Download Serious Incident Requiring Investigation Policy

Serious Incident Requiring Investigation Policy
Serious Incident Requiring Investigation Policy
Version:
2.0.0
Approved by:
Clinical Risk and Quality Assurance
Committee
Date Approved:
24th October 2014
Ratified by:
Policy Review Group
Date ratified:
13 November 2014
Name of originator/author:
Nina Barbosa (Risk Manager)
Name of responsible committee/individual:
Clinical Risk and Quality Assurance
Committee
Date issued:
November 2014
Review date:
October 2017
Target audience:
All Staff
Version 1.2.1
1/42
Serious Incident Requiring Investigation Policy
Contents
Section
Page
1
Introduction
3
2
Purpose
3
3
Duties
3
3.1
Duties within the Organisation
3
3.2
Identification of Stakeholders
6
4
Method of development
6
4.1
Consultation and communication with stakeholders
6
5
Content
6
5.1
Definitions
6
5.2
Serious Incident Requiring Investigation process
8
5.2.1
Notification and basic fact finding
8
5.2.2
Initial enquiries
10
5.2.3
Agreeing the level and framework of the investigation
11
5.2.4
The main investigation
14
5.2.5
Closing the incident
16
6
Support for staff involved in SIRIs
17
7
Education/Training
17
8
Monitoring Compliance With and the Effectiveness of Procedural
Documents
17
8.1
Process for Monitoring Compliance and Effectiveness
17
8.2
Standards/Key Performance Indicators
18
9
Links with other Trust Policies
18
10
References
18
Appendix 1
Quick Reference Flow Chart
19
Appendix 2
SIRI grading algorithm
20
Appendix 3
Specific Examples of Application
21
Appendix 4
Core List of Never Events
29
Appendix 5
Basic Principals of RCA
35
Appendix 6
Suggested Tools for RCA
37
Appendix 7
Incident Decision Tree
40
Appendices
Version 1.2.1
2/42
Serious Incident Requiring Investigation Policy
1
Introduction
Investigations are an important part of learning from our experiences and sharing lessons
so that we improve where we could be better and continue what we do well. This in turn
helps to improve the quality of care and service delivery we provide at BCH and helps to
promote and develop its ‘open, just and fair’ environment. The NHS has made several
commitments over the years to improving the safety and quality of care that we provide
(Department of Health, 2000, 2008 & 2010). The Trust recognises that systematic review
of incidents can be a significant driver for improvement.
Staff are encouraged to use the principles of Root Cause Analysis (RCA) for all
investigations and so that they achieve a systematic approach which ensures all aspects
are reviewed and none are overlooked. This will enable more effective planning of any
necessary change.
2
Purpose
This Policy sets out the process and responsibilities for managing and investigating Serious
Incidents Requiring Investigation (SIRIs), formerly referred to as Serious Untoward
Incidents (SUIs).
It defines the notifications to our commissioners and other external agencies, and
timescales for completion so that our management of SIRIs meets local and national
standards.
It sets out the responsibilities of individual staff in being open with our patients and their
families when a Serious Incident (SI) has occurred.
3
Duties
3.1 Duties within the Organisation
3.1.1 Trust board
● To review information provided on SIRIs.
● To ensure that lessons are learnt following SIRIs.
● If further assurance of learning from SIRIs is required, to make further
recommendations.
3.1.2 Trust committees
The following committees have involvement in the management of SIRIs:
●
●
●
Clinical Risk and Quality Assurance Committee;
Non-Clinical Risk Coordinating Committee;
Regulatory Compliance Committee (for confidentiality breaches).
They are required to review the outcome of SIRI investigations in their
respective fields and to ensure that lessons learnt from those investigations
are monitored and completed in a timely manner.
Version 1.2.1
3/42
Serious Incident Requiring Investigation Policy
3.1.3 Chief Executive
The Chief Executive is ultimately responsible for ensuring that robust
investigations are carried out as required, and that these are completed in a
fair and timely manner.
3.1.4 Chief Medical Officer

To assess the information available and declare a clinical incident as a
SIRI for notification to commissioners.
Participate within the review of SIRIs and apply the principles of RCA.
To promote an open, just and timely reporting culture as a key
mechanism for enhancing safety.
To provide updates to Trust Board on clinical SIRIs.



3.1.5
3.1.6
Chief Nursing Officer
 To assess the information available and confirm as SIRI in the case of
significant safeguarding incidents, infection control incidents such as
outbreaks and confidentiality breaches.
 Participate within the review of SIRIs and apply the principles of RCA.

To promote an open, just and timely reporting culture as a key
mechanism for enhancing safety.

To provide updates to Trust Board on safeguarding SIRIs, infection
control SIRIs and confidentiality breach SIRIs.
Chief Operating Officer




3.1.7
Associate Chief Medical Officers for Safety

On behalf of the Chief Medical Officer, to assess the information
available and declare a clinical incident as a SIRI for notification to
commissioners.
Participate within the review of SIRIs and apply the principles of RCA.
To promote an open, just and timely reporting culture as a key
mechanism for enhancing patient safety.


3.1.8
Associate Chief Nursing Officer


3.1.9
Participate within the review of SIRIs and apply the principles of RCA.
To promote an open, just and timely reporting culture as a key
mechanism for enhancing patient safety
Associate Director of Governance


Version 1.2.1
To assess the information available and declare a non-clinical incident
as a SIRI for notification to commissioners.
Participate within the review of SIRIs and apply the principles of RCA.
To promote an open, just and timely reporting culture as a key
mechanism for enhancing safety.
To provide updates to Trust Board on non-clinical SIRIs.
Participate within the review of SIRIs and apply the principles of RCA.
To promote an open, just and timely reporting culture as a key
mechanism for enhancing patient safety.
4/42
Serious Incident Requiring Investigation Policy
3.1.10 The Executive On-call (Out of hours)

Out of hours the on-call Executive is the person who must be
immediately notified of the possible SI. They are also responsible for
notifying the Risk Manager of the SI as soon as possible on the next
working day.
3.1.11 Directorate Management Teams (including the Clinical Director, Head of
Nursing and Associate Service Director)


To promote an open, just and timely reporting culture as a key
mechanism for enhancing patient safety.
To ensure that lessons arising from SIRIs are cascaded within their
Directorates
3.1.12 Risk Management Specialists
The following members of staff are the designated Trust risk management
specialists who will lead on SIRIs:




The Head of Risk
The Risk Manager – clinical risk
The Health, Safety and Security Manager – health, safety and security
risks
The Information Governance Manager – information governance
risks, including confidentiality breaches.
Their key responsibilities are:



To facilitate and lead on incident investigations within their areas of
responsibility, using appropriate techniques.
To report updates on investigations and learning outcomes to the
appropriate Trust Board subcommittee.
To liaise with external partners and other organisations in the
reporting and investigation of serious incidents.
3.1.13 Lead Doctor & Lead Nurse for Child Protection
They are responsible for leading or appropriately delegating investigations
into safeguarding SIRIs.
3.1.14 Lead Doctor & Infection Control and Prevention Team
They are responsible for leading or appropriately delegating investigations
into Infection Control SIRIs, this includes outbreaks.
3.1.15 Managers


Version 1.2.1
To ensure that any incident which meets the criteria for a SIRI is
referred to the Risk Manager immediately upon becoming aware of it
within normal office hours. Outside normal office hours the manager
is responsible for contacting the On-call Executive.
To support staff when reporting incidents and as a consequence of an
incident having been reported, and enable them to participate in
investigations, including the nomination of investigating officers with
requisite skills and ensuring that their staff have time to prepare
reports required for the investigation.
5/42
Serious Incident Requiring Investigation Policy



To complete and follow up action plans as highlighted.
To provide information and updates on action plan implementation in
response to SIRI reviews.
Provide staff with feedback on the outcomes of incident
investigations and changes made as a result.
3.1.16 All staff




To familiarise themselves with the definition of a serious incident and
escalate any incident which meets that criteria to their manager or
the Risk Manager immediately upon becoming aware of it.
To participate as required in serious incident investigations, including
the timely production of witness statements and reports required to
inform the investigation.
To ensure that the principles of being open with families and patients
are met.
To provide support for colleagues when involved in a SIRI
3.2 Identification of Stakeholders
All staff are potential stakeholders in this policy as anyone may witness or be
involved in a SIRI. Key staff who have specific responsibility for risk, either due to
membership in a key risk committee or due to holding a senior managerial
perspective were identified for consultation on this policy.
4.0 Method for development
This policy was developed with reference to best practice guidance and our host
commissioner’s policy.
4.1 Consultation and Communication with Stakeholders
The Clinical Risk and Quality Assurance Committee were consulted with during the
developments to this version of the policy.
The Lead Doctor and Nurse for Safeguarding, Infection Control and Prevention Team
and Lead Nurse for Tissue Viability were also consulted with during the development of
this version of the policy.
5.0 Content
5.1 Definitions
5.1.1 What is a Serious Incident Requiring Investigation?
5.1.1.1 Harm
The following definition of Serious Incident Requiring Investigation (SIRI), is taken
from the West Midlands Strategic Health Authority SIRI policy 2010 and Heart of
Birmingham’s SIRI policy (2010), and is adopted at the Trust:
A Serious Incident Requiring Investigation is defined as an incident that occurred
in relation to NHS funded services and care resulting in:
Version 1.2.1
6/42
Serious Incident Requiring Investigation Policy
●
●
●
●
●
the unexpected or potentially avoidable death of one or more patients, staff,
visitors or members of the public, or permanent harm to one or more patients,
staff, visitors or members of the public
or where the outcome requires life-saving intervention or major surgical/medical
intervention or will shorten life expectancy (this includes incidents graded under
the NPSA definition of severe harm)
a scenario that prevents or threatens to prevent a provider organisation’s ability
to continue to deliver health care services, for example, actual or potential loss or
damage to property, reputation or the environment
a person suffering from abuse (e.g. neglect, of safeguarding concerns of a
significant nature)
adverse media coverage or public concern for the organisation or the wider NHS
5.1.1.2 Significant Trust-wide systems failure
In addition to situations which result in significant harm to an individual or the
organisation, BCH consider events which highlight potentially significant trustwide systems failures which have a reasonable potential to result in significant
harm a SIRI. These events can be classed as a SIRI whether significant actual harm
has been caused or not.
Please see appendix 2 for details of how SIRIs are classified.
5.1.1.3 Significant Confidentiality Breach
In addition the Department of Health (2013) has identified that a serious
confidentiality breach is, any incident involving actual or potential failure to meet
the requirements of the Data Protection Act 19981
• This includes unlawful disclosure or misuse of confidential data, recording or
sharing of inaccurate data, information security breaches and inappropriate
invasion of people’s privacy, and/or the Common Law of Confidentiality.
• Such personal data breaches which could lead to identity fraud or have other
significant impact on individuals.
• This applies irrespective of the media involved and includes both electronic
media and paper records.
The Trust will also investigate any incident declared as an SIRI, by the Chief
Medical Officer or Chief Operations Officer in line with this policy.
If staff are in doubt about whether or not such an incident is an SIRI, they should
contact the Risk Manager or Health, Safety and Security Manager for advice.
5.1.2 What is an Incident?
An event or circumstance which represents a divergence from expected practice,
a defined protocol, or accepted standard. These events could result in
unnecessary damage, loss or harm to a patient, staff, visitors or members of the
public, or may not actually result in harm, either due to staff action or the
circumstances of the event.
Please note that an event can be classed as an incident and be reported on the
BCH incident reporting system (IR1 system) whether this represents a concern
Version 1.2.1
7/42
Serious Incident Requiring Investigation Policy
with BCH processes or care or not. If the event either affects or has the potential
to affect a BCH patient or member of staff, then this should be reported on our
system.
 Patient Safety Incidents (PSIs)
Also called clinical incidents, these were defined by the National Patient Safety
Agency (NPSA) as any unintended or unexpected incident which could have, or
did, lead to harm to one or more patients receiving NHS-funded healthcare.
 Personal Accidents
Unintended or unexpected incidents which could have, or did, lead to harm to
staff or visitors on BCH premises.
5.2 Serious Incidents Requiring Investigation process
This process is time bound as defined by the NPSA and our commissioners. The
figure below provides an outline of the stages involved.
Stage 1 Notifications and basic fact finding
Day 1
Stage 2 Initial Enquiries
Day 1-3
Stage 3 Agreeing the Investigation
Day 3
Stage 4 Investigating
Day 3-45
Stage 5 Closing the Incident
Up to six months after the
incident
5.2.1 Stage 1: Notifications and basic fact finding
5.2.1.1 When an SIRI is suspected
When the member(s) of staff involved in or witnessing an incident suspects
that a SIRI has occurred they must immediately notify their line manager
and the Risk Manager. Likewise when an individual investigating an
incident, not previously recognised by the reporter as a SIRI, suspects that
the incident does in fact reach the threshold for a SIRI, they should inform
their manager and the Risk Manager. If an individual suspects that an
incident meeting the threshold for a SIRI has not been reported they should
contact the Risk Manager immediately.
When the incident occurs out of hours, it must be immediately reported to
the Clinical Co-ordinator / Executive Director on call, who must inform the
Risk Manager on the next working day.
Version 1.2.1
8/42
Serious Incident Requiring Investigation Policy
If Staff employed by other healthcare organisations witness a SIRI which
occurs at BCH, or staff employed by BCH witness a SIRI at other healthcare
organisations, they should report these incidents to the Risk Manager
responsible for the organisation where the incident occurred for action,
and to their own employer’s Risk Manager for information.
Although notification of the Risk Manager should be done urgently
following the discovery of the potential SIRI, and may best be achieved by
telephone or face-to-face conversation, in all cases an IR1 form must be
completed.
All equipment and documentation related to the incident must be secured
and consideration should also be given to quarantining the environment.
5.2.1.2 Notification of suspected incidents to the patient, their parents or
carers.
If a patient has suffered harm, what has happened must be explained fully
and accurately to the patient and/or carers, including information on the
likely long and short-term effects. This should be done as soon as the staff
are aware an incident has occurred and in line with the Trust’s Being Open
policy. The key principals, which must be adhered to include:
(a) Ensure that the initial communication is prompt and that where
significant harm has been caused there is agreement across the team about
what the patient and their family will be advised.
(b)Provide a sincere apology for the harm caused. This is not an
admission of liability; it is a necessary expression of regret.
(b) Avoid supposition and stick only to the known facts, as the
investigation can sometimes highlight unexpected factors.
(c) Advise the patient and the family how the incident will be investigated
and when they can expect to receive feedback on the investigation.
(d) Provide the patients, families and carers with contact details for
further support, both in terms of the consequences of the harm caused
and in terms of an update for the investigation.
5.2.1.3 Establishment of basic facts
On notification of the incident, the Risk Manager or Health, Safety and
Security Manager will carry out basic fact finding into the incident,
obtaining information to provide to the relevant Chief Officer.
Certain incidents will always be classed as SIRIs, these are detailed in
appendix 3 and include MRSA bacteraemia, incidents subject to a Serious
Case Review under child protection procedures, and incidents classed as
Never Events in line with the current list of Never Events. The 2010/11
Never Event Framework is included at appendix 3.
5.2.1.4 Referral of suspected incidents to the relevant Chief Officer
Upon notification of a potential SIRI the Risk Manager or Health, Safety and
Security Manager will discuss the available details with either an Associate
Chief Medical Officer (ACMO), Chief Nursing Officer (CNO) or Chief
Version 1.2.1
9/42
Serious Incident Requiring Investigation Policy
Operating Officer (COO). The ACMO, CNO or COO will declare the incident
to be a SIRI or not based on these facts.
In the absence of an ACMO, CNO or the COO, a discussion will be held with
another Executive Director.
The decision to declare a SIRI should be made as quickly as possible.
Guidance in the National Framework for Serious Incident Reporting and
Learning Framework (SIRL) (2010) and the Birmingham South Central
Clinical Commissioning Group (2014) Serious Incident Reporting and
Management Policy policies stipulates that this decision should be made
within 48 hours of notification of the possible SIRI.
5.2.1.5 Referral of suspected incidents to commissioners
The Risk Manager will notify the appropriate commissioner using the
format agreed with that commissioner. Initial notification will be made
within 48 hours of the Risk Manager becoming aware of the incident.
Preferably initial notification will be made through a telephone
conversation. If the commissioner is not available then initial notification
will be made via e-mail.
The time constraints on initial notification mean that the incident is unlikely
to have been fully scoped. As much information as possible will be given at
this stage.
5.2.1.6 Referral of suspected incidents to StEIS
On notification of a SIRI the Risk Manager or Health, Safety and Security
Manager is responsible for recording the incident on the Strategic
Executive Information System (StEIS). The system must be updated
regularly at key stages of the investigation.
5.2.1.7 Referral of suspected incidents to the National Reporting and
Learning System (NRLS)
The incident will be entered onto the Trust’s incident management system
and notified to the NRLS within 48 hours of notification of the incident.
Organisations such as the Care Quality Commission (CQC) will be notified
by the NRLS report.
5.2.1.8 Referral of suspected incidents to the Police, HSE and other bodies
If an incident requires referral to another organisation such as the Police
and Health and Safety Executive (HSE) this will be done in accordance with
the Memorandum of Understanding (2006). Depending on the nature of
the incident it may also be necessary to notify other agencies such as the
Medicines and Healthcare products Regulatory Agency (MHRA) or the
Health Protection Agency (HPA). For full details of when to notify other
agencies and who to notify please see appendix 3. If required, this will be
done by the Risk Manager, following discussion with the appropriate Chief
Officer.
Version 1.2.1
10/42
Serious Incident Requiring Investigation Policy
5.2.2 Stage 2: Initial Enquiries - Scoping the Incident
Scoping the incident will begin as soon as this is notified to the Risk Manager or
Health, Safety and Security Manager. This will be started during the notification
phase and will be used to inform the Chief Officer’s decision on whether to declare
a SIRI. This process may take up to two days.
Through this process the people, processes and equipment involved in the incident
shall be identified. Terms of reference shall begin to be developed for any
subsequent investigation. Sources of evidence will be identified which could
include witness statements, monitor data, health records, equipment maintenance
logs, procedural documents and photographs.
Part of the scoping of the incident will include outlining a communication plan with
the patient, family, carers and staff. This will allow the teams involved in the
investigation, to support those affected by events and keep them updated.
The purpose of the scoping phase of the investigation is to draw up a framework
for the investigation following review of the initial facts. This concludes with the
agreement of the Terms of Reference (TOR) for the investigation with the
investigation chair and the assembly of the multi-disciplinary team who will carry
out the review.
5.2.3 Stage 3: Agreeing the level of Investigation and specific framework
for the investigation
The full details of the incident shall be discussed with the appropriate
commissioner. This conversation will agree the:
●
●
Level of incident Investigation (see Section 5.2.3.2).
The timescale for completion of the investigation (excluding completion of
action plans).
Terms of reference and review team composition as internally agreed.
●
5.2.3.1 Communication with patient, their parents or carers
The patient and their families must be told if a decision to de-escalate the
incident from an SIRI is made, giving the reasons for this decision and any
alternative investigative process that will be applied. This communication
should be led by the person who initially informed the family that the incident
might be classified as a SIRI, and if they are not available, then the discussion
must be held by a senior member of the clinical team, or other suitable
member of staff such as Family Liaison Officer.
Where an incident is investigated as an SIRI, families must be informed of
what that process involves and the timescale agreed with the commissioners.
Where families are unhappy with the suggested timescale, their concerns
must be explored and where possible an alternative timescale agreed. If a
revised timescale is agreed with the family, this must be reported to the
commissioners.
Families must be presented with the terms of reference of an investigation
and given the opportunity to suggest areas which they want the investigation
Version 1.2.1
11/42
Serious Incident Requiring Investigation Policy
to look at. This role would typically be undertaken by the investigating officer,
assisted by the responsible doctor or senior ward nurse for in-patients.
Where it is not convenient for families to be party to these discussions within
the short timeframe presented the investigation must proceed on agreed
timescale and terms of reference. However, it may be necessary to revisit
certain outcomes following discussion with families.
5.2.3.2 Level of Investigation
The National Patient Safety Agency (2010) identified 3 grades of serious
incident as detailed in the table below:
Table 1
Grade
Definition
SIRI?
Timescale for
completion of
investigation
0
Where an incident has occurred but it is unclear
whether it meets the definition of a Serious
Incident Requiring Investigation.
No
45 days
1
Where an incident has occurred which meets the
definition of a Serious Untoward Investigation and
is to be investigated through an NPSA Level 2
Investigation.
Yes
45 days
2
Where an incident which meets the definition of a
Serious Untoward Investigation is considered to
be of the most severe type and this investigation
may be carried out by the Trust, but may also be
subject to an Independent Investigation.
Yes
60 days
In line with national guidance (NPSA, 2010), the Trust investigates all SIRIs using Root
Cause Analysis (RCA) techniques. RCA techniques include a range of tools which are
designed to identify systemic failures and uncover root causes of incidents. It is
recommended that RCA techniques are used for all grades of incident including level 0 as
defined in the table above.
There are a number of levels of investigation determined by the NPSA. The table below
(table 2) details a few key features of each of level of investigation, including
recommended RCA tools for the investigation.
Version 1.2.1
12/42
Serious Incident Requiring Investigation Policy
Table 3
Level
Investigative techniques applicable
Led by
Approved by
1
Investigation carried out using concise
format which reviews incident
causation in a rapid manner. Is often
carried out by an individual or two
person team. Suitable RCA tools
include:
Local lead with
support of person(s)
experienced and/or
trained in RCA.
Directorate
Governance
forum with
presentation of
executive
summary at
Trust
committee with
responsibility
for risk.
Led by person(s)
experienced and/or
trained in RCA,
human error and
effective solutions
development.
Overseen by
executive
appointed chair
or facilitator.
●
●
●
●
●
2
3
Chronology of events
Timelines
Brainstorming
Cause & effect
Time person grid
Conducted with a high level of detail,
including all elements of a thorough
and credible investigation. Includes
patient/relative/carer involvement and
should include an offer to
patient/relative/carer of links to
independent representation or
advocacy services. May require
management of the media via the
organisation’s communications
department. Includes robust
recommendations for shared learning,
locally and/or nationally as appropriate.
Suitable tools include those listed
under level 1 and spider diagrams, and
the Ishikawa (Fishbone) diagram.
As with level 2, but must be
commissioned and co-ordinated by the
Commissioning PCT or SHA and
independent to the organisations
involved in the incident.
Generally used for incidents, claims,
complaints and concerns which would
attract a high level of media or public
interest.
Should be used when Article 2 of the
Human Rights Convention has been
breached.
Version 1.2.1
Results in full
report with an
executive
summary and
appendices.
Conducted by a
multidisciplinary
team, or involves
experts/expert
opinion/independent Approved at
advice or specialist
Trust
investigator(s).
committee with
responsibility
Conducted by staff
for risk.
not involved in the
incident, locality or
directorate in which
it occurred.
Has commissioner
representation.
Investigation is
Trust
commissioned by the committee with
PCT or SHA.
responsibility
for risk and the
SHA Patient
Safety Team
13/42
Serious Incident Requiring Investigation Policy
The NPSA guidance also recommends that all actions that are proposed following
completion of the SIRI investigation are closed within six months of the incident.
The Trust acknowledges that in some rare occasions it will be necessary for the
action plan to include some long-term actions, which may not be completed
within six months. It is important that under such circumstances important
milestones are recorded on the action plan. In all instances completion of actions
must be monitored by the appropriate risk committee. Risks to the timely
completion of actions must be risk assessed and recorded on an appropriate Risk
Register.
5.2.4 Stage 4: The Main Investigation
The main investigation will be carried out as agreed between the Chair of the
investigation and the Investigating Officer. The Investigating Officer will be the
member of staff with RCA expertise who has been assigned to facilitate the
investigation.
5.2.4.1 Governance function
Throughout the investigation the Investigating Officer must:
●
●
●
●
●
●
●
Identify and collect evidence relevant to the circumstances of the
incident and with reference to the initial terms of the
investigation.
In liaison with the Chair, review evidence collected, comparing it to
the terms of reference of the investigation and identifying
sources of new evidence.
Identify additional terms of reference based on evidence collected
and additional issues raised by it.
Liaise with the person nominated to lead patient/carer/staff
communication.
Ensure that the multi-disciplinary review team receive the required
information for the review meeting and subsequently meet to
discuss the causation of the incident and develop an action plan for
mitigating recurrence.
Following analysis of the evidence by the review group the
Investigating Officer must prepare the report of the analysis. This
draft report must be shared for comment with the members of the
review group and those members of staff directly involved with the
incident. The Investigation Officer must review these comments and
make any necessary changes to the report prior to presentation to
the appropriate committee for ratification.
Ensure any urgent risks are flagged to the appropriate people for
action or information.
5.2.4.2 Composition of the Review Group
The review group must include:
●
Version 1.2.1
A senior clinical or managerial member of staff that has been
trained by the Governance team to carry out this duty, and who is
part of the RCA chair rota (Chair of the RCA)
14/42
Serious Incident Requiring Investigation Policy
●
●
A facilitator competent in application of the Root Cause Analysis
techniques (usually the Investigating Officer).
Expert representatives from the disciplines involved in the incident.
The review group must invite:
●
●
●
A Non-Executive Director.
A representative of the relevant commissioning team.
A member of the education team.
The review group must strongly consider inviting:
●
Staff members directly involved in the incident. Traditional guidance
has been that RCA investigations should not involve staff members
directly involved in SIRI since this may affect the objectivity of the
investigation. However, there is now significant evidence suggesting
the benefits of those directly involved in the occurrence of the incident
participating on the incident investigation. These benefits include:
o The ability during the RCA meeting to clarify specific facts relating to
the incident which may not have been included in witness
statements
o Contribution to the development of counter measures, to prevent
recurrence of such an incident (those directly involved in the
incident almost always have spent considerable time considering
how the incident could have been prevented)
o Reduction in the risk of ‘Second Victim’ phenomenon (staff
members involved in such incidents are often traumatised by the
event and may exhibit significant signs and symptoms such as
insomnia, depression, anxiety and other stress-related symptoms.
Allowing them to be a ‘part of the solution’ has been shown to
reduce the risk of this occurring)
There may be situations where even given these benefits, the attendance
at the RCA meeting of those directly involved in the incident is not
conducive to an effective investigation. The decision not to invite staff
members directly involved in the incident should be made jointly by the
investigation chair and the Investigation Officer, but there should be a good
reason for not doing so.
When a staff member involved in an incident a to be agrees to be a part of
the RCA meeting, it is the responsibility of their line manager to ensure that
they are provided with the appropriate support.
5.2.4.3 Key activities of the Review Group
The review group meet at the end of the evidence collection process to
analyse the evidence using techniques appropriate to the level of the
investigation. Their key duties are to:
●
●
Version 1.2.1
Represent their discipline during the course of the investigation.
When presented with the investigation plan, highlight potential key
evidence that has not already been identified.
15/42
Serious Incident Requiring Investigation Policy
●
●
●
●
●
●
Meet to analyse the evidence within timeframes specified by the
investigation.
Ensure appropriate analytical techniques are applied to
consideration of the evidence
Identify system changes based on the analysis.
Identify the contribution of Human Factors to the incident
occurrence.
Develop a time bound action plan for implementation of changes
and give and agree responsibility for completion to named
individuals.
Respond to any draft report and propose changes for inclusion in
any final report within timeframes specified by the investigation.
5.2.4.4 Ratifying Investigation Reports
Investigation reports must be presented to the appropriate committee
within timeframes specified by the investigation.
It is the role of the committee to take assurance that the investigation has
been completed using techniques in line with the level of the investigation.
If the committee is not able to take such assurance, then direction for
further action must be provided.
5.2.4.5 Monitoring Action Plans
The committee must also agree the action plan presented within the final
report. If the action plan does not provide adequate assurance that
measures will be taken to mitigate identified risks, then the committee
must direct further course of action.
Action plans shall be included in Directorate Learning from Experience
Reports and included in the analysis provided in the monthly Action Plan
report. Both the Directorate Management Teams and relevant risk
committee are responsible for ensuring that the action plans are monitored
to completion in a timely manner.
The Investigating Officer or relevant Service Line Manager must submit to
the risk register any risks and actions highlighted by the investigation that
cannot be immediately mitigated.
5.2.4.6 Communication with patient, their parents or carers
The patient and their families must be kept informed of the progress of the
investigation. This will include information on:
●
●
●
●
The process of investigation and analysis being undertaken and to
be undertaken by the Investigating Officer and the review group.
The progress of the investigation
Significant, relevant facts identified by the evidence collection and
review process.
Changes identified by the review group as a result of the analysis.
The way in which information is shared should be agreed with the family at
the outset of the investigation and should include:
Version 1.2.1
16/42
Serious Incident Requiring Investigation Policy
●
●
●
Format of any meeting or alternative format for feedback.
Frequency of any meeting.
Preferred attendance at any meeting.
Additionally, once the report is ratified, the Chair of the Group, supported
by a clinician caring for the child, should meet with the family and discuss
the findings and changes to be made with them, in line with the Being
Open Policy.
5.2.4.7 Communication with staff involved in the incident and sharing of
lessons across the Trust
It should be usual practice for all staff involved in the incident to be sent a
draft copy of the report to give them the opportunity to comment on
matters of fact (see 5.2.4.1 above). Once the report is ratified they must
receive feedback based on the final report, its findings and
recommendations. The format of the feedback will be dependent on the
details of the incident and the type of staff involved, however, as a
minimum, all staff involved in the incident will be provided with access to
the final investigation report, and will be given an opportunity to discuss
this further.
5.2.5 Closing the incident investigation
There are three stages of in the closure of an incident investigation. The first is
completion of the investigation, which is marked by the investigating team being
satisfied that they have comprehensively investigated the incident and that the
investigation report is an accurate reflection of their findings. The Trust will
monitor compliance with the investigation completion target by this measure.
The second is ratification, which is when the Trust’s appropriate risk committee
has accepted the investigation report and its accompanying action plan. Once
ratification has occurred the investigation outcome will be shared with Trust Board
and other relevant organisations.
The final stage is closure, which is when the action plan is complete. Current
guidance from NPSA recommends that SIRI action plans should be completed no
later than 6 months after the incident occurred. In situations where this is not
believed to be possible the closure date must be agreed with the commissioners.
The SIRI can be downgraded at any stage, if information comes to light which
indicates that the incident was of a lower grade. If this is believed to be the case,
then the Investigating Officer will discuss and agree the downgrading with the
relevant commissioners. In many situations an incident that is downgraded from a
SIRI will still require investigation at Directorate Level, using RCA. The Directorate
Management Team will then be expected to appoint an Investigating Officer and
ensure that RCA techniques are applied. Although communication with our
commissioners may have ceased at this point, the need to maintain
communication with the patient, their parents or carers remains, as does the need
to feedback to staff involved.
Version 1.2.1
17/42
Serious Incident Requiring Investigation Policy
6.0 Support for staff involved in SIRIs
BCH recognises that involvement in a SIRI can result in significant distress for staff
whether they had a pivotal role in the event on not. The occurrence of ‘Second Victim’
phenomenon in staff who were directly involved in the incident is now well recognised. A
second victim is defined as:
‘A healthcare provider involved in an unanticipated adverse patient event, medical error
and/or a patient-related injury who becomes traumatised by the event. Frequently,
second victims feel personally responsible for the unexpected patient outcomes and feel
as though they have failed their patient, and feel doubts about their skill and knowledge
base.’
The second victim may experience symptoms of insomnia, nightmares, reliving the
incident repeatedly, lack of self-confidence, anxiety (usually related to a fear of making a
further error) and depression. Such symptoms are not dissimilate to those seen in posttraumatic stress disorder. Such symptoms often affect the individual’s ability to continue
to work effectively.
BCH is committed to providing support for all staff involved in SIRIs. The support required
by individual members of staff may vary according to their level of involvement, the
severity of the incident and the outcome, and their own perception of their level of
contribution to the occurrence of the incident.
Once a potential SIRI has occurred, local managers should hold a debriefing session with
their teams as soon after the event as is practical. Consideration should be given to
reallocating duties for the remainder of a shift if a member of staff has been involved in a
SIRI. A period of supported practice may also be of benefit following a SIRI. It is however,
important that any measures intended to support staff are handled in such a way that it is
clear that the action is non-punitive. Staff should be provided with and encouraged to
take up support offered by the Trust, this can include support by the chaplaincy and
occupational health.
As noted above (see 5.2.4.2), it should be standard practice to invite those significantly
involved in a SIRI to be a part of the investigation process and the RCA meeting. Support
should be provided during this process, whether or not these individuals attend the RCA
meeting or not. As a minimum staff will be provided with information on the RCA process
when asked to provide information to support the investigation and will be provided with
feedback on the investigation findings. It is imperative that individuals involved in a SIRI be
kept up to date with the progress of the investigation, whether or not they are part of the
investigation process.
7.0 Education and Training
All types of risk training are detailed in the Governance Training Needs Analysis. In
relation to RCA and serious incident training, the previous training courses have been
replaced with a one day ‘Advanced Investigations Training’. This course is aimed at all staff
who are involved in the investigation of incidents, whether at the local level or through a
commissioned RCA. The training includes investigations skills as well as background on
how to support patients, families and members of staff who have been involved in an
incident.
Version 1.2.1
18/42
Serious Incident Requiring Investigation Policy
Staff who have experience in investigating incidents through repeated exposure to the
process and techniques of RCA may be identified as exempt from formal training through
demonstration of their existing competence.
GOVERNANCE TRAINING NEEDS ANALYSIS
Foundation Governance Training
Topic areas
Incident reporting
Advanced Governance Training

