Guideline for Systems Analysis Investigation of
Incidents and Complaints
November 2012
Document
Reference
Number
QPSD-GL-521.1
Document
Developed by
Revision
Number
1.1
Document
Approved By
Date
06.12.2012
Revision
Date
November
2013
Responsibility for
Implementation
Responsibility for
Review and Audit
HSE Investigation
Processes Working
Group Chaired by Ms.
Cora McCaughan
Dr. Philip Crowley,
National Director,
Quality and Patient
Safety, on 16.11.12.
Quality and Patient
Safety Directorate
Cora McCaughan, cochair HSE National
Incident Management
Team
Table of Contents
1.0 Policy
3
2.0 Purpose
3
3.0 Scope
5
4.0 Glossary of Terms and Definitions
6
5.0 Roles and Responsibilities
9
6.0 Guidelines for Systems Analysis Investigation of Incidents and Complaints
6.1 The context of the systems analysis investigation procedure
10
6.2 Step 1: Organise the investigation and gather the data
11
6.3 Step 2: Determine the incident chronology
12
6.4 Step 3: Identify the key causal findings (and incidental findings)
18
6.5 Step 4: Identify the contributory factors related to the key causal factors
and incidental findings
19
6.6 Step 5: Make recommendations that will reduce risk and improve quality
and safety
20
6.7 Step 6: Write the Investigation Report
24
7.0 Appendices
Appendix 1: Proposed membership of local incident management team
29
Appendix 2: Template terms of reference for local incident management
30
team
Appendix 3: Template incident management team meeting agenda
31
Appendix 4: Template investigation terms of reference for an
32
investigation
Appendix 5: Letter of invitation to go from investigation commissioner to
34
interviewees
Appendix 6: Introduction to interviews
Page 1 of 62
35
Appendix 7: Information sheet for complainants/those affected
36
Appendix 8: Headings to be included at top of each note of an interview
37
Appendix 9: Confidentiality Agreement (accompanying persons)
38
Appendix 10: Form to Request a Nomination for External Clinical
39
Expertise Support to a HSE investigation
Appendix 11: Confidentiality agreement
40
(external nominees to input to HSE investigations)
Appendix 12: Template Investigation Report.
43
Appendix 13: Suggested Content :Registered Letter/Secure
46
Email inviting feedback to first draft investigation report.
Appendix 14: Suggested Content :Registered Letter/Secure
48
Email inviting feedback to final draft investigation report.
8.0 References & Bibliography Used to Inform the Development of This
50
Guideline
9.0 Audit Tool to Assess Compliance with this Guideline
Page 2 of 62
53
1.0
Policy Statement
Incidents that result in death or serious harm will be investigated using a systems
analysis method. In particular, incidents that result in death and serious harm will be
assessed following steps 1-3 of this guideline.
Near miss incidents will be considered “risks” and should be reviewed using systems
analysis methods and the identified “contributory factors/hazards” managed and
communicated via the Risk Register and according to the HSE’s risk management policy
and procedures.
Systems analysis is a methodical investigation of an incident which involves collection of
data from the literature, records (general records in the case of non clinical incidents and
healthcare records in the case of clinical incidents), interviews with those involved in
delivering the care/service where the incident occurred and analysis of this data to
establish the chronology of events that lead up to the incident, identifying the key causal
factors that had an effect on the eventual adverse outcome, the contributory factors, and
recommended control actions to address the contributory factors to prevent future harm
arising as far as is reasonably practicable.
2.0
Purpose
The purpose of this guideline is to provide a standardised methodology (six steps) for
systems analysis investigations undertaken by the HSE. In particular this guideline
applies to any investigation of incidents that result in death or serious harm. The
purpose of this guideline is to ensure that HSE investigations are valid, reliable and
generalisable and carried out in line with principles of open disclosure and a just culture.
This guideline has been designed to guide investigators in conducting robust
investigations using the systems analysis method and good investigation practice to:
•
•
•
•
•
•
•
•
Ensure appropriate terms of reference are developed for the investigation
Use appropriate data collection methods and a high standard of record keeping
throughout the investigation process
Determine the chronology of events
Identify any key causal factors that may exist
If any key causal factors are identified to then identify the contributory factors
associated with each key causal factor
Make recommendations to address the contributory factors in accordance with an
agreed hierarchy of preferred control measures
Conduct fair investigations in a manner that is cognisant of natural and constitutional
justice, due process and data protection requirements
Conduct investigations in a manner that balances the need for the HSE to achieve
it’s safety objectives with the need not to jeopardise the rights of individuals in
concurrent or future investigations by external agencies including An Garda
Siochána or the professional regulators etc.
Page 3 of 62
The aim of investigations carried out using this guideline is
•
•
To find out the truth about what happened for all those affected and involved
To identify causes so that these can be addressed to prevent future harm arising
from them
This guidance document replaces section 5 ‘Systems Analysis Guidance’ from within the
previous Health Service Executive Document “Toolkit of Documentation to Support the
Health Services Executive Incident Management” (2009).
Page 4 of 62
3.0
Scope
This guideline applies to all investigations undertaken by HSE staff and staff working in
HSE Funded Services.
Systems analysis investigations will be carried out according to various HSE policies,
procedures and guidelines including:
•
•
•
•
HSE Health and Safety investigations including those related to the Health Safety
and Welfare at Work Act 2005 and other Relevant Legislative requirements
pertaining to the Health, Safety and Wellbeing of employees
HSE Incident Management Policy
Radiation Exposure Incidents that are notifiable to the Medical Exposure
Radiation Unit (managed by the HSE)
Your Service Your Say, HSE Policy and Procedure for the Management of
Consumer Feedback.
Page 5 of 62
4.0
Glossary of Terms and Definitions –
Term
Accident
Adverse events
Commissioner
Contributory factor
Harm
Definition
An unplanned, unexpected, and undesired event, usually
with an adverse consequence (WHO (2009), HSE Quality
and Risk Taxonomy (2009)).
An incident which resulted in harm.
The commissioner of an investigation differs across the
health system, but it is typically the senior accountable
officer in a service, directorate or care group that
commissions an investigation of a clinical or non-clinical
incident.
A circumstance, action or influence which is thought to have
played a part in the origin or development of an incident or to
increase the risk of an incident. (WHO 2009).
Harm means injury to a person, or damage done to a thing.
In this context injury to a person means harm to body or
mind and includes pain and unconsciousness.
Hazard
Incident Management
Team
Damage to a thing may include damage to facilities or
systems, for example environmental, financial, data
protection breach etc
A circumstance, agent or action with the potential to cause
harm (WHO 2009.).
An incident management team is convened by the senior
accountable officer in a service, directorate or care group.
The incident management team takes responsibility for the
management of an incident to include, for example:
•
•
•
•
•
•
•
Arranges to provide care required to those affected
without delay
Reports the incident to appropriate personnel and
agencies (internal and external) – including escalation as
required
Addresses immediate safety concerns
Makes contingency plans
Manages internal and external communications including
communications with those affected and media
management
Commissions an appropriate investigation to inform
organisational learning
Manages associated costs efficiently
Page 6 of 62
Term
Incident:
Definition
An event or circumstance which could have, or did lead to
unintended and/or unnecessary harm. (Adapted from WHO
(2009) and DoH (2010), HSE Quality and Risk Taxonomy
(2009)).
Incidents include adverse events which result in harm; and
near-misses which could have resulted in harm, but did not
cause harm, either by chance or timely intervention.
Incidents can be clinical or non-clinical and include incidents
associated with harm to:
•
•
•
•
•
our patients, service users, staff and visitors
the attainment of HSE objectives
HSE ICT systems
data security e.g. data protection breaches
the environment
Incidents include complaints which are associated with harm
and as such these complaints are service user reported
incidents.
Just Culture
Key Causal Factors
Look back review
Near-misses
NIMT
Open Disclosure
Serious Harm
Refers to a culture that is both fair to staff who make errors
and effective in reducing safety risks.
Issues that arose in the process of delivering and managing
health services which had an effect on an eventual adverse
outcome.
Review of a number of people who have been exposed to
a specific hazard in order to identify if any of those exposed
have been harmed and how to take care of those harmed.
An incident which could have resulted in harm, but did not
either by chance or timely intervention.
National Incident Management Team
An open, consistent approach to communicating with
patients when things go wrong in healthcare. This includes
expressing regret for what has happened, keeping the
patient informed, providing feedback on investigations and
steps taken to prevent a recurrence of the adverse event.
Serious harm means serious injury to a person, or serious
damage done to a thing.
•
•
Serious harm means an injury which creates a
substantial risk of death or which causes serious
disfigurement or substantial loss or impairment of the
mobility of the body as a whole or of the function of any
particular bodily member or organ.
See HSE Impact table for specific description of serious
harm for both clinical and non-clinical incidents.
Page 7 of 62
Term
Serious incident
Systems analysis
investigation of an
incident
Definition
An incident that resulted in death or serious harm.
A methodical investigation of a specific incident which
involves collection of data from the literature, records
(general records in the case of non clinical incidents and
healthcare records in the case of clinical incidents),
interviews with those involved in delivering the care/service
where the incident occurred and analysis of this data to
establish the chronology of events that lead up to the
incident, identifying the key causal factors that had an effect
on the eventual adverse outcome, the contributory factors,
and recommended control actions to address the
contributory factors to prevent future harm arising as far as is
reasonably practicable.
Page 8 of 62
5.0
Roles and Responsibilities
5.1 Role of Managers & Staff
It is the role of all HSE staff (and staff in HSE funded-services) to ensure that effective
investigations using a systems analysis methodology are carried out.
It is the responsibility of staff and managers that commission or conduct investigations
undertaken according to various HSE policies, procedures and guidelines (specified in
section 3.0) to:
−
−
−
−
−
Comply with this policy
Ensure that employees are aware of this policy and guidelines
Facilitate training for employees where necessary
Ensure that employees comply with this policy and guidelines
Ensure that the incident is reported to the appropriate personnel and agencies
(internal and external) – including escalation as required
It is the role of all employees associated with incidents investigated to comply with this
policy and associated guidelines and to participate in and to co-operate with
investigations conducted in accordance with this guideline and related policies.
