An Organisation-wide Document for the Investigation of Incidents, Complaints and Claims
NHS Trust
An Organisation-wide Document for the Investigation
of Incidents, Complaints and Claims
Version:
Ratified by:
Date ratified:
Name of originator/author:
Name of responsible committee/individual:
Name of executive lead:
Date issued:
Review date:
Target audience:
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An Organisation-wide Document for the Investigation of Incidents, Complaints and Claims
Contents
1
Introduction ............................................................................................................. 5
2
Purpose .................................................................................................................... 5
3
Explanation of Terms ............................................................................................... 5
4
Duties ....................................................................................................................... 5
4.1
4.2
4.3
5
Duties within the Organisation ............................................................................................... 5
Committees and Groups with Overarching Responsibilities .................................................. 6
Links Between the Management of Incidents, Complaints and Claims .................................. 7
Key Issues ................................................................................................................. 7
5.1
5.2
5.3
5.4
Why is Investigation Necessary?............................................................................................. 7
The Importance of Learning from Adverse Events and Sharing Safety Lessons ..................... 7
The Need for Effective Communication .................................................................................. 7
Support for Patients, Carers, Relatives and Staff .................................................................... 8
6
Staff Training ............................................................................................................ 8
7
Investigation and Root Cause Analysis .................................................................... 8
7.1
7.2
7.3
7.4
7.5
7.6
7.7
7.8
8
Identifying which Incidents, Complaints and Claims need to be Investigated ....................... 8
Investigation Process .............................................................................................................. 8
Gathering the Information ...................................................................................................... 9
Mapping the Events ................................................................................................................ 9
Analysing the Information ...................................................................................................... 9
Barrier Analysis ..................................................................................................................... 10
Developing Solutions and an Action Plan for Implementation............................................. 10
Completing a Report ............................................................................................................. 10
Performance Management and Data Collection ................................................... 11
8.1
9
Reports to the Nominated Committee and the Board ......................................................... 11
Learning from Experience ...................................................................................... 11
10
Equality Impact Assessment ............................................................................... 12
11
Monitoring Compliance with the Document ..................................................... 12
11.1
11.2
12
12.1
12.2
13
Process for Monitoring Compliance ..................................................................................... 12
Standards/Key Performance Indicators ................................................................................ 12
References .......................................................................................................... 12
Legislation ............................................................................................................................. 13
Guidance from Other Organisations ..................................................................................... 13
Associated Documentation ................................................................................ 14
Appendix A - Investigation Report Template ............................................................... 15
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An Organisation-wide Document for the Investigation of Incidents, Complaints and Claims
Appendix B - Flowchart Illustrating Stages of Investigation ........................................ 24
Appendix C - Root Cause Analysis Tools ....................................................................... 24
Appendix D - Template Document for the Investigation of Incidents, Complaints and
Claims............................................................................................................................ 25
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An Organisation-wide Document for the Investigation of Incidents, Complaints and Claims
Review and Amendment Log
Version no.
Type of change
Date
Description of change
V.5
Annual review
Mar 2011
Update to section 12 ‘References’
V.5
Amendment
Mar 2011
Addition of amendment log
Addition of example of definition
Addition of examples of associated documents
V.6
Annual review
Mar 2012
Update to section 1 ‘Introduction’
Update to section 5 ‘Key Issues’
Update to section 4 ‘Duties’
V.6
Amendment
Mar 2012
Change to format
contents page
including
automated
Please Note the Intention of this Document
This document has been developed with the aim of providing a model document template. However,
any documentation subsequently produced must follow its own rules and include details of all the
requirements set out in sections 1-13, where relevant. The organisation may use this template and
adapt it to reflect procedures within the organisation or alternatively use a document already in
existence. Whichever approach is used the organisation must ensure it is compliant with the minimum
requirements of the relevant National Health Service Litigation Authority (NHSLA) Risk Management
Standards.
a
To assist the organisation, areas have been identified in the margins where the section within
the template document relates to the minimum requirements for the criterion in the relevant
NHSLA Risk Management Standards.
It is important that the document should follow any pre-existing guidance within the organisation in
relation to style and format of documentation. Please note that a template document entitled An
Organisation-wide Document for the Development and Management of Procedural Documents can be
found on the NHSLA website which may provide the organisation with additional guidance.
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An Organisation-wide Document for the Investigation of Incidents, Complaints and Claims
1
Introduction
This section could give an overview of the importance of effective incident investigation. It
should introduce the need to learn from adverse incidents, complaints and claims in order to
improve safety within the organisation. This section should introduce the use of root cause
analysis within the organisation and explain how this analysis is a systematic investigation
technique that looks beyond the individuals concerned and seeks to understand the
underlying causes.
The investigation of incidents, complaints and claims data will follow on from the process
described in the organisation’s document for the reporting and management of incidents,
complaints and claims, and will lead into the document for the analysis of and making
improvements following incidents, complaints and claims. (Template documents for these
stages of the process are available on the NHSLA website).
2
Purpose
This section could give an explanation of the purpose of the document, including the
rationale for development. This section should illustrate the importance of looking for the
underlying causes of incidents, complaints and claims, and how the organisation intends to
learn from them in order to ensure that they are not repeated.
3
Explanation of Terms
This section should list and describe the meaning of the terms used in the context of the
document if considered necessary.

