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:
Ratified By:
Review Date:
Accountable Directorate:
Corresponding Author:
October 2010
Governance and Risk Committee
October 2012
Safety and Governance
Head of Governance and Safety Improvement
Paper Copies of this Document

If you are reading a printed copy of this document you should check the
Trust’s Policy website (http://sharepoint/policies) to ensure that you are
using the most current version.
©Heart of England NHS Foundation Trust
View/Print date 05 February 2016
Page 1 of 44
Meta Data
Document Title:
Status
Document Author:
Source Directorate:
Date Of Release:
Ratification Date:
Ratified by:
Review Date:
Related documents
Superseded
documents
Relevant External
Standards/ Legislation
Key Words
Serious Untoward Incident (SUI) Policy and Procedure v3.0
Active
Head of Governance and Safety Improvement
Safety and Governance
October 2010
October 2010
Governance & Risk Committee
October 2012
 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
SUI Policy 2007
NHSLA Risk Management Standards
Care Quality Commission Regulations
Serious Untoward Incident, SUI
Revision History
Version Status
Date
1.1
Review July 2008
1.5
Review October
2008
Final
November
2008
Draft
June
2010
2.0
2.1
2.2
Draft
3.0
Final
Consultee
Healthcare
Governance
Healthcare
Governance
Healthcare
Governance
Safety and
Governance
Sept 2010 Safety and
Governance
Oct 2010 Safety and
Governance
©Heart of England NHS Foundation Trust
Action from
Comment
Review to ensure compliance with Policy reviewed
practice and healthcare standards and updated
Comments
Further review to ensure policy
reflects actual practice
Further review to ensure policy
reflects actual practice
Changes to reflect revised
national guidance and changes
to procedure
Further changes on
consultation
Further changes on
consultation
View/Print date 05 February 2016
Policy
amended
Policy
amended
Policy updated
Policy updated
Policy updated
Page 2 of 44
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 .......................................................
37
Attachment 7: Communications with External organisations .......................................
38
Attachment 8: Equality and Diversity - Policy Screening Checklist ..............................
40
Attachment 9: Approval/Ratification Checklist .............................................................
42
Attachment 10: Launch and Implementation Plan .......................................................
44
©Heart of England NHS Foundation Trust
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SUI Investigation Process
©Heart of England NHS Foundation Trust
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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.
©Heart of England NHS Foundation Trust
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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
6.1
Standards
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 reoccurrence 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.
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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 incidents1 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
7.1
Responsibilities
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 lead2. 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
1
Subject to confirmation of incident and grading
For the purpose of this policy and procedure, this includes the Director of Medical Safety, the Deputy Chief Nurse and
the Group Medical Directors.
©Heart of England NHS Foundation Trust
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2
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
Directorate3
 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
3
Primarily (where possible) via the Director of Safety and Governance, the Director of Medical Safety, the Head of
Governance and Safety Improvement, the Clinical Investigations Advisor or on call Executive Director.
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 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
 Set up a communication infrastructure to facilitate patients, staff, public and media enquiries
 To report to the Investigation Lead any issues arising from the enquiries that may impact upon the
investigation
 Coordinate all press interviews and press conferences and agree with the Director of Safety and
Governance or Director of Medical Safety any press release to be issued.
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7.9
Investigation Lead
 To secure the medical notes and coordinate an initial scoping of the incident to determine the extent
of the problem and any resources needed to manage the incident.
 To support the clinical lead in the investigations process
 To arrange the round table meetings
 To ensure that external organisations are kept informed of the investigations process – as outlined in
the SUI procedure
 To ensure that SUI documentation is kept as appropriate and in line with SUI investigation process
on p4 of this document
 To communicate with the patient(s)/relative(s) where possible, advising them of the investigation in
line with the Being Open Policy.
 To provide appropriate advice and support for staff in line with the Supporting Staff Policy
 To ensure that the action plan is forwarded to the Group Medical Director and Clinical Lead who will
take overall responsibility for ensuring implementation and monitoring through to completion
7.10 Clinical Lead
 Working with the Investigation lead, undertake an investigation utilising the RCA approach, which
includes the following tasks:
- To obtain draft statements from all those involved in the incident
- To draft SUI report, where possible, using the template enclosed with this policy, with assistance
from the Investigation Lead.
- To produce a final SUI report and recommendations / action plan with the clinical team, where
appropriate
 Agree recommendations and appropriate time frames and leads for each recommendation
 To ensure that support is provided to all staff during the investigation, as appropriate.
 To debrief the staff involved in the incident, in conjunction with the Group Medical Director, Head
Nurse or other management lead as appropriate.
 To attend the meeting with the patient(s) / relative(s).
7.11 Safety and Governance Directorate
 To provide representation at the first round table meeting and provide advice on any complaints,
claims or coroner’s aspects of the investigation.
 To provide representation at the second round table meeting and provide advice on the development
of the recommendations.
 Collect evidence to support implementation of recommendations from the SUI report
8
8.1
Committee Responsibilities
Governance and Risk Committee
 Governance and Risk Committee is responsible for assuring the Trust Board that SUIs are being
investigated using RCA and providing assurance that any risks arising are being addressed
appropriately.
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8.2
Group Quality and Safety Committees
 To monitor the implementation of the SUI recommendations and action plans relevant for their
group
 To report assurance and exceptions to the Group Board / Executive and Governance and Risk
Committee
9
Training
The Safety and Governance Directorate will ensure provision of training for relevant staff, to enable them to
carry out their duties and responsibilities relating to incident management. This may include the risk
management training day, the online NPSA tool and other support and advice, as appropriate to the needs
of the individual.
For more details of this contact the Safety and Governance Directorate.
10 Monitoring and Compliance
The Safety and Governance Directorate is responsible for producing the Safety Situation (SITREP) report.
This is used by the lead Committees for the monitoring of SUI investigations.
This policy will be monitored through:
 PCT contractual requirements in respect of SUI reporting
 SITREP
 Group Quality and Safety Committee / Governance and Risk action plans
11 Improvement
The Trust is committed to ensuring local and organisational learning from aggregated data, including SUI’s,
in line with the Trust Incident Reporting and Management Policy and Procedure.
The Trust also shares lessons across the local health economy with the Clinical Quality Review Group
(HEFT, BEN, Solihull, South Staffs PCTs) via the following reports:
 Governance Annual Report (breakdown and analysis of incidents, complaints and claims)
 SITREP report
As a minimum, the Trust will seek to use lessons learnt to make changes in organisational culture or
practice from SUI’s
The Group Quality & Safety Committees are responsible for monitoring improvement actions and
addressing barriers to implementation. The status of outstanding actions is reported bi-monthly to
Governance and Risk Committee.
©Heart of England NHS Foundation Trust
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12 Attachments
Attachment 1: Procedure for the management of SUIs
Attachment 2: Predetermined SUIs (Guidance)
Attachment 3: Data loss and breach of confidentiality SUIs
Attachment 4: National and local never events
Attachment 5: SUI Statement – Pro-Forma (Guidance)
Attachment 6: Communications with External Agencies
Attachment 7: Equality and Diversity - Policy Screening Checklist
Attachment 8: Ratification Checklist
Attachment 9: Launch and Implementation Plan
©Heart of England NHS Foundation Trust
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Attachment 1: Procedure for the Reporting, Management and Investigation of Serious
Untoward Incidents
1. Aim
The aim of this procedure is to ensure that all Serious Untoward Incidents (SUIs) are properly reported and
investigated, that actions are taken to improve quality of care and patient safety and that lessons are
learned in order to minimise the risk of similar incidents occurring again in the future
A list of pre defined SUIs can be found in Attachment 2, 3 and 4.
2. Identification and response to a Serious Untoward Incident
In the event of an incident, employees are responsible for ensuring that appropriate remedial action is taken
immediately after the event to minimise or prevent further harm to the individuals concerned and to reestablish a safe environment. Employees should have regard for their own health and safety at such times –
and therefore request assistance, where appropriate.
Where the incident has involved any equipment, the equipment and any consumables e.g. medicines
should be isolated immediately, by the ward staff, and labelled. It should not be used and should be
preserved as evidence as part of an investigation.
The equipment and any consumables should be retained in a secure location pending further instructions.
Where practical, the scene of the incident / immediate environment should also be ‘preserved’ to allow for
more detailed investigation. Patients’ belongings should also be stored securely, where appropriate, as they
may be required by the police or other external agencies.
All relevant documentation including the medical records should be secured. Original Medical records
should be provided to the Clinical Investigations Advisor and copies should not be released to a third party
without prior agreement. A full record of the details of the event should be documented in the medical
records or a statement as soon as possible by staff involved
3. Reporting a suspected SUI
The incident should be reported immediately to the relevant line manager or to the person in charge of the
ward/department at the time and appropriately escalated to the senior management team.
Within office hours. the senior management team should notify the Safety and Governance Directorate
(Principally, where possible, via the Director of Safety and Governance, Director of Medical Safety, Head of
Governance and Safety Improvement or the Clinical Investigations Advisor) within 24 hours, where a SUI
is suspected.
At weekends and during holiday periods the on call Executive Director should be notified and should take
responsibility for the immediate management of the incident and initial phase of the investigation to make
the situation secure and safe. If possible, further action to commence the formal SUI process is left for the
next working day.
The escalation process may include the need to inform one or more external agencies e.g. the Health and
Safety Executive, the Police, the Medicines Healthcare Regulatory Agency, CQC and the NPSA.
©Heart of England NHS Foundation Trust
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Early consideration should be given to the provision of information and support to the patient / relatives,
carers and staff involved in the incident in line with the Trust’s Being Open policy and Supporting Staff
Involved in Traumatic Events Policy. Any formal action in relation to staff should be undertaken following
discussion with the appropriate Medical Director, Head Nurse or other management lead as appropriate.
Further advice is available from the Clinical Investigations Advisor or Safety and Governance Directorate.
Following verbal notification, an online incident form should be completed. This will ensure that relevant
incidents are reported in to the National Patient Safety Agency in line with Care Quality Commission
guidance on incident reporting.
4
Incident Management
Healthcare Acquired Infection SUIs and Data loss SUIs may be handled differently, in line with routine
infection control investigation and practice and in line with Attachment 3 for Data loss SUI’s
a) Determining a SUI
The Director of Medical Safety / Director of Safety and Governance will nominate an appropriate
Investigation lead, depending on the nature of the incident e.g.
Health and Safety: Health and Safety Manager
Data loss:– Information Governance Manager
Clinical:– Clinical Investigations Advisor or Senior Investigations Manager
Safeguarding adult or child: Trust’s Safeguarding lead
Healthcare acquired infection: Infection Prevention and Control lead
Maternity:– Clinical Risk Coordinator / Governance lead
Note: If the incident occurs out of working hours the on call Executive Director will take initial
responsibility for the immediate management of the incident and initial phase of the investigation.
The nominated Investigation Lead will coordinate an initial scoping exercise. The result of this will determine
whether the incident is considered to be a SUI and level of investigation required. This will be confirmed by
the Director of Medical Safety / Director of Safety & Governance / Head of Governance & Safety
An Executive Director will be nominated as executive lead by the Director of Medical Safety / Director of
Safety and Governance. / Head of Governance & Safety Improvement and a Clinical Lead suggested.
b)
Reporting
Once the incident is confirmed as a SUI the Director of Medical Safety should ensure that the following staff,
as appropriate, are or already have been, notified of the incident via a briefing note:








