the Modern NHS: a framework for the initial handling of concerns about doctors and dentists in the NHS (HSC 2003/12) significant disciplinary matters of other staff serious verbal and/or physical aggression where a member of staff shows gross disrespect for the dignity of a patient/deceased patient Terrorism and Chemical, Biological, Radiological or Nuclear (CBRN) Incidents 9.31 Any act of terrorism is normally covered under the Major Incident Policy and will therefore have a comprehensive list of definitions. Generally, the following incidents must be reported: terrorist threats/incidents, which include incendiary devices, or the use of other weapons, including chemical, biological, radiological or nuclear agents (CBRN) 21

29 potential, or confirmed, accidental chemical, biological, radiological or nuclear agents (CBRN) incident Unexpected Death, Serious Harm or Injury 9.32 Serious incident involving unexpected death, serious harm or injury: patients, individuals, or groups of individuals, suffering serious, or catastrophic harm, or unexpected death, whilst in receipt of health services, including screening and immunisation/radiation errors and equipment failures serious injury, or unexpected death of any individual, to whom the organisation owes a duty of care, including staff, visitor, contractor, or any other person Violence towards Health Care Staff 9.33 Counter Fraud and Security Management Service (CFSMS) in the case of fraud, and violence to staff. In such circumstances, this serious incident framework should be followed in conjunction with the national guidance. serious violence/death of healthcare worker 10 MONITORING AND COMPLIANCE 10.1 In order to comply with the requirements of the National Patient Safety Agency, National Framework for Reporting and Learning from Serious Incidents Requiring Investigation, Providers and Commissioners should monitor trends in serious incident reporting. This trend analysis should include not only a quantitative report, but also a qualitative analysis of those incidents, where root causes and lessons learned have been identified Feedback from staff utilising the policy when a serious incident occurs will be sought and the policy amended as necessary The commissioner will monitor the performance of all NHS providers in managing serious incidents through quarterly reports on the status of all incidents on STEIS to the Patient Safety and Quality Assurance Committee. The Patient Safety Team will evaluate the quality of all investigation reports at its Serious Incident review meeting and ensure that these are robust and include the lessons learned and include a timed action plan. Where there are further recommendations raised at the Serious Incident Review, this will be feed back to the Trust, for inclusion in the report. 22

30 10.4 The commissioner will monitor the implementation of all action plans from serious incidents, through the Clinical Quality Review meetings with NHS providers. All action plans for Grade 2 incidents will be monitored through Patient Safety and Quality Assurance Committee The commissioner will report on performance in managing serious incidents and trends in incident reporting, and key themes from lessons learned on a quarterly basis to the Governing Body. Never events will also be reported to the Governing Body in the quarterly report Somerset Clinical Commissioning Group is committed to providing equal access to healthcare services, to all members of the community. To achieve this, gathering information is essential to help ensure that we deliver the most effective and appropriate healthcare. Attached at appendix 11 are the nine protected groups, which where possible, should be included in all root cause analysis investigation reports. RAPID RESPONSIVE REVIEW 10.7 A rapid responsive review provides commissioners with a means by which they can carry out a structured and purposeful visit to a trust or other provider as part of their routine assurance monitoring of the quality of care being delivered. The process can also be used where issues have been raised that could potentially impact adversely on an n aspect of the quality of care, including patient safety and/or experience. A rapid response review can be used both on a planned basis and as an immediate response to a problem or crisis A rapid responsive review may be considered where there have been a cluster of SIRIs or failings that may lead to the requirements of a rapid responsive review. Reference: National Quality Board How to: Organise and Run a rapid Responsive Review: 2012/2013. RISK SUMMITS 10.9 A risk summit is a meeting of high-level leaders called to shape a programme of action which is focused on sharing information willingly to help achieve a consensus about the situation under scrutiny and the actions required to mitigate the identified risks. Normally the risk summit will need to continue over several says or even weeks before the SHA and stakeholders can be satisfied that matters under review can be safely handed over to routine operational management systems, which is the ultimate goal Potential triggers for when a risk summit might be called by Somerset Clinical Commissioning Group with the Area Team for the NHS Commissioning Board include: Care Quality Commission issues a warning notice(s), applies material conditions on a provider or serve notice to withdraw registration 23