Root cause analysis
A way of conducting an investigation into an identified problem that allows the
investigator(s), and other involved parties, to understand better the root, or fundamental,
cause of the problem so that it can be put right.
The following list is a guide only and is not exhaustive:
a
4

Investigation

External agency
Duties
Give a brief overview of the roles, responsibilities and accountabilities for the
implementation of the organisation’s process. This section should be a brief overview only
and the details of the process for managing this should be incorporated within later sections
of the document. The following list is a guide only and is not exhaustive:
4.1
Duties within the Organisation
Some example responsibilities have been identified below; however, these should
be considered within the context of the individual organisational structure.
Chief Executive
This section should state that the chief executive is ultimately accountable for the
implementation of this organisation-wide process.
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Senior Management
This section will introduce the senior manager/management team and their role in
providing help and support to all staff that investigate and respond to incidents,
complaints and claims. This section should also describe how they will monitor the
quality and effectiveness of the investigation process.
Investigating Manager/Team
This section will expand on who within the organisation will be responsible for an
investigation and when. Different severities of incident, complaint or claim, will
require differing levels of investigation; this section should include how the
responsibility for investigation may be delegated.
Role of Clinicians/Specialist Advisors
This section should detail:

how and when other individuals should be involved in the investigation
process;

how and when the organisation will involve the clinical staff; and

how and when the organisation utilises specialist advisors, etc.
All Staff
This section should describe how all individuals have a responsibility to highlight any
risk issues which could warrant further investigation. Staff should be fully open and
cooperative with any investigation process.
4.2
Committees and Groups with Overarching Responsibilities
Trust Board
For effective implementation of the Organisation-wide Document for the
Investigation of Incidents, Complaints and Claims there must be active support from
the most senior members of the organisation. Organisations should detail how the
chief executive and the nominated directors are to gain assurance that this
document is being implemented within the organisation. There must be effective
cooperation at all levels of the organisation in order for this process to be successful.
Committee with Responsibility for Investigations
This section should identify the committee/group which will have overall
responsibility for the management of investigations. The section should include:
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
how this committee/group links with all the other relevant risk management
committees;

the role this committee/group has with ensuring continuous development of
this document;

the role the committee/group has in the analysis of causal factors;
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An Organisation-wide Document for the Investigation of Incidents, Complaints and Claims

how this committee/group communicates both up to board level, and down
to the local management levels;

the role the committee/group has with regard to the continuous monitoring
of the completion of action plans;

how the committee/group facilitates organisational
improvement as a result of effective investigations; and