Complaints
Staff
Incident management and
investigation
Claims and Inquest

SIRI investigation
Risk Management

Statement writing
Security Management

Complaints Investigation
Health and Safety

Risk Register Management

Policies

Processes

Responsibilities

Risk Awareness
All Staff
Ward Managers
Department Managers
Specialty Managers
Service Managers
Directorate Managers
DLR Investigators
SIRI chairs
Refresher
Every 2 years
frequency
Delivery
Need determined on individual basis
through PDR
Class-room learning sessions
Blended delivery of class-room
Moodle
learning sessions supported by online resources.
8.0 Monitoring Compliance With and the Effectiveness of the policy
8.1 Process for Monitoring Compliance and Effectiveness
Monitoring adherence with the SIRI process as defined in the policy will be carried out
as follows:
8.1.1 Committee monitoring
The Clinical Risk and Quality Assurance Committee will receive monthly reports,
which provide an update on all ongoing SIRI investigations and all open action plans.
When required the Regulatory Compliance Committee and Non-Clinical Risk
Coordinating Committees will receive updates on relevant SIRIs and action plans.
8.1.2 Audit
An annual audit of adherence to this policy will be presented to CRAQ and will include
a consideration of:
● Timeliness of notifications
Version 1.2.1
19/42
Serious Incident Requiring Investigation Policy
● Appropriateness of strategy agreed between the chair person and the facilitator,
including whether the investigation was appropriate for the grade of incident.
● Timeliness of being open, including whether the family were given an opportunity
to input into the investigation and whether they were provided with feedback on the
outcome of the investigation in a timely manner.
8.2 Standards/Key Performance Indicators
Monthly trust-wide performance indicators are developed and shall be included as
part of performance review mechanisms:
● the timeliness of internal escalation of SIRIs and escalation to the commissioners.
● the completion of SIRIs within timeframes.
In addition the proportion of action plans closed within allocated timescales are
monitored on a monthly basis by the Clinical Risk and Quality Assurance Committee
9.0 Links with other Trust Policies and procedural documents
●
●
●
●
●
●
●
●
●
●
●
●
Safety Strategy
Incident Reporting policy
Being Open policy
Learning from Experience policy
Health and Safety Policy
Counter-Fraud Policy & Guidance
Policy for the Management and Processing of Serious Case Reviews
Procedure for responding to episodes of infection subject to mandatory
Department of Health Surveillance.
Policy for the Control of Methicillin-Resistant Staphylococcus Aureus
(MRSA)
Policy for the Control of Outbreaks of Infection in the Hospital (including
major outbreak plan)
Investigations Policy (HR)
Governance Training Needs Analysis
10.0 References
●
●
Birmingham South and Central CCG (2014) Policy on Serious Incidents
Department of Health (2013) The Never Events Policy Framework – An
update to the Never Events Policy
● National Patient Safety Agency (2010), National SIRL Framework
● Information Commissioner (2013) Checklist for Reporting, Managing and
Investigating Information Governance Serious Untoward Incidents.
● Department of Health (2006), Memorandum of Understanding
Version 1.2.1
20/42
Serious Incident Requiring Investigation Policy
Appendix 1
Quick reference guidance to the SIRI process
Incident Occurs or is identified
Day of
Process
If required, the area is made
safe/ remedial action is taken
Evidence is
Safeguarded
Staff member notifies line
manager and Risk Manager
Day 1
Stage 1
Basic fact finding and briefing to appropriate Chief Officer.
Decision regarding level of investigation made (SIRI/ DLR).
Chair approached and investigation plan agreed.
SIRI: No
Day 1 –
3
Stages 2
and 3
Directorate
Management Team,
staff involved, patient
and family/carers,
commissioners, and
Strategic Executive
Information System
all Notified along with
other relevant
agencies
SIRI: Yes
Chief Officer advises on next
course of action e.g. DLR
Information gathering and gap analysis
Days 3 –
45
Stage 4
Multidisciplinary Team Root Cause Analysis
Report produced and action plan
confirmed
Up to 6
Months
Stage 5
Version 1.2.1
Share with all
stakeholders
Committee Review
Monitor action plan
21/42
Serious Incident Requiring Investigation Policy
Appendix 2
SIRI grading algorithm
Was there an impact above moderate?
Yes
No
Was an impact above moderate
avoided by chance or exceptional
action?
No
Does the incident appear
to be preventable?
Yes
Is there a reasonable
chance of repetition?
Yes
No
No
Consider
discussion at an
M&M meeting
DLR
Yes
Yes
Is the incident specific to
one specialty or
department?
No
SIRI
Version 1.2.1
22/42
Serious Incident Requiring Investigation Policy
Appendix 3
Specific examples of application
Example of Application
Specific
Stage 1
Notifications to
consider
Blood transfusion.
MRHA
•
Any serious adverse reaction
following administration.
European
Blood Safety
Directives/Re
gulations
•
Any other serious event related to
the storage, prescription, collection or
administration.
Safeguarding.
•
Any serious harm which required
initiation of child protection procedures,
including Serious Case Reviews.
Local
Safeguarding
Board
Stage2
Stage 4
Stage 5
In line with the main policy
Fact finding
carried out
by the Lead
Social Services Doctor or
Lead Nurse
for Child
Protection
Local
Authority
Initial enquiries
carried out by
the Lead Doctor
and lead Nurse
for Child
Protection in
conjunction with
Governance
CEMACH
Version 1.2.1
Stage 3
23/42
Automatic SIRI
As with Stage 2 The report
should be
The Chief
reported to
Nursing Officer
the
has executive
Safeguarding
responsibility for
Committee for
child protection,
initial approval
therefore must
before being
be urgently
presented to
advised of a
the Clinical
safeguarding
Risk and
concern.
Quality
Serious Incident Requiring Investigation Policy
Example of Application
Specific
Stage 1
Notifications to
consider
Stage2
Stage 3
Stage 4
Stage 5
Assurance
Committee.
Emergency Plan Evoked / Major Incident.
Police
Automatic SIRI
•
Including terrorism, biological,
chemical or nuclear incidents.
NHS Security
Management
Service
In line with the main policy.
Local Transport
Local
Ambulance
Armed Forces
Outbreaks of communicable diseases.
HPA
•
Any episode of two people having
HSE
developed and infection following contact,
or use of the same space or equipment, the
episode must be treated as an outbreak until
confirmed otherwise.
Version 1.2.1
Fact finding
As with Stage 1
carried out by
a Consultant
Microbiologis
t, or the
Infection
Prevention
and Control
Team
24/42
Automatic SIRI
The CNO is the
executive lead
for infection
prevention and
control,
therefore must
be urgently
advised of a
possible
As with Stage 1 The report
should be
approved at
the Infection
Prevention
and Control
Committee
before
presentation
to the Clinical
Serious Incident Requiring Investigation Policy
Example of Application
Specific
Stage 1
Notifications to
consider
Information Governance.
•
Major confidentiality breaches.
•
An incident that could lead to actual
or potential identify fraud or have a serious
impact on individuals.
Information Technology.
•
Any form of systems loss leading to
serious outcomes.
Media Issues.
•
Matters which are likely to attract
significant media attention, including
apparently trivial ones which may become
more serious.
Version 1.2.1
Information
commissioner
Police
Stage2
Fact finding
As with Stage 1
carried out by
the
Information
Governance
Manager.
Connecting for
Health
In line with the main policy
SHA's media
centre
In line with main policy
HSE
NHS Counter
Fraud Service or
25/42
Stage 3
Stage 4
Stage 5
outbreak.
Risk and
Quality
Assurance
Committee.
The Chief Office As with Stage 1
for Governance
is the Trust's
Caldicott
Guardian,
therefore must
be advised of the
incident urgently.
The report
should be
approved at
the
Information
Governance
Steering
Group.
Serious Incident Requiring Investigation Policy
Example of Application
Specific
Stage 1
Notifications to
consider
•
Security
Management
Service
Any Health Improvement Notices.
Medical Devices.
MHRA
Stage2
In line with main policy
•
Any serious harm or potential serious The
harm, arising from the use of a medical
manufacturer
device.
Medico-legal incidents.
NHSLA
•
Suspicion of large scale theft which
may require police involvement.
Police
•
Potential legal claims against the
hospital due to a serious incident.
In line with main policy
NHS Security
Management
Service
•
Potential legal claims that may affect
national policy.
Mental Health, Substance Misuse, Learning
Difficulties related incidents.
•
Serious offences including homicide
committed by a person in receipt of mental
Version 1.2.1
CQC
Automatic SIRI
Police
In line with main policy
Probation Staff
26/42
Stage 3
Stage 4
Stage 5
Serious Incident Requiring Investigation Policy
Example of Application
Specific
Stage 1
Notifications to
consider
Stage2
healthcare.
•
Absence with out leave of a person
detained under the Mental Health Act (1983)
who are a danger to themselves or others.
•
A patient who is receiving inpatient
mental health care in a secure unit going
missing.
Mortality/Morbidity Care Incidents.
Coroner
•
Clusters of unexpected or unusual
deaths.
HSE
•
Deaths resulting in adverse
comments fro the coroner.
In line with main policy.
Police
Professional
bodies.
•
Suicide of any one in receipt of heath
care or having been discharged within the
last 12 months.
Premises and Equipment Incidents.
MHRA
•
Incidents causing serious damage to
healthcare premises.
HSE
•
In line with main policy.
NHS Security
Incidents resulting in serious harm to Management
Version 1.2.1
27/42
Stage 3
Stage 4
Stage 5
Serious Incident Requiring Investigation Policy
Example of Application
Specific
Stage 1
Notifications to
consider
individuals or serious disruption of services.
Service
Stage2
Stage 3
Stage 4
Stage 5
Automatic SIRI
As with Stage 1 The report
should be
approved at
the Infection
Prevention
and Control
Committee
before
presentation
to the Clinical
Risk and
Quality
Assurance
Committee.
•
Failure of equipment which could
endanger life, even if this does not occur.
•
Malicious damage to equipment or
property .
MRSA bacteraemia (each case)
Version 1.2.1
Fact finding
As with Stage 1
carried out by
a Consultant
Microbiologis
t or the
Infection
Prevention
and Control
Team
28/42
The CNO is the
executive lead
for infection
prevention and
control,
therefore must
be urgently
advised.
Serious Incident Requiring Investigation Policy
Example of Application
Specific
Stage 1
Notifications to
consider
Radiology.
MHRA
•
Severe equipment failure leading to
harm or death.
Royal College of
Radiologists
Screening Programme.
SHA screening
lead
•
Loss of test results.
•
Failure to detect cancer.
•
Incorrect notification of results to
patients or carers.
Staff Related.
•
Serious complaints about members
of staff.
•
staff.
Serious criminal acts by members of
•
Serious drug errors.
Professional
bodies
Stage 4
Stage 5
In line with main policy.
In line with main policy.
In line with main policy.
Any investigations into serious fraud will be led by the Trust Counter Fraud
National Clinical Specialist.
Assessment
Service
Police
NHS Counter
Fraud Service
•
Occupational
Health
Version 1.2.1
Stage 3
Relevant
Screening
Programme
Centre
•
Issue of competence (See Incident
Decision Tree, Appendix 7).
Serious fraud.
Stage2
29/42
Serious Incident Requiring Investigation Policy
Example of Application
Specific
Stage 1
Notifications to
consider
Unexpected death, serious harm or injury.
HSE
•
Including clusters of some lower
harm incidents.
Police
Violence towards healthcare staff.
Security
Management
Service
Version 1.2.1
Stage2
In line with main policy.
Coroner
In line with main policy.
30/42
Stage 3
Stage 4
Stage 5
Serious Incident Requiring Investigation Policy
Appendix 4
Core list of Never Events
A Never Event is a specific type of incident that has previously caused significant harm, and
has specific guidance which if fully implemented would prevent the incident from
happening.
Never Events will always automatically be SIRIs. Our Commissioners can impose financial
penalties if we have a Never Event.
Surgical Never Events
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 patient’s anatomy. This should be documented in the patient’s notes.
Please note that a severe patient outcome is not required for a wrong site surgery to be
classed as a Never Event.
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 judgement 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.
Please note that a severe patient outcome is not required for a wrong implant/prosthesis to
be classed as a Never Event.
3. Retained instrument 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.
SIRI draft Policy version 0.3
31/42
Serious Incident Requiring Investigation Policy
• Excludes where any relevant objects are found to be missing prior to the completion of
the surgical 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 patient’s notes and the patient informed.
Please note that a severe patient outcome is not required for a retained instrument postoperation to be classed as a Never Event.
Medication Never 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 events policy, which may vary from the NHS Aseptic Pharmacy Services Group
list, depending on local circumstances.
• The patient receives a wrongly prepared high risk injectable medication if it was not;
 prepared in accordance with the manufacturer's Specification of Product
Characteristics;
 prepared in accordance with a protocol formally agreed by the local organisation (for
example for off-label or unlicensed product use);
 prepared in accordance with patient specific directions of a prescriber 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.
5. Maladministration of a potassium-containing solution
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
administration given peripherally,
• infusion at a rate greater than intended.
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).
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.
8. Intravenous administration of epidural medication
SIRI draft Policy version 0.3
32/42
Serious Incident Requiring Investigation Policy
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
both parts A (updated) and B of the Safer spinal (intrathecal), epidural and regional devices
patient safety alert have passed.
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.
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.
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.
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.
SIRI draft Policy version 0.3
33/42
Serious Incident Requiring Investigation Policy
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 non
collapsible curtain or shower rails.
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.
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.
16. Entrapment in beds rails
Death or severe harm as a result of entrapment of an adult in bedrails that do not comply
with Medicines and Healthcare products Regulatory Agency (MHRA) dimensional guidance.
17. Transfusion of ABO-incompatible blood components
Death or severe harm as a result of the inadvertent transfusion of ABO-incompatible blood
components.
18. Transplantation of ABO incompatible organs as a result of error
Death or severe harm arising from inadvertent ABO mismatched solid organ
transplantation.
• Excluded are scenarios in which clinically appropriate ABO incompatible solid organs are
transplanted deliberately
• In this context, ‘incompatible’ antibodies must be clinically significant. If the recipient has
donor specific anti-ABO antibodies and is therefore, likely to have an immune reaction to a
specific ABO compatible organ then it would be a never event to transplant that organ
inadvertently and without appropriate management.
19. Misplaced naso- or oro-gastric tubes
Death or severe harm due to a misplaced naso- or oro-gastric tube being used where the
misplacement of the tube is not detected prior to commencement of feeding, flush or
medication administration.
SIRI draft Policy version 0.3
34/42
Serious Incident Requiring Investigation Policy
• Where appropriate checks are conducted and documented and demonstrate that the tube
is in the correct place, but the tube is subsequently found to have become misplaced, for
example after becoming dislodged, provided there has been regular checking of tube
placement, this is not a never event.
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 directly to a portable gas cylinder.
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).
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.
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,
SIRI draft Policy version 0.3
35/42
Serious Incident Requiring Investigation Policy
• printing several labels with patient details at one time.
This event does not apply to those units where wristbands are not used, for example some
mental health inpatient units (this requires local agreement).
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.
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 (e.g. from
kettles)
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.
SIRI draft Policy version 0.3
36/42
Serious Incident Requiring Investigation Policy
Appendix 5
Basic principles of Root Cause Analysis
1.
What is a root cause and root cause analysis?
A root cause is a fundamental cause which must be addressed in order eliminate or reduce
the highlighted risk or problem. For example, a root cause may illustrate a need for clearer
communication lines. Root causes have the following properties:

Underlying causes – the ones that if addressed would stop this type of
incident.

Can reasonably be identified

Are those for which effective recommendations must be generated to
prevent recurrence of the incident.
There are many academic definitions of what root cause analysis is, but in essence it is a
process that enables the root causes to be identified and then used to reduce future risks.
The following is one examples of RCA definitions:
“RCA “is a retrospective review of an event undertaken in order to identify what, how and
why it happened. The analysis is then used to identify areas for change, recommendations
and sustainable solutions, to help minimise the re-occurrence of the incident type in the
future.” (RCA training and tool kit section from the NPSA website.)
It can therefore by concluded that RCA is asking the following questions:

What happened?

Why did it happen?

How did it happen?

What can we learn from it?
These questions form the core element of investigations at BCH, and should be reflected in
any investigation undertaken.
2.
When can I do a RCA review?
This Policy outlines the process for investigating Serious Untoward Incidents and gives
responsibility to the Chief Medical Officer, supported by Risk Specialists at the Trust for
agreeing the level of investigation of SUI’s with our commissioners and families.
Incidents of other grades may be investigated using RCA in a process managed at local level.
Those investigations may draw on RCA as a technique and may be prompted by:

Review of an IR1 form or other report of an incident.

Complaints

Claims

Operational / Business review
SIRI draft Policy version 0.3
37/42
Serious Incident Requiring Investigation Policy

Finance review

Participation review
Investigations may take the form of a general review undertaken by any member of staff, or
be more formal, requiring an RCA meeting.
SIRI draft Policy version 0.3
38/42
Serious Incident Requiring Investigation Policy
Appendix 6
Suggested tools for RCA reviews
There are many tools and techniques for RCA sessions. It is strongly recommended that
staff attend the RCA training that is provided as part of Level 2 or Level 3 risk training. Please
contact the Education Department to book a slot.
The following are brief introductions and suggestions:
1. chronology of events
2. brainstorming
3. timelines
4. contributory factors checklists
5. cause and effect diagrams
6. fishbone diagram
7. time person grid
8. summary of the above
Staff are referred to the NPSA website which has a tool kit for staff to gain more knowledge
on RCA and the tools available.
1. Chronology of events:
A descriptive account of the risk / problem. This may be taken from the case notes,
statements and alike. A chronology of events given to participants at the start /
before the session is useful; however, the session may be concerned with seeking
others opinions on the chronology of events so may be done during the session. A
chronology of events is sometimes a good way to start a RCA report.
2. Brainstorming
Brainstorming is a group of people highlighting their suggestions or concerns. It is
designed to obtain the maximum number of ideas relating to a specific area of
interest. The aim is to end up with a list of raw ideas to use later on in the session,
so ideally should be undertake towards the start of the meeting.
3. Timelines
An essential tool for any investigation, a timeline is a visual representation of the
chronology and allows the investigator to discover points in the process where
problems may have occurred or where gaps in our understanding of the events may
exist. Especially useful if it tracks to point in time before the incident, for instance,
the point of admission, the point of referral etc.
4. Contributory Factors checklists
The NPSA has produced a checklist of possible contributory factors, reference to the
checklist when carrying out an analysis of the sequence of events can help ensure
SIRI draft Policy version 0.3
39/42
Serious Incident Requiring Investigation Policy
that we do not miss any possible causes of the incident. This is the most common
tool for carrying out RCA in our Trust.
5. Cause and effect
A cause and effect diagram is a tool that helps identify, sort and display possible
causes of a specific problem. It graphically illustrates the relationship between a
given outcome and all the factors that influence the outcome. Constructing a cause
and effect diagram can help your team when you need to:
•
identify the possible root causes
•
Understand the interactions among the factors affecting a particular process
of effect.
•
Analyse existing problems so that corrective action can be taken.
6. Fishbone diagrams
This type of diagram is sometimes called an “Ishikawa diagram” because it was
invented by Kaoru Ishikawa, or a ‘fishbone diagram’ because of the way it looks. This
is a very useful tool when the incident is complex and there are many possible
contributory factors. The tool is used for drilling down into the contributory factors
to identify root causes.
7. Time person grid
This allows you to graphically put together what happened during a short time
period and is good for highlighting in a report specific items and timings and the
actions taken by individuals at those times. The basic layout is available on the
Governance intranet site.
The basic layout of a cause and effect diagram and the NPSA fishbone are available on the
Governance intranet site, alongside the contributory factor framework used in the NPSA
methodology
8. Characteristics of some RCA tools
The following are a few of the pros and cons for each of the above tools:
Chronology of events
Tells the story of what happened in a logical
format.
Key points may get lost
Timelines
Can view the event in one diagram
Difficult to use for long time period
Brainstorming
Quick
Can be unstructured and strong characters
dominate
Cause & effect
Good if problem areas are known
Specific and may limit the review
SIRI draft Policy version 0.3
40/42
Serious Incident Requiring Investigation Policy
Time person grid
Can see where people are
Person focused
Fishbone
9 contributory factors in one tool
Can use headings as topics for discussion
General and time consuming.
SIRI draft Policy version 0.3
41/42
Serious Incident Requiring Investigation Policy
Appendix 7
Incident Decision Tree
START
HERE
Were the actions
as intended?
ILL HEALTH
NO
Does there appear
NO
to be evidence of
ill health or
substance misuse?
YES
YES
Were adverse
consequences
intended?
YES
NO
Did the individual
YES
know they have a
medical condition?
NO
FORESIGHT
TEST
Did the individual
knowingly depart
from agreed
protocols or safe
procedures?
SUBSTITUTION
TEST
NO
YES
NO
Were the protocols and
safe procedures available,
workable, intelligible,
correct and in routine use?
Were there any
deficiencies in training
and selection or
experience?
YES
Is there evidence
of reckless
behaviour?
NO
Guidance on appropriate
management action
required, please refer to
Human Resources. RCA may
be required.
YES
SYSTEM
INDUCED
ERROR
YES
NO
YES
Guidance on appropriate
Guidance on appropriate
management action
management action
required, please refer to
required, please refer to
Human Resources. RCA may
Human Resources.
RCA may
SIRI draft Policy
version 0.3
be required.
be required.
Would another individual
coming from the same
professional group,
possessing comparable
qualifications and experience
behave in the same way?
RCA required
Were there mitigating
YES
circumstances, e.g.
root causes promoting
protocol violations?
NO
Guidance on appropriate
management action
required, please refer to
Human Resources. RCA may
be required.
42/42
Birmingham Children’s Hospital NHS Foundation Trust – Risk Management Manual 2008/2009
Risk Management Manual
Version:
1.0.1
Ratified by:
Clinical Risk & Quality Assurance
Date ratified:
April 2008
Name of originator/author:
Michelle Errington
Name of responsible committee/individual:
Risk Manager
Date issued:
April 2008
Review date:
April 2011
Target audience:
All Trust Staff
1
Birmingham Children’s Hospital NHS Foundation Trust – Risk Management Manual 2008/2009
1.0 Contents Page – Risk Management Manual
1.0
2.0
3.0
4.0
5.0
6.0
7.0
8.0
1.0
2.0
3.0
4.0
5.0
6.0
7.0
8.0
9.0
1.0
2.0
3.0
4.0
5.0
6.0
7.0
8.0
9.0
10.0
11.0
12.0
13.0
14.0
Ap 1
Ap 2
Ap 3
Ap 4
Ap 5
Introductory Section
Contents page
Policy Statement
Introduction to Risk Management Manual
Purpose
Definitions used in risk Manual
Implementation and Dissemination plan for this Manual
Monitoring of this Manual
References for Introductory Section
PART A – Risk Strategy
Forward
Introduction
Trust risk management vision
Roles and responsibilities for delivery of this strategy and risk
management agenda
Training for senior management, board members and executives
Process for Board review of the risk register
Performance review of risk management by the board
Process for the management of risk at local level, including authority
of line managers
Monitoring of part A – risk strategy
Part B – Incident Reporting, including Serious Untoward
Incidents and Being Open.
Introduction
Purpose
Objectives
Definitions
Duties
Communication and notification
Completion of IR1 forms and linking to the complaints and claims
process
Incident investigation
Serious Untoward Incidents
Incident and causal factor analysis
Hotline arrangements
Being Open
Monitoring part B
References
Appendix one – incident form procedural guidelines
Appendix two – statement writing guidance
Appendix three – flowchart for triggering an SUI
Appendix four – Hotline forms
Appendix five – Quick reference guide for being open
Page 2
Page 12
Page 21
2
Birmingham Children’s Hospital NHS Foundation Trust – Risk Management Manual 2008/2009
1.0
2.0
3.0
4.0
5.0
6.0
7.0
8.0
9.0
10.0
11.0
12.0
Ap 1
1.0
2.0
3.0
4.0
5.0
6.0
7.0
8.0
9.0
10.0
Ap1
Ap 2
Part C – Investigation / Root Cause Analysis Guidance
Forward
Introduction
Why are investigations necessary and what is RCA?
When do I do a RCA review?
Ir1 forms and RCA reviews
Trust RCA reviews
RCA reviews and complaints
RCA reviews and claims
Suggested tools for RCA reviews
Staff responsibilities
Monitoring of Part C
References
Appendix one – Contributory factors classification framework
Part D – Risk Assessment and Risk Register
Introduction
Defining risk
Procedures and process for undertaking a risk assessment
Risk register
Staff responsibilities and review at trust level
Staff training and information
Trust review of risk assessment / risk register
Extreme risks
Monitoring of part D
References
Appendix one – Risk scoring system 2008
Appendix two – Proforma for risk assessments
Page 51
Page 69
3
Birmingham Children’s Hospital NHS Foundation Trust – Risk Management Manual 2008/2009
2.0 Policy Statement
The Birmingham Children’s Hospital (BCH) NHS Foundation Trust is committed to the
active management of risk and is dedicated to establishing an organisational culture
that ensures that risk management is an integral part of everything it does. Risk
management will be a key part of all management systems and corporate planning as
well as the setting of strategy and objectives. The Trust takes the view that it is
unacceptable to reach other objectives at the expense of safety.
The objective of the Trust is to provide a responsive, high quality service to patients.
This is achieved by promoting a policy of openness and accountability and by
effective communication with the local community. The continued delivery of such
quality requires BCH to identify, manage and reduce the effect of events or activities,
which could result in a risk to patients, staff and the community.
The management of such risks is a key organisational responsibility across the Trust,
and at all levels. All managers and clinicians accept the management of risks as one
of their fundamental duties. Additionally every member of staff must be committed to
identifying and reducing risks. This is best achieved through an environment of
honesty and openness, where mistakes and untoward incidents are identified quickly
and dealt with in a positive and responsive way.
4
Birmingham Children’s Hospital NHS Foundation Trust – Risk Management Manual 2008/2009
3.0 Introduction to Risk Management Manual
This risk management Manual has been written to assist staff in using the principles and tools of
risk management in their day to day roles as well at strategic and operational level. The Manual is
divided into four parts, with part A focused on the risk management strategy, and parts B, C and D
focused on risk management in practice. Although each part of the Manual focuses on one aspect
of risk, staff are reminded that each part links in with the others and therefore must be considered
as a whole.
PART A
Risk Management Strategy
PART B
Incident Reporting, including Serious Untoward Incidents and Being Open
PART C
Investigation / Root Cause Analysis Guidance.
PART D
Risk Assessment and Risk Register Guidance
Each part of the Manual includes the duties for staff, and how monitoring is to be undertaken. The
dissemination and implementation of the Manual is outlined in this introductory section.
The Manual focuses on risks, claims, and complaints, which are collectively called INCIDENTS
within this Manual. Staff are referred to the following personnel if they require specific detail
relating to a claim, complaint or risk:
Chief Medical Officer
Ext 8077
Director of Healthcare Governance & Education
Ext 8433
Head of Legal and Corporate Affairs
Ext 8423
Health, Safety and Security Manager
Ext 8431
Risk Manager
Ext 8959
Patient Interface Manager
Ext 8419
Moving and Handling Advisor
Ext 8953
Claims, complaints and risks are discussed further in the Learning from Experience Policy.
4.0 Purpose
The Trust has a statutory responsibility to patients, parents, public and commissioners to ensure
that it has effective processes, policies and people in place to deliver its objectives and to control
any risk that it may face in achieving these objectives. The Trust will take all steps (reasonably
practicable), in the management of risk with the overall objective of protecting patients, staff,
members of the public and its assets. The Trust’s primary concern is the provision of safe, minimal
5
Birmingham Children’s Hospital NHS Foundation Trust – Risk Management Manual 2008/2009
risk environments and services, achieved through a structured approach to risk assessment and
minimisation across the organisation.
The aim of this Manual is to ensure that the Trust has a risk management approach that:
 ensures the safe delivery of health care within the available financial resources and






other resource limits;
ensures compliance with national statutory requirements;
ensures there is a standardised, systematic mechanism to identify, assess, control and
minimise risks across the organisation, principally through the further development and
maintenance of a Trust risk register;
enables staff to undertake risk management as part of their every-day activities;
ensures staff use the principles and practice of risk management, including root cause
analysis and risk assessment;
supports the organisation with continually improving services through the principles of
risk management.
ensures that the principles of being open are utilised.
5.0 Definitions used in risk Manual
A list of definitions is found at the start of Part B, C and D of the Manual and outlines definitions
relevant to that part. The following is a list of all key definitions used within all of the Manual.
Risk Management Is the assessment, analysis and management of
risks. It is simply a way of recognising which events
(hazards) may lead to harm in the future, and
minimising their likelihood of occurrence (how
often?) and consequence(s) (how bad?).
NPSA (January
2008) A risk
matrix for risk
managers
Integrated Risk
Management
NPSA (July 2004)
Seven steps to
patient safety.
The full reference
guide.
Patient
Incident
Is the process of identification, assessment, analysis
and management of all risks and incidents for every
level of an organisation, and aggregation of the
results at a corporate level. This facilitates prioritysetting and improved decision making to reach an
optimal balance of risk, benefit and cost.
Safety A patient safety incident is any unintended or
unexpected incident which could have or did lead to
harm for one or more patients receiving NHS care. It
is a specific type of adverse event.
NPSA website.
Hazards
Are situations with the potential to cause harm
NPSA (March
2007) Healthcare
risk assessment
made easy
Likelihood
The likelihood score is a reflection of how likely it is
that the adverse consequence described will occur.
NPSA (January
2008) A risk
matrix for risk
managers
Consequence
The outcome or the potential outcome of an event.
NPSA (January
6
Birmingham Children’s Hospital NHS Foundation Trust – Risk Management Manual 2008/2009
There may be more than one consequence of a
single event.
2008) A risk
matrix for risk
managers
Adverse incident
Is any event or circumstance leading to unintentional
harm or suffering.
NPSA (January
2008) A risk
matrix for risk
managers
Near Miss
Incidents that have been prevented (also known as
near misses).
NPSA Seven
Steps to Patient
Safety April 2004
Control measures Risks are usually analysed by combining estimates
of consequence and likelihood in the context of
existing controls measures. (e.g. policies, guidelines
and so on).
Action
plan
treatment
Guidelines for
managing risks in
healthcare.
(2000) Standards
Australia
International
Sydney
/ Risk Treatment is the process of selecting and
implementing of measures to modify risk. Risk
treatment measures can include avoiding,
optimizing, transferring or retaining risk. Treatment
is more commonly known as action plans.
Safety Culture
The safety culture of an organisation is the product
of individual and group values, attitudes,
perceptions, competencies and patterns of behaviour
that determine the commitment to, and the style and
proficiency of, an organisation's integrated risk
management system.
Harm
The severity of a loss which has occurred to people,
property or the organisation.
Investigation
The collection of information to enable a review to be
undertaken and to determine learning outcomes and
what we did well.
Causal Factors
The factors which contribute to the incident, and are
sometimes known as contributory factors.
Risk Reduction
The process of reducing the likelihood that harm will
occur to the lowest possible level.
Inherent Risk
This is a permanent or currently unavoidable risk that
is associated with a particular event / task / practice.
The risk that should be targeted when an inherent
risk is noted, is the risk that is added to the inherent
risk, e.g. poor communication or teamwork.
NPSA (March
2007) Healthcare
risk assessment
made easy
Risk Assessment
A risk assessment is simply a careful examination of
Health and Safety
Health and Safety
Executive HSE65
(2003)
7
Birmingham Children’s Hospital NHS Foundation Trust – Risk Management Manual 2008/2009
what, in your work, could cause harm to people, so
that you can weigh up whether you have taken
enough precautions or should do more to prevent
harm
Executive – Risk
management part
of website.
www.hse.gov.uk
Risk Score
Is the combination of likelihood and consequence.
The risk scores are not intended to be precise
mathematical measures of risk but they are useful for
prioritising control measures.
NPSA (March
2007) Healthcare
risk assessment
made easy
Residual risk
Residual risk is a risk that remains after Risk
Management options have been identified and action
plans have been implemented. It also includes all
initially unidentified risks as well as all risks
previously identified and evaluated but not
designated for treatment at that time.
Low Risk Scores Quick, easy measure implemented immediately and
between 1 and 10 further action planned for when resources permit.
and is the green
colour on the risk
matrix.
NPSA (March
2007) Healthcare
risk assessment
made easy
Moderate
Risk Actions implemented as soon as possible, but no
scores between 11 later than a year.
and 16 and is the
yellow colour on
the risk matrix.
NPSA (March
2007) Healthcare
risk assessment
made easy
High Risk scores Actions implemented as soon as possible, but no
between 17 and 19 later than 6 months.
and is the orange
colour on the risk
matrix.
NPSA (March
2007) Healthcare
risk assessment
made easy
Extreme
Risk Requires urgent action. The Trust board is made
scores between 20 aware and actions are undertaken as soon as
and 25 and is the possible.
red colour on the
risk matrix.
NPSA (March
2007) Healthcare
risk assessment
made easy
Root Cause
Analysis
RCA “is a retrospective review of a patient safety
incident undertaken in order to identify what, how
and why it happened. The analysis is then used to
identify areas for change, recommendations and
sustainable solutions, to help minimise the reoccurrence of the incident type in the future.”
RCA training and
tool kit section
from the NPSA
website
8
Birmingham Children’s Hospital NHS Foundation Trust – Risk Management Manual 2008/2009
6.0 Implementation and Dissemination plan for this Manual
Action
Launch of Risk Management Manual:





Timescale
October
2008
Risk Manager / Health,
Safety and Security
Manager
April 2008
onwards
Via Trust Intranet
Trust P Drive
Governance Bulletin
Copy sent to Executive Team, Directorate
Management Teams and Heads of
Departments
Staff information:

Lead
Risk Manager
Risk Awareness in Governance Support
Training
Key facts from Manual in staff risk
management leaflet (included in new staff
induction program)
7.0 Monitoring of this Manual
The overall responsibility for the monitoring of this Manual belongs to the Risk Manager.
8.0 References
NPSA (2004) Seven Steps to Patient Safety
9
Birmingham Children’s Hospital NHS Foundation Trust – Risk Management Manual 2008/2009
Risk Management Strategy
PART A of the Risk
Management Manual
1.0 Forward
This strategy outlines the principles of risk management and the Trust’s collective responsibilities
and risk management structure. This will enable the Trust to deliver its objectives and meet its
statutory requirements. It also forms a key component of the Trust’s overall approach to
Governance. This strategy is supported by Part B, C and D of the risk management Manual which
outlines guidance for staff on the procedural aspects of risk management. That is,
B – incident reporting including serious untoward incidents and being open
C – investigations and root cause analysis
D – risk assessment and risk register
2.0 Introduction
For the purposes of this strategy, risk is defined as “anything which prevents an organisation
from achieving its declared aims and objective” and Risk Management can be considered
as the systematic processes and procedures that an organisation puts in place to ensure
that it identifies, assesses, prioritizes and takes action to manage these risks to ensure it
continues to deliver its objectives.
The Trust has a statutory responsibility to patients, parents, the public and commissioners to
ensure that it has effective processes, policies and people in place to deliver its objectives and to
control any risks that it may face in achieving these objectives.
The need for the organisation to have effective risk management systems and processes in place
is governed by the following key requirements:

Statutory Controls Assurance Statement of Internal Control - One of the principle
approaches that the Department of Health requires organisations to use as an assurance of
this, is to produce an annual Statement of Internal Control, signed by the Chief Executive. This
statement is produced as part of the Trust’s annual report and must be signed by the Chief
Executive. It aims to demonstrate that the organisation is doing its “reasonable best” to
manage its affairs efficiently and effectively through the implementation of internal controls to
manage risk, (HSC 2001/005. Governance in the new NHS: Controls Assurance Statements
2000/2001).

