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Policy for the Investigation of Incidents, Complaints and Claims, including Analysis and Improvement

DOCUMENT CONTROL Version: 3 Ratified by: Risk Management Sub Group Date Ratified: 15 January 2013 Name of Originator / Author: Head of Patient Safety & Experience Name of Responsible Committee/Individual: Risk Management Sub Group Date Issued: 18 January 2013 Review Date: January 2016 Target Audience All staff

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CONTENTS SECTION PAGE

1. INTRODUCTION 4

1.1 Rationale 4

1.2 Incident investigation 4

1.3 Definitions 5

2. PURPOSE 5

3. SCOPE 6

4. RESPONSIBILITIES, ACCOUNTABILITIES AND DUTIES 6

4.1 Board of Directors 6

4.2 Chief Executive 6

4.3 Executive Director Business Assurance

7

4.4 Directors 7

4.5 Deputy Chief Executive/Director of Nursing and Partnerships 7

4.6 Chief Operating Officer 7

4.7 Assistant Directors 7

4.8 Head of Patient Safety & Experience 7

4.9 Head of Learning and Development 8

4.10 Risk Management Sub Group 8

4.11 Organisational Learning Forum 8

4.12 Clinical Governance Group 8

4.13 Health, Safety and Security Forum 9

4.14 Human Resources and Organisational Development Group

9

4.15 Managers 9

4.16 Investigators 10

4.17 Trust Lead Specialists/Other Specialists 11

4.18 All staff 12

5. PROCEDURE / IMPLEMENTATION 13 5.1 Investigation 13

5.2 Analysis 20

5.3 Improvement 20

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6. TRAINING IMPLICATIONS 21

7. MONITORING ARRANGEMENTS 22

8. EQUALITY IMPACT ASSESSMENT 23

8.1 Privacy, Dignity and Respect 23

8.2 Mental Capacity Act 23

9. LINKS TO ANY ASSOCIATED DOCUMENTS 23

10. REFERENCES 24

11. APPENDICES

Appendix 1 – NPSA Risk Matrix 25 Appendix 2 - Terms of Reference Organisational Learning Forum (OLF)

28

Appendix 3 – NPSA Root Cause Analysis Investigation Tools - three levels of Root Cause Analysis Investigation Guidance

31

Appendix 4 - NPSA Contributory factor classification framework 34 Appendix 5 – Level 1 Concise Investigation Report Template 38 Appendix 6 - Level 2 Comprehensive Investigation Report Template 41 Appendix 7 - Investigation checklist and helpful investigation planning

templates

50

Appendix 8 - Guidance on Witness Statements 53

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1. INTRODUCTION

1.1 Rationale Assuring the safety of patients, staff and visitors should be a key priority within any

healthcare organisation. This requires a collaborative approach to the analysis of incidents, complaints and claims and ensuring that lessons learned from this analysis are shared across the organisation as well as across the local health community. The analysis can provide an opportunity for proactive risk management, learning from what has happened and implementing controls to prevent recurrence. Many serious events have occurred because organisations have ignored the warning signs of incidents, complaints or claims and failed to learn from the lessons of the past. Systematic processes are required that clearly determine when, how and by whom learning should be cascaded and acted upon and that plans for improvement are formulated, acted on and followed up. Organisations should make use of root cause analysis techniques to ensure there is a systematic investigation process that looks beyond the individuals concerned to discover underlying causes. Organisations should value the importance of identifying and learning from the causes of incidents, complaints and claims and implementation of solutions to prevent recurrence (NHSLA, 2012).

The process for learning will take place in line with Trust Business Division/Directorate and corporate risk registers using the risk grading matrix (see Appendix 1) and managers’ authority to treat risk. The Trust has developed ways of determining what the learning points are and how they will be shared internally across the Trust and externally, as set out later in this policy.

The sharing of lessons learnt from one service to other areas of the Trust will help ensure that similar incidents do not repeat across Business Divisions/services and that any system failures discovered during investigations are adopted by the Trust as a whole and pockets of good practice are not isolated.

1.2 Incident investigation Incident investigation is an essential element of the Trust’s approach to

investigating, analysing and learning from experience, in order to improve the safety and quality of services.

In most cases an incident does not result from a single event, but it is more likely to have involved cumulative triggers and effects which in isolation may have no noticeable impact, but when they occur in an event chain, the result can be serious or even catastrophic. It is essential when investigating an incident that blame, early judgments and assumptions are avoided.

To this end, the Trust is committed to the use of Root Cause Analysis (RCA) as the basis for a chronological, objective and systematic investigation. The use of RCA

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will lead to the identification of preventative measures to address underlying causes, in order to prevent incidents happening again and to remove or reduce the risk.

1.3 Definitions 1.3.1 Incident For the purposes of this policy the term ‘incident’ is used to cover incidents,

complaints and claims, and is defined as any reportable event which could have or did lead to unintended or unexpected harm, loss or damage (including reputation).

1.3.2 Root Cause Analysis (RCA) A way of conducting an investigation into an identified problem that allows the

investigator(s), and other involved parties, to understand better the root, or fundamental, cause of the problem so that it can be put right.

1.3.3 Investigation The work of inquiring into something thoroughly and systematically.

1.3.4 Root Cause Defined as the underlying cause to which the incident can be ultimately attributed

and which if corrected, will prevent a recurrence.

1.3.5 Contributory Cause Defined as a cause which contributes to the incident but which by itself, would not

cause the incident.

1.3.6 External Agency A body that is recognised as having an interest in the investigation, such as

Commissioners, the Coroner, Health and Safety Executive (HSE), National Patient Safety Agency (NPSA), Care Quality Commission (CQC) etc.

A comprehensive list of external agencies to which various types of incidents are required to be reported is provided in the Incident Reporting Policy.

1.3.7 Aggregated data Data from incidents, complaints and claims which have been analysed both

separately and all together, and in a number of different ways e.g. by service type, location, cause, etc. to determine a comprehensive risk profile of the organisation.

2. PURPOSE

The purpose of this policy is to set out the Trust’s arrangements for investigation, analysis and learning and improvement from incidents, complaints and claims. Specifically:

• The investigation of incidents, complaints and claims • The aggregation and analysis of incidents, complaints and claims • Learning and improvement in practice

The Trust aims to achieve this within a progressive, honest and open environment, where risks and incidents are identified quickly and acted upon in a positive and constructive way, and where an ethos of learning and improvement is fostered.

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3. SCOPE

This policy applies to all staff that are required to report incidents and to contribute to investigation, analysis and learning and improvement activities, from a basic to a complex level, depending on their role.

The policy provides guidance on investigation, as shown in Appendix 3 - NPSA Root Cause Analysis Investigation Tools - Three Levels of Root Cause Analysis Investigation.

The policy supports the arrangements set out in the following Trust procedural documents, which should be referred to in relation to the specific arrangements for each subject:

• Policy and Procedure Relating to the Handling of Formal Complaints

• Claims Handling Policy for the Management of Clinical Negligence Claims, Employer Liability Claims and Property Expense Claims

• Policy for the Management of Serious Incidents (SIs)

• Incident Reporting Policy

4. RESPONSIBILITIES, ACCOUNTABILITIES AND DUTIES

All members of staff have an individual responsibility for the identification of risk and

all levels of management must understand and implement the Trust’s Risk Management Strategy and supporting policies and procedures.

4.1 Board of Directors The Board of Directors is responsible for ensuring that the Trust consistently follows

the principles of good governance applicable to NHS organisations. This includes the development of systems and processes for investigation, analysis, learning and improvement.

The Board of Directors is responsibility for ensuring that it receives assurance that this policy is being implemented, that lessons are being learnt and improvements made, and areas of vulnerability are improving.

This will be achieved through the arrangements set out in this policy. Where concerns are identified relating to the robustness of learning and improvement or actions planned, the Board will seek assurances that these concerns are being acted upon.

4.2 Chief Executive The Board of Directors delegates to the Chief Executive the overall responsibility for

effective risk management in the Trust, meeting all statutory requirements and adhering to guidance issued.

The Chief Executive is ultimately accountable for the implementation of this policy.

