Serious Incident Policy and Procedures

Public Health Commissioned Services – SERIOUS INCIDENT POLICY AND PROCEDURES

Contents

CIRCULATED TO: ESCC public health senior team; commissioners of public health services; providers of public health services; ESCC communications team; and ESCC contracts and purchasing unit.

Providers should report a Serious Incident (SI) to the Public Health Business Manager who is responsible for managing the SI procedure. The Public Health Business Manager will work with both the commissioner of the service and the provider to ensure the policy is followed. Contact details are listed below.

Contact Telephone Email

Tracey Houston [email protected], and cc 01273 481932 Public Health Business Manager [email protected]

For urgent notification of SI out of hours, contact the ESCC Duty Emergency Planning Officer, contact via East Sussex Fire & Rescue Service Sussex Control Centre Tel: 01444 411828 who will contact ESCC Public Health On Call. Public Health On Call will then contact the Director of Public Health or nominated deputy. Please indicate nature of incident and provide contact details for your call to be returned by Public Health.

ESCC Public Health Commissioned Services: serious incident policy Page 1 of 17 2 Introduction and Purpose Serious Incidents1 (SI) are adverse events, where the consequences to patients, clients, families and carers, staff or organisations are so significant or the potential for learning is so great, that a heightened level of response is justified. SI include acts or omissions in care that result in; unexpected or avoidable death, unexpected or avoidable injury resulting in serious harm - including those where the injury required treatment to prevent death or serious harm, abuse, Never Events2, incidents that prevent (or threaten to prevent) an organisation’s ability to continue to deliver an acceptable quality of services and incidents that cause widespread public concern resulting in a loss of confidence in services.

The needs of those affected should be the primary concern of those involved in the response to and the investigation of serious incidents. Patients, clients and their families/carers and victims’ families must be involved and supported throughout the investigation process.

Providers are responsible for the safety of their patients, clients, visitors and others using their services, and must ensure robust systems are in place for recognising, reporting, investigating and responding to SI and for arranging and resourcing investigations. Commissioners are accountable for quality assuring the robustness of their providers’ SI investigations and the development and implementation of effective actions, by the provider, to prevent recurrence of similar incidents.

This document sets out:

1. Definitions and thresholds of a SI. 2. Responsibility and accountability for the management of SIs. 3. The SI reporting mechanisms for providers of public health services.

The reporting and management of incidents involving ESCC employees under the County Council procedures for reporting incidents and accidents at work are not within the scope of the procedure.

Definitions and thresholds A SI is an event or circumstance that could have resulted, or did result, in unnecessary damage, loss or harm such as physical or mental injury to a patient, staff, visitors or members of the public. For the purposes of this policy, an SI is defined as an incident that occurred in relation to public health commissioned services and care resulting in one of the following:  Unexpected or avoidable death of one or more patients, clients, staff, visitors or members of the public.  Serious harm to one or more patients, clients, staff, visitors or members of the public or where the outcome requires life-saving intervention, major surgical/medical intervention, permanent harm or will shorten life expectancy or result in prolonged pain or psychological harm (this includes Incidents graded under the NPSA definition of severe harm).  A scenario that prevents or threatens to prevent a provider organisation’s ability to continue to deliver services, for example, actual or potential loss of personal/organisational information, damage to property, reputation or the environment, or IT failure.

1 The terms ‘serious incident requiring investigation (SIRI)’, ‘serious incident (SI)’ or ‘serious untoward incident (SUI)’ are often used interchangeably. This document will refer to ‘SIs’ and serious incidents. 2 Never Events arise from failure of strong systemic protective barriers which can be defined as successful, reliable and comprehensive safeguards or remedies e.g. a uniquely designed connector to prevent administration of a medicine via the incorrect route - for which the importance, rationale and good practice use should be known to, fully understood by, and robustly sustained throughout the system from suppliers, procurers, requisitioners, training units, and front line staff alike. See the Never Events Policy and Framework available online at: http://www.england.nhs.uk/ourwork/patientsafety/never-events/ 2  Allegations of abuse.  Adverse media coverage or public concern about the service, organisation or the wider County Council or NHS.

