Serious Untoward Incident (SUI)
Policy and Procedure v3.0
Policy Statement:
This policy describes the Trust’s policy for the management of incidents classified as ‘Serious Untoward Incidents’ that members of staff must follow if the event occurs as a result of any work activity conducted by or on behalf of the Trust. It encompasses the management of both clinical and non-clinical Serious Untoward Incidents.
Key Points· What is a Serious Untoward Incident?
· Guidance for managers and staff in the investigation process for Serious Untoward Incidents
· Reporting requirements and timeframes
Ratified Date: October 2010
Ratified By: Governance and Risk Committee
Review Date: October 2012
Accountable Directorate: Safety and Governance
Corresponding Author: Head of Governance and Safety Improvement
Meta Data
Status / Active
Document Author: / Head of Governance and Safety Improvement
Source Directorate: / Safety and Governance
Date Of Release: / October 2010
Ratification Date: / October 2010
Ratified by: / Governance & Risk Committee
Review Date: / October 2012
Related documents / · Risk Management Strategy
· Incident Reporting Policy and Procedure
· Health and Safety Policy
· Disciplinary Procedure
· Memorandum of Understanding: Investigating Patient Safety incidents involving unexpected death or serious untoward harm
· Being Open Policy
· Supporting Staff Involved in traumatic events policy
· Integrated Major Incident /Disaster Plan
· Safeguarding Children and Adults Policies
· Safeguarding Adults Policy
· Information Governance Policies
Superseded documents / SUI Policy 2007
Relevant External Standards/ Legislation / NHSLA Risk Management Standards
Care Quality Commission Regulations
Key Words / Serious Untoward Incident, SUI
Revision History
Version / Status / Date / Consultee / Comments / Action from Comment1.1 / Review / July 2008 / Healthcare Governance / Review to ensure compliance with practice and healthcare standards / Policy reviewed and updated
1.5 / Review / October 2008 / Healthcare Governance / Further review to ensure policy reflects actual practice / Policy amended
2.0 / Final / November 2008 / Healthcare Governance / Further review to ensure policy reflects actual practice / Policy amended
2.1 / Draft / June 2010 / Safety and Governance / Changes to reflect revised national guidance and changes to procedure / Policy updated
2.2 / Draft / Sept 2010 / Safety and Governance / Further changes on consultation / Policy updated
3.0 / Final / Oct 2010 / Safety and Governance / Further changes on consultation / Policy updated
Table of Contents
SUI Investigation Process 4
1 Circulation 5
2 Scope 5
3 Definitions 5
4 Reason for Development 6
5 Aims and Objectives 6
6 Standards 6
7 Responsibilities 7
8 Committee Responsibilities 10
9 Training 11
10 Monitoring and Compliance 11
11 Improvement 11
12 Attachments 12
Attachment 1: Procedure for the Reporting, Management and Investigation of Serious Untoward Incidents 13
Attachment 2: Examples of Serious Untoward Incidents as defined by the West Midlands Strategic Health Authority 19
Attachment 3: Managing Serious Untoward Incidents Relating to Actual or Potential Breaches of Confidentiality Involving Person Identifiable Data (P.I.D). 21
Attachment 4: National Never Events 24
Attachment 5: Serious Untoward Incident Statement Template (or Electronic Pro-Forma) 35
Attachment 6: SUI Report – Pro-Forma Guidance 36
Attachment 7: Communications with External organisations 37
Attachment 8: Equality and Diversity - Policy Screening Checklist 40
Attachment 9: Approval/Ratification Checklist 42
Attachment 10: Launch and Implementation Plan 44
SUI Investigation Process
1 Circulation
This Policy should be read by all staff involved in the management of Serious Untoward Incidents (SUIs). It applies equally to staff in a permanent, temporary, voluntary or contractor role acting for, or on behalf of, Heart of England NHS Foundation Trust (HEFT).
2 Scope
Includes:
· This policy supports the Trust’s ‘Incident Reporting Policy and Procedure’ and describes the Trust’s approach to the reporting and management of all incidents classified as Serious Untoward Incidents (SUIs).