1999 Health Act – Following the introduction of the Health Act 1999 (and the preceding
publication A First Class Service 1998), a statutory duty for the quality of care was imposed on
all Chief Executives and Trust Boards throughout the NHS. For the first time since the
creation of the NHS, an equal emphasis of statutory duty was placed on quality and finance.
10
Birmingham Children’s Hospital NHS Foundation Trust – Risk Management Manual 2008/2009
This duty explicitly described the need for organisation to have effective risk management
systems in place to maintain a safe system of care for patients and public.
3.0 Trust risk management vision statement
The Trust’s strategy aims to deliver pragmatic and effective multi-disciplinary approach to Risk
Management, which is underpinned by a clear accountability structure from Board to Practitioner
level.
It recognises the need for robust systems and processes to support continuous programmes of
Risk Management, enabling staff to integrate Risk Management into their daily activities, where
possible.
Delivery of the strategy will support the development of continuous improvements in care and
practice, recognising that these may only be incremental changes over a period of time. It will
produce clear outcomes, which can be measured against targets and performance indicators to
ensure national and local standards are achieved.
The Trust will continue to work towards an integrated governance agenda. This risk management
strategy will contribute to supporting this. It will enable the Trust to achieve and maintain high
levels of accreditation against the NHSLA standards for clinical and non-clinical claims, risk
management and complaints management.
The Trust will endeavour to proactively involve patient, parents and the public to create a ‘real’ user
involvement where appropriate. Other key partners and stakeholders will be encouraged to
participate in initiatives that foster a multi-professional, multidisciplinary and multi-agency
approach.
Staff will be encouraged and supported to share learning and best practice in a way that creates a
culture of open supportive learning with accountability, even when mistakes have been made.
Knowledge will be seen as a cornerstone of building safer care in the future and the Trust will work
to adopt and provide a proactive knowledge management infrastructure.
4.0 Roles and responsibilities for delivery of this strategy and the risk management agenda
This section of the strategy identifies the roles and responsibilities of key individuals and
committees, highlighting accountability levels at each stage. It provides a brief synopsis of key role
and key committees. Further details on staff and committee responsibility can be found in parts B,
C and D of the risk management Manual.
4.1
Role responsibilities
The Trust Board, managers and staff are responsible for establishing, maintaining and supporting
a holistic approach to risk management, in all areas of their responsibility. They should comply
with the Trust Risk Management policy and procedures and ensure effective risk management
mechanisms are implemented in accordance with these. Some members of staff and Committees
have particular specialist functions in relation to risk management as described below.
4.1.1
Chief Executive
The Chief Executive has overall responsibility for the Trust’s risk management programme
and ensuring that this operates effectively. As Accountable Officer, he is responsible for
signing the Statutory Statement of Internal Control. Although operational responsibility for
11
Birmingham Children’s Hospital NHS Foundation Trust – Risk Management Manual 2008/2009
risk management is delegated to all Executive Directors, the Chief Medical Officer and
Director of Governance and Education have lead responsibilities in these areas.
4.1.2
Chief Medical Officer
The Chief Medical Officer is responsible to the Trust Board and Chief Executive in relation
to clinical risk management and provides quarterly reports to the Integrated Governance
Committee and in turn the Trust Board in this regard. The Director of Healthcare
Governance and Education assists with the performance of his/her duties. The Chief
Medical Officer has a particular role in overseeing the provision of internal clinical advice in
relation to risk management.
4.1.3 Director of Healthcare Governance and Education
The Director of Healthcare Governance and Education is responsible for the risk
management strategy within the Trust, and for the direction of the Risk Management
Department generally. He/she will regularly report to the Chief Medical Officer, to the
Integrated Governance committee and to the Trust Board in relation to risk management
activities (in particular adverse incident report and risk register status), and will liaise with
other senior members of the Trust as required. In addition the Director of Healthcare
Governance and Education has responsibility for developing the assurance framework.
Utilising the assistance of other senior managers within the Trust as appropriate, the
Director of Healthcare Governance and Education will oversee the work of the Trust Risk
Manager.
4.1.4
Executive Directors
All Executive Directors are responsible for overseeing a programme of risk management
activities, in accordance with the Trust’s risk management policies and procedures and
advising the Chief Medical Officer and Director of Healthcare Governance and Education
on risk issues in areas of their responsibility. By working closely together these individuals
will ensure an integrated and holistic approach to the Trust’s risk management activities.
All Directors are members of the Integrated Governance Committee.
4.1.5
Non-executive Directors
All Non-executive Directors are responsible for assuring themselves that the systems of
internal control, including Clinical Governance and financial management, are properly
established and that appropriate systems of risk management are in place.
4.1.6
All Staff
All staff across the Trust have a responsibility to ensure they comply with local risk
management strategies, policies and procedures.
4.2.
Committee responsibilities
4.2.1
Trust Board
The Trust Board is responsible for assuring that appropriate risk management systems are
in place to enable the organisation to deliver its objectives. It will delegate operational
12
Birmingham Children’s Hospital NHS Foundation Trust – Risk Management Manual 2008/2009
responsibility for the delivery of risk management to the Integrated Governance Committee
and Clinical Risk and Quality Assurance Committee.
4.2.2
Integrated Governance Committee
The Integrated Governance Committee, which is chaired by the Chief Executive, is
responsible for ensuring that individual Directorates, through the Integrated Governance
Executive Committee structure, undertake a full programme of risk management activities,
maintain up-to-date risk registers and take action to control these risks. It is responsible for
reviewing these risks on a quarterly basis. It has a particular role in overseeing the
management of risks that have significant funding implications and/or are Corporate/Trustwide in nature.
4.2.3
Integrated Governance Executive Committees
The Executive Committees consist of:







Clinical Risk and Quality Committee
Staff and Environment Committee
Asset Management Committee
Research and Development Committee
Information Governance Committee
Information Management & Technology Committee
Patient, Parents and Public involvement Committee
These Committees are responsible for risk management in relation to their individual areas
of specialism and are responsible for advising the Integrated Governance Committee Board
on risks in these particular areas.
4.2.5
Audit Committee
The Audit Committee, through the Internal Audit Department is responsible for monitoring
and reviewing the adequacy the Trust’s internal control systems for risk management and,
ensuring that these are effective and comply with the national standards.
4.2.6
Clinical Risk and Quality Assurance Committee
This committee is responsible for ensuring that all clinical risks are reviewed and actioned
in an appropriate manner. The committee is chaired by the Chief Medical Officer and the
vice chair is the Director of Healthcare Governance and Education. Information from this
meeting is cascaded to the executive management committee and Trust Board.
The committee is attended by the directorate clinical directors who are responsible for
cascading information back to the directorates.
4.2.7
Non Clinical Risk Co-ordinating Committee
This committee is responsible for ensuring that all non clinical risks are reviewed and
actioned in an appropriate manner. The committee is chaired by the Director of Healthcare
Governance and Education. Information from this meeting is cascaded to the integrated
governance meeting, executive management committee and Trust Board.
13
Birmingham Children’s Hospital NHS Foundation Trust – Risk Management Manual 2008/2009
4.2.8
Drugs and Therapeutic Committee
This committee’s responsibilities include ensuring that all appropriate risks and incidents
are reviewed in an appropriate manner. The Information from this meeting is cascaded to
the clinical risk and quality assurance committee via a subcommittee report. The Chief
Pharmacist is responsible for producing and maintaining the Trust Medicine’s Policy. This is
reviewed by the Drug and Therapeutics Committee which reports to the CRQAC. The
Policy will include the following topics: Prescribing, Storage and dispensing and
Administration of Medicinal Products. It will be compliant with Statutory Regulations and
Policies, Guidelines and Advice published by the Department of Health, National Institute
for Clinical Excellence, Medicines’ Healthcare Regulatory Agency, National Patient Safety
Agency and other relevant bodies. The policy is approved by the Drug and Therapeutics
Committee
5.0 Training for senior management - Board members and Executives
Full details for risk management training are outlined in the risk management training needs
analysis.
All staff are required to attend mandatory Governance Training or otherwise meet the learning
outcomes of that session. Alternatives methods to meet these learning outcomes for Senior
Managers (Executive Team and Board) will be defined by the Director of Governance and
Education. Examples of existing types of alternative training are outlined below.
Method of delivery
Annual update of risk
management policies at Trust
Board and Executive
Management Team meetings
Aim
To provide an awareness of the
policy contents and developments:
Annual Risk Register updates
and developments at Trust
Board and Executive
Management Team meetings
To provide an awareness of the risk
assessment and risk register
process and concept.
By whom
Director of Healthcare
Governance and
Education
Risk Strategy
Risk Reporting
Risk Assessment
Serious Untoward Incidents
Integrated Risk Management
And other related topics
Director of Healthcare
Governance and
Education
Follow up of non compliance against the defined learning outcomes is undertaken on an annual
basis by the Director of Governance & Education. Follow up of non attendance is via a letter from
the Director of Governance & Education. Information from this meeting is passed to the Education
Department and attendance is entered onto the Trust database for staff training.
14
Birmingham Children’s Hospital NHS Foundation Trust – Risk Management Manual 2008/2009
6.0 Process for Board review of the Risk Register
The risk register can be described as a ‘log of all risks that may threaten the success of the Trust in
achieving its declared aims and objectives.” The risk register is populated by reviews undertaken
at Department, Directorate and Trust level.
The information entered at department level is entered into the assurance framework and Trust risk
register, via two ways. Firstly, those which are scored 20 or 25 on the department risk registers
and secondly via information provided by the monthly risk register review meeting led by the Chief
Medical Officer.
Trust board information is presented by the Director of Governance and Education, who is
responsible for ensuring that the Trust Board receives its information in a timely and effective
manner.
The board is responsible for reviewing, actioning and validating these risks and for cascading
information to the subcommittees/ directorates for follow up.
7.0 Performance review of Risk Management by the Board
The Trust will utilise the following tools to support performance review:









NHSLA Risk Management Standards
NHS high-level performance indicators
Benchmarking activity
Internal standards
Use of risk management tools by departments
Compliance with mandatory induction and training standards
Incident investigations and complaints
Patient and staff attitude surveys
Standards for Better Health
The Trust Board may develop and use additional indicators to monitor risk management
performance, as considered necessary.
8.0 Process for the management of risk at local level, including authority of managers
Full details on the following processes can be found in the remainder of this Manual and the
Learning from Experience Policy.
8.1 Learning from experience
The concept of learning from experience plays a key role within risk management and is one which
is echoed throughout this Manual. All risk management activity at both local and corporate level
must endeavour to incorporate this philosophy to ensure that the hospital maximises the benefits of
the risk management and governance systems. This in turn will aid the Trust in meeting its
corporate objectives and aims.
At local level the key activity for staff is to share lessons learnt and to incorporate incidents, claims,
complaints and PALS information in their action plans. Staff are aided with a quarterly directorate
patient experience report and monthly risk management reports which are sent to each directorate.
15
Birmingham Children’s Hospital NHS Foundation Trust – Risk Management Manual 2008/2009
It is the responsibility of the directorate management teams and heads of departments to ensure
that staff adopt this approach in their day to day activities.
8.2 Being open
The being open process is outlined in Part B of the risk management Manual.
This process is aimed at improving communication between healthcare professionals with other
staff, external agencies and patients and their relatives, with the ultimate aim an improvement in
patient safety. All staff are encouraged to be open and say sorry for any incidents or near misses
and explain what happened. Local managers are encouraged to support staff in this process. This
is complimented by the staff support policy following incidents.
The principles which staff are provided with follow the national patient safety agency (NPSA)
guidance and are fully supported by the royal colleges and professional organisations.
8.3 Risk Assessment / Risk Register
The risk assessment process and risk register is outlined in Part D of the risk management
Manual.
All staff are responsible for completing risk assessments appropriate to their area. Risks are
registered onto the department risk register and actioned appropriately to reduce the residual risk
score. Risks which are noted as high risk or extreme risk (20 and 25 scores) are notified to the
appropriate line manager and the directorate management team. The Risk Manager is informed
within 24 hours or the next working day, who informs the appropriate Director for action / review at
the appropriate Trust subcommittee and / or Trust board. This cascade of information applies to
action points which are to be taken at Trust level and those which departments and directorates
are unable to complete or require advice.
Trust board is informed of Directorate risks via reports to the clinical risk and quality assurance
committee and the non clinical risk committee. These reports are presented quarterly and enable
discussion, review and validation of risks.
8.4 Incidents, external stakeholders and communication
Information for incident reporting and serious untoward incidents is found in part B and C of the risk
management Manual.
All staff are responsible for completing incident report forms for incidents and near misses in their
area and day to day work. These forms are reviewed at local level and actioned appropriately.
Those which are potential claims or complaints are forwarded to the appropriate manager in the
Governance department. The principles of being open are followed as required.
All investigations follow the principles of root cause analysis, to ensure that all lessons to be learnt
are identified and that good practice is acknowledged. This information forms the basis of the
action plans and recommendations.
Incidents and near misses which are serious untoward incidents are notified to the Risk Manager
within 24 hours or the next working day. The process is commenced immediately and external
stakeholders informed as outlined in the Manual.
16
Birmingham Children’s Hospital NHS Foundation Trust – Risk Management Manual 2008/2009
Lessons learnt from serious untoward incidents and significant risks highlighted at local level are
shared with the rest of the Trusts staff via the risk mail and risk alert system which is coordinated
by the Risk Manager.
8.5 Authority of line managers
All line managers are responsible for ensuring that their staff remain risk aware and that they apply
the general principles of risk management to their day to day roles. Managers are therefore
responsible for:






Sifting incidents to ensure that only appropriate incidents and near misses are reviewed in
detail and for ensuring that serious untoward incidents are reported immediately.
Complaints and claims processes highlighted in the appropriate policy are included within
their risk management processes
Relevant risk assessments are undertaken and entered onto the department risk register
and escalated to the appropriate personnel for information, review or action.
Principles of root cause analysis are used for investigations
Lessons learnt are shared with staff and others department / Trust which have been
identified in any risk management process
Ensuring that staff are supported for the being open process
9.0 Monitoring the effectiveness of Part A.
Item for
monitoring
Structure of
committees
responsible for the
co-ordination of
risk.
Process for the
board review of the
organisation wide
risk register
Purpose of
monitoring
Ensure that the
committees are
meeting the
requirements of the
Terms of Reference.
To ensure escalation
of appropriate risks to
Board.
Process for
monitoring
Audit performance
against terms of
reference and action
plan accordingly.
Monitoring by
whom and when?
Governance team
Annual
Minutes of trust boards
meetings confirming
review of the
Assurance Framework
and confirming receipt
of reports from these
committees with
responsibility for coordinating risk.
Board
Ongoing
Process for
management of
risk locally
To ensure that there
effective local risk
management.
100 IR1 audit to
demonstrate that all
areas are reporting
incidents
Risk Manager
Annual
Risk Register Review
to ensure that all areas
are registering risks
Risk Manager
Annual
Directorate Risk
Reports in accordance
with the reporting
Directorate
management
Teams
17
Birmingham Children’s Hospital NHS Foundation Trust – Risk Management Manual 2008/2009
committee framework
outlined within the
Learning from
Experience Policy
Duties of key staff
Authority of all
managers
regarding risk
management
To ensure that key
staff meet their
obligations as defined
in this Manual.
To ensure that
managers participate
within the risk
management systems
and enable staff to
incorporate these
systems within their
daily activities.
Quarterly
Audit performance
against terms of
reference and action
plan accordingly.
Governance team
Annual
100 IR1 audit to
demonstrate that all
areas are reporting
incidents
Risk Manager
Annual
Risk Register Review
to ensure that all areas
are registering risks
Risk Manager
Annual
Directorate Risk
Reports in accordance
with the reporting
committee framework
outlined within the
Learning from
Experience Policy
Directorate
management
Teams
Annual Review of
Serious Untoward
Incident Investigations
Risk Manager
100 IR1 audit to
demonstrate that all
areas are reporting
incidents
Risk Manager
Annual
Risk Register Review
to ensure that all areas
are registering risks
Risk Manager
Annual
Directorate Risk
Reports in accordance
with the reporting
committee framework
outlined within the
Learning from
Experience Policy
Directorate
management
Teams
Quarterly
Annual
Quarterly
18
Birmingham Children’s Hospital NHS Foundation Trust – Risk Management Manual 2008/2009
Incident Reporting, including Serious
Untoward Incidents & Being Open
PART B of the Risk Management Manual
1.0 Introduction
The Birmingham Children’s Hospital NHS Foundation Trust (BCH) is committed to providing high
quality patient care within a safe environment, with one aspect of this commitment: learning from
our experiences which are highlighted via the incident reporting system, claims and complaints
which is collectively called INCIDENT in this Manual.
BCH has recognised the value of incident reporting, and stresses the importance of consistent
monitoring and review of incidents which resulted, or had the potential to result in injury, damage or
other loss. BCH therefore aims to develop its current systems and facilitate a wider organisational
learning process and to be open. BCH believes that risk management is the responsibility of all
staff, from the board to the practitioner. The board is committed to developing an open and honest
environment and learning from the hospitals lessons.
This policy is part of the risk management Manual and should be read in conjunction with
the other parts.
2.0Purpose
It is the policy of BCH to record all incidents, claims and complaints (known as incidents in this
policy) which have resulted in injury or loss or have the potential to do so. With these reported to
an appropriate person in a timely manner to ensure that they are reviewed at local level. This
applies to incidents affecting patients, directly employed staff and others including visitors,
contractors and volunteers. This will enable lessons to be identified and action points to be noted
and implemented. Incidents which fit the serious untoward incident (SUI) criterion must be notified
within 24 hours or the next working day.
“An Organisation with a Memory” (Department of Health 2000) has firmly established the need for
better reporting systems across the health service and demonstrated the impact of such systems
on safety in other industries. The analysis and investigation of incidents form an integral part of the
strategy for risk management and is therefore fully supported by the board and executive team.
In line with the National Patient Safety Agency (NPSA) safer practice notice BCH will be open
when patients are harmed and ensure that the organisation and individuals try to make amends to
the injured party for any hurt caused. In addition it will report all appropriate incidents to it host
PCT (Heart of Birmingham) and the NPSA database, along with other appropriate regulatory
bodies.
19
Birmingham Children’s Hospital NHS Foundation Trust – Risk Management Manual 2008/2009
3.0Objectives
The following are the objectives of incident reporting for BCH:
BCH has a statutory duty to report certain kinds of accidents, violent incidents, dangerous
occurrences and occupational ill health under the Health and Safety at Work Act 1974 and more
specifically in accord with the Reporting of Injuries, Diseases and Dangerous Occurrences
Regulations (RIDDOR) 1995. It is also required to report certain incidents to a national body, e.g.
Medicine and Healthcare products Regulatory Agency (MHRA), NHS estates, National Patient
Safety Agency (NPSA) and the Counter Fraud and Security Management Service (CFSMS) within
a specific timeframe.
BCH seeks to promote a positive and non-punitive culture for incident reporting so that individuals
and BCH can learn from incidents, so long as there has been no flagrant disregard to the Trust
Policies, repetitious incidents, fraud or gross misconduct, or knowingly been involved in an incident
but failed to report it or cooperate with the investigation. It is the duty of all staff to be aware of and
understand the basic concepts of this and other risk management policies.
BCH seeks to ensure that when patients, carers or the public are harmed by the actions of the
Trust they will make every effort to be open in explaining what has occurred, and what action can
be taken to prevent it happening again.
The risk management team within governance services is responsible for ensuring that the incident
reporting system is maintained and for producing monthly Directorate summary reports for their
review and action. This is complemented with a quarterly Trust report for both Clinical Risk and
Quality Assurance Committee and Non Clinical Risk Committee for review and action, which are
part of the patient experience reports (incidents, claims, complaints, PALS and participation).
Information is passed to the Trust board via the Director of Healthcare Governance & Education
and the Chief Medical and Nursing Officers to enable a Trust wide overview of risk management
with regards to the wider business of the Trust.
4.0
Duties
4.1



4.2


Trust board
To review information provided within the patient experience and exception report
To follow up high risks and action appropriately
To make recommendations following review of the information provided
Trust sub committees
Clinical risk and quality assurance committee is responsible for reviewing information
provided by the Risk Manager
o SUI reports
o SUI updates on action plans
o Annual audit on all SUI’s
Non clinical risk meeting is responsible for reviewing information provided by the Health,
Safety and Security Manager
o SUI reports
o SUI updates on action plans
o Annual audit on all SUI’s
20
Birmingham Children’s Hospital NHS Foundation Trust – Risk Management Manual 2008/2009
5.3 Chief Executive
 The chief executive is ultimately responsible for investigations, and ensuring that they are
dealt with effectively and appropriately.
5.4 Chief Medical Officer
 To participate within the review of SUI’s and apply the principles of RCA
 To encourage all medical staff to report incidents using the BCH system
 Overall Clinical Risk responsibility
5.5 Director of Healthcare Governance and Education
 To support the governance team and ensure that the incident reporting system is robust
 To present to the board any developments within the reporting system
 To participate within the review of SUI’s and apply the principles of RCA
 To present the patient experience report to the board
 To provide the board and executives with updates and developments in appropriate
meetings.
5.6 Risk Manager / Health, Safety and Security Manager / Patient Interface Manager / Head of
Legal and Corporate Affairs / Moving and Handling Advisor
 To develop and maintain current reporting systems at BCH
 To support staff when reporting any type of incident
 To report to the subcommittees updates on investigations and learning outcomes
 To provide relevant meetings with area specific reports
 To provide relevant meetings with a patient experience report
 To support staff who are undertaking investigations
5.7 Directorate Management Team
 To support staff when reporting incidents, and enable them to participate in investigations
 To undertake and follow up action plans as highlighted
 To report any risks with scores of 20 or 25 within 24 hours or the next following day
 To include updates on reviews within the appropriate quarterly directorate risk reports.
 Provide staff with feedback
5.8 All staff
 To report incidents using the BCH systems
 To report incidents in a timely manner
 To escalate high risks within 24 hours or the next working day
 To undertake training and updates and remain risk aware
 To undertake and follow up action plans as highlighted
 To report incidents to the appropriate person, which may require an investigation
6.0Communication and Notification
6.1Patient / Relative / Visitor / Contractors Communication and Support
This communication and support process links in with the Trust’s being open philosophy, the PALS
and complaints process.
Further details can be found in 12.0, the complaints policy and the policy for the delivery of PALS.
21
Birmingham Children’s Hospital NHS Foundation Trust – Risk Management Manual 2008/2009
6.2Process by which to raise concerns
Staff are referred to:



Human Resources Policies including the Whistle blowing Policy.
Policy for the delivery of PALS
Staff support policy
6.3Internal communication
All staff are responsible for ensuring that appropriate information about incidents are
communicated to Line Managers, Directorate Management Team and the Risk Manager or Health,
Safety and Security Manager in a timely manner. This information will include details of incidents,
complaints and claims with action plans.
The governance team is responsible for sharing information about complaints, claims and incidents
with the Directorates, who in turn share the information with the staff within their area.
Further information can be found in the Learning from Experience Strategy.
6.4External stakeholder notification
Staff are referred to 9.7.
6.5Media involvement
If appropriate, the Executive Director on-call or the Chief Executive will inform the press office and
a press statement will be prepared. The press statement will be updated on a regular basis as
appropriate. In exceptional circumstances, the Chief Executive may convene a special group to
co-ordinate the Trust’s media response.
Under no circumstances should any member of staff discuss an incident with the media, without
receiving express permission from the Chief Executive or Executive Director on Call.
Staff are reminded that they need to inform patient/staff/relatives and other persons (i.e.
contractors involved in or affected by the event) before the media as outlined above.
7.0 Completion of incident forms (IR1’s) and linking to the claims and complaints process.
Appendix One outlines the process for completing incident forms in detail. The following are the
key points:
7.1 Procedural requirements for completing the reporting section of the incident
form

All incidents, whether they impact on a person, service, property, reputation or
finance must be reported using the incident reporting form. Events which are part
of a management plan or are expected to occur, that have no adverse effect / near
miss do not need to be reported.
22
Birmingham Children’s Hospital NHS Foundation Trust – Risk Management Manual 2008/2009






The incident form must be accurate, complete and factual. Include the outcome for
the patient or member of staff in terms of harm, or in rare cases, death. Do not give
opinions, draw conclusions or make subjective statements.
The report must be completed by a member of staff who was involved in or
witnessed the event, or by the person to whom the incident is reported to. All forms
should be completed within 48 hours.
Incidents must not be left in the reporting pad if they require immediate review.
Potential SUI’s must be reported within 24 hours or the next working day. Non
SUI’s must be reported to line management as indicated.
If a potential compliant is highlighted on the incident form, discuss with the parents /
patient and inform them of the PALS and complaints process. Inform the Patient
Interface Manager if appropriate (refer to the Complaints Policy).
If a potential claim is highlighted on the incident form information should be passed
to the relevant line manager who will inform the Head of Legal and Corporate
Affairs as required. Potential claims which are SUI’s must follow the SUI process.
Being Open with patients / parents and staff is vital to ensure effective
communications.
Support can be obtained from your line manager, or





Risk Manager
Health, Safety and Security Manager
Moving and Handling Advisor
Patient Interface Manager
Head of Legal and Corporate Affairs.
8.0 Incident investigation
Staff are referred to: PART C of the risk management Manual (Investigation / Root Cause
Analysis Guidance) which outlines the processes and information needed to undertake an
investigation using the principles of root cause analysis.
The following is information to compliment PART C of the risk management Manual.
A statement writing advice sheet for staff can be found in appendix two.
8.1 Action planning
8.1.1 Action plans and monitoring
These can be outlined on the back of the IR1 forms as appropriate, or within a report. Actions
should clearly state its aim, by whom and by when it will be completed. The author of the report or
IR1 form reviewer is responsible for ensuring that all relevant people are aware of their action
points within a timely manner. This person is responsible for following up action points but the lead
for the action point is responsible for completing the action and for feedback to the author.
Where a concern or issue arises within the action points the author of the action plan should
discuss with their line manager or Directorate Management Team in the first instance and if
required with the Risk Manager or Health, Safety and Security Manager. The latter will forward the
concern to the relevant Trust meeting for discussion.
23
Birmingham Children’s Hospital NHS Foundation Trust – Risk Management Manual 2008/2009
8.2.2 SUI action plans
These are to be included in the SUI report, with a copy sent to the Risk Manager for inclusion on
the central action point database and the CR&QA agenda. The action plan update is presented
quarterly with risks discussed and forwarded to the Executive Management Team as required.
The database is forwarded to the host PCT (HOB) following this meeting, to ensure that they are
kept up to date with actions. The PCT discuss the action plan in their integrated governance
meeting and provide feedback to the BCH Risk Manager via the PCT Risk Manager.
The action plan should outline all of the actions and recommendations made within the report. It is
important to highlight by whom and when the actions will be completed. It is the responsibility of
both the SUI chair and the individuals allocated to each action point to ensure that actions are
completed within the specified timescale. The Risk Manager is to be kept informed of progress
and completion of actions. Appropriate information and concerns are highlighted at the CR&QA
committee.
SUI chairs are responsible for ensuring that the appropriate personnel are informed of the action
and timescale outlined in the SUI action plan. A further action plan in the SUI report should
highlight how feedback will be provided to the Trust.
If assistance is required with formatting the action plan please contact the Risk Manager.
8.2.3 Process of ensuring continual risk reduction following the implementation of
action plans
The Risk Manager is responsible for presenting to CR&QA an annual audit of the trends and
themes within the SUI action plans. This will highlight any risks which have not effectively been
reduced and may require further action to be taken. This audit will also outline repetitious action
points in the different SUI’s.
Investigation action plans are followed up by the author of the action plan. Where actions taken
have not reduced the risk to an acceptable level, information is to be passed in the first instance to
their line manager or Directorate Management Team and as appropriate to either the Risk
Manager or Health, Safety and Security Manager who will forward the action point to the relevant
Trust meeting for discussion.
8.3 Involvement of relevant stakeholders including the process for updating lessons learnt
and action taken.
BCH has a responsibility to inform external agencies about certain incidents and SUI’s. Some of
these incidents may be notified by a specific area or lead practitioner. For example the Coroner,
MESH, IRMER, SHOT, Child Protection and so on. It is the responsibility of the person notifying
the agency to inform the Risk Manager that this has been completed.
For those agencies which have not been notified, it is the responsibility of the Risk Manager and
Health, Safety and Security Manager to notify them. It is therefore important that they are informed
of the details within 24 hours of the incident or at the start of the following working day.
Notification is via a telephone call, with details supplied in an email to the Governance Support
Team.
On receipt of the information the Risk Manager will inform the host PCT of the SUI and other
agencies as highlighted by the SUI.
24
Birmingham Children’s Hospital NHS Foundation Trust – Risk Management Manual 2008/2009
The following is a list of agencies which may need to be notified of certain incidents or SUI’s.













Other NHS Organisations
Health & Safety Executive
Healthcare Commission
NHS Directorate of Health and Social Care
NHS Litigation Authority
The Police
HM Coroner
Social Services
Medicines and Healthcare Products Regulatory Agency (MHRA)
Health Protection Agencies
Head of Corporate Affairs and Legal Services
National Patient Safety Agency
Other
During the SUI process, the host PCT is updated on a quarterly basis, with the SUI action plan
update sent to their integrated governance meeting. Following completion of the SUI, all external
agencies / stakeholders are sent copies of the final report, following review at the relevant Trust
meeting, as indicated by the incident. The reports outline lessons learnt, and action plans to
reduce or eliminate future risks. Other information is sent to external stakeholders as highlighted
by the individual incident.
All staff are responsible for timely reviews and notification of incidents, to ensure that BCH is
effective in its communication with its external stakeholders.
8.4 Sharing of lessons learnt
The following are some of the methods for sharing lessons learnt at BCH:
Method
Information
Aim
By whom
Patient
experience
report
Aggregated information
on risk, claims,
complaints, PALS and
patient experience.
To provide reports to
each Directorate and
the Trust to review /
encourage learning
from an integrated risk
management
viewpoint.
Governance team
SUI reports
Significant SUI’s are
reviewed at either the
trust clinical or non
clinical risk meetings.
To ensure that the
process for SUI’s
involves the Trust.
Risk Manager or
Health, Safety and
Security Manager
Risk Mail
Newsletter sent to all
departments following
completion of SUI’s
To share key
information and
learning points from
SUI’s with staff.
Risk Manager with
support from chair
of SUI or
appropriate
personnel.
Risk Alert
Newsletter sent to all
departments with
To share urgent
information with staff.
Risk Manager with
support from
25
Birmingham Children’s Hospital NHS Foundation Trust – Risk Management Manual 2008/2009
urgent information
highlighted from
another part of the risk
management process.
appropriate senior
personnel.
Meetings and
handovers
Line manager or
nominated personnel
updates on completed
investigations to their
team and Directorate.
To provide feedback to
staff and updates on
internal reviews and
other information
cascaded from
Directorate meetings.
Line Managers and
Directorate
Management
Team, with support
from senior
personnel in their
Directorates.
Monthly
Directorate risk
reports
Aggregated risk
management
information on
incidents.
To provide feedback to
directorate
management for action
and review.
Risk Manager
sends reports
monthly to DMT.
To provide staff
information of incidents
in their area.
DMT cascade
information to their
staff.
Report available on
risk management
intranet page.
Participation from all staff is essential to ensure an effective system for providing feedback to staff
and sharing lessons learnt by our experiences at BCH.
Staff suggestions for improving these methods are welcome and should be sent to the Risk
Manager / Health, Safety and Security Manager on the governance support team email.
9.0 Serious Untoward Incidents (SUI)
9.1 Definition of SUI
A serious untoward incident, is described by the Strategic Health Authority ((West Midlands) (SUI
policy 2007 – 2008) as:

A serious untoward incident (SUI) is an accident or incident when a patient, member of staff
(including those working in the community), or member of the public suffers serious injury,
major permanent harm or unexpected death (or the risk of death or serious injury) on either
premises where health care is provided, or whilst in receipt of health care or,

Any event where 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 loss of the Trust’s reputation or assets.
The following are examples of SUI’s and are taken from our host PCT (HOB) incident reporting
policy (2007 – 2009) and should be considered as SUI’s at BCH:
26
Birmingham Children’s Hospital NHS Foundation Trust – Risk Management Manual 2008/2009

Where there is suspicion that a patient was potentially at risk of serious harm as a result of
possible negligence or error by a member of directly employed staff or service.