ESCC Public Health Commissioned Services: serious incident policy Page 3 of 17 4 An Incident Investigation is a process to determine the underlying reason for an incident and to identify actions to minimise the likelihood of the event recurring. The needs of those affected should be the primary concern of those involved in the response to and the investigation of SIs. Where applicable, the principles of openness and honesty as outlined in the NHS Being Open guidance3 and the NHS contractual Duty of Candour4 must be applied in discussions with those involved. This includes staff and patients, victims and perpetrators, and their families and carers

The scale of the investigation and the level of escalation should be proportionate to the seriousness of the incident, should include a root cause analysis5 and recommendations to prevent a similar event occurring in the future.

1.1. Assessing whether an incident is a serious incident In many cases it will be immediately clear that a serious incident has occurred and further investigation will be required to discover what exactly went wrong, how it went wrong (from a human factors and systems- based approach) and what may be done to address the weakness to prevent the incident from happening again. Whilst a serious outcome can provide a trigger for identifying serious incidents, outcome alone is not always enough to delineate what counts as a serious incident. Upsetting outcomes are not always the result of error/ acts and/ or omissions in care. Equally some incidents, such as those which require activation of a major incident plan for example, may not reveal omissions in care or service delivery and may not have been preventable in the given circumstances. However, this should be established through thorough investigation and action to mitigate future risks should be determined.

Where it is not clear whether or not an incident fulfils the definition of a serious incident, providers and commissioners must engage in open and honest discussions to agree the appropriate and proportionate response. It may be unclear initially whether any weaknesses in a system or process (including acts or omissions in care) caused or contributed towards a serious outcome, but the simplest and most defensible position is to discuss openly, to investigate proportionately and to let the investigation decide. If a serious incident is declared but further investigation reveals that the definition of a serious incident is not fulfilled the incident can be downgraded. This can be agreed at any stage of the investigation and the purpose of any downgrading is to ensure efforts are focused on the incidents where problems are identified and learning and action are required.

1.2. Can a ‘near miss’ be a serious incident? It may be appropriate for a ‘near miss’ to be a classed as a serious incident 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. Deciding whether or not a ‘near-miss’ should be classified as a serious incident should therefore be based on an assessment of risk that considers:

 The likelihood of the incident occurring again if current systems/process remain unchanged; and  The potential for harm to staff, patients, and the organisation should the incident occur again.

3 http://www.nrls.npsa.nhs.uk/beingopen/?entryid45=83726 4 The Department of health has introduced regulations for the Duty of Candour. It requires providers to notify anyone who has been subject (or someone lawfully acting on their behalf) to a ‘notifiable incident’. This notification must include an appropriate apology and information relating to the incident. Failure to do so may lead to regulatory action. http://www.cqc.org.uk/sites/default/files/20141120_doc_fppf_final_nhs_provider_guidance_v1-0.pdf 5 Root Cause Analysis (RCA) - A systematic process whereby the factors that contributed to an incident are identified. As an investigation technique for patient safety incidents, it looks beyond the individuals concerned and seeks to understand the underlying causes and environmental context in which an incident happened. 4 This does not mean that every ‘near-miss’ should be reported as a serious incident but, where there is a significant existing risk of system failure and serious harm, the serious incident process should be used to understand and mitigate that risk.

ESCC Public Health Commissioned Services: serious incident policy Page 5 of 17 6 Responsibility and accountability

2. 1 Responsibilities and obligations The primary responsibility in relation to SIs is from the provider of the care to the people who are affected and/or their families/carers.

The contractual obligation of provider organisations to report SIs is contained within the appropriate schedule of their standard ESCC contract. All providers of ESCC Public Health commissioned services should consider this procedure as contractually binding and ensure any internal procedures/policies are compatible with it.

Providers of ESCC Public Health commissioned services are contractually required to have a designated post holder and deputising post with responsibility for reporting an SI. The provider is responsible for ensuring the safety of patients/clients whilst on their premises and/or receiving the service from their staff and departments and/or throughout the whole process. The commissioner expects that they have robust risk management systems in place including incident reporting and learning, and risk assessment. It is expected that all provider organisations will manage incidents in accordance with the National Patient Safety ‘being open’ guidance6.