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A number of Directors have responsibilities in relation to this policy as detailed below. They are

responsible for cooperating with each other to ensure that assurance is gained that this policy is

being effectively implemented within the organisation.

4.3 Executive Director Business Assurance The Executive Director Business Assurance is the Director designated with lead responsibility for risk management.

4.4 Directors Directors (both Executive and other Directors) have the delegated authority for

ensuring that risk is managed appropriately in their area of responsibility and are responsible for the effective implementation and monitoring of this policy.

The Risk Management Strategy identifies Directors with responsibility for specific aspects of risk which may require investigations.

All Directors are responsible for providing leadership for the development of a learning organisation that recognises that improvement occurs through people who need support to enable them to improve on the work they do today.

For the most serious incidents, Directors will be responsible for the direct appointment of an Investigator, but in most other cases this will be delegated to a next in line Manager.

4.5 Deputy Chief Executive/Director of Nursing and Partnerships The Deputy Chief Executive/Director of Nursing and Partnerships is responsible for

the effective management of clinical risk, liaising with the Chief Operating Officer.

4.6 Chief Operating Officer The Chief Operating Officer (COO) is responsible for the effective management of

clinical risk within the Trust’s Business Divisions.

4.7 Assistant Directors Assistant Directors will be responsible for overseeing the processes in this policy in

their Business Division including: • appointing an Investigator

• approving reports/letters

• acting as the lead for action plans

They are responsible for making sure that learning is cascaded and acted upon

within theire services and that plans for improvement are formulated, acted on and followed up.

4.8 Head of Patient Safety & Experience • The Head of Patient Safety & Experience is responsible for providing support

to Directors, Assistant Directors, Managers, Lead Specialists and staff to

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facilitate the effective implementation and monitoring of this policy. • They will:

• Oversee the production of the Triangulated Report

• Provide information in the Quality Account and Trust Annual Report

• Chair the Organisational Learning Forum to ensure that learning is shared

via this forum across complaints, claims, incidents and safety, and that appropriate action is reported via the forum

• Complete an aggregated analysis of incidents (Triangulated Report) on a

quarterly basis

4.9 Head of Learning and Development

Investigation training is mandatory. The Head of Learning and Development is responsible for the implementation of the Mandatory Risk Management Training Policy and associated Training Needs Analysis, providing reports on compliance to the Human Resources and Organisational Development Group See Mandatory Risk Management Training Policy and Mandatory Risk Management Training Needs Analysis

4.10 Risk Management Sub Group The Risk Management Sub Group is responsible for approving certain policies and for providing assurance to Policy and Planning Group level around its key responsibilities. It gives delegated responsibility to the Organisational Learning Forum (OLF) for the implementation of its work streams and action plans.

4.11 Organisational Learning Forum (OLF)

The Organisational Learning Forum is responsible for developing and managing a structured approach to active organisational learning, where lessons learned are embedded in the Trust’s culture and practice. The group will help to facilitate a fair blame (no blame) culture. This will include: the sharing of lessons learnt from incidents, complaints and claims from one service to other areas of the Trust in order that any system failures discovered during investigations are adopted by the Trust as a whole and pockets of good practice are not isolated. The fostering of a learning and improvement culture, where all staff understand the value and benefits of learning from error and feel confident to report incidents.

4.12 Clinical Governance Group

The purpose of the Clinical Governance Group is to enable the Board of Directors to obtain assurance that high standards of care are provided by the Trust and, in particular, that adequate and appropriate governance structures, processes and

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controls are in place throughout the Trust This will include:

- monitoring trends in incidents, complaints and claims received by the Trust and commissioning actions in response to adverse trends where appropriate

- identifying areas for improvement in respect of incidents, complaint and claim

trends and ensuring appropriate action is taken.

4.13 Health, Safety and Security Forum One of the key responsibilities of the Health and Safety Forum is to actively champion health, safety and security, promoting incident reporting, learning from experience and best practice. The Health and Safety Forum monitors incident reporting through the quarterly report produced by the Health and Safety Lead, including any associated learning and improvements fed through by Managers for inclusion in the report. The Health and Safety Forum reports to the Risk Management Sub Group through the monthly standing agenda item.

4.14 Human Resources and Organisational Development (HR&OD)Group The HR&OD Group is responsible for receiving though the Head of Learning and Development reports on Mandatory Risk Management Training compliance and for taking appropriate action as required.

4.15 Managers All levels of management must understand and implement the Trust’s Risk

Management Strategy and supporting processes.

Managers are responsible for:

• Disseminating, implementing and monitoring this policy within their services. • Building a learning and improvement culture within their services where staff

understand the value and benefits of learning from error, feel confident to report incidents and know that timely feedback will be provided to them. This will require close working with the Lead Specialists

• Providing local induction on this and related policies for all new starters appropriate to need.

• Planning for and monitoring the training of their staff in relation to this policy - see Mandatory Risk Management Training Policy and Training Needs Analysis.

• All incidents being reported on Safeguard in line with the requirements of the Incident Reporting Policy.

• The risk grading of incidents using the NPSA Risk Matrix (see Appendix 1) and their recording and monitoring via the Risk Register process as appropriate.

• Discussing incidents graded as ‘High’ or ‘Extreme’ with the relevant Director/Assistant Director.

• Notifying the Chief Operating Officer if an incident is believed to fall within the definition of a Serious Incident, where the arrangements set out within the Policy for the Management of Serious Incidents will apply.

• Initiating investigations at an appropriate level in line with this policy and the

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Policy for the Management of Serious Incidents. • Seeking advice on levels of investigation from Directors/Assistant

Directors/Lead Specialists as required. • Identifying relevant staff to undertake investigations, which may include cross-

Business Division/Directorate investigations. • Agreeing terms of reference for investigations, which describe the plan and

latitude allowed to those conducting the investigation. • Applying Being Open principles as set out in Being Open - Communicating

Openly and Honestly with Service Users following a Patient Safety Incident or Related Complaint or Claim.

• Providing advice and support to staff as set out in Supporting Staff involved in an Incident, Complaint or Claim Policy.

• The completion of investigations within any identified timescales, as set out in the individual policies shown in Section 9.

• Receiving and acting on requests to investigate incidents, Serious Incidents, complaints and claims as per this policy and the Policy for the Management of Serious Incidents.

• Monitoring trends and themes identified by incident investigation and analysis, and commissioning investigations where concerns are raised about a specific issue, trend or theme or where concerns are raised about the safety of systems/processes.

• Investigating and taking action when requested on events referred to the Business Division/Directorate, and feeding back to the relevant Director, Assistant Director and/or Lead Specialist.

• Monitoring the quality of investigations by commenting on investigation reports. • Devising and monitoring action plans and risk reduction measures to reduce

the likelihood of repeat incidents, taking steps to address any delays in implementation.

• Updating action plans on Safeguard and Risk Registers and informing, as appropriate, the relevant Director, Assistant Director and/or Lead Specialist if there are any changes to action plans timescales or actions which cannot be met.

• Recording any residual risks on the relevant Risk Register. • Facilitating full co-operation with investigations undertaken by external

stakeholders. • Having clear processes in place locally for timely feedback to staff on the

results of investigations, lessons learned and areas for improvement. • Communicating learning and improvement through the Organisational Learning

Forum (OLF) (see Appendix 2) and the learning and improvement sections of relevant reports.

4.16 Investigators Investigators are responsible for:

• Conducting Level One Concise Investigations and Level Two Comprehensive

Investigations based on the risk grading of incidents, using the guidance provided in Appendices 3 - 8 of this policy, and the Policy for the Management of Serious Incidents as appropriate.

• Seeking specialist advice, support or assistance where identified as being required.

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N.B. Level Three Independent Investigations are conducted by those independent to the Trust.

Level Two Comprehensive Investigations require investigators to:

• Conduct to a high level of detail, a thorough investigation. • Bring together an investigation team (as and when required) comprising

multi-disciplinary staff. • Agree timescales for feedback to interested parties. • Involve patients and carers as appropriate (see Being Open Policy). • Develop an action plan to address the recommendations from the

investigation. • Develop robust recommendations for shared learning both internally to the

Trust and externally as appropriate.

Investigators are responsible for, and have authority to:

• Collect evidence by direct observation, documentation reviews and interviews.