Chief Executive
Director of Safety and Governance
Head of Governance and Safety Improvement
Medical Director
Chief Nurse / Head of Maternity Service (for Maternity related SUIs)
Director of Human Resources
Director of Communications
Relevant Group Lead (e.g. Medical Director, Head Nurse and Operations Director)
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



Relevant directorate Lead (e.g..Clinical Director, Matron and general manager)
Solicitors, if appropriate
Health & Safety Manager, if appropriate
Head of Bereavement Services, if appropriate
The Director of Medical Safety / Director of Safety and Governance, along with the appropriate Medical
Director / Group Medical Director, Chief Nurse / Group Head Nurse or other appropriate management lead,
should consult the NPSA’s Incident Decision Tree and undertake appropriate immediate action as advised
to ensure that patients are not put at risk whilst an investigation is undertaken. Various options for staff
remaining at work should be considered for the protection of both patient and staff.
The patient(s) / relatives, where appropriate, and relevant staff should be notified at the earliest opportunity,
in line with the Trust’s Being Open policy. If there is a delay in informing the patient / relative then the most
appropriate person and method of communication should be discussed with the Director of Medical Safety /
Director of Safety and Governance / Head of Governance and Safety Improvement.
The PCT will be informed verbally within 24 hours of the confirmation of a SUI by the Investigation Lead. If
this occurs at the weekend, it should be notified on the Monday following. If media attention is likely, and the
incident occurs on the weekend, the on call Executive Director should be informed and relevant
stakeholders notified.
The Trust will then inform the PCT in writing within 3 working days, following a fact finding period, as to
whether the incident is a SUI or whether it can be downgraded.
At this stage further consideration should also be given to the immediate notification of any external
agencies including: Police; NPSA; HSE; Coroner; MRHA; Social Services; Care Quality Commission,
Monitor; Trust Solicitors. The Investigation Lead is responsible, on behalf of the Director for Medical Safety,
for ensuring all relevant stakeholders have been informed.
Consideration should also be given to any other Trust policies e.g. Safeguarding Vulnerable Adults /
Safeguarding Children – to determine specific actions.
c)
First round table meeting
A meeting to review the incident must be held, where possible within 2 working days of the declaration of a
SUI.
The Investigation Lead is responsible for arranging the first round table meeting. The following individuals
will be invited to attend this meeting as required:







Director of Medical Safety and / or Director of Safety and Governance / Head of Governance
and Safety Improvement
Executive Lead
Clinical Lead
Investigation Lead
Senior Investigations Manager
A representative from the relevant Group - Group Medical Director; Group Head Nurse; Group
Operations Manager as appropriate
A representative from the relevant directorate - Clinical Director; Matron; General Manager as
appropriate
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
Any other expert help as required e.g. Pathology, Radiology, Pharmacy, Tissue Viability
Facilities, IT, Interpreters, Trust Solicitors, HR, Head of Bereavement
The purpose of the first round table meeting is to:










Review progress of immediate actions
Ensure that all relevant stakeholders have been notified;
Consider NPSA Incident Decision Tree to determine any immediate action required in relation to
staff involved or systems;
Determine the terms of reference for the investigation and the level of investigation required
Establish links with other Trust policies e.g. Safeguarding
Confirm a clinical lead to work with the investigation lead;
Explore what support may be required in line with the Supporting Staff Involved in Traumatic
Events Policy;
Plan communication with the family in line with the Trust’s Being Open Policy; Ensure
appropriate support is offered to the family in the case of bereavement
Confirm timeline for the investigation.
Identify witness statements/ that are needed and how these will be requested / supported by the
investigation team. Consider potential media plan where required
All meetings relating to the investigation should be documented.
Note: the work of this group may need to be adjourned if for example a Police / Health and Safety
Executive investigation commences
d)
Investigation - Root Cause Analysis and Action Plan Development
The Clinical Lead, in conjunction with the Investigation Lead will be responsible for conducting the
investigation and carrying out a Root Cause Analysis (RCA).
Staff involved in the incident will be required to attend interviews or submit statements as requested by the
Investigation Lead and Clinical Lead, ideally within 10 working days. The release of staff and cover of their
duties to attend these meetings should be prioritised with their line manager.
The Clinical Lead and Investigation Lead will obtain witness statements, interview staff and use this
information along with the medical records and any other relevant evidence available to complete an RCA.
The Investigation Lead will advise and support the clinical lead with this process.
The Clinical Lead and Investigation Lead will be responsible for ensuring an appropriate record is kept of all
meetings and documentation is kept secure.
On completion of the RCA, a final draft report and recommendations will be produced, ideally within 30
working days, by the Clinical Lead and Investigation Lead, following discussions with relevant staff
including the Director of Medical Safety / Director of Safety and Governance and / or the Head of
Governance and Safety Improvement.
A second round table meeting will be arranged by the Investigation Lead, ideally within 35 working days.
The purpose of this meeting will be to agree and finalise the report and recommendations, identifying
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recommendation / action leads where possible. If an inquest is planned, the Trust Solicitors may be asked
to attend this meeting.
The group will review the outcome of the investigation and agree any further actions required in relation to:



e)
Review of final report to confirm accuracy of facts
Agree recommendations including system improvement where appropriate.
Review any performance/ capability concerns considered in line with HR procedures and NPSA
Incident decision tree (If the individual is a medical trainee this will be discussed further with the
Deanery).
Executive Director Review and Sign off
The final report, action plan and recommendations will be reviewed and formally signed off by the
Director of Safety and Governance / Director of Medical Safety, where possible within 45 working
days. The report and recommendations are then provided to the relevant PCTs via BENPCT.
e)
Actions Implementation, Monitoring and Closure
The Investigation Lead will be responsible for ensuring that:






The report is anonymised and does not contain the names of practitioners or patients. Person identifiers
must be documented separately.
A meeting has been offered to the patient / relative / carer for presentation of the report by the Incident
Investigation team;
The recommendations / action plan is forwarded to the PCT within 5 days of the report being signed off;
The recommendations / action plan is copied to the relevant Governance manager who will be
responsible for ensuring the monitoring of the action plan by Group Quality and Safety Committees.
Evidence and/or confirmation of completion of actions will be collected as appropriate.
An executive summary Closedown report is been prepared for Governance and Risk Committee, Trust
Board and other relevant Quality and Safety Committees.
The Senior Investigation Manager is provided with the relevant documentation to assist in any
complaint, coroner’s or claim’s process.
The Clinical Lead will be responsible for ensuring that:


A summary of the report is fed back to staff and other relevant individuals in the organisation;
A debrief of the staff / teams directly involved in the incident has been arranged.
Any ongoing risks identified in the final report will, where appropriate, be included on the SITREP Report
and any lessons learned will be disseminated by the Safety and Governance Directorate by way of the
Integrated Governance Reports and regular reports to Group Quality and Safety Committees.
5
Record Keeping
It is easy in the immediate aftermath of an incident to overlook the need to secure and preserve evidence.
This may be particularly true of busy clinical areas that are in constant use by patients and staff and when
people are following routine Trust operational practice.
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However, safeguarding physical, scientific and documentary evidence is critical to understanding what has
happened, thereby protecting public safety and ensuring the conduct of a satisfactory investigation. Advice
about the storage of evidence will be provided, as required, by the investigation lead.
Clear and factual records should be made by staff involved in the incident and by the investigation team
throughout the investigation process.
6
Communications
The Director of Corporate Affairs, in liaison with the Director of Safety and Governance or Director of
Medical Safety will assume responsibility for developing the communication strategy in relation to the SUI
when media attention has been attracted. They should ensure the relevant external stakeholders are made
aware of any media attention.
Patient(s) and Relatives
It is essential to work on the principle that the patient / relatives must know of the incident before the media
(although it is recognised that this is not always achievable). The incident must be communicated to the
family in line with the Trust’s Being Open Policy. The Investigation Lead should ensure that the family
receive updates, as required, on the progress of the investigation and arrange a meeting with them for
discussion of the final report.
Staff
Staff must be reminded of the issues of confidentiality and must not communicate with the media, unless
with the approval of Director of Medical Safety / Director of Safety & Governance.
Media
The Trust must expect that any SUI may result in a media interest. The Director of Corporate Affairs will
take responsibility for dealing with the press.
7
Staff support
Counselling and staff support via the Occupational Health Department and the external employee
assistance service must be offered to staff involved with the SUI, in line with the Trust ‘Supporting Staff
involved in Traumatic Events’. It is the responsibility of the Investigation lead to ensure that this has
happened. Further information relating to staff support is included in this Policy.
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Attachment 2: Examples of Serious Untoward Incidents as defined by the West
Midlands Strategic Health Authority
 The death of a person currently in receipt of NHS care where the death is suicide, as a result of a
homicide or is likely to be of public concern, e.g. of particular concern is any such death occurring on
NHS premises or potentially high profile patient suicides involving bridges and railway lines.
 Homicide or serious injury to a member of staff or patient (including independent contractors) in the
course of their duties or whilst on NHS premises.
 Death or serious injury to a child which results in a Part 8 review under the Children’s Act 1989 in which
health has a major role.
 Death leading to public concern or inquiry (including children, vulnerable and other adults).
 Staff actions that my lead to the involvement of the criminal justice system.
 Death resulting from violence/aggression.
Serious risk or injury
 Serious injury of a person currently in receipt of NHS care such as deliberate self harm, accidental injury
or injury inflicted by another person.
 Incidents which involve concerns regarding the actions of NHS staff (including independent contractors)
which is likely to lead to lead to the involvement of the criminal justice system e.g. fraudulent behaviour,
actions resulting in harm to patients.
 Any instance of staff or patients being poisoned in the course of receiving treatment or as a direct result
of NHS employment.
 Patients detained under the Mental Health Act 1983 who abscond from mental health/learning disability
services who present a serious risk to themselves and/or to others. Of particular concern are those
patients who abscond from medium secure or specialist forensic services, those who are likely to pose a
risk to the public, attract media attention and/or who commit an offence whilst at large.
 Serious injury to a vulnerable adult resulting in an inquiry.
Public Health
 Any incident involving serious outbreaks of infectious diseases in hospital or the wider community (e.g.
Food poisoning, MRSA etc).
 The transmission of infectious diseases from an NHS member of staff to a patient.
 Any incident involving blood borne viruses infected health care worker(s).
 The unplanned release of substances into the environment likely to cause a substantial hazard to the
public (e.g. toxic gas, infected clinical material etc.)
 Incidents involving the integrity/ effectiveness of population
screening programmes.
 Chemical or microbiological contamination.
 Systems failure regarding decontamination processes.
Corporate
 Any incident which is attracting media attention, is high profile or likely to be of public concern.
 Serious Fraud
 Removal of accreditation by an external body of major risk issues e.g. NHSLA, RPST.
 Actual or potential breaches of confidentiality involving loss of person identifiable data, including data
loss which could seriously impact on the persons concerned or could lead to identity fraud e.g. theft of
laptop, release of highly sensitive information (e.g. sexual health)
 A pattern emerging that is causing local concern such as a high number of complaints regarding a
member of staff, a particular service and/or hospital that may warrant further investigation and action.
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 Serious fire or other serious damage which occurs on health service premises, particularly if the fire
resulted in the death or serious injury of patients or staff and/or would result in the major disruption of
service provision.
 Any incident involving serious implications for patient or staff safety – involving potential as opposed to
actual risk to patients or staff.
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Attachment 3: Managing Serious Untoward Incidents Relating to Actual or Potential
Breaches of Confidentiality Involving Person Identifiable Data (P.I.D).
1. Introduction
The Trust will investigate all serious incidents concerning information governance issues to ensure that
lessons are learnt and the risk of reoccurrence is minimised. The process for investigation is similar to that
detailed in the Trust’s Serious Untoward Incident Policy as follows:






Scoping
Assessing grade
Initial reporting
Managing the incident
Investigating
Final reporting and lessons learnt
2. Definition of a Serious Untoward Incident in relation to Personal Identifiable Data
Department of Health4 guidance explains that there is no simple definition of a serious incident. What may at
first appear to be of minor importance may, on further investigation, be found to be serious and vice versa.
As a guide, any 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.
3. Assessing the Severity of the Incident
The immediate response to the incident and the escalation process for reporting and investigating this will
vary according to the severity of the incident.
Once we have determined that the incident is serious we should then grade the incident according to the
following table; an incident should be categorised at the highest level that applies when considering the
characteristics and risks of the incident.
0
1
2
3
4
5
No significant
reflection on any
individual or
body
Media interest
very unlikely
Minor breach of
confidentiality.
Only a single
individual
affected
Damage to an
individuals
reputation.
Possible media
interest, e.g.
celebrity involved
Potentially serious
breach. Less than
5 people affected
or risk assessed
as low, e.g. files
were encrypted
Damage to a
team’s reputation.
Some local media
interest that may
not go public
Damage to a
services
reputation/
Low key local
media coverage.
Damage to an
organisation’s
reputation/
Local media
coverage.
Damage to
NHS
reputation/
National media
coverage.
Serious potential
breach & risk
assessed high e.g.
unencrypted
clinical records
lost. Up to 20
people affected
Serious breach of
confidentiality
e.g. up to 100
people affected
Serious breach
with either
particular
sensitivity e.g.
sexual health
details, or up to
1000 people
affected
Serious breach
with potential
for ID theft or
over 1000
people affected
4. Reporting to external bodies.
4
Checklist for Reporting, Managing and Investigating Information Governance Serious Untoward Incidents (DoH)
2010
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If a SUI is classified as level 0 then the Trust may manage this locally and there is no requirement to report
externally.
If the SUI is classified as level 1-5 then the Trust will report the SUI to the PCT in line with the SUI reporting
policy
If the SUI is classified as level 3-5 then the Trust will also report to the Information Commissioner.
The decision to inform any other bodies will also be taken, dependent upon the circumstances of the
incident, e.g. where this involves risks to the personal safety of patients, the National Patient Safety Agency
(NPSA) may also need to be informed.
5. Informing Patients
Consideration should always be given to informing patients when person identifiable information about them
has been lost or inappropriately placed in the public domain. Where there is any risk of identity theft it is
strongly recommended that this done.
6. Publishing details of SUIs in annual reports and Statements of Internal Control Principles
The reporting of personal data related incidents in the Trust’s Annual Report should observe the principles
listed below. The principles support consistency in reporting standards across Organisations while allowing
for existing commitments in individual cases.
a) The Trust will ensure that information provided on personal data related incidents is complete, reliable
and accurate.
b) The Trust will review all public statements you have made, particularly in response to requests under the
Freedom of Information Act 2000, to ensure that coverage of personal data related incidents in your report
is consistent with any assurances given.
c) The Trust will consider whether the exemptions in the Freedom of Information Act 2000 or any other UK
information legislation apply to any details of a reported incident or whether the incident is unsuitable for
inclusion in the report for any other reason (for example, the incident is sub judice and therefore cannot be
reported publicly pending the outcome of legal proceedings).
d) The loss or theft of removable media (including laptops, removable discs, CDs, USB memory sticks,
PDAs and media card formats) upon which data has been encrypted to the approved standard, is not a
Serious Untoward Incident unless you have reason to believe that the protections have been broken or were
improperly applied.
6a. Content to be included in Annual Reports
Incidents classified at a severity rating of 3-5 are those that should be captured as Serious Untoward
Incidents and should be reported to the PCT and to the Information Commissioner. These incidents need to
be detailed individually in the annual report in the format provided as Table 1 below. All reported incidents
relating to the period in question should be reported, not just those that have been closed.
Table 1
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SUMMARY OF SERIOUS UNTOWARD INCIDENTS INVOLVING PERSONAL DATA AS
REPORTED TO THE INFORMATION COMMISSIONER’S OFFICE IN (year)
Date of incident
(month)
Nature of incident
Jan
Loss of inadequately
Name; address;
Individuals
protected electronic
NHS No
notified by
storage device
post
The Trust will continue to monitor and assess its information risks, in light
of the events noted above, in order to identify and address any
weaknesses and ensure continuous improvement of its systems.
The member of staff responsible for this incident has been dismissed.
Further action on
information risk
Nature of data
involved
Number of
people
potentially
affected
1,500
Notification
steps
Incidents classified at lower severity ratings
Incidents classified at a severity rating of 1-2 should be aggregated and reported in the annual report in the
format provided as Table 2 below.
Incidents rated at a severity rating of 0 need not be reflected in annual reports.
Table 2
SUMMARY OF OTHER PERSONAL DATA RELATED INCIDENTS IN 2007-08
Category
I
II
III
IV
V
Nature of incident
Loss/theft of inadequately protected electronic equipment, devices or paper
documents from secured NHS premises
Loss/theft of inadequately protected electronic equipment, devices or paper
documents from outside secured NHS premises
Insecure disposal of inadequately protected electronic equipment, devices or
paper documents
Unauthorised disclosure
Other
Total
SIC Guidance
It is important to remember that the Trust’s assets include information as well as more tangible parts of the
estate. Information may have limited financial value on the balance sheet but it must be managed
appropriately and securely. All information used for operational purposes and financial reporting purposes
needs to be encompassed and evidence maintained of effective information governance processes and
procedures with risk based and proportionate safeguards. Personal and other sensitive information clearly
require particularly strong safeguards.
The SIC should, in the description of the risk and control framework, explicitly include how risks to
information are being managed and controlled as part of this process. This can be done for example by
referencing specific work undertaken by your organisation and by reference to the Trust’s use of the
Information Governance Toolkit. The SIC will then be reflected formally in the Trust’s Annual report.
Any incidence of a Serious Untoward Incident should be reported in the SIC as a significant control issue.
For the avoidance of doubt these are those incidents with a severity rating of 3,4 or 5.
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Attachment 4: National Never Events
SURGICAL
1. Wrong site surgery
A surgical intervention performed on the wrong site (for example wrong knee, wrong eye, wrong patient,
wrong limb, or wrong organ) ; the incident is detected at any time after the start of the operation and the
patient requires further surgery, on the correct site, and/or may have complications following the wrong
surgery.



Includes biopsy, radiological procedures and drain insertion, where the intervention is considered
surgical.
Excludes wrong site anaesthetic block.
Excludes interventions where the wrong site is selected because of unknown/unexpected
abnormalities in the patients anatomy. This should be documented in the patients notes.
Setting: All healthcare premises.
Guidance:
- Safer Practice notice – Standardising Wristbands improves patient safety, 2007, available at
http://www.nrls.npsa.nhs.uk/resources/?entryid45=59824
- - Patient Safey Alert – WHO Surgical Safery Checklist, 2009, available at
http://www.nrls.npsa.nhs.uk/resources/clinical-specialty/surgery/
2. Wrong implant/prosthesis
Surgical placement of the wrong implant or prosthesis where the implant/prosthesis placed in the patient is
other than that specified in the operating plan either prior to or during the procedure. The incident is
detected at any time after the implant/prosthesis is placed in the patient and the patient requires further
surgery to replace the incorrect implant/prosthesis and/or suffers complications following the surgery.
 Excludes where the implant/prosthesis placed in the patient is intentionally different from the
operating plan, where this is based on clinical judgment at the time of the operation.
 Excludes where the implant/prosthesis placed in the patient is intentionally planned and placed but
later found to be suboptimal.
Setting: All healthcare premises.
Guidance:
Safer Practice notice – Standardising Wristbands improves patient safety 2007, available at
http://www.nrls.npsa.nhs.uk/resources/?entryid45=59824
- Patient Safey Alert – WHO Surgical Safery Checklist, 2009, available at
http://www.nrls.npsa.nhs.uk/resources/clinical-specialty/surgery/
- Safer Surgery checklist for Cataract Surgery 2009, available at
http://www.rcophth.ac.uk/core/core picker/download.asp?id=375
3. Retained foreign object post-operation
Unintended retention of a foreign object in a patient after surgical intervention, including interventional
radiology, cardiology and vaginal birth.

Includes swabs, needles, implants, fragments of screws, instruments and guidewires.

Excludes where any relevant objects are found to be missing prior to the completion of the surgical
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intervention and may be within the patient, but where further action to locate and/or retrieve would
be more damaging than retention, or impossible this must be documented in the patients notes and
the patient informed.
Settings: All healthcare premises.
Guidance:
- Standards and recommendations for safe perioperative practice, 2007, available at
http://www.afpp.org.uk/news/safe-practice-highlighted-in-new-afpp-publication
- Swab, instrument and needle counts: Managing the risk, 2005, available at
http://www.afpp.org.uk/filegrab/07Swabandinstrumentcount.pdf?ref=1040
- Patient Safety Alert – WHO Surgical Safety Checklist, 2009, available at
http://www.nrls.npsa.nhs.uk/resources/clinical-speciality/surgery/
MEDICATION EVENTS
4. Wrongly prepared high-risk injectable medication
Death or severe harm as a result of a wrongly prepared high-risk injectable medication.

High-risk injectable medicines are identified using the NPSA’s risk assessment tool.
A list of high-risk medicines has been prepared by the NHS Aseptic Pharmacy Services Group
using this tool*. Organisations should have their own list of high-risk medications for the purposes
of the “never event” policy, which may vary from the NHS Aseptic Pharmacy Services Group list,
depending on local circumstances.