Commissioners of public health services are responsible for having a process in place to receive reports of SIs from providers. The commissioner is responsible for:  ensuring that the provider fully understands and is able to comply with the SI Policy;  leading or delegating relevant actions for SI management referred to within this policy;  reviewing Root Cause Analysis reports from providers and making a decision as to whether to submit to the Public Health Senior Team to close the incident. 2.2 Accountability and Governance The Director of Public Health is accountable for developing, implementing and monitoring the systems and processes for reporting, investigation and management of SIs within public health services commissioned by ESCC. The Public Health Senior Team has the responsibility for reviewing and quality assuring the robustness of SI investigation, learning and action plan implementation undertaken by their providers. The commissioner will produce reports when appropriate to meet external requirements for SI reporting.

The commissioner is responsible for liaising with the provider risk management team and ensuring the appropriate level of investigation takes place, including any reference to the ESCC policy statement: Anti- Fraud and Corruption Strategy (July 2012). The ESCC Communications lead is responsible for managing, defining, and mitigating any reputational risk to ESCC and liaising with ESCC communications team where required. The public health business manager will log all SI, maintain an overview of any developing trends and escalate when necessary 2.3 Involvement of multiple commissioners The model of providers reporting incidents to the commissioner who commissions the contract may not always be practicable in a complex commissioning landscape where multiple commissioners may commission different services from the same provider. 7,8 Where this scenario is identified, ESCC Public Health, as accountable commissioner, will delegate responsibility for the management of the SI to the lead commissioning body for the provider using a RASCI (Responsible, Accountable, Supporting, Consulted, Informed) approach.9

6 http://www.nrls.npsa.nhs.uk/resources/collections/being-open/?entryid45=65077 7 NHS England - Serious incident framework: supporting learning to prevent recurrence, 2015 8 PHE Quality governance guidance for local authority commissioners of alcohol and drug services, 2015 Appendix 1 http://www.nta.nhs.uk/publications.aspx 9 NHS England - Serious incident framework: supporting learning to prevent recurrence, 2015 Appendix 5 6 Using this approach, the accountable commissioner (contract signatory) will work collaboratively with and through other commissioners, to ensure the reporting arrangements are included within contracts. This means that a provider reports and engages with one single commissioning organisation who can then liaise with other commissioners as required (see Figure 1). Whilst accountable commissioners may delegate responsibilities for SI management to other commissioners they remain accountable for quality assuring the robustness of the SI investigation, learning and action plan implementation undertaken by their providers. Reporting a Serious Incident

3.1 All providers All providers must report a SI to the Public Health Business Manager who will liaise with the commissioner of the service or the commissioning organisation with delegated responsibility for the management of SIs. Contact details are listed on the front page.

Reporting a possible SI to an external body other than ESCC does not remove the need to report the incident to the commissioner and the Public Health Business Manager and complete the SI reporting process.

Any SI reported to the commissioner involving a patient under the age of 18 will be forwarded to the ESCC child protection leads. This does not in any way override provider organisations’ responsibilities in regard to the reporting of child protection/safeguarding children issues.

The reporting of an SI does not remove the provider organisation’s responsibility for contacting any external bodies that need to be informed of the SI, including adult and child safeguarding.10 The provider will also comply at all times with the Sussex Multi-Agency Policy and Procedures for Safeguarding Adults at Risk and undertake reporting as agreed in respect of this policy. The provider will continue to work with the commissioner to harmonise the Safeguarding Adults at Risk and SI processes and to ensure that adult safeguarding is informed by the SI investigations and that the outcomes of these investigations are shared where necessary. Similarly, the provider will work with the commissioner to ensure harmonisation of the safeguarding children processes with SI process. The provider will comply at all times with the East Sussex Child Protection and Safeguarding Procedures, including the safeguarding of adults at risk.11,12

If an SI involves a number of providers and those providers are unable to agree on the organisation responsible for reporting on the SI Reporting Form, the commissioner will assign a lead organisation on the available evidence. Failure of that organisation to report on the SI Reporting Form and lead the investigation will be considered a possible breach of contract.

