guidance on undertaking a root cause analysis (rca)

22
This procedure / guidance forms part of the Incident Management Policy P057 Procedure /Guidance Version No Policy Expiry Date Page: 3.0 21 Oct 2016 1 of 22 Appendix D12: Guidance on undertaking a Root Cause Analysis Investigation (RCA) 1. Before the RCA investigation is commissioned a) The Patient Safety Systems Team will determine the level of investigation required into a serious untoward incident with reference to the table in appendix D1 and seeking the views of the relevant Delivery Unit Triumvirate as necessary. b) The Team Manager will be fully briefed on the known circumstances of the serious adverse incident and commence the first stage investigation as swiftly as the incident warrants. Where an incident scene has been preserved, for example, the investigation would need to commence immediately. The Team Manager would normally commence this first stage investigation within 24 hours. The resulting management report is required within 48 hours and will be approved and released to the commissioners within 72 hours. c) Usually, the only information available at the start of an investigation will be the completed incident report, accompanied by staff statements. The incident should have been reported in an objective and factual way, however it is important to check that this is in fact the case to ensure false assumptions are not made. For example, an incident is reported as “Patricia was late for the meeting again” should be changed to “The meeting started before Patricia arrived”. It is important to remove any subjectivity that may have innocently been introduced by the incident reporter. 2. The RCA investigation process 2.1. Collecting the information for the second stage investigation (the RCA) a) The Team Manager will scope the incident and collect all relevant evidence in preparation for the RCA. b) The Trust recognises that collecting information in a thorough and effective way takes time. The Team Manager will be supported by their line manager in ring- fencing time to undertake this important work. c) In scoping the incident, the Team Manager needs to determine what information should be collected, e.g. medical records, policies/procedures, off duty records, etc. The chair may ask for further information once appointed. d) The Team Manager will provisionally determine at what point in time the investigation needs to start, e.g. immediately before the incident, one

Upload: others

Post on 19-Apr-2022

6 views

Category:

Documents


0 download

TRANSCRIPT

Page 1: Guidance on undertaking a Root Cause Analysis (RCA)

This procedure / guidance forms part of the Incident Management Policy P057

Procedure /Guidance Version No

Policy Expiry Date Page:

3.0 21 Oct 2016 1 of 22

Appendix D12: Guidance on undertaking a Root Cause Analysis Investigation (RCA)

1. Before the RCA investigation is commissioned

a) The Patient Safety Systems Team will determine the level of investigation required

into a serious untoward incident – with reference to the table in appendix D1 and seeking the views of the relevant Delivery Unit Triumvirate as necessary.

b) The Team Manager will be fully briefed on the known circumstances of the serious

adverse incident and commence the first stage investigation as swiftly as the incident warrants. Where an incident scene has been preserved, for example, the investigation would need to commence immediately. The Team Manager would normally commence this first stage investigation within 24 hours. The resulting management report is required within 48 hours and will be approved and released to the commissioners within 72 hours.

c) Usually, the only information available at the start of an investigation will be the

completed incident report, accompanied by staff statements. The incident should have been reported in an objective and factual way, however it is important to check that this is in fact the case to ensure false assumptions are not made. For example, an incident is reported as “Patricia was late for the meeting again” should be changed to “The meeting started before Patricia arrived”. It is important to remove any subjectivity that may have innocently been introduced by the incident reporter.

2. The RCA investigation process

2.1. Collecting the information for the second stage investigation (the RCA)

a) The Team Manager will scope the incident and collect all relevant evidence in

preparation for the RCA.

b) The Trust recognises that collecting information in a thorough and effective way takes time. The Team Manager will be supported by their line manager in ring-fencing time to undertake this important work.

c) In scoping the incident, the Team Manager needs to determine what information

should be collected, e.g. medical records, policies/procedures, off duty records, etc. The chair may ask for further information once appointed.

d) The Team Manager will provisionally determine at what point in time the

investigation needs to start, e.g. immediately before the incident, one

Page 2: Guidance on undertaking a Root Cause Analysis (RCA)

This procedure / guidance forms part of the Incident Management Policy P057

Procedure /Guidance Version No

Policy Expiry Date Page:

3.0 21 Oct 2016 2 of 22

day/week/month/year before, etc. This will be confirmed with the RCA chair once they are appointed. Ultimately the decision regarding the period covered by the investigation rests with the Patient Safety Systems Team.

e) The Team Manager will ensure that statements are provided by the relevant staff

and review these to establish whether further statements are required. The RCA chair may subsequently ask the Team Manager to arrange for further statements to be provided. The Chair will also wish to see any reports prepared for the Coroner.

f) The chair will identify which, if any staff, need to be interviewed by him/her and

arrangements for these interviews will be made in conjunction with the appropriate Team Manager.

g) The Team Manager will create a file to store all investigation papers. These papers

will form appendices to the final report. The papers will be passed to the RCA Chair when appointed.