31 Serious failings in the provision of care such that patients are at imminent or immediate risk. For example; - Quality, patient safety / experience metrics causing alarm - Clinical services poorly performing, missing targets and the serious incidents / never event profile suggests / confirms there to be an unsafe or failing service - Serious and sustained safety breaches indicative of a more systemic quality failure within a single provider or across a health and social care system - Death of a patient(s) which is unexpected and avoidable and which raises specific alarms about clinical practice - Significant safeguarding breaches and breakdown in systems which compromise the protection of vulnerable adults and children (statutory and other formal processes apply) Soft intelligence, which when triangulated against the quantitative data, including trend analysis, clearly identifies a serious problem Patients / carers speak out at a level beyond that which would be expected to be addressed by the provider and local commissioners Monitor raises serious concerns about the governance and/or leadership of an FT One or more of the professional regulators raises concerns about the appropriateness of trainees /students remaining on clinical placements in a provider and are considering / intend withdrawing them An independent report, such as a Royal College report, raises serious concerns about patient safety which cannot be managed locally through routine service improvement Reference: National Quality Board Organise and Run a Risk Summit: 2012/ DISSEMINATION OF LEARNING 11.1 The NHS has a responsibility to ensure that when a serious event or incident occurs, there are systematic measures in place for safeguarding people, property, NHS resources and reputation, for understanding why the event occurred, and ultimately to ensure steps are taken to reduce the chance of a similar incident happening again Provider organisations should have systems in place, to ensure that learning is disseminated within their organisation. 24

32 11.3 The commissioner has processes in place to share learning more widely within the local health community, through the SafetyNet Newsletter, and through the quarterly quality monitoring meetings with NHS providers. 12 COMMUNICATION BEETWEEN ORGANISATIONS 12.1 When there is an SIRI involving more than one provider, it is essential that there is robust communication between these organisations. Somerset Clinical Commissioning Group has developed a communication template, to share patient details and contact details at appendix Contact details for each organisation are listed below: Somerset Clinical Commissioning Group Patient Safety Team Telephone Number Address SIRI@somerset.nhs.uk Somerset Partnership NHS Foundation Trust Telephone Number Address riskteam@sompar.nhs.uk Taunton and Somerset NHS Foundation Trust Governance Support Unit Telephone Number Address Riskman@tst.nhs.uk Yeovil District Hospital NHS Foundation Trust Clinical Governance Department Telephone Number Address incidents@ydh.nhs.uk South Western Ambulance Services NHS Foundation Trust Telephone Number: Address: SUI@swast.nhs.uk NHS III Telephone Number Address NCGT@nhsdirect.nhs.uk 25

33 13 MEMORANDUM OF UNDERSTANDING: INVESTIGATING PATIENT SAFETY INCIDENTS INCLUDING UNEXPECTED DEATH OR SERIOUS UNTOWARD HARM 13.1 In 2006, the Department of Health produced Guidelines for the NHS: In support of the Memorandum of Understanding- Investigating Patient Safety Incidents Involving Unexpected Death or Serious Untoward Harm (DH Guidance 22/11/2006). These guidelines may be referred to provide practical advice about what to do, when faced with a patient safety incident that may require investigation by the police and/or Health and Safety Executive (HSE) It will sometimes be immediately obvious that the police and/or the Health and Safety Executive should be contacted, but in other cases, the need may not come to light until the organisation, coroner or other body, such as the Medicines and Healthcare Products Regulatory Agency has carried out its own investigations. The decision to report an incident to the police should be made at a sufficiently senior level, for example, by either the chief executive, or another executive director Once such a decision has been taken, representatives of the organisation, police and, where appropriate Health and Safety Executive, should arrange an initial meeting. The meeting of this Incident Coordination Group should be called, as soon as practicable, following the referral and, in any case, the group should meet within five working days of the referral. All three organisations are entitled to call an Incident Coordination Group meeting, but responsibility for organising the meeting rests with the CCG The police, and/or the Health and Safety Executive may also call an Incident Coordination Group meeting, in response to a complaint, referral from a coroner, or in response to other concerns Until the first meeting of the Incident Coordination Group, the organisation should continue to deal with concerns about patient safety, but not undertake any activity that may compromise any subsequent investigations conducted by the police and/or the Health and Safety Executive. If in doubt about this matter, the organisation should seek legal advice and consult the police, the Health and Safety Executive, or where appropriate, other investigating bodies It is also critical that any relevant physical, scientific and documentary evidence is secured and preserved Some patient safety incidents may result in the police, or Health and Safety Executive investigating possible offences by individual employees and/or the employer. Investigation of the NHS employer will normally involve the Health and Safety Executive, because health and safety legislation places the primary responsibility on the employer. In such cases, it may not be appropriate for those who may be investigated, or could be defendants in a criminal case, to be members of the Incident 26