Employees will not be disciplined nor referred to their professional regulatory bodies
when they comply with this policy and procedure except in the following circumstances
⇒ Non-participation in the HSE investigation1
⇒ Where an individual deliberately concealed an incident
⇒ Where an employee acted criminally, or in a deliberately malicious manner
All employees should receive training in relation to incident management appropriate to
their role and responsibilities.
It is the responsibility of investigators who follow this guidance document to monitor their
own compliance with this guideline using the audit tool in section 9.0 of this document.
⇒
1
It will be considered a disciplinary offence to intimidate or exert pressure on any person who may be
involved in an investigation or to attempt to obstruct the investigation process in any way.
Page 9 of 62
5.2 Roles & Responsibilities of an Incident Management Team in the case of
incidents that result in death or serious harm
An incident management team is convened by the senior accountable officer in a
service, directorate or care group or their nominee. It is the policy of the HSE that an
incident management team is convened for incidents that result in death or serious
harm.
The incident management team takes responsibility for the management of an incident
to include, for example:
•
•
•
•
•
•
Arranges to provide care required to those affected without delay
Addresses immediate safety concerns
Makes contingency plans
Manages internal and external communications including communications
with those affected and media management
Commissions an appropriate investigation to inform organisational learning
Manages associated costs efficiently
For supporting documentation relevant to incident management teams see
•
•
•
Appendix 1: Proposed membership of local incident management teams
Appendix 2: Template terms of reference for local incident management team
Appendix 3: Template Incident Management Team Meeting Agenda
Page 10 of 62
6.0 Guidelines for Systems Analysis Investigation of Incidents
and Complaints
6.1
The Context of the Systems Analysis Investigation Procedure.
Once an investigation has been activated or commissioned it will follow the 6 steps as
outlined in figure 1 below.
Before an investigation commences the terms of reference must be agreed (See
Appendix 4 for a template terms of reference for an investigation).
Figure 1: The 6 steps of the investigation procedure.
Commissioner commissions the investigation
Step 1
Organise the investigation and gather the data
Step 3
Identify the key causal factors & Incidental Findings
Step 4
Identify the contributory factors
Step 6
Write the investigation report and
submit to the commissioner
Step 2
Determine the incident chronology
Step 5
Make recommendations
Please read this investigation process through at least once before embarking on the
stages.
Note: Other Ongoing Investigations
A HSE investigation may be carried out while external investigations are ongoing into the
same issue(s) such as civil litigation being managed by CIS, investigation of crime by the
An Garda Siochána, views of the DPP, the conduction of an inquest by the coroner.
Similarly, investigation by other bodies may occur at the same time as HSE
investigations such as, but not limited to, the Health and Safety Authority, HIQA, Mental
Health Commission. It is important that the HSE investigation proceeds carefully, if
appropriate, and that care is taken to ensure that the HSE investigation does not
jeopardise the external investigation(s). It is important that the investigation teams notify
Commissioners when these issues arise. It is the role of the commissioner of the
investigation to ensure/facilitate appropriate communications and linkages between the
various investigation bodies. This has to be carefully considered.
Page 11 of 62
6.2
STEP 1: Organise the investigation and gather the data
It is important to follow fair procedures)2, follow all relevant protocols (outlined in this
document) and assess whether consent is required to collect data (court data or
otherwise).
6.2.1 In step 1, investigators must ensure that they:
-
Develop and review the terms of reference for the investigation and ensure that
they can fulfil them (See appendix 4 for a template terms of reference). Collect all
pertinent information about the incident (See below), and
Plan and conduct interviews with relevant individuals (See below).
6.2.2 Collect all pertinent information
Collect all pertinent information and physical items related to the incident where
appropriate as soon as possible. Secure equipment where appropriate if involved in the
incident.
6.2.3 Data to be collected includes but not limited to the following:
→ All relevant records (consider consent, data protection)
→ Documentation related to the incident being investigated (e.g. policies,
procedures, guidelines and incident report forms)
→ Statements. Statements should be limited to the individual’s account of the
sequence and timing of events, a clear account of their involvement in the
incident, and an account of any difficulties they faced and problems (such as
faulty equipment) that may not be detailed in the records.
→ Physical evidence
→ Information about relevant conditions affecting the event (e.g. staff rota,
availability of trained staff, etc)
→ Where appropriate, photographs (consider consent issue) should be taken to
capture visual information that might assist with subsequent investigation
activity.
→ Determine whether a similar incident occurred before.
-
Conduct interviews where required with those involved in the incident (See section
below on planning and conducting interviews)
2
HSE staff members are indemnified by the HSE to carry out investigations in line with this guideline. The
HSE arranges professional indemnity insurance for non-HSE staff who contribute external, independent or
specialist advice to HSE investigations. HSE and non-HSE staff are expected to follow these guidelines for
a systems analysis investigation and in particular the guidance on the application of fair procedures to
ensure due process, natural justice, constitutional justice and factual accuracy checking throughout the
investigation process and prior to completion of final reports (see section 6.7.3.1).
Page 12 of 62
The use of a tracking system for information and other data sources, including physical
evidence, is important. The following is an example of a tracking form that could be
adapted to suit local needs (Table 1).
Table 1. Example of a tracking form
Ref. Information/Data
Date
Source
requested
From
whom?
Date
received
Location
of data
Comments
6.2.4 Plan and conduct interviews with all relevant individuals
Conducting interviews can be very resource intensive but can yield substantial
information. The individuals that need to be interviewed should be carefully selected
and interviewed as soon as possible after the incident. However, some individuals may
be traumatised by an incident and this should be considered sensitively when planning
interviews.
The following are key elements to consider in planning interviews:
6.2.4.1
Interviews should be conducted in a supportive and understanding manner.
Interviews should not be judgemental or confrontational. Diplomacy, tact, sensitivity,
empathy and objectivity are important skills for investigators. Investigators should also
be aware of the pitfalls of investigator bias including hindsight bias; confirmation bias;
outcome bias etc. The application of fair procedures is vital (see section 6.7.3.1).
6.2.4.2
Endeavour to have a link person who is familiar with the investigation process that can
meet and/or communicate with individuals who will be involved in the investigation to
communicate the investigation process and address any concerns and queries
individuals may have about the process.
6.2.4.3
Arrange to interview all individuals who can give information that is pertinent to the
investigation. This should include the person(s) harmed, which may be a staff member
and/or a service user and/or his or her family where appropriate provided they are
agreeable to this. In the case of a complaint investigation, this should include the
complainant and/or his or her family where appropriate provided they are agreeable to
this.
6.2.4.4
Arrange the sequence of interviews. Wherever possible, it is helpful to interview the
service user and/or his or her family and the complainant in the case of an investigation
of a complaint - first. This helps to get a sense of the service user’s experience and to
clarify their views on the pertinent issues. After this, it is helpful to interview more senior
managers, as they will help to give the general context of the incident. Finally, interview
those who were directly involved in the incident.
Page 13 of 62
6.2.4.5
Ensure that interviewees get sufficient notice about the interview. This should be
communicated to them in a letter from the commissioner of the investigations (see
appendix 5) which should include a copy of the terms of reference for the investigation
(see appendix 4); and details of the link person (alluded to in section 6.2.4.2 on previous
page) who can arrange to address any concerns or queries about the interview in a
positive and supportive manner. The “Introduction to interviews” in appendix 6, may be
included and/or may be read out at the start of interviews.
•
Interviewees should be furnished with any relevant documentation (including
Terms of Reference/Protocols of Investigations etc.) in advance, for their
consideration.
•
Interviewees should be advised that information may be given to third parties
and used in the Report, which may be published.
Please see the following support documents in relation to communications to
interviewees.
Appendix 4
Template Investigation Terms of Reference for an Investigation
Appendix 5
Letter of invitation to go from investigation commissioner to HSE
interviewees
Appendix 7
Information sheet for complainants/those affected/staff to
frequently asked questions about systems analysis investigations
address
6.2.4.6
Arrange for interviews to take place in a private, comfortable environment.
Interviews should be conducted where there will be no interruptions. Ideally, interviews
should be conducted away from the place where the incident occurred.
6.2.4.7
Ensure that appropriate support is available for all involved in the investigation as
required, such as counselling and, in the case of employees - employee assistance
services.
6.2.4.8
Arrange for access to appropriate expert advice to inform the HSE investigation
(including clinical expertise where indicated) as necessary for the purpose of the
investigation
6.2.4.9
Determine a semi-structured schedule of questions for each interview. These
questions should derive from the analysis of the documentary evidence and the
formulation of a rough draft chronology of events leading up to the incident.
Page 14 of 62
6.2.4.10
Should have two investigators involved in interviews.
Prior to each interview, determine which investigator will conduct the interview and which
interviewer will take notes, and explain to the interviewee that one of the interviewers will
be taking notes. Advise the interviewee that they will have an opportunity to review and
give feedback in relation to the factual accuracy of a draft of the report of the
investigation. In order to protect the confidentiality of the interview, only interviewers
should have access to notes of the interview after the interview when they can use them
to develop the draft investigation report. Interview notes should be kept safely and
securely at all times. Notes of interviews should have headers as per appendix 8
‘Headings to be included at top of each Note of an Interview’.
6.2.4.11
Take account of the fact that some individuals may need to be interviewed more
than once and that leave arrangements need to be catered for when planning time for
interviews.
6.2.4.12
Interviewees should be advised that they may be accompanied if they wish. If
interviewees are accompanied, consideration needs to be given to confidentiality and
privacy issues. See confidentiality agreement for accompanying persons in appendix 9.
The confidentiality agreement for accompanying persons should also be referred to in
the letter of invitation to interview.
6.2.4.13
Interviewees should be advised that a report (anonymised by location and individuals)
may be published (as stated in the terms of reference supplied to interviewees) and that
the review report is potentially discoverable under Freedom of Information (F.O.I).
6.2.5 Commence the interview
-
-
The investigation Chairperson should introduce the interviewer(s) to the interviewee
and any individual accompanying the interviewee.