• Assemble and consider evidence to determine causation. • Compare findings with relevant standards. • Draw up action plans, including timescales. • Debrief staff. • Assist in the implementation of the improvement strategy and help track

progress. • Provide reports to Directors/Managers/Lead Specialists and others as and

when required.

Where a particular need is identified to access Specialist advice (see Section 4.17) internal to the Trust, prior approval is required from the relevant Manager who the Investigator is reporting to for the investigation.

Where a need is identified to access Specialist advice external to the Trust, prior approval is required from the relevant Director.

4.17 Trust Lead Specialists/Other Specialists 4.17.1 Trust Lead Specialists Investigators may need to involve Trust Lead Specialists to advise, support and/or

assist in the investigation.

Investigators are responsible for determining when specialist advice is required and Lead Specialists have a duty to provide support and advice as and when required.

This may be in the form of: reviewing investigation findings to date; attendance at multi-disciplinary investigation meetings; provision of a written report/opinion or review of recommendations; or, acting as a facilitator so that all those involved can make a full and honest contribution in a non-threatening environment.

4.17.2 Health and Safety Lead, Patient Safety Lead, Complaints Manager, Claims Manager, Local Security Management Specialist

The above officers are responsible for:

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• Providing advice, support and assistance in relation to the implementation of this policy and with the requirements of the subject specific policies set out in Section 9.

• Providing advice on the appropriate risk grading and required level of investigation of incidents.

• Contacting the relevant Business Division/Directorate to request that an investigation is commissioned where an incident report is received with an incorrect risk grading, or where an investigation has not been commissioned but should have been.

• Monitoring the timeliness, quantity, quality and effectiveness of investigations, as well as learning and improvement and the embedding of actions within the Trust. This will be achieved through the normal course of their day to day work - with the facility for any concerns to be escalated to the Executive Director Business Assurance - and through the relevant groups identified in Section 4..

• Following up and monitoring action plans through to completion via the Safeguard system and/or via other systems specific to the incident subject i.e. Incident, Serious Incident, Complaint or Claim.

• The production of a quarterly Incident Report for the Health and Safety Forum by the Health and Safety Lead.

4.17.3 Other Specialists It may be necessary at times to seek advice and/or involvement of other Specialists

with particular expertise which will be helpful to the investigation. These individuals may be internal or external to the Trust. Reasons for doing this might include insufficient expertise within the Trust, or the need to eliminate bias etc.

A clear rationale and parameters for advice and/or involvement should be agreed by the Investigator prior to seeking involvement.

Where a particular need is identified to access Specialist advice internal to the Trust, prior approval is required from the relevant Manager who appointed the Investigator.

Where a need is identified to access Specialist Advice external to the Trust, prior approval is required from the relevant Director.

4.18 All Staff All members of staff have an individual responsibility for the identification of risk and

all levels of management must understand and implement the Trust’s Risk Management Strategy and supporting processes.

All staff are required to be aware of and comply with this policy, and are responsible for:

• Highlighting any risk issues which would warrant further investigation. • Being open and co-operative with any investigation process.

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• Contributing to learning and improvement activity

5. PROCEDURE / IMPLEMENTATION Some of the procedures which support implementation of this policy are set out

in Section 4, and will therefore not be duplicated in this section.

5.1 Investigation The specific techniques and tools of Root Cause Analysis (RCA) are not described

in detail in this policy. Guidance is provided in Appendices 3-8.

The use of RCA provides analysis through systematic investigation techniques that look past the immediate causes or active failures and seek to understand the underlying or latent failures to clearly identify causal factors and remedial actions.

5.1.1 Different levels of investigation appropriate to the severity of the event(s)-concise, comprehensive, independent

The level of investigation undertaken will dictate the degree of leadership, overview and strategic review required.

Not all incidents need to be investigated to the same extent or depth. The risk matrix shown in Appendix 1 will be used by Managers to assess the impact of an incident, which provides a grading on the consequence and likelihood of recurrence.

The level of investigation to be undertaken will be determined by the risk grading of the incident, and will be conducted at a level appropriate and proportionate to the incident under review. Appendix 4 provides guidance on what might be considered appropriate and proportionate.

There are three main considerations when making this decision:

• The level of severity of harm. • The likelihood of the event recurring. • The potential for learning (which can result in the investigation of those

incidents which are high in frequency but of low severity).

Where an incident is believed to fall within the definition of a Serious Incident, Managers will notify the Chief Operating Officer immediately in line with the requirements of the Policy for the Management of Serious Incidents.

All incidents require some level of local review and it is a requirement for Managers to document this on the IR1 incident report form on Safeguard as per the requirements of the Incident Reporting Policy.

The time spent on investigation will normally, but not exclusively, be in direct relation to the risk grading of the incident.

5.1.2 Low Risk Incidents Although these incidents represent relatively low risk, this does not mean they can

be ignored. They represent small failures and vulnerabilities that may signal action to avoid escalation of a situation.

Where it is determined that further local investigation is required, this will be initiated

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by the Manager responsible for signing off the IR1 form. Appendix 4 provides guidance for Level One Concise Investigations which can be used as required as a prompt. However, it is accepted that many local incidents will not require a formal investigation report.

The process may involve for example, the multi-disciplinary team exploring ways to minimise a recurrence, or a review of a care plan. The Contributory Factor Classification Framework shown in Appendix 5 also provides a useful prompt. The outcome will be clearly documented on the IR1 in the Management Action section along with details of any further action planned.

The Manager will identify improvement measures which are within their control, and they will notify any that are not within their control to the relevant Director/ Manager for consideration/action.

Lessons learned will be documented on the IR1. The Manager will sign off the IR1 and record the final risk grading.

The Manager and their team will monitor trends/themes associated with this grade of incident, and identify where the underlying causes are common to the service area, taking appropriate action to address any local system weaknesses identified.

Where incidents appear to be occurring with increasing frequency and a trend/theme is identified, Businesses Divisions/Directorates or Lead Specialists may request a root cause analysis exercise to be undertaken in line with a Level One Concise Investigation to provide further causal analysis and actions to prevent the frequency of recurrence.

5.1.3 Moderate Risk Incidents As a guide, the Manager will take immediate action to try to reduce the risk of a

recurrence, record this on the IR1 and sign off the IR1 with the risk grading, indicating that a Level One Concise Investigation is to be undertaken –see Appendix 4.

Local investigation will normally be carried out by one or two key staff only e.g. local manager with assistance from another member of staff, but should be led by a person who has undertaken RCA training. An attempt should be made to establish root cause(s), but this will be a smaller scale investigation than for higher risk incidents.

Lead Specialists may be requested to support these investigations as required. A Level One Concise Investigation report template is provided in Appendix 6.

5.1.4 High Risk Incidents These incidents may or may not fall within the scope of the Policy for the

Management of Serious Incidents, and Managers will seek advice from the relevant Director/Lead Specialist based on their initial risk grading of the incident.

Based on the outcome of the above, a Level I Concise Investigation may be adequate for some High Risk Incidents and others will require a Level 2 Comprehensive Investigation.

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High risk incidents require an investigation employing RCA techniques and the investigation will be led by a person who has undertaken RCA training.

These investigations will normally be led by a person from the Business Division/Directorate where the incident occurred. On occasions they may be led by an investigator outside of the Business Division/Directorate, as agreed between relevant Managers/Directors as appropriate.

When an incident is declared not to fall within the scope of the Policy for the Management of Serious Incidents, the Manager will sign off the IR1 detailing the completion of the immediate actions taken to try and reduce the risk of recurrence, indicating what level of investigation is to be undertaken and will record the risk grading allocated to the incident.

Where a Level 2 Comprehensive Investigation is required, it will require the full co-operation of the teams/departments involved. A report template for a Level 2 Comprehensive Investigation is provided in Appendix 7.

5.1.5 Extreme Risk Incidents These incidents will fall within the scope of the Policy for the Management of

Serious Incidents, and should be notified immediately to the Chief Operating Officer.

Depending on the nature of the incident, it may be investigated internally though a Level 2 Comprehensive Investigation or it may be required to be investigated externally as a Level 3 Independent Investigation. Further guidance is provided in the Policy for the Management of Serious Incidents.