34 Coordination Group. When this issue arises, it should normally be discussed, at the outset, by the agencies involved, and if necessary, the Strategic Health Authority should take on the role of liaising with the police and Health and Safety Executive, on behalf of the Trust. 14 ACKNOWLEDGEMENTS National Patient Safety Agency, National Framework for Reporting and Learning from Serious Incidents Requiring Investigation NHS South of England for the Serious incident Reporting Process September 2010 NHS South of England Guidance on Managing Serious Incidents Reported by NHS Organisations Through the Strategic Executive Information System (STEIS) 2008 NHS South of England Guidance on Process for Reporting and Learning from Serious Incidents Requiring Investigation National Quality Board How to: Organise and Run a rapid Responsive Review: 2012/2013 National Quality Board Organise and Run a Risk Summit: 2012/2013 Department of Health, Never Events Framework 2012/2013, published 18 January 2012 Care Quality Commission: Guidance about compliance Essential standards of quality and safety March 2010 Managing Serious Incidents in the English NHS National Screening Programmes - Guidance on behalf of the UK National Screening Committee (UK NSC) June

35 28

36 Out of Hours Reporting and Media Relations APPENDIX 1 1. Introduction 1.1 Serious incidents requiring investigation should be reported on the Strategic Executive Information System (STEIS), within two working days. If a reporting organisation, or Lead Commissioner (Specialist Commissioning Group where relevant) needs to verbally inform the NHS Commissioning Board Area Team contact should be made via the Patient Safety Team at BNSSSG Area Team. The reporting organisation should also inform the Lead Commissioner (Specialist Commissioning Group where relevant). 1.2 During out-of-hours, the senior manager or director on-call in the NHS trust or Lead Commissioner will be responsible for the reporting of any serious incidents requiring investigation. 1.3 All incidents falling into any of the serious incident categories, listed below, or where there is any doubt over the matter must be notified to the Area Team senior manager on call including: incidents which necessitate activation of the NHS Trust or Area Team Major Incident Plan, where the Area Team needs to take action. incidents which will give rise to significant media interest, or will be of significance to other agencies, such as the police, or other external agencies incidents which will be of significant public concern 1.4 Having advised the Area Team senior manager on-call, the reporting organisation must complete the web-based Strategic Executive Information System (STEIS) form by 12:00pm, on the first working day. Once the on-line form has been completed and saved, an automatic alert will be sent to nominated personnel. 1.5 If the serious incident does not fall within the categories listed above, the NHS Area Team on-call manager need not be notified, but the Strategic Executive Information System (STEIS) form should be completed, as soon as possible, by the Trust, certainly within two working days. 29