how the committee/group ensures continuous sustainability of risk
reduction measures.
learning
and
It would be considered good practice if the organisation developed terms of
reference for this committee/group including accountability, responsibility,
authority, membership (including identified co-opted members and deputies)
meeting schedule and quorum, etc. In addition the terms of reference should be
dated and signed.
4.3
Links Between the Management of Incidents, Complaints and Claims
This section should expand on how the organisation ensures an effective interface
between claims handling, complaints management and incident reporting. All these
elements are important risk identification tools for the organisation and in order to
ensure effective risk management there need to be robust communication chains.
Close liaison is necessary to avoid duplication. It is suggested that all relevant
procedures are closely coordinated.
5
Key Issues
5.1
Why is Investigation Necessary?
This section should explain that investigations are necessary to provide a
retrospective review of an event in order to identify what, how, and why it
happened. The analysis should then be used to identify areas for change,
recommendations and sustainable solutions, to help minimise recurrence in the
future.
5.2
The Importance of Learning from Adverse Events and Sharing Safety Lessons
This section should explain that learning from experience is critical to the delivery of
safe and effective services in the NHS. To avoid repeat mistakes, organisations need
to recognise and learn from them and to ensure that lessons are communicated and
plans for improving safety are formulated and acted upon. This section should
clearly cross reference other supporting and related documents, for example the
organisation’s document for analysis and improvement following incidents,
complaints and claims.
5.3
The Need for Effective Communication
Organisations should describe within this section how they plan to engage with
patients and staff during the course of an investigation in an open and honest
manner. This section should describe who within the organisation is responsible for
this communication and when it should take place. Organisations should also
illustrate how they intend to communicate with staff involved, both directly and
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indirectly, and state the importance of documenting all discussions. This section
may cross reference to the organisation’s document covering the principles of ‘Being
open’.
5.4
Support for Patients, Carers, Relatives and Staff
Being involved in an incident, complaint or claim which is under investigation can be
an incredibly stressful experience. The organisation should illustrate how it will
endeavour to support patients, carers, relatives and staff during this difficult time.
These mechanisms need to follow the principles of ‘being open’ and this information
could be included within this document along with a description of the process for
ensuring that all staff involved in traumatic/stressful incidents, complaints or claims
are adequately supported. Alternatively the organisation could include a clear cross
reference to the organisation’s documents covering the principles of ‘Being open’
and support for staff.
b
6
Staff Training
This section should describe the process for investigation and/or root cause analysis training
which should enable staff of all levels to undertake or participate in the investigation of
incidents, complaints and claims.
It is expected that each organisation will provide sufficient and appropriate investigation
training for each of the identified staff groups, appropriate to grade and job role, and should
take into consideration both local and national guidelines. This section could crossreference to the organisation’s training needs analysis.
c
7
Investigation and Root Cause Analysis
7.1
Identifying which Incidents, Complaints and Claims need to be Investigated
The organisation may not have the resources to conduct detailed investigations into
each and every incident, complaint or claim; therefore there will have to be a
‘sifting’ process to decide which will be fully investigated. This section should
explain how the severity of an event and the corresponding investigation are
determined. The level of authority of managers in terms of risk grade, to undertake
an investigation, should also be explained and linked to the risk matrix used within
the organisation.
There are two main considerations when making this decision:
7.2

the level of severity of harm to the patient/carer/relative or staff member;
and

the potential for learning (which could include investigating those incidents,
complaints or claims which are high frequency, but are of low severity).
Investigation Process
This section should describe the investigation process. The investigation method of
choice for NHS organisations is Root Cause Analysis (RCA). This section should
outline how to conduct a root cause analysis investigation following an incident,
complaint or claim. It should introduce the concept of looking past immediate
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causes or active failures, and digging deeper for the underlying or latent failures to
identify causal factors and remedial actions.
This section could include cross references to the organisational documents relating
to ‘being open’ and support for staff.
This section should identify the process for the:

appointment of an investigating manager;

identification of people to be interviewed;

conducting interviews;

timescales for feedback to interested parties (for example: claims manager,
claimant and all those involved in any allegations);

involvement of any external agencies;

development of action plans including timescales; and

debriefing staff.
The organisation should consider and list the circumstances in which external
agencies such as enforcing agencies, external stakeholders, external advisors, etc.
might need to be informed and/or involved in investigations. Third party
investigation could be required if there is: insufficient expertise or test equipment
within the organisation, political considerations, the need to eliminate bias, etc.
7.3
Gathering the Information
This section should describe the importance of gathering factual information as soon
as possible following an incident, complaint or claim. Organisations should include
within this section what sort of information should be collected. Some information
may need to be collected as soon as possible after the event, whilst other pieces
may take longer to obtain. Preservation of a scene should occur, where relevant
and practical.
7.4
Mapping the Events
This section should explain the mapping process after all the basic data surrounding
an incident, complaint or claim, has been collected. Organisations may decide that
this mapping will involve a multidisciplinary team, including those who were directly
involved. Such a mapping exercise may need an experienced facilitator, whose role
would be to ensure that all those involved can make a full and honest contribution in
a non-threatening environment.
Timelines may also be a useful tool for mapping and tracking a chronological chain
of events, they will also allow the investigator to identify any information gaps and
any critical problems that arose.
7.5
Analysing the Information
Once the information has been gathered and mapped the organisation should
endeavour to conduct an analysis which will determine the underlying causes and
lessons that can be learned.
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There are a number of analysis tools which can be used. The following list is a guide
only and is not exhaustive:
7.6