Where there is suspicion that a patient may have suffered injury as the result of a deliberate
act by a member of directly employed staff, another patient or a member of the public.

Where there is suspicion that a patient may have suffered serious harm as a result of faulty
procedures, a lack of proper procedures or failure to follow proper procedures.

Where there is suspicion of serious harm to a patient, member of directly employed staff, or
member of the public, resulting from faulty equipment, drugs or unsafe environment.

Where a patient or member of directly employed staff attempts serious harm to themselves
on BCH premises.

A fire, where damage has occurred and where patients and directly employed staff have
been put at risk and / or circumstances are suspicious.

Any other serious untoward incident which would not be included within any of the above
categories, is to be discussed with the Chief Medical Officer and / or Chief Nursing Officer
and / or Director of Healthcare Governance & Education in conjunction with the Risk
Manager or Health, Safety and Security Manager.
In addition to this list, as highlighted by the Department of Health 2008:

Any incident involving the actual or potential loss of personal information that could lead to
identity fraud or have other significant impact on individuals.
If staff are in doubt about whether or not an incident is an SUI, they should contact the Risk
Manager or Health, Safety and Security manager for advice.
The process for undertaking an SUI is outlined in part C. Staff have access to a progress
report on SUI’s and Trust RCA’s on the Risk Management intranet page.
9.2 The process for reporting / triggering a SUI
When a SUI occurs it is important to take action at the time to ensure that the risk is eliminated or
reduced as much as possible with this action depending on the individual incident. Appendix three
highlights the steps to take to trigger the SUI process which MUST start within 24 hours or the next
working day. This includes informing the appropriate regulatory bodies, host PCT and alike within
24 hours or the next working day.
Staff are reminded that the following types of incidents MUST also be reported to the relevant lead
professionals and their policies followed. Incident types which are not highlighted must be referred
as appropriate.
Incident type
Lead professional
Child Protection
Infection
IRMER
Assault / violence
Transfusion
Lead for child protection
Lead consultant for infection control
Radiology Manager
Health, Safety and Security Manager
Blood Bank Manager
27
Birmingham Children’s Hospital NHS Foundation Trust – Risk Management Manual 2008/2009
Medication
Unexpected Death
Information Security
Chief Pharmacist
Lead consultant
Head of IM&T
9.3 Information at the start of the SUI process
To enable an effective start to the SUI process, brief information MUST be passed to the on call
executive and risk manager within 24 hours or the next working day.
All Incidents must include relevant information in the following areas:











Patient / staff / visitor details
Equipment details
Service Delivery details
Day / date / time of incident
Location of incident
Description of incident
What action was taken at the time of the incident?
What follow up action is planned?
Whether a) the individuals concerned have been informed, b) a decision has been taken no
to inform, c) this has not yet been decided
Whether the SUI is in the public domain and the extent of any media interest and / or
publication.
Who was the incident initially reported to?
Incidents which involve information security must also include the following information:





Details of how the information was held: paper, memory stick, disc, laptop etc
Details of any safeguards such as encryption that would mitigate risk
Details of the number of individuals whose information is at risk.
Details of the type of information: demographic, clinical, bank details etc
Whether a) the information commissioner has been informed, b) a decision has been taken
not to inform or c) this has not yet been decided
9.4 SUI Training
Training for chairs of SUI’s and incident leads is bespoke and is arranged through the Risk
Manager on ext 8959. A basic introduction to SUI’s is included in the new management training
programme which is led via the education department.
Further information is available in the risk management training needs analysis.
10.0 Incident & Causal Factor Analysis
Please also refer to the Learning from Experience policy.
10.1
Responsibility for incident analysis and trend analysis
Incident and trend analysis is divided into four levels at BCH.
Level one: IR1 reviews at local level, as indicated by the IR1 forms. With the line manager
responsible for the risks reported within their area. This type of review is qualitative in nature and
forms part of local level discussions and passed to the Directorate Management Team if there are
any trends which need inclusion on the Directorate quarterly risk reports for Trust meetings.
28
Birmingham Children’s Hospital NHS Foundation Trust – Risk Management Manual 2008/2009
Level two: Monthly Directorate risk reports produced by the Risk Manager, with information
included from the Health, Safety and Security Manager and Moving and Handling Advisor. These
reports are both quantitative and qualitative in nature. They include a rolling monthly statistic
review and trend analysis on themes. With these themes further explored and actioned at
Directorate level. Information from the Directorate reviews is forwarded to the Risk Manager for
inclusion in the appropriate Trust risk management reports. The monthly risk reports are
considered at performance reviews.
Level three: Quarterly risk management reports produced by the Risk Manager, Health Safety and
Security Manager, Moving & Handling Advisor and Patient Interface Manager. These reports are
both quantitative and qualitative in nature and discuss any trends which have been identified.
These reports form part of level four reviews.
Level four: The patient experience report brings together the reports in level three and includes
claims, complaints, PALS and patient experience information. The report is complied by the
Governance Team on a quarterly basis and is both quantitative and qualitative. This report is
discussed further in the Learning from experience strategy.
11.0 Hotline Arrangements
In the event of a serious untoward incident involving multiple individuals a “Help line/hotline”
service may need to be established. The decision to set up a ‘hotline’ will be made by the Chief
Executive Officer, or in their absence, another Executive Director. As per the Major Incident Plan,
there are designated telephone lines that can also be used should the need arise. These lines are
included on the Hospital backup system and will therefore be available for use in the event of a
major switchboard failure.
11.1. Setting up the ‘hotline’
Once the decision has been made that a hotline needs to be set up to deal with enquiries from the
public, the Press and Communications Officer, the Risk Manager and the appropriate Director will
take responsibility for activating the ‘hotline’. They will also be responsible for identifying a named
person to set up the ‘hotline’ room. The control centre for a serious untoward incident will be the
A&E seminar room, as per the Major Incident Plan. Out of hours will be arranged via the on call
executive with support from the clinical co-ordinators or as otherwise indicated.
11.2. Staffing the ‘hotline’
The Director responsible must ensure that the appropriate staff for the incident manage the
telephones, e.g. microbiologist or infection control nurse for enquiries regarding an outbreak of
infection query. All staff will be briefed and provided with sufficient information to deal with the
queries.
Consideration must be given to recruiting adequate staff to manage the queries over the time that
telephone calls may be received. This will depend on the type of incident, but the ‘hotline’ may
need to be open over several days or weeks.
11.3. Informing the public of the contact number
The Communications Officer will be responsible for arranging for the publicising of the ‘hotline’
number to both patients / families and staff. During ‘out of hours’ this responsibility will fall to the
Executive Director on call.
11.4. Record keeping and Documentation
29
Birmingham Children’s Hospital NHS Foundation Trust – Risk Management Manual 2008/2009
Printed forms for recording telephone conversations are detailed in Appendix four and will be
utilised to note all calls received and made.
Facilities must be in place for collecting and responding to other modes of communication such as
e-mails and letters and queries through other modes of communication must be recorded on the
forms
11.5. Review of ‘hotline’ arrangements
In discussion with the person designated to manage the incident, the Director responsible for the
service/Head of service and the Chief Executive, the Risk Manager will decide whether or not to
continue to run the ‘hotline’ from the ED seminar room. If another site is considered to be more
appropriate, the Communications Officer will take responsibility to ensure that the resources and
arrangements are adequate. This will include postal and IT arrangements as indicated.
11.6.
Media Contact
If appropriate, the Executive Director on-call or the Chief Executive will inform the press office and
a press statement will be prepared. The press statement will be updated on a regular basis as
appropriate. In exceptional circumstances, the Chief Executive may convene a special group to
co-ordinate the Trust’s media response.
Under no circumstances should any member of staff discuss an incident with the media, without
receiving express permission from the Chief Executive or Executive Director on Call.
12.0 Being Open
Central to the Trust’s strategy to improve patient safety is its commitment to improving
communication between healthcare professionals / teams and patients and/or carers when a
patient is harmed as a result of a patient safety incident. This communication is known as being
open (NPSA 2005). Being open involves apologising and explaining what happened. It ensures
communication is open, honest and occurs as soon as possible following an incident. Being open
about what happened and discussing incidents promptly, fully and compassionately can help
patients cope better with the after-effects.
Incident refers to: incidents, concerns, complaints and claims.
Being open will help to:

Establish an environment where healthcare professionals, or patient and/or their carers
receive the information they need to enable them to understand what happened and the
reassurance that everything possible will be done to ensure that a similar type of incident
does not recur;

Create an environment where patients and/or carers, healthcare professionals and
managers all feel supported when things go wrong.
30
Birmingham Children’s Hospital NHS Foundation Trust – Risk Management Manual 2008/2009
The principles of being open are fully supported by the Royal Colleges and professional
organisations.
If a patient has suffered serious harm, immediate action should be taken to provide prompt and
appropriate clinical care and prevention of further harm, if that is possible. When appropriate, an
apology should be offered. What has happened should be explained fully and accurately to the
patient and/or carers, including information on the likely long and short-term effects. A verbal
apology allows face-to-face contact between the patient and their carers and the healthcare team.
This should be given as soon as the staff are aware an incident has occurred.
It must be recognised that information on an incident that has resulted in serious harm may cause
added stress to the patient and/or their carers and potential loss of confidence in the standard of
care. Continued and open discussion with the patient and carers is essential. Communication
should be timely: patients and/or their carers should be provided with information that is based
solely on the facts known at the time. It should be explained that new information may emerge as
an incident investigation is undertaken and they should be kept up-to-date with the progress of an
investigation.
Patients and/or their carers should receive clear, unambiguous information and be given a single
point of contact for any questions or requests they may have. They should not receive conflicting
information from different members of staff. The use of medical jargon should be avoided at all
times.
In undertaking such open discussions with the patient and carers, it is important that the criteria
detailed in Appendix five are met.
Sometimes, despite the best efforts of staff or others, the relationship between the patient, their
carers and the healthcare professional may breakdown as a result of the incident. The patient and
family may not accept the information provided and may not wish to participate in the process of
being open. Consideration should be given to utilising PALS as a mechanism to support the
patient/relatives during this process. Information provided should be clear, concise and consistent.
Consideration should also be given to the need to use an interpreting service for families’ whose
first language is not English.
Ensure the patient and/or their carers are aware of the formal complaints procedure. Advice can
be obtained from the Patient Interface Manager.
A good way to be open and learn from lessons is to use the principles of root cause analysis. Staff
are referred to PART C of the risk management Manual.
13.0 Process for monitoring the effectiveness of part B
Item for
monitoring
Being Open
Purpose of
monitoring
Ensure process for
encouraging
open
communication
is
followed
Process for
monitoring
100 IR1 Audit.
Monitoring by
whom and when?
Risk
Manager.
Quarterly.
Complaints / Claims – Patient
Interface
Audit.
Manager.
Quarterly
Ensure that being 100 IR1 Audit.
open
process
is
Risk Manager.
Monthly.
6
31
Birmingham Children’s Hospital NHS Foundation Trust – Risk Management Manual 2008/2009
documented
appropriately
Incidents
Complaints / Claims – Patient
Interface
ongoing audit.
Manager.
To ensure incidents Minutes of clinical risk Risk Manager
are
reported
to and quality assurance 6 Monthly.
external agencies
committee,
which
demonstrate
that
papers were sent to
Host
PCT
Risk
Manager.
SUI
audit
which
demonstrates that all
SUIs were reported to
the
appropriate
external agencies (e.g.,
Host PCT, Monitor etc.)
100 IR1 audit
To ensure that the 100 IR1 audit
process for reporting is
followed
To ensure that staff 100 IR1 audit
meet their duties to
report
Risk Manger
6 Monthly.
Risk Manager
6 monthly
14.0 References
National Patient Safety Agency website: www.npsa.nhs.uk
General Medical Council website:
Organisation with a memory: Department of Health 2000
32
Birmingham Children’s Hospital NHS Foundation Trust – Risk Management Manual 2008/2009
APPENDIX One
INCIDENT REPORT FORM PROCEDURAL GUIDELINES
1.
Incident Reporting forms
All incidents are reported on an IR1 form, contained within the Incident Reporting books. The
incident reporting books are held in each Ward/department or Service area. Replacement books
can be obtained from the Governance Support Team on ext 8541.
2.
Who reports?
Any person who is directly employed by the Trust or who is working for the Trust on a temporary,
locum, or agency basis, as a contractor or volunteer, including placement students, may complete
an incident form.
Ideally the person who was directly involved in the incident should report the incident as soon as
possible after the event. Where this is not possible a witness or supervisor may complete the
incident report.
If the incident is reportable under RIDDOR it is the responsibility of the individual’s line
manager/supervisor and/or the Head of Service to ensure this incident has been reported.
3.
Where do you report?
Ideally an incident should be reported on the IR1 form held at the ward/department where the
incident occurred or at the nearest locality possible. If an incident reporting book is not available at
the time of the incident, please use another department’s and order another book as soon as is
practical.
4.
Estates Incidents
Incidents involving the Estate should be completed by the Estates staff where they are present. If
they are not in attendance it is the duty of the individual who first identified the incident to complete
the form.
5.
Legal Issues
Completion of the form does not constitute any admission of liability of any kind on any person.
However, completed forms may be requested as part of a freedom of information request, coroner
request, complaint, claim or trend analysis. It is therefore essential that they are completed
accurately and factually.
THE INCIDENT REPORT SHOULD IDENTIFY FACTS NOT OPINIONS AND SHOULD GIVE AN
OBJECTIVE AND CLEAR ACCOUNT OF WHAT HAPPENED.
Any clinical opinion or professional judgement noted on the form should be clearly separated and
identified from the factual evidence.
6.
What should be reported?
It is the policy of BCH to record all incidents which have resulted in injury or loss or have the
potential to do so. However, when interpreting this statement the following must be applied:



Common sense – is it an incident?
Is it reasonably expected? For example if the event is part of a management plan then it
may not be an incident, but if the event results in injury to a person or impacts on patient
care or the environment, then it may be an incident.
Healthcare acquired infections are incidents and must be reported to infection control and
risk management as soon as is practical.
33
Birmingham Children’s Hospital NHS Foundation Trust – Risk Management Manual 2008/2009







Is it an unexpected outcome and not included in any risk assessment or management plan?
It may be an incident.
Does the incident come under any regulatory bodies? For example, IRMER, MESH and
HSE? These are incidents.
Unexpected Death is an incident.
Cardiac arrest is an incident.
A series of similar events which are graded high or extreme are reportable, until an action
plan is put into place and monitored.
Environmental contamination is an incident.
If in doubt please contact your line manager, or the risk manager on ext 8959 or the health,
safety and security manager on ext 8541.
7.
Where more than one person is involved
In the case of incidents involving more than one person, when reporting via the IR1 form, a form
should be completed for each person. For example if there was an incident where 4 people were
injured then 4 forms should be completed.
8.
Complaints
Reference is to be made to the Trust policy on complaints.
9.
Defective Equipment
The following basic principles are taken from the guidance given by the Medical Devices
Directorate at the Department of Health (RIDDOR, 1995).
 Ensure the patient is safe.
 Quarantine the device involved in the Incident, including packaging and instructions, where
appropriate, and secure safely.
 If it is a machine, try to leave all switches and controls as they were at the time of the Incident,
unless they have to be changed to make them safe.
 Complete an incident report/IR1 form, giving details and the number of the device.
 Ensure the device is labelled with a red warning sticker, giving the database ID/IR1 form
reference number before reporting and sending to the Medical Devices (engineering)
department
 Do not return the device to the manufacturer before an appropriate person, i.e. medical
engineer, examines it.
 If the item is part of a batch, check the remaining stock and ask if the defect has arisen due to
faulty storage. The batch may need to be withdrawn.
The Medications and Healthcare Products Regulatory Agency (MHRA) will be notified of adverse
Incidents involving devices, equipment or related procedures. The Health and Safety Advisor will
normally undertake this action. If a serious incident occurs involving defective equipment/products,
any witness to the incident should make a written report and submit to the Health and Safety
Advisor.
Any device involved in an incident will only be released back into use following a full examination
by the medical engineering team and written authorisation by a member of the Governance
Support Unit.
10.
DELAYED REPORTING
THE OUTCOMES OF MANY INCIDENTS ARE IDENTIFIED IMMEDIATELY E.G. BROKEN
BONE, DAMAGED EQUIPMENT, FIRE. HOWEVER IT IS JUST AS IMPORTANT TO
REPORT INCIDENTS WHERE THE OUTCOMES ARE IDENTIFIED AT A LATER STAGE.
34
Birmingham Children’s Hospital NHS Foundation Trust – Risk Management Manual 2008/2009
FOR EXAMPLE A BACK SPRAIN RESULTING FROM MANUAL HANDLING MAY NOT BE
APPARENT FOR A FEW DAYS, SIMILARLY A PATIENT WHO DEVELOPS UNEXPECTED
PRESSURE TISSUE DAMAGE OR COMPLICATION WHILST IN THE CARE OF BCH.
All staff should report delayed incidents as soon as possible and inform the risk manager or health,
safety and security manager on the governance support team email as soon as is practical.
11.
When should it be reported?
The person who first becomes aware of the incident should report the incident on the IR1 form
within 24 hours. The IR1 form should then be forwarded to the line manager within 2 working
days to enable a local review to take place. The completed IR1 form (including information about
the line managers review) is then sent within 2 weeks to the governance support team for review
by the risk manager / health, safety and security manager before entry onto the risk management
database. Forms which are expected to take longer than 2 weeks to complete, information is to be
sent to the risk management team on the governance support team email.
Incidents which are major or serious ones, should be immediately reported to the line manager
who should IMMEDIATELY inform the Head of Service/Clinical Director (or to the Clinical Coordinator / Executive Director on call during out of hours) and is to be complimented with an IR1
form at the time of the incident. The risk manager, or health, safety and security manager are to
be informed as soon as practical.
Incidents which require reporting to an external agency MUST be reported to the risk
manager or health, safety and security manager as soon as practical to enable statutory
requirements to be met.
12.
Information to record
Detailed instructions on completing the IR1 forms are given on the inside cover of the Incident
Reporting form book held in each area.
The following sections are included:
Section A
The type of incident;
Section B
The individual affected by the incident;
Section C
Attention offered to the person if appropriate e.g. first aid. The
details recorded in this section of the form for patients are in addition
to clear and accurate documentation in patient records;
Section D
Physical Injury - body part affected, nature of incident, apparent
cause;
Section E
Details of the location where the incident occurred and date and time
of the incident;
Section F
An outline of the circumstances of the incident;
Section G
Any immediate or remedial action that was taken following the
incident. This may include removing equipment from use, liasing with
patients, relatives or phoning the police;
Section H
Details of witnesses where appropriate;
Admin. Details Name of person reporting the incident;
35
Birmingham Children’s Hospital NHS Foundation Trust – Risk Management Manual 2008/2009
13.
Where do the forms go?
Following completion of an IR1 form, the blue and pink copies should then be removed from the
book. Both copies should be sent to the ward/department Line manger within 2 working days, for
review on content, grading according to severity and likely hood of reoccurrence. Grading the
incident will assist the manager to determine the level of investigation required. Details on the
investigation should be detailed on the back of the IR1 form. The Blue copy should be sent to the
Governance Support Unit within 2 weeks. The line manager stores the pink copy.
The IR1 form is a confidential document and should be treated accordingly, ensuring that it is
secured and stored correctly in order to maintain confidentiality.
Note: previous IR1s and IR1 books should be treated as confidential and secured and only
accessed for legitimate reasons. Alternatively the incident forms and books should be destroyed in
accordance with the confidential waste policy.
The grey copy should be retained in the IR1 book and secured as confidential information.
All IR1 forms received by the Governance Support Unit will be stored as confidential information
and retained for 10 years unless the incident relates to:
1. Legal action in which case advice should be sought from the Trust solicitors
2. Exposure to hazardous substances or biological agents which may lead to disease (e.g.
asbestos, latex and other respiratory sanitizers, noise) in which case they should be kept
for 40 years from the date of entry.
It is important that any records retained are properly controlled, readily accessible and available for
use to authorised persons, and eventually archived or otherwise disposed of in accordance with
best practice guidance and the Data Protection Act.
14.
Options for reporting
All directly employed staff are encouraged to report ‘near miss’ Incidents using the above system
with completion of the incident forms. In circumstances where an individual feels awkward about
reporting a sensitive incident or near miss (for example in cases of whistle blowing), telephone
contact can be made direct to the Risk Manager or Health, Safety and Security Manager to
highlight the incident.
Directly employed staff must be aware that if the issue is serious the Risk Manager may be
required to discuss the situation with other Trust managers to ensure that prompt action was taken.
Reporting in this way may be applicable where the situation is sensitive and a member of directly
employed staff requires advice on how to manage the incident. However situations where
anonymous reporting would be appropriate are very rare.
15.
Losses
The form can be used to record losses of property that may also result in payment of
compensation subject to the Trust’s Standing Financial Instructions. In addition to completing
sections A, B, E, F, and G on the IR1 form, it is also necessary to include the owner of the property
i.e. Trust or named individual, a full description of the item stolen with its purchase price and
current value and any steps that have been taken to repair/replace items.
Completion of an incident report form in no way guarantees that a payment will be made to a
claimant. Each report will be thoroughly investigated to determine whether or not the Trust was
liable for the property, whether the Trust acted negligently and whether there was an actual loss.
36
Birmingham Children’s Hospital NHS Foundation Trust – Risk Management Manual 2008/2009
16.
Fire Incidents
In the case of fire incidents the information given on the form must include the following:
 False alarms or actual fire
 Method used to raise the alarm
 Whether evacuation occurred and to what extent
 Any method used to fight the fire e.g. extinguisher, hose reel
 Whether the Fire Service attended
The materials that first ignited
 The cause and spread of the fire if known
This reporting system does NOT affect the need to involve the Fire Safety Advisor. This must
continue in line with the Trust’s Fire Policy.
37
Birmingham Children’s Hospital NHS Foundation Trust – Risk Management Manual 2008/2009
Appendix 2
GUIDELINES FOR PREPARING AND WRITING STATEMENTS
It is hoped that these guidelines may be helpful to staff who are asked to provide written statements which
relate to:
legal claims
complaints
adverse incidents
General


o
o
o
At all times statements must be factual and exclude personal opinions, unless these have been
specifically requested, and emotional statements
They should follow the order in which the events occurred
Always check your statement before you hand it in. Help may be obtained from a variety of sources,
for example your line manager, colleague, union representative or other of your choice.
Remember to send your statement in by the requested time. This helps to ensure that reviews are
completed as quickly as possible. If you are unable to complete the statement by the stated time,
please inform the requestor, and provide a new date for submission (exceptional circumstances).
It is good practice to refer to case notes or other documentation when writing statements. If you are
writing something from memory, please state this in your statement.
Recommended format
1.
state your present::






2.
if different from the above, give the following information as it applied when the incident / events
that are under investigation occurred:






3.
name
address [if not still employed by the Trust]
position
relevant qualifications at the time
how long you had occupied that post
relationship to patient:
e.g. named nurse, ward manager, Consultant/doctor on take, Consultant in
charge of patient, radiographer, physiotherapist etc.
provide a narrative of the events - this does not need to be elaborate, just keep to the facts and in
date and time order state:


4.
name
address or location in the hospital
position
relevant qualifications
how long you have been in the post
how you can be contacted most easily
when and what you did and why
where relevant, identify your contributions to nursing or medical notes - add an explanation if you
feel there is any doubt as to what you meant by the entries
Sign, date and time of writing statement
Remember:
STATEMENTS ARE NOT ABOUT ATTRIBUTING BLAME :
THEY ARE ABOUT ESTABLISHING WHAT HAPPENED
38
Birmingham Children’s Hospital NHS Foundation Trust – Risk Management Manual 2008/2009
Appendix 3
Flowchart for triggering a Serious Untoward Incident (SUI)
Potential SUI occurs as
described in the policy
Information about a
potential SUI is
highlighted post incident
Take immediate action as
highlighted by the incident or
information
Inform Line
Manager ASAP
Inform DMT or
Clinical
Co-ordinator
ASAP
Information passed to
executive risk team for
consideration and to
determine type of review
Department
review
Trust RCA
review
Inform Risk
Manager
(x8959) within
24 hours or
the next
working day
Regulatory bodies
and Host PCT
informed of incident.
SUI
39
Birmingham Children’s Hospital NHS Foundation Trust – Risk Management Manual 2008/2009
APPENDIX 4
FORM A
Incident ‘Hotline’ documentation form (Patient/Relative)
Call No: ……. Date: ……….
Time: ………….
Recipient:: ………………….
CALLER DETAILS
Caller's Name: .......................................................................……....................………
Caller's Address:
......................................................….............................…………………………………
…………………………………………………………………………………………………
...................................……............................................................................…………
....................................……............................................................................……….
………………………………………………………………………………………………..
Caller's Telephone Number
Home: ...........……...........................................…….
Work: …….....................................................….…..
Is caller a patient (P) or relative(R): .......……...................................................………...
If relative name and address of person they are calling on behalf of:
..........................................................…….......................................................……
...................................................…….............................................................…….
....................................……............................................................................……
....................................……............................................................................……
....................................……............................................................................………
DETAILS OF ENQUIRY
Nature of query: ..................…….....................................................................………
....................................……............................................................................………
....................................……............................................................................………
....................................……............................................................................………
40
Birmingham Children’s Hospital NHS Foundation Trust – Risk Management Manual 2008/2009
....................................……............................................................................………
....................................……............................................................................………
....................................……............................................................................………
....................................……............................................................................………
Information given: ….....................................................................................…………..
................................................................................................................……………
................................................................................................................……………
…………………………………………………………………………………………………
....................................……............................................................................……
....................................……............................................................................………
Any other relevant information e.g. questions asked that you could not answer:
………............................................................................................................…………
.....................................................................................................………..................…
................................................................................................................……….......…
Does patient need appointment?
Yes/No
Would patient like to speak to someone else?
Yes/No
Would patient like copy of information sheet?
Yes/No
Information (if appropriate) about how the Trust will handle the enquiry and feedback mechanisms
……………………………………………………………………………………….…………………………
……………………………………………………………….…………………………………………………
……………………………………….…………………………………………………………………………
…………………………………………
How would you like to be contacted in future?
Telephone:
Yes / No
Letter:
Yes / No
Meeting:
Yes / No
Nil:
Yes / No
41
Birmingham Children’s Hospital NHS Foundation Trust – Risk Management Manual 2008/2009
Trusts Direct Telephone Number is
(0121) 333 9999
Any other comments to note:
…………………………………………………………………………………………………………………
…………………………………………………………………………………………………………………
…………………………………………………………………………………………………………………
…………………………………………………………………………………………………………………
…………………………………………………………………………………………………………………
…………………………………………………………………………………………………………………
…………………………………………………………………………………………………………………
…………………………………………………
Signature:
____________________
Name (in block capitals):
____________________
Designation:
____________________
42
Birmingham Children’s Hospital NHS Foundation Trust – Risk Management Manual 2008/2009
FORM B
Incident ‘Hotline’ documentation form (G.P’S)
Call No: ……. Date: ……….
Time: ………….
Recipient: ……………………
Name of GP:........................................................…………..................................……
Address of surgery:
.........................................................................……….......……
…………………………………………………………………………………………………
…………………………………………………………………………………………………
…………………………………………………………………………………………………
Contact tel. No:
……..................................................................................………
Fax No.:
……..................................................................................………
Information required:
……................................................................................………...........................
................................................................................................................…………
................................................................................................................…………
................................................................................................................…………
If information about individual patients required please take details
Name: .................................................................... Date of Birth: ............……………
Address:...................................................................................................…….………
.................................................................................................................…….………
.................................................................................................................…….………
NHS No if known: ......................................................................................…….…….
Consultant if known: ..................................................................................…….…….
Signature:
Name (in block capitals):
Designation:
____________________
_______________________________
____________________
43
Birmingham Children’s Hospital NHS Foundation Trust – Risk Management Manual 2008/2009
FORM C
Incident ‘Hotline’ documentation form (Media feedback)
Call No: ……. Date: ……….
Time: ………….
Recipient: ………………….…..
Name of Caller: ..................................................................................………….............
Who does caller work for?:.............................................................................………
News organisation:
.........................................................................................…….
Fax:
.........................................................................................……
Nature of query?
.............................................................................................................................................................
.............................................................................................................................................................
....................................................................................................................................................…..…
……………………………………………
Information given:
.............................................................................................................................................................
.............................................................................................................................................................
.............................................................................................................................................................
.............................................................
Broadcast/story filing requirements:
.............................................................................................................................................................
.............................................................................................................................................................
............................................…..…..……...............................................................................................
...............…...........................................................................................................................................
....................................
Signature:
Name (in block capitals:)
Designation:
____________________
_______________________________
____________________
44
Birmingham Children’s Hospital NHS Foundation Trust – Risk Management Manual 2008/2009
FORM D
Incident ‘Hotline’ documentation form (Other Organisations)
Call No: ……. Date: ……….
Time: ………….
Recipient:: ……………….…..
Name of caller: ....................................................………….........................................
Organisation: .....................................................................…………...........................
Contact No.
Tel: ..........................................................................………....................
Fax: ....................................................................................……….........
Nature of query:
.............................................................................................................................................................
.............................................................................................................................................................
.............................................................................................................................................................
.................….…....................................................................................................................................
.............................................................................................................................................................
.............
Information given:
.............................................................................................................................................................
.............................................................................….…........................................................................
.............................................................................................................................................................
..........….…...........................................................................................................................................
....................................................................................................….….................................................
..............................................................................…………………………………………..……………
……………………………..….………...……………………………………………
Signature:
Name (in block capitals):
Designation:
____________________
____________________
____________________
45
Birmingham Children’s Hospital NHS Foundation Trust – Risk Management Manual 2008/2009
Appendix 5
Quick reference guide to Being Open
Apologising and explaining when patients have been harmed can be very difficult. You may have
already considered some or all of the recommendations below, but this guide will help ensure that
you follow best practice.
Patients and/or their carers should receive an apology as soon as possible after a patient safety
incident has occurred and staff should feel able to apologise on the spot. Saying sorry is not an
admission of liability and it is the right thing to do. Patients have a right to expect openness in their
healthcare.
The key points to remember are:
 Truthfulness
 Clarity of communication
 Timeliness.
 Documentation of communication
Stage 1: preliminary meeting with the patient and/or their carer
Who should attend?

A lead staff member who is normally the most senior person responsible for the patient’s
care and/or someone with experience and expertise in the type of incident that has
occurred.

Ensure that those members of staff who do attend the meetings can continue to do so;
continuity is very important in building relationships.

The person taking the lead should be supported by at least one other member of staff, such
as the risk manager, nursing or medical director, or member of the healthcare team treating
the patient.

Ask the patient and/or their carers who they would like to be present.

Consider each team member’s communication skills; they need to be able to communicate
clearly, sympathetically and effectively.

Hold a pre-meeting amongst healthcare professionals so that everyone knows the facts and
understands the aims of the meeting.
When should it be held?

As soon after the incident as possible.

Consider the patient’s and/or their carer’s home and social circumstances.

Check that they are happy with the timing.

Offer them a choice of times and confirm the chosen date in writing.

Do not cancel the meeting unless absolutely necessary.
Where should it be held?

Use a quiet room where you will not be distracted by work or interrupted.

Do not host the meeting near to the place where the incident occurred if this may be difficult
for the patient and/or their carers.
46
Birmingham Children’s Hospital NHS Foundation Trust – Risk Management Manual 2008/2009
Stage 2: Discussion
How should you approach the patient and/or their carers?

Speak to the patient and/or their carers as you would want someone in the same situation
to communicate with a member of your own family.

Do not use jargon or acronyms: use clear, straightforward language.

Consider the needs of patients with special circumstances, for example, linguistic or cultural
needs, and those with learning disabilities.
What should be discussed?

Introduce and explain the role of everyone present to the patient and/or their carers and ask
them if they are happy with those present.

Acknowledge what happened and apologise on behalf of the team and the organisation.
Expressing regret is not an admission of liability.

Stick to the facts that are known at the time and assure them that if more information
becomes available, it will be shared with them.

Do not speculate or attribute blame.

Suggest sources of support and counselling.

Check they have understood what you have told them and offer to answer any questions.

Provide a named contact who they can speak to again.
Stage 3: follow-up and documentation

Clarify in writing the information given, reiterate key points, record action points and assign
responsibilities and deadlines.

In respect of IR1 incidents, the patient’s notes should contain a complete, accurate record
of the discussion(s) including the date and time of each entry, what the patient and/or their
carers have been told, and a summary of agreed action points. For complaints / claims
information will be documented within the specific file.

Maintain a dialogue by addressing any new concerns, share new information once
available and provide information on counselling, as appropriate.

Indicate on the IR1 form when the being open process has been commenced.