If there is an individual accompanying the interviewee, ensure that they understand
the need for confidentiality and that they sign the confidentiality agreement (See
appendix 9).
Ensure that the interviewee has received and read a copy of the terms of reference
for the investigation and that they understand the purpose of the investigation and
why they were invited to attend for interview. Build a rapport before starting the
interview properly. Be aware that the interviewee may be apprehensive so make
sure that explanations are reinforced and that the interviewees understanding is
checked.
Advise the interviewee that one interviewer will ask questions, and the other will take
notes of their answers.
Advise the interviewee that the interview will be conducted in a positive and
supportive manner where all involved will be treated with dignity and respect, and
that if they have any concerns as the interview proceeds, they should communicate
this to the interviewers.
Page 15 of 62
6.2.6 Establish the chronology
-
-
-
Determine the role of the interviewee in the incident and the limits of their
involvement
Determine the chronology of events as the interviewee saw them.
Questions should focus on what happened, where, when, how and why. The
interviewer should start by requesting that the interviewee use “free recall” to
take them back to the events that occurred e.g. “tell me what happened on
………, start from the beginning, when did you come on duty, what was
happening…….” .
Be aware that interviewees will not necessarily remember things in the correct
order but do not interrupt them. Once they have recounted everything, go
through the sequence of events with them and recap e.g. “so you said that you
came in at ….. you were involved in ………. and you saw ………. Is that
correct?”
Use a semi-structured questionnaire
Compare this new information with what is known of the overall sequence.
Where necessary revisit aspects of the interview that are not clear.
(For more information see also Step 2 below, section 6.3)
6.2.7 Identify any Key Causal Factors & Incidental Findings
- Identify all important acts or omissions made by staff, or other key causal factors
that were important in the chain of events leading up to the incident/complaint.
- Identify any incidental findings, i.e. issues identified in the course of the review
which did not impact on the outcome but are system development issues
- Record disagreements between accounts as to the course of events
- Review relevant policies, procedures and / or guideline to determine whether
there were major departures from accepted practice. If such policies, procedures
and / or guidelines do not exist, access expert advice where necessary through
the commissioner who in turn may seek a nomination from an external agency
via the National Incident Management Team (see appendix 10).
(See also step 3 below, section 6.4)
6.2.8 Identify the contributory factors
-
Ask specifically about each key causal factor separately in the context of the
framework of contributory factors (See table 3, page, section 6.5).
For each key causal factor identified, ask whether this was specific to this
occasion, or whether it was a more general key causal factor
(See also step 4 below section 6.5)
6.2.9 Close the interview:
Ask the interviewee if they are aware if a similar incident occurred before.
Ask the interviewee:
- If they have any other comments to make, or questions to ask.
Page 16 of 62
-
To contact the interviewers if they think of any information that is pertinent to the
investigation after they leave the interview.
Advise the interviewee:
- The investigators may come back to them if they need further information
- They may be asked to attend another interview if information comes to light that
only they can clarify. Explain that this is not unusual, and that it is not a cause for
concern.
- Of the timescale for the interviews and plans for concluding the report.
Thank the interviewee for giving of their time to the interview and for the important
contribution they made.
As noted earlier, conducting interviews is resource intensive. Where death and/or
serious harm occurs the full investigation procedure should be undertaken. There are
instances where it will be sufficient to conduct a desk top investigation supported by
interviews, or phone or written validation of the documentation with the people
involved in the incident.
Page 17 of 62
6.3 STEP 2: Determine the Incident Chronology
Investigators must review notes of interviews, statements, and records to establish a
detailed chronology that demonstrates what happened and when. Disagreements and
discrepancies must be clearly identified. If the evidence indicates the need for a look
back review or a clinical performance review, arrange for these to occur according to the
relevant HSE Policies, Procedures, Protocols, and Guidelines.
A chronology form such as the one in table 2 below may be helpful in determining the
chronology.
Table 2. Chronology Form
Ref.
Date
Time
Location
(24
hour
clock)
Event
description
Key
person(s)
involved/
affected
Comments/Queries
A flowchart can be helpful for visually determining the precise sequence of events and
for presenting information to others.
Page 18 of 62
6.4 STEP 3: Identify Key Causal Findings & Incidental Findings
Key Causal Factors are issues that arise in the process of delivering and managing
health services which had an effect on the eventual adverse outcome. They have one
essential feature:
→ The key causal factor had a direct effect on the eventual adverse outcome for
the individual(s)/property/systems harmed.
Examples of key causal factors are:
•
•
•
Failure to monitor, observe or act
Incorrect (with hindsight) decision
Not seeking help when necessary
From data analysis and the chronology developed, determine whether any key causal
factors can be identified using the definition outlined above. Several key causal factors
may be identified for the incident being investigated.
Occasionally, no key causal factors may be identified. This occurs when an incident of
harm appears to have occurred. However, when investigated, it becomes evident that
what happened was unforeseeable, and therefore, while it is regrettable that harm
occurred/may have occurred, it was not actually an incident of harm caused by some
action or omission on the part of the HSE. When this occurs, it is not necessary to
proceed with the stages of the investigation procedure outlined below. However, a
report must still be completed. The final report should indicate how the investigation
team came to their conclusion that there were no key causal factors.
Incidental Findings
In the event that issues are identified in the course of a review which did not impact on
the outcome serve to identify issues for system improvement e.g. issues relating to
issues surrounding documentation. Such issues or incidental findings should be listed
under a section ‘incidental findings’ and should be accompanied by relevant
recommendations, within the recommendations section of the report.
Page 19 of 62
6.5 STEP 4: Identify the Contributory Factors related to the Key
Causal and Incidental Findings
Use the Contributory Factors Framework in table 3 (next page) to analyse each key
causal factor and incidental findings identified and to determine the contributory
factors/causes of the incident.
Each key causal factor and incidental findings may be associated with several
contributory factors at different levels of the contributory factors framework.
A useful tools to help organise and present thoughts regarding contributory factors is the
fishbone diagram (figure 2) also presented in section 6.5
Contributory factors/causes are hazards as they are the cause of harm in the incident
being investigated and potential causes of future harm if not mitigated. The list of
contributory factors outlined within the Contributory Factors Framework is not an
exhaustive list of all possible contributory factors/causes of the incident. Therefore, it is
important for investigators to be vigilant in order to identify contributory factors that are
not listed in table 3 (next page).
In some cases following a review of the key causal or incidental findings using the
contributory factor framework it may be difficult to distinguish whether a key causal factor
contributed to the outcome.
It may not be possible to determine if the key causal factors were as a result of
deviations from safe/acceptable practice or would have occurred naturally.
Page 20 of 62
Table 3. Framework of Contributory Factors
Factor Types
Contributory Factor
(i.e. potential causes related to each key causal factor and
incidental finding identified in Step 3)
Individual affected/harmed
Task and Technology
Factors
Individual (Staff) Factors
Team Factors
Work Environmental Factors
Organisational &
Management Factors
Institutional Context Factors
Condition (complexity & seriousness)
Language and communication
Personality and social factors
Psychological, existing mental health condition, stress
Task design and clarity of structure
Availability and use of protocols, policies, standards
Policies etc. relevant, unambiguous, correct and realistic
Availability and accuracy of test results
Decision-making aids
Knowledge and skills
Competence – education, training, supervision
Physical, psychological and mental health illness.
Verbal communication
Written communication
Supervision and seeking help
Team structure (leadership, congruence, consistency etc.)
Staffing levels and skills mix
Workload and shift patterns
Administrative and managerial support
Environment - Physical and cognitive.
Design, availability and maintenance of equipment
Organisational structure
Financial resources and constraints
Policy, standards and goals
Quality & Safety culture and priorities
Economic and regulatory context
National health service executive
Links with external organisations
Figure 2 – Fishbone diagram
Factors
associated with
the harmed
individual(s)
Task &
Technology
Factors
Individual Staff
Factors
Key Causal
Factors
Being
Explored
Team
Factors
Work
environmental
factors
Organisational &
Management
Factors
Page 21 of 62
Institutional
Context
Factors
As contributory factors identified within the investigation process are hazards they
should be addressed as per step 5 below. In cases where contributory factors can not
be addressed immediately they should be put onto the relevant risk register and dealt
with as part of the overall service risk management process.
Refer to the HSE’s Guidance for Developing and Populating a Risk Register (2011) for
further information.
6.6 STEP 5: Make Recommendations that will Reduce Risk and
Improve Quality and Safety
6.6.1 Overview of Making Recommendations
Making recommendations is one of the most important elements of an investigation
report. Recommendations must be linked to the terms of reference and each
contributory factor identified as linked to each key causal factor and incidental finding
identified.
Recommendations should aim to be achievable, realistic and likely to avoid
reoccurrence of this incident or issue. Therefore, the risk associated with every
identified contributory factor/hazard must be assessed as outlined in the HSE’s
Guidance for Developing and Populating a Risk Register (2011).
The recommended actions/risk control measures developed in this way are the
recommendations of the investigation. If the contributory factor/hazard is one that may
exist elsewhere in the HSE, the associated recommendations should be communicated
to other relevant parts of the HSE for learning and quality and safety improvement
purposes. This should be reflected in the review report by the investigators.
6.6.2 Hierarchy of hazard controls (recommended actions)
The recommendations made to address the hazards identified are known as control
measures. Certain types of controls are preferable to others. For example, it is usually
preferable to eliminate the hazard wherever possible rather than to train staff to avoid or
manage the hazard. Indeed, any controls that rely on people are inherently potentially
weak as people are fallible and make errors.
The hierarchy of hazard controls (Table 4 overleaf) can be used to help ensure that the
most effective hazard control measures / recommendations are made.
Page 22 of 62
Table 4 Hierarchy of Hazard Controls
Strength of
control
Strongest control
Category of control
Comments/Examples
Elimination
The work process or task is redesigned so as to
remove the hazard/contributory factor. However, the
alternative method should not lead to a less
acceptable or less effective process e.g. stop
providing service; discontinue a particular procedure;
discontinue use of a particular product or service, e.g.
stop using a particular type of equipment.
If hazard elimination is not successful or practical, the
next control measure is Substitution.