5.1.6 Terms of Reference Managers will agree terms of reference for investigations which describe the plan

and latitude allowed to those conducting the investigation. These will have regard for previous investigation findings and identify:

• Specific problems or issues to be addressed.

• Who commissioned the investigation (and at which level in the Trust).

• Investigation lead (and team where relevant).

• Aims and objectives of the investigation and desired outputs.

• Scope and boundaries beyond which the investigation should not go e.g. disciplinary process.

• Timescales for the report and for reviewing progress on the action plan.

• Administration arrangements (including accountability, meetings, resources, reporting and monitoring arrangements).

• Actual or potential for involvement of the police, Health and Safety Executive

etc and plans for this to be addressed and managed effectively at the earliest point.

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• Who the audience is for the final report (distribution list).

5.1.7 Key Components of the Investigation Process Preservation of an incident scene should occur where relevant and practical.

A number of tools have been provided in this policy to support the investigation

process:

• Appendix 4 - NPSA Contributory Factor Classification Framework

• Appendix 5 and 6 - Report templates

• Appendix 7 - Investigation Checklist and useful investigation planning templates

• Appendix 8 - Guidance on Witness Statements.

All investigations have four key components:

a) What happened? Establish the chronology of events and state the immediate action taken.

Identify who was involved in the event, when the event took place and where

the event occurred.

Identify people to be interviewed - those directly involved or who have an expert knowledge.

Obtain written statements from those involved and obtain, preserve and

examine any evidence (e.g. equipment).

Conduct interviews in private with staff representation as appropriate ensuring adequate staff support.

b) How did it happen?

• Identify the problems or events that led to the occurrence.

• Identify good practice.

• Establish a chronology or sequence of events for these details and facts.

c) Why did it happen? • Compare the evidence with relevant standards, policies, protocols, guidelines

or professional practice (local or national) to identify care management problems or system weaknesses.

• Consider possible and known causal and risk factors.

• Identify the contributing factors and root cause(s) that led to the incident occurring.

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• Remember it is unusual for an incident to occur as a direct result of any one

factor but more usually due to a combination of several factors.

d) What does all this tell us and what next? • Review all the information gathered and draw conclusions.

• From the results of the root cause analysis it should be clear where the

problems lie.

• Develop recommendations to address the root causes.

• Agree timescale for feedback of findings and draft recommendations to stakeholders.

• RCA concludes with an investigation report (see report templates at Appendices 8 and 9) dealing with all aspects of the investigation, the recommendations made as a result of the investigation, lessons learnt and actions required to reduce any highlighted risks(s) and to avoid recurrence.

• Any changes recommended need to be incorporated into the way staff work at all levels of the Trust. Investigations leads will propose risk reduction measures which are:

- realistic - sustainable

- cost effective

• These measures should be reviewed by staff and where possible and relevant by service users and carers to make sure that they will be achievable in practice, before implementation.

• Any risks which cannot be immediately rectified resulting from an incident

investigation will be risk assessed and recorded on the relevant Risk Register.

• Debrief staff ensuring that lessons are learnt and shared.

N.B. It is important that lessons learned should be identified, numbered and addressed by the recommendations, including any root causes.

5.1.8 Involvement and support for service users, carers and staff Being involved in an incident which is under investigation can be an incredibly

stressful experience. The Trust will endeavour to support service users, carers and staff during this difficult time.

The arrangements for supporting and involving service users, carers and staff are set out fully in: Being Open and Communicating Openly and Honestly with Service Users following a Patient Safety Incident or Related Complaint or Claim; and, in the Policy on Supporting Staff involved in an Incident, Complaint or Claim.

5.1.8.1 Service users and carers

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In line with Being Open, the investigation report should demonstrate the extent to which those affected have:

• Been given an accurate, open, timely and clear explanation of what has happened, regardless of, but with sensitivity to, the distressing nature of the event.

• Received an apology in the form of a sincere expression of sorrow or regret for the harm that has resulted from the incident.

• Been informed of what can be done in terms of care and treatment to repair or redress the harm done.

• Been given a clear statement of what is going to happen regarding any investigation.

The report should also explain to what extent the service user and/or carers were involved in the investigation. This might include detail on whether they were:

• Asked how much involvement they want.

• Interviewed to establish the questions they hope the investigation will address and to hear their recollection of events.

• Asked how they would like their involvement and/or their names referred to in the report.

• Offered a point of contact (Family liaison person) with regard to the investigation.

• Given information on sources of independent support/advocacy.

• Informed and kept up to date with the investigation process, including agreeing the frequency with which they wanted to be updated.

• Advised that the report and/or findings will be shared with them as they wish, and that it will be written in plain English.

• Advised of whom they can contact in the future (job title), should they want information on implementation of recommendations.

5.1.8.2 Staff It is important to keep staff informed at all times, and to provide advice, support and

opportunities for involvement in the process.

In the investigation report, the help received from staff should be acknowledged. Names of staff should not feature in the RCA investigation other than in the archived master, and staff should be advised that the report will be made anonymous before any circulation or publication.

The report should outline any support given or offered to staff after the incident and during the investigation, such as counselling, support during interviews or debriefing. Refer to local support from colleagues, as well as formal support, written materials

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or access to support networks. Good practice in this regard will include debriefing sessions.

Support should be considered for all involved in the process, including for example, students, contractors and investigators.

5.1.9 Process for involving and communicating with internal and external stakeholders to share lessons learned

The process for involving and communicating with internal stakeholders to share lessons is through:

• The use of the aggregated analysis within the Triangulated Report and the themes and trends which are identified from this for inclusion in the Quality Improvement Report.

• The information is discussed and disseminated at the relevant Trust

Committees and Group identified at the next available meeting after the report is produced.

• The Trust Committees/Groups with responsibilities in relation to this policy,

who are expected to disseminate key information through their membership.

• Established Business Division/Directorate management arrangements, where Managers have a defined responsibility to involve and feedback to relevant staff in a timely and appropriate way. The report is shared at the next round of Divisional meetings following its production by the Assistant Directors.

• Practice Development Bulletins.

• The Mandatory Risk Management Training Programme whose content is

updated to reflect the outcomes of investigations and lessons learned.

The process for involving and communicating with external stakeholders to share lessons is through:

• Reports provided to Commissioners.

• Joint investigations e.g. Complaints, where there is an opportunity to share lessons across the whole care pathway.

• Reports to the National Reporting and Learning Service (NRLS) at the NPSA.

• As requested by an external agency e.g. Coroner, Heath and Safety

Executive etc

• The inclusion of an annual trend and theme update through the Trust Annual Report and Quality Account - which is published on the trust website and is presented to external stakeholders and widely disseminated - will facilitate the sharing of learning actions with the wider public.

5.1.10 Process for following up relevant action plans Managers, in conjunction with the Lead Specialists will follow up and monitor action

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plans through to completion via the Safeguard system and/or via other systems specific to the incident subject and in accordance with individual policies e.g. Policy and Procedure Relating to the Handling of Formal Complaints.

The Organisational Learning Forum has responsibility for overseeing completion of action plans as part of the sharing of lessons learnt (see Appendix 2), monitoring this on a monthly basis.

5.2 Analysis 5.2.1 Coordinated approach to the aggregation of incidents, complaints and claims The purpose of a coordinated approach to the aggregation of incidents, complaints

and claims is to determine a comprehensive risk profile of the Trust.

A Triangulated Report is produced on a quarterly basis of incidents, complaints and claims or the Risk Management Sub Group and Commissioners.

5.2.2 Frequency with which an aggregated analysis of incidents is to be completed An aggregated analysis is completed on a quarterly basis.

5.2.3 Minimum content required within the analysis report, including qualitative and

quantitative analysis The analysis report will include as a minimum:

• Separate quantitative and qualitative analysis summaries of incidents,

complaints and claims. • Aggregated quantitative and qualitative analysis summaries of incidents,

complaints and claims. • Summary of trends, themes, causal factors and any subsequent changes in

practice. • Data will be analysed by service type, location, cause, etc. • Summary review of outcomes of investigations and performance against

action plans. • Summary of actions taken to disseminate lessons. • Summary of risk reduction measures implemented. • Summary of improvements made. • Areas identified for action with timescales - Actions will be identified to a

particular area where relevant in order to focus improvement and learning

5.2.4 Process for communicating this information to relevant individuals or groups The process for communicating this information to relevant individuals or groups is as set out in Section 5.1.9 above.