37 2. Media Relations (Also See Pages of National Framework) 2.1 In many cases, serious incidents requiring investigation can lead to a high level of media attention, not only in the immediate aftermath. The management, investigation and learning from incidents can all be triggers for media coverage for months, and in some cases years after the incident itself. Somerset Clinical Commissioning Group has media relations policies in place, which include the appropriate action to be taken, in relation to serious incidents, including protocols with other local organisations and agencies on media handling and strategies for on-going, and longer term management of media coverage. 2.2 Communication regarding serious case reviews (child abuse) will be managed by the Chair of the Local Children s Safeguarding Board (LCSB). 2.3 The communications leads in NHS organisations will work closely with the communications team at the Area Team, on agreeing appropriate media handling strategies, working alongside the relevant colleagues responsible for the wider management of the incident. The Area Team and responsible Director of NHS South of England will brief the Department of Health Media Centre as necessary. In forensic/criminal cases, the police lead all communications with the media. 2.4 Media coverage itself can also be the incident. Where adverse media coverage becomes the issue (and where it is not triggered by an adverse event as such) it is expected that the communications lead for the NHS organisation would be in direct contact with the NHS South of England Communications Team, to discuss handling and reporting strategies accordingly. 2.5 If the serious incident has occurred within an acute, community, mental health or ambulance trust, that trust will take the responsibility for advising the Lead Commissioner (Specialist Commissioning Group where relevant). 2.6 All incidents automatically receive a unique log number when entered within the Strategic Executive Information System (STEIS) system. To maintain confidentiality this number will be used in all communication with Trusts. 2.7 Somerset Clinical Commissioning Group will implement its communication plan to ensure relevant colleagues, both internally and externally, are informed to support effective management of the serious incident. 30

38 APPENDIX 2 Flowchart for Reporting and Management of Grade 2 Serious Incidents Serious incident requiring investigation is reported within 2 working days of occurrence or date of knowledge Incident is graded a 2 following national framework and local process with agreement from the CCG/AT 72 hour management report undertaken by provider and received by the commissioner and sent to NHSCB AT see appendix 3 Completed Root Cause Analysis report is sent to the commissioner and NHS South of England within 60 working days NHSCB AT and the commissioner will provide feedback to Provider within 20 working days Agreement to close incident between NHSCB AT and the commissioner. If the incident is a Never Event, the commissioner will apply the penalties in accordance with national contract requirements Where appropriate, lessons learned are disseminated across the local health economy and NHSCB AT 31

39 APPENDIX 3 Serious Incident Requiring Investigation (SIRI) 72 Hour Report SIRI Reference Number: STEIS Identification Number: Patient Initials Date/Time/Location of Incident including hospital / ward / team level information Incident type Description of incident including reason for admission and diagnosis (for mental health please include Mental Health Act status and date of referral and last contact) Details of any police or media involvement/interest Details of contact with or planned contact patient/family or carers Immediate actions taken including actions to mitigate any further risk Details of other organisations/individuals notified Lead Commissioner Report completed by Designation Date / time report completed Does this constitute a further full view? Please insert below a brief chronology of key events 32

40 Maternity Serious Incident (SI) Definition APPENDIX 4 Maternal death A maternal death is defined as any death which occurs during or within 42 days of pregnancy, ectopic pregnancy or abortion which is directly or indirectly related to these conditions. Intrauterine death (antenatal) Any intrauterine death at 24 weeks and above where service or clinical factors may have contributed to the outcome. Intrapartum death (during labour) Unexpected intrapartum death during labour regardless of gestational age where service or clinical factors may have contributed. Intrapartum-related deaths: Deaths that are directly related to events occurring from the onset of labour until birth. Intrapartum-related stillbirth:a stillborn baby (shows no signs of life at delivery and weighs more than 500g or is greater than 22 weeks of gestation) with intact skin and no signs of disintegration in utero. The death is assumed to have occurred in the 12 hours before delivery and was most likely due to an intrapartum hypoxic event. Babies with severe congenital abnormalities are not included (based on Wigglesworth's classification). Intrapartum-related neonatal deaths: (previously called birth asphyxia deaths):neonatal deaths of term babies with neonatal encephalopathy (see below) or who cannotbe resuscitated (or for whom resuscitation is not available).where possible, other causes should be excluded such as lethal congenital malformations and preterm birth complications (less than 34 completed weeks of gestation or birth weight b2000 g). Also includes a smaller group of babies who die from birth injury without hypoxic brain injury.ture. Unexpected Neonatal Death Unexpected death of a baby aged 0-28 days. The requirement is to report unexpected death as the death of a neonate that was not anticipated as a significant possibility 24 hours before the death or where there was a similarly unexpected collapse leading to or precipitating the events that led to the death. If there is any doubt the designated paediatrician for the unexpected death should be consulted. If doubt persists, the incident should be reported as an SI until evidence suggests otherwise. Unexpected admission to NICU (Neonatal Intensive Care Unit) Infants > 37 completed weeks of gestation that have a sudden and unexpected collapse following delivery or in the early postnatal period of a previously well infant requiring intensive care (positive pressure ventilator support). Suspension of maternity services Any time a decision is made to suspend maternity services regardless of outcome or when the maternity services tries to suspend services and is unable to due to no other units being able to accept transfers. Maternal unplanned admission to ITU- An unexpected admission to ITU during pregnancy or within 28 days following birth (either flu or pregnancy related)where service or clinical factors might have contributed. Any other incidents that are considered locally as serious incidents. 33