Substitution
Replacing the material or process with a less harmful
one. Re-engineer a process to reduce potential for
‘human error’.
If no suitable practical replacement is available the
next control measure is engineering controls.
Engineering controls
Installing or using additional equipment. Introduce
‘hard’ engineering controls, e.g. installation of
handling devices for moving and handling people and
objects, e.g. Re-engineer equipment so that it is
impossible to make errors.
If no suitable engineering control is available the next
control measure is administrative procedures.
Administrative
procedures.
Ensure that administrative policies, procedures and
guidelines are in place.
Ensure staff are appropriately trained in these.
Monitor compliance with policies, procedures and
guidance through audit.
If no administrative procedure is available the next
control measure is work practice controls.
Weakest control
Work Practice Controls
This is the last control measure to be considered.
Change the behaviour of staff, e.g. make staff wear
personal protective equipment, etc. Work Practice
Controls should only be considered after all the
previous measures have been considered and found
to be impractical or unsuccessful.
Page 23 of 62
6.7 STEP 6: Write the Investigation Report
6.7.1 Purpose of an Investigation Report
The purpose of the report is to convey the methods and findings of the investigation and
the proposed risk reduction/quality and safety improvement recommendations in a
logical, concise and comprehensive manner.
6.7.2 Format of an Investigation Report
In order to comply with good practice in relation to confidentiality and data protection the
report should include only information that it is necessary to achieve the purpose of the
report; the report should be anonymised. Investigation reports should include, but not
limited to the following:
Title Page
Table of Contents
Executive Summary
Apology
Background
Methods
Chronology
Aftermath of incident
Key Causal Factors
Contributory Factors
Incidental Findings
Recommendations
Appendices
(Date, Title, Reference Number and Authors)
The executive summary should include key causal factors
Describe the background to the incident, including
individuals (anonymised) involved in the investigation.
Outline of the method of the investigation including
sources of information and the terms of reference for the
investigation.
Showing the chronology of events leading up to the
incident.
A brief summary of what happened immediately after the
incident and what happened in the longer term if this is
known.
Provide a definition of the key causal factors identified
Showing the contributory factors framework and the
contributory factors identified for each key causal factor
and incidental finding (where any incidental findings are
found).
Provide a definition the incidental findings that did not
impact on the incident but are areas for system
improvement identified during the investigation
Risk
reduction/quality
and
safety
improvement
recommendations linked to the contributory factors
identified and should be the product of an assessment of
the risk associated with the hazards/contributory factors for
each key causal factor and incidental finding using the
hierarch of preferred controls.
May include supporting data/material
Please see detailed template investigation report under appendix 12 of this
guideline for a more thorough explanation of the information to be covered within
each section of an investigation report.
Page 24 of 62
6.7.3 Finalise the Report
6.7.3.1 Factual Accuracy Checking, Due Process, Natural and Constitutional
Justice
Staff who participated in the investigation process must have an opportunity to give input
into the relevant parts of the final draft report in the interest of natural justices and for the
purpose of ensuring the report is factually accurate and complete. The service
user/individual harmed should be given an opportunity to review and give input into the
draft chronology of the report to ensure its factual accuracy and completeness. The
investigators must consider and take account of the responses received.
In circumstances where sections of the draft report reflect adversely on an individual(s),
the individual(s) should be afforded an opportunity to review and input into those
sections and the conclusions of the draft report to ensure it is factually accurate before
others see it. Responses must be considered in the context of enhancing the factual
accuracy of the report and ensuring full application of fair procedures. In summary, draft
findings that may reflect adversely on an individual(s) are sent to person(s) for their
consideration and response.
All feedback will be accepted, and all suggested amendments made, unless making
these amendments detracts from the factual accuracy of the report or from the ability of
the report to attain the objectives of the investigation set out in the terms of reference.
Where there is variance of opinion with regard to events, all recollections should be
reflected in the report.
Please see appendix 13 and appendix 14 for suggested content of registered
letter/secure e-mail inviting feedback to the first and final draft investigation reports.
6.7.3.2 Write an apology
If someone has been harmed linked to key causal factors identified within an
investigation report, it is common practice to include an apology in the investigation
report.
Where harm caused to an individual clearly lies with the HSE, those negatively affected
by the incident deserve an expression of sympathy and apology for any distress,
concern or delay they have experienced while in our care or working for the HSE.
The investigation process must uphold and protect the rights of both the service / staff
members and the patient / service user, however, where appropriate, an apology must
be made to the individual.
Explanations and apologies within an investigation report should include the following:
•
•
•
The reasons for harm caused identified within the investigation report (i.e. the
contributory factors linked to the key causal findings);
An apology for any hurt, inconvenience or hardship caused;
An assurance that all steps will be taken so that lessons will be learned and
improvements put in place to help prevent an incident happening again
Page 25 of 62
6.7.3.4 Plain English Check
Investigation reports should be well structured, comprehensive and match a good
investigation process. Reports should be written in plain English taking account of the
target audience, their expectations.
Investigation reports should:
•
•
•
•
•
•
•
Use everyday words and avoid jargon
Only use words you really need
If you must use specialised language, give definitions or examples
When using abbreviations, define each one the first time you use it e.g.,
Emergency Department (ED)
Avoid Latin and French phrases and Latin abbreviations
Be consistent with words used and use the same words for the same concept
throughout e.g. heart attack v coronary event.
Ensure medical and technical terms are accompanied by plain English
definitions and that where definitions are used the source of the definition is
referenced
6.7.3.4 Present Final Report to Relevant Manager
The final report should be presented by the Chair of the investigation team to the report
Commissioner.
6.7.3.5 Manager assumes responsibility for implementation of the
recommendations
The manager responsible for the area where the incident occurred will be responsible for
making sure that the recommendations are considered and an appropriate action plan
for the implementation of the recommendations be put in place.
Page 26 of 62
6.8 Collection and Storage of Information
Investigations into incidents and complaints are conducted in private and all information
obtained by an investigating officer shall be deemed to be confidential information which
he or she may not discuss, communicate or disclose except as is necessary for the
proper investigation of the incident/complaint. The information gathered must be treated
as confidential at all times and stored away in a locked filing cabinet when not in use.
At all stages during the investigation process the collection and storage of information
must comply with our obligations under the Data Protection Acts 1988 and 2003. That
is, the information must be obtained and processed fairly; kept only for one or more
specified, explicit and lawful purposes; used and disclosed only in ways compatible with
these purposes; kept safe and secure; kept accurate, complete and up-to-date;
adequate, relevant and not excessive; retained for no longer than is necessary for the
purpose or purposes for which it was collected and a copy given to the individual of
his/her personal data on request.
The use of electronic means for sending and storing this information must be done in
compliance with the Health Service Executive’s Information & Communication
Technology Policies for the use of Information Technology (I.T.) Resources. In particular
the following policies are most relevant:
Information Security Policy
http://hsenet.hse.ie/HSE_Central/Commercial_and_Support_Services/IC
T/Policies_and_Procedures/Policies/HSE_Information_Security_Policy.pd
f
I.T. Acceptable Usage Policy
http://hsenet.hse.ie/HSE_Central/Commercial_and_Support_Services/IC
T/Policies_and_Procedures/Policies/HSE_Information_Technology_Acce
ptable_Use_Policy.pdf
Electronic Communications Policy
http://hsenet.hse.ie/HSE_Central/Commercial_and_Support_Services/IC
T/Policies_and_Procedures/Policies/HSE_Electronic_Communications_P
olicy.pdf
Enrryption Policy
http://hsenet.hse.ie/HSE_Central/Commercial_and_Support_Services/IC
T/Policies_and_Procedures/Policies/HSE_Encryption_Policy.pdf
Password Standard Policy
http://hsenet.hse.ie/HSE_Central/Commercial_and_Support_Services/IC
T/Policies_and_Procedures/Policies/HSE_Password_Standards_Policy.p
df
In short, the information gathered as part of an investigation should not be held outside
of HSE offices and must be adequately protected and stored while in the possession of
the HSE. Confidential information should only be sent to an email address which ends
in: @hse.ie.
Page 27 of 62
Where individuals are requested by investigators to provide feedback on anonymised
(by person and location) draft and final draft reports they should be requested:
•
•
to return the draft report securely to be destroyed, or to confirm to HSE
investigators in writing that they have destroyed the draft report.
to not return any personal data within your comments unless they are being
returned by secure email (i.e. password protected or encrypted) or by secure
postal mail.
Where external reviewers are contributing to HSE investigations, external reviewers
must have signed a confidentiality agreement prior to being given access to information
related to HSE investigations (including a request for external reviewers to return all data
to the HSE at the end of the review/investigation process).
Page 28 of 62
7.0 Appendices
Appendix 1
Proposed membership of local incident management team and
roles of members:
Senior Delegated Officer e.g. ISA Manager/Voluntary Hospital CEO/Area Manager
− Chair’s Incident Management Team
− Ensures that all members of the incident management team fulfil their role to achieve
the terms or reference of the Incident Management Team
Communications Manager:
− Deals with communications issues including communications with those affected,
staff, service users, the public and the media if required. Links with national
communications as necessary
Relevant senior clinician in the case of a clinical incident and relevant senior
manager in the case of a non-clinical incident
− Manages clinical issues as they arise during the course of managing and
investigating the incident
− Supports staff involved with management and investigating the incident
Competent Investigator (i.e. healthcare risk manager/advisor, clinical risk
manager/advisor, health and safety/coordinator/advisor
−
May lead the systems analysis investigation and submit an incident investigation
report to the chair of the incident management team
Finance Manager (If it is a finance related incident or if there are finance
implications)
− Deals with finance related issues
Human Resources Manager (If it is a HR related incident or if there are HR
implications)
− Deals with HR issues
Complaints Officer/Consumer Affairs Manager/Area Officer
− May lead the systems analysis investigation if the incident came through the
complaints process and if so submits incident investigation report to the chair of the
incident management team or may liaise with the risk advisor/manager who leads
the investigation. Incidents identified through a complaint under Part 9, Health Act
2004 should be managed in accordance with HSE Incident Management Guidelines
(2012).