Events of media interest that are not SIs If events cause media interest or have the potential to cause media interest but do not meet with the SI definition, then the provider need only report the event via phone or email to the appropriate commissioner and the Public Health Business Manager. In these cases, an SI Reporting Form should not be submitted and the commissioner in consultation with the ESCC Communications lead will decide on any further action. 3.2 Reporting procedures ESCC Public Health will commission services from essentially three types of organisations. Each organisation will have different reporting processes depending on their status and registration. Figure 1 outline’s the different processes for reporting and managing SIs. It should be noted that, as the contract holder, public health retain the overall accountability for assurance of providers SI management and reporting.

10 http://pansussexadultssafeguarding.proceduresonline.com/index.htm 11 https://new.eastsussex.gov.uk/childrenandfamilies/childprotection/ 12 https://new.eastsussex.gov.uk/socialcare/worried/safeguarding/what/

ESCC Public Health Commissioned Services: serious incident policy Page 7 of 17 8 NHS organisations NHS organisations will automatically report SI through the NHS STEIS (Strategic Executive Information System) system. These SI will be received by the Pan-Sussex SI group, and will be managed through that process. The ESCC Public Health lead for Quality is a member of the Pan-Sussex SI group by exception and attends when SIs relating to ESCC Public Health Commissioned Services are discussed.

CQC registered organisations These cover organisations who are CQC registered and as such are required to report incidents to the CQC and to the commissioner.

Figure 1: SI reporting process for ESCC public health commissioned services

All other providers For all other providers, all SI are managed through the normal contract monitoring process. Providers should use the SI Reporting Form at Appendix 1 to record the details of an incident. The key reporting stages and expected timescales are set out at Appendix 2 together with the obligations of both the provider and the commissioner.

SIs reported from a third party: if a possible SI under the responsibility of the provider is reported to ESCC from a different source than the provider organisation, then the commissioner of the service will contact the identified provider and request investigation of the incident and a decision on SI reporting. If the commissioner has reason to believe the provider organisation had knowledge of the SI beforehand but failed to report the incident, the commissioner will record this as a possible breach of contract.

The commissioner and Public Health Business Manager will be responsible for monitoring the SI investigation and may request additional information from the provider and or higher levels of investigation, up to an external review. If the commissioner feels an external investigation is required, a request must be made to the Contract Holder. The Director of Public Health is accountable for authorising any external investigation.

Any SIs reported to the commissioner involving information governance breaches will be reported to the ESCC Information Governance Lead. The provider will forward to the appropriate professional lead any SI that identifies possible professional misconduct or professional negligence by a registered health care professional. The commissioner and the Public Health Business Manager will ensure compliance with timescales for SI and Root Cause Analysis (RCA) reporting.

The commissioner will require the provider to:

 produce the provider SI policy within five working days of the request;  produce an action plan within ten operational days of a request to do so; and/or  submit further reports within ten operational days of a request to do so; and/or  attend meetings with regard to implementation of the action plan within ten operational days of a request to do so.

At the point the provider organisation has completed investigation it should update the SI Reporting Form with the date the investigation was completed. The full investigation report should be sent electronically and securely to the commissioner and the Public Health Business Manager within the timescale. All RCA reports and action plans should be submitted according to the format in Appendix 3. The report should not contain 8 person or patient identifiable information. If there is concern that a patient, staff member or member of the public may be able to be identified from the report, the provider must arrange and confirm with the commissioner how to send the report to a secure email account.

The Public Health Senior Team will decide whether to close a SI reported by a provider.13 The commissioner of the service will present the investigation report and recommendation for closure to the Public Health Senior Team for consideration.

If the provider organisation is unable to provide the full investigation report within the timeframes in Appendix 3, a request for an extension should be made to the commissioner explaining the reasons. Requests for extensions will be granted for any delay in the investigation that is outside of the provider organisation’s control. Examples include:

 Police investigation  Safeguarding investigation  Awaiting statements or reports from individuals not employed by the provider organisation  Awaiting external investigation reports  Extensive investigation required ( Example: reviewing 100+ patient records)

Extensions will not be granted for the following:

 Delay in reporting of incidents  Staff annual leave  Lack of available investigators

Delays in reporting attributed to these reasons will be considered a breach of contract.