5.3 Improvement 5.3.1 Process by which the Trust ensures local and organisational learning from incidents

and that lessons learned from analysis result in a change in organisational culture and practice

To be an active learning organisation requires the Trust to embed lessons learned in its culture and practice, rather than identifying lessons but not putting them into practice.

This will require more than following up the implementation of action plans, but also the ongoing monitoring of trends, themes and causal factors and the use of methods

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such as clinical audit to check that improvements have been sustained over time.

There may be occasions when nothing could have prevented an incident and no root causes are identified. However, there are always lessons to learn and key safer practice issues may be identified which did not materially contribute to the incident.

Organisational learning will be monitored through the ongoing processes for the analysis of incidents and for following up relevant action plans.

The Trust Lead Specialists will monitor the timeliness, quantity, quality and effectiveness of investigations, as well as learning and improvement and the embedding of actions within the Trust.

This will be achieved through the normal course of their day to day work and through the Trust Committees/Groups with responsibilities in relation to this policy.

5.3.2 Opportunities for sharing lessons learnt from incidents across the local health community

Opportunities for sharing lessons learnt across the local health community will be afforded by:

• Discussions with, and reports provided for, Commissioners on a quarterly and annual basis

• Participation in multiagency investigations and reviews e.g. safeguarding.

• Participation in multiagency events with an emphasis on learning and improving.

• The Trust’s Annual Report/Quality Account

• Joint investigations which provide wider opportunities for sharing lessons across for example, a whole pathway of care.

5.3.3 Process for implementing risk reduction measures The use of RCA should result in preventative measures to ensure that similar

incidents do not happen again and that the risk is removed or reduced.

Risk reduction measures will be implemented in line with Trust Business Division/Directorate and corporate risk registers using the risk grading matrix (see Appendix 1) and managers’ authority to treat risk.

The sustainability of risk reduction measures will be measured over time as described above in order to illustrate that they have not led to the transfer of risk, or that they are becoming unsustainable.

6. TRAINING IMPLICATIONS

The Training Needs Analysis (TNA) for this policy can be found in the Training Needs Analysis document which is part of the Trust’s Mandatory Risk Management Training Policy located under policy section of the Trust website.

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7. MONITORING ARRANGEMENTS

Area for Monitoring How Who by Reported to Frequency

Investigations:

Duties Report Triangulated Report

Lead Specialists/ Head of Patient Safety and Experience

Organisational Learning Forum

Risk Management Sub Group

Commissioners

Monthly Quarterly

Different levels of investigation appropriate to the severity of the event How the trust shares safety lessons with internal and external stakeholders How action plans are followed up

How the Trust trains staff in line with the training needs analysis

Report Head of Learning and development

Human Resources and Organisational Development Group

Quarterly

Analysis and improvement:

a)Duties

Triangulated report Quality Improvement Report

Lead Specialists/ Head of Patient Safety and Experience

Organisational Learning Forum Risk Management Sub Group

Commissioners Clinical Governance Group

Quarterly

b) How incidents, complaints and claims are analysed c) How this information is combined to provide a risk profile for the Trust d) A report template which includes qualitative and quantitative analysis e) How this information will be shared with relevant individuals or groups

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f) How action plans are followed up

Report Lead Specialists/ Head of Patient Safety and Experience


Monthly

g) timescales for minimum requirements b) to f)

8. EQUALITY IMPACT ASSESSMENT SCREENING The completed Equality Impact Assessment for this Policy has been published on the

Equality and Diversity webpage of the RDaSH website click here

8.1 Privacy , Dignity and Respect The NHS Constitution states that all patients should feel that

their privacy and dignity are respected while they are in hospital. High Quality Care for All (2008), Lord Darzi’s review of the NHS, identifies the need to organise care around the individual, ‘not just clinically but in terms of dignity and respect’. As a consequence the Trust is required to articulate its intent to deliver care with privacy and dignity that treats all service users with respect. Therefore, all procedural documents will be considered, if relevant, to reflect the requirement to treat everyone with privacy, dignity and respect, (when appropriate this should also include how same sex accommodation is provided).

Indicate how this will be met

There is no requirement for additional consideration to be given with regard to privacy, dignity or respect.

8.2 Mental Capacity Act

Central to any aspect of care delivered to adults and young people aged 16 years or over will be the consideration of the individuals capacity to participate in the decision making process. Consequently, no intervention should be carried out without either the individuals informed consent, or the powers included in a legal framework, or by order of the Court

Therefore, the Trust is required to make sure that all staff working with individuals who use our service are familiar with the provisions within the Mental Capacity Act. For this reason all procedural documents will be considered, if relevant to reflect the provisions of the Mental Capacity Act 2005 to ensure that the interests of an individual whose capacity is in question can continue to make as many decisions for themselves as possible.

Indicate How This Will Be Achieved.

All individuals involved in the implementation of this policy should do so in accordance with the Guiding Principles of the Mental Capacity Act 2005. (Section 1)

http://www.rdash.nhs.uk/information-for-the-public/equality-and-diversity/equality-impact-assessments/

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9. LINKS TO ANY ASSOCIATED DOCUMENTS • Risk Management Strategy

• Incident Reporting Policy

• Policy for the Management of Serious Incidents (SIs)

• Policy and Procedure Relating to the Handling of Formal Complaints

• Claims Handling Policy for the Management of Clinical Negligence Claims, Employer/Public Liability Claims and Property Expense Scheme Claims

• Being Open: Communicating Openly and Honestly with Service Users and their Carers following a Patient Safety Incident or Related Complaint or Claim

• Mandatory Risk Management Training Policy and Training Needs Analysis

• Policy on Supporting Staff involved in a Traumatic/Stressful Incident, Complaint or Claim

• Clinical Audit Policy

• Implementing Best Practice from National Confidential Enquiries/Inquiries 10. REFERENCES • NHS Litigation Authority Risk Management Standards

• NHS Litigation Authority (2011) An Organisation-wide Document for the Investigation of Incidents, Complaints and Claims

• Department of Health: National Quality Board (2010) Review of early warning systems in the NHS

• National Framework for Reporting and Learning from Serious Incidents Requiring Investigation (2009)

• National Patient Safety Agency (2005). Building a Memory: Preventing Harm, Reducing Risks and Protecting Patient Safety. London: National Patient Safety Agency.

• National Patient Safety Agency (2004). Seven Steps to Patient Safety. London: National Patient Safety Agency.

• National Patient Safety Agency - Root Cause Analysis Investigation Tools. Guide to investigation report writing following Root Cause Analysis of patient safety incidents. London: National Patient Safety Agency. Available at: http://www.npsa.nhs.uk/nrls/

11. APPENDICES

http://www.npsa.nhs.uk/nrls/

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Appendix 1 NPSA Risk Matrix

Table 1 Consequence scores

Choose the most appropriate domain for the identified risk from the left hand side of the table Then work along the columns in same row to assess the severity of the risk on the scale of 1 to 5 to determine the consequence score, which is the number given at the top of the column.