2.2. The Four P’s (People, Paper, Parts, Place)

a) In preparing for the RCA, the Chair will consider a number of hypotheses as to why

the incident occurred. Eg: Why was Patricia late for the meeting – because the train was late; because she wanted to be; because she wasn’t advised of the meeting start time; because she thought the meeting started later; because her earlier meeting overran.

b) At this stage these hypotheses may be as creative as the Chair chooses and this broad thinking will help the Chair generate the questions that they will seek to answer when undertaking the investigation and analysing the information collected.

c) For each of the hypotheses, the Chair will consider the evidence received to date and whether further evidence is required. It is important to think creatively at this stage so that the best effort is made to collect all relevant information at the outset.

d) The evidence will be gathered under the headings of the 4 P’s (people, paper, parts, place).

- The people will be the individuals he/she has or requires statements from or wishes to interview

- The paper will be the documentation he/she has or requires e.g.medical records, policies/procedures, complaints file, etc.

- The parts will be what equipment needs to be considered, eg, medical device, door lock, wheelchair, furniture, etc.

- The place will consider environmental factors and perhaps photographic evidence of a place or a sketch/report made at a site visit, etc.

e) After the creative thinking, it is important to undertake a reality check and focus on collecting all of the papers in a bundle, that will be indexed. For example.

Page 3: Guidance on undertaking a Root Cause Analysis (RCA)

This procedure / guidance forms part of the Incident Management Policy P057

Procedure /Guidance Version No

Policy Expiry Date Page:

3.0 21 Oct 2016 3 of 22

- RCA Report template (obviously not written yet) - Adverse Incident Report - Red management report - Witness Statements - Any paper copies of records - Notes of Site Visit - Etc.

f) The Chair should request the outstanding information from the Team Manager and file it appropriately as the information is received. At this early stage, the index for the file may reflect progress in the data collection, e.g.

Index Requested Received

1. Report

2. Adverse Incident Report 22.9.13

3. Witness Statements 3.1 Patricia 3.2 John

20.9.13

22.9.13

4. Medical Records Chased 19.9.13

2.3. Interviewing Staff

a) After reviewing the statements received, there may be follow up questions that need to be addressed with individual members of staff. In some cases, these issues may be minor and can be followed up by telephone or by asking the member of staff to amend their statement to clarify a particular point. Where the issues are more complex individual interviews may be arranged.

b) Arrangements for interviewing staff should be made in conjunction with the Service Manager (or equivalent). It is recognised that staff may find this a daunting process and as much support and assistance as possible should be offered to them. They should be sent a letter setting out an explanation of the RCA investigation process and the role of the Chair, together with a copy of their statement. They should be invited to bring a colleague to support them, if they wish.

c) It is good practice for the Chair to prepare any questions he/she wishes to address

to the staff member beforehand, so that no important point is lost.

d) Advice on conducting interviews is contained in Appendix D4.

2.4. Timeline

a) The Chair will begin by recording key events leading up to the incident - starting from the first date of the period the investigation is intended to cover. He/she will record the date and time, describe the event, identify the staff involved and include

Page 4: Guidance on undertaking a Root Cause Analysis (RCA)

This procedure / guidance forms part of the Incident Management Policy P057

Procedure /Guidance Version No

Policy Expiry Date Page:

3.0 21 Oct 2016 4 of 22

any supplementary information that helps to tell the “story” of the incident. Completing a tabular timeline may assist with this process, but is not mandatory.

b) In doing this the Chair will identify any potential problems in the delivery of care or

the delivery of service. It is sometimes difficult to assess whether actions were reasonable or not. It will be useful for the Chair to consider the Bolam and Bolitho tests in these situations, i.e. would a responsible body of peers have behaved in the same way, and did the behaviour have a logical, reasonable and responsible explanation. It is important that any care delivery problems or service delivery problems are specific to the actual event.

c) The Chair will also identify any potential safeguards or barriers that were in place to

prevent an adverse event. There are many different sorts of safeguards – physical safeguards (e.g., insulation on hot pipes), natural safeguards (e.g. long walk to get controlled drugs), human action safeguards (e.g. test the temperature of water before bathing) and administrative safeguards (e.g. protocols and procedures).

d) Whilst recording the chronology of events, the Chair may identify further information

that may be required and this should be noted and sought accordingly from the Team Manager.

2.5. Multi-Disciplinary Team Meeting

a) When the RCA investigation is commissioned, the Team Manager is asked to

contact the chair to set a date for this meeting. It is imperative that this is done promptly to facilitate the attendance of key staff and ensure that the investigation deadline is met.

b) The Team Manager is responsible for inviting the relevant staff (including the GP) in consultation with the Chair

c) The purpose of this meeting is to share emerging findings and:

- Identify/confirm care delivery/service delivery problems/lessons learned - identify contributory factors - identify the focus for the recommendations

d) The purpose is not to establish the facts – most of this will have already been done through the review of the records and statements from/interviews with staff.

e) Confirmation of the facts, however, may be a useful way to get the meeting started

and to ease staff into talking about the more difficult issues.