Any specialists relevant to the incident
Page 29 of 62
Appendix 2
Template terms of reference for local incident management team
The terms of reference of the local incident management is to:
1. Oversee the management of the incident including caring for those harmed, ensuring
that the source of harm is addressed so the risk of further harm arising is eliminated
or reduced as far as is reasonably practicable and contingency plans for service
continuity if required
2. Ensure an appropriate investigation of the incident is conducted as per HSE incident
management policies and guidelines
3. Facilitate sourcing of external independent experts to the investigation team if the
investigators deem this necessary as per HSE Incident Management Guidelines.
4. Managing communications with services users, staff, the public, and external
agencies as required linking with the National Communications representatives on
the National Incident Management Team if necessary
5. Inform the recommendations arising out of investigations
6. Arrange for expeditious implementation of recommendations of investigations as part
of the organisations risk management work, including entering, managing and
communicating “contributory factors” on the risk register.
Page 30 of 62
Appendix 3:
Template Incident Management Team Meeting Agenda
1. Managing immediate safety issues
2. Caring for those harmed/affected including service users, the public and staff
3. Contingency planning for service continuity
4. Update on incident investigation from incident investigators
5. Communications to those harmed affected, services users, the public, staff, the
public and external agencies (link with national communications representatives on
the National Incident Management Team if necessary)
Management and communication of identified “contributory factors” including entering,
communicating and monitoring on the risk register and Implementation of
recommendations arising from investigation, as per HSE Guidance on Populating a Risk
Register (2011).
Page 31 of 62
Appendix 4
Template Investigation Terms of Reference
Introduction
These are the terms of reference for an investigation commissioned by [xxx[ into [an
incident/complaint/allegation of … that arose at … on …(include date)]
Purpose
The purpose of this investigation is to:
→ Establish the factual circumstances leading up to the incident/complaint /allegations
→ Identify any key causal factors that may have occurred
→ Identify the contributory factors that caused the key causal factors
→ Recommend actions that will address the contributory factors so that the risk of
future harm arising from these factors is eliminated or if this is impossible, is reduced
as far as is reasonably practicable.
Scope of the Investigation/Review
The time frame of this investigation/review will be [include the time frame
of the investigation here]
Please note:
• The “time frame” in question here is the “scope in time” that was reviewed in
the investigation (e.g. from the time of admission to the time surgery
commenced)
• The timeframe must be the shortest sufficient period of time to ensure
the investigation purposes as outlined will be achieved.
• The final timeframe will be stipulated and adhered to unless good and
valid reasons for extending this timeframe become apparent during the
review process.
The investigation members
Membership of the investigation team includes:
→ Chairperson (Should be a competent investigator)
→ Other members of the investigation team
Where external expert input is required please contact the HSE National Incident
Management Team (NIMT).
Through the Chairperson, the investigation team will:
→ Be afforded the assistance of all relevant staff (including former staff) and other
relevant personnel.
→ Have access to all relevant files and records (subject to any necessary consent/data
protection requirements including court applications, where necessary).
Should immediate safety concerns arise, the Chair of the Investigation Team will convey
the details of these safety concerns to the Commissioner as soon as possible.
Page 32 of 62
Investigation method
The investigation will follow the HSE Investigation Procedure and will be cognisant of the
rights of all involved to privacy and confidentiality; dignity and respect; due process; and
natural and constitutional justice.
The investigation will commence on [xxx] and will be expected to last for a period of
approximately [xxx], provided unforeseen circumstance does not arise.
Following completion of the investigation, an anonymised draft report will be prepared by
the investigation team outlining the chronology, findings and recommendations. All who
participated in the investigation will have an opportunity to give input to the extracts from
the report relevant to them to ensure that they are factually accurate and fair from their
perspective.
The anonymised Report may be published and may be subject to a freedom of
information request.
Recommendations and Implementation
The report, when finalised, will be presented to the commissioner of the report.
Implementation of the recommendations will be undertaken by local managers who will
oversee the implementation of the applicable recommendations.
Local managers will communicate nationally applicable recommendations to the National
Director and National Directors will oversee the implementation of the nationally
applicable recommendations.
Communication Strategy for the Investigation
A communication strategy will be determined. (Give the name of an individual, who is
not directly involved in the investigation process but who understands the process and is
continually updated on the progress of the process - here), will be appointed for the
purpose of communicating information pertaining to the investigation to the
patient/family/staff member(s) (delete as appropriate) affected by and/or involved in the
incident/complaint (delete as appropriate). .
Reference:
− HSE 2012 Guideline for Systems Analysis Investigation of
Incidents and Complaints
Page 33 of 62
Appendix 5
Letter of invitation to go from investigation commissioner to interviewees
Insert commissioners address
Insert phone number
Insert fax number
Insert e-mail address
08/04/11
[delete content as appropriate to incidents and/or complaints]
Strictly Private and Confidential
[Insert invitee’s address]
Re: [Insert incident number]
Dear [write invitee’s name],
I have commissioned a review of a [complaint made by (insert name) about/incident
involving (insert)]
[This review is overseen by the HSE National Incident Management Team (Delete if not
applicable)]
As you were involved in [this matter/delivering care to (insert)], I have arranged for you
to attend an interview with the reviewers [insert names in insert details of venue] at
[insert details of time] on the [insert date]. If you wish, you may be accompanied at the
interview by a family member etc….
I attach the terms of reference for this review. The review will follow a systems analysis
method of investigation. Therefore, I also attach some information about systems
analysis investigations.
You may wish for a family member, friend or another person to accompany you on the
day. I would be grateful if you could advise me if anyone else will be attending this
meeting with you. In order to ensure the confidentiality of this process for all involved,
accompanying individuals would be asked to sign a confidentiality agreement.
I hope you find all in order with the above and the attached. I hope you will be able to
attend this interview, and please do not hesitate to contact my office on [insert phone
number] if you think I can help further in relation to this matter.
Yours sincerely,
_________________________
[Insert name of commissioner
Insert job title of commissioner]
Page 34 of 62
Appendix 6
Introduction to Interviews
To go with invitation to interviews and / or to be read out at interview
1. This investigation is a learning exercise with the purpose of enhancing safety for our
service users and service providers. You have been given a copy of the terms of
reference for this investigation. These interviews are being conducted according to
these terms of reference.
2. The interviews are confidential, and will be conducted in a manner that is respectful
of the rights of all to privacy, confidentiality, due process and natural justice
3. The interviews will be conducted in a manner that is positive and supportive and
respectful of interviewees’ and interviewers’ at all times
4. One of the interviewers will make notes of answers given in the interview, or may
tape record the interview. If interviews are taped, you will be asked to consent to this
before taping commences.
5. We do not expect all interviewees to know all the answers to all of the questions. If
you are unsure of something – we will ask you to check your information, and revert
to us with the answer.
6. We may call some interviewees back for a second interview. This is not unusual in
these investigations, and it is not a cause for concern for anybody.
7. If you have any concerns about the interview process, you are invited to
communicate these concerns to the interviewers or to [write name of commissioner
here] as the commissioner of this investigation.
8. The final investigation report (anonymised by location and individuals) may be
published
9. The final review report is potentially discoverable under Freedom of Information
(F.O.I).
Page 35 of 62
Appendix 7
Information sheet for complainants/those affected/staff to address frequently
asked questions about investigations.
Systems Analysis Investigation Information
A key element in the development of a robust governance structure in any organisation
is the ability of that organisation to learn from adverse incidents, near misses and
complaints. It is generally accepted that systems analysis is the most effective tool for
the investigation of incidents, near misses and complaints that are identified as incidents
occurring in healthcare.
Taylor-Adams et al., (2006) describe systems analysis as the process used to ensure a
comprehensive and thoughtful investigation of an incident, going beyond the more usual
identification of fault and blame. They are clear that the approach does not supplant
clinical expertise or deny the importance of the reflections of individual clinicians on an
incident. Rather the aim is to utilise clinical experience and expertise to the fullest extent.
The approach assists the reflective investigation because:
−
While it is sometimes straightforward to identify a particular action or omission as the
immediate cause of an incident, closer analysis usually reveals a series of events
leading up to an adverse outcome. The identification of an obvious departure from
good practice is usually only the first step of an investigation
−
A structured and systematic approach means that the ground to be covered in any
investigation is, to a significant event, already mapped out.
−
If a consistent approach to investigation is used, members of staff who are
interviewed will find the process less threatening than traditional unstructured
approaches
−
The methods used are designed to promote a greater climate of openness and to
move away from finger pointing and the routine assignation and blame (Taylor et al.,
2006)
The HSE’s policy on incident investigation adopted systems analysis as the method for
investigating incidents has it is an accepted method of the effective identification of the
systems causes of incidents’ and because the methodology is ‘designed to promote a
greater climate of openness and (a) move away from individual blame towards systemic
analysis which assists in identifying solutions that are long term and not just a ‘quick fix’.’
References:
− HSE 2012 Guideline for Systems Analysis Investigation of
Incidents and Complaints
− Taylor-Adams S, Vincent C, (2006) Systems analysis of Clinical Incidents: The
London Protocol. Clinical Safety Research Unit, Imperial College, London
− Taylor-Adams, S., and Vincent, C., (2004) Systems Analysis of Clinical Incidents;
The London Protocol, London
Page 36 of 62
Appendix 8
Headings to be included at top of each Note of an Interview
Introduction to Interview
The information contained in these notes has been given on the basis that it will:
1. Be used to develop a Draft Report in relation to the incident/complaint being
reviewed using a Systems methodology i.e. the purpose of the review is to learn
lessons from the incident/complaint being reviewed in order to correct any systems
failures identified.
2. That the interviewee will have an opportunity to review any Draft Report prepared in
order to correct any factual/clinical inaccuracies contained in the Draft Report and;
3. That the information will be held in confidence and will be used for the purposes
outlined in 1) above.
These notes can be expected to contain factual/clinical inaccuracies and/or information
that may require additional clarification. Clarification of such information is achieved
through the issuing of a draft report for the purposes as outlined above.
The following information was given to the interviewee;
•
•
•
The purposes of system analysis i.e. find out the facts, identify system failures
and make recommendations to prevent/reduce the likelihood of a recurrence of
such failures.