fishbone and spider diagrams;

five whys;

brainstorming; and

nominal group technique.
Barrier Analysis
A barrier is a defence or control measure to prevent harm. In healthcare a barrier
can either be an obstruction (for example, a locked controlled drug cupboard) or a
preventative action (for example, a checklist). Barriers can be:
e
7.7

physical barriers;

natural barriers;

human action barriers; and

administrative barriers.
Developing Solutions and an Action Plan for Implementation
This section should describe how the organisation decides which results from the
investigation of incidents, complaints and claims needs to be ‘active’. Any changes
made need to be incorporated into the way staff work at all levels of the
organisation, and should be sustainable in nature. Organisations should ensure that
solution risk reduction measures are:

realistic;

sustainable; and

cost effective.
These measures should be reviewed by staff (and if possible patients and the public)
before implementation to ensure that they will be achievable in practice. This
section should include how the organisation intends to move forward from a passive
learning organisation (where lessons are identified, but not put into practice) to an
active learning organisation (where lessons learnt are embedded into an
organisation’s culture and practice), through proactive, systematic follow up. This
section may cross-reference to the organisation’s document for analysis and
improvement following incidents, complaints and claims.
7.8
Completing a Report
Root cause analysis concludes with an investigation report. All root cause analysis
reports and recommendations should be monitored by the relevant committee, and
the board need to be assured that remedial actions are being taken. Organisations
may use the report template adapted from the NPSA document: Root Cause Analysis
Investigation Tools. Guide to investigation report writing following Root Cause
Analysis of patient safety incidents (2008) at Appendix A.
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8
Performance Management and Data Collection
This section should include how often causal factor analysis should take place, which
committees the information will be submitted to, and how this information ultimately
informs the board. This analysis should be both qualitative and quantitative in nature, and
discuss any trends that have been identified as a result of investigations. Reports should
expand from the purely statistical and document aggregated trends and themes, identified
causal factors, and any subsequent changes in practice. This section may cross-reference to
the organisation’s document for analysis and improvement following incidents, complaints
and claims.
8.1
Reports to the Nominated Committee and the Board
This section should describe the process for informing the nominated committee
and the board of causal factor analysis. Organisations should consider and
document how this information will be presented; who will have responsibility for
completing this; and how often reporting will occur. The impact of action plans and
subsequent risk reduction measures should be measured over time in order to
illustrate that they have not led to the transfer of risk, or that they are becoming
unsustainable.
d
9
Learning from Experience
This section should clearly detail how the organisation intends to share the trends, themes
and lessons learnt post investigation; how this communication will be cascaded throughout
the organisation and across the wider health community, including the public and external
stakeholders; and how the organisation will be assured that this good practice is adopted at
a local level. This should include:

organisational sharing of lessons learnt;

local implementation of action plans;

links with all other areas of risk management within the organisation; and

identification of organisational or clinical risks which should be added to the risk
register.
Organisations may also need to provide information and reports on root cause analysis
trends, themes, outcomes and learning actions to external bodies such as:
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
commissioning bodies for incidents that fall under the Never Events Framework
(NPSA 2009);

Coroners Rule 43 - where an inquest is being held into a person’s death, the
evidence gives rise to a concern that circumstances creating a risk of other deaths
will occur or continue to exist in the future and in the coroner’s opinion, action
should be taken to prevent an event from occurring (Ministry of Justice 2008);

commissioning bodies for complaints under the Health and Social Care Act 2008;
and