2.5.1. Preparation by the chair a) The chair will need to meet with the Director of Quality towards the end of the RCA

process to agree the recommendations (the letter commissioning the investigation will

Page 5: Guidance on undertaking a Root Cause Analysis (RCA)

This procedure / guidance forms part of the Incident Management Policy P057

Procedure /Guidance Version No

Policy Expiry Date Page:

3.0 21 Oct 2016 5 of 22

give details of when this should happen). Setting up this meeting in advance should be an early priority.

b) If there is more than one chair, it is important to be clear about who is doing what. c) Agree with the Team Manager who will be invited and confirm that they have checked

availability and sent an invitation. d) Remember that staff outside the immediate team may need to attend. e) Consider how to facilitate attendance by and/or input from the GP and key AWP staff –

bearing the timescale in mind. f) Review who is coming; who will be missing; what can be done about this and how their

input will be obtained. g) Consider whether input from other agencies is needed and how it can be obtained:

Probation Officers, Child Care Social Workers, and outreach housing workers. h) Decide who will not be invited to the meeting e.g. the police.

i) Consider whether input is needed from a Trust Specialist and how this will be obtained

(e.g. discussing an issue relating to medication with a pharmacist in advance of the meeting or inviting a PMVA trainer to attend the RCA meeting following an assault on staff).

j) Confirm that the Team Manager has found someone to take notes. k) Pull together a summary of the background and the incident chronology. This should be

shared with participants before the meeting.

l) Pull together your provisional thoughts on good practice, problems, lessons learned and contributory factors. A list of questions that may prompt thinking about this is included in appendix 1.

2.5.2. Chairing the meeting

a) The meeting should be conducted in an informal, supportive but business-like fashion.

b) The Chair should be aware throughout the meeting of the sensitivities of the staff

concerned. Some of the staff may still be experiencing difficult emotions about the incident, such as distress, feelings of guilt, or anger.

c) The role of the Chair is to help all the staff present to contribute to the process of the

meeting in a constructive way, whilst at the same time recognising these emotions.

Page 6: Guidance on undertaking a Root Cause Analysis (RCA)

This procedure / guidance forms part of the Incident Management Policy P057

Procedure /Guidance Version No

Policy Expiry Date Page:

3.0 21 Oct 2016 6 of 22

d) The Chair should be sensitive to the power issues in the relationships amongst staff present at the meeting. Junior staff may be reluctant to disagree with more senior staff in either fact or opinion. Senior staff may be reluctant to discuss their own decisions and practice in the presence of junior staff.

e) The role of the Chair is to attempt to overcome these power and status issues by

facilitating contributions from all of the staff who are present and by ensuring that all members of staff have the opportunity to comment and give their perspective.

f) As a general rule the staff who have the closest knowledge of the service user, and

who were most involved with the care plan at the time of incident, should make the largest contribution to the meeting.

g) The discussion held at the meeting is confidential and the report itself will be

anonymised. However, staff involved need to be aware that the anonymised report may be shared within the Trust and with partner agencies. Staff also need to be aware that the report may be made available to the Coroner or for other external inquiries.

2.5.3. The Agenda (appendix 2)

1. Introduction The Chair should outline the purpose of the meeting, emphasising the need to learn lessons rather than allocate blame. Staff should be informed about confidentiality arrangements, and about how the meeting will be reported. They should also be reminded of their duty to check the draft report for factual accuracy when it is available. 2. Staff Present and Apologies Received These should be noted. 3. Summary of roles in the case This achieves a quick synopsis of the knowledge of the case by all of the staff present. 4. Documents available The Chair should briefly confirm the documents available, including any which have been brought to the meeting by participants (e.g. Primary Care Notes). 5. Circumstances of Incident This should be a brief factual summary of the known circumstances, including the Post Mortem report if applicable/available. 6. Background of the person

Page 7: Guidance on undertaking a Root Cause Analysis (RCA)

This procedure / guidance forms part of the Incident Management Policy P057

Procedure /Guidance Version No

Policy Expiry Date Page:

3.0 21 Oct 2016 7 of 22

This section of the meeting should provide a brief pen portrait of the individual, and is divided into 3 parts: describing the individual, their physical health and their mental health history. Most of this information is likely to be known to those present and can be briefly summarised and shared to confirm consensus.

6.1 Personal and Family History: This should include educational and occupational history, as well as information about the individuals adult relationships, personality and lifestyle. 6.2 Physical Health History: A brief summary of the nature, history and severity of physical health problems. 6.3 Mental Health History: A brief summary of the nature, history and severity of mental health problems. The diagnosis, any secondary diagnoses, and formulation should all be confirmed.