A high risk injectable medicine is considered wrongly prepared if it was not;
o Prepared in accordance with the manufacturers specification of product characteristics;
o Prepared in accordance with a protocol formally agreed by the local organization (for
example, for off-label or unlicensed product use);
o Prepared in accordance with patient specific directions of a prescribver in an urgent or
emergency situation and supported by evidence or expert advice.
This event excludes any incidents that are covered by other “never events”.
Where death or severe harm cannot be attributed to incorrect preparation, treat as a Serious
Untoward Incident.


Settings: All healthcare premises.
Guidance:
Patient Safety Alert – Promoting safer use of injectable medicines, 2007, available at
http://www.nrls.npsa.nhs.uk/resources/patients-safety-topics/medication-safety/?entryid45=59812&p=4
*NPSA high risk medication risk assessment tool 2007, available at
http://www.nrls.npsa.nhs.uk/EasySiteWeb/getresource.axd?AssetD=60097&type=full&servicetype=Attach
ment
Pharmaceutical Aseptic Services Group. Example risk assessment of injectable medicines. 2007.
Available at http://www.civas.co.uk/
5. Maladministration of potassium-containing solutions
Death or severe harm as a result of maladministration of a potassium-containing solution.
Maladministration refers to;


Selection of strong* potassium solution instead of intended other medication
Wrong route administration, for example a solution intended for central venous catheter
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
administration given peripherally
Infusion at a rate greater than intended.
Settings: All healthcare premises.
Guidance:
Patient safety alert – Potassium chloride concentrate solutions, 2002 (updated 2003), available at
http://www.nrls.npsa.nhs.uk/resources/?entryid45=59882
- Standard Operating Protocol fact sheet; Managing Concentrated Injectable Medicines, part of the
WHO High 5’s project, available at https://www.high5s.org/bin/view/Main/WebHome
6. Wrong route administration of chemotherapy
Intravenous or other chemotherapy (for example, vincristine) that is correctly prescribed but
administered via the wrong route (usually into the intrathecal space).
Setting: All healthcare premises.
Guidance:
- HSC2008/001: Updated national guidance on the safe administration of intrathecal chemotherapy,
available at
http://www.dh.gov.uk/en/publicationsandstatistics/lettersandcirculars/healthservicecirculars/dh_08687
0
- Rapid Response Report NPSA/2008/RRR004 using vinca alkaloid minibags (adult/adolescent units),
available at http://www.nrls.npsa.nhs.uk/resources/?entryid45=59890
‡
≥10% potassium w/v (eg ≥ 0.1mg/ml potassium chloride, 1.3mmol/ml potassium chloride)
7. Wrong route administration of oral/enteral treatment
Death or severe harm as a result of oral/enteral medication, feed or flush administered by any
parenteral route.
Setting: All healthcare settings.
Guidance:
- Patient Safety Alert NPSA/2007/19 - Promoting safer measurement and administration of liquid
medicines via oral and other enteral routes, 2007, available at
http://www.nrls.npsa.nhs.uk/resources/?entryid45=59808
8. Intravenous administration of epidural medication
Death or severe harm as a result of intravenous administration of epidural medication.
 A broader “never event” covering intravenous administration of intrathecal medication or
intrathecal administration of intravenous medication is intended once the deadlines for Patient
Safety Alert 004A and B actions have passed.
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Setting: All healthcare premises.
Guidance:
- Patient Safety Alert NPSA/2007/21, Safer practice with epidural injections and infusions, available at
http://www.nrls.npsa.nhs.uk/resources/?entryid45=59807
- Safer spinal (intrathecal), epidural and regional devices - Parts A and B, available at
http://www.nrls.npsa.nhs.uk/resources/?EntryId45=94529
9. Maladministration of Insulin
Death or severe harm as a result of maladministration of insulin by a health professional.
Maladministration in this instance refers to when a health professional
 uses any abbreviation for the words ‘unit’ or ‘units’ when prescribing insulin in writing,
 issues an unclear or misinterpreted verbal instruction to a colleague,
 fails to use a specific insulin administration device e.g. an insulin syringe or insulin pen to draw
up or administer insulin, or
 fails to give insulin when correctly prescribed.
Setting: All healthcare settings.
Guidance:
- Rapid response report – Safer administration of insulin, 2010, available at
http://www.nrls.npsa.nhs.uk/alerts/?entryid45=74287
- NHS Diabetes – Safe use of insulin, 2010, available at
http://www.diabetes.nhs.uk/safe_use_of_insulin/
- NHSIII Toolkit – Think Glucose, 2008, available at www.institute.nhs.uk/thinkglucose
- NHS Diabetes guidance - The Hospital Management of Hypoglycaemia in Adults with Diabetes
Mellitus, 2010, available at
http://www.diabetes.org.uk/About_us/Our_Views/Care_recommendations/The-hospital-managementof-Hypoglycaemia-in-adults-with-Diabetes-Mellitus/
10. Overdose of midazolam during conscious sedation
Death or severe harm as a result of overdose of midazolam injection following use of high strength
midazolam (5mg/ml or 2mg/ml) for conscious sedation.
 Excludes areas where use of high strength midazolam is appropriate. These are specifically
only in general anaesthesia, intensive care, palliative care, or where its use has been formally
risk assessed.
 Excludes paediatric care.
Setting: All healthcare premises.
Guidance:
- Rapid Response Report - Reducing risk of overdose with midazolam injection in adults, 2008,
available at
http://www.nrls.npsa.nhs.uk/resources/patient-safety-topics/medication-safety/?entryid45=59896&p=2
- Guidelines for nursing care in interventional radiology, 2006, available at
http://www.rcr.ac.uk/docs/radiology/pdf/GuidelinesforNursing.pdf
- Safe sedation, analgesia and anaesthesia with the radiology department, 2003, available at
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http://www.rcr.ac.uk/publications.aspx?PageID=310&PublicationID=186
11. Opioid overdose of an opioid-naïve patient
Death or severe harm as a result of an overdose of an opioid given to a patient who was opioid naïve.
Specifically this means:



Where a dose is used that is not consistent with the dosing protocol agreed by the healthcare
organisation, or the manufacturer’s recommended dosage for opioid-naïve patients*.
Where the prescriber fails to ensure they were familiar with the therapeutic characteristics of
the opioid prescribed.
Excluded are cases where the patient was already receiving opioid medication.
Setting: All healthcare settings.
Guidance:
- Rapid Response Report – Reducing dosing errors with opioid medicines, 2008, available at
http://www.nrls.npsa.nhs.uk/resources/?entryid45=59888
- *Specific Product Characteristics available at www.medicines.org.uk
12. Inappropriate administration of daily oral methotrexate
Prescription, supply or administration of daily oral methotrexate to a patient for non-cancer treatment
including supply to the patient with the instruction to take daily.


Excludes cancer treatment with daily oral methotrexate
Excludes where the error is intercepted before the patient is supplied with the medication.
Setting: All healthcare settings.
Guidance:
- Patient safety alert - Improving compliance with oral methotrexate guidelines, 2006, available at
http://www.nrls.npsa.nhs.uk/resources/?entryid45=59800
MENTAL HEALTH
13. Suicide using non-collapsible rails
Death or severe harm to a mental health inpatient as a result of a suicide attempt using noncollapsible curtain or shower rails.
Setting: All mental health inpatient premises.
Guidance:
- NHSE SN (2002) 01: Cubicle rail suspension system with load release support systems, available at
http://www.dh.gov.uk/en/publicationsandstatistics/lettersandcirculars/estatesalerts/dh_4122863
- NHSE (2004) 10: Bed cubicle rails, shower curtain rails and curtain rails in psychiatric in-patients
settings, available at
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www.dh.gov.uk/en/publicationsandstatistics/lettersandcirculars/estatesalerts/dh_4119476
- Clinical guideline 16 – self-harm: the short term physical and psychological management and
prevention of self-harm in primary and secondary care, 2004, available at
www.nice.org.uk/guidance/CG16
- DH (2007)08: Cubicle curtain track rails (anti-ligature), available at
http://www.dh.gov.uk/en/publicationsandstatistics/lettersandcirculars/estatesalerts/dh_076400
14. Escape of a transferred prisoner
A patient who is a transferred prisoner escaping from medium or high secure mental health services
where they have been placed for treatment subject to Ministry of Justice restriction directions.
Setting: All medium and high secure mental health inpatient premises.
Guidance:
- Standards for medium secure units, 2007, available at
www.rcpsych.ac.uk/pdf/Final%20Standards%20for%20Medium%20Secure%20Units%20PDF.pdf
- Best Practice Guidance: Specification for adult medium-secure services, 2007, available at
http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_0
78744
GENERAL HEALTHCARE
15. Falls from unrestricted windows
Death or severe harm as a result of a patient falling from an unrestricted window.