41 APPENDIX 4a Guidance for Infant and Child Incidents reported onto the Strategic Executive Information System (STEIS) When to report the types of incidents that should be reported onto the Strategic Executive Information System (STEIS) The following types of maternity, infant and child incidents should be reported onto the Strategic Executive Information System (STEIS). This is in line with the National Patient Safety Agency National Framework for Reporting and Learning from Serious Incidents Requiring Investigation and the NHS South of England Process for Reporting and Learning from Serious Incidents Requiring Investigation. Incident Category Child Abuse (family) (Grade 2 incident) Child abuse (institutional) (Grade 2 incident) Child Abuse (multiple) (Grade 2 incident) Child Death (Grade 2 incident) Description To be reported where a local multi agency /organisational review has identified a failure in the duty of care by a health professional or organisation. To be reported when this has been a factor in a child death or a child has suffered significant injuries either in the past as a missed opportunity or currently. Abuse or neglect of one or more children by one or more perpetrators in an institutional setting where there is a health professional linked to the institution (this would include a school, nursery, child minder etc) and children who are looked after in a residential setting or an inpatient in a health care setting. Networked abuse of one or more children by one or more perpetrators and where multiple complex and abuse procedures are initiated, e.g. paedophile ring, child trafficking etc. All unexpected and/or unexplained child deaths up to the age 4 years and 364 days. Unexpected death of a child aged 5 to 17 years and 364 days (where natural causes are not suspected) should be reviewed within 48 hours if: they are known to additional health care providers; or where it has been agreed, following the initiation of the rapid response process, that further exploration of the circumstances is required urgently. This includes all children in an institutional setting, e.g. school, youth offenders setting, respite care or secure unit. 34

42 Child Serious Injury Maternity services - intrapartum death Maternity services - intrauterine death The death of any child on a child protection plan or looked after child must be reported. Where there is permanent harm or injury that occurs in a healthcare setting or where healthcare is delivered and the injury is related to the healthcare delivery that does not involve safeguarding or abuse. Unexpected intrapartum death during labour regardless of gestational age where service or clinical factors may have contributed. Any intrauterine death at 24 weeks and above where service or clinical factors may have contributed to the outcome. Since April 1 st 2008, there has been a statutory requirement for all Local Safeguarding Children Boards (LSCB) to review the death of all children under 18 years of age, who live within the LSCB area. The purpose of the review is to identify any factors which could have contributed to a child s death; to learn lessons which might benefit children in the future; and ultimately to potentially reduce the number of children who die. The deaths of all children who are resident in Somerset are reviewed anonymously by the Somerset Child Death Overview Panel. A death which was originally believed not to be suspicious and not therefore reported follows the Child Death Overview Panel (CDOP) process. The Child Death Overview Panel (CDOP), with a fuller picture of the evidence, may decide that there are safeguarding issues and that it should be referred to the Local Safeguarding Children Board Serious Case Review Panel. The panel may then determine that the incident meets the criteria for a Serious Case Review. In this case, the incident should then be reported onto the Strategic Executive Information System (STEIS) and the date of knowledge of the incident will be the date of the referral to the serious case review panel of the Local Safeguarding Children Board. Definitions Neonate A child aged between 0 to 28 days. Unexpected death Death of a child that was not anticipated as a significant possibility 24 hours before the death or where there was an unexpected collapse or incident leading to or precipitating the events which led to the death. Unexplained circumstances Factors in the environment, history or examination which may give rise to concern about the circumstances surrounding the death. Examples: non-accidental injury, environment which highlights issues of neglect. 35