7. Review of care prior to incident The chair should confirm with staff present their summary of the care offered in the period leading up to the incident, which will have been circulated to those attending prior to the meeting. 8. Events following the incident The chair should confirm how those affected by the incident (e.g. service user, family/carers and others) were informed about it and and what support has been offered to date. This assists the chair in confirming whether the Trust has met its Duty of Candour. Any concerns raised by those affected should be noted at this point so that they can be considered as part of the review of care. Additional information which has come to light since the incident should be noted. 9. Good Practice The Chair should invite suggestions about any good or notable practice that has been identified during the process of reviewing the care given. The chair should also suggest good or notable practice which they have identified from their review of the case. 10. Care Delivery Problems and Service Delivery Problems The chair should present the potential CDP’s and SDP’s that they believe have emerged from their review of the care offered. The focus here is on problems (errors or omissions in care) which may have caused this particular incident to occur. The Chair should invite suggestions from participants about any CDP’s or SDP’s that have emerged during the RCA meeting.

Page 8: Guidance on undertaking a Root Cause Analysis (RCA)

This procedure / guidance forms part of the Incident Management Policy P057

Procedure /Guidance Version No

Policy Expiry Date Page:

3.0 21 Oct 2016 8 of 22

Views should be shared and consensus sought as far as possible. 12. Lessons Learned The focus here is on issues or problems which, although they did not cause this particular incident, increase the risk of other serious incidents happening in future. The Chair should encourage wide-ranging discussion about the issues raised for the team and for individual staff by the case. This section of the meeting is a helpful part of the learning and team-building process of the RCA meeting. 11. Contributory factors This is the nub of the meeting. It is unlikely that the chair will have been able to fully clarify these from the review of the notes or from staff statements/interviews. The chair should encourage the meeting to think about how and why each of the CDP’s happened. If appropriate, the chair should also encourage the meeting to think about how and why each of the SDP’s and lessons learned happened. In some cases this may not be appropriate e.g.

- If a service delivery problem arises from management or commissioning arrangements, the clinical team will not be able to explain how this came about or

- If the current procedure was followed, but a lesson learned is identified which suggests a change to this procedure in future, then there is no error or omission in care for the team to explore further

The chair should persist in asking ‘why’ until the bottom line is reached. This approach is intended to help us establish whether there were precipitating or predisposing factors to the incident and whether there were protective or perpetuating factors (barriers or latent conditions) which minimised or exacerbated the risk of the incident occurring. It is helpful to encourage free thinking when identifying contributory factors, and it may be helpful to employ brain-writing or thought shower techniques. It there are large numbers of care/service delivery problems/lessons learned then it may be helpful to focus on the most serious ones. This could be done by each

Page 9: Guidance on undertaking a Root Cause Analysis (RCA)

This procedure / guidance forms part of the Incident Management Policy P057

Procedure /Guidance Version No

Policy Expiry Date Page:

3.0 21 Oct 2016 9 of 22

member of the team prioritising (e.g. 1-5) the problems and attention being given to those with the most votes. 13. Recommendations The broad issues that need to be addressed by a recommendation should be discussed at the meeting and these will emerge from the CDP’s, SDP’s and Lessons Learned. The chair should use the discussion at the meeting as a way of understanding the contributory factors, as this will inform the detail of how the recommendation should be worded. The recommendations themselves will be written after the meeting and in discussion with the Director of Quality/supervising reviewer. If the meeting has been successful the relevant Recommendations will have become obvious to all of the participants. Discussion about recommendations should not focus negatively on services or on individual staff, but should instead focus on how good practice can be developed 14. Summarising and Concluding It is helpful to finish with a summary of what has been discussed and to prepare staff for the next stage of the process – i.e. production of the report. Alert those present to the fact that they will be asked to comment on the draft report and give a sense of the timescale for this.

2.5.4. After the meeting

The draft report should be completed as soon as possible (usually within a week) and it should be circulated by the Chair to the staff involved (including any who gave apologies for the meeting); the Team Manager; the supervising reviewer/Director of Quality; the Clinical Director; the Clinical Risk Manager/Head of Patient Safety Systems and any relevant Trust specialist for feedback.

This circulation list should invite comment from anyone who will have responsibility for implementing the draft recommendations when they are agreed, so that they can offer advice on refining the wording of the recommendations

- The Team Manager will be responsible for Team recommendations; - The Delivery Unit Clinical Director will be responsible for Delivery Unit

recommendations; - Trust specialists will be responsible for trustwide recommendations (e.g. the

Trust CPA lead will need to comment on proposed changes to CPA Policy).

Page 10: Guidance on undertaking a Root Cause Analysis (RCA)

This procedure / guidance forms part of the Incident Management Policy P057

Procedure /Guidance Version No

Policy Expiry Date Page:

3.0 21 Oct 2016 10 of 22

The purpose of this circulation is to check for matters of factual accuracy with participants, to achieve consensus about the findings of the report, and to the meet Trust quality standards for the investigation and report.