The Incident Review process e.g. that a draft report which is anonymised will be
developed and that the relevant section of the report will be sent to the
interviewee to ensure it is factually correct in relation to their
involvement/recollection in/of the incident/complaint under review,
That the review report is potentially discoverable under F.O.I.
Page 37 of 62
Appendix 9: Confidentiality Agreement (Accompanying Person)
Investigation into …….
[Write Date]
Confidentiality Agreement (Accompanying Person)
I [insert name] confirm and agree that in the event I receive, hear or otherwise become
aware of any confidential information (including documentation) in the course of the
investigation interview I am attending, I shall maintain all such information in strict
confidence and I shall not disclose it to any third parties whatsoever.
This agreement is subject to information being disclosed to comply with a legal or
professional obligation. Such intended disclosures for legal or professional obligations
are to be notified in advance to the HSE.
This Agreement is subject to and made under Irish Law.
Signed:
___________________________________________________________
Print Name:
_____________________________________________________
Position:
_____________________________________________________
Date:
/ /
_____________________________________________________
Page 38 of 62
Appendix 10
Form to Request a Nomination for External Clinical Support to a HSE Investigation
To Be Submitted to
The Irish Forum of Postgraduate Medical Training Bodies
via Regional Offices for Quality and Patient Safety and the HSE National Incident
Management Team
Date
Date of the Request- xxxx
Requesting
Organisation
xxxx
Request To
Or Royal College of Physicians, Ireland (RCPI) for a Consultant XXX
Royal College of Surgeons of Ireland (RCSI) for a Consultant Surgeon
Local Liaison Contact
Details
Related Requests
XXXX
Case Background
Terms of reference for the HSE review to be drafted and agreed.
Goals/Scope of the
HSE Review that the
external nominee will
provide advice to
Type of assistance
required
Information/Records
to be made available
to the participating
clinician
Methodology
Indemnity
Expected timescale
Costs.
Governance
Communications
The HSE investigation team require the external nominee to provide an external
assessment of:
Please note that to comply with guidance from the Data Protection
Commissioner all information/confidential records must be returned to the
HSE following completion of the review process
Brief outline of the process to include requirements for Confidentiality, Data
Protection & Natural Justice Process
Please note: only external nominee to HSE investigations who have signed a
confidentiality agreement will have access to patient data/records relevant to their
contribution to a HSE investigation process.
(Local) Network Manager will confirm full indemnity for the review team members
that are not HSE employees. The local manager will progress this through the
regional office for quality and patient safety who in turn will contact the National
Incident Management Team.
XXX Manager will govern RCPI approved costs (approval of rates, delivery of
service and authorisation of payment) and cover the costs of the review.
The external clinicians will be invited to contribute to all aspects of the review
communication process and can decide individually on their input in this regard
Page 39 of 62
Appendix 11
Confidentiality Agreement to Be Signed by Independent External
Expert Giving Input to a HSE Investigation
1.
The External Independent Expert giving input to a HSE investigation
acknowledges that in the course of the Engagement he/she will have access to
Confidential Information. The External Independent Expert has therefore agreed
to accept and comply with the restrictions in this confidentiality agreement.
2.
The External Independent Expert shall not (except in the proper course of his/her
duties) at any time for any reason whatsoever use or disclose to any person, firm
or company (and shall use its best endeavours to prevent the publication or
disclosure of) any Confidential Information without obtaining the relevant
consents (including leave of Court, where applicable). This restriction does not
apply to:
3.
4.
2.1
any use or disclosure authorised by the HSE or required by law;
2.2
any information which is already in, or comes into, the public domain
otherwise than through the External Independent Expert’s unauthorised
disclosure;
2.3
disclosures to the HSE’s professional advisers.
Without prejudice to the generality of the foregoing, the External Independent
Expert shall be permitted to make limited disclosures of Confidential Information
where the External Independent Expert reasonably and in good faith believes
that such disclosure is necessary for the purposes of performing the Services
(including but not limited to disclosures required in connection with any
investigation or examination carried out by the External Independent Expert),
provided always that:
3.1
any such disclosure shall only be made to the extent reasonably
necessary for the purposes of fair procedures;
3.2
the External Independent Expert shall seek the advice or direction of the
HSE and/ or a suitable legal advisor in the event of any uncertainty as to
the scope and/ or application of this clause
3.3
any disclosure pursuant to this clause shall not breach, (or, if made,
would be in breach of) the “in camera rule”, or otherwise contravene any
Court order or direction.
All documents, manuals, hardware and/ or software provided for the External
Independent Expert’s use by the HSE, and any data or documents (including
copies) produced, maintained or stored on the HSE's computer systems or other
electronic equipment (including Mobile Devices), remain the property of the HSE.
Page 40 of 62
5.
The External Independent Expert shall take all necessary precautions to ensure
that any Confidential Information held by, or available to, it is not disclosed, lost
or permitted to be disclosed or accessed by third parties except as permitted by
clause 2 or 3.
6.
The External Independent Expert shall not send, take or remove any Confidential
Information (or copies thereof) from premises owned or occupied by HSE without
having received the written authorisation of the HSE. Where the External
Independent Expert receives the HSE’s consent to remove any Confidential
Information (or copies thereof), the External Independent Expert shall:
6.1
implement all reasonable human, organisational and technological
controls to protect against accidental loss, destruction, damage,
alteration, or disclosure of the Confidential Information;
6.2
take the necessary precautions to maintain the security and confidentiality
of, and prevent the unauthorised access to, or disclosure of, the
Confidential Information; and
6.3
adhere to any protocols, guidelines or requirements of the HSE.
7.
Without prejudice to the generality of the foregoing, External Independent Expert
shall ensure the security and integrity of all Confidential Information stored or
maintained on mobile computing devices including laptop, notebook and netbook
computers, personal digital assistants and mobile storage devices, including CDROMs, CDs, DVDs, portable hard drives and data/ USB keys (together “Mobile
Devices”).
8.
The External Independent Expert shall indemnify and hold the HSE harmless
from any loss, damage or claim arising out of or in connection with the use of
Mobile Devices for any purpose whatsoever in connection with the provision of
the Services provided that this indemnity shall not apply to any liability of the
HSE in respect of the Excluded Liabilities.
9.
The External Independent Expert shall not without the express prior written
consent of the HSE use, access, store or maintain Confidential Information on
Mobile Devices and where HSE has provided such consent, the External
Independent Expert shall:
9.1
ensure that only such Confidential Information as is absolutely necessary
for the purpose of providing the Services is stored on Mobile Devices and
that the Confidential Information is held on such Mobile Devices for the
minimum period of time as is necessary and is promptly deleted from
such Mobile Devices following such period;
9.2
take all necessary precautions to minimise the risk of theft or loss of the
Mobile Devices;
9.3
ensure that all Confidential Information held on Mobile Devices is
protected by the use of strong complex passwords and encryption
methods;
Page 41 of 62
9.4
ensure that all external reviewers return all confidential information
related to their work on behalf of the HSE to the HSE at the end of the
review process.
9.5
such other requirements as the HSE may from time to time in its absolute
discretion specify.
10.
The External Independent Expert shall ensure the security and integrity of any
Confidential Information or other information or documentation which is required
to be put in transit before, during and after transit.
11.
The confidentiality obligations and restrictions of this confidentiality agreement
will survive and continue to bind the parties following the termination or expiry of
this Agreement.
Details and signature of person giving external independent input to HSE
investigations:
Signed:
________________________________________________________
Print Name:
_____________________________________________________
Position:
_____________________________________________________
Date: / /
____________________________________
Page 42 of 62
Appendix 12
Template Investigation Report.
Note: The report should be anonymous (i.e. remove names, addresses) with codes for
individuals and locations. Only information that is necessary to achieve the purpose of
the report should be included.
Title Page:
The Title Page should be marked strictly private and confidential and
• State the title of the investigation including the scope of time reviewed in the
investigation (e.g. from time of admission to time surgery commenced).
• State the name of the Service / Investigators who conducted the investigation
• Name of Investigation Commissioner & date that the report was commissioned
• Date that the report was completed
Table of Contents Page:
A full contents page should be included.
Apology
Executive Summary
The executive summary should state the aim of the investigation as per the terms of
reference and also state the timeframe of the investigation (i.e. the timeframe examined
by the investigation).
The methodology used should be summarised to include stating:
→
that a systems analysis method was used as per HSE guidance
→
details of who conducted the investigation
→
the methods used to ensure safe management of sensitive material
→
the methods used to ensure factual accuracy, due process, and fair procedures
The executive summary should summarise the key causal factors, contributory factors
and the recommendations to address the findings of the investigation.
Background:
This section needs to be concise and without duplication or repetition. It should provide
a brief summary of the events leading up to the incident/complaint/allegation including
the circumstances surrounding the incident and who was involved in it.
Methods:
The terms of reference for the investigation should be included in this section (See
Appendix 4). This section should show the purpose of the investigation, who undertook
the investigation, the scope in time of the investigation and the time it took the
investigation team to complete the investigation. Describe the method of the
investigation (i.e. HSE Investigation Guideline).
The methods section should state the sources of information for the investigation
including referral letters, records, rotas, ward diaries etc.
Page 43 of 62
The methods section should also list all the documents used in an appendix or
references as appropriate. This section should be explicit in explaining that the data
used was from literature searches and review of documents. Documents reviewed
should be listed, such as:
• Policy, Procedure or Guideline Documentation
• Medical Records Reviewed
• Notes of interviews (including state the numbers of staff interviewed etc.). If
necessary this section should also state the cadre/grade of employees involved
taking care to protect the anonymity of those involved)
Chronology of Events
Outline the chronology of events and the responses to the incident/complaint/allegation.
Specify the date and time of each event. In chronological order, put the exact date and
time in bold font in the left-hand margin. Where the exact time of certain events is
unknown, but where it can be approximated by placing chronologically in the order at
which events occurred, state the approximate time of occurrence and show that the time
is an approximation.