The commissioner or Public Health Business Manager will inform the provider of its decision to close or keep open the SI case within 20 working days of receipt of an RCA report.

13 To be quorate the group must consist of a minimum of the Director of Public Health, a Public Health Consultant and two other members of the Team. No member of the Team should be involved in the RCA of any incident being assessed for closure, as this will be classed as a conflict of interest.

ESCC Public Health Commissioned Services: serious incident policy Page 9 of 17 Appendix 1

A1 Serious Incident (SI) Reporting Form

Please remember you have a duty of confidentiality to patients and staff. Try to record your information in a factual and objective way.

Reporting Organisation

Contracted service Organisation Date Lead contact Job Title Tel. No Email

Incident Overview

Status (e.g. first report or update) Date/time of Incident Site/location of Incident

What happened?

Actual incident or near-miss Type of incident

Type of Incident (tick box): Allegation against Provider staff Delayed Diagnosis Allegation against Provider staff (Fraud) Deliberate self-harm by patient / client Adult Safeguarding issue Drug Incident (general) Assault by patient / client Equipment Failure Assault (unknown assailant) Failure to obtain consent Attempted homicide by patient / client Fire Bogus health worker Health and Safety Chemical Incident Infection / communicable disease issue Closure / suspension of service Homicide by patient/client Child Safeguarding issues Security threat Child Serious Injury Suicide by patient / client Child Death Unexpected death Confidential Information Leak Other

ESCC Public Health Commissioned Services: serious incident policy Page 10 of 17 Description of what happened

Immediate action taken

Is anyone affected by the incident – staff, patients, visitors, members of the public?

YES/NO (delete as appropriate).

If Yes, complete the sections below:

General details of those affected

How many people are affected? Age of person / people affected Gender of person / people affected

Risk assessment

Apparent outcome of incident Likelihood of recurrence/further impacts

Closure

RCA Report submission date Date closed

External reporting

Is there media interest? Has there been reporting to external (see page 10 for external reporting requirements) agencies (e.g. police, Safeguarding)?

ESCC Public Health Commissioned Services: serious incident policy Page 11 of 17 External reporting requirements

Other commissioners: will be informed by the is perceived that a child or children (under 18 years commissioner within three working days of receipt of of age) are involved in or are victims of an SI (with the SI Report when any person, premises or respect to Caldicott Principles and on a strictly need property involved in a Serious Incident (SI) is linked to know basis). Where the incident involves the to them or of interest to them in understanding the death of a child the anonymised report of the whole picture of a provider organisation’s safety investigation will additionally be sent to the East record. For example, the commissioner may inform Sussex Local Safeguarding Children Board and a the Commissioning Support Unit (CSU) of a SI Safeguarding Alert raised. Where persons involved where a provider has contracts both with public in an incident lack capacity under the definition of health and with other services commissioned the Mental Capacity Act 2007, the Act must be through the CSU. considered. Public Health England: will be informed immediately Safeguarding Adults Board (SAB) adult by ESCC Public Health where a SI is associated safeguarding policy and procedures should be with adverse affect upon the health and wellbeing of applied by raising an alert and relevant NHS Adult the public, e.g., infections, diseases, chemicals, Protection Lead will be informed immediately by the radiation hazards, etc. commissioner when it is perceived that an adult or adults (over 18 years of age) are involved in or are Care Quality Commission: will be informed by the victims of a SI (with respect to Caldicott Principles provider of any SI associated with serious failings and on a strictly need to know basis). Where the SI (actual or alleged) which may have a negative involves the death of an adult the anonymised report impact on the safety of patients, clinical of the investigation should additionally be sent to the effectiveness or responsiveness to patients. SAB’s Safeguarding Investigation Manager. Where Police: will be informed immediately by the provider persons involved in an incident lack capacity under (and Crime Number Recorded) when it is perceived the definition of the Mental Capacity Act 2007, the that a SI may have involved foul play, flagrant or Act must be considered. wilful negligence or malicious intent, acts of violence Legal Advisers: The provider will inform its legal to any person/s, premises. If the police are involved, advisors immediately when it is perceived that a SI they will guide the organisation as to the parameters may give rise to legal proceedings. of the local investigation under the Memorandum of Understanding of the Department of Health. Estates: Will be informed by the provider immediately when it is perceived that a SI may be Fire/Ambulance/Other Emergency Services: will be related to Estates & Facilities. requested by the provider immediately when required. Professional Regulatory Bodies/Medical Defence Organisation: Health Professionals involved in a SI Social Services: will be informed by the provider will be advised by the provider to inform their immediately when it is perceived that a SI may have Professional Regulatory Bodies/Medical Defence involved persons under the care of Social Services, Organisation, e.g. General Medical Council, Nursing or where persons are put at risk as a result of a SI and Midwifery Council, etc, immediately when it is and may require the assistance of Social Services perceived that a SI may give rise to legal (with respect to Caldicott Principles and on a strictly proceedings. Under these circumstances, Legal need to know basis). Advisers can provide valuable information and Medicines & Healthcare Products Regulatory advice, along with union representation. Agency: will be informed by the Provider Trading Standards: Will be informed immediately by immediately when it is perceived that a SI may be the provider when it is perceived that a SI may be the result of a Medical Device fault, failure or user the result of a product (whether failure or user error) error or an adverse drug or blood product reaction is falling outside of the remit of the MHRA. suspected (please refer to the Medicines Policy). Relevant Counter Fraud and Security Management Health and Safety Executive: will be informed Services: Will be informed immediately by the immediately when it is perceived that a SI is provider if any SIs are associated with fraud or reportable under the Reporting of Injuries, Diseases security. and Dangerous Occurrences Regulations 1995 (RIDDOR) or may be the result of non-compliance Care Quality Commission: Will be notified by the with Health & Safety Legislation. provider where a SI indicates a breach of the National Care Standards. Area Safeguarding Children’s Board Lead: will be informed immediately by the commissioner when it