Consequence score (severity levels) and examples of descriptors

1 2 3 4 5

Domains Negligible Minor Moderate Major Catastrophic Impact on the safety of patients, staff or public (physical/psychological harm)

Minimal injury requiring no/minimal intervention or treatment. No time off work

Minor injury or illness, requiring minor intervention Requiring time off work for >3 days Increase in length of hospital stay by 1-3 days

Moderate injury requiring professional intervention Requiring time off work for 4-14 days Increase in length of hospital stay by 4-15 days RIDDOR/agency reportable incident An event which impacts on a small number of patients

Major injury leading to long-term incapacity/disability Requiring time off work for >14 days Increase in length of hospital stay by >15 days Mismanagement of patient care with long-term effects

Incident leading to death Multiple permanent injuries or irreversible health effects An event which impacts on a large number of patients

Quality/complaints/audit Peripheral element of treatment or service suboptimal Informal complaint/inquiry

Overall treatment or service suboptimal Formal complaint (stage 1) Local resolution Single failure to meet internal standards Minor implications for patient safety if unresolved Reduced performance rating if unresolved

Treatment or service has significantly reduced effectiveness Formal complaint (stage 2) complaint Local resolution (with potential to go to independent review) Repeated failure to meet internal standards Major patient safety implications if findings are not acted on

Non-compliance with national standards with significant risk to patients if unresolved Multiple complaints/ independent review Low performance rating Critical report

Totally unacceptable level or quality of treatment/service Gross failure of patient safety if findings not acted on Inquest/ombudsman inquiry Gross failure to meet national standards

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Human resources/ organisational development/staffing/ competence

Short-term low staffing level that temporarily reduces service quality (< 1 day)

Low staffing level that reduces the service quality

Late delivery of key objective/ service due to lack of staff Unsafe staffing level or competence (>1 day) Low staff morale Poor staff attendance for mandatory/key training

Uncertain delivery of key objective/service due to lack of staff Unsafe staffing level or competence (>5 days) Loss of key staff Very low staff morale No staff attending mandatory/ key training

Non-delivery of key objective/service due to lack of staff Ongoing unsafe staffing levels or competence Loss of several key staff No staff attending mandatory training /key training on an ongoing basis

Statutory duty/ inspections

No or minimal impact or breech of guidance/ statutory duty

Breech of statutory legislation Reduced performance rating if unresolved

Single breech in statutory duty Challenging external recommendations/ improvement notice

Enforcement action Multiple breeches in statutory duty Improvement notices Low performance rating Critical report

Multiple breeches in statutory duty Prosecution Complete systems change required Zero performance rating Severely critical report

Adverse publicity/ reputation

Rumours

Potential for public concern

Local media coverage – short-term reduction in public confidence Elements of public expectation not being met

Local media coverage – long-term reduction in public confidence

National media coverage with <3 days service well below reasonable public expectation

National media coverage with >3 days service well below reasonable public expectation. MP concerned (questions in the House) Total loss of public confidence

Business objectives/ projects

Insignificant cost increase/ schedule slippage

<5 per cent over project budget Schedule slippage

5–10 per cent over project budget Schedule slippage

Non-compliance with national 10–25 per cent over project budget Schedule slippage Key objectives not met

Incident leading >25 per cent over project budget Schedule slippage Key objectives not met

Finance including claims

Small loss Risk of claim remote

Loss of 0.1–0.25 per cent of budget Claim less than £10,000

Loss of 0.25–0.5 per cent of budget Claim(s) between £10,000 and £100,000

Uncertain delivery of key objective/Loss of 0.5–1.0 per cent of budget Claim(s) between £100,000 and £1 million Purchasers failing to pay on time

Non-delivery of key objective/ Loss of >1 per cent of budget Failure to meet specification/ slippage Loss of contract / payment by results Claim(s) >£1 million

Service/business interruption Environmental impact

Loss/interruption of >1 hour Minimal or no impact on the environment

Loss/interruption of >8 hours Minor impact on environment

Loss/interruption of >1 day Moderate impact on environment

Loss/interruption of >1 week Major impact on environment

Permanent loss of service or facility Catastrophic impact on environment

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Table 2 Likelihood score (L)

What is the likelihood of the consequence occurring? The frequency-based score is appropriate in most circumstances and is easier to identify. It should be used whenever it is possible to identify a frequency.

Likelihood score 1 2 3 4 5 Descriptor Rare Unlikely Possible Likely Almost certain Frequency How often might it/does it happen

This will probably never happen/recur

Do not expect it to happen/recur but it is possible it may do so

Might happen or recur occasionally

Will probably happen/recur but it is not a persisting issue

Will undoubtedly happen/recur,possibly frequently

Note: the above table can be tailored to meet the needs of the individual organisation.

Some organisations may want to use probability for scoring likelihood, especially for specific areas of risk which are time limited. For a detailed discussion about frequency and probability see the guidance notes. Table 3 Risk scoring = consequence x likelihood (C x L) Likelihood

Likelihood score 1 2 3 4 5

Rare Unlikely Possible Likely Almost certain

5 Catastrophic 5 10 15 20 25

4 Major 4 8 12 16 20

3 Moderate 3 6 9 12 15

2 Minor 2 4 6 8 10

1 Negligible 1 2 3 4 5 Note: the above table can to be adapted to meet the needs of the individual trust. For grading risk, the scores obtained from the risk matrix are assigned grades as follows

1 - 3 Low risk 4 - 6 Moderate risk

8 - 12 High risk 15 - 25 Extreme risk

Instructions for use

1 Define the risk(s) explicitly in terms of the adverse consequence(s) that might arise from the risk.

2 Use table 1 (page 13) to determine the consequence score(s) (C) for the potential adverse outcome(s) relevant to the risk being evaluated.

3 Use table 2 (above) to determine the likelihood score(s) (L) for those adverse outcomes. If possible, score the likelihood by assigning a predicted frequency of occurrence of the adverse outcome. If this is not possible, assign a probability to the adverse outcome occurring within a given time frame, such as the lifetime of a project or a patient care episode. If it is not possible to determine a numerical probability then use the probability descriptions to determine the most appropriate score.

4 Calculate the risk score the risk multiplying the consequence by the likelihood: C (consequence) x L (likelihood) = R (risk score)

5 Identify the level at which the risk will be managed in the organisation, assign priorities for remedial action, and determine whether risks are to be accepted on the basis of the colour bandings and risk ratings, and the organisation’s risk management system. Include the risk in the organisation risk register at the appropriate level.

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APPENDIX 2

TERMS OF REFERENCE 1. NAME OF COMMITTEE/SUB-GROUP


2. PURPOSE The Organisational Learning Forum is responsible for developing and managing a structured approach to active organisational learning, where lessons learned are embedded in the Trust’s culture and practice. The group will help to facilitate a fair blame (no blame) culture. This will include: the sharing of lessons learnt from one service to other areas of the Trust in order that any system failures discovered during investigations are adopted by the Trust as a whole and pockets of good practice are not isolated. The fostering of a learning and improvement culture, where all staff understand the value and benefits of learning from error and feel confident to report incidents.

3. MEMBERSHIP Members are responsible for communicating learning and improvements to the forum from their Business Divisions/Directorates.

- Head of Patient Safety and Experience/Deputy AHP Lead (Chair) - Patient Safety Lead (Deputy Chair) - Deputy Director Operations - Head of Clinical Effectiveness - Patient Safety Officer - PALS Coordinator - Health and Safety Lead - Complaints Manager - Claims Manager - Back Care Advisor - Head of Health Safety and Security - Safeguarding Team representative - HR Operational Lead - Nomination from Adult Mental Health Business Division (Community) - Nomination from DCIS - Nomination from Children and Young People Mental Health Business Division - Nomination from Substance Misuse Business Division - Nomination from Older People Mental Health Services Business Division - Nomination from Psychological Therapies Business Division - Nomination from Learning Disabilities - Nomination from Forensic Business Division - Nomination from Adult Mental Health Business Division (In-Patients) - Learning and Development Team representative - Medical Representative - Pharmacy Representative - Others by invitation as appropriate

4. QUORUM

The group will be considered quorate with representatives from at least four of the Business Divisions and the Chair/Deputy Chair

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5. MEETING ARRANGEMENTS (FREQUENCY, CHAIR, VENUE, ADMINISTRATIVE SUPPORT ARRANGEMENTS) Meetings will normally be chaired by the Head of Patient Safety and Experience/Deputy AHP Lead or nominated deputy and will be held on a monthly basis. Meetings will normally take place at Park Lodge, Doncaster and administrative support will be provided by the Business Assurance Directorate.

6. ATTENDANCE AT MEETINGS Members (or a nominated deputy) are required to attend every meeting. If members or nominated deputies are not able to attend a meeting, reports on identified agenda items should be made to the Chair of the Group in advance. Attendance at the meetings is monitored by the Chair of the Group from the ‘Present’ list on the minutes.

7. KEY RESPONSIBILITIES/OBJECTIVES/DUTIES/ POWERS The principal responsibilities of the group are to:

• Review and improve operational, reporting and learning processes relating to Incidents, SIs, Complaints and Claims

• Review and improve the reporting of Incidents, SIs, Complaints and Claims both internally and externally to provide assurance, including the quarterly SI report for the Board of Directors.

