Strictly Private and Confidential

This is a draft document and can only be considered as such. This document can be expected to be incomplete and to contain factual/clinical inaccuracies and/or information that may require additional clarification.

[Note: the above statement must be added as a header to all pages of the draft report and removed once the report is finalised prior to submission to the Investigation Commissioner]


Strictly Private and Confidential

Investigation Title:

Division(s):

Incident Investigation Reference Number:

First Draft Report/Final Report: (Insert date)

Investigators: (Insert names)

Date incident occurred: (Insert date)

Date investigation commenced: (Insert date)

Table of Contents Page No.

  • Glossary of terms and abbreviations
  • Apology (delete from table of contents if apology not required i.e. if no KCFs identified)
  • Acknowledgement
  • Executive Summary
  • Methodology
  • Background to the Incident
  • Chronology of Events
  • Aftermath of the Incident
  • Key Causal Factors, Contributory Factors, Incidental findings and linked Recommendations
  • Urgent Follow-up Required Post Investigation.
  • References (This might include the reference(s) for any literature, national PPPGs, local PPPGs, Standards etc. cited in the report)

Appendices

Appendix 1 – Terms of Reference for this Incident Investigation

Appendix 2 – Framework of Contributory Factors

Appendix 3 – (Any other relevant information)

Apology (delete this section if not required)

Note: the following is to be considered as guidance only in relation to the wording of this section. The wording of the apology should be tailored so that that it is appropriate to and reflective of the circumstances of each individual case while ensuring that the apology is compassionate and meaningful.

The (service where incident occurred – remember to anonymise) and the Health Service Executive would like to sincerely apologise to the patient and their family for the events that occurred on the (insert date of incident) related to (brief description of incident)

The (site) and the HSE acknowledge that the patient’s experience on the (insert date) was devastating for them and that it has had a profound and lasting effect on the patient and their family.

The willingness of the patient to share their experience was invaluable in allowing this investigation to learn from their experience and in helping to make recommendations to improve the systems and processes in place at (the site) related to the delivery of (insert title) Services.

The HSE and the (insert site) confirm that they are committed to ensuring that the recommendations identified by this investigation report are implemented as a matter of urgency.

Acknowledgement

Note: the following is to be considered as guidance only in relation to the wording of this section. The wording of the acknowledgement should be tailored so that that it is appropriate to and reflective of the circumstances of each individual case.

The(service where incident occurred – remember to anonymise) and the Health Service Executive (HSE) would like to sincerely thank the patient and their family for their willingness to share their experiences related to the events that occurred on the (insert date of incident) related to (brief description of incident)

The information provided by the patient and their family was invaluable in allowing this investigation to learn from their experience and in helping to make recommendations to improve the systems and processes in place at the (insert service) related to the delivery of services.

The contribution of all of the staff who participated and assisted in this investigation is also acknowledged / The investigators would also like to thank all of the staff who participated in this investigation for their invaluable contribution to the process.

The HSE and the (insert service)confirm that they are committed to ensuring that the recommendations identified by this investigation report are implemented in a timely manner.

1.0Executive Summary:

This report relates to the investigation of an incident/complaint that occurred ---- (include the brief details of the incident/complaint being investigated and the time-frame covered by the scope of the investigation)

Also include in this Section the aim of the investigation and details of the Investigation Team who carried out the investigation i.e.

The purpose of the investigation was to:

-Establish the factual circumstances leading up to the incident

-Identify any Key Causal Factorsthat contributed to the incident

-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.

The investigation was carried out by:

  • ------Investigator 1, Title
  • ------Investigator 2, Title

The Investigation Team was established on (insert date)

Please note that the investigators were not responsible for the service within which the incident occurred and that they had no prior involvement in any aspect of the issue being investigated.

The investigators worked with the following representatives who gave input into recommendations identified by the investigation (complete as appropriate outlining the role of the representatives referred to):

Key Findings:

This section should set out the key findings of the investigation e.g. what the Key Causal Factor(s) were and a brief outline of the factors that contributed to the development of the Key Causal Factor, in addition to any Incidental Findings identified. If there were no Key Causal Factors this section should briefly refer to the evidence to support this finding. This section should also include the recommendations identified by the investigation.

This investigation identified the following recommendations:

Recommendation 1:

Recommendation 2:

Recommendation 3:

Recommendation 4:

Recommendation 5:

2.0 Methodology:

This section should set out how the investigation was conducted; for example:

This investigation was undertaken using the methodology for incident investigations outlined in the HSE Guideline for System Analysis Investigation of Incidents and Complaints 2015[1]. This approach is an internationally recognised methodology for investigating adverse incidents in healthcare.