2.5.5. A note about performance and disciplinary issues

The management investigation and report undertaken following a serious incident should already have considered whether there were any concerns about staff performance, but occasionally an issue may not become apparent until the time of the multidisciplinary meeting.

It is unlikely that this should be of a disciplinary nature, as such matters should have been detected by the management review; however a need for training or for closer supervision for an individual member of staff may well emerge.

When this does occur the Chair should deal with the matter sensitively during the meeting, remembering at all times that the purpose of the meeting is to learn lessons from the incident rather than to allocate blame.

Following the meeting it is the responsibility of the Chair to raise the concern about the particular member of staff with the relevant manager.

The Chair should inform the member of staff concerned that they have taken this step.

If the performance issue will be highlighted in the report as a Care Delivery Problem, it should be stated in a general way without identifying the staff concerned.

3. Analysing the Information Collected and Writing the Report

a) The standard template for the report is set out in appendix D13.

b) Guidance on writing the report is contained in appendix D27 (check)

c) To analyse the incident the chair should reflect on the evidence gathered prior to and during the RCA meeting.

d) It may be helpful to consider this evidence against the questions that the Chair posed prior to or during the RCA meeting.

e) Chairs should not, however, document the more ‘creative/free-thinking’ hypotheses generated at the beginning of the investigative process, as these are intended solely as a way of generating the questions that need to be answered.

Page 11: Guidance on undertaking a Root Cause Analysis (RCA)

This procedure / guidance forms part of the Incident Management Policy P057

Procedure /Guidance Version No

Policy Expiry Date Page:

3.0 21 Oct 2016 11 of 22

3.1 Good Practice a) Chairs should consider if they have found evidence of:

- Practice which met the standard expected by the Trust - Practice above and beyond the expected standards of care and/or evidence of good

quality care provided in exceptionally difficult circumstances. 3.2. Care Delivery Problems (CDP’s), Service Delivery Problems (SDP’s) (i.e. causal

problems) and Lessons Learned (i.e. non-causal problems or learning)

a) Chairs should consider if

- Problems or issues have been identified with the care or service provided - Other learning emerges from the incident and - Determine whether any of these problems or issues led to this particular incident.

b) A CDP is a problem that arises in the process of care, usually actions or omissions

by staff. For example not using Trust Risk Assessment procedures.

c) An SDP refers to acts or omissions that are identified during the analysis of the incident, which are not associated with the direct provision of care. For example the lack of availability of a 24-hour crisis service, or inadequate staffing to provide the service defined by the relevant Standard Operating Procedure.

d) The brief definition is that CDP’s are staff not doing what is expected of them, whilst an SDP is the Trust not doing what is expected of it as an organisation.

e) Care and Service Delivery Problems are considered causal problems if they are thought to have led directly to the occurrence of this particular incident.

f) Lessons Learned are issues identified with the care or service offered which did not

directly lead to the incident. These may arise because:

- The care and service provided did not meet the accepted standard, but the problems identified did not directly lead to the occurrence of the incident or

- The care and service provided did meet the accepted standard, but the review of what happened identifies points at which care or the service could have been improved

3.3. Contributory Factors

a) Contributory factors to an incident may be classified under different headings.

b) The Fishbone Classification Diagram (appendix 3) and the Contributory Factors Classification Framework (appendix 4) will assist in identifying contributory factors.

Page 12: Guidance on undertaking a Root Cause Analysis (RCA)

This procedure / guidance forms part of the Incident Management Policy P057

Procedure /Guidance Version No

Policy Expiry Date Page:

3.0 21 Oct 2016 12 of 22

c) Contributory factors for each care delivery problem should be identified.

d) Contributory factors should be identified, wherever possible, for every service delivery problem and lesson learned.

3.4. Identifying the Root Cause

a) In commissioning a Root Cause Analysis investigation the Trust is seeking to establish whether there were problems with the care or service offered and what the Root Causes of these problems were.

b) In doing this we may come to an understanding about the root cause of the incident

itself, but this may not always be possible. For example, in the case of an unexpected death the post mortem may not have established the cause of death at the point when the RCA is undertaken and, in the absence of this information, it is unlikely to be possible to fully establish the root cause of the incident itself.

c) In order to establish the root cause or causes, the chair should consider each of the

contributory factors in turn and ask themselves if the incident would still have happened in the absence of this contributory factor. If the answer is that the event still could have happened then this is unlikely to be the root cause. If, however, the answer is yes, then the contributory factor is likely to be the root cause or one of the root causes.

d) By asking these questions, you will also be generating information that can be used

to develop solutions, which is the main aim of root cause analysis. 3.5 Recommendations

a) The team and/or the chair may have identified a range of potential solutions to the problems identified by the serious incident at the RCA meeting. Before these

solutions are suggested as recommendations, the following checks should be made (seeking advice from Quality Directors and Trust specialists as necessary)

- ask again whether the solution being suggested would have stopped (or

contributed to stopping) the incident in question; - consider the implications of the solution – could it cause more problems then

it solves; - is the financial cost of the solution prohibitive; - will the solution be acceptable to staff and patients.

b) Even if the recommendation does not meet each of these ‘tests’, the chair may still wish for it to be included in the report for the Delivery Unit’s governance team to consider, e.g. if the cost of implementing the recommendation is prohibitive, the Delivery Unit’s governance team may instead wish to add the residual risk to their risk register.

