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Serious Incident Framework

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Serious Incident Framework
NameSerious Incident Framework
PurposeGuidance for managing major incidents
Developed byHealth and Safety Executive; NHS England; Department of Health and Social Care
Introduced2015
JurisdictionUnited Kingdom

Serious Incident Framework is a policy and procedural guidance document used to identify, report, investigate, and remediate major adverse events in National Health Service (England), public sector settings and regulated organisations. It provides structured criteria, processes, and accountability mechanisms to ensure consistent response across bodies such as NHS Trusts, Clinical Commissioning Groups, Care Quality Commission, and other statutory actors. The Framework aligns with legislative instruments and regulatory expectations including Health and Social Care Act 2012, Care Act 2014, and standards set by NHS Resolution.

Overview

The Framework synthesises guidance from entities including NHS England, Health and Safety Executive, Care Quality Commission, British Medical Association, and Royal College of Nursing to produce operational protocols for accident and emergency response, serious incident reporting, and system-wide learning. It situates incident management within statutory duties under the Health and Social Care Act 2008 and links to compensation and litigation frameworks such as Clinical Negligence Scheme for Trusts and processes administered by NHS Resolution. The document cross-references established methodologies from Institute for Healthcare Improvement, Root Cause Analysis, and Safety-II thinking.

Principles and Objectives

The Framework establishes principles drawn from sources including World Health Organization, Royal College of Physicians, Royal College of Surgeons, and regulatory guidance from Care Quality Commission. Objectives comprise timely identification, proportional investigation, patient-centred disclosure consistent with Duty of Candour requirements, system learning aligned with National Reporting and Learning System, and prevention of recurrence through evidence-based corrective actions. Emphasis is placed on transparency with partners such as Clinical Commissioning Groups, Integrated Care Systems, Local Healthwatch, and legal obligations under Freedom of Information Act 2000.

Scope and Definitions

Scope covers incidents referenced by organisations like NHS Trusts, Foundation Trusts, General Medical Council, and Nursing and Midwifery Council where harm could trigger reporting thresholds. Definitions integrate terminology from Department of Health and Social Care and Health and Safety Executive, distinguishing events such as Never event, Serious untoward incident, and incidents falling within statutory reporting regimes like Reporting of Injuries, Diseases and Dangerous Occurrences Regulations 2013. The Framework delineates affected populations including patients, staff, and visitors at sites such as Royal Free Hospital, St Thomas' Hospital, or community services coordinated by Local Authorities.

Incident Classification and Thresholds

Classification criteria reference clinical standards from National Institute for Health and Care Excellence and regulatory thresholds used by Care Quality Commission and NHS England. Thresholds incorporate outcomes such as unexpected death, severe harm, prolonged hospitalization, and incidents with potential for systemic harm or media scrutiny involving institutions like Barts Health NHS Trust or Cambridge University Hospitals NHS Foundation Trust. The Framework adapts classifications for complex events including data breaches evaluated under Data Protection Act 2018 and high-profile systemic failures comparable to inquiries like the Francis Inquiry.

Reporting and Notification Procedures

Reporting pathways require immediate notifications to bodies including NHS England Regional Teams, Clinical Commissioning Groups, Care Quality Commission, and where appropriate Police or Crown Prosecution Service. The Framework prescribes timelines mirroring standards in Duty of Candour and mandates alignment with reporting tools such as the National Reporting and Learning System. Communications protocols involve liaison with stakeholders including Healthwatch England, Local Resilience Forums, and commissioners such as NHS Improvement.

Investigation and Root Cause Analysis

Investigations draw on methods endorsed by Root Cause Analysis, Human Factors Assessment, and guidance from Institute for Healthcare Improvement. Teams often include clinical leads from organisations like Royal College of Anaesthetists and specialists from Public Health England or NHS England Patient Safety Translational Research Centre. Investigations seek causal chains analogous to analyses in reports by Healthcare Safety Investigation Branch and formal inquiries such as Shipman Inquiry or Paterson Inquiry, using structured timelines, witness interviews, and systems mapping.

Remediation, Learning and Preventive Actions

Remedial measures align with recommendations typical of Francis Inquiry, Berwick Report, and regulatory enforcement by Care Quality Commission. Actions include policy revision, staff training coordinated with organisations like Health Education England, changes to clinical pathways referenced by National Institute for Health and Care Excellence guidance, and system redesign using Lean methodology or Human Factors interventions. Learning is disseminated through networks such as NHS Improvement bulletins, Patient Safety Collaboratives, and professional bodies including Royal College of Nursing.

Governance, Roles and Accountability

Governance structures allocate responsibilities among boards of NHS Trusts, executives, designated senior responsible officers, and external regulators including Care Quality Commission and NHS England. Accountability mechanisms reference legal duties under Health and Social Care Act 2012 and professional standards enforced by General Medical Council and Nursing and Midwifery Council. External scrutiny may involve independent reviews, parliamentary scrutiny by committees such as the Health and Social Care Select Committee, or statutory inquiries under the Inquiries Act 2005.

Category:Health policy