ESCC Public Health Commissioned Services: serious incident policy Page 12 of 17 _matter_suffix»

Appendix 2 A2 Reporting stages and timescales

Due Insert date Stage 1

Provider to:

 Email relevant commissioner and Public Health Business Manager and Immediately xx/xxx/xx give a brief summary of the incident.  Collect as much specific detail as possible, but do not delay reporting to wait for all details. Stage 2:

Provider to:

 Update the relevant commissioner and the Public Health Business Manager with any immediate actions taken. On the same  Report the incident to the providers own communications team and or nearest xx/xxx/xx determine any actions needed on contacting external organisations. working day Commissioner to:

 Determine actions needed within ESCC in terms of communications  Determine any actions needed on contacting external organisations / Safeguarding  Update Provider in terms of any actions taken. Stage 3:

Provider to:

 Send SI Reporting Form by e-mail to relevant commissioner and Public Health Business Manager and start internal investigation procedures Commissioner to: Within the  Seek advice if it appears from the provider SI report that issues of next two prescribing or dispensing of medicines are involved. xx/xxx/xx working days  Exchange information with Provider on communications/ media role and what has been reported to external organisations  Inform the relevant Clinical Commissioning Group  Determine actions needed within ESCC in terms of communications  Determine any further actions needed on contacting external organisations / Safeguarding  Determine, with the Director of Public Health or Public Health Consultant whether additional clinical opinion is required in the investigation of the SI Stage 4:

Provider to:  Conduct Root Cause Analysis (RCA) Within 60  Update commissioner and Public Health Business Manager if required working days xx/xxx/xx  Meet commissioner and Public Health Business Manager if requested  Submit RCA report to commissioner and Public Health Business Manager  Update SI Reporting Form Stage 5: Within next Commissioner to: 20 working xx/xxx/xx  Extend Stage 4 until evidence gathering is complete in cases reported to days external organisations / Safeguarding.

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Due Insert date  Inform Provider of decision to close or keep open the SI by electronic letter.

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Appendix 3

A3 Root Cause Analysis (RCA) Template

Root Cause Analysis investigation is a well-recognised way to ensure that lessons are learned to prevent the same incident occurring elsewhere. A helpful guide to completing an RCA report is available at http://www.nrls.npsa.nhs.uk/resources/collections/root-cause-analysis/.