Applies to windows “within reach” of patients. This means windows (including the window sill)
that are within reach of someone standing at floor level and that can be exited/fallen from
without needing to move furniture or use tools to assist in climbing out of the window. Includes
windows located in facilities/areas where healthcare is provided and where patients can and do
access.

Includes where patients deliberately or accidentally fall from a window where a restrictor has
been fitted but previously damaged or disabled, but does not include events where a patient
deliberately disables a restrictor or breaks the window immediately before the fall.
Setting: All healthcare premises.
Guidance:
- Health Technical Memorandum (HTM) 55: Windows, available via
http://www.spaceforhealth.nhs.uk/England/space-health
 - DH(2007)09 – Window restrictors, 2007, available at
http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/@dh/@en/documents/digitalas
set/dh_080164.pdf
17. Transfusion of ABO-incompatible blood components
Death or severe harm as a result of the inadvertent transfusion of ABO-incompatible blood
components.

Excludes where ABO-incompatible blood components are deliberately transfused with
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appropriate management.
Setting: All healthcare premises.
Guidance:
- Safer Practice Notice – Right Patient, Right Blood, 2006, available at
http://www.nrls.npsa.nhs.uk/resources/?entryid45=59805
- SHOT Lessons for clinical staff, 2007, available at http://www.shotuk.org/wpcontent/uploads/2010/03/SHOT-lessons-for-clinical-staff-website.pdf
- SHOT Lessons for Clinical Staff 2009, available at http://www.shotuk.org/wpcontent/uploads/2010/12/Lessons-for-Clinical-Staff-Dec-2010.pdf
18. Transplantation of ABO or HLA-incompatible organs
Death or severe harm as a result of inadvertent HLA (Human Leukocyte Antigen) or ABO antibodyincompatible solid organ transplantation, where the antibodies are of clinical significance.
 Excluded are scenarios in which clinically appropriate ABO and/or HLA incompatible solid
organs are transplanted deliberately.
 In this context, ‘incompatible’ antibodies must be clinically significant. If the recipient has donorspecific anti-ABO and/or anti-HLA antibodies and is therefore likely to have an immune reaction
to a specific ABO and/or HLA incompatible organ, then it would be a “never event” to transplant
that organ inadvertently and without appropriate management.
Setting: All healthcare premises.
Guidance:
- BSHI and BTS Guidelines for the Detection and Characterisation of Clinically Relevant Antibodies in
Allotransplantation, 2010, available at http://bts.demo.eibs.co.uk/transplantation/standards-andguidelines/- Antibody incompatible transplant guidelines, 2006, available at
http://bts.demo.eibs.co.uk/transplantation/standards-and-guidelines/Patient Safety Alert – WHO
Surgical Safety Checklist, 2009, available at http://www.nrls.npsa.nhs.uk/resources/clinicalspecialty/surgery/
19. Misplaced naso- or oro-gastric tubes
Death or severe harm as a result of a naso- or oro-gastric tube being misplaced in the respiratory
tract.
Setting: All healthcare premises.
Guidance:
- Patient safety alert – Reducing harm caused by misplaced nasogastric feeding tubes, 2005,
available at http://www.nrls.npsa.nhs.uk/resources/?entryid45=59794
- Patient safety alert – Reducing harm caused by misplaced naso and orogastric feeding tubes in
babies under the care of neonatal units, 2005, available at
http://www.nrls.npsa.nhs.uk/resources/?entryid45=59798&q=0%c2%acnasogastric%c2%ac
20. Wrong gas administered
Death or severe harm as a result of the administration of the wrong gas, or failure to administer any
gas, through a line designated for Medical Gas Pipeline Systems (MGPS) or through a line connected
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directly to a portable gas cylinder.
Setting: All healthcare premises.
Guidance:
- Health Technical Memorandum 02-01 parts A & B, 2006, available at
https://publications.spaceforhealth.nhs.uk/?option=com_documents&task=new_pubs&Itemid=1&regio
n=England
- Rapid Response Report - Oxygen Safety in Hospitals, 2009, available at
http://www.nrls.npsa.nhs.uk/resources/type/alerts/?entryid45=62811
- NHSE SN (2003) 02: Medical liquid oxygen supply systems, 2003, available at
http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/@dh/@en/documents/digitalasset/dh_
4121320.pdf
- NHSE SN (2003) 01: Oxygen cylinder manifolds used to supply oxygen for patient use, 2003,
available at
http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/@dh/@en/documents/digitalasset/dh_
4121317.pdf
- DH (2008) 06 - Medical air plant, 2008, available at
http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/@dh/@en/documents/digitalasset/dh_
087060.pdf
21. Failure to monitor and respond to oxygen saturation
Death or severe harm as a result of failure to monitor or respond to oxygen saturation levels in a
patient undergoing general or regional anaesthesia, or conscious sedation for a healthcare procedure
(e.g. endoscopy).
 Includes failure to physically have monitoring in place, and failure to act on relevant information
from monitoring oxygen saturation.
Excludes where action is taken in response to recorded adverse oxygen saturation levels, but this fails
to prevent death or severe harm for other reasons (e.g. pre-existing problems with oxygenation that
cannot be resolved).
 Excludes incidents where the accepted limitations of monitoring equipment mean that adverse
readings may be artefactual (e.g. shock/vasoconstriction).
Setting: All healthcare premises.
Guidance:
- Recommendations for the Standards of Monitoring During Anaesthesia and Recovery (4), 2007,
available at
http://www.aagbi.org/publications/guidelines/docs/standardsofmonitoring07.pdf
- Royal College of Anaesthetists, Guidance on the provision of anaesthetic care in the non-theatre
environment, revised 2010, available at
http://www.rcoa.ac.uk/docs/GPAS-ANTE.pdf
-British Society of Gastroenterology, Guidelines on safety and sedation during endoscopic
procedures, 2003, available at http://www.bsg.org.uk/clinical-guidelines/endoscopy/guidelines-onsafety-and-sedation-during-endoscopic-procedures.html
- Academy of Royal Medical Colleges, Implementing and ensuring safe sedation practice for
healthcare procedures in adults. Report of an intercollegiate working party chaired by the Royal
College of Anaesthetists, 2001, available at http://www.rcoa.ac.uk/docs/safesedationpractice.pdf
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22. Air embolism
Death or severe harm as a result of intravascular air embolism introduced during intravascular
infusion/bolus administration or through a haemodialysis circuit.
• Excludes the introduction of air emboli through other routes. This therefore excludes introduction via
surgical intervention (particularly Ear, Nose and Throat surgery and neurosurgery), during foam
scleropathy and during the insertion of a central venous catheter.
• Introduction of an air embolism after the insertion of a central venous catheter, through the line, and
during its removal, is included.
• Excludes where the introduction of the air embolism was caused by the actions of the patient.
Settings: All healthcare premises.
Guidance:
- Section 9.8 - Air Embolism, RCN; Standards for Infusion Therapy, 2010, available at
http://www.rcn.org.uk/__data/assets/pdf_file/0005/78593/002179.pdf
Avoidance of air embolism is part of basic training of clinicians, hence a lack of additional alerts to
date. However, this is to be the subject of a forthcoming evidence based guideline from the Society of
Acute Medicine. More information and basic instruction is available from the following medical texts;
- pp 366-372, Lippincott’s Nursing Procedures, Lippincott, Williams and Wilkins
- pp254-256, Clinical Dialysis, Nissenson AR and Fine RN
23. Misidentification of patients
Death or severe harm as a result of administration of the wrong treatment following inpatient
misidentification due to a failure to use standard wristband (or identity band) identification processes.
Failure to use standard wristband identification processes means;
• failure to use patient wristbands that meet the NPSA’s design requirements,
• failure to include the four core patient identifiers on wristbands – last name, first name, date of birth
and NHS number,
• failure to follow clear and consistent processes for producing, applying and checking patient
wristbands,
• printing several labels with patient details at one time.