the STEIS Reporting Systems from SHAs.
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It would also be good practice to share the root cause analysis trends, themes, outcomes
and learning actions with the wider public. This could be achieved by including an annual
trend and theme update within the organisation’s annual report.
Organisations should consider and document the processes for dealing with the above or
should include a cross reference to other relevant documents.
10
Equality Impact Assessment
The organisation should identify who will undertake the Equality Impact Assessment which is
required to consider the needs and assess the impact of this document in accordance with
the Organisation-wide Document for the Development and Management of Procedural
Documents. The Equality Impact Assessment Tool found at Appendix E of the Organisationwide Document for the Development and Management of Procedural Documents could be
completed and form part of the body of the document, but as a minimum a statement
should be included within the document to demonstrate that an Equality Impact Assessment
has been carried out and that the document does not discriminate, highlighting any areas of
good practice or risk areas requiring attention.
f
11
Monitoring Compliance with the Document
11.1
Process for Monitoring Compliance
This section should identify how the organisation plans to monitor compliance with
the Organisation-wide Document for the Investigation of Incidents, Complaints and
Claims. As a minimum it should include the review/monitoring of all the minimum
requirements within the NHSLA Risk Management Standards. The following list is a
guide to issues which could be considered within this section and should be added
to where appropriate:
11.2

Who will perform the monitoring?

When will the monitoring be performed?

How are you going to monitor?

What will happen if any shortfalls are identified?

Where will the results of the monitoring be reported?

How will the resulting action plan be progressed and monitored?

How will learning take place?
Standards/Key Performance Indicators
This section could contain auditable standards and/or key performance indicators
(KPIs) which may assist the organisation in the process for monitoring compliance.
12
References
This section should contain the details of any reference materials reviewed in the
development of the procedural document.
Listed below are some useful sources of reference material:
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V.6
12.1
Legislation

The Data Protection Act 1998

Freedom of Information Act 2000
12.2
Guidance from Other Organisations

National Patient Safety Agency (NPSA) website provides further information and
resources in relation to incident reporting, ‘Being Open’ and root cause analysis:
www.npsa.nhs.uk.

‘Root Cause Analysis (RCA) report-writing tools and templates’ NPSA list of
resources

‘Incident decision tree’ Online tool

Seven Steps to Patient Safety in Primary Care Trusts (2006)

Briefing 161: Act on reporting (2008)

National Framework for Reporting and Learning from Serious Incidents
Requiring Investigation (2009)

National Reporting and Learning Service (NRLS) Data Quality Standards:
Guidance for Organisations Reporting to the Reporting and Learning System
(RLS) (2009)

Patient Safety Alert: Update WHO Surgical Safety Checklist (2009)

Being open: Saying sorry when things go wrong (2009)

Patient Safety Alert Being Open: Communicating with patients, their families
and carers following a patient safety incident (2009)

Questions are the answer! Seven questions every board member should ask
about patient safety (2009)

Never Events: Framework – Update for 2010/11: Process and action for
Primary Care Trusts (2010)

Medical Error: What to do if things go wrong: A guide for junior doctors
(2010)

Department of Health (2004) Memorandum of understanding: Investigating patient
safety incidents involving unexpected death or serious untoward harm: A protocol for
liaison and effective communications between the National Health Service,
Association of Chief Police Officers and Health and Safety Executive

Healthcare Commission (HCC) (2008) Learning from investigations

Healthcare Commission (HCC) (2009) Safe in the knowledge: How do NHS trust
boards ensure safe care for their patients

House of Commons (2009) House of Commons Health Committee: Patient Safety:
Sixth Report of Session 2008-09, Volume I
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
13
Patient Safety First (2009) The ‘How to Guide’ for Implementing Human Factors in
Healthcare
Associated Documentation
This section should provide a cross reference to any other related organisational procedural
document(s).
The following list is a guide only and not exhaustive:
V.6

Risk management strategy

Incident reporting

Complaints management

Claims management

Investigation and root cause analysis

Learning

Being open

Support for staff

Training needs analysis
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Appendix A - Investigation Report Template
Comprehensive and Independent Investigation Report Template (NPSA 2010). A Concise Investigation
Report Template is also available. The full guide can be found at www.npsa.nhs.uk/nrls alongside
the ‘Root Cause Analysis (RCA) toolkit’ Online tool (NPSA).
Comprehensive and Independent Investigation Report Template
 See associated NPSA quick ref. guide, or the more detailed RCA investigation report writing
guidance.
 Save the document with the chosen file name. Always include a version number in the
filename.
 On completion ensure all guidance (in green) is deleted.
[Add trust logo]
Root Cause Analysis Investigation Report
Incident Investigation Title:
Incident Date:
Incident Number:
Author(s) and Job Titles
Investigation Report Date:
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Contents
Executive Summary
MAIN REPORT:
Incident description and consequences
Pre-investigation risk assessment
Background and context
Terms of reference
Level of investigation
Involvement and support of patient and relatives
Involvement and support provided for staff involved
Information and evidence gathered
FINDINGS:
Chronology of events
Detection of incident
Notable practice
Care and service delivery problems
Contributory factors
Root causes
Lessons learned
Post-investigation risk assessment
CONCLUSIONS:
Recommendations
Arrangements for Shared Learning
Distribution List
Appendices
Action Plan
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Executive Summary
Complete this summary AFTER the main report has been written. This forms an important précis of the report.