43 Please note these examples are not exhaustive. Scenarios detailing who should report an incident on to the Strategic Executive Information System (STEIS) The examples detailed below are not an exhaustive list. Each incident should be dealt with on its own merits. Some examples illustrate specific scenarios, others are more generic. If in doubt, contact the NHS South of England for further advice. Scenario 1 unexpected unexplained child death All deaths of children are reported to the Child death Overview Panel. The rapid response team will investigate the incident and review the care. If the child is known to the health service (for example under the care of a health visitor or an inpatient in an acute trust) then the organisation whose care the patient was under at the time of the incident will report the incident on to the Strategic Executive Information System (STEIS) as a child death and undertake the investigation. Following the investigation, if there are no suspicious circumstances and no safety lessons to be learned, the Primary Care Trust Commissioner will request that the incident be deleted from the Strategic Executive Information System (STEIS) by the Strategic Health Authority (paragraph 4.3 of this guidance also applies). N.B. If the child is under 5 years of age, they should be known to their health visitor and as such all cases should be reported for this age group. Scenario 2 unexpected explained child death Example A: a road traffic accident; meningococcal sepsis. If there are no safeguarding concerns then the incident will be reported to the Child Death Overview Panel but not to the Strategic Executive Information System (STEIS). If there are safeguarding concerns then the Primary Care Trust Commissioner will ensure that the incident is reported onto the Strategic Executive Information System (STEIS) by the appropriate organisation. N.B. If the child is under the age of 5 years, then this should be reported on the Strategic Executive Information System (STEIS). If the child is over 5 years old an investigation should be undertaken to check if the child is known to another health provider for example CAMHS or disability services. The findings of this investigation will determine if a report is made. 36

44 Example B: the (seemingly deliberate) suicide of an adolescent If the child has been in contact with health services then the report to the Strategic Executive Information System (STEIS) and subsequent investigation should be made by the main provider of those services e.g. the relevant mental health trust. If the child has not had contact with health services, then the Commissioner should make the report onto to the Strategic Executive Information System (STEIS) and investigate the circumstances of the death. If it subsequently transpires that there are no safeguarding issues then a request will be made to the Strategic Health Authority to delete the record from the Strategic Executive Information System (STEIS) Scenario 3 expected and unexplained child death - for example a child expected to die but the cause of death is not explained by the condition (e.g. a malignancy) who dies earlier than is expected or in unexplained circumstances) In this scenario, the incident should be reported on to the Strategic Executive Information System (STEIS) as a child death by the organisation whose care the patient was under. Following the investigation, if there are no suspicious circumstances and no safety lessons to be learned, the investigation is referred to the Child Death Overview Panel and the Primary Care Trust Commissioner will request that the incident be deleted from the Strategic Executive Information System (STEIS) by the Strategic Health Authority (paragraph 4.3 of this guidance also applies). Scenario 4 expected and explained child death - for example a child with malignancy who dies in appropriate circumstances In this scenario, the incident does not need to be reported on to the Strategic Executive Information System (STEIS) as long as the assessed and agreed package of care has been delivered appropriately. Scenario 5 unexpected child death pronounced within an emergency department For example a child is brought into the emergency department of an acute trust. The child either requires lifesaving treatment and subsequently dies or is pronounced dead on arrival Assumption The care of the child by the attending staff is within guidelines and there is nothing to suspect the care of the child in the emergency department was substandard (if the standard of care is suspect, the acute trust will report as a patient safety incident). Outcome The child death is reported to the rapid response team by the emergency department. The acute trust will report the death to the Child Death Overview Panel and the primary care trust child protection lead who will ensure that the incident is 37