If appropriate inform the Patient Interface Manager, Legal and Corporate Affairs Manager,
or Risk Manager that the being open process has been commenced.
47
Birmingham Children’s Hospital NHS Foundation Trust – Risk Management Manual 2008/2009
Investigations
Root Cause Analysis
PART C
1.0 Forward
This guidance policy has been produced to support staff undertaking an investigation using root
cause analysis (RCA) principles and is a part of the Risk Management Manual. It is acknowledged
that each investigation will be individual, but the basic concept of the RCA framework must be
applied. Staff are referred to Part B of the risk management Manual which includes information to
compliment RCA and the process for following up action plans.
The aim of this guidance policy (part C) is therefore:



To outline the concept of RCA
To outline the process for investigations of incidents, complaints and claims
Provide an outline of the possible tools staff may use for an investigation
The Trust makes reference to the NPSA website which provides staff with RCA information and a
teaching package to explain the tools. Full details of staff training can be found in the risk
management training needs analysis.
WWW.NPSA.NHS.UK
2.0 Introduction / Why are investigations necessary?
Investigations are an important part of learning from our experiences and sharing lessons learnt.
That is, they provide valuable information on lessons learnt and what we do well. This in turn helps
to improve the quality of care and service delivery we provide at BCH and help to promote and
develop its ‘open, just and fair blame’ environment.
BCH encourages staff to use the principles of RCA for all investigations and reviews because
using RCA principles provides staff with a systematic methodology to ensure that all aspects of the
incident / claim / complaint are reviewed and that important aspects are not ignored.
To utilise the benefits of RCA, the BCH promotes its use in all types of incidents, claims and
complaints. This includes; clinical, non clinical, finance, strategic, reputation and operational risks.
This approach will enable the Trust to comply with its terms of authority, its objectives and targets.
Investigations and RCA is therefore a key component for ensuring that the hospital provides high
quality care and service delivery.
3.0 What is a root cause and root cause analysis?
48
Birmingham Children’s Hospital NHS Foundation Trust – Risk Management Manual 2008/2009
A root cause is a fundamental cause, if resolved will eliminate or reduce the highlighted risk or
problem. For example, a root cause may illustrate a need for clearer communication lines. Root
causes can be summarised into the following sections:
Root causes are




Underlying causes
Those that can reasonably be identified
Those over which management has control
Those for which effective recommendations can be generated.
There are many academic definitions of what root cause analysis is, but in essence it is a process
that enables the root causes to be identified and then used to reduce future risks. The following is
one examples of RCA definitions:
“RCA “is a retrospective review of a patient safety incident undertaken in order to identify
what, how and why it happened. The analysis is then used to identify areas for change,
recommendations and sustainable solutions, to help minimise the re-occurrence of the incident
type in the future.” (RCA training and tool kit section from the NPSA website.)
It can therefore by concluded that RCA is asking the following questions:




What happened?
Why did it happen?
How did it happen?
What can we learn from it?
The above therefore forms the core element of investigations at BCH, and should be
reflected in any investigation undertaken. This will enable BCH to learn from its lessons
and help to avoid similar events in the future.
This is in conjunction with governmental developments and the National Patient Safety Agency
(NPSA) recommendations.
4.0 When do I do a RCA review?
All investigations/reviews should apply the principles of RCA, with these investigations originating
from one of the following (this is not an exhaustive list).







Review for an IR1 form
Serious Untoward Incident review
Complaints
Claims
Operational / Business review
Finance review
Participation review
Investigations may take the form of a general review undertaken by any member of staff, or be
more formal, requiring an RCA meeting.
The following sections outline how the principles may be used for an IR1 investigation, SUI or
complaint. Claims are outlined in the Claims Handling Policy and Procedure, with support provided
by the Head of Legal and Corporate Affairs.
49
Birmingham Children’s Hospital NHS Foundation Trust – Risk Management Manual 2008/2009
5.0 IR1 forms and RCA reviews
The ward / area or specialty manager is responsible for ensuring that IR1 incidents are ‘sifted’
appropriately and that detailed reviews are limited to those which require them. The following
matrix demonstrates what type of review should be considered when an incident occurs. Please
refer to the PART B and D of the risk management Manual for further information on the
matrix and definitions.
Likelihood x
Severity
Rare – Not in
next 5 years
Unlikely –
Once in every
3 to 5 years
Possible –
once or twice
a year
Likely – once
or twice a
month
Almost
Certain –
more than
once a week.
Insignificant
1
Minor
2
Moderate
3
Major
4
Catastrophic
5
2
4
6
8
10
3
6
9
12
15
4
8
12
16
20
5
10
15
20
25
SEVERITY
GREEN
TYPE OF REVIEW
General review using RCA
principles
LEVEL OF STAFF AS REVIEW LEAD
Any appropriate member of staff who has attended
governance or other relevant training
YELLOW
RCA report
ORANGE
RCA report or
RCA meeting with report
Line managers who have attended governance or
other relevant training
Area / ward / specialty managers
senior medical staff
RED
SUI process, including RCA
review / report
Governance Team
Reviews and reports may be delegated to another member of staff, but ultimate responsibility
remains with the highlighted staff type in the table above.
If you are unsure and require support, please contact:
 Risk Manager
 Health, Safety and Security Manager
 Moving & Handling Advisor
 Patient Interface Manager
 Head of Legal and Corporate Affairs
Staff are referred to the supporting staff policy for information on staff/patient and relatives support.
50
Birmingham Children’s Hospital NHS Foundation Trust – Risk Management Manual 2008/2009
5.1 The process for undertaking an RCA review / investigation at Directorate and
Department level
The process for undertaking an investigation using RCA principles has been divided into two to aid
the flow of the information in this guidance. Please note, that some investigations may require a
combination of both.
Please remember to complete the RCA within a timely manner, to ensure that actions are
completed and risks for future incidents are reduced as quickly as possible. This will require
effective communications which will enable the lessons learnt to be shared and the principles of
Being Open to be followed.
Reference is made to the investigation part (PART B) of the risk management Manual.
5.2 Using RCA principles to write a report or to complete the IR1 form investigation part
(with NO formal RCA meeting required) (LOW SEVERITY incidents)
1. Identification of the event which requires an investigation.
IR1’s which are significant MUST be notified to your line manager and Risk Manager within
24 hours, or the next working day. A serious untoward incident may be commenced.
Please refer to part (B)
2. Identification of person to complete the investigation, write the report and follow up
action plans.
3. Data collection
a. Statements (Part B, appendix 2 for statement writing advice sheet for staff)
b. Policies / Procedures
c. Case notes
d. Other documents
e. Discussions with relevant staff or external agencies/stakeholders
When requesting information from staff, consider sending the RCA staff information leaflet
(different versions of this leaflet can be found on the risk management intranet page).
4. Use the tools outlined in section 6.0, which are applicable to your investigation.
Remember to keep any relevant documents.
5. The format for your findings will depend on the type of investigation which you are
carrying out. A basic IR1 review may only require a few sentences or paragraphs on
the back of the IR1 form. A more general review will require a report to be written, with
the detail depending on the incident (Don’t forget to acknowledge good practice in your
report).
6. Investigations require actions and recommendations to be made, which will need a lead
person and time scale for completion identified. Actions should be sustainable, realistic
and cost effective. The author of the report is responsible for ensuring that all risks are
followed up, but the identified lead for each action point is responsible for completing
the action. Actions which have a significant risk attached to them must be passed to
the Risk Manager for inclusion on the agenda of either Clinical Risk and Quality
51
Birmingham Children’s Hospital NHS Foundation Trust – Risk Management Manual 2008/2009
Assurance or Non Clinical Risk Committee. Line Managers must be kept informed of
key action points and their progress.
7. It is good practice to discuss your report or findings at staff handovers, meetings and
alike. Minutes of meetings will need to reflect any discussions and action points. This
will enable the staff to feel part of the process and learn from others experiences.
Consider one to one feedback of lessons learnt with staff involved in the incident, this
may be in person or a summary letter.
Key points which have lessons to share with the rest of the Trust should be forwarded
to the Risk Manager. These will be included within a risk alert and sent to all areas
within the Trust.
8. Enter any highlighted risks onto the appropriate risk register. Risks with scores of 20 or
25 must be forwarded to the Directorate Management Team and Risk Manager within
24 hours or the next working day. These high risks are forwarded to the appropriate
Trust meeting for discussion and / or review by the Risk Manager, which will
compliment the work undertaken at local level.
Items on the risk register must follow the process outlined in Part D.
9. Following completion of the action plan, a review of the original risks is required to
determine if the action taken was effective and that the residual risk score is
acceptable. Additional action plans are to be used where required.
5.3 Investigations which require a RCA meeting and formal report:
1. Identification of an event which requires a RCA meeting.
Reference is made to the investigation policy (Part B) within the Risk Management Manual,
which outlines what an incident is, and when it may be a serious untoward incident.
Do any external agencies need to be informed of the incident and RCA review? If yes,
inform the Risk Manager as soon as possible.
2. Identification of lead personnel
a. Identify a person to co-ordinate the RCA meeting and write up the report.
b. Identify who the chair of the meeting is, and involve them in the pre meeting
preparations. It is good practice to consider a chair from a different area / specialty.
3. Data collection to prepare the pre – meeting reading and for the meeting
a. Statements
b. Policies / Procedures
c. Case notes
d. Other documents
e. Discussions with relevant staff or external agencies/stakeholders
4. Identify staff to attend the meeting
a. It is good practice to have a representatives from each area / speciality involved
b. A member of staff from a different area / speciality should be considered.
5. Consider inviting the patients and / or relatives. This links in with the Trust’s being open
policy and complaints policy.
52
Birmingham Children’s Hospital NHS Foundation Trust – Risk Management Manual 2008/2009
6. Consider the involvement of external agencies within the investigation process.
7. Send pre – meeting information to attendees.
8. RCA session
a. Consider which tools may be applicable for the meeting / review
b. Identify the key contributory factors and actions / recommendations required (see
appendix 1)
9. Write up the RCA report
a. Identify the contributory factors (this may include using some of the RCA tools in
your report)
b. Identify action points and recommendations (with leads and timescale for
completion). Actions should be sustainable, cost effective and realistic.
c. Consider writing a summary sheet for the report, to circulate to staff and / or patients
for an update on the investigation. (This links in with Part B and Being Open).
10. Follow up action plans and report updates to appropriate meetings. The author of the
report is responsible for ensuring that all risks are followed up, but the identified lead for
each action point is responsible for completing the action. Actions which have a significant
risk attached to them must be passed to the Risk Manager for inclusion on the agenda of
either Clinical Risk and Quality Assurance or Non Clinical Risk Committee.
11 It is good practice to discuss your report or findings at staff handovers, meetings and alike.
Minutes of meetings will need to reflect any discussions and action points. This will enable
the staff to feel part of the process and learn from others experiences.
Consider one to one feedback of lessons learnt with staff involved in the incident.
Key points which have lessons to share with the rest of the Trust should be forwarded to
the Risk Manager. These will be included within a risk alert and sent to all areas within the
Trust.
12 Enter highlighted risks onto the Risk Register. Risks with scores of 20 or 25 must be
forwarded to the Risk Manager and Directorate Management Team within 24 hours or the
next working day.
13 Following completion of the action plan, a review of the original risks is required to
determine if the action taken was effective. Additional action plans are to be used where
required.
14. Support for RCA meetings can be obtained from:





Risk Manager
Health, Safety and Security Manager
Patient Interface Manager
Moving and Handling Advisor
Head of Legal and Corporate Affairs
53
Birmingham Children’s Hospital NHS Foundation Trust – Risk Management Manual 2008/2009
6.0 TRUST RCA REVIEWS by Risk Manager and Health, Safety and Security Manager.
Trust RCA reviews form part of the serious untoward incident review process. They follow the
same format as above (point 5.0). Completed reports are forwarded to Clinical Risk and Quality
Assurance, or Non Clinical Risk Co-ordinating Committee every quarter for discussion and review.
These reports are followed up every quarter until completion of all action points. The action up
date information is presented in an excel sheet format, and uses a colour coding system to
highlight actions within or outside of the time scale for completion. This is complemented by an
annual audit of all significant reviews, to determine trends and themes, and is completed by the
Risk Manager and presented to Clinical Risk and Quality Assurance Agenda, or Non Clinical Risk
Co-ordinating Committee.
The board is informed of the above information via the minutes of the relevant meetings and via an
exception report which highlights the key points from SUI’s. Key points are highlighted in the board
meetings by the relevant Director or Chief Officer.
This information, along with completed reports is forwarded to BCH’s host PCT and is discussed at
the PCT integrated governance meeting.
Highlighted risks are entered onto the risk register and follow the procedure outlined in PART D.
6.1 SUI / RCA reviews and information security
This type of RCA review must include the following information as highlighted by the Department of
Health. This information MUST be forwarded to the appropriate on call Executive (out of hours)
and the Risk Manager (in office hours) within 24 hours or the next working day.








A short description of what happened, including the actions taken and whether the incident
has been resolved.
Details of how the information was held: paper, memory stick, disc, laptop etc
Details of any safeguards such as encryption that would mitigate risk
Details of the number of individuals whose information is at risk.
Details of the type of information: demographic, clinical, bank details etc
Whether a) the information commissioner has been informed, b) a decision has been taken
not to inform or c) this has not yet been decided
Whether a) the individuals concerned have been informed, b) a decision has been taken no
to inform, c) this has not yet been decided
Whether the SUI is in the public domain and the extent of any media interest and / or
publication.
7.0 RCA reviews and complaints
The investigations conducted in line with the NHS Complaints Procedure should follow the RCA
guidance contained within this document and should use the standard investigation report format
as detailed in the Complaints Policy.
The investigation can take the form of a report and/or a meeting with the family.
The main points to consider during this type of investigation are:




Underlying causes, i.e. what happened? When? Where and why?
What can we learn from it and what recommendations can be generated?
Clearly identify what (if anything) went wrong in line with ‘Being open’;
Clearly identify good practice;
Clarify any points with the complainant;
54
Birmingham Children’s Hospital NHS Foundation Trust – Risk Management Manual 2008/2009



Complete the investigation in a timely manner;
Ensure accuracy in the content of the report;
Utilise any documents to ensure a comprehensive investigation e.g.
o
Statements from the staff involved
o
Medical notes
o
Policies and Procedures
o
Other documents
Use the tools outlined in section 8.0, which are applicable to your investigation. Remember to
keep any relevant documents. Consider whether the issues identified require escalation and
consider whether any risks have been highlighted that require registration.
Request for investigations are sent the relevant Directorate Management Team or Head of
Department. This person will then determine the appropriate member of staff to undertake the
review, depending on the severity of the complaint. The matrix in 5.0 is to be used as a guide.
Should you require any assistance with the investigation, help and guidance can be sought from
the Patient Interface Manager.
8.0 RCA reviews and claims
Staff are referred to the Policy and Procedures for Claims Management.
9.0 Suggested tools for RCA reviews
There are many tools and techniques for RCA sessions. The following are brief introductions and
suggestions:
1.
2.
3.
4.
5.
6.
7.
chronology of events
brainstorming
cause and effect diagrams
fishbone diagram
timelines
time person grid
summary of the above
Staff are referred to the NPSA website which has a tool kit for staff to gain more knowledge on
RCA and the tools available.
9.1. Chronology of events:
A descriptive account of the risk / problem. This may be taken from the case notes, statements
and alike. A chronology of events given to participants at the start / before the session is useful;
however, the session may be concerned with seeking others opinions on the chronology of events
so may be done during the session. A chronology of events is sometimes a good way to start a
RCA report.
9.2 Brainstorming
Brainstorming is a group of people highlighting their suggestions or concerns / a process designed
to obtain the maximum number of ideas relating to a specific area of interest. The aim is to end up
with a list of raw ideas to use later on in the session.
55
Birmingham Children’s Hospital NHS Foundation Trust – Risk Management Manual 2008/2009
Ideally a brainstorming activity (if appropriate) should be undertake towards the start of the
meeting.
9.3. Cause and effect & fishbone diagrams
A cause and effect diagram is a tool that helps identify, sort and display possible causes of a
specific problem. It graphically illustrates the relationship between a given outcome and all the
factors that influence the outcome. This type of diagram is sometimes called an “Ishikawa
diagram” because it was invented by Kaoru Ishikawa, or a ‘fishbone diagram’ because of the way it
looks.
Constructing a cause and effect diagram can help your team when you need to:



identify the possible root causes, the basic reasons, for a specific effect, problem or
condition.
Sort out and relate some of the interactions among the factors affecting a particular process
of effect.
Analyze existing problems so that corrective action can be taken.
The following is the basic layout of a cause and effect diagram:
CAUSE A
CAUSE B
EFFECT
CAUSE C
CAUSE D
Some risks / problems may benefit from using the NPSA fishbone diagram, as below:
56
Birmingham Children’s Hospital NHS Foundation Trust – Risk Management Manual 2008/2009
Help with categories for the fishbone diagram can be found in appendix one. If the diagram is not
appropriate to your review or meeting, consider using the headings to divide the meeting review or
report into sections.
9.4.Timelines
A timeline tracks the incident and allows the investigator to discover any parts of the process
where problems may have occurred or there are gaps in the events.
An example may include:
Prepare drugs Prepared Medications
12 noon
disrupted 12.45pm
Patient dies
1.45pm
Wrong medication
given 1.15pm
Respiratory arrest
1.30pm
9.5 Time person grid
This allows you to graphically put together what happened during a short time period and is good
for highlighting in a report specific items and timings.
57
Birmingham Children’s Hospital NHS Foundation Trust – Risk Management Manual 2008/2009
Mary
John
12.00
12.15
12.30
12.45
Admitted
patient
Buzzer
……
…..
Answers
buzzer
9.6 Summary of key points for RCA tools
The following are a few of the pros and cons for each of the above tools:
 Chronology of events
 Tells the story of what happened in a logical format.
 Key points may get lost.
 Brainstorming
 Quick
 Can be unstructured and strong characters dominate
 Timelines
 Can view the event in one diagram
 Difficult to use for long time period
 Time person grid
 Can see where people are
 Person focused
 Cause & effect
 Good if problem areas are known
 Specific and may limit the review
 Fishbone
 9 contributory factors in one tool
 Can use headings as topics for discussion
 General and time consuming.
58
Birmingham Children’s Hospital NHS Foundation Trust – Risk Management Manual 2008/2009
10.0 STAFF RESPONSIBILITIES
10.1 Trust board
 To review information provided within the patient experience and exception report
 To follow up high risks and action appropriately
 To make recommendations following review of the information provided
10.2 Trust sub committees
 Clinical risk and quality assurance committee is responsible for reviewing information
provided by the Risk Manager
o SUI reports
o SUI updates on action plans
o Annual audit on all SUI’s

Non clinical risk meeting is responsible for reviewing information provided by the Health,
Safety and Security Manager
o SUI reports
o SUI updates on action plans
o Annual audit on all SUI’s
10.3 Chief Executive
 The chief executive is ultimately responsible for investigations, and ensuring that they are
dealt with effectively and appropriately.
10.4 Chief Medical Officer
 To participate within the review of SUI’s and apply the principles of RCA
 To chair RCA reviews as appropriate
 Overall Clinical Risk responsibility
10.5 Director of Healthcare Governance and Education
 To support the governance team and ensure that investigations are carried out
appropriately
 To present the exception report to the board.
 To present the patient experience report to the board
 To provide the board and executives with updates and developments in appropriate
meetings.
 To chair RCA reviews as appropriate
10.6 Risk Manager / Health, Safety and Security Manager / Patient Interface Manager / Head
of Legal and Corporate Affairs / Moving and Handling Advisor
 To undertake Trust investigations as required
 To report to the subcommittees updates on investigations and learning outcomes
 To provide relevant meetings with area specific reports
 To provide relevant meetings with a patient experience report
 To support staff who are undertaking investigations
10.7 Directorate Management Team
 To support staff, and enable them to participate in investigations
 To undertake and follow up action plans as highlighted
 To report any risks with scores of 20 or 25 within 24 hours or the next following day
 To include updates on reviews within the appropriate quarterly directorate risk reports.
 Provide staff with feedback
59
Birmingham Children’s Hospital NHS Foundation Trust – Risk Management Manual 2008/2009
10.8 Role of co-ordinators and chairs
 To participate within investigations as highlighted, to ensure that reports and meetings are
undertaken with action plans followed up
 To forward any risks or action plan points to the Risk Manager and their line manager as
appropriate
 To report any risks with scores of 20 or 25 within 24 hours or the next following day.
 To undertake training and updates on investigations
10.9 All staff
 To participate in investigations as required
 To undertake training and updates on investigations
 To undertake and follow up action plans as highlighted
 To report incidents to the appropriate person, which may require an investigation
Incidents, complaints and claims are jointly reviewed within the patient experience report.
11.0 Monitoring of the effectiveness of Part C.
Item for
monitoring
Staff duties
Purpose of
monitoring
To ensure that
investigations use
RCA principles.
Process for
monitoring
Annual review of SUIs.
Monitoring by
whom and when?
Governance team
Annual
Different levels of
investigations
To ensure
investigations are
appropriate to the
severity of the incident
Other incidents are
reviewed in the 100
IR1 audit and SUI
annual review.
Governance team
Process for
following up
relevant action
plans
To ensure closure of
action points and that
they are followed up
appropriately.
SUI action update
taken to CR&QA
Risk Manager
Quarterly.
Sharing safety
lessons with
stakeholders
To ensure that they
are communicated
internally and
externally.
Trust Risk Reports, will
outline key lessons
learnt and with whom
Risk Manager
Quarterly.
Review of 100 IR1
forms
Annual Review of
SUIs.
12.0 References
Tool kit for RCA training:
National Patient Safety Agency Website: www.npsa.nhs.uk
60
Birmingham Children’s Hospital NHS Foundation Trust – Risk Management Manual 2008/2009
Appendix 1: RCA contributory factor classification framework
Individual Factors
Individual Factors
Physical issues
Components
 General Health (e.g. nutrition, diet, exercise, fitness)
 Physical disability (e.g. eyesight problems, dyslexia)
 Fatigue
 Stress (e.g. distraction/preoccupation)
 Specific mental health illness (e.g. Depression)
 Mental impairment (e.g. illness, drugs, alcohol, pain)
 Motivation (e.g. boredom, complacency, low job satisfaction)
 Cognitive factors (e.g. attention deficit, distraction,
preoccupation, overload and boredom)
 Domestic/lifestyle problems
 Low self confidence/over confidence
 Gregarious/interactive, reclusive
 Risk averse/risk taker
Psychological Issues
Social Domestic
Personality Issues
Team and Social Factors
Team Factors
Role
Congruence
Leadership
Support and
cultural factors
Components

Is there parity of understanding

Are role definitions correctly understood

Are roles clearly defined

Is there effective leadership – clinically

Is there effective leadership – managerially

Can the leader lead

Are leadership responsibilities clear and understood

Is the leader respected

Are there support networks for staff

Team reaction to adverse events

Team reaction to conflict

Team reaction to newcomers

Team openness
Communication Factors
Communication
Factors
Verbal communication
Components





Written
communication





Non verbal
communication

Verbal commands / directions unambiguous
Tone of voice and style of delivery appropriate to situation
Correct use of language
Made to appropriate person(s)
Recognised communication channels used (e.g. head of
service)
Are records easy to read
Are all relevant records stored together and accessible when
required
Are the records complete and contemporaneous (e.g.
availability of patient management plans, patient risk
assessments, etc)
Are memo’s circulated to all members of team
Are communications directed to the right people
Body Language issues (closed, open, aggressive, relaxed,
stern faced)
61
Birmingham Children’s Hospital NHS Foundation Trust – Risk Management Manual 2008/2009
Task Factors
Task Factors
Guidelines
Procedures and
Policies
Decision making aids
Procedural or Task
Design
Components
 Up-to-date
 Available at appropriate location (e.g. accessible when needed)
 Understandable / useable
 Relevant; Clear; Unambiguous; Correct Content; Simple
 Outdated; Unavailable/missing; Unrealistic
 Adhered to / followed
 Appropriately targeted ( e.g. aimed at right audience)
 Availability of such aids e.g. CTG machine, risk assessment
tool, fax machine to enable remote assessment of results
 Access to senior / specialist advice
 Easy access flow charts and diagrams
 Complete information - test results, informant history
 Do the guidelines enable one to carry out the task in a timely
manner
 Do staff agree with the ‘task/procedure design’
 Are the stages of the task such that each step can realistically
be carried out
Education and Training Factors
Education and
Training
Competence
Components






Supervision



Availability /
accessibility





Appropriateness




Adequacy of knowledge
Adequacy of skills
Length of experience
Quality of experience
Task familiarity
Testing and Assessment
Adequacy of supervision
Availability of mentorship
Adequacy of mentorship
On the job training
Emergency Training
Team training
Core skills Training
Refresher courses
Content
Target audience
Style of delivery
Time of day provided
62
Birmingham Children’s Hospital NHS Foundation Trust – Risk Management Manual 2008/2009
Equipment and Resources Factors
Equipment
Displays
Integrity
Positioning
Usability
Components
 Correct information
 Consistent and clear information
 Legible information
 Appropriate feedback
 No interference
 Good working order
 Appropriate size
 Trustworthy
 Effective safety features
 Good maintenance programme
 Correctly placed for use
 Correctly stored
 Clear controls
 User manual
 Familiar equipment
 New equipment
 Standardisation
Working Conditions
Work
Environment
Factor
Administrative
factors
Component




Design of physical
environment


Environment




Staffing






Work load and
hours of work





Time


The general efficiency of administrative systems e.g. reliability
Systems for requesting medical records
Systems for ordering drugs
Reliability of administrative support
Office design: computer chairs, height of tables, anti-glare
screens, security screens, panic buttons, placing of filing
cabinets, storage facilities, etc.
Area design: length, shape, visibility, cramped, spacious
Housekeeping issues – cleanliness
Temperature
Lighting
Noise levels
Skill mix
Staff to patient ratio
Workload / dependency assessment
Leadership
Use Temporary staff
Retention of staff / staff turnover
Shift related fatigue
Breaks during work hours
Staff to patient ratio
Extraneous tasks
Social relaxation, rest and recuperation
Delays caused by system failure or design
Time pressure
63
Birmingham Children’s Hospital NHS Foundation Trust – Risk Management Manual 2008/2009
Organisational and Strategic Factors
Organisational Factor
Organisational
structure
Priorities
Externally imported
risks
Safety culture
Patient Factors
Clinical condition
Social factors
Physical factors
Mental/ psychological
factors
Interpersonal
relationships
Components
 Hierarchical structure, not conducive to discussion, problem
sharing, etc.
 Tight boundaries for accountability and responsibility
 Clinical versus the managerial model
 Safety driven
 External assessment driven e.g. Star Ratings
 Financial balance focused
 Locum / Agency policy and usage
 Contractors
 Equipment loan
 PFI
 Safety / efficiency balance
 Rule compliance
 Terms and Conditions of Contracts
 Leadership example (e.g. visible evidence of commitment to
safety)
 Open culture
Components
 Pre-existing co-morbidity
 Complexity of condition
 Seriousness of condition
 Treatability
 Culture / religious beliefs
 Life style (smoking/ drinking/ drugs/diet)
 Language
 Living accommodation (e.g. dilapidated)
 Support networks
 Physical state – malnourished, poor sleep pattern, etc.
 Motivation (agenda, incentive)
 Stress (family pressures, financial pressures)
 Existing mental health disorder
 Trauma
 Staff to patient and patient to staff
 Patient to patient
 Inter family – siblings, parents, children
64
Birmingham Children’s Hospital NHS Foundation Trust – Risk Management Manual 2008/2009
Risk Assessment &
Risk Register Guidance
PART D of Risk
Management Manual
1.0 Introduction
A risk assessment is a careful examination of an actual or potential risk, with these risks including
clinical, non clinical and corporate risks.
Risk assessments highlight whether adequate
precautions are being taken or if further measures are needed to reduce or eliminate them, with
the process of risk assessment seeking to answer four simple, related questions:
Reference for table: National Patient Safety Agency
This guidance is an outline of how to undertake a risk assessment, the role of the risk register and
responsibilities of staff. It shows Birmingham Children’s Hospital (BCH) commitment to improving
care and services and ultimately a safe environment and excellent patient experience.
This guidance forms part of the Risk Management Manual and is intended to be read in
conjunction with the other parts.
Staff who wish to raise a concern which does not fit into the risk assessment process, are referred
to the whistle blowing policy, which is located on the intranet. Full advice on raising a concern and
the process to do so, can be obtained from the Human Resources department.
65
Birmingham Children’s Hospital NHS Foundation Trust – Risk Management Manual 2008/2009
2.0 Procedure and process for undertaking a risk assessment
From the Source of risk
Identify the risk
Equality impact
assessment
Identify the
associated risks
What are the controls
in place?
What is the original
risk score?
What action is required?
Discussion at
appropriate
meetings /
inclusion in
reports as
required.
Extreme risks
MUST be
notified to
senior
management /
Trust board.
What is the residual
risk score?
Completion of risk
assessment or review of
action plan.
66
Birmingham Children’s Hospital NHS Foundation Trust – Risk Management Manual 2008/2009
2.1 Source of the risk
A risk can be identified from a variety of sources, they are not just related to risks identified by staff
self assessment. The following are examples of where risks for risk assessment can be sourced:






















Audit / benchmarking / gap analysis
NHSLA Risk Management standards
Media
External reports / National enquiry
Trend analysis
Complaints / PALS
Coroners reports
Corporate issues
New legislation
IR1 forms
Moving & Handling
Team meeting
Self assessment
Financial / business concern
Health & Safety Executive
Safety alerts / bulletins
Healthcare Commission
Professional bodies
Service user group
Service process or procedures
Risk review process
Business risks
The source of the risk is to be included in the description of the risk on both the risk assessment
proforma and on the risk register.
2.2 Identification of the associated risks
Once a risk has been identified it needs to be reviewed in detail to determine what risks are
associated with it. For example, if an identified risk is a cable lying across the floor, it’s associated
risks would include: potential for staff / visitor / patient accident, damage to equipment if cable
pulled and so on. A clinical example is a lack of guideline for a new procedure, with the associated
risks lack of clarity for staff to undertake procedures, no continuity of care for patient, potential for
errors or miscommunication and so on. A finance example may include lack of resources for
services or a decision between two.
The process for determining the associated risks may come from a variety of methods, for
example:




Pre determined in a report
Brain storming
Meeting
Incident / complaint or claim trends
It is important to consider:
67
Birmingham Children’s Hospital NHS Foundation Trust – Risk Management Manual 2008/2009