Excludes:
· It does not include the management of incidents that are not classified as SUIs. A separate Trust policy ‘Incident Reporting Policy and Procedure’ addresses this.
· It does not include the management of Major Incidents which are covered by a separate policy under the Trust’s Integrated Major Incident /Disaster Plan.
3 Definitions
A Serious Untoward Incident is defined by West Midlands Strategic Health Authority as:
· An accident or incident when a patient, member of staff or member of the public suffers serious injury, major unexpected harm or unexpected death (or the risk of death or serious injury) on premises where health care is provided, or whilst in receipt of healthcare
· Any event where the actions of health service staff are likely to cause significant public concern
· Any event that might seriously impact upon the delivery of services and / or which is likely to produce significant legal, media or other interest and which, if not properly managed, may result in the loss of the Trust’s reputation or assets
A list of national never events have also been agreed – which are required to be reported and managed as SUIs. A never event is defined as:
‘Serious, largely preventable, patient safety incidents that should not occur if the available preventative measures have been implemented’
Attachment 2 provides further detailed examples of the types of SUIs which are covered by this policy.
Attachment 3 includes details of the data loss and breach of confidentiality incidents which should be managed as SUIs.
Attachment 4 includes details of the never events which should also be reported by all staff as a SUI.
4 Reason for Development
HEFT is committed to providing high quality safe care for its patients and providing a safe environment for its patients, visitors and staff.
The Trust recognises the importance of investigating all SUIs in a structured way utilising Root Cause Analysis (RCA) techniques as a method to understand why an adverse event has occurred. The emphasis is upon the exploration of the underlying and contributory factors which, if allowed to persist, could create the potential for the same adverse event to reoccur. Understanding the factors that cause an incident allows lessons to be learned and actions to be developed to minimise the risk of the incident reoccurring.
This policy provides the necessary structure within which such incidents should be managed.
5 Aims and Objectives
The Trust, in its approach to incident investigation, aims to develop a non punitive culture so long as there has been no flagrant disregard of the Trust’s policies, fraud or gross misconduct.
The aim of an investigation into a Serious Untoward Incident is to identify any deficiencies in care using RCA and to learn lessons from these findings to develop safer practices and environment for the benefit of patients, staff and visitors to its premises.
A procedure (Attachment 1) is attached to this policy which summarises the steps, illustrated in the flow chart on p4 of this document, to be followed for reporting, managing and investigating a SUI.
6 Standards
6.1 General
· The investigation will be undertaken in line with the SUI investigation process on p4 of this document
· Where appropriate, the implementation of immediate action to prevent or minimise the risk of re-occurrence of the incident must be initiated;
· All SUIs, once identified must be brought to the attention of the Safety and Governance Directorate;
· Out of hours SUI’s should be brought to the attention of the on call director;
· An online incident form should be submitted and graded as ‘red’;
· A Clinical lead will co-ordinate the management of the incident;
· The initial scope of the investigation will determine the extent of the problem and define the resources required to support the investigation;
· The SUI process will incorporate the appropriate communication standards described in the Being Open Policy;
· The SUI process will incorporate the appropriate standards described in the Support Staff Policy
· The Trust will communicate with all relevant external organisations during the investigation, as appropriate.
6.2 Reporting
Once confirmed as a SUI, the Trust’s principle commissioner (Birmingham East and North PCT) will be informed verbally within 24 hours. The Trust will also inform them, in writing, within 72 hours of initial notification. The NPSA will also be informed via the NRLS upload.
6.3 Classification of Incident Grading
The classification of incidents can be scored using a simple risk quantification matrix. The matrix used by the Trust has been adapted from an International Risk Management Standard (Australian Standard / New Zealand Standard 4360:1999) and recognised by the National Patient Safety Agency.
The grading of the incident is determined by two factors:
· The actual consequence / outcome or severity of the incident
· The probability or likelihood of the incident occurring/reoccurring.
Further details regarding the classification of Incidents can be found in the Trust risk management policy. All red incidents[1] will be managed as a SUI.