Under each time describe the events that took place at this time, the individuals involved
in or witness to the incident, using the information from the entries made in records and
from information received during interviews with employees. All personnel should be
referred to by their title and by the code name e.g. Staff Nurse 1, Consultant A, etc.
Consider the issue if code used and take additional care if only a single or small number
of people can be identified by the description. The key to the codes allocated must be
retained as part of the back-up file for the incident investigation (but not linked on any
correspondence issued during the investigation process, e.g. factual accuracy checks).
Abbreviations of clinical or technical terms must not be used, but rather the full text
should be included in the report in the first instance. A glossary of abbreviations must be
included.
Aftermath of Incident
In this section provide a brief summary of what happened immediately after the incident
and what happened in the longer term if this is known i.e. what the eventual outcome
was for the person involved in the incident, did they make a full recovery, did they suffer
permanent injury.
Key Causal Factors Identified
Include the definition of key causal factors here.
“Issues that arise during the process of delivering and managing health services that had
an effect on the eventual adverse outcome”
If key causal factors have been identified, state that within this section. If no key causal
factors are identified, state this also.
If key causal factors were not identified, this means that the incident was an
unforeseeable event and this should be the end of the investigation report. Otherwise,
proceed with the template below.
Page 44 of 62
Contributory Factors
This section provides information about the contributory factors identified in relation to
each key causal factor. Include the contributory factors framework table here. As
required by the systems analysis method, contributory factors may come under the
headings of: Patient/Service User Factors; Task and Technology Factors; Individual
(Staff) Factors; Team Factors; Work Environmental Factors; Organisational and
Management Factors; Institutional Context Factors
A brief description and results of the analyses that were conducted (e.g. fishbone
diagram,) should be included. Include charts or diagrams, if relevant, in the report
appendices.
Incidental Findings
This section of the report should identify any issues that emerged during the
investigation process while not impacting on this incident highlight an area for service
improvement.
Recommendations to reduce risk and enhance quality and safety.
Include recommendations to address the risk associated with each hazard/contributory
factor identified in the investigation using the hierarchy of hazard control measures as
per step 5 of the HSE Guidance document on conducting a systems analysis
investigation.
Within this section report writers must ensure:
• Each recommendation is linked to the contributory factors identified in
investigation
• Each recommendation must ensure that the risks associated with
contributory factors are reduced so far as is reasonably practical so that
incident is unlikely to reoccur
• Each recommendation is linked to the hierarchy of controls
• That the report states who has responsibility for implementation of
recommendations (this may be covered in the terms of reference).
the
the
the
the
The recommendations section should also refer to any action plans that have been
developed in relation to implementation of the recommendations of the investigation
report.
Additional Information to Include Within an Investigation Report
Reference to reasons for a delay with the completion of an investigation within the
timeframe specified in the terms of reference.
Appendices
Include additional data in the appendices.
Page 45 of 62
Appendix 13
Suggested Content :Registered Letter/Secure
Email inviting feedback to first draft investigation report.
Notes for Investigators:
•
Please note the items within the letter below marked in red/brackets are intended for
the investigator to amend or delete as appropriate.
•
If posting a draft report, please send by registered or secure post and ensure any
envelope is marked “strictly private and confidential” and “for addressee only”. Also
ensure that you request the recipient to return draft securely to be destroyed, or to
confirm that they have destroyed the draft report
•
If e-mailing the draft report, please ensure the email is marked “strictly private and
confidential” and “for addressee only” and that it is only sent to a checked/correct
and secure e-mail address (ending in @hse.ie), be properly encrypted and password
protected.
•
Please note: if there is an implied criticism of an individual(s) or an adverse finding
against an individual within a first draft report; the individuals that such sections
relate to must have an opportunity to comment on the factual accuracy of such
sections/report before others see it. This is to ensure factual accuracy checking and
to uphold the confidentiality of the investigation process. . It is recommended that in
such instances draft reports are sent by hard copy, rather than email.
****************************************************************************************************
Strictly Private and Confidential. For addressee only:
Not for copying or for onward circulation.
[write recipient name]
[write recipient’s address]
[write date]
Re: First Draft Copy of Report [include incident number]
Dear [write recipient name],
Attached please find the First Draft Copy of the report of the investigation into [write
incident number] - for your consideration. If being circulated by e-mail [This draft copy is
password protected. The password will be sent via separate cover email].
Please note that the attached is a draft only and as such it is expected to be incomplete
and to contain factual inaccuracies. We would appreciate if you would read the
document and satisfy yourself that it is correct from a factual and technical perspective
and that your recollections and input to the process have been accurately recorded.
Page 46 of 62
Please make any comments that you have on a separate document and return the
document via email marked "Strictly Private and Confidential: [write incident number] in
your response. Please do not return any personal data within your comments unless it
is being emailed securely (i.e. password protected or properly encrypted) or posted by
registered post.
Please note that we require receipt of feedback by not later than [write date].
In order to maintain patient confidentiality and the confidentiality of all individuals who
participated in this review; the Draft Report must not be copied or shared with anyone
not named in this correspondence.
Following your review of this draft report I/we ask that you either
a)
b)
return the draft report to us either by secure email or by registered post or
confirm by email or letter to the investigation team that you have destroyed the
draft report.
If I/we have not received a response outlining your comments/feedback or have not
heard from you by the [write date], we will assume that you are satisfied with the
document in its present format.
Once I/we have received all feedback and have made the required changes to the Draft
Report we will circulate a Final Draft Report for your consideration.
Please do not hesitate to contact [write name and contact details] if you require any
further information or clarification.
Please find attached a copy of the terms of reference for this investigation [attach terms
of reference].
Thank you for your valuable assistance to date.
Yours sincerely
[write investigators title and name]
Investigation Team Chairperson
[write investigators title and name]
Investigator
Page 47 of 62
Appendix 14
Suggested Content :Registered Letter/Secure
Email inviting feedback to final draft investigation report.
Notes for Investigators:
•
Please note the items in red/brackets are intended for an investigator to amend as
appropriate.
•
If posting, please send by registered or secure post and ensure any envelope is
marked “strictly private and confidential” and “for addressee only”. Also ensure that
you request the recipient to return the final draft securely to be destroyed, or to
confirm that they have destroyed the final draft report
•
If e-mailing the final draft report, please ensure the email is marked “strictly private
and confidential” and “for addressee only” and that it is only sent to a
checked/correct and secure e-mail address (ending in @hse.ie), be properly
encrypted and password protected.
•
Please note: Where there are sections of a report that include an implied criticism of
an individual(s) or an adverse finding against an individual within a final draft report
[not considered/amended following earlier factual accuracy checks] the individuals
that such sections relate to must have an opportunity to comment on the factual
accuracy of such sections before others see the final draft report. This is to ensure
factual accuracy checking and to uphold the confidentiality of the investigation
process. It is recommended that in such instances final draft reports are sent by
hard copy, rather than email.
****************************************************************************************************
Strictly Private and Confidential. For addressee only:
Not for copying or for onward circulation.
[write recipient name]
[write recipient’s address]
[write date]
Re: Final Draft Report [include incident number]
Dear [include recipient name],
Thank you for your feedback in relation to the First Draft Report in relation to [write
incident number] that was circulated to you. We have endeavoured to incorporate all of
the feedback that we received into the updated report as far as is reasonably
practicable.
Page 48 of 62
Please find the enclosed copy of the Final Draft Report [If e-mail - The password will be
sent via separate email]. We are sending this final draft to you with a request that you
review it once more prior to its release to ensure that the document does not contain any
factual inaccuracies. We would appreciate if you could return the document with any
feedback related to inaccurate information by not later than [write time] on [write date].
Please make any comments that you have on a separate document and return it to:
[write contact details]. Please do not return any personal data within your comments
unless it is being emailed securely (i.e. password protected or properly encrypted) or
posted by registered post.
The reason that we have given such a short turn around time for receipt of feedback is
that we do not anticipate that any substantive changes to the report should be required
as these changes have all been made on receipt of your previous feedback. Please note
that if we do not receive feedback from you we will assume that you are satisfied that it
is factually correct from your perspective.
In order to maintain patient confidentiality and the confidentiality of all individuals who
participated in the review this document must not be copied, or shared with anyone not
named in this correspondence.
Following your review of this draft report we ask that you either
a)
b)
return the draft report to us either by secure email or by registered post or
confirm by email or letter to the investigation team that you have destroyed the
draft report.
Please also find attached the terms of reference for this investigation.
Thank you for once again for your valuable assistance to date. Please do not hesitate to
contact [write name and contact details of contact person] if you require any further
information or clarification.
Yours sincerely,
[write investigators title and name]
Investigation Team Chairperson
[write investigators title and name]
Investigator
Page 49 of 62
8.0 References & Bibliograhy Used to Inform the Development of
This Guideline
Adams, J.A., (2001), “Risk”. Routledge, London.
AIRMIC (2002), “Risk Management Standard”. www.airmic.com
Borgstede James P., Lewis Rebecca S., Bhargavan Mythreyi, Sunshine Jonathan H.,
(2004), RADPEER Quality Assurance Program: A Multifacility Study of
Interpretive Disagreement Rates, J Am Coll Radiol, 1:59-65.
Boxwala A, Dierks M, Keenan M, Jackson S, Hanscom R, Bates D (2004) “Organisation
and Representation of Patient Safety Data: Current Status and issues around
Generalisability and Scalability. J Am Med Inform Assoc 2004; 11:468-378.
Campbell JL et al., 2008, Assessing the professional performance of UK doctors: an
evaluation of the utility of the General Medical Council patient and Colleague
Questionnaire, Journal of Quality and Safety in Healthcare, 17: 187- 193
Catto G, 2003, Improving professional competence – the way ahead? International
Journal for Quality in Healthcare. 15(5): 375- 376
Clinical Indemnity Scheme (2009) Standard Operating Procedure for the Notification of
Incidents to the State Claims Agency Clinical Indemnity Scheme (CIS) by
participating enterprises:
www.stateclaims.ie/ClinicalIndemnityScheme/publications/2009/SOPIncidentNoti
ficationRequirements.pdf
Clinical Indemnity Scheme (2011) Notification Form:
www.stateclaims.ie/ClinicalIndemnityScheme/publications/2009/CISIncidentForm
June2009.pdf
Cox, L.A. (2008), “What’s wrong with risk matrices?” Risk Analysis, Vol 28, No.2., 2008.