This event excludes where the patient refuses to wear a wristband despite a clear explanation of the
risks of not doing so, or where it has been documented that the patient cannot wear a wristband due
to their clinical condition or treatment, or in emergency care environments where high patient turnover,
insufficient patient identity information, or the need for rapid treatment can delay wristband use.
Setting: All healthcare premises.
Guidance:
- Patient Identifiers for Identity Bands: Information standard; Information Standards Board for Health
and Social Care - DSCN 04/2009, March 2009, available at http://www.isb.nhs.uk/library/standard/175
- Safer Practice Notice – Standardising Wristbands improves patient safety, 2007, available at
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http://www.nrls.npsa.nhs.uk/resources/?entryid45=59824- Safer practice notice – Safer Patient
Identification, 2005, available at http://www.nrls.npsa.nhs.uk/resources/patient-safety-topics/patientadmission-transfer-
24. Severe scalding of patients
Death or severe harm as a result of a patient being scalded by water used for washing/bathing.
• Excludes scalds from water being used for purposes other than washing/bathing (eg from kettles)
Settings: All healthcare premises.
Guidance:
- Health Technical Memorandum 04-01 - The control of Legionella, hygiene, “safe” hot water, cold
water and drinking water systems, 2006, available from http://www.spaceforhealth.nhs.uk/
- Hospital Technical Memorandum HTM64 (Sanitary assemblies), 2006, available from
http://www.spaceforhealth.nhs.uk/
- NHS Model Engineering Specification D08 (Thermostatic Mixing Valves – healthcare premises),
1999, available from http://www.spaceforhealth.nhs.uk/
- Scalding risks from hot water in health and social care LAC: 79/5, 2007, available at
http://www.hse.gov.uk/lau/lacs/79-5.htm
MATERNITY
25. Maternal death due to post partum haemorrhage after elective caesarean section
In-hospital death of a mother as a result of haemorrhage following elective caesarean section.
• Excludes cases where placenta accreta is found, or where there is a pre-existing bleeding disorder,
or the mother refuses blood components for any reason.
• Excludes emergency caesarean section and where a scheduled elective caesarean section is
brought forward.
Setting: All healthcare premises.
Guidance
- The role of emergency and elective interventional radiology in postpartum haemorrhage, good
practice No. 6, 2007, available at http://www.rcog.org.uk/womens-health/clinical-guidance/roleemergency-and-elective-interventional-radiology-postpartum-haem
- Saving mothers’ lives: Reviewing maternal deaths to make motherhood safer – 2003-2005
2007, available at http://www.cemach.org.uk/Publications-Press-Releases/ReportPublications/Maternal-Mortality.aspx
- Patient Safety alert – WHO safer surgery checklist, 2009, available at
http://www.nrls.npsa.nhs.uk/resources/clinical-specialty/surgery/
- BCSH Guidelines on the Management of Massive Blood Loss, 2006, available at
http://www.bcshguidelines.com/documents/massive_bloodloss_bjh_2006.pdf
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References
1
National Patient Safety Agency, ‘Never Events – Framework: Update for 2010-11’, March 2010.
Available at http://www.nrls.npsa.nhs.uk/resources/?entryid45=68518
2
Department of Health, ‘Equity and Excellence: Liberating the NHS’, July 2010. Available at
http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_11
7353
3
National Patient Safety Agency, Never Events Annual Report 2009/10, October 2010, available at
http://www.nrls.npsa.nhs.uk/resources/collections/never-events/?entryid45=83319
4
National Patient Safety Agency, ‘Seven Steps to Patient Safety; The Full Reference Guide, second
print, August 2004, available at http://www.nrls.npsa.nhs.uk/resources/collections/seven-steps-topatient-safety/
5
National Patient Safety Agency, ‘Being Open: communicating patient safety incidents with patients,
their families and carers’, November 2009, available at
http://www.nrls.npsa.nhs.uk/resources/?EntryId45=83726
6
Care Quality Commission, Essential Standards of Quality and Safety, March 2010, available at
http://www.cqc.org.uk/_db/_documents/Essential_standards_of_quality_and_safety_March_2010_FINA
L.pdf
7
National Patient Safety Agency, National Framework for Reporting and Learning from Serious
Incidents Requiring Investigation, March 2010, available at
http://www.nrls.npsa.nhs.uk/resources/?entryid45=75173
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Attachment 5: Serious Untoward Incident Statement Template (or Electronic Pro-Forma)
Name of Patient (If appropriate)
Patient’s Date of Birth
PID No:
Date of Incident
Full Name of Person Providing
Statement
Department
Hospital And Address
GMC Number/ Professional
Registration Number
Professional Qualifications
(including Year(s) obtained and an
explanation of any abbreviations
Include Relevant Training /
Experience
Current Position and number of
years in post
Your position at time of the
incident
(Include copy of CV if available)
Chronological narrative of your involvement in the incident (as set out in item 4 of guidance)
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Statement of Truth:
I believe that the facts stated in this statement are true
Signed (Full name)
………………………………………….
Date
……….…………………………………
Contact Details
………………………………………….
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Attachment 6: SUI Report – Pro-Forma Guidance
The SUI Report should contain the following information:
1.
Introduction
This
section should contain the date, time, and location of the incident and some generic information
about the area in which the incident occurred. It should also provide a brief summary of procedures
or protocols within the area which may be relevant to the inquiry.
2.
Aim
This section defines the purpose and the method of the investigation
3.
Outline of Events
Within this section a brief summary of the incident should be documented. This provides an overview
of the principle events and helps to formulate an indication of the issues involved.
From this a list of key staff involved should be identified and a decision taken as to who should
provide statements or be interviewed and in what order to see them.
4.
Chronology of Events
The first step in the analysis of the incident is to produce a chronology of events. This is simply an
agreed history of events in which you should identify any deviations between accounts or
recollections of the staff involved and the documented notes. It is also useful to identify any
documentation issues such as illegible signatures, absence of dates, contradictions within the
documentation etc.
5.
Findings
Explain the investigation findings in this section. The root cause analysis should be attached as an
appendix to the report. Summarise your findings under the specific contributory factors or in
chronological order to make it easy for the reader to follow.
The summaries should also highlight any risk reduction strategies already implemented/ being
considered for implementation as a result of the root cause analysis.
6.
Conclusions
It may not be possible or appropriate to write conclusions for all SUI reports. They may be included
where it is helpful to summarise the overall findings for the reader.
7.
Recommendations
Summarise the inquiry recommendations and develop this into an action plan with a defined
timeframe for implementation and identified individuals to carry out the actions. The actions should
focus on delivering realistic and sustainable solutions in order to successfully implement the
recommendations and learning from the incident
8.
Appendix
All statements, reports, protocol, letters etc should be in an appendix at the end of the report and
referred to within the main report if necessary.
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Attachment 7: Communications with External organisations
1. Involvement of the Police or Health & Safety Executive
The Department of Health has released a document “A Memorandum of Understanding: Investigating
patient safety incidents involving unexpected death or serious untoward harm” which should be followed
where there is concern that a SUI may require the involvement of the police or Health & Safety Executive
(HSE).
The following paragraphs illustrate the early stages that should be followed in such an incident and are not
intended to be a full appraisal of the Memorandum of Understanding.
The types of patient safety incident that may prompt the involvement of the police or HSE are those that
display one or more of the following characteristics:



Evidence or suspicion that the actions leading to harm were intended.
Evidence or suspicion that adverse consequences were intended.
Evidence or suspicion of gross negligence and/or recklessness in a serious safety incident,
including as a result of failure to follow safe practice, procedures or policies.
Once such a decision has been taken to involve external agencies, representatives of the Trust, police and,
where appropriate HSE, 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,
but responsibility for organising the meeting rests with the Trust. Until the first meeting of the Incident
Coordination Group, the Trust 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 HSE. If
in doubt about this matter, the Trust should seek legal advice and consult the police, the HSE or where
appropriate, other investigating bodies. It is also critical that any relevant physical, scientific and
documentary evidence is secured and preserved.
The purpose of the Incident Coordination Group is to provide strategic oversight of a patient safety incident
involving the NHS and the police and/or HSE. It is a forum for communicating, exchanging information and
coordinating multiple investigations. It allows all three organisations to set out their needs so that actions
can be agreed that do not prejudice the work of each organisation e.g. legal proceedings, or the phasing,
extent and timing of further NHS investigations.
Those who attend on behalf of the three organisations should be sufficiently senior to take decisions
concerning the management of the incident. They must also have sufficient skills, experience and training to
deal with any immediate concerns. Police representation should normally be an accredited senior
investigating officer at the level of inspector or above. HSE representation will normally be at main grade
inspector level. NHS representation will normally be at executive director level. In instances of suspicious
death, the Incident Coordination Group may ask the coroner if he or she wishes to send a representative to
the meeting, in addition to the police. In instances of the unexpected death of a child where an investigation
under child protection procedures might be appropriate, the Incident Coordination Group may want to ask
children’s social services if they want to send a representative to the meeting. The NHS should chair the
first meeting of the group unless the circumstances preclude this.
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2.
Involvement of Other Outside Agencies
The Director of Governance and Standards will decide which other organisations need to be informed, and
will include:





Incidents relating to medical devices which may need to be reported to the MHRA (Medicines
and Healthcare products Regulatory Agency)
Incidents leading to a death which should be reported to the Coroner
Incidents which are likely to lead to a clinical negligence claim which should be reported to the
NHS Litigation Authority
incidents/accidents to staff or the public including deaths, major injuries, accidents resulting in
over 3 day injury, diseases, dangerous occurrences, gas incidents which should be reported to
the Health & Safety Executive under Reporting of Injuries, Diseases and Dangerous
Occurrences Regulations (RIDDOR) regulations.
Incidents reportable to the National Patient Safety Agency. All incidents are uploaded regularly
to the NPSA from the Trust Risk Management Database however certain incidents may require
immediate notification.
Incidents related to staff performance which may be reportable to the General Medical Council, Nursing and
Midwifery Council or Other Professional Bodies. Any such referral will be undertaken in line with guidance
from the appropriate Medical or Nursing Director or equivalent and with regard to the National Patient Safety
Incident Decision Tree and, where appropriate, advice from the Human Resources Department Reporting of
the above incident types to external agencies will be undertaken by the Healthcare Governance Directorate
who have established links with the above agencies and will determine whether reporting is required before
liaising with the appropriate agency.
Referral to professional bodies should be taken by the Medical or Nursing Director.
SUIs requiring investigation by the Police should not be subject to investigation within the Trust until the
Police have given clearance to initiate an internal investigation.
SUIs should not be subject to investigation within the Trust until the Police have given clearance to initiate
an internal investigation. If the police are involved, accommodation and telephone facilities will be provided.
©Heart of England NHS Foundation Trust
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Attachment 8: Equality and Diversity - Policy Screening Checklist
Policy/Service Title: Serious Untoward Incident (SUI) Policy
Directorate: Healthcare
Governance
Name of person/s auditing/developing/authoring a policy/service: Investigations Manager
Aims/Objectives of policy/service:
Policy Content:

For each of the following check the policy/service is sensitive to people of different age, ethnicity, gender,
disability, religion or belief, and sexual orientation?

The checklists below will help you to see any strengths and/or highlight improvements required to ensure that
the policy/service is compliant with equality legislation.
1. Check for DIRECT discrimination against any group of SERVICE USERS:
Question: Does your policy/service contain any
statements/functions which may exclude people
from using the services who otherwise meet the
criteria under the grounds of:
1.1
Age?
1.2
Gender (Male, Female and Transsexual)?
1.3
Disability?
1.4
Race or Ethnicity?
1.5
Religious, Spiritual belief (including other belief)?
1.6
Sexual Orientation?
1.7
Human Rights: Freedom of Information/Data
Protection
Response
Yes
Action
required
No
Yes
No
Resource
implication
Yes
No
x
x
x
x
x
x
x
If yes is answered to any of the above items the policy/service may be considered discriminatory and
requires review and further work to ensure compliance with legislation.
2. Check for INDIRECT discrimination against any group of SERVICE USERS:
Question: Does your policy/service contain any
statements/functions which may exclude employees
from operating the under the grounds of:
2.1
Age?
2.2
Gender (Male, Female and Transsexual)?
2.3
Disability?
2.4
Race or Ethnicity?
2.5
Religious, Spiritual belief (including other belief)?
2.6
Sexual Orientation?
2.7
Human Rights: Freedom of Information/Data
Protection
Response
Yes
Action
required
No
Yes
No
Resource
implication
Yes
No
x
x
x
x
x
x
x
If yes is answered to any of the above items the policy/service may be considered discriminatory and
requires review and further work to ensure compliance with legislation.
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TOTAL NUMBER OF ITEMS ANSWERED ‘YES’ INDICATING DIRECT DISCRIMINATION = 0
3. Check for DIRECT discrimination against any group relating to EMPLOYEES:
Question: Does your policy/service contain any
conditions or requirements which are applied
equally to everyone, but disadvantage particular
persons’ because they cannot comply due to:
3.1
Age?
3.2
Gender (Male, Female and Transsexual)?
3.3
Disability?
3.4
Race or Ethnicity?
3.5
Religious, Spiritual belief (including other belief)?
3.6
Sexual Orientation?
3.7
Human Rights: Freedom of Information/Data
Protection
Response
Yes
Action
required
No
Yes
Resource
implication
No
Yes
No
x
x
x
x
x
x
x
If yes is answered to any of the above items the policy/service may be considered discriminatory and
requires review and further work to ensure compliance with legislation.
4. Check for INDIRECT discrimination against any group relating to EMPLOYEES:
Question: Does your policy/service contain any
statements which may exclude employees from
operating the under the grounds of:
4.1
Age?
4.2
Gender (Male, Female and Transsexual)?
4.3
Disability?
4.4
Race or Ethnicity?
4.5
Religious, Spiritual belief (including other belief)?
4.6
Sexual Orientation?
4.7
Human Rights: Freedom of Information/Data
Protection
Response
Yes
Action
required
No
Yes
Resource
implication
No
Yes
No
x
x
x
x
x
x
x
If yes is answered to any of the above items the policy/service may be considered discriminatory and
requires review and further work to ensure compliance with legislation.
TOTAL NUMBER OF ITEMS ANSWERED ‘YES’ INDICATING INDIRECT DISCRIMINATION = 0
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Attachment 9: Approval/Ratification Checklist
Title
Serious Untoward Incident policy
Ratification checklist
Details
1
2
Is this a: Policy
Is this: Revised
3*
Format matches Policies and Procedures
Template (Organisation-wide)
Consultation with range of internal /external
groups/ individuals
Equality Impact Assessment completed
Yes
Are there any governance or risk implications?
(e.g. patient safety, clinical effectiveness,
compliance with or deviation from National
guidance or legislation etc)
Are there any operational implications?
Are there any educational or training
implications?
Are there any clinical implications?
Are there any nursing implications?
Does the document have financial
implications?
Does the document have HR implications?
No
4*
5*
6
7
8
9
10
11
12
13*
14*
Group Medical Directors, Head Nurses
Yes
No
Is there a
launch/communication/implementation plan
within the document?
Is there a monitoring plan within the document?
15*
Does the document have a review date in line
with the Policies and Procedures Framework?
Yes
16*
Is there a named Director responsible for
review of the document?
Is there a named committee with clearly stated
responsibility for approval monitoring and
review of the document?
Yes
17*
Governance & Risk Committee
Document Author / Sponsor
Signed ……………………… ………….…………
Title…………………………………………………
Date…………………….………….………….……
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Approved by (Chair of Trust Committee or Executive Lead)
Signed ……………………… ………….…………
Title…………………………………………………
Date…………………….………….………….……
Ratified by (Chair of Trust Committee or Executive Lead)
Signed ……………………… ………….…………
Title…………………………………………………
Date…………………….………….………….……
©Heart of England NHS Foundation Trust
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Attachment 10: Launch and Implementation Plan
To be completed and attached to any document which guides practice when submitted to the
appropriate committee for consideration and approval.
Action
Identify key users / policy
writers
Present Policy to key user
groups
Add to Policies and
Procedures intranet page /
document management
system.
Offer awareness training /
incorporate within existing
training programmes
Circulation of
document(paper)
Circulation of
document(electronic)
Who
When
How