6.4 Predetermined Serious Untoward Incidents
Some incidents are classified as SUIs on a national level. These incidents may not fit the above criteria of the Trust’s definition of a SUI, however they must be managed by the Trust as a SUI as required by the National Patient Safety Agency, and other external organisations. The Safety and Governance Directorate will cascade information about predetermined SUIs to the relevant departments when applicable.
Further details relating to predetermined SUIs can be found in Attachment 2, 3 & 4
7 Responsibilities
7.1 All employees
All staff are required to report incidents in line with the Incident Reporting and Management Policy and Procedure.
7.2 Executive Director
An Executive Director will be nominated as the executive lead[2]. By default this will be the Director of Medical Safety, however a more appropriate Executive Director may be appointed as required. They will:
· Take Executive lead for the investigation of the SUI.
· Oversee a thorough and timely investigation process
As required, they may also
· Attend the first and second round table meeting
· Meet with the family
· Attend inquest
7.3 Directorate Team
· To ensure that all potential SUIs have been appropriately reported to the Safety and Governance Directorate[3]
· To ensure that support is provided for staff involved in a SUI in line with the Trust’s Supporting Staff policy.
· To co-ordinate the actions required for the directorate to address all risk management issues in relation to the incident.
· To co-ordinate communication with the patient(s)/relative(s), where appropriate, and in line with the Trust Being Open Policy
· To facilitate communication between the Safety and Governance Directorate and any clinical staff involved in the incident.
· To provide advice on clinical issues relating to the incident.
· To work with the clinical lead and investigation lead to develop an action plan to improve systems and minimise the risk of reoccurrence, as identified by the RCA and investigation report
7.4 Director of Safety and Governance
· To ensure that the Trust has an appropriate infrastructure for investigating SUIs and oversee the Trust’s response to serious adverse incidents including learning lessons.
· To advise the Chief Executive of any SUIs
· Act as executive lead for a SUI as required
· Confirm the incident as a SUI and determine the level of investigation required in consultation with the Director of Medical Safety / Head of Governance and Safety Improvement.
· To report to the Trust Board and Governance and Risk Committee on all relevant matters relating to SUI investigation.
· To sign off the final investigation report
7.5 Director of Medical Safety
Working with the Head of Governance and Safety Improvement and Clinical investigations Advisor:
· To initiate a round table meeting (which may include Director of Medical Safety, Medical Director, Nursing Director, Clinical Director, Matron, Investigations Manager, Clinical investigation Advisors and Directorate Manager as appropriate).
· To nominate an appropriate Investigation lead
· Act as executive lead for a SUI as required or nominate appropriate alternative.
· To nominate a Clinical Lead
· Confirm the level of investigation required in consultation with the Director of Safety and Governance / Head of Governance and Safety Improvement.
· Ensure that relevant internal stakeholders are notified once the incident has been confirmed as an SUI
· Consult with the Group Medical Director and appropriate Head Nurse regarding the application of the NPSA Incident Decision Tree, as appropriate.
· To provide progress reports to the Director of Safety and Governance and other external organisations, where appropriate.
· To act as an expert medical advisor on the Trust’s approach to SUI investigation.
· To review the final report and recommendations from the investigation.
· To sign off the final investigation report as requested by the Director of Safety and Governance
· To agree the communications strategy with the Director of Communications as appropriate
7.6 Group Medical Director / Head Nurse or other professional lead.
· Consult NPSA Incident decision tree and take appropriate action to ensure that patients are not put at any further risk whilst the investigation continues.
· Facilitate the release of staff to support the inquiry
7.7 On Call Executive Director
When notified out of hours that a SUI has occurred.
· Ensure that the situation has been made safe and take any immediate remedial action
· To report the incident to the Safety and Governance Department as soon as possible on the next working day.
· To initiate the initial phase of the investigation to scope the extent of the problem, resources required to manage it and ensure that the patient(s)/relative(s) where possible, have been informed in line with the being open policy.
· To assess the potential for any public relations implications and agree an approach liaising with the Director of Corporate Affairs
7.8 Director of Corporate Affairs
· To develop a communication strategy, where appropriate, for the media when a SUI has occurred in liaison with Director of Safety and Governance, Director of Medical Safety or On Call Executive Lead