Brief incident description:

Incident date:

Incident type:

Healthcare Specialty:

Actual effect on patient and/or service:

Actual severity of incident:
Level of investigation conducted
Involvement and support of the patient and/or relatives
Detection of the incident
Care and service delivery problems
Contributory factors
Root causes
Lessons learned
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Recommendations
Arrangements for sharing learning
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MAIN REPORT:
Incident description and consequences
Incident description:
Incident date:
Incident type:
Specialty:
Actual effect on patient:
Actual severity of the incident:
Pre-investigation risk assessment
A
B
C
Potential severity
(1-5)
Likelihood of recurrence
at that severity (1-5)
Risk rating
(C = A x B)
Background and context
Add text here
Terms of reference
Guide provided below. Amend this to build your own. Add only a summary to the body of the report.
Purpose
To identify the root causes and key learning from an incident and use this information to significantly reduce the
likelihood of future harm to patients
Objectives
To establish the facts i.e. what happened (effect), to whom, when, where, how and why (root causes)
To establish whether failings occurred in care or treatment
To look for improvements rather than to apportion blame
To establish how recurrence may be reduced or eliminated
To formulate recommendations and an action plan
To provide a report and record of the investigation process & outcome
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To provide a means of sharing learning from the incident
To identify routes of sharing learning from the incident
Key questions/issues to be addressed
...specific to this incident or incident type
Key Deliverables
Investigation report, action plan, implementation of actions
Scope (investigation start and end points)
Investigation type, process and methods used