A multi disciplinary approach in determining the associated risks because most risks are
not isolated to one area or to one staff type.
Not to exclusively narrow the assessment to one type, for example a clinical risk
assessment may have finance risks, non clinical risks and operational risks.
2.3 Equality Impact Assessment
When undertaking your risk assessment, it is important to consider the impact on equality and
disability. Please indicate on the risk assessment proforma and the risk register if you have
undertaken an assessment for equality and disability. Any appropriate actions should be included
on the risk assessment action plan.
For further information please refer to the guidance on Equality Impact Assessment .
2.4 Review of the risk controls & risk scoring
Appendix One: Staff risk scoring information leaflet.
The next part of the process is to review the risk and identify the score. This will include looking at
the controls / actions in place at that moment which are aimed at reducing the risk. This follows
the advice outlined in the January 2008 NPSA document, risk matrix for risk managers.
For example:
A control may be a checklist to ensure that staff check a piece of equipment at a specified time to
ensure that it is in working order when required.
The purpose of giving risks scores is to give the risk a priority / severity rating that enables BCH to
review it’s risks in a more objective and systematic way. At BCH the following newly developed
risk matrix scoring system is used.
Likelihood
1
2
3
4
5
1
1
2
3
4
5
2
2
4
6
8
10
Consequence
3
4
3
4
6
8
9
12
12
16
15
20
5
5
10
15
20
25
The matrix explained:
The likelihood is the frequency that the risk will occur, with the scoring column located in the left
column. 1 is a low likelihood and 5 is high.
The consequence is the adverse outcome associated with the risk that has occurred. The scoring
row is located in the top row of the matrix. 1 is a low impact and 5 is high.
After the likelihood and consequence have been decided they are multiplied together and equal the
risk score. The overall risk score CANNOT exceed 25.
Likelihood x Consequence = Risk Score
The following outlines the priority / severity rating for the above matrix in more detail:
68
Birmingham Children’s Hospital NHS Foundation Trust – Risk Management Manual 2008/2009
Risk type
Low risk
Moderate risk
High risk
Extreme risk
Risk Colour
Green
Yellow
Orange
Red
Risk Score
1 to 6
7 to 10
11 to 19
20 to 25
Choosing risk scores is very subjective and may mean different things to different people, for
example driving without a seat belt on may be considered by some as low risk and others as high
risk. To ensure that the risks assessed at BCH are risk scored using the same thought process,
the following is used.
2.4.1
To determine the Likelihood score
If possible score the likelihood by assigning a predicted frequency of the adverse outcome
occurring.
If this is not possible then assign a probability to the adverse outcome occurring within a given time
frame, such as the lifetime of the project or the patient care episode. If it is not possible to
determine a numerical probability then use the probability descriptions to determine the most
appropriate score.
The likelihood score is at the top of the column with the most relevant description.
Likelihood Scoring Matrix:
1
Rare
Descriptor
Frequency
Probability
Not expected
to occur for
years
< 1%
Will only occur
in exceptional
circumstances
2
Unlikely
3
Possible
4
Likely
Expected to
occur at least
annually
1-5%
Expected to
occur at least
monthly
6-20%
Reasonable
chance of
occurring
Expected to
occur at least
weekly
21-50%
5
Almost
Certain
Expected to
occur at least
daily
>50%
Likely to
occur
More likely to
occur than not
Unlikely to
occur
3.4.2 To determine the Consequence score
Use the table below and choose the relevant descriptor(s) and work across the columns until the
most relevant description is found. The Consequence score is at the top of this column.
Descriptor
Objectives/
Projects
1
Insignificant
Insignificant cost
increase/ schedule
slippage. Barely
noticeable reduction
in scope or quality
2
Minor
3
Moderate
<5% over budget/
schedule slippage.
Minor reduction in
quality/ scope
5-10% over budget/
schedule slippage.
Reduction in scope or
quality.
Injuries
Minor Injury not
requiring first aid
Minor injury or illness,
first aid treatment
needed
RIDDOR/ Agency
reportable. Moderate
injury.
Patient Care
Acceptable
management
Unacceptable
management but no
adverse outcome
Moderate
Mismanagement of
patient care with
4
Major
10-25% over
budget/ schedule
slippage. Doesn’t
meet secondary
objectives
Major injuries, or
long term
incapacity/
disability (loss of
limb)
5
Catastrophic
>25% over
budget/ schedule
slippage. Doesn’t
meet primary
objectives
Serious
Mismanagement of
Death
Death or major
permanent
incapacity
69
Birmingham Children’s Hospital NHS Foundation Trust – Risk Management Manual 2008/2009
adverse outcome
patient care with an
adverse outcome
Complaints/
Claims
Locally resolved
complaint
Justified complaint
peripheral to clinical
care
Below excess claim.
Justified complaint
involving lack of
appropriate care
Claim above
excess level.
Multiple justified
complaints
Service/
Business
Interruption
Loss/ interruption > 1
hour
Loss/ interruption > 8
hours
Loss/ interruption > 1
day
Loss/ interruption >
1 week
Staffing and
Competence
Short term low
staffing level
temporarily reduces
service quality (<1
day)
Ongoing low staffing
level reduces service
quality
Late delivery of key
objective/ service due
to lack of staff. Minor
error due to poor
training. Ongoing
unsafe staffing
Uncertain delivery
of key objective/
service due to lack
of staff. Serious
error due to poor
training
Financial
Small loss
Loss > 0.1% of
budget
Loss >0.25% of
budget
Inspection/
Audit
Minor
recommendations
Minor noncompliance with
standards
Recommendations
given. Noncompliance with
standards
Reduced rating.
Challenging
recommendations.
Non-compliance with
core standards
Loss of >0.5% of
budget
Enforcement
Action. Low rating.
Critical report.
Major noncompliance with
core standards
Rumours
Local Media – short
term. Minor effect on
staff morale
Local Media – long
term. Significant
effect on staff morale
Adverse
Publicity/
Reputation
National Media < 3
Days
Multiple claims or
single major claim
Permanent loss
of service or
facility
Non delivery of
key objective/
service due to
lack of staff. Loss
of key staff.
Critical error due
to insufficient
training
Loss of >1% of
budget
Prosecution. Zero
Rating. Severely
critical report
National Media >
3 Days. MP
Concern
(Questions in
House)
3.4.3 Consequence Modifiers
Modifiers may be necessary for certain consequences involving the probability (not frequency) of a
risk affecting more than one person or involving a risk to minor or very important services, projects
or objectives.
Modifiers should only be used when scoring consequences with descriptors highlighted in the
same colours as in the modifier table.
Staff are reminded that when modifying the score for the consequence, the score can not be higher
than 5 and the minimum is 1. For example:


if the consequence score is 4, only 1 can be added and not 2.
If the consequence score is 1, nothing can be taken away.
C = -1 (Minimum 1)
Number of people Affected
Importance of service, project
or object at risk
Minor service/ project/
objective
C = +1 (Maximum 5)
More than a single ward or
department
Service/ project/ objective
important to the whole Trust
C = +2 (Maximum 5)
More than the whole Trust
(Local Health Economy)
Service/ project/ objective
critical to the whole Trust
2.5 Risk treatment / action plans / Monitoring
Following the identification of the risks and their appropriate risk scores, relevant actions /
treatment need to be identified to reduce or eliminate the risk from (re)occurring. These actions /
treatment need to have a lead person identified and a time scale. If actions/ treatment are required
in another department or directorate who are not part of the original assessment process above;
the risk assessment lead is responsible for ensuring that the relevant person / department is
informed in a timely manner with their comments added to the risk assessment process.
70
Birmingham Children’s Hospital NHS Foundation Trust – Risk Management Manual 2008/2009
Actions that are required by or are to be accepted at Directorate / Trust level must be notified
within a timely manner to the relevant Head of Nursing / Directorate General Manager / Clinical
Director. Trust actions are to be taken to either the Clinical Risk and Quality Assurance Committee
or Non Clinical Risk Committee, as appropriate. This links in with section 5.0.
Monitoring of action plans is the responsibility of the risk assessment lead, with the residual risk
score updated on the relevant risk register to reflect actions taken. Overdue actions / treatments
must be notified to the relevant line manager, with the relevant Head of Nursing / Directorate
General Manager / Clinical Director informed if appropriate.
2.6 Residual risk
The residual risk score is the risk rating when actions taken are partly or wholly completed and is
determined by the same method as the original risk score in section 3.3. This score is either
entered onto the risk register, to complete or update the assessment or is used to re decide the
actions / treatment required to reduce or eliminate the risk. The original risk score WILL NOT alter,
the residual risk score is the reflection of actions taken.
If the residual risk is not acceptable on completion of the actions / treatment, the risk assessment is
referred to the appropriate line manager and if applicable to the relevant Head of Nursing /
Directorate General Manager / Clinical Director. Information is passed to either the Clinical Risk
and Quality Assurance Committee or Non Clinical Risk Committee if the residual risk is above 16
(orange) or as appropriate.
2.7 Templates / proforma for risk assessment process
Appendix two has an example of the Trust’s risk assessment proforma. A ‘Word’ copy of this can
be found on the risk management webpage and can be made a longer or short document. The
proforma can be used for all types of risks, including non clinical, clinical and corporate. Annual
risk reviews can also follow the same format.
3.0 Risk register
The aim of the risk register is to populate all risks at BCH in one place to enable an effective and
systematic review of the risks and ultimately improve care and service delivery.
When a risk is entered onto a risk register it will automatically be entered onto all of the appropriate
registers if the score is too high for the original register. For example:


If a risk is entered onto the department risk register and scores 18 it will automatically be
entered onto the Department register, Directorate register and also the Trust register.
If a risk is entered onto department risk register and scores 8 it will not cascade upwards to
the Directorate risk register. It will only be entered onto the Department risk register.
The scoring system for which register the risk is located is outlined below:
Risk
Score
1 – 10
11 – 16
17 – 25
Department
Directorate
Trust
Assurance Framework
Yes
Yes
Yes
No
Yes
Yes
No
No
Yes
No
No
Yes (only score 20 and 25)
71
Birmingham Children’s Hospital NHS Foundation Trust – Risk Management Manual 2008/2009
Access to the risk register is not just limited to one person per area, a wide range of staff can be
nominated following a brief training outline from the Risk Manager or Health, Safety and Security
Manager. Do not attempt to use the register without training.
A staff Manual for how to enter and update risks on the risk register is available on the hospital
intranet site, or can be obtained from the Trust Risk Manager or the Trust Health, Safety and
Security Manager.
The risk register at BCH can be found on the V drive.
4.0 Staff responsibilities and review at Trust level
The following table shows the responsibilities for action, decision to accept a risk and which risk
register this is related to. A more detailed outline of staff responsibilities is highlighted below.
Risk
Colour
Green
Yellow
Orange
Red
Decision to accept
Remedial Action
risk
Department Manager Department Manager
Department Manager
DGM / CD
DGM / CD
DGM / CD
CR&Q
Board of Directors
Risk register level
Department
Department
Directorate / Trust
ALL registers
All risks of 20 and 25 scores or those which have been passed to the Risk Manager which require
Trust review, are reviewed monthly by the following staff:




Chief Medical Officer
Chief Operations Officer
Director of Governance and Education
Risk Manager
Information from this monthly review is passed to the Trust board and the relevant sub committee
for review and action as appropriate.
4.1 ALL STAFF:
 Are responsible for contributing to the risk assessment process, for example:
o Highlighting risks and concerns
o Participation in risk reviews / including all risks severities
o Undertaking actions and monitoring these actions
4.2 Link workers:
 To provide representation for their clinical area within the network by attending
meetings and acting as a resource.
 Establish efficient communication strategies between department, manager and
network group to enable sharing of relevant information in a timely manner.
 Be committed to active implementation of group objectives within department.
 Participate in relevant audit, teaching or development of practice as appropriate.
 Negotiate with department manager appropriate time out of their normal clinical
duties to enable them to fully undertake the role.
4.3 Department / speciality leads:
 Ensure that the department / speciality risk registers are regularly reviewed and
updated.
 Update staff with the successes of the risk register and how practice has developed.
72
Birmingham Children’s Hospital NHS Foundation Trust – Risk Management Manual 2008/2009

Monitoring action plans and taking the appropriate action.
4.4 Directorate General Manager / Clinical Director / Head of Nursing:
 Ensure that the Directorate risk register is regularly reviewed and updated.
 Update staff within their Directorate with the risk register developments, and
changes in practice and it’s successes.
 Provide information on the Directorate risk register in their quarterly governance
report which is submitted to the Clinical Risk and Quality Assurance Committee.
Specific attention is to be given to their top 5 clinical risks, actions or risks for other
Directorates and actions for Trust attention.
 Provide information on the Directorate risk register in their quarterly report which is
submitted to the Non Clinical Risk Committee. Specific attention is to be given to
their significant non clinical risks, actions or risks for other Directorates and actions
for Trust attention.
 Monitoring action plans and taking the appropriate action.
 Cascade risks for review at Trust level to the Risk Manager.
4.5 Moving and Handling Advisor / Facilitator:
 To support staff when undertaking moving and handling risk assessments
 Participate in risk assessment training
4.6 Health, Safety and Security Manager:
 Support staff when undertaking risk assessments in the area of health & safety and
security
 Work in conjunction with the risk manager to deliver risk assessment training
 Assist the risk manager in conducting an annual risk register audit.
 Share information and safety risks with the directorates
 Maintain / review the health & safety and security risk register
 Provide non clinical risk committee with information on risk assessments / risk
register
 Support the Trust in ensuring departments can meet their statutory duties for risk
assessment.
4.7 Risk Manager
 Support staff when undertaking risk assessments in the area of corporate and
clinical risks
 Work in conjunction with the health & safety and security manager to deliver risk
assessment training
 Conduct an annual risk register audit, with assistance from the health & safety and
security manager
 Share information and risks with the directorates
 Ensure that the risk register database is reviewed and developed
 Provide clinical risk and quality assurance committee with information on risk
assessments / risk register
 Participate in the monthly Trust risk review
4.8 Director of Healthcare Governance & Education
 To support the Board and executives when undertaking risk assessments or review
the current highlighted risks.
 To provide the Board with information on risks with scores of 20 and 25.
 To provide the Board and executives with updates and developments within the risk
assessment system.
 To support the Risk Manager with the yearly risk register audit.
73
Birmingham Children’s Hospital NHS Foundation Trust – Risk Management Manual 2008/2009



To assess strategic risks.
Participate in the monthly Trust risk review
Responsibility for the Assurance Framework
4.9 Medical and Nursing Chief Officers
 To assess strategic risks in conjunction with the Director of Healthcare Governance
and Education.
 To support the Board and executives when undertaking risk assessments or review
the current highlighted risks.
 Responsibilities for clinical risks
4.10



Trust Board
Review the information provided by the monthly trust review meeting. That is risks
with scores of 20 or 25 or those which are lower scores but significant.
To ensure that risk assessment and risk register review is included within their
agenda. That actions and decisions are passed to the appropriate meeting /
person.
Validate risks and amend / action as required.
5.0 Staff training and information
Full details on risk assessment training and the risk register is outlined in the risk management
training needs analysis.
Basic information for staff is found on the risk management intranet page.
6.0 Trust review of risk assessment / risk register
6.1 Annual audit
An annual review of the risk register system is undertaken by the Risk Manager with a report
produced. The report will outline:




Review of risks entered onto the risk register
Trend analysis
Outline of outstanding actions
Review of the risk register success’s
This report is circulated to the Board and the Directorates for information and action as
appropriate.
6.2 Trust board review of risks
The Board is responsible for ensuring that it reviews and actions appropriately, any risk which is
presented by the Director of Healthcare Governance and Education, as highlighted in the monthly
Trust risk register meetings. These risks will mainly include those with a risk score of 20 or 25.
6.3 Risk Register
The database which contains all of the risk assessments is reviewed annually by the Risk Manager
with updates and developments added. These updates are announced on the risk management
intranet page.
74
Birmingham Children’s Hospital NHS Foundation Trust – Risk Management Manual 2008/2009
6.4 Assurance Framework
This is aligned to the 5 Corporate Objectives and is populated by the Director of Governance and
Education. Information is taken from the Trust Risk Register and reflects the Trust’s extreme risks.
The framework is discussed at the Executive Management Team (EMT) meeting and the Trust
board. Action points resulting from these meetings is cascaded to the relevant sub committee
meeting.
Staff are able to indicate which of the corporate objectives their risk is related to, via the type of risk
section on their department risk registers.
7.0 Extreme risks
Significant risks are classified as extreme risks (red risks) and MUST be actioned in a timely
manner. Risks with scores of 20 or 25 must be notified within 24 hours or the next working day.
These must be escalated to the relevant Directorate General Manager / Clinical Director / Head of
Nursing, with information passed to the Trust via the Risk Manager, Health, Safety and Security
Manager, Director of Healthcare Governance and Education or the Chief Medical or Nursing
Officer.
9.0 Monitoring of this policy.
Issue
Purpose
Monitoring process
By Whom and by
when?
Staff duties
To ensure that
different staff groups
with key
responsibilities for risk
management
undertake risk
assessment
Directorates review
their risk register
Annual risk review
process report.
Risk Manager
Annually
Staff duties
Staff duties
Trust review of risks at
Trust board
Audit of Risk Register
Quarterly Directorate
Governance reports to
committees with
responsibility for coordinating risk, in
accordance with the
Learning from
Experience Policy.
Minutes of Trust Board
meetings confirming
review of the
Assurance Framework
and confirming receipt
of reports from those
committees with
responsibility for co-
Directorate
Management Teams
Quarterly
Board
Ongoing
75
Birmingham Children’s Hospital NHS Foundation Trust – Risk Management Manual 2008/2009
ordinating risk.
Risk register has
minimum requirements
captured
Risks are populated
from a variety of
sources
Risk assessment
identified actions are
completed
Strategic risks are
reviewed
Annual review of risk
register database
system
Annual review of risk
register data.
Risk Register Review
Risk Manager
Annually
Risk Register Review
Risk Manager
Annually.
Directorate and
Department reviews
Quarterly Directorate
Governance reports.
Directorate staff
Ongoing
Risk Register Review
Risk Manager
Annually.
Trust board and
performance meetings
Minutes of meetings
Director of
Governance and
Education & Director
of Performance
Ongoing
High and extreme
risks are considered
by a multidisciplinary
Trust team
Monthly risk register
review
Risk Manager,
Director of
Governance and
Education, Chief
Medical Officer, Chief
Operations Officer
Monthly
Process for assessing
all types of risks
Assurance framework
– high / extreme risks
are linked to the
corporate objectives.
To ensure that all
types of risks are
reported
Minutes of EMT and
the framework
Director of Healthcare
Governance and
Education
Risk Register Review
Risk Manager
Annual
10.0 References
National Patient Safety Agency website: www.npsa.nhs.uk
76
Birmingham Children’s Hospital NHS Foundation Trust – Risk Management Manual 2008/2009
Appendix One - Risk Register Scoring System 2008
Instructions for use:
1. Define the risk(s) explicitly in terms of the adverse consequence(s) that might arise from the
risk.
2. Use table 1 (see over) to determine the consequence score(s) C, for the potential adverse
outcome(s) relevant to the risk being evaluated.
3. Use table 2 (see over) to determine the likelihood score(s) L, for those adverse outcomes.
If possible score the likelihood by assigning a predicted frequency of the adverse outcome
occurring.
If this is not possible then assign a probability to the adverse outcome occurring within a
given time frame, such as the lifetime of the project or the patient care episode. If it is not
possible to determine a numerical probability then use the probability descriptions to
determine the most appropriate score.
4. Modifiers may be used to increase or decrease the consequence score in certain
circumstances.
If the consequence involves injury, adverse patient experience, complaint or claim (shown as light
blue) a modifier of +1 or +2 (to a maximum of 5), may be applied to the consequence score if large
numbers of people are affected by the risk as shown in table 3 (see over).
This type of modifier should only be used when the likelihood score is calculated based on
the probability of the adverse outcome occurring to a single individual.
If the consequence involves partial or complete failure to meet an objective, problems with a
project or temporary loss of a service, a modifier of –1, +1 or +2 (minimum score 1, maximum
score 5) may be applied to the consequence score depending upon the importance of the
objective, project or service to the organisation as shown in table 3 (see over).
5. Multiply the Consequence Score (C) (after any relevant modifiers have been applied) with
the likelihood score (L) to obtain the risk rating which should be between 1 and 25.
RISK = Consequence score x Likelihood score.
6. Use the risk matrix below to determine the colour banding for the risk.
Consequence
Likelihood
1
2
3
4
1
1
2
3
4
5
5
2
2
4
6
8
10
3
3
6
9
12
15
4
4
8
12
16
20
5
5
10
15
20
25
7. Identify the level at which the risk will be managed in the organisation, assign priorities for
remedial action, and determine whether risks are to be accepted or not on the basis of the
colour bandings and risk ratings.
77
Birmingham Children’s Hospital NHS Foundation Trust – Risk Management Manual 2008/2009
Risk Colour
Remedial Action
Decision to accept risk
Risk register level
Green
Department Manager
Department Manager
Department
Yellow
Department Manager
DGM / CD
Department
Orange
DGM / CD
DGM / CD
Directorate / Trust
Red
CR&QA
EMT
Directorate / Trust / Corporate
Scores of 1 – 10 = Department Risk Register
Scores of 11 – 16 = Directorate Risk Register
Scores of 17 – 25 = Trust Risk Register
Controls Assurance Register = Scores of 20 and 25.
Table 1 – Consequence Score (C)
Descriptor
Objectives/
Projects
Injuries
Patient Care
1
Insignificant
2
Minor
3
Moderate
4
Major
Insignificant cost
increase/
schedule slippage.
Barely noticeable
reduction in scope
or quality
<5% over budget/
schedule slippage.
Minor reduction in
quality/ scope
5-10% over
budget/ schedule
slippage.
Reduction in scope
or quality.
10-25% over
budget/ schedule
slippage. Doesn’t
meet secondary
objectives
Minor Injury not
requiring first aid
Minor injury or
illness, first aid
treatment needed
RIDDOR/ Agency
reportable.
Moderate injury.
Major injuries, or
long term
incapacity/
disability (loss of
limb)
Acceptable
management
Unacceptable
management but
no adverse
outcome
Moderate
Mismanagement of
patient care with
adverse outcome
Serious
Mismanagement
of patient care
with an adverse
outcome
Locally resolved
complaint
Justified complaint
peripheral to
clinical care
Below excess
claim. Justified
complaint involving
lack of appropriate
care
Claim above
excess level.
Multiple justified
complaints
Service/
Business
Interruption
Loss/ interruption
> 1 hour
Loss/ interruption >
8 hours
Loss/ interruption >
1 day
Loss/ interruption
> 1 week
Staffing and
Competence
Short term low
staffing level
temporarily
reduces service
quality (<1 day)
Ongoing low
staffing level
reduces service
quality
Late delivery of key
objective/ service
due to lack of staff.
Minor error due to
poor training.
Ongoing unsafe
staffing
Uncertain
delivery of key
objective/ service
due to lack of
staff. Serious
error due to poor
training
Financial
Small loss
Loss > 0.1% of
budget
Loss >0.25% of
budget
Inspection/
Audit
Minor
recommendations
Minor noncompliance with
standards
Recommendations
given. Noncompliance with
standards
Reduced rating.
Challenging
recommendations.
Non-compliance
with core
standards
Loss of >0.5% of
budget
Enforcement
Action. Low
rating. Critical
report. Major
non-compliance
with core
standards
Adverse
Publicity/
Reputation
Rumours
Local Media – short
term. Minor effect
on staff morale
Local Media – long
term. Significant
effect on staff
morale
Complaints/
Claims
National Media <
3 Days
5
Catastrophic
>25% over
budget/
schedule
slippage.
Doesn’t meet
primary
objectives
Death or major
permanent
incapacity
Death
Multiple claims
or single major
claim
Permanent loss
of service or
facility
Non delivery of
key objective/
service due to
lack of staff.
Loss of key
staff. Critical
error due to
insufficient
training
Loss of >1% of
budget
Prosecution.
Zero Rating.
Severely critical
report
National Media
> 3 Days. MP
Concern
(Questions in
78
Birmingham Children’s Hospital NHS Foundation Trust – Risk Management Manual 2008/2009
House)
Table 2 – Likelihood Score (L)
1
Rare
Descriptor
Frequency
Not expected to
occur for years
Probability
< 1%
Will only occur in
exceptional
circumstances
2
Unlikely
Expected to
occur at least
annually
1-5%
Unlikely to occur
3
Possible
Expected to
occur at least
monthly
6-20%
Reasonable
chance of
occurring
4
Likely
Expected to
occur at least
weekly
21-50%
Likely to occur
5
Almost Certain
Expected to occur
at least daily
>50%
More likely to occur
than not
Table 3 – Consequence Modifiers
Modifiers may be necessary for certain consequences involving the probability (not frequency) of a
risk affecting more than one person or involving a risk to minor or very important services, projects
or objectives. Modifiers should only be used when scoring consequences with descriptors
highlighted in the same colours as in the modifier table.
C = -1 (Minimum 1)
Number of people Affected
Importance of service,
project or object at risk
Minor service/ project/
objective
C = +1 (Maximum 5)
More than a single ward or
department
Service/ project/ objective
important to the whole Trust
C = +2 (Maximum 5)
More than the whole Trust
(Local Health Economy)
Service/ project/ objective
critical to the whole Trust
A modified score CAN NOT go above 25.
79
Birmingham Children’s Hospital NHS Trust - Risk Management Manual.
Appendix 2 - Risk Assessment Proforma
Risk Assessors Name:
Date of Assessment:
Overall Risk Assessment Score (highest original risk score):
Area / Speciality (completing proforma):
Location of Risk:
Equality / Disability assessment
completed?
Type of risk (e.g., clinical, non clinical, finance)
Y/N
Description of Risk Assessment (include here: Main Risk, Source of risk, & Reason for assessment):
RESIDUAL
RISK
SCORE
C
C
L
L
=
=
C
C
L
L
=
=
C
C
L
L
=
=
80
Complete?
ACTIONS / TREATMENT
REQUIRED to reduce /
eliminate the effects (inc.
costs)
Timescale
ORIGINAL
RISK SCORE
LEAD
Trust
Other
CONTROL MEASURES IN
PLACE to prevent risk &
hazards occurring.
Staff
EFFECTS OF THE RISKS &
HAZARDS
Patient
RISKS & HAZARDS (associated
with the description)
Incident reporting Policy
Version:
2.0.0
Approved by:
Clinical Risk And Quality Committee
Date Approved:
24 October 2014
Ratified by:
Policy Review Group
Date ratified:
13 November 2014
Name of originator/author:
Bryan Healy, Head of Risk
Name of responsible committee/individual:
Clinical Risk And Quality Committee
Date issued:
November 2014
Review date:
October 2017
Target audience:
All Staff
1
Contents
Section
Page
1
Introduction
3
2
Purpose
3
3
Duties
3
3.1
Duties within the Organisation
3
3.2
Identification of Stakeholders
5
4
Method of development
5
4.1
Consultation and communication with stakeholders
5
5
Contents
6
5.1
Definitions
6
5.2
Incidents Reporting Process
7
5.3
Managing Reported Incidents
8
5.4
Notifying stakeholders and external agencies
9
5.5
Sharing of lessons learnt
10
5.6
Additional Reporting Arrangements
10
5.7
Staff training
12
6
Process for monitoring the effectiveness of this Policy
12
7
Links with other Trust Policies and procedural documents
12
Appendices
App. I
Quick reference guide to Being Open
13
App. 2
Information required by the on-line IR1 and how it compares to the
old blue paper form
15
2
1.0 INTRODUCTION
The Birmingham Children’s Hospital NHS Foundation Trust (BCH) is committed to
providing high quality patient care within a safe environment. Where errors or
defects are identified they must be analysed so that we can learn from experience
and avoid further repetition.
BCH recognises the value of incident reporting, and the importance of consistent
investigation of incidents which resulted, or had the potential to result in injury,
damage or other loss. BCH therefore aims to use its reporting systems to ensure
that learning is captured and improvements are made at a local and organisational
level. The Trust is committed to developing an open and honest environment where
concerns can be raised and improvements made without fear of criticism or reprisal.
It is the policy of BCH to record all incidents, claims and complaints (known as
incidents in this policy) which have resulted in injury or loss or have the potential to
do so. With these reported to an appropriate person in a timely manner to ensure
that they are reviewed at local level. This applies to incidents affecting patients,
directly employed staff and others including visitors, contractors and volunteers.
This will enable lessons to be identified and action points to be noted and
implemented. Incidents which fit the criteria of a serious incident requiring
investigation (SIRI) must be notified within 24 hours or the next working day.
2.0 PURPOSE
This Policy sets out the responsibilities and process for individual staff to report
incidents and of mangers to investigate incidents and to feed back outcomes at a
local level.
It defines the corporate response to incidents reported, including their use in trend
analysis and the feedback of this information at a corporate level.
It sets out the responsibilities of individual staff in being open with our patients and
their families when an incident has occurred.
It defines serious incidents requiring investigation (SIRI’s) and highlights
responsibilities to report them, but does not define the management of them which
is included in the investigations policy
3.0 DUTIES
3.1
DUTIES WITHIN THE ORGANISATION
a.
TRUST BOARD
To review information provided within the quality report.
To note high risks identified by this information.
To make recommendations following review of the information provided.
b.
TRUST COMMITTEES WITH RESPONSIBILITY FOR RISK
The Clinical Risk and Quality Assurance committee is responsible for reviewing
information provided by the Risk Manager in the following areas:
 Clinical Incident Trend analysis
 SIRI reports
3
 SIRI updates on action plans
 A programme of annual audit covering the Incidnet Reporting and SIRI
policies.
Non clinical risk co-ordinating committee is responsible for reviewing information
provided by the Health, Safety and Security Manager in the following areas:
 Non-Clinical Incident Trend analysis
 SIRI reports
c.
CHIEF EXECUTIVE
 The chief executive is ultimately responsible for investigations, and ensuring
that they are dealt with effectively and appropriately.
d.
CHIEF MEDICAL OFFICER
To encourage all medical staff to report incidents using the BCH system
Overall Clinical Risk responsibility
To support the governance team and ensure that the incident reporting
system is robust
To present to the board any developments within the reporting system
To participate within the review of SIRI’s and apply the principles of RCA
To present the quality report to the board
To provide the board and executives with updates and developments in
appropriate meetings.
To participate within the management of SIRI investigations which apply the
principles of RCA.








e.
RISK MANAGEMENT SPECIALISTS
The Associate Director of Governance, the Head of Risk, the Risk Manager, the
Health, Safety and Security Manager and the Moving and Handling Advisor are key
individuals identified as competent people within the risk management structure at
the Trust. Their key responsibilities are:
 To develop and maintain current reporting systems at BCH.
 To support staff when reporting any type of incident.
 To report to the subcommittees updates on investigations and learning
outcomes.
 To provide relevant meetings with area specific reports.
 To provide relevant meetings with a patient experience report.
 To support staff who are undertaking investigations.
 To liase with external partners in the reporting and investigation of serious
untoward incidents and any other for which there is a statutory duty to
report.
f.
DIRECTORATE, SPECIALITY AND DEPARTMENTAL MANAGERS
 To support staff when reporting incidents, and enable them to participate in
investigations.
 To undertake and follow up action plans as highlighted.
4
 To ensure that any incident which meets the criteria for a serious incident is
referred to the risk manager immediately upon becoming aware of it.
 To provide information and updates on action plan implementation in
response to SIRI reviews and the Quality report.
 Provide staff with feedback on the outcomes of incident investigations and
changes made as a result.
g.