• Keep under review the policies for Investigations, Incidents, SIs, Complaints and Claims

• Analyse information relating to Incidents, SIs, Complaints and Claims both individually and on an aggregated basis in order to identify trends and themes

• Encourage learning and promote improvements in practice, based on the individual and aggregated analysis of incidents, complaints and claims

• Determine what the learning points are and how they will be shared systematically across the organisation as well as across the local health community as appropriate.

• Promote quality incident reporting and follow up to ensure recording of outcomes by managers

• Review incident data with a view to identifying “Hot spots,” trends, themes and causal factors and support dissemination to staff teams to improve quality

• Identify lessons learned and good practice and share Trust wide

• Discuss and share solutions and risk reduction measures

• Identify poor practice and areas for improvement and address the issues with the Business Divisions/Directorates

• Consider compliance issues for all external bodies

• Facilitate information sharing to Business Divisions/Directorates and across the Trust as a whole via Business Division feedback and/or Organisational Bulletin

• Advise on any training programmes needed, relating to lessons learnt

8. RECEIPT OF MINUTES AND REPORTS FROM

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The Forum will receive:

• Patient Safety Incident (PSI) reports • Serious Incident (SI) reports • Complaints reports • Claims reports • Aggregated Reports (Triangulated) of Incidents, Complaints and Claims. • Safeguarding Incident/Serious Incident updates

9. REPORTING ARRANGEMENTS

The Forum will report to the Risk Management Sub Group (RMG) and the Clinical Governance Group via the Head of Patient Safety and Experience/Deputy AHP Lead (or nominated deputy) on a monthly basis.

10. DATE: October 2012

11. REVIEW DATE: January 2013

12. DOCUMENT OWNER/RESPONSIBILITY FOR REVIEW (LEAD DIRECTOR): Director of Business Assurance

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APPENDIX 3

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APPENDIX 4

NPSA CONTRIBUTORY FACTOR CLASSIFICATION FRAMEWORK

Individual Factors Individual Factors Components

Physical issues General Health (e.g. nutrition, diet, exercise, fitness) Physical disability (e.g. eyesight problems, dyslexia) Fatigue

Psychological Issues

Stress (e.g. distraction / preoccupation) Specific mental health illness (e.g. Depression) Mental impairment (e.g. illness, drugs, alcohol, pain) Motivation (e.g. boredom, complacency, low job satisfaction) Cognitive factors (e.g. attention deficit, distraction,

preoccupation, overload and boredom) Social Domestic Domestic / lifestyle problems

Personality Issues Low self confidence / over confidence Gregarious / interactive, reclusive Risk averse / risk taker

Team and Social Factors Team Factors Components Role Congruence Is there parity of understanding

Are role definitions correctly understood Are roles clearly defined

Leadership Is there effective leadership – clinically Is there effective leadership – managerially Can the leader lead Are leadership responsibilities clear and understood Is the leader respected

Support and cultural factors

Are there support networks for staff Team reaction to patient safety incidents Team reaction to conflict Team reaction to newcomers Team openness

Communication Factors Communication Factors

Components

Verbal communication

Verbal commands / directions unambiguous Tone of voice and style of delivery appropriate to situation Correct use of language Made to appropriate person(s) Recognised communication channels used (e.g. head of

service). Written communication

Are records easy to read Are all relevant records stored together and accessible

when required Are the records complete and contemporaneous (e.g.

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availability of patient management plans, patient risk assessments, etc)

Are memo’s circulated to all members of team Are communications directed to the right people

Non verbal communication

Body Language issues (closed, open, aggressive, relaxed, stern faced)

Task Factors Task Factors Components Guidelines Procedures and Policies

Up-to-date Available at appropriate location (e.g. accessible when

needed) Understandable / useable Relevant; Clear; Unambiguous; Correct Content; Simple Outdated; Unavailable/missing; Unrealistic Adhered to / followed Appropriately targeted (e.g. aimed at right audience)

Decision making aids

Availability of such aids e.g. CTG machine, risk assessment tool, fax machine to enable remote assessment of results

Access to senior / specialist advice Easy access flow charts and diagrams Complete information - test results, informant history

Procedural or Task Design

Do the guidelines enable one to carry out the task in a timely manner

Do staff agree with the ‘task/procedure design’ Are the stages of the task such that each step can

realistically be carried out

Education and Training Factors Education and Training

Components

Competence Adequacy of knowledge Adequacy of skills Length of experience Quality of experience Task familiarity Testing and Assessment

Supervision Adequacy of supervision Availability of mentorship Adequacy of mentorship

Availability / accessibility

On the job training Emergency Training Team training Core skills Training Refresher courses

Appropriateness Content Target audience Style of delivery Time of day provided

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Equipment and Resources Factors Equipment Components Displays Correct information

Consistent and clear information Legible information Appropriate feedback No interference

Integrity Good working order Appropriate size Trustworthy Effective safety features Good maintenance programme

Positioning Correctly placed for use Correctly stored

Usability Clear controls User manual Familiar equipment New equipment Standardisation

Working Conditions Work Environment Factor

Component

Administrative factors

The general efficiency of administrative systems e.g. reliability

Systems for requesting medical records Systems for ordering drugs Reliability of administrative support

Design of physical environment

Office design: computer chairs, height of tables, anti-glare screens, security screens, panic buttons, placing of filing cabinets, storage facilities, etc.

Area design: length, shape, visibility, cramped, spacious Environment Housekeeping issues – cleanliness

Temperature Lighting Noise levels

Staffing Skill mix Staff to patient ratio Workload / dependency assessment Leadership Use Temporary staff Retention of staff / staff turnover

Work load and hours of work

Shift related fatigue Breaks during work hours Staff to patient ratio Extraneous tasks Social relaxation, rest and recuperation

Time Delays caused by system failure or design Time pressure

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Organisational and Strategic Factors Organisational Factor

Components

Organisational structure

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

Tight boundaries for accountability and responsibility Clinical versus the managerial model

Priorities Safety driven External assessment driven e.g. Star Ratings Financial balance focused

Externally imported risks

Locum / Agency policy and usage Contractors Equipment loan PFI

Safety culture Safety / efficiency balance Rule compliance Terms and Conditions of Contracts Leadership example (e.g. visible evidence of commitment to

safety) Open culture

Patient Factors Patient Factors Components Clinical condition Pre-existing co-morbidity

Complexity of condition Seriousness of condition Treatability

Social factors Culture / religious beliefs Life style (smoking/ drinking/ drugs/diet) Language Living accommodation (e.g. dilapidated) Support networks

Physical factors Physical state – malnourished, poor sleep pattern, etc.

Mental/ psychological factors

Motivation (agenda, incentive) Stress (family pressures, financial pressures) Existing mental health disorder Trauma

Interpersonal relationships

Staff to patient and patient to staff Patient to patient Inter family – siblings, parents, children

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APPENDIX 5

Level 1 Concise Investigation Report Template

Concise incident description and consequences IR1 reference no: Business

Division/Directorate: Incident date: Team/Ward/Department: Incident type: Site: Risk Grading and Score: Actual effect on person and/or service

Scope of investigation Involvement and support of patient and relatives Chronology of events See format below Detection of incident Care and service delivery problems Contributory factors Root causes Lessons Learned Recommendations See format below 1. 2.

Sum up briefly what went wrong and what the outcome was - e.g. patient sustained an allergic reaction after being administered a drug she was known to be allergic to.

One or two sentences summarising what time period the investigation set out to consider and what care episodes/specialties/staff groups were included.

If patient incident, a summary addressing as a minimum the following: • Apology given? • Being Open Lead appointed? • Meetings with family? • Correspondence? • Patient/carers helped determine

what went wrong/contributed to investigation?

• Investigation’s findings shared with patient?

• Meeting offered to discuss?

Who noticed and how? At what point during/after the incident did what had happened come to light? Was there a delay?

Describe the incident. What went wrong with the care or service in relation to the incident?

Why did it go wrong?