Single or multi-incident investigation

Gathering information, e.g. Interviews

Incident mapping, e.g. Tabular timeline

Identifying care and service delivery problems, e.g. Change analysis

Identifying contributory factors and root causes, e.g. Fishbone diagrams

Generating solutions, e.g. Barrier analysis
Arrangements for communication, monitoring, evaluation and action
Investigation commissioner
Investigation team
Names, roles, qualifications, departments
Resources
Involvement of other organisations
Stakeholders/audience
Investigation timescales/schedule
Level of investigation
Add text here
Involvement and support of patient and relatives
Add text here
Involvement and support provided for staff involved
Add text here
Information and evidence gathered
Add text here
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FINDINGS:
Chronology of events
Chronology (timeline) of events
Date & Time
Event
Detection of incident
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Notable practice
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Care and service delivery problems
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Contributory factors
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Root causes
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Lessons learned
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Post-investigation risk assessment
V.6
A
B
C
Potential severity
(1-5)
Likelihood of recurrence
at that severity (1-5)
Risk rating
(C = A x B)
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CONCLUSIONS:
Recommendations
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Arrangements for Shared Learning
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Distribution List
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Appendices
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Action Plan
See also ‘Types of Preventative Actions Planned’- tool at www.npsa.nhs.uk/rca
Action 1
Action 2
Action 3
Root CAUSE
EFFECT on patient
Recommendation
Action to address root cause
Level for action
(Org, direct, team)
Implementation by:
Target date for
implementation
Additional resources required
(Time, money, other)
Evidence of progress and
completion
Monitoring and evaluation
Arrangements
Sign off - action completed
date:
Sign off by:
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Appendix B - Flowchart Illustrating Stages of Investigation
Appendix C - Root Cause Analysis Tools
Organisation to develop
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Appendix D - Template Document for the Investigation of Incidents, Complaints
and Claims
NHS Trust
An Organisation-wide Document for the Investigation
of Incidents, Complaints and Claims
Version:
Ratified by:
Date ratified:
Name of originator/author:
Name of responsible committee/individual:
Name of executive lead:
Date issued:
Review date:
Target audience:
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Contents
1
Introduction ........................................................................................................... 28
2
Purpose .................................................................................................................. 28
3
Explanation of Terms ............................................................................................. 28
4
Duties ..................................................................................................................... 28
4.1
4.2
4.3
5
Duties within the Organisation ............................................................................................. 28
Committees and Groups with Overarching Responsibilities ................................................ 28
Links Between the Management of Incidents, Complaints and Claims................................ 28
Key Issues ............................................................................................................... 28
5.1
5.2
5.3
5.4
Why is Investigation Necessary?........................................................................................... 28
The Importance of Learning from Adverse Events and Sharing Safety Lessons ................... 28
The Need for Effective Communication ................................................................................ 28
Support for Patients, Carers, Relatives and Staff .................................................................. 28
6
Staff training .......................................................................................................... 28
7
Investigation and Root Cause Analysis .................................................................. 28
7.1
7.2
7.3
7.4
7.5
7.6
7.7
7.8
8
Identifying which Incidents, Complaints and Claims need to be Investigated ..................... 28
Investigation Process ............................................................................................................ 29
Gathering the Information .................................................................................................... 29
Mapping the Events .............................................................................................................. 29
Analysing the Information .................................................................................................... 29
Barrier Analysis ..................................................................................................................... 29
Developing Solutions and an Action Plan for Implementation ............................................. 29
Completing a Report ............................................................................................................. 29
Performance Management and Data Collection ................................................... 29
8.1
9
Reports to the Nominated Committee and the Board ......................................................... 29
Learning from Experience ...................................................................................... 29
10
Equality Impact Assessment ............................................................................... 29
11
Monitoring Compliance with the Document ..................................................... 29
11.1
11.2
12
12.1
12.2
13
Process for Monitoring Compliance ..................................................................................... 29
Standards/Key Performance Indicators ................................................................................ 29
References .......................................................................................................... 29
Legislation ............................................................................................................................. 30
Guidance from Other Organisations ..................................................................................... 30
Associated Documentation ................................................................................ 30
Appendix A
V.6
Investigation Report Template ............................................................. 30
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Appendix B
Flowchart Illustrating Stages of Investigation ...................................... 30
Appendix C
Root Cause Analysis Tools .................................................................... 30
Appendix D
Checklist for the Review and Approval of Procedural Documents ...... 30
Appendix E
Version Control Sheet ........................................................................... 30
Appendix F
Plan for Dissemination .......................................................................... 30
Appendix G
Equality Impact Assessment Tool ......................................................... 30
Examples of the Checklist for the Review and Approval of Procedural Documents, Version Control
Sheet, Plan for Dissemination and the Equality Impact Assessment Tool can all be found within the
Organisation-wide Document for the Development and Management of Procedural Documents on
the NHSLA website.
Appendix B in the Organisation-wide Document for the Development and Management of Procedural
Documents contains a flowchart to assist with the process for the creation and implementation of
procedural documents.
Review and Amendment Log
Version no.
V.6
Type of change
Date
March 2012
Description of change
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An Organisation-wide Document for the Investigation of Incidents, Complaints and Claims
1
Introduction
2
Purpose
3
Explanation of Terms
4
Duties
5
4.1
Duties within the Organisation
4.2
Committees and Groups with Overarching Responsibilities
4.3
Links Between the Management of Incidents, Complaints and Claims
Key Issues
5.1
Why is Investigation Necessary?
5.2
The Importance of Learning from Adverse Events and Sharing Safety Lessons
5.3
The Need for Effective Communication
5.4
Support for Patients, Carers, Relatives and Staff
6
Staff training
7
Investigation and Root Cause Analysis
7.1
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Identifying which Incidents, Complaints and Claims need to be Investigated
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8
7.2
Investigation Process
7.3
Gathering the Information
7.4
Mapping the Events
7.5
Analysing the Information
7.6
Barrier Analysis
7.7
Developing Solutions and an Action Plan for Implementation
7.8
Completing a Report
Performance Management and Data Collection
8.1
Reports to the Nominated Committee and the Board
9
Learning from Experience
10
Equality Impact Assessment
11
Monitoring Compliance with the Document
12
V.6
11.1
Process for Monitoring Compliance
11.2
Standards/Key Performance Indicators
References
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13
V.6
12.1
Legislation
12.2
Guidance from Other Organisations
Associated Documentation
Appendix A
Investigation Report Template
Appendix B
Flowchart Illustrating Stages of Investigation
Appendix C
Root Cause Analysis Tools
Appendix D
Checklist for the Review and Approval of Procedural Documents
Appendix E
Version Control Sheet
Appendix F
Plan for Dissemination
Appendix G
Equality Impact Assessment Tool
March 2012
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