ALL STAFF
To report incidents using the BCH systems
To report incidents in a timely manner
To familiarise themselves with the definition of a serious incident and
escalate any incident which meets that criteria to the risk manager
immediately upon becoming aware of it.
To undertake training and updates and remain risk aware
To undertake and follow up action plans as highlighted
3.2
IDENTIFICATION OF STAKEHOLDERS
All staff are given duties within their contract of employment for the management of
risk. As such, in addition to those with defined responsibilities in managing risk, all
staff are considered to be stakeholders.
4.0 METHOD FOR DEVELOPMENT
This policy version renews existing arrangements for risk assessment as defined in
the Risk Manual ratified in April 2008 that forms version 1.01 of this policy. The
introduction of a web-accessed incident reporting system introduced new processes
for the recording of incidents and their escalation. The rules which govern escalation
and reporting of incidents through the organisation were adjusted in the previous
Policy version. This updated policy version strives to improve the process based on
further experience of working in the system and lessons from audit of that system.
4.1
CONSULTATIONS AND COMMUNICATION WITH STAKEHOLDERS
Clinical Risk and Quality Committee and Non-clinical Risk Coordinating Committee
are identified as the sub- committees with responsibility for risk. The membership of
these committees is identified as primary stakeholders for consultation.
5
5.0 DEFINITIONS
a. WHAT IS AN INCIDENT?
NHS England defines any unintended or unexpected incident which could have,
or did, lead to harm as being reportable.
It is the policy of BCH to record incidents in line with this definition whether they
affect patient, staff, visitor, equipment or the services we provide.
In addition staff shoud be aware that:
 Healthcare acquired infections are incidents and must be reported to
infection control and risk management as soon as is practical.
 Some incidents need additional reporting to regulatory bodies. For example,
IRMER, MESH and HSE.
 Unexpected Death is an incident.
 Cardiac arrest is an incident.
 Environmental contamination is an incident.
If in doubt please contact your line manager, or the risk manager on ext 8959 or
the health, safety and security manager on ext 8541.
b. WHAT IS A SERIOUS INCIDENT REQUIRING INVESTIGATION (SIRI)?
A SIRI is one of the most serious types of incident we experience and may involve:
 death of, or permanent harm to, patients, staff, visitors or members of the
public
 an outcome which requires life-saving intervention or major surgical/medical
intervention or will shorten life expectancy
 a scenario that prevents or threatens to prevent our ability to continue to
deliver health care services,
 a person suffering from abuse
 adverse media coverage or public concern for the organisation or the wider
NHS
 a serious confidentiality breach is
Staff should ensure they are familiar with the fuller definition and management
process described in the Serious Incident Requiring Investigation Policy,
If staff are in doubt about whether or not an incident is a SIRI, they should
contact the Risk Manager or Health, Safety and Security manager for advice.
c. CLINICAL INCIDENTS
Also called Patient Safety Incidents, they are defined by NHS England as any
unintended or unexpected incident which could have, or did, lead to harm for
one or more patients receiving NHS-funded healthcare.
d. PERSONAL ACCIDENTS
6
Unintended or unexpected incidents which could have, or did, lead to harm for
staff or visitors on BCH premises.
e. SECURITY INCIDENTS
Incidents involving physical or non-physical assault (including verbal abuse,
attempted assaults and harassment), theft of or criminal damage (including
burglary, arson, and vandalism) to Trust property or to staff or patient personal
property.
f. INCIDENTS RELATING TO PERSONAL INFORMATION (INFORMATION GOVERNANCE)
Involving actual or potential breaches of confidentiality including data loss.
g. INCIDENT REPORTING FORMS
Incidents may be reported online at http://safeguard/safeguard/.
Remote workers can report incidents via laptop or tablet using the link on the BCH
internet home page
.
6.0 THE INCIDENT REPORTING AND MANAGEMENT PROCESS
6.1 REPORTED BY
Any person who is directly employed by the Trust or who is working for the Trust on
a temporary, locum, or agency basis, as a contractor or volunteer, including
placement students, may complete an incident form.
Ideally the person who was directly involved in the incident should report the
incident as soon as possible after the event. Where this is not possible a witness or
supervisor may complete the incident report.
6.2 REPORTED TO
Incidents should be reported to the senior person in charge where the incident
occurred. The designated manager of that location is responsible for investigating
the incident and implementing remedial measures. Where the cause of the incident
and mitigating actions are outside of the authority of the local manger the incident
must be identified to a manager with the authority to implement the necessary
change.
6.3
DEFINITIONS OF HARM
Since definitions of harm were originally described by the NPSA in their Publication,
‘7 Steps to Patient Safety’ there have been a number of definitions introduced to
reflect that an outcome might not always involve personal injury. Hence diffiernet
7
terms are encontered. The Incident reporting system replicates these grades under
the field Actual Impact and the manager’s form adopts them for grading of incident
Severity on the risk mmatrix. BCH adopts the NPSA definitions and for clarity,
equivalent terms and scores used across risk management systems are given below.
Score
5
4
3
2
1
Term in Safeguard
Severity (risk)
Actual Impact
Catastrophic
Catastrophic, Death
4 - Severe, Severe
Major
Permanent Harm
3 - Moderate, Semi
Moderate
Permanent Harm (Upto 1
M)
2 - Minor, Non Permanent
Minor
Harm (Upto 1 M)
Insignificant
1 - No Harm
NPSA term
Death:
Significant:
Moderate:
Low:
NPSA definition
Death
Severe
Moderate
Low
No harm
Definition of term
Any patient safety incident that
directly resulted in the death z
of one or more persons
receiving NHS funded care.
Any patient safety incident that
appears to have resulted in
permanent harm y to one or
more persons receiving NHSfunded care.
Explanation of harm casued
The death must relate to the
incident rather than to the natural
course of the patient’s illness or
underlying condition.
Permanent harm directly related to
the incident and not related to the
natural course of the patient’s
illness or underlying condition is
defined as permanent lessening of
bodily functions, sensory, motor,
physiologic or intellectual, including
removal of the wrong limb or
organ, or brain damage.
Any patient safety incident that x Moderate increase in treatment is
resulted in a moderate increase defined as a return to surgery, an
in treatment x and which caused unplanned re-admission, a
significant but not permanent
prolonged episode of care,extra
harm, to one or more persons
time in hospital or as an
receiving NHS-funded care.
outpatientor transfer to another
area such as intensive care as
aresult of the incident.
Any patient safety incident that Minor treatment is defined as first
required extra observation or
aid, additional therapy, or
minor treatmentw and caused
additional medication. It does not
minimal harm, to one or more
include any extra stay inhospital or
persons receiving NHS-funded
any extra time as an outpatient, or
care.
continued treatment over and
above the treatment already
8
planned. Nordoes it include a
return to surgery or re-admission.
No harm:
• Impact
prevented
Any patient safety incident that
had the potential to cause harm
but was prevented, resulting in
no harm to people receiving
NHS-funded care.
Any patient safety incident that
ran to completion but no harm
occurred to people receiving
NHSfunded care
• Impact
not
prevented
6.4
BEING OPEN & DUTY OF CANDOUR
BCH is committed to being open and honest about incidents which have happened
and the reasons for them. Staff are encouraged to discuss incidents with families and
carers and provide an apology where we have made a mistake.
For all incidents where a patient has suffered more than moderate harm the duty of
candour requires us to:
 Provide an initial verbal apology and explanation
 Offer a written explanation
 Record the details of that conversation in the patient record
Staff should record this conversation in the ‘Being Open’ section of the incident
report form.
6.5
MANAGING REPORTED INCIDENTS
6.5.1
GRADING INCIDENTS
Upon receiving incidents managers should undertake an initial grading of the
incident. This will allow them to identify the level of investigation required in relation
to the incident and help them prioritise action toward higher risk incidents. The table
below indicates the escalation rules and timeframes which would be applied to
closing incidents at different levels of severity and the authority that local managers
have to undertake the investigation.
Using Trust
5x5 matrix
Using matrix on IR1
form
1-6
Delegate investigation to
Low harm, unlikely to member of staff who has
recur
attended governance or
other relevant training
1 month
8-10
Moderate
harm,
Investigate
unlikely to recur
1 week
Managers authority
Timescale
9
12-15
16+
Significant
harm,
likely to recur
Escalate to Risk Manager
Immediate
Severe harm, likely to for consideration as SUI.
recur
6.5.2
INVESTIGATING INCIDENTS
Responsibility for investigating incidents or escalating them to a manager with the
appropriate authority is given to local ward and departmental managers. The
process of investigating may be given to other senior staff members within the
department but outcomes and recommendations must be validated by the
departmental manager.
The findings of investigations should be detailed on the incident reporting form.
Actions arising to mitigate risk should also be described here.
6.5.3
WHEN A SIRI IS SUSPECTED
When an investigating manager has concern that a SIRI has occurred they must
immediately notify the Governance department. Initial scoping of the incident and
discussion with the commissioners of that service will identify the level of
investigation which is required. The investigation process described in the Serious
Incident Requiring Investigations Policy will be adopted.
6.5.4
DEVELOPING ACTIONS
Responsibility for developing actions is given to local ward and departmental
managers. Actions should have a clearly stated aim, responsible person and date for
completion. The author of the report or investigator is responsible for ensuring that
all relevant people are aware of their action points within a timely manner. This
person is responsible for following up action points but the lead for the action point
is responsible for completing the action and for feedback to the author.
Where a concern or issue arises within the action points the author of the action
plan should discuss with their line manager or Directorate Management Team in the
first instance and if required with the Risk Manager or Health, Safety and Security
Manager.
6.6
NOTIFYING STAKEHOLDERS AND EXTERNAL AGENCIES
BCH has a statutory duty to report certain kinds of work place accidents,
occupational ill health, violent incidents and dangerous occurrences in accordance
with the Reporting of Injuries, Diseases and Dangerous Occurrences Regulations
(RIDDOR) 1995.
We are also required to report certain incidents to a national body, e.g. Medicine
and Healthcare products Regulatory Agency (MHRA), NHS estates, National Patient
Safety Agency (NPSA) and the Counter Fraud and Security Management Service
(CFSMS) within a specific timeframe.
10
Some incidents may be notified by a specific area or lead practitioner. Staff are
reminded that the following types of incidents MUST also be reported to the
relevant lead professionals and their policies followed. Incident types which are not
highlighted must be referred as
Appropriate.
 Patient Safety Incidents to NHS England (National Reporting and Learning
System).
 Medical Device Incidents to the MHRA (Medicines and Healthcare products
Regulatory Agency).
 Non-medical equipment failures and unsafe or dangerous practices to NHS
Estates.
 Adverse Medication Reactions to MHRA.
 Serious Adverse Blood Reactions and Transfusion Hazards to SABRE/SHOT
 Physical Assault against staff to NHS Protect (SIRS).
 Prescribed Health and Safety Incidents to the HSE (The Health and Safety
Executive).
 Incidents involving Ionising Radiation to the CQC, HSE, Environment Agency
and /or Police
The process and responsibilities for this reporting is detailed in the ‘Reporting
Incidents to External Agencies Protocol.’
11
6.7
SHARING OF LESSONS LEARNT
6.7.1
LOCAL FEEDBACK
Managers should ensure that they have robust feedback mechanisms implemented
locally so that all staff are aware of the hazards in their environment and the steps
they are expected to take to mitigate them.
6.7.2
ORGANISATIONAL FEEDBACK
The Safety Dashboard provides aggregated information on risk, claims, complaints,
PALS and patient feedback. It is produced on a quartelry basis.
It informs the Quality report which is produced monthly. Both reports identify
trends and give recommended actions to the Directorates and departments within.
SIRI reviews are reported to the trust clinical or non clinical risk meetings and
onward to Trust Board. They are also shared with the staff members involved in the
incident.
6.8
ADDITIONAL REPORTING ARRANGEMENTS
6.8.1
NOTIFYING SIRI’S OUT-OF-HOURS
Major or serious incidents should be immediately reported to the Clinical Coordinator / Executive Director on call during out of hours.
The risk manager, or health, safety and security manager are to be informed as soon
as practical.
6.8.2
STAFF NOT EMPLOYED AT BCH
Should staff employed at other healthcare organisations be involved in or witness
incidents which occurred at BCH they must be reported on BCH incident forms and
are subject to investigation at BCH.
6.8.3
INCIDENTS OCCURRING OUTSIDE BCH
Should staff employed at BCH be involved in or witness incidents which occurred at
other healthcare organisations they must be reported on incident forms and are
subject to investigation at that host organisation. Incidents which are referred to
managers at BCH regarding other healthcare organisations shall be referred to the
Governance Team at those organisations.
6.8.4
ESTATES INCIDENTS
Incidents involving the Estate should be completed by the Estates staff where they
are present. If they are not in attendance it is the duty of the individual who first
identified the incident to complete the form.
6.8.5
WHERE MORE THAN ONE PERSON IS INVOLVED
In the case of incidents involving more than one perso (for example an outbreak
incident involves at least 2 people) only one form needs to be completed. The online
reporting form has capability to report multiple individuals involved in an incident.
6.8.6
COMPLAINTS
Reference is to be made to the Trust policy on complaints.
12
6.8.7
DELAYED REPORTING
The outcomes of many incidents are identified immediately e.g. broken bone,
damaged equipment, fire. However it is just as important to report incidents where
the outcomes are identified at a later stage. For example a back sprain resulting
from manual handling may not be apparent for a few days, similarly a patient who
develops unexpected pressure tissue damage or complication whilst in the care of
BCH. All staff should report delayed incidents as soon as they become aware that an
incident has occurred
6.8.8
OPTIONS FOR REPORTING
All directly employed staff are encouraged to report incidents using the web-based
incident reporting system. In circumstances where an individual feels unable to
report an incident locally they may report the incident direct to the Governance
Team who shall assist in the completion of the form. However, staff must be aware
that where risks are identified the investigation must be referred to either
departmental or service manager and the maintenance of anonymity cannot be
assured. Alternatively, staff may refer to the Trust whistle blowing policy.
6.8.9
FIRE INCIDENTS
In the case of fire incidents the information given on the form must include the
following:
 False alarms or actual fire.
 Method used to raise the alarm.
 Whether evacuation occurred and to what extent.
 Any method used to fight the fire e.g. extinguisher, hose reel.
 Whether the Fire Service attended.
 The materials that first ignited.
 The cause and spread of the fire if known.
This reporting system does NOT affect the need to involve the Fire Safety Advisor.
This must continue in line with the Trust’s Fire Policy.
6.9
TRAINING AND EDUCATION
Incdent reporting forms part of Governance Training which is a mandatory
requirement for all staff.
The Education & Learning (E & L) department will be proactive in the consultation of
E & L delivered at BCH NHS FT in response to workforce and service needs. For all
Statutory and Mandatory Training E & L will design and facilitate the events. In order
to demonstrate compliance; the following statements apply:


Attendance at all Statutory and Mandatory learning/training events will
be recorded onto the Oracle Learning Management (OLM) system.
Any non-attendance, for booked places, will be escalated to the relevant
individual and their line manager and department.
13


Statutory and Mandatory Training attendance % be reported for line
managers and departments to monitor compliance % on a Trust
Dashboard; against defined Key Performance Indicators (KPIs). Each
department and Directorate will be able to use this information for
robust reporting (to the relevant committees, meetings and forums
within the current Governance framework), monitoring and to produce
action plans to assure that compliance is met.
E & L will undertake quarterly audits of policies that they
originate/develop to assure monitoring and compliance is met.
Incdent mangement and investigation forms part of Advanced Governance Training
which is a necessary requirement for all staff with a responsibility for the
management of incidents
7.0 PROCESS FOR MONITORING THE EFFECTIVENESS OF THIS POLICY
The chairs of the Clinical risk and Quality Assurance Committee and Non-clinical risk
coordinating committee will receive reports from the Directorates in line with the
reporting frameworks for those committees. Those reports will detail:


progress against the actions given within the Quality Report and Safety
Dashboard in response to incident trends arising;
Progress against actions arising from SIRI investigations.
In addition the Chair of the Clinical risk and Quality Assurance Committee shall
receive annual audits of:
 Use of the incident reporting process across all staff types; and
 SIRI investigations undertaken.
8.0 LINKS WITH OTHER TRUST POLICIES AND PROCEDURAL DOCUMENTS
 Patient Safety Strategy
 SIRI Policy
 Being Open policy
 Health and Safety Policy
 Counter-Fraud Policy & Guidance
 Policy for the Management and Processing of Serious Case Reviews
 Procedure for responding to episodes of infection subject to mandatory
Department of Health Surveillance.
 Policy for the Control of Methicillin-Resistant Staphylococcus Aureus (MRSA)
 Policy for the Control of Outbreaks of Infection in the Hospital (including
major outbreak plan)
 Investigations Policy (HR)
14
APPENDIX 1 QUICK REFERENCE GUIDE TO BEING OPEN
Stage 1: preliminary meeting with the patient and/or their carer
Who should attend?

A lead staff member who is normally the most senior person responsible for
the patient’s care and/or someone with experience and expertise in the type
of incident that has occurred.

Ensure that those members of staff who do attend the meetings can continue
to do so; continuity is very important in building relationships.

The person taking the lead should be supported by at least one other
member of staff, such as the risk manager, nursing or medical director, or
member of the healthcare team treating the patient.

Ask the patient and/or their carers who they would like to be present.

Consider each team member’s communication skills; they need to be able to
communicate clearly, sympathetically and effectively.

Hold a pre-meeting amongst healthcare professionals so that everyone
knows the facts and understands the aims of the meeting.
When should it be held?

As soon after the incident as possible.

Consider the patient’s and/or their carer’s home and social circumstances.

Check that they are happy with the timing.

Offer them a choice of times and confirm the chosen date in writing.

Do not cancel the meeting unless absolutely necessary.
Where should it be held?

Use a quiet room where you will not be distracted by work or interrupted.

Do not host the meeting near to the place where the incident occurred if this
may be difficult for the patient and/or their carers.
Stage 2: Discussion
How should you approach the patient and/or their carers?

Speak to the patient and/or their carers as you would want someone in the
same situation to communicate with a member of your own family.

Do not use jargon or acronyms: use clear, straightforward language.

Consider the needs of patients with special circumstances, for example,
linguistic or cultural needs, and those with learning disabilities.
15
What should be discussed?

Introduce and explain the role of everyone present to the patient and/or
their carers and ask them if they are happy with those present.

Acknowledge what happened and apologise on behalf of the team and the
organisation. Expressing regret is not an admission of liability.

Stick to the facts that are known at the time and assure them that if more
information becomes available, it will be shared with them.

Do not speculate or attribute blame.

Suggest sources of support and counselling.

Check they have understood what you have told them and offer to answer
any questions.

Provide a named contact who they can speak to again.
Stage 3: follow-up and documentation

Clarify in writing the information given, reiterate key points, record action
points and assign responsibilities and deadlines.

In respect of IR1 incidents, the patient’s notes should contain a complete,
accurate record of the discussion(s) including the date and time of each
entry, what the patient and/or their carers have been told, and a summary of
agreed action points. For complaints / claims information will be documented
within the specific file.

Maintain a dialogue by addressing any new concerns, share new information
once available and provide information on counselling, as appropriate.

Indicate on the IR1 form when the being open process has been commenced.

If appropriate inform the Patient Interface Manager, Legal and Corporate
Affairs Manager, or Risk Manager that the being open process has been
commenced.
16
APPENDIX 2 GOVERNANCE TRAINING NEEDS ANALYSIS
Foundation Governance Training
Topic areas Incident reporting
Complaints
Claims and Inquest
Risk Management
Security Management
Health and Safety
 Policies
 Processes
 Responsibilities
 Risk Awareness
Staff
All Staff
Refesher
frequency
Delivery
Every 2 years
Class-room learning sessions
Moodle
Advanced Governance Training
 Incident management and
investigation
 SIRI investigation
 Statement writing
 Complaints Investigation
 Risk Register Management
Ward Managers
Department Managers
Speciality Managers
Service Managers
Directorate Managers
DLR Investigators
SIRI chairs
Need determined on individual
basis through PDR
Blended delivery of class-room
learning sessions supported by online resources.
17
Risk Assessment Policy
Version:
1.1.1
Approved by:
Clinical Risk And Quality Committee
Date Approved:
31st Jan 2011
Ratified by:
Policy Review Group
Date ratified:
24th February 2011
Name of originator/author:
Bryan Healy, Head of Risk and Counter
Fraud
Name of responsible committee/individual:
Clinical Risk And Quality Committee
Date issued:
1st March 2011
Review date:
31st January 2014
Target audience:
All Staff
Contents
Section
Page
1
Introduction
3
2
Purpose
3
3
Duties
3
3.1
Duties within the Organisation
3
3.2
Identification of Stakeholders
5
Method of development
5
Consultation and communication with stakeholders
5
Contents
6
5.1
Definitions
6
5.2
The Risk Assessment Process
6
5.3
The Risk Register
13
5.4
The assurance framework
13
5.5
Staff training
14
6
Monitoring of this policy
14
7
Links with other Trust Policies and procedural documents
15
Appendix I
Risk Matrix
16
Appendix 2
Risk Assessment Proforma
20
Appendix 3
Risk Assessment Options Appraisal
21
4
4.1
5
Appendices
1.0
Introduction
Birmingham Children’s Hospital NHS Foundation Trust (BCH) is committed to providing
high quality patient care within a safe environment. Legislation places a duty upon us
to identify foreseeable risks and take reasonably practicable steps to minimise them.
Through this requirement, legislation recognises that staff, patient and visitor safety is
best delivered through a proactive approach to identifying and controlling risk. The
Trust adopts this vision but realises that if it is to provide quality services, it must also
identify and control risks to clinical effectiveness and patient satisfaction. Risk
Assessment is adopted as the tool which is used Trust wide to identify and control risks
to the quality and, by extension, the safety of our services.
2.0
Purpose
This Policy sets out the responsibilities for assessment of risks within the organisation
alongside the process for doing so. It provides guidance on how to undertake a risk
assessment, scoring and prioritisation of risk and the role of the risk register. It defines
the escalation routes from local risk assessments to consideration at a Directorate and
corporate level.
3.0
3.1
DUTIES
Duties within the organisation
a. Trust board
Trust Board will:
review information provided within reports arising from the risk register;
review action plans developed in respect of high risks;
make recommendations following review of the information provided.
b. Trust committees with responsibility for risk
Clinical risk and quality assurance committee and the Non clinical risk co-ordinating
committee are responsible for reviewing information provided in the following areas:
High Risk Reports
Significant risks escalated by the Clinical Directorates and Corporate support
departments
3
c. Chief Executive
The CEO is ultimately accountable for risk management, which includes ensuring that
those with delegated responsibility for the identification, management and review of
risks meet their duties within a timescale and with a priority commensurate with the
severity of the risk identified.
d. Chief Medical Officer
The CMO has overall responsibility for the management of Clinical Risk, which includes
participation in the review of risks and action plans arising and the encouragement of
all medical staff to escalate risk through the BCH risk register and reporting systems
e. Director of Governance and Education
The Director of Governance and Education has overall responsibility for the
management of Non-Clinical Risk, which includes participation in the review of risks
and action plans arising and the encouragement of all staff to escalate risk through the
BCH risk register and reporting systems.
f. Director of Healthcare Governance and Education
The Director of Healthcare Governance and Education will:
support the governance team and ensure that the incident reporting system is
robust
present to the board any developments within the reporting system
participate within the review of risk assessments
present the risk register summary reports to the board
g. Risk Management Specialists
The Associate Director of Governance, the Head of Risk and Counter-Fraud, the Risk
Manager, the Health, Safety and Security Manager and the Moving and Handling
Advisor are key individuals identified as competent people within the risk management
structure at the Trust. Their key responsibilities are:
To develop and maintain the risk register and reporting systems at BCH.
To support staff when assessing risk.
To provide relevant meetings with area specific reports.
To provide relevant meetings with a patient experience report.
4
To review the risk registers at the Trust, providing speciality and directorate managers
with reports of trends which arise.
h. Directorate, speciality and departmental managers
Directorate, speciality and departmental managers will:
Maintain a programme of risk identification and review within the Directorate,
speciality and wards for which they have responsibility.
Support staff undertaking risk assessment, including the identification of
training needs and provision of time and other resources to enable the process
of review and assessment
Undertake and follow up action plans arising from risk assessment;
Validate risks within their authority and escalate those outside of their
authority
i. All staff
All stuff must:
Familiarise themselves with the definition of hazard and risk;
Maintain an awareness of risks within their working environment, highlighting
concerns to their departmental, speciality or directorate managers as
necessary;
Participate in the implementation of action plans arising from risk assessments
where necessary;
Undertake risk management training and updates.
3.2
Identification of Stakeholders
All staff are given duties within their contract of employment for the management of
risk. As such, in addition to those with defined responsibilities in managing risk, all staff
are considered to be stakeholders.
4.0
Method for development
This policy version renews existing arrangements for risk assessment as defined in the
Risk Manual ratified in April 2008 that forms version 1.01 of this policy. The
introduction of a new risk register to the organisation, which is accessed through an
online interface, has introduced new processes in the recording of risk, notification
and escalation. Accordingly the rules which govern notification, escalation and
5
reporting of risks through the organisation have been adjusted. This policy version
reflects those changes.
4.1
Consultations and communication with stakeholders
Clinical Risk and Quality Committee and Non-clinical Risk Coordinating Committee are
identified as the high level committees with responsibility for risk. The membership of
these committees are identified as primary stakeholders for consultation. .
The Policy will be launched to coincide with a month long series of activities and
training sessions held to promote an on-line incident reporting system linked to the risk
register.
5.0
Content
5.1
Definitions
A risk assessment is a careful examination of an actual or potential risk. Risk
assessments identify the existing precautions which are being taken and what further
measures are needed to reduce the risk to an acceptable level. The process of risk
assessment seeking to answer four simple, related questions:
Within this process one considers potential hazards and their outcomes, controls
which mitigate these outcomes and the likelihood of an adverse event occurring given
the controls in place.
Hazard is the potential to cause harm. A hazard is a situation that poses a level of
threat to life, health, property, environment or the services which we provide. Most
hazards are dormant or potential, with only a theoretical risk of harm. The term
consequence is used to refer to the actual type of outcome which may occur.
Controls are anything which reduces the likelihood of that potential harm actually
occurring; or the consequences of it. They may be physical, such as an item of
protective clothing; or they may be procedural such as a protocol or a management
process.
6
Risk is the likelihood of that potential hazard actually occurring. The Risk score is
calculated by multiplying the hazard and the likelihood scores.
5.2
The Risk Assessment Process
5.2.1 Identifying risk
A risk can be identified from a variety of sources, they are not just related to risks
identified by staff self assessment. The following are examples of where risks for risk
assessment can be sourced:
Audit /
Corporate issues
Healthcare
benchmarking /
New legislation
Commission
gap analysis
IR1 forms
Professional
NHSLA Risk
Moving &
bodies
Management
Handling
Service user
standards
Team meeting
group
Media
Self assessment
Service process
External reports
Financial /
or procedures
/ National
business
Risk review
enquiry
concern
process
Trend analysis
Health & Safety
Business risks
Complaints /
Executive
PALS
Safety alerts /
Coroners
bulletins
reports
7
5.2.2 Documenting Risk Assessments
The organisation has a duty to record the findings of risk assessments. That may be
achieved by using the Risk Assessment proforma at Appendix B or by direct entry to
the risk register.
5.2.3 The Risk Assessment proforma
The proforma at Appendix A is particularly suited to describing complex risks. A
problem may present different risks to different groups. Some risks may be greater
and in need of more urgent action than other risks highlighted by the problem. This
proforma is offered as a structured document to help describe the risk. A summary of
the risks must be subsequently transcribed on the risk register.
5.2.4 The Risk register
The risk assessment proforma does not need to be used in every case; risks may be
entered directly to the risk register. This may be appropriate for risks which are more
simply described.
5.2.5 Specialist risk assessments
Requirements for specialist risk assessments exist in other policies, e.g. Moving and
Handling, Display Screen Equipment, COSHH, Work at Heights, Lone Worker, First Aid
needs. These policies typically describe risks within a discrete activity or pertaining to
the needs of an individual patient. They exist as a description of how risks are
controlled in the undertaking of an activity and should not be entered on the risk
register.
However, they may used to identify where risks exist. For example: A patient handling
assessment may say use a hoist but the department does not possess a hoist. The
department should then assess the risks of not having a hoist to assist with the
handling of any patient on the ward and enter that risk on the risk register.
8
Fig 1. The Risk assessment Process
Risk assessment should follow the process outlined in the flow chart below:
Describe the situation,
giving background to a
problem where hazards may
exist
List those hazards and the
expected typical outcome of
them
Detail the existing controls
that reduce the likelihood of
an accident and severity of
harm caused.
Significant risks
and action plans
must be
reported
through clinical
and non-clinical
committee
reporting
frameworks.
Calculate a risk score and
escalate the risk for
validation
Detail the outstanding
controls needed to reduce
the likelihood and harm.
High risks
must be
notified Chief
Operating
Officer and
Governance
Team for
validation.
Develop and monitor an
action plan which puts
outstanding controls in
place.
Update progress on actions.
Review the risk score in light
of changes.
Close the risk.
9
5.2.6
Authority to accept risks
Risks must be scored according to severity and likelihood of outcome using the risk
matrix at Appendix A and defined as minor, moderate, significant and high risks. Table
1 identifies the authority of managers to accept risks at each level of harm.
Table1 Escalating risks
Risk Colour
Remedial
Decision to
Action
accept risk
Authority of the Manager
The department manager can:
Green
Department
Department
•
Enter the risk as validated.
(minor)
Manager
Manager
•
Close the risk when they are
satisfied it is controlled
The department manager must:
•
Yellow
Department
(moderate)
Manager
Validate the risk after
discussion with the
DGM / CD
Directorate Team.
•
Close the risk after discussion
with the Directorate Team.
The Directorate management Team
must:
Orange
(significant)
•
Directorate
Directorate
management
management
discussion with the
Team
Team
department.
•
Validate the risk after
Close the risk after discussion
with the department.
The Directorate Team must:
Red
(high)
CR&Q
Board of
•
Escalate the risk for validation.
Directors
•
Closely manage reduction of
the risk.
5.2.7 Validation of risks
Where a manager does not have the authority to accept a risk it is recorded on the risk
register as ‘Not yet Validated.’ The validation process should agree the severity and
outcome of a risk in light of the existing controls. When validated, that risk is described
10
as ‘Partially Controlled’ to both reflect the presence of existing controls and need for
additional controls.
5.2.8 Development of outstanding controls
Where a risk is not controlled as far as is reasonably practicable, actions to reduce the
risk must be developed.
The term, as far as is reasonably practicable, reflects our legal duties to reduce risk.
This standard is best met through a balancing of the inputs required to manage a risk
against the reduction in risk which we expect to achieve.
That judgement must be made by or in consultation with a manager with authority to
accept risk.
Balancing risk
The options appraisal proforma at Appendix C is offered as a structured document to
help undertake a detailed justification for the selection of the most appropriate control
and from which an action plan may be developed.
11
5.2.9 Reviewing risks
Table 2 identifies the expected frequency of risk review at each level of harm.
Table 2 Expected review frequency
Risk
Colour
Green
Yellow
Reviewer
Department
Manager
Department
Manager
Review frequency
Following changes to risk or implementation of controls
Following changes to risk or implementation of controls
Orange
DMT
As required but at least quarterly
Red
CRAQ
Monthly
5.2.10 Closing Risks
Closed risks may be described as:
Risk Removed
o Where the hazard has been removed and there is no further exposure
to risk.
Risk Controlled
o Where the hazard remains present but the physical and management
controls are sufficient to ensure that both the severity of outcome and
the likelihood of an incident are reduced as far as is reasonably
practicable.
Closure of a risk will involve reduction of the risk score and that reduction must be
validated by a manager with the authority to accept the original risk score.
5.2.11 Equality Impact Assessment
When undertaking your risk assessment, it is important to consider the impact on
equality and disability. Please indicate on the risk assessment proforma and the risk
register if you have undertaken an assessment for equality and disability. Any
appropriate actions should be included on the risk assessment action plan.
For further information please refer to the guidance on Equality Impact Assessment .
12
5.3
The Risk Register
The web-based risk register is accessible at http://safeguard/safeguard/
Access to the risk register is given to department, speciality and directorate managers
with access rights given to reflect the authority of the manager, so:
department managers can see all the risks in their department,
speciality managers can see the aggregated risks of departments in that
speciality and,
Directorate management teams can see aggregated risks from all specialities
and departments under their control.
The organisational risk register comprises the aggregated risks from all clinical
directorates and non-clinical departments and is accessible by the Executive
Management Team and those specialists managing risk at the Trust, with filters
allowing a focus on high and significant risks.
The committee reporting framework facilitates reporting escalation and monitoring of
high and significant risks from the organisational risk register with the frequency given
at table 2 above.
5.3.1 High Risks on the risk register
High risks are those scoring above 16 and must be escalated to the relevant
Directorate Management Team and to the Risk Manager, Health, Safety and Security
Manager, Director of Healthcare Governance and Education or the Chief Medical or
Nursing Officer.
5.4
The assurance framework
Strategic or Corporate risks are those that transcend the department, speciality or
directorate that have identified and escalated them and are expected to affect the
strategy and direction of the Trust with an impact on numerous people within or
outside of the Trust.
Corporate objectives which are recognised by the Trust Board as priorities to the
organisation are defined within 5 themes. Known risks to meeting these objectives are
aligned to these themes. Actions to mitigate those risks are monitored through the
assurance framework.
The assurance framework is also populated with those high risks escalated through the
risk register.
13
5.5
Staff training
Training in risk awareness and use of the risk register is delivered to staff in accordance
with the Training Needs Analysis developed by the Governance Support Unit and
implemented at departmental level.
Additional training documentation and support is found within the Governance
Support Unit intranet pages.
Access to the risk register is not just limited to one person per area, a wide range of
staff can be nominated following a brief training outline from the Risk Manager or
Health, Safety and Security Manager. Do not attempt to use the register without
training.
6.0 Monitoring of this policy
6.1 Risk Register Review
An annual review of the risk register system is undertaken by the Risk Manager and
submitted to the Clinical Risk and Quality Assurance Committee. That report shall
consider:
Type of risks entered onto the risk register;
Source of risks entered onto the risk register
Severity of risks entered onto the risk register;
Departments populating the risk register;
Outstanding actions within significant risks entered on the risk register.
6.2 Review of High Risks
High Risk Reports are received by the Clinical Risk and Quality Committee on a monthly
basis. High Risks are reported to Non-clinical risk co-ordinating committee through
Directorate Reports.
6.3 Review of Significant Risks
Directorates are expected to report significant clinical risks and work toward
controlling them as part of the reporting framework to the Clinical Risk and Quality
Committee.
Directorates are expected to report significant non-clinical risks and work toward
controlling them as part of the reporting framework to the Non-Clinical Risk
Coordinating Committee.
14
6.4 Assurance Framework Review
Progress in action plans developed to mitigate risks appearing on the assurance
framework is reported to Trust Board on a quarterly basis.
7.0 Links with other Trust Policies and procedural documents
Safety Strategy
SIRI Policy
Incident Reporting Policy
Being Open policy
Learning from Experience policy
Health and Safety Policy
Counter-Fraud Policy & Guidance
Governance Training Needs Analysis
15
Appendix 1 Risk Matrix
1
The matrix explained
The purpose of giving risks scores is to give the risk a priority / severity rating that
enables BCH to review it’s risks in a more objective and systematic way. At BCH the
following risk matrix scoring system is used.
Consequence
Likelihood 1
2
3
4
5
1
1
2
3
4
5
2
2
4
6
8
10
3
3
6
9
12
15
4
4
8
12
16
20
5
5
10
15
20
25
The likelihood is the frequency that the risk will occur, with the scoring column located
in the left column. 1 is a low likelihood and 5 is high.
The consequence is the adverse outcome associated with the risk that has occurred.
The scoring row is located in the top row of the matrix. 1 is a low impact and 5 is high.
Likelihood x Consequence = Risk Score
After the likelihood and consequence have been decided they are multiplied together
and equal the risk score. The overall risk score CANNOT exceed 25.
The following outlines the priority / severity rating for the above matrix in more detail:
Risk type
Risk Colour
Risk Score
Low risk
Green
1 to 6
Moderate risk
Yellow
7 to 10
High risk
Orange
11 to 19
Extreme risk
Red
20 to 25
16
Choosing risk scores is very subjective and may mean different things to different
people, for example driving without a seat belt on may be considered by some as low
risk and others as high risk. To ensure that the risks assessed at BCH are risk scored
consistently, the following descriptors of consequence and likelihood are used.
2
To determine the Consequence score
Consequence may be scored on a number of scales depending on the nature of the risk
being assesses. These are listed I Table A1 below. Different risk types defined in the
first column should be used to determine on which row the risk is being scored. Read
across subsequent columns unto identify the descriptor which best mirrors the typical
outcome from this hazard and use the numerical score at the top of that column as the
consequence score.
2.1
Consequence Modifiers
Some hazards may affect only one person or a small number of people within a ward
or department at BCH.
Larger groups may be affected as hazards stretch across multiple wards or
departments at BCH; or even to our patients and families outside of BCH.
Harm to these larger groups which is minor in nature can be missed as we prioritise
more severe harm. But where there is a cumulative affect of lots of minor harm across
a large number of people we want to reflect that in our scoring.
The consequence modifiers in Table A2 are used to raise the consequence scores and
better reflect the severity of these risks.
2 rules apply to using modifiers:
They should only be used when scoring consequences with descriptors
highlighted in the same colours as in the modifier table.
The final outcome score can not be higher than 5 and the minimum is 1.
3
To determine the Likelihood score
Score the likelihood by assigning a predicted frequency of the adverse outcome
occurring. That may be the simple descriptor; the more quantitative description given
under frequency; or the more accurate probability, which may be derived from a
measurement of an actual incident rate.
17
Table A1 Consequence scores
Descriptor
1
2
3
4
5
Insignificant
Minor
Moderate
Major
Catastrophic
Insignificant cost
Objectives/
Projects
increase/ schedule
slippage. Barely
noticeable reduction
in scope or quality
Injuries
Patient Care
<5% over budget/
5-10% over budget/
schedule slippage.
schedule slippage.
Minor reduction in
Reduction in scope or
quality/ scope
quality.
Minor injury or
RIDDOR/ Agency
illness, first aid
reportable. Moderate
treatment needed
injury.
Unacceptable
Moderate
Acceptable
management but no
Mismanagement of
management
adverse outcome
patient care with
Minor Injury not
requiring first aid
adverse outcome
Complaints/
Locally resolved
Claims
complaint
Service/
Business
Interruption
Justified complaint
peripheral to clinical
care
Below excess claim.
Justified complaint
involving lack of
appropriate care
10-25% over
budget/ schedule
slippage. Doesn’t
meet secondary
objectives
Major injuries, or
long term
incapacity/ disability
(loss of limb)
>25% over
budget/ schedule
slippage.
Doesn’t meet
primary
objectives
Death or major
permanent
incapacity
Serious
Mismanagement of
Death
patient care with an
adverse outcome
Claim above excess
Multiple claims
level. Multiple
or single major
justified complaints
claim
Loss/ interruption > 1
Loss/ interruption >
Loss/ interruption > 1
Loss/ interruption >
hour
8 hours
day
1 week
Permanent loss
of service or
facility
Non delivery of
Short term low
Staffing and
Competence
staffing level
Ongoing low staffing
temporarily reduces
level reduces service
service quality (<1
quality
day)
Late delivery of key
Uncertain delivery
key objective/
objective/ service due
of key objective/
service due to
to lack of staff. Minor
service due to lack
lack of staff. Loss
error due to poor
of staff. Serious
of key staff.
training. Ongoing
error due to poor
Critical error due
unsafe staffing
training
to insufficient
training
Financial
Small loss
Minor
Inspection/
Audit
recommendations
Minor noncompliance with
standards
Adverse
Publicity/
Reputation
Rumours
Loss > 0.1% of
budget
Recommendations
given. Noncompliance with
standards
Loss >0.25% of budget
Loss of >0.5% of
Loss of >1% of
budget
budget
Reduced rating.
Enforcement Action.
Challenging
Low rating. Critical
recommendations.
report. Major non-
Non-compliance with
compliance with
core standards
core standards
Local Media – short
Local Media – long
term. Minor effect
term. Significant effect
on staff morale
on staff morale
National Media < 3
Days
Prosecution.
Zero Rating.
Severely critical
report
National Media >
3 Days. MP
Concern
18
(Questions in
House)
Table A2 Consequence Modifiers
C = -1 (Minimum 1)
C = +1 (Maximum 5)
C = +2 (Maximum 5)
Number of people
More than a single ward or
More than the whole Trust
Affected
department
(Local Health Economy)
Importance of service,
Minor service/ project/
Service/ project/ objective
Service/ project/ objective
project or object at risk
objective
important to the whole Trust
critical to the whole Trust
Table A3 Likelihood Score
Descriptor
Frequency
Probability
1
2
3
4
5
Rare
Unlikely
Possible
Likely
Almost Certain
Not expected to occur for
Expected to occur
Expected to occur at
Expected to occur
Expected to occur
years
at least annually
least monthly
at least weekly
at least daily
< 1%
1-5%
6-20%
21-50%
>50%
Will only occur in
exceptional circumstances
Unlikely to occur
Reasonable chance
of occurring
Likely to occur
More likely to
occur than not
19
Appendix 2 - Risk Assessment Proforma
Risk Assessors Name:
Date of Assessment:
Overall Risk Assessment Score (highest original risk score):
Area / Speciality (completing
Location of Risk:
Type of risk (e.g., clinical, non clinical, finance)
proforma):
Description of Risk Assessment (include here: Main Risk, Source of risk, & Reason for assessment):
Through a description of the background to the problem being considered, hazards may be identified. Descriptions of the backg round would
answer the questions:
What are we risk assessing? Some answers are given in the tables at Appendix B
What are the drivers? Some answers are given at Section 5 above
What is the problem? This is the heart of the description and may refer to a piece of equipment, may describe a work area; it may describe
the findings of an incident investigation; it may summarise e the findings of an external or internal audit report or review.
hazards occurring.
REQUIRED to reduce /
eliminate the effects (inc.
Responsibility
PLACE to prevent risk &
ACTIONS / TREATMENT
Time scale
with the description)
HAZARDS
CONTROL MEASURES IN
RISK SCORE
RISKS & HAZARDS (associated
EFFECTS OF THE RISKS &
costs)
20
Appendix 3 Risk Assessment Options Appraisal
Location of risk:
Risk Assessment Ref.:
Author of submission:
Date:
Essential Background Information:
(maximum of 500 words – an outline of background information to support this submission)
Results of Risk Assessments:
(e.g. general risk assessment or specialist assessments such as COSHH, handling (patient and non-patient,
display screen, personal protective equipment, violence and aggression, latex etc.)
Options for Discussion:
Implications for the Trust:
(including financial and other resource implications)
Recommendation:
Outcome:
(to be completed by the chair of the group to which the submission has been made)
Signature: …………………………………………….
Date: …………………………….
Title: ………………………………..…………………
21
Appendix Ci Risk Assessment Options Appraisal on the risk register
An appraisal of the benefits of identified controls may be undertaken directly on the risk
register.
Click on the pencil to open a
larger window with the boxes to
fill out
22
Risk Assessment Policy
Version:
2.0.0
Approved by:
Clinical Risk And Quality Committee
Date Approved:
24 October 2014
Ratified by:
Policy Review Group
Date ratified:
13 November 2014
Name of originator/author:
Head of Risk
Name of responsible committee/individual:
Bryan Healy, Head of Risk
Date issued:
November 2014
Review date:
October 2017
Target audience:
All Staff
Contents
Section
Page
1
Introduction
3
2
Purpose
3
3
Duties
3
3.1
Duties within the Organisation
3
3.2
Identification of Stakeholders
5
Method of development
5
Consultation and communication with stakeholders
5
Contents
6
5.1
Definitions
6
5.2
The Risk Assessment Process
6
5.3
The Risk Register
13
5.4
The assurance framework
13
5.5
Staff training
14
6
Monitoring of this policy
14
7
Links with other Trust Policies and procedural documents
15
Appendix I
Risk Matrix
16
Appendix 2
Risk Assessment Proforma
20
Appendix 3
Risk Assessment Options Appraisal
21
4
4.1
5
Appendices
1.0
Introduction
Birmingham Children’s Hospital NHS Foundation Trust (BCH) is committed to providing
high quality patient care within a safe environment. Legislation places a duty upon us
to identify foreseeable risks and take reasonably practicable steps to minimise them.
Through this requirement, legislation recognises that staff, patient and visitor safety is
best delivered through a proactive approach to identifying and controlling risk. The
Trust adopts this vision but realises that if it is to provide quality services, it must also
identify and control risks to clinical effectiveness and patient satisfaction. Risk
Assessment is adopted as the tool which is used Trust wide to identify and control risks
to the quality and, by extension, the safety of our services.
2.0
Purpose
This Policy sets out the responsibilities for assessment of risks within the organisation
alongside the process for doing so. It provides guidance on how to undertake a risk
assessment, scoring and prioritisation of risk and the role of the risk register. It defines
the escalation routes from local risk assessments to consideration at a Directorate and
corporate level.
3.0
DUTIES
3.1
Duties within the organisation
a. Trust board
Trust Board will:

review information provided within reports arising from the risk register;

review activity taken to mitigate high risks;

Make recommendations following review of the information provided.
b. Trust committees with responsibility for risk
Clinical risk and quality assurance committee and the Non clinical risk co-ordinating
committee are responsible for reviewing information provided in the following areas:

High Risk Reports

Significant risks escalated by the Clinical Directorates and Corporate support
departments
3
c. Chief Executive
The CEO is ultimately accountable for risk management, which includes ensuring that
those with delegated responsibility for the identification, management and review of
risks meet their duties within a timescale and with a priority commensurate with the
severity of the risk identified.
d. Chief Medical Officer
The CMO has overall responsibility for the management of Clinical Risk, which includes
participation in the review of risks and action plans arising and the encouragement of
all medical staff to escalate risk through the BCH risk register and reporting systems
e. Chief Operating Officer
The Chief Operating Officer has overall responsibility for the management of NonClinical Risk, which includes participation in the review of risks and action plans arising
and the encouragement of all staff to escalate risk through the BCH risk register and
reporting systems.
f. Associate Director of Governance
The Associate Director of Governance, through the Governance team, will:

ensure that the organisation maintains a robust, dynamic risk register

participate within the review of risk assessments
g. Risk Management Specialists
The Head of Risk, the Risk Manager, the Health, Safety and Security Manager and the
Moving and Handling Advisor are key individuals identified as competent people within
the risk management structure at the Trust. Their key responsibilities are:

To develop and maintain the risk register and reporting systems at BCH.

To support staff when assessing risk.

To provide Directorate, Speciality and Department meetings and subcommittees with area specific reports.

To review the risk registers at the Trust, providing speciality and directorate
managers with reports of trends which arise.
h. Directorate, speciality and departmental managers
The Directorate, speciality and departmental management Teams will:
4

Maintain a programme of risk identification and review within the Directorate,
speciality and wards for which they have responsibility.

Support staff undertaking risk assessment, including the identification of
training needs and provision of time and other resources to enable the process
of review and assessment

Undertake and follow up action plans arising from risk assessment;

Validate risks within their authority and escalate those outside of their
authority
i. All staff
All staff must:

Familiarise themselves with the definition of hazard and risk;

Maintain an awareness of risks within their working environment, highlighting
concerns to their departmental, speciality or directorate managers as
necessary;

Participate in the implementation of action plans arising from risk assessments
where necessary;

3.2
Undertake risk management training and updates.
Identification of Stakeholders
All staff are given duties within their contract of employment for the management of
risk. As such, in addition to those with defined responsibilities in managing risk, all staff
are considered to be stakeholders.
4.0
Method for development
This policy version renews existing arrangements for risk assessment as defined in the
Risk Assessment Policy ratified in 2011 that forms version 1.1.1 of this policy.
4.1 Consultations and communication with stakeholders
Clinical Risk and Quality Committee and Non-clinical Risk Coordinating Committee are
identified as the high level committees with responsibility for risk. The membership of
these committees is identified as primary stakeholders for consultation. Additionally,
Directorate Management Teams were consulted.
5
5.0
Content
5.1
Definitions
A risk assessment is a careful examination of an actual or potential risk. Risk
assessments identify the existing precautions which are being taken and what further
measures are needed to reduce the risk to an acceptable level. The process of risk
assessment seeking to answer four simple, related questions:
Within this process one considers potential hazards and their outcomes, controls
which mitigate these outcomes and the likelihood of an adverse event occurring given
the controls in place.
Hazard is the potential to cause harm. A hazard is a situation that poses a level of
threat to life, health, property, environment or the services which we provide. Most
hazards are dormant or potential, with only a theoretical risk of harm. The term
consequence is used to refer to the actual type of outcome which may occur.
Controls are anything which reduces the likelihood of that potential harm actually
occurring; or the consequences of it. They may be physical, such as an item of
protective clothing; or they may be procedural such as a protocol or a management
process.
The term Directorate refers to the Clinical Directorates and non-clinical units
(Workforce, Estates and Facilities and the Corporate Directorate comprising
Governance, Finance and IT).
5.2
The Risk Assessment Process
5.2.1 Identifying risk
A risk can be identified from a variety of sources; they are not just related to risks
identified by staff self-assessment. The following are examples of where risks for risk
assessment can be sourced:
6

Audit / benchmarking / gap

Moving & Handling
analysis

Team meeting
NHSLA Risk Management

Self-assessment
recommendations

Financial / business concern

Media

Health & Safety Executive

External reports / National

Safety alerts / bulletins
enquiry

Healthcare Commission

Trend analysis

Professional bodies

Complaints / PALS

Service user group

Coroners reports

Service process or procedures

Corporate issues

Risk review process

New legislation

Business

IR1 forms

5.2.2 Describing risky situations
The situation where the risk sits should be described. The mnemonic INSIDE is a useful
tool for structuring that description:
Introduction: who/where are we assessing?
Scene setting: describe the activity or the problem or the general situation where the
risk resides
Individuals: Who are the people, processes, equipment or places that might be
affected by this risk?
Dangers: describe the hazards or the dangers we see here.
Effect: And describe the outcome should the hazard affect those people.
5.2.3 Describing Controls
The controls which are currently in place and stop people in the situation being
affected by the hazard should be identified.
5.2.4 Assessing risks
The information collected so far can now be analysed to see how likely the hazard is to
occur and how severely people may be affected by it. That will be strongly influenced
by the controls currently in place and how effective they are at protecting people.
It will be informed by individual experiences and opinions.
7
It is important at all stages to include a number of stakeholders in the assessment
process to ensure that a holistic view of the problem is established, rather than an
individual opinion.
5.2.5 Scoring risks
The assessment should ask if this risk is realised:

What is the severity of the outcome expected to be? Scored on a scale of 1 to
5, this provides the hazard score (also referred to as the severity or
consequence score). A hazard score of 1 indicates that the anticipated outcome
is minor; a hazard score of 5 indicates a more serious outcome

How likely is it that outcome to occur? Scored on a scale of 1 to 5, this provides
the likelihood score (also referred to as the frequency score). A likelihood score
of 1 indicates that the anticipated outcome occurs rarely; a likelihood score of 5
indicates the outcome is almost imminent.

The Risk score is calculated by multiplying the hazard and the likelihood scores.
Hazard scores related to safety, quality and patient experience (full table of hazard scores is in Appendix 1)
1
Descriptor
Injuries
Patient Care
Insignificant
Minor Injury not
requiring first aid
Acceptable
management
Complaints/
Locally resolved
Claims
complaint
2
3
Minor
Moderate
Minor injury or
RIDDOR/ Agency
illness, first aid
reportable.
treatment needed
Moderate injury.
Unacceptable
management but no
adverse outcome
Justified complaint
peripheral to clinical
care
4
Major
Catastrophic
Major injuries, or
long term
incapacity/ disability
(loss of limb)
Moderate
Serious
Mismanagement of
Mismanagement of
patient care with
patient care with an
adverse outcome
adverse outcome
Below excess claim.
Justified complaint
involving lack of
appropriate care
5
Claim above excess
level. Multiple
justified complaints
Death or major
permanent
incapacity
Death
Multiple claims or
single major claim
Likelihood Score
1
Descriptor
Frequency
Probability
2
3
4
5
Rare
Unlikely
Possible
Likely
Almost Certain
Not expected to
Expected to occur at
Expected to occur at
Expected to occur at
Expected to occur at
occur for years
least annually
least monthly
least weekly
least daily
< 1%
1-5%
6-20%
21-50%
>50%
8
Will only occur in
exceptional
circumstances
Unlikely to occur
Reasonable chance
of occurring
Likely to occur
More likely to occur
than not
9
5.3 Documenting Risk Assessments
The organisation has a duty to record the findings of risk assessments. That may be
achieved by using the Risk Assessment Proforma at Appendix B or by direct entry to
the risk register.
5.3.1 The Risk Assessment Proforma
The Proforma at Appendix A is particularly suited to describing complex risks. A
problem may present different risks to different groups. Some risks may be greater
and in need of more urgent action than other risks highlighted by the problem. This
Proforma is offered as a structured document to help describe the risk. A summary of
the risks must be subsequently transcribed on the risk register.
5.3.2 The Risk register
The risk assessment Proforma does not need to be used in every case; risks may be
entered directly to the risk register. This may be appropriate for risks which are more
simply described.
5.3.3 Specialist risk assessments
Requirements for specialist risk assessments exist in other policies, e.g. Moving and
Handling, Display Screen Equipment, COSHH, Work at Heights, Lone Worker, First Aid
needs. These policies typically describe risks within a discrete activity or pertaining to
the needs of an individual patient. They exist as a description of how risks are
controlled in the undertaking of an activity and should not be entered on the risk
register.
However, they may be used to identify where risks exist. For example: A patient
handling assessment may say use a hoist but the department does not possess a hoist.
The department should then assess the risks of not having a hoist to assist with the
handling of any patient on the ward and enter that risk on the risk register.
10
Fig 1. The Risk assessment Process
Risk assessment should follow the process outlined in the flow chart below:
Describe the situation, giving
background to a problem
where hazards may exist
List those hazards and the
expected typical outcome of
them
Detail the existing controls
that reduce the likelihood of
an accident and severity of
harm caused.
Significant risks
and action plans
must be
reported
through clinical
and non-clinical
committee
reporting
frameworks.
Calculate a risk score and
escalate the risk for
validation
Detail the outstanding
controls needed to reduce
the likelihood and harm.
High risks
must be
notified Chief
Operating
Officer and
Governance
Team for
validation.
Develop and monitor an
action plan which puts
outstanding controls in
place.
Update progress on actions.
Review the risk score in light
of changes.
Close the risk.
11
5.3.4
Authority to accept risks
Risks must be scored according to severity and likelihood of outcome using the risk
matrix at Appendix A and defined as minor, moderate, significant and high risks. Table
1 identifies the authority of managers to accept risks at each level of harm.
Table1 Escalating risks
Risk Colour
Remedial
Decision to
Action
accept risk
Authority of the Manager
The department manager can:
Green
Department
Department
•
Enter the risk as validated.
(minor)
Manager
Manager
•
Close the risk when they are
satisfied it is controlled
The department manager must:
•
Yellow
Department
(moderate)
Manager
Validate the risk after
discussion with the
DGM / CD
Directorate Team.
•
Close the risk after discussion
with the Directorate Team.
The Directorate management Team
must:
Orange
(significant)
•
Directorate
Directorate
management
management
discussion with the
Team
Team
department.
•
Validate the risk after
Close the risk after discussion
with the department.
The Directorate Team must:
Red
(high)
CR&Q
Board of
•
Escalate the risk for validation.
Directors
•
Closely manage reduction of
the risk.
5.3.5 Validation of risks
Where a manager does not have the authority to accept a risk it is recorded on the risk
register as ‘Not yet Validated.’ The validation process should agree the severity and
outcome of a risk in light of the existing controls. When validated, that risk is described
12
as ‘Partially Controlled’ to both reflect the presence of existing controls and need for
additional controls.
5.3.6 Development of outstanding control strategies
Where a risk is not controlled as far as is reasonably practicable, actions to reduce the
risk must be developed.
The term, as far as is reasonably practicable, reflects our legal duties to reduce risk.
This standard is best met through a balancing of the inputs required to manage a risk
against the reduction in risk which we expect to achieve.
That judgement must be made by or in consultation with a manager with authority to
accept risk.
Balancing risk
On Balance
Control
B
?
Risk A
4x4 = 16
?
Control
C
Time
Cost
Resources
Practicability
Proportionate
response
Acceptance
of risks
Competing
prioritises
Risk A
4x3 = 12
Risk A
3x3 = 9
?
Control D
Risk A
3x2 = 6
The options appraisal Proforma at Appendix C is offered as a structured document to
help undertake a detailed justification for the selection of the most appropriate control
and from which an action plan may be developed.
Responses to risk might attempt to reduce the severity of the risk should it happen of
risks; or they might attempt to reduce the likelihood of the risk occurring; or they
might target both.
5.3.7 Principles of prevention in controls
13
There is a hierarchy of control measures at the top of which is, ‘Avoid the risk all
together’. If possible do the work in a different way, taking care not to introduce new
hazards; this is not always possible in healthcare, we expose the patient and are
exposed to risk as part of treatments which are necessary and cannot be avoided. In
such cases we should use risk assessment to identify the controls we will use to reduce
risk:

Control at source: if we can remove the risk altogether, we should do so.
o A good example of this is the use of ‘safer sharps’ where needles are
replaced with devices which have a cover to stop users suffering an
accidental needle stick injury

Use controls which protect the largest number of people from risk.
o
In rooms where X-rays or, lasers are used, we have interlocks on doors
so that people who do not need to enter dangerous areas cannot enter
them.
o Our wards and departments have controlled access, only allowing entry
to people who need to be there.

Where it is not possible to use mechanical controls we develop procedures to
restrict the number of people who have access to the hazardous area or are
exposed to the hazard.

Standard procedures e.g. the preparation and administration of medicines will
define the safest way of performing a task. These are probably our most
frequent type of control; but they also rely on users adhering to these
procedures. When developing procedures:
o They are supported by induction and training.
o
It is important that procedures are developed in consultation with the
teams who will perform them so that they are sensible and achievable by
the team, so that team members see value in them and own them.
o And they should be monitored to make sure they continue to work: that
could be formal monitoring of the process (e.g. PEWS monitoring and
NCQI’s); it could be monitoring outcomes (e.g. M&M review, audit,
feedback, complaints, incidents); or it could be an on-going discussion with
users to make sure the procedures are the right ones.
o Monitoring will most likely be a mixture of all three types. The results of
monitoring should be fed into review of the risk assessment.
14
5.3.8 Reviewing risks
Table 2 identifies the expected frequency of risk review at each level of harm.
Table 2 Expected review frequency
Risk
Colour
Green
Yellow
Reviewer
Department
Manager
Department
Manager
Review frequency
Following changes to risk or implementation of controls
Following changes to risk or implementation of controls
Orange
DMT
As required but at least quarterly
Red
CRAQ
Monthly
5.3.9 Closing Risks
Closed risks may be described as:

Risk Removed
o Where the hazard has been removed and there is no further exposure
to risk.

Risk Controlled
o Where the hazard remains present but the physical and management
controls are sufficient to ensure that both the severity of outcome and
the likelihood of an incident are reduced as far as is reasonably
practicable.
Closure of a risk will involve reduction of the risk score and that reduction must be
validated by a manager with the authority to accept the original risk score.
5.3.10 Equality Impact Assessment
When undertaking your risk assessment, it is important to consider the impact on
equality and disability. Please indicate on the risk assessment Proforma and the risk
register if you have undertaken an assessment for equality and disability. Any
appropriate actions should be included on the risk assessment action plan.
For further information please refer to the guidance on Equality Impact Assessment.
15
5.4
The Risk Register
The web-based risk register is accessible at http://safeguard/safeguard/
Access to the risk register is given to department, speciality and directorate managers
with access rights given to reflect the authority of the manager, so:

department managers can see all the risks in their department,

speciality managers can see the aggregated risks of departments in that
speciality and,

Directorate management teams can see aggregated risks from all specialities
and departments under their control.
The organisational risk register comprises the aggregated risks from all clinical
directorates and non-clinical departments and is accessible by the Executive
Management Team and those specialists managing risk at the Trust, with filters
allowing a focus on high and significant risks.
The committee reporting framework facilitates reporting escalation and monitoring of
high and significant risks from the organisational risk register with the frequency given
at table 2 above.
5.4.1 High Risks on the risk register
High risks are those scoring above 15 and must be escalated to the relevant
Directorate Management Team and to the Risk Manager, Health, Safety and Security
Manager, Director of Healthcare Governance and Education or the Chief Medical or
Nursing Officer.
5.5
The assurance framework
Strategic or Corporate risks are those that transcend the department, speciality or
directorate that have identified and escalated them and are expected to affect the
strategy and direction of the Trust with an impact on numerous people within or
outside of the Trust.
Corporate objectives which are recognised by the Trust Board as priorities to the
organisation are defined within 5 themes. Known risks to meeting these objectives are
aligned to these themes. Actions to mitigate those risks are monitored through the
assurance framework.
The assurance framework is also populated with those high risks escalated through the
risk register.
16
5.6
Training and Education
Training in risk awareness and use of the risk register is delivered to staff in accordance
with the Training Needs Analysis developed by the Governance Support Unit and
implemented at departmental level.
Additional training documentation and support is found within the Governance
Support Unit intranet pages.
Access to the risk register is not just limited to one person per area, a wide range of
staff can be nominated following a brief training outline from the Risk Manager or
Health, Safety and Security Manager. Do not attempt to use the register without
training.
The Education & Learning (E & L) department will be proactive in the consultation of E
& L delivered at BCH NHS FT in response to workforce and service needs. For all
Statutory and Mandatory Training E & L will design and facilitate the events. In order
to demonstrate compliance; the following statements apply:

Attendance at all Statutory and Mandatory learning/training events will be
recorded onto the Oracle Learning Management (OLM) system.

Any non-attendance, for booked places, will be escalated to the relevant
individual and their line manager and department.

Statutory and Mandatory Training attendance % be reported for line managers
and departments to monitor compliance % on a Trust Dashboard; against
defined Key Performance Indicators (KPIs). Each department and Directorate
will be able to use this information for robust reporting (to the relevant
committees, meetings and forums within the current Governance framework),
monitoring and to produce action plans to assure that compliance is met.

E & L will undertake quarterly audits of policies that they originate/develop to
assure monitoring and compliance is met.
6.0 Monitoring of this policy
6.1 Risk Register Review
An annual review of the risk register system is undertaken by the Risk Manager and
submitted to the Clinical Risk and Quality Committee. That report shall consider:

The location of risks and use of the risk register

Risk scoring and validation;

Controls in place;
17

Actions to put additional controls in place;

Review and closure of risks.
6.2 Review of High Risks
Risk Reports are presented to the Clinical Risk and Quality Committee and Non-Clinical
Risk Coordinating Committee on a monthly basis.
These reports include all high risks and other risks which those committees have asked
to receive information about. Reports are received in order to discuss progress toward
implementing actions which will reduce risk.
High risks are subsequently highlighted to the Quality Committee of the Board:

By CRAQ through the monthly Quality Report.

From NCRCC through its’ monthly report to that committee.
6.3 Review of Significant Risks
Directorates are expected to report significant clinical risks and work toward
controlling them as part of the reporting framework to the Clinical Risk and Quality
Committee.
Directorates are expected to report significant non-clinical risks and work toward
controlling them as part of the reporting framework to the Non-Clinical Risk
Coordinating Committee.
7.0 Links with other Trust Policies and procedural documents

Safety Strategy

SIRI Policy

Incident Reporting Policy

Being Open policy

Learning from Experience policy

Health and Safety Policy

Counter-Fraud Policy & Guidance

Governance Training Needs Analysis
18
Appendix 1 Risk Matrix
1
The matrix explained
The purpose of giving risks scores is to give the risk a priority / severity rating that
enables BCH to review its risks in a more objective and systematic way. At BCH the
following risk matrix scoring system is used.
Consequence
Likelihood 1
2
3
4
5
1
1
2
3
4
5
2
2
4
6
8
10
3
3
6
9
12
15
4
4
8
12
16
20
5
5
10
15
20
25
The likelihood is the frequency that the risk will occur, with the scoring column located
in the left column. 1 is a low likelihood and 5 is high.
The consequence is the adverse outcome associated with the risk that has occurred.
The scoring row is located in the top row of the matrix. 1 is a low impact and 5 is high.
Likelihood x Consequence = Risk Score
After the likelihood and consequence have been decided they are multiplied together
and equal the risk score. The overall risk score CANNOT exceed 25.
The following outlines the priority / severity rating for the above matrix in more detail:
Risk type
Risk Colour
Risk Score
Low risk
Green
1 to 6
Moderate risk
Yellow
8&9
Significant risk
Orange
10 & 12
High risk
Red
15 to 25
19
Choosing risk scores is very subjective and may mean different things to different
people, for example driving without a seat belt on may be considered by some as low
risk and others as high risk. To ensure that the risks assessed at BCH are risk scored
consistently, the following descriptors of consequence and likelihood are used.
2
To determine the Consequence score
Consequence may be scored on a number of scales depending on the nature of the risk
being assesses. These are listed I Table A1 below. Different risk types defined in the
first column should be used to determine on which row the risk is being scored. Read
across subsequent columns unto identify the descriptor which best mirrors the typical
outcome from this hazard and use the numerical score at the top of that column as the
consequence score.
2.1
Consequence Modifiers
Some hazards may affect only one person or a small number of people within a ward
or department at BCH.
Larger groups may be affected as hazards stretch across multiple wards or
departments at BCH; or even to our patients and families outside of BCH.
Harm to these larger groups which is minor in nature can be missed as we prioritise
more severe harm. But where there is a cumulative effect of lots of minor harm across
a large number of people we want to reflect that in our scoring.
The consequence modifiers in Table A2 are used to raise the consequence scores and
better reflect the severity of these risks.
2 rules apply to using modifiers:

They should only be used when scoring consequences with descriptors
highlighted in the same colours as in the modifier table.

3
The final outcome score cannot be higher than 5 and the minimum is 1.
To determine the Likelihood score
Score the likelihood by assigning a predicted frequency of the adverse outcome
occurring. That may be the simple descriptor; the more quantitative description given
under frequency; or the more accurate probability, which may be derived from a
measurement of an actual incident rate.
20
Table A1 Consequence scores
Descriptor
1
2
3
4
5
Insignificant
Minor
Moderate
Major
Catastrophic
Insignificant cost
Objectives/
Projects
increase/ schedule
slippage. Barely
noticeable reduction
in scope or quality
Injuries
Patient Care
<5% over budget/
5-10% over budget/
schedule slippage.
schedule slippage.
Minor reduction in
Reduction in scope or
quality/ scope
quality.
Minor injury or
RIDDOR/ Agency
illness, first aid
reportable. Moderate
treatment needed
injury.
Unacceptable
Moderate
Acceptable
management but no
Mismanagement of
management
adverse outcome
patient care with
Minor Injury not
requiring first aid
adverse outcome
Complaints/
Locally resolved
Claims
complaint
Service/
Business
Interruption
Justified complaint
peripheral to clinical
care
Below excess claim.
Justified complaint
involving lack of
appropriate care
10-25% over
budget/ schedule
slippage. Doesn’t
meet secondary
objectives
Major injuries, or
long term
incapacity/ disability
(loss of limb)
>25% over
budget/ schedule
slippage.
Doesn’t meet
primary
objectives
Death or major
permanent
incapacity
Serious
Mismanagement of
Death
patient care with an
adverse outcome
Claim above excess
Multiple claims
level. Multiple
or single major
justified complaints
claim
Loss/ interruption > 1
Loss/ interruption >
Loss/ interruption > 1
Loss/ interruption >
hour
8 hours
day
1 week
Permanent loss
of service or
facility
Non delivery of
Short term low
Staffing and
Competence
staffing level
On-going low
temporarily reduces
staffing level reduces
service quality (<1
service quality
day)
Late delivery of key
Uncertain delivery
key objective/
objective/ service due
of key objective/
service due to
to lack of staff. Minor
service due to lack
lack of staff. Loss
error due to poor
of staff. Serious
of key staff.
training. On-going
error due to poor
Critical error due
unsafe staffing
training
to insufficient
training
Financial
Small loss
Minor
Inspection/
Audit
recommendations
Minor noncompliance with
standards
Adverse
Publicity/
Reputation
Rumours
Loss > 0.1% of
budget
Recommendations
given. Noncompliance with
standards
Loss >0.25% of budget
Loss of >0.5% of
Loss of >1% of
budget
budget
Reduced rating.
Enforcement Action.
Challenging
Low rating. Critical
recommendations.
report. Major non-
Non-compliance with
compliance with
core standards
core standards
Local Media – short
Local Media – long
term. Minor effect
term. Significant effect
on staff morale
on staff morale
National Media < 3
Days
Prosecution.
Zero Rating.
Severely critical
report
National Media >
3 Days. MP
Concern
21
(Questions in
House)
Table A2 Consequence Modifiers
C = -1 (Minimum 1)
C = +1 (Maximum 5)
C = +2 (Maximum 5)
Number of people
More than a single ward or
More than the whole Trust
Affected
department
(Local Health Economy)
Importance of service,
Minor service/ project/
Service/ project/ objective
Service/ project/ objective
project or object at risk
objective
important to the whole Trust
critical to the whole Trust
Table A3 Likelihood Score
Descriptor
Frequency
Probability
1
2
3
4
5
Rare
Unlikely
Possible
Likely
Almost Certain
Not expected to occur for
Expected to occur
Expected to occur at
Expected to occur
Expected to occur
years
at least annually
least monthly
at least weekly
at least daily
< 1%
1-5%
6-20%
21-50%
>50%
Will only occur in
exceptional circumstances
Unlikely to occur
Reasonable chance
of occurring
Likely to occur
More likely to
occur than not
22
Appendix 2 - Risk Assessment Proforma
Risk Assessors Name:
Date of Assessment:
Overall Risk Assessment Score (highest original risk score):
Area / Speciality (completing
Location of Risk:
Type of risk (e.g., clinical, non-clinical, finance)
Proforma):
Description of Risk Assessment (include here: Main Risk, Source of risk, & Reason for assessment):
Through a description of the background to the problem being considered, hazards may be identified. Descriptions of the background would
answer the questions:

What are we risk assessing? Some answers are given in the tables at Appendix B

What are the drivers? Some answers are given at Section 5 above

What is the problem? This is the heart of the description and may refer to a piece of equipment, may describe a work area; it may describe
the findings of an incident investigation; it may summarise e the findings of an external or internal audit report or review.
hazards occurring.
REQUIRED to reduce /
eliminate the effects (Inc.
Responsibility
PLACE to prevent risk &
ACTIONS / TREATMENT
Time scale
with the description)
HAZARDS
CONTROL MEASURES IN
RISK SCORE
RISKS & HAZARDS (associated
EFFECTS OF THE RISKS &
costs)
23
Appendix 3 Risk Assessment Options Appraisal
Location of risk:
Risk Assessment Ref.:
Author of submission:
Date:
Essential Background Information:
(maximum of 500 words – an outline of background information to support this submission)
Results of Risk Assessments:
(E.g. general risk assessment or specialist assessments such as COSHH, handling (patient and non-patient,
display screen, personal protective equipment, violence and aggression, latex etc.)
Options for Discussion:
Implications for the Trust:
(including financial and other resource implications)
Recommendation:
Outcome:
(to be completed by the chair of the group to which the submission has been made)
Signature: …………………………………………….
Date: …………………………….
Title: ………………………………..…………………
24
Appendix 4 Risk Assessment Options Appraisal on the risk register
An appraisal of the benefits of identified controls may be undertaken directly on the risk
register.
Choose the solution type
Describe the solution
Weigh up the pros and cons
Add in any
25
Click on the pencil to open a
larger window with the boxes to
fill out
26
APPENDIX 5 GOVERNANCE TRAINING NEEDS ANALYSIS
Foundation Governance Training
Topic areas
Staff
Advanced Governance Training
Incident reporting

Complaints
Claims and Inquest
Incident management and
investigation

SIRI investigation
Risk Management
Security Management

Statement writing

Complaints Investigation
Health and Safety

Risk Register Management

Policies

Processes

Responsibilities

Risk Awareness
All Staff
Ward Managers
Department Managers
Speciality Managers
Service Managers
Directorate Managers
DLR Investigators
SIRI chairs
Refresher
frequency
Every 2 years
Need determined on individual basis
through PDR
Delivery
Class-room learning sessions
Moodle
Blended delivery of class-room
learning sessions supported by online resources.
27