Prior to commencement of the investigation; consent was sought and gained from the patient to allow the investigators to access the patient’s healthcare records in order to complete a systems analysis investigation.

Details provided in this report have been obtained from a review of the relevant documentation and interviews with the patient and relevant personnel. Timings are based on records and the patient’s and staff’s recollection(s).

While carrying out this investigation the investigators examined relevant literature and documentation including the following:

  • Patient X’s healthcare record
  • List any other sources of information used by the Investigators e.g. Titles of PPPGs, articles reviewed etc. (Refer to the fact that a list of references for the literature, PPPGs etc. is included in the Reference Section of this report)

In addition, individual interviews were undertaken with staff members involved in the patient’s care during the period covered by the scope of the Terms of Reference for the investigation.

The investigators also met with the patient and/or their family members (amend as appropriate) on xxx (insert date).

A total of ---- staff members were interviewed as part of the investigation.

Those interviewed were:

Ensure that the list of individuals included does not allow for identities of individuals to be known.

Example:

  • X members of nursing staff who cared for Patient X during the time period covered by the scope of this investigation.
  • Staff Nurse A was interviewed on xxx (insert date)
  • Staff Nurse B was interviewed on xxx (insert date) etc
  • Consultant X was interviewed on xxx (insert date) etc
  • Senior House Officer X was interviewed on xxx (insert date) etc
  • Any others

(If there were a large number of people interviewed it is best to list those interviewed under specific categories i.e. Nursing staff, Clinical staff, Management staff etc)

The interviews were conducted by all members of the investigation team; the interviews were conducted in a manner that aimed to ensure that the optimal levels of information were obtained whilst ensuring that the individuals being interviewed were treated with dignity and respect.

All information gathered during the documentation/literature review and interview stages of the investigation process were treated confidentially. Information gathered was maintained securely.

On completion of the interview and documentation/literature review process a Draft Report was prepared; the Draft Report was shared with all of those individuals who were interviewed as part of the investigation to ensure that the report was factually accurate; amendments were made to correct any erroneous information contained in the report and to enhance the factual accuracy of the information contained in the report.

The Draft report identified recommendations to address those issues which were identified as contributing to the (incident/complaint – delete as appropriate). The recommendations were developed based on consideration of the hierarchy of controls (see Appendix 3) which is a validated tool to identify control measures that would have the most effective outcome.

Feedback was sought to ensure that the recommendations identified were a) specific, b) measurable, c) achievable, d) reasonable and e) timely as far as was reasonably practicable.

On this basis the Final Report of the investigation was developed.

The methodology section of the report should also include the following information re investigators:

A statement that the members of the Investigation Team are not responsible for the service within which the incident occurred and that they had no prior involvement in any aspect of the issue being investigated.

Whether the investigators are internal or external (where an external investigator is defined as an individual nominated to a HSE investigation by and external agency such as the Forum or Irish Post-graduate Medical Training Bodies).

Whether the investigators are investigation experts or subject experts (where a subject expert is defined as someone with knowledge and experience within the area being covered by the investigation such as a consultant obstetrician and/or a midwife; and an investigation expert is considered to be someone who may not have subject knowledge and experience but who has training and experience in conducting investigations in line with HSE guidelines such as a risk advisor/manager, a quality and patient safety manager, a clinical audit officer etc.).

If a Legal Review of the report was undertaken.

Limitations to the investigation:

If appropriate there may be a requirement to include a reference to any limitations on the investigation i.e. length of time that has elapsed since the incident/events complained of occurred and impact on staffs recollections of events or inability to access to certain information etc.

In addition, if the investigation process was delayed, please also state the reasons for this delay.

3.0 Background to the Incident:

(Provide a brief/concise summary here of the incident and events leading up to the incident/complaint i.e. that period of time prior to the scope of time indicated in the Terms of Reference for the Investigation)

4.0 The chronology of events has been established as follows:

Specify day and date of incident e.g. Tuesday 10th September 2013:

(Specify times on the left - hand margin in bold, and use the twenty four-hour clock, all timings referred to throughout the report should be made using the twenty four hour clock)

22.00 hours

Describe the events that took place and the individuals involved in or observing the incident at this time using information from entries made in records, interviews that have been conducted etc.

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.

All personnel should be referred to by their title and by the code name e.g. Staff Nurse 1, Consultant Physician A, etc. Do not use Doctor A or Senior House Officer A as this causes confusion – you must indicate Surgical/Medical/Paediatric Senior House Officer 1 etc. Take additional care if only a single or small number of staff fit into the category to ensure that individuals cannot be identified. The key to codes allocated must be retained as part of the back-up file for the Incident Investigation.