Cover page • Involvement and support of the patient and/or • Organisation name and / or logo relatives • Title or Brief outline of incident • Detection of Incident • Incident date and number and date of report • Care and Service Delivery Problems • Author(s) • Contributory Factors • Document version/file path • Root Causes • All RCA reports must contain a footer with mage • Lessons learned and recommendations numbers and document title • Arrangements for Sharing Learning

Contents page Incident description and consequences • Executive summary • Concise incidence description • Incident description and consequences • Incident date • Pre-investigation risk assessment • Incident type • Background and context • Speciality involved • Terms of reference • Actual effect on patient and / or service • The investigation team • Actual severity of incident • Scope and level of investigation • Investigation type, process and methods used Pre-investigation risk assessment • Involvement and support of patient and relatives • Background and context to the incident, • Involvement and support provided for staff • A brief description of the service type, service involved size, clinical team, care type, treatment provided etc. • Information and evidence gathered • An Assessment of the realistic likelihood and • Chronology of events severity of recurrence, using your organisation’s • Detection of incident Risk Matrix. • Notable practice • Care and service delivery problems Terms of reference • Contributory factors • Specific problems to be addressed • Root causes • Who commissioned the report • Lessons learned • Investigation lead and team • Recommendations • Aims, Objectives and Outputs (see examples opposite) • Arrangements for shared learning • Scope, boundaries and collaborations • Distribution list • Administration arrangements (accountability, • Appendices resources, monitoring) Executive summary • Timescales • Brief Incident description As an example, the Terms of Reference may be to • Incident date: look for improvements rather than to apportion • Incident type: blame or to establish the facts of what happened • Healthcare specialty: and the impacts; whether failings occurred in care or treatment; how recurrence may be reduced or • Actual effect on patient and/or service: eliminated and to formulate recommendations and • Actual severity of the incident: an action plan. • Level of investigation conducted Investigation team

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• Names Detection of incident • Roles • Note at which point in the service to the patient the error was identified, and by which process • Qualifications (e.g. by an IT system or by a face-to-face • Department assessment). • Organisation

Chronology of events • For complex cases, any timeline included in the report should be a summary.

Notable practice • Points in the incident or investigation process where care and/or practice had an important positive impact and may provide valuable Scope and level of investigation learning opportunities. • State level of investigation (NPSA -1.Concise; 2.Comprehensive.; 3.Independent) Root Cause Analysis: Care and service delivery • Describe the start and end points problems • List services & organisations involved • A themed list of the key problem points. • Investigation type (i.e. Single / Aggregation / Multi-incident), process, and methods used Root Cause Analysis - Contributory factors • Gathering information e.g. Interviews • A list of significant contributory factors (where many contributory factors are identified a full list • Incident Mapping e.g. Tabular timeline or ‘fishbone diagrams’ should be included in the • Identifying care and service delivery problems appendix) e.g. Change analysis • Identifying contributory factors & root causes Root causes (numbered) e.g. Fishbones • These are the most fundamental underlying • Generating solutions e.g. Barrier analysis factors contributing to the incident that can be addressed. There should be a clear link, by Involvement and support of patient and relatives analysis, between root CAUSE and EFFECT on • Meetings to discuss questions the patient the patient. anticipates the investigation will address and to hear their recollection of events (anonymised in Lessons learned (numbered) line with the patient/relative wishes). • Key safety and practice issues identified which • Family liaison person appointed, information may or may not have contributed to this incident given on sources of independent support but from which others can learn.

Involvement and support for staff involved Recommendations Refer (anonymously) to involvement of staff in the • Numbered and referenced, recommendations investigation, and to formal and informal support should be directly linked to root causes and provided to those involved and not involved in the lessons learned. incident. Arrangements for shared learning Information and evidence gathered • Describe how learning has been or will be • A summary of relevant local and national policy / shared with staff and other organisations. guidance in place at the time of the incident, and any other data sources used Distribution list • Any relevant content from management • Describe who (e.g. patients, relatives and staff information or patient clinical records involved) will be informed of the outcome of the (anonymous) investigation and how. • Any interviews conducted – with staff or patients relatives for example Appendices • Information derived from any visits to the • Include key explanatory documents. location of the incident • Acknowledgements to patients, family, staff or experts etc.

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