Cox, L.A., Babayev, D., Huber, W., (2005), “Some Limitations in Qualitative Risk Rating
Systems”. Risk Analysis, Vol. 25., No.3., 2005.
Council of Europe (2005) “Glossary of terms related to patient and medication safety –
approved terms, Committee of Experts on Management of Safety and Quality in
Healthcare
Department of Health (2010) “A National Policy for reporting and Learning from
incidents”
Department of Health (2010) “National Guidance for Open Disclosure to patients
following an Adverse Event ”
Department of Health (2010) “National Guidance for Reporting and Learning from
Incidents in Health and Social Care Settings in Ireland”.
Department of Health (2010) “Serious Reportable Events”
Department of Health (UK) and National Patient Safety Agency, (2001), “Doing Less
Harm: Improving the Safety and Quality of Care through analysing and learning
from adverse incidents involving NHS patients – Key Requirements for
Healthcare Providers”.
Page 50 of 62
Department of Health (UK) and National Patient Safety Agency, (2008), “Root Cause
Analysis Investigation Tools; Three levels of RCA investigation - guidance”.
Department of Health (UK) and National Patient Safety Agency, (2009), “National
Reporting and Learning System: Data Quality Standards: Guidance for
Organisations reporting to the Reporting and Learning System”.
www.npsa.nhs.uk/nrls
Epstein R, Hundert E, 2002, Defining and Assessing Professional Competence, JAMA,
287(2): 226- 235
Federal Aviation Administration, (2007),
www.faa.gov.airports_airtraffic/airports/resources/advisory_circulars/media/150520037/150_5200_37.doc.
Gibb, G. (2007), Can simply correcting deficiencies found through incident investigation
reduce error?”, in “Multimodal safety management and human factors”. Edited by
Jose M. Anca Jr, Swinburne University, Australia, Ashgate Publishing.
Goddard M, Davies HTO, Dawson D, Mannion R, McInnes F, 2002, Clinical performance
measurement: part 1—getting the best out of it. J R Soc Med, 95:508 -10
Health Service Executive (2009) “Toolkit of Documentation to Support the Health
Services Executive Incident Management”
Kak N, Burkhalter B and Cooper MA, (2001), Measuring the Competence of Healthcare
Providers. Operations Research Paper 2(1): Published for the U.S. agency for
International Development (USAID) by the Quality Assurance (QA) Project.
Lane DS and Ross VS, (1998), Defining Competencies and performance indicators for
physicians in medical management. American Journal of Preventative Medicine
14: 229-36.
Mahgerefteh S, Kruskal JB, Yam CS, et al., (2009) Peer review in diagnostic radiology:
current state and a vision for the future. Radiographics, 29:1221-1231.
McEnery KW et al., (2000), Integration of radiologist peer review into clinical review
workstation. J. Digit Imaging, 13(2): 101-4
Medical Council, 2008, Professional Practice Review.
Medical Council. 2008, Professional Assessment, Developing Standards 2008
National Patient Safety Agency (2008) “Root Cause Analysis Investigation Tools”
NHS, National Clinical Assessment Authority, 2004, Understanding Performance
Difficulties in Doctors.
Health Service Executive (2009), “Risk Assessment Tool”
Marshall, G (2007), “Governance and Safety Management” in “Multimodal safety
management and human factors”. Edited by Jose M. Anca Jr, Swinburne
University, Australia, Ashgate Publishing.
Maurino, D.E., Reason, J., Johnston, N., Lee, R (1995), “Beyond Aviation Human
factors; Safety in High Technology Systems”. Aldershop: Avebury Aviation.
Page 51 of 62
Reason, J., (2000), “Human Error: Models and Management”, British Medical Journal,
March, 2000, 768-770
Taylor-Adams, S., Vincent, C., (2004), “Systems Analysis of Clinical Incidents: The
London Protocol”. Clinical Safety and Research Unit, Imperial College London.
Toft, B., (1996), “Limits to the Mathematical Modelling of Disasters”. In Accident and
Design: Contemporary debates in risk management”. Published in C. Hood and
D.K.C. Jones (Eds) by University College London Press. 11/23/2012 15:40:00
Toft, B and S. Reynolds, Learning from Disasters: a management approach, (Extended
3rd Edition), Palgrave Macmillan, 2005, pp. 3
Veterans health Administration National Centre for Patient Safety “Safety Assessment
Code” http://www.patientsafety.gov/SafetyTopics/HFMEA/HFMEA_SAC.html
World Health Organisation (2009), “The Conceptual Framework for the International
Classification for Patient Safety”. Version 1.1. Final Technical Report
Page 52 of 62
9.0 Audit Tool to Asses Compliance with This Guideline
The HSE Guideline for Systems Analysis Investigation of Incidents and Complaints have been designed to guide investigators in
conducting robust investigations using the systems analysis method and good investigation practice to:
1.
2.
3.
4.
5.
6.
Ensure appropriate terms of reference are developed for the investigation
Use appropriate data collection methods and a high standard of record keeping throughout the investigation process
Determine the chronology of events
Identify any key causal factors that may exist
If any key causal factors are identified to then identify the contributory factors associated with each key causal factor
Make recommendations to address the contributory factors in accordance with an agreed hierarchy of preferred control
measures
7. Conduct fair investigations in a manner that is cognisant of natural and constitutional justice, due process and data
protection requirements
8. Conduct investigations in a manner that balances the need for the HSE to achieve it’s safety objectives with the need not
to jeopardise the rights of individuals in concurrent or future investigations by external agencies including An Garda
Siochána or the professional regulators etc,
Audit Details
1
2
3
4
Investigation/Complaint
Reference Number
Other Reference
Date Reviewed
Reviewed By
Page 53 of 62
REPORT SECTION
YES/NO/
PARTIAL
COMMENT
Title Page: Are the following items included?
Marked strictly private and confidential?
Does it state the title of the incident investigation?
Does it state the name of the service that conducted
the investigation?
Does it state the date of the Report?
Contents Page
Is a contents page included?
Anonymising the report
Are codes used in order to anonymise the report in
terms of persons?
Are codes used in order to anonymise the report in
terms of location?
Plain English
Is the document written in plain English, including
ensuring that medical and technical terms are
accompanied by plain English definitions and that
Page 54 of 62
definitions, where used, are referenced?
Is full text rather than abbreviations of terms used?
Apology
Is an apology included in the report?
Executive Summary
Is the aim of the investigation stated?
Is the timeframe of the investigation stated?
Does the executive summary summarise the
methodology used including stating:
→ that a systems analysis method was used?
→ details of who conducted the investigation?
→ the methods used to ensure safe management of
sensitive material?
→ the methods used to ensure factual accuracy, due
process, and fair procedure.?
Are the documents used as part of the investigation
named, such as referral letters, records, rotas, ward
diaries?
Is the number of employees who gave information or
were interviewed stated?
Does the executive summary summarise the key
findings of the report and include the key causal
Page 55 of 62
factors and recommendations to address these?
Background
Is there a background section?
Is it concise?
Does it avoid repetition?
Is there a brief summary of events leading up to the
incident?
Chronology of Events
Is there a chronology of events?
Is the exact date and time of each event specified?
Where an exact time and date is not known is the
approximate time noted?
Where an exact time and date is not known is the
event placed in chronological order?
Are the individuals involved or that witnessed each
event specified?
Does the chronology clearly indicate where there was
a variance in recollections or views of those involved
in the incident and are both views stated?
Page 56 of 62
Aftermath of Incident
Is there a summary of the immediate aftermath of the
incident?
Is there a summary of what happened in the longer
term after the incident?
Key Causal Factors: “Issues that arise during the
process of delivering and managing health services
that had an effect on the eventual adverse outcome”
Are key causal factors identified and/or does the
report state that none were identified following the
analysis of the chronology?
Contributory Factors
Does the report show that the investigators used the
contributory factors framework to identify the
contributory factors for each key causal factor?
If no contributory factors are identified does the report
state a reason for this?
Incidental findings
Does the report identify issues that while not
impacting on this incident highlight an area for
service improvement?
Recommendations
Page 57 of 62
Are recommendations included in the report?
Are the recommendations linked to the contributory
factors highlighted in the investigation?
Do the recommendations include all actions
necessary to ensure that the risks associated with the
contributory factors are reduced as far as is
reasonably practical so that the incident is unlikely to
recur?
Is there evidence that a hierarchy of controls was
used to determine the weakest to the strongest
recommendations
Does the report state who has responsibility for
implementation of the recommendations? This may
be covered in the terms of reference.
Action Plans
Does the report refer to a requirement for the report
commissioner/person responsible for implementing
the report recommendations to oversee the
development of an action plan?
Timeframe (For final draft investigation reports)
Are any delays with the completion of this
investigation within the timeframe specified in the
terms of reference - noted in the report?
If yes to the above question, what were the reasons
given for the delays
Page 58 of 62
Terms of Reference
Are terms of reference included in the investigation
report
Was the timeframe for this investigation appropriate
for the incident under investigation? Please note:
The “time frame” in question here is the “scope in
time” that was reviewed in the investigation (e.g.
from the time of admission to the time surgery
commenced)
Is it clear who commissioned this investigation?
Is it clear who is responsible for implementing the
recommendations of the report?
Due Process and Natural Justice
Does the report state if interviewees were allowed the
opportunity to comment on the draft report in terms of
it’s fairness and factual accuracy?
Does the report state if it was considered that any
aspect of the report could be construed to reflect
adversely on any individual, that that individual was
given an opportunity to review the report/relevant
section in terms of it’s fairness and factual accuracy
before it was circulated to others?
Does the report state if feedback from interviewees
was incorporated into the final report?
Page 59 of 62
Does the report state that the person
affected/complainant was given an opportunity to
review and comment on the Chronology section of
the report?
Does the investigation report appear biased – either
towards an individual or as a result of hindsight bias
or outcome bias or in terms of the language used?
Notes:
Page 60 of 62