If there are variations in recollections of events – state that a variation/difference of recollection exists and describe both versions of the event.

As far as is reasonably practicable abbreviations of clinical or technical terms shouldnot be used, therefore terms such as B/P, Hb or bpm should not be used but rather the full text should be included in the report e.g. Blood Pressure, Haemoglobin, beats per minute etc.

If abbreviations are used; the first time the term is used the full wording should be included; thereafter the abbreviation can be used.

Include the normal or reference values of pulse rate, haemoglobin where they are relevant etc. so that non-clinical staff/the patient can understand the significance of this information.

References must be included for explanations of clinical/technical terms. Explanations should be inserted as a foot-note to the report or included as a Glossary.

22.30 hours:

Move on todescribe the events that took place in this time segment.

In the event that the incident extends over more than a one day period, specify the date of the next day as a new heading on a new page e.g.

Wednesday 11th September 2013:

(Specify times as outlined above)

Example:

00.15 hours

01.30 – 1.45hours

If the events that you are describing extended over a defined period

02.00 hours (approximately)

If exact time unknown

5.0 Aftermath of Incident:

In this section provide a brief summary of what happened immediately after the incident to include support provided to the patient and staff (if this is not covered by the time scope outlined in the Terms of Reference for the Incident Investigation), and what happened in the longer term if known i.e. what was the eventual outcome for the person involved in the incident – did they make full recovery, did they suffer a permanent injury etc.

In addition include details of how the incident was reported in this section.

6.0 Key Causal Factors, Contributory Factors, Incidental findings and linked Recommendations

This section of the report documents the analysis of the incident/complaint.

The report should clearly identify the Key Causal Factor – the report should not describe Contributory Factors unless a Key Causal Factor has been identified and described.

If no Key Causal Factor was identified during the analysis of the incident; the report should state this and should outline the examples of care given that met the required standards or that demonstrated good/acceptable practice i.e. to support finding of no Key Causal Factor.

When making recommendations, please refer to Appendix 3, Hierarchy of Controls to assist with the identification of the strongest controls as possible.

The text for this section of the report is as follows:

Key Causal Factors are issues that arose in the process of delivering and managing health services which had an effect on the eventual harm.

An examination of the incident/complaint involving (insert code for individual involved), in (insert location of incident) on the (insert date of incident), identified the following Key Causal Factor(s):

Insert title of Key Causal Factor(s)

The/Each Key Causal Factor identified was analysed by the investigators to identify the ‘Contributory Factors’.

Contributory Factors are considered to be the hazards and potential causes of harm, if not mitigated (through appropriate recommendations being put in place).

The list of Contributory Factors outlined within the Contributory Factors Framework used to analyse each Key Causal Factor identified by this investigation is included in Appendix 2 of this report.

The following section(s) of this report analyse (each of)/ the Key Causal Factors and the Contributory Factors identified for each.

Key Causal factor 1: Insert title of Key Causal Factor

You may want to use the template Fish-bone diagram here to illustrate the KCF and associated Contributory Factors)

Framework of Influencing/Contributory factors

This section examines the Contributory Factors that led to the development of Key Causal Factor 1 using the Framework of Influencing/Contributory Factors outlined in Appendix 2.

Discuss the individual influencing Contributory Factors that have been identified during interviews, documentation review etc. using the Framework. For each Contributory Factor use a separate sub-heading and identify the specific element of the CF that you are referencing e.g. Work Environment (Shift Patterns) i.e. current shift patterns do not facilitate opportunity for hand-over or Work Environment (Design, availability and maintenance of equipment) i.e. inadequate maintenance of (insert name of equipment) etc.

Note; When analysing the Contributory Factors that led to the Key Causal Factor use the order of Contributory Factors as set out in Framework i.e.

  • Patient/Service User Factors
  • Task and Technology Factors
  • Individual (Staff) Factors
  • Team Factors
  • Work Environmental Factors
  • Organisational and Management Factors
  • Institutional Context Factors

Example:

Patient Factors and recommendations to address these:

(Language and communication):

For example, if it was reported at interview that the patient did not speak any English and this contributed to difficulties communicating with the patient which in turn contributed to the Key Causal Factor that developed, this may be discussed under the Key Causal Factor ‘Failure to communicate information to the patient’ , ‘Patient factors’ heading, sub-heading Language and communication.

The recommendations that have been identified to address these Contributory Factors should be included at the end of the section so that a link is formed between Contributory Factors and recommendations.