Purpose The Framework to support the NHS to ensure that robust systems are in place for reporting, investigating and responding to serious incidents so that lessons are learned and appropriate action taken to prevent future harm. The Framework is into three parts; Part One: Definitions and Thresholds - sets out what a serious incident is and how serious incidents are identified. This section also outlines how the Framework must be applied in various settings. Part Two: Underpinning Principles - outlines the principles for managing serious incidents. It also clarifies the and responsibilities in relation to serious incident management, makes reference to legal and regulatory requirements and signposts to tools and resources. Part Three: Serious Incident Management Process - outlines the process for conducting investigations into serious incidents in the NHS for the purposes of learning to prevent recurrence. It covers the process from setting up an investigation team to closure of the serious incident investigation. It provides information on timescales, signposts tools and resources that support good practice and provides an assurance Framework for investigations. The Framework aims to facilitate learning by promoting a fair, open, and just culture that abandons blame as a tool and promotes the belief that ‘incidents cannot simply be linked to the actions of the individual healthcare staff involved but rather the system in which the individuals were working. Looking at what was wrong in the system helps organisations to learn lessons that can prevent the incident recurring’. It is recognised that serious incidents that require investigation extend beyond those which affect patients directly and include incidents which may indirectly impact patient safety or an organisation’s ability to deliver ongoing healthcare. The Framework describes the process for undertaking systems-based investigations that explore the problem (what?), the contributing factors to such problems (how?) and the root cause(s)/fundamental issues (why?). It endorses the recognised approach applied within the NHS (currently referred to as Root Cause Analysis investigation) and recognises that ‘serious incidents’ span a vast range of healthcare providers and settings, extending into social care and the criminal justice system. The Framework acknowledges the interfaces with organisations, particularly those with a statutory responsibility to investigate specific types of incidents which may involve the delivery of healthcare and therefore can coincide with serious incident investigations led by the health service. In doing so, it recognises that a variety of investigation methodologies may be applied and promotes the ever increasing need to work collaboratively in an effort to draw lessons to inform systematic learning and improvement. Local operational guidance for serious incident management (within commissioning and provider organisations) must be consistent with this Framework.
the investigation process. Within the NHS there are three recognised levels of systems-based investigation (currently referred to as RCA investigation). These are described in the table below. Information in this table provides an outline of the levels of systems-based investigations recognised in the NHS (currently referred to as RCA investigation). Within the NHS, most serious incidents are investigated internally using a comprehensive investigation approach. Resources to support systems-based investigation in the NHS are available online from: For further information relating to the circumstances and requirements for commissioning independent investigations see appendix 3. Level Application Product/ outcome Owner Timescale for completion Level 1 Concise internal investigation Suited to less complex incidents which can be managed by individuals or a small group at a local level Concise/ compact investigation report which includes the essentials of a credible investigation Provider organisation (Trust Chief Executive/relevant deputy) in which the incident occurred, providing principles for objectivity are upheld Internal investigations, whether concise or comprehensive must be completed within 60 working days of the incident being reported to the relevant commissioner All internal investigation should be supported by a clear investigation management plan Level 2 Comprehensive internal investigation (this includes those with an independent element or full independent investigations commissioned by the provider) Suited to complex issues should be managed by a multidisciplinary team involving experts and/or specialist investigators where applicable Comprehensive investigation report including all elements of a credible investigation Provider organisation (Trust Chief Executive/relevant deputy) in which the incident occurred, providing principles for objectivity are upheld. Providers may wish to commission an independent investigation or involve independent members as part of the investigation team to add a level of external scrutiny/objectivity 3 Independent investigation Required where the integrity of the investigation is likely to be challenged or where it will be difficult for an organisation to conduct an objective investigation internally due to the size of organisation or the capacity/ capability of the available individuals and/or number of organisations involved (see Appendix 1 and 3 for further details) Comprehensive investigation report including all elements of a credible investigation The investigator and all members of the investigation team must be independent of the provider. To fulfil independency the investigation must be commissioned and undertaken entirely independently of the organisation whose actions and processes are being investigated. 6 months from the date the investigation is commissioned
The UK Safety and Quality Regulations 2005 and the EU Blood Safety Directive require that serious adverse incidents and serious adverse reactions related to blood and blood components are reported to the MHRA, the UK Competent Authority for blood safety. This information is vital to the work that the Serious Hazards of Transfusion (SHOT) uses to compile its reports. Further details on reporting can be found at: Appendix 3: Independent Investigation (level 3) Introduction This appendix describes the process for undertaking independent investigations for the purposes of learning to prevent recurrence. It describes the circumstances in which an independent investigation may be required and the process for commissioning and managing these types of investigation. It also outlines the potential scope of independent investigations and the circumstances where it may be necessary to involve the expertise of NHS England Regional investigation teams. It does not describe the regional process that has been established for investigating homicide by those in receipt of mental health care. This process is described in appendix 1. This appendix should be read in conjunction with the main Framework. Scope Investigations carried out under this Framework are conducted for the purposes of learning to prevent recurrence. They are not inquiries into how a person died (where applicable) as this is a matter for Coroners. Neither are they conducted to hold any individual or organisation to account. Other processes exist for that purpose including: criminal or civil proceedings, disciplinary procedures, employment law and systems of service and professional regulation, such as the Care Quality Commission and the Nursing and Midwifery Council, the Health and Care Professions Council, and the General Medical Council. In circumstances where the actions of other agencies are required then those agencies must be appropriately informed and relevant protocols, outside the scope of this Framework, must be followed. An independent investigation is an investigation into an incident is both commissioned and undertaken independently of those directly responsible for and directly involved in the delivery of the elements that the investigation is considering. This guidance considers two of independent investigation: The first is an independent provider-focussed investigation considering the specific care given to a patient or patients by one or more providers. This type of investigation should be commissioned by the commissioner of the care within which the serious incident occurred and undertaken by individuals who are all independent of the provider(s) in question. The second type is a independent investigation of the role of the commissioning system or the configuration of services, which must be