Page 13: Guidance on undertaking a Root Cause Analysis (RCA)

This procedure / guidance forms part of the Incident Management Policy P057

Procedure /Guidance Version No

Policy Expiry Date Page:

3.0 21 Oct 2016 13 of 22

c) Recommendations should be SMART (Specific, Measurable, Achievable, Realistic and Time Specific).

d) The RCA chair is responsible for ensuring that they are (Specific, Measurable and

Achievable).

e) The Clinical Director is responsible for ensuring that they are Realistic and Time Specific)

4. Review, acceptance and ratification of the RCA report

a) A letter confirming the timescales for the investigation and the process of getting the report reviewed, accepted and ratified is sent to RCA chairs when the report is commissioned.

b) The first and final drafts of the report should be sent to the clinical team involved; the

Team Manager; the supervising reviewer/Quality Director; the Clinical Director; the Clinical Risk Manager/Head Of Patient Safety Systems and any relevant Trust Specialists

c) The report will be accepted by the appropriate Clinical Director.

d) Once accepted the report will be ratified by an Executive Director.

e) Reports relating to the most serious incidents will also be reviewed by the Critical

Incident Overview Group.

f) In the event of dispute about the reports findings these should be escalated to the appropriate Executive Director for resolution.

g) Once ratified the recommendations will be added to the Patient Safety Development Plan so that they can be implemented.

Page 14: Guidance on undertaking a Root Cause Analysis (RCA)

This procedure / guidance forms part of the Incident Management Policy P057

Procedure /Guidance Version No

Policy Expiry Date Page:

3.0 21 Oct 2016 14 of 22

APPENDIX 1. Possible questions for the chair to consider while undertaking an RCA:

1. When was the last risk assessment? 2. Was risk information collected from the family?

3. What was the diagnosis?

4. What was the risk management plan?

5. Were there warning signs, recent suicide attempts?

6. Do we know what triggered the incident ? (e.g. from a note, statements made by the

service user, etc)

7. Had there been a team risk review?

8. What are the findings of the NPSA team audit?

9. Were there any team disagreements about risk, diagnosis or the care plan?

10. Was information shared across the team?

Page 15: Guidance on undertaking a Root Cause Analysis (RCA)

This procedure / guidance forms part of the Incident Management Policy P057

Procedure /Guidance Version No

Policy Expiry Date Page:

3.0 21 Oct 2016 15 of 22

Appendix 2: Suggested agenda for the RCA meeting

A G E N D A

1. Introduction to the meeting

2. Staff Present and Apologies

3. Summary of roles in the case 4. Documents available

5. Circumstances of incident

6. Background of the person

7. Review of care

8. Events following the incident

9. Good Practice

10. Care Delivery Problems & Service Delivery Problems & Lessons Learned

11. Contributory Factors

12. Proposed Recommendations

13. Summary and Conclusions

Page 16: Guidance on undertaking a Root Cause Analysis (RCA)

This procedure / guidance forms part of the Incident Management Policy P057

Procedure /Guidance Version No

Policy Expiry Date Page:

3.0 21 Oct 2016 16 of 22

Page 17: Guidance on undertaking a Root Cause Analysis (RCA)

This procedure / guidance forms part of the Incident Management Policy P057

Procedure /Guidance Version No

Policy Expiry Date Page:

3.0 21 Oct 2016 17 of 22

Patient factors: Clinical condition

Physical factors

Social factors

Psychological/

mental factors

Interpersonal

relationships

Individual (staff)

factors: Physical issues

Psychological

Social/domestic

Personality

Cognitive factors

Task factors: Guidelines/

procedures/

protocols

Decision aids

Task design

Communication

factors: Verbal

Written

Non-verbal

Management

Team factors: Role congruence

Leadership

Support + cultural factors

Education + Training

Factors: Competence

Supervision

Availability / Accessibility

Appropriateness

Equipment +

resources: Displays

Integrity

Positioning

Usability

Working condition factors: Administrative

Design of physical environment

Environment

Staffing

Workload and hours

Time

Organisational +

strategic factors: Organisational structure

Priorities

Externally imported risks

Safety culture

Problem

or issue

(CDP/SDP)

Appendix 3

Page 18: Guidance on undertaking a Root Cause Analysis (RCA)

This procedure / guidance forms part of the Incident Management Policy P057

Procedure /Guidance Version No

Policy Expiry Date Page:

3.0 21 Oct 2016 18 of 22

Appendix 4: Root Cause Analysis Investigation tools

Contributory Factors Classification Framework

Patient Factors Components

Clinical condition Pre-existing co-morbidity Complexity of condition Seriousness of condition Limited options available to treat condition Disability

Physical Factors Poor general physical state Malnourished Dehydrated Age related issues Obese Poor sleep pattern

Social Factors Cultural / religious beliefs Language Lifestyle (smoking/ drinking/ drugs/diet) Sub-standard living accommodation (e.g. dilapidated) Life events Lack of support networks / (social protective factors -Mental Health Services) Engaging in high risk activity

Mental/ Psychological Factors

Motivation issue Stress / Trauma Existing mental health disorder Lack of intent (Mental Health Services) Lack of mental capacity Learning Disability

Interpersonal relationships

Staff to patient and patient to staff Patient engagement with services Staff to family and family to staff Patient to patient Family to patient or patient to family Family to family (Siblings, parents, children)

Staff Factors Components

Physical issues Poor general health (e.g. nutrition, hydration, diet, exercise, fitness) Disability (e.g. eyesight problems, dyslexia) Fatigue Infected Healthcare worker

Psychological Issues

Stress (e.g. distraction / preoccupation) Specific mental illness (e.g. depression) Mental impairment (e.g. illness, drugs, alcohol, pain) Lack of motivation (e.g. boredom, complacency, low job satisfaction)

Social Domestic Domestic problems (e.g. family related issues) Lifestyle problems (e.g. financial/housing issues) Cultural beliefs Language

Personality Issues

Low self confidence / over confidence (e.g. Gregarious, reclusive, interactive) Risk averse / risk taker Bogus Healthcare worker

Cognitive factors Preoccupation / narrowed focus (Situational awareness problems) Perception/viewpoint affected by info. or mindset (Expectation/Confirmation bias) Inadequate decision/action caused by Group influence Distraction / Attention deficit Overload

Page 19: Guidance on undertaking a Root Cause Analysis (RCA)

This procedure / guidance forms part of the Incident Management Policy P057

Procedure /Guidance Version No

Policy Expiry Date Page:

3.0 21 Oct 2016 19 of 22

Boredom

Task Factors Components

Guidelines, Policies and Procedures

Not up-to-date Unavailable at appropriate location (e.g. Lost/missing/non-existent/not

accessible when needed) Unclear/not useable (Ambiguous; complex; irrelevant, incorrect) Not adhered to / not followed Not monitored / reviewed Inappropriately targeted/focused (i.e. not aimed at right audience) Inadequate task disaster plans and drills

Decision making aids

Aids not available (e.g. CTG machine; checklist; risk assessment tool; fax machine to enable remote assessment of results)

Aids not working (e.g. CTG machine, risk assessment tool, fax machine) Difficulties in accessing senior / specialist advice Lack of easy access to technical information, flow charts and diagrams Lack of prioritisation of guidelines Incomplete information (test results, patient history)

Procedural or Task Design

Poorly designed (i.e. Too complex; too much info.; difficult to conceive or remember)

Guidelines do not enable one to carry out the task in a timely manner Too many tasks to perform at the same time Contradicting tasks Staff do not agree with the ‘task/procedure design’ Stages of the task not designed so that each step can realistically be carried out Lack of direct or understandable feedback from the task Misrepresentation of information Inappropriate transfer of processes from other situations Inadequate Audit, Quality control, Quality Assurance built into the task design Insufficient opportunity to influence task/outcome where necessary Appropriate automation not available

Communication Components

Verbal communication

Inappropriate tone of voice and style of delivery for situation Ambiguous verbal commands / directions Incorrect use of language Made to inappropriate person(s) Incorrect communication channels used

Written communication

Inadequate patient identification Records difficult to read All relevant records not stored together and accessible when required Records incomplete or not contemporaneous (e.g. unavailability of patient

management plans, patient risk assessments, etc) Written information not circulated to all team members Communication not received Communications directed to the wrong people Lack of information to patients Lack of effective communication to staff of risks (Alerts systems etc)

Non verbal communication

Body Language issues (closed, open, body movement, gestures, facial expression)

Communication Management

Communication strategy and policy not defined / documented Ineffective involvement of patient/carer in treatment and decisions Lack of effective communication to patients/relatives/carers of risks Lack of effective communication to patients about incidents (being open) Information from patient/carer disregarded Ineffective communication flow to staff up, down and across Ineffective interface for communicating with other agencies (partnership working) Lack of measures for monitoring communication

Page 20: Guidance on undertaking a Root Cause Analysis (RCA)

This procedure / guidance forms part of the Incident Management Policy P057

Procedure /Guidance Version No

Policy Expiry Date Page:

3.0 21 Oct 2016 20 of 22

Work Environment

Components

Administrative factors

Unreliable or ineffective general administrative systems (Please specify e.g.: Bookings, Patient identification, ordering, requests, referrals, appointments)

Unreliable or ineffective admin infrastructure (e.g. Phones, bleep systems etc) Unreliable or ineffective administrative support

Design of physical environment

Poor or inappropriate office design (computer chairs, height of tables, anti-glare

screens, security screens, panic buttons, placing of filing cabinets, storage facilities, etc.) Poor or inappropriate area design (length, shape, visibility, provision of space) Inadequate security provision Lack of secure outside space Inadequate lines of sight Inadequate/inappropriate use of colour contrast/patterns (walls/doors/flooring etc)

Environment Facility not available (failure or lack of capacity) Fixture or fitting not available (failure or lack of capacity) Single sex accommodation limitation/breach Ligature/anchor points Housekeeping issues – lack of cleanliness Temperature too high/low Lighting too dim or bright, or lack of Noise levels too high or low Distractions

Staffing Inappropriate skill mix (e.g. Lack of senior staff; Trained staff; Approp. trained staff)

Low staff to patient ratio No / inaccurate workload / dependency assessment Use of temporary staff High staff turnover

Work load and hours of work

Shift related fatigue Excessive working hours Lack of breaks during work hours Excessive of extraneous tasks Lack of social relaxation, rest and recuperation

Time Delays caused by system failure or design Time pressure

Equipment Components

Displays Incorrect information / feedback available Inconsistent or unclear information Illegible information Interference/unclear equipment display

Integrity Poor working order Inappropriate size Unreliable Ineffective safety features / not designed to fail safe Poor maintenance programme Failure of general services (power supply, water, piped gases etc)

Positioning Correct equipment not available Insufficient equipment / emergency backup equipment Incorrectly placed for use Incorrectly stored

Usability Unclear controls Not intuitive in design Confusing use of colour or symbols Lack of or poor quality user manual Not designed to make detection of problems obvious Use of items which have similar names or packaging Problems of compatibility

Page 21: Guidance on undertaking a Root Cause Analysis (RCA)

This procedure / guidance forms part of the Incident Management Policy P057

Procedure /Guidance Version No

Policy Expiry Date Page:

3.0 21 Oct 2016 21 of 22

Organisational Components

Organisational structure

Hierarchical structure/Governance structure not conducive to discussion, problem sharing, etc.

Tight boundaries for accountability and responsibility Professional isolation Clinical versus the managerial model Inadequate maintenance Lack of robust Service level agreements/contractual arrangements Inadequate safety terms and conditions of contracts

Priorities Not safety driven External assessment driven e.g. Annual Health checks Financial balance focused

Externally imported risks

Unexpected adverse impact of national policy/guidance (from Department of Health / Health authorities /Professional colleges) Locum / Agency policy and usage Contractors related problem Equipment loan related problem Lack of service provision Bed Occupancy levels (Unplanned bed opening/closures) PFI related problems (Private Finance Initiative)

Safety culture Inappropriate safety / efficiency balance Poor rule compliance Lack of risk management plans Inadequate leadership example (e.g. visible evidence of commitment to safety) Inadequately open culture to allow appropriate communication Inadequate learning from past incidents Incentives for 'at risk'/'risk taking' behaviors Acceptance/toleration of inadequate adherence to current practice Ignorance/poor awareness of inadequate adherence to current practice Disempowerment of staff to escalate issues or take action

Education and Training

Components

Competence Lack of knowledge Lack of skills Inexperience Inappropriate experience or lack of quality experience Unfamiliar task Lack of testing and assessment

Supervision Inadequate supervision Lack of / inadequate mentorship Training results not monitored/acted upon

Availability / accessibility

Training needs analysis not conducted/acted upon On the job training unavailable or inaccessible Emergency Training unavailable or inaccessible Team training unavailable or inaccessible Core skills training unavailable or inaccessible Refresher courses unavailable or inaccessible

Appropriateness Inappropriate content Inappropriate target audience Inappropriate style of delivery Time of day provided inappropriate

Page 22: Guidance on undertaking a Root Cause Analysis (RCA)

This procedure / guidance forms part of the Incident Management Policy P057

Procedure /Guidance Version No

Policy Expiry Date Page:

3.0 21 Oct 2016 22 of 22

Team Factors Components

Role Congruence

Lack of shared understanding Role + responsibility definitions misunderstood/not clearly defined

Leadership Ineffective leadership – clinically Ineffective leadership – managerially Lack of decision making Inappropriate decision making Untimely decision making (delayed) Leader poorly respected

Support and cultural factors

Lack of support networks for staff Inappropriate level of assertiveness Negative team reaction(s) to adverse events Negative team reaction to conflict Negative team reaction to newcomers Routine violation of rules/regulations Lack of team openness/communication with colleagues Inadequate inter-professional challenge Failure to seek support Failure to address/manage issues of competence (whistle blowing)