45 reported onto the Strategic Executive Information System (STEIS) by the primary care commissioner. The primary care trust child protection lead will make enquiries into the child s situation and ensure that an investigation is undertaken. The investigation will involve the acute trust; however the lead investigating authority is the primary care trust commissioner. If there are child safeguarding issues, the incident will be reported to the Local Child Safeguarding Board. Investigations by the Primary Care Trust Commissioner can be undertaken in conjunction with any reporting to other bodies unless specifically prohibited by the Police. Following the investigation, if there are no suspicious circumstances and no safety lessons to be learned, the investigation is referred to the Child Death Overview Panel and the Primary Care Trust Commissioner will request that the incident be deleted from the Strategic Executive Information System (STEIS) by the Strategic Health Authority (paragraph 4.3 of this guidance also applies). Scenario 6 suspected child abuse whilst under the care of an NHS organisation The incident will be reported on to the Strategic Executive Information System (STEIS) as Child abuse (institutional) by the organisation whose care the child is under. Scenario 7 suspected child abuse in the community For example, not known to health services but has died or has suffered significant injuries as a result of abuse This is dependent on how the abuse is uncovered. If it has been discovered by a health worker then it should be reported on the Strategic Executive Information System (STEIS). Where a case is discovered by other agencies, a report on the Strategic Executive Information System (STEIS) will not be necessary, unless either a Serious Case Review is initiated (any Serious Case Review should be reported on STEIS) or there are alleged failings by health agencies or there is media interest in any healthcare provided. 38

46 Liaison with police and other key stakeholders regarding investigation process Mental HealthTrust and NHSCB AT communications team updated with progress of investigation by Mental Health Trust Lead APPENDIX 5 Flowchart for the management of mental health homicide incidents Homicide occurs. Mental Health Trust informed of arrest by police Mental Health Trust Lead identified Serious Incident Requiring Investigation (SIRI) confirmed by Mental Health Trust Mental HealthTrust identifies police contact and police confirm the record number SI logged onto STEIS as grade 2 homicide 2 working days Trust communications lead liaises with NHSCB AT communications lead to develop a media handling strategy 5 working days Mental Health Trust completes initial service management review report within 72 hours Terms of reference for internal investigation are agreed 15 working days Internal investigation undertaken and report received and agreed by Trust, Lead Commissioner and NHSCB AT 60 working days 90 working days Internal investigation report and action plan considered by Lead Commissioner and NHSCB AT Homicide Review Group 39

47 60 working days Decision made at NHSCB AT Homicide Review Group to commission an independent investigation. Letter sent from Chair of SHA Homicide Review group and Lead Commissioner Yes No Close incident when assurance received that robust action plan is in place and monitoring arrangements confirmed Independent investigation commissioned 26 weeks Independent investigation reported Time-framed action plan developed from the recommendations of the independent investigation monitored by Lead Commissioner and NHSCB AT. Close incident only when assurance received that all actions contained within the action plan have been implemented 40

48 APPENDIX 6 Root Cause Analysis Investigation Report Serious Untoward Incident no: Incident form no: Authors: Date Investigation commenced: Final Report date: Incident date: Incident type: Healthcare specialty: Actual effect on patient and/or service: Actual severity of the incident: Level of investigation conducted Terms of reference: Involvement and support of the patient and/or relatives Involvement and support provided for staff involved Detection of Incident Information and evidence gathered Investigation type, process and methods used Summary of events Care and Service Delivery Problems Notable practice Contributory Factors 41

49 Root Causes Lessons Learned Recommendations Arrangements for Sharing Learning Distribution list (The following list is not exhaustive and may be amended as appropriate) Appendices Time line Author Job title Date Chronology (timeline) of events Date & Time Event 42

50 Adult Safeguarding Flow Chart APPENDIX 7 43