What is the main problem/reason underpinning the problems listed above? The root cause(s) will be the central issue that, if addressed, would significantly reduce the likelihood of the incident happening again.

What could be done/changed to eliminate or reduce the risk of the root cause(s) happening again? Try to avoid the use of new policies/checklists; instead consider changing the times that things are done or the places/positions that objects or people are in, or the physical way people carry out certain tasks, for example.

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3. Arrangements for shared learning Author Date

Split up your lessons learned into key recommendations that can be enacted to reduce the risk of the incident happening again.

Any lessons that could be applicable to other areas or other organisations should be shared. Here are some conventional ways, but you should think about the most appropriate methods for communicating the learning you are trying to share; you may come up with something more effective: • Fill in a Risk Alert and send to Risk

Management for dissemination to other areas/organisations

• Practice Development Bulletin • Trust’s Weekly Bulletin • Via email • Notices in the Departments • Share at staff meetings • Business Division/Directorate Forums

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Action plan Issue identified

Remedial action Name of lead

Date due for completion

Date completed

Evidence and lead for collation

1 2 3 4

Chronology Date and Time Event Supplementary

Guidance Good practice Care and

service delivery problems

These should be based on your recommendations. Be very specific and to the point so it will be clear when the action has been completed.

Evidence to provide assurance that action has been implemented, and lead for gathering this evidence. The evidence should be very specific and measurable, e.g. audit of patient pathway with the result being that 95% of patients are seen within agreed waiting period, or, audit of infusion devices, where 100% of pumps are reset to 0 after use. This evidence should be uploaded to the incident record on SAFEGUARD.

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APPENDIX 6

Please do not use the old logo with ‘Mental Health’

Report Author (s): ?? Title: ?? Date: ?? Version: ?? (Please State what version e.g., if a resubmission, it is a version 2)

CONFIDENTIAL REPORT

FINAL REPORT

Investigation into the Serious Incident 2012/????

Add relevant STEIS Log no, e.g. 2012/207

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SERIOUS INCIDENT FINAL REPORT

SI number 2012/???? (Please insert full STEIS log number) 1 Brief Outline of Incident Please give a brief description of the incident and its

effect/outcome on the patient, the staff, the service and any other significant other. This could include:

• a concise description of the incident; • incident date; • incident type; • ward/service in which the incident occurred; • actual effect of the incident on patient and/or service and others;

2 Contents Page 1 Brief Outline of Incident

2 Contents Page 3 Summary 4 Main Body of Report 4.1 Terms of reference 4.2 Lead investigator 4.3 Investigation Team/SUI panel 4.4 Sources of data 4.5 Guidance, legislation, policy and procedures

consulted 4.6 Involvement of patient/family in investigation 4.7 Support provided for patient/family 4.8 Support provided to other patients 4.9 Support provided for staff involved 4.10 Investigation process 4.11 Any immediate preventative action taken 5 Timeline 6 Detection of incident 7 Good practice 8 Key Care and Service Delivery Problems 9 Key Contributing Factors 10 Root Causes/causal factors 11 Lessons learned 12 Recommendations 13 Post- Recommendations Risk assessment 14 Likelihood of recurrence 15 Arrangements for shared learning 16 Monitoring Arrangements 17 Acknowledgements 18 Dissemination List 19 Conclusion

3 Summary Give a summary of the incident considering the following:

• Set the scene. Give a brief description of the type of care and/or treatment being provided.

• Summary of the incident description and consequences including-

o brief incident description; o incident date; o incident type; o ward/service where

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incident occurred; o actual effect on the patient

and/or service; • Include details around the Care and service delivery problems identified; • Detection of incident, when and how it became known; • Details of the contributory factors identified • Details of Lessons learnt

4 Main Body of Report

4.1 Terms of Reference • specific problem or issues to be addressed; aims and objectives of the investigation and desired outputs

• scope and boundaries of the investigation should not go;

4.2 Lead Investigator State here your name and title.

4.3 Investigation Team/SUI Panel State here the names and titles of the members of the investigation panel.

4.4 Sources of Data Use here to state the sources of your data e.g. electronic records, nursing and medical notes, interviews etc.

4.5 Guidance, Legislation, Policy and Procedures Consulted:

Please state for example, the legislations, Trust policy and procedures and National guidance relevant to the event that you investigated.

4.6 Involvement of Patient/Family in Investigation

State here how you have involved the patient/family. If the patient/family does not wish to be involved please state actions taken and include why this was refused. In this section demonstrate how those affected have been given an accurate, open, timely and clear explanation of what has happened, received an apology, been informed of immediate actions taken, been given a clear statement of what is going to happen regarding any investigation. You could also include:

• whether the patient or family was asked how much involvement they want

• interviewed to establish the questions they hope the investigation will address and to hear their recollection of events

• asked how they would like their involvement referred to in the report (explain that our reports are anonymised)

• offered a point of contact (e.g. family liaison person) • given information on sources of independent

support/advocacy • informed and kept up to date with the investigation

process, including agreeing the frequency with which they wanted to be updated

4.7 Support Provided for

Patient/Family State what actual intervention or support was provided to the patient/family following the incident.

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Do not leave blank, if this was not completed or refused by the patient/family please give an explanation.

4.8 Support Provided to other Patients

State what actual intervention or support was provided to other patients, following the incident. Do not leave blank, if this was not completed or refused by patients please give an explanation.

4.9 Support Provided for Staff Involved

Include what actual intervention or support was provided to the staff following the incident. Examples may include: counseling, support during interviews, or debriefing sessions. Also refer to informal support from colleagues, as well as formal support, written materials or access to support networks. Do not leave blank, if this was not completed or refused by staff please give an explanation.

4.10 Investigation Process Explain that the NPSA Root Cause Analysis (RCA) process is used and describe how you used it to:

• Gather information, for example: interviews (for example cognitive interviewing); retrospective clinical records; multidisciplinary team reviews; photographs, diagrams or drawings.

• Map the incident, for example: narrative chronology; timeline/tabular timeline; time person grid; cause and effect chart.

• Identify care and service delivery problems, for example: multidisciplinary review meeting; brainstorming/ Brainwriting; nominal group technique; change analysis.

• Analyse problems to identify contributory factors and root causes, for example: fishbone; contributory factors classification/framework; 5 whys.

• Generate solutions and recommendations, for example: barrier analysis; risk benefit analysis.

4.11 Any Immediate Preventative Action Taken

Please state any immediate action if any to mitigate impact, harm or recurrence.

5 Timeline

Decide the appropriate date range to use for the timeline and record all events relating to the patients during this time using the patient’s records. Please include every entry during that time period even if nothing specific has happened. Also include any police or safeguarding involvement.

Date Event Supplementary Information

1

2

3

4

5

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6

7

8

9

10

11

12

13

14

15

16

17

18

19

20

6 Good Practice

Use this section for any good practice you identified during the cause of the investigation.

7 Key Care and Service Delivery Problems

Use this section to bullet point any key issues identified relating to care or service delivery. Please be brief but specific.

8 Key Contributing Factors Bullet point any factors that have contributed to the incident that are not necessarily failures in care or service delivery. For example patient/environmental factors.

9 Root Causes/Causal Factors Using your preferred NPSA technique e.g. 5 whys or fish bone, use the key care or service delivery problems to identify the root cause.

10 Impact on outcome Describe how the root cause impacted on the incident.

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11 Recommendations State the recommendations that need to be implemented to reduce the likelihood of the incident re-occurring. Remember that each recommendation should have an Action Plan (AP) to address the specific issues identified. Please ensure that recommendations are:

• clearly linked to the identified root cause • address all of the root causes and key care or service

delivery problems • be designed to significantly reduce the likelihood of

recurrence and/or severity of outcome; • be clear and concise and kept to a minimum wherever

possible; • be Specific, Measurable, Achievable, Realistic and Timed

(SMART) so that changes and improvements can be made and evaluated;

• Include provision of ongoing support of patients and staff affected by the incident.

12 Risk Assessment This section is interpreted differently by every investigator. Use this section to Risk Assess the incident prior to the recommendations being completed. Think about the risk to the Trust as well as to the individual patient.

13 Likelihood of Recurrence Use this section to Risk Assess the incident after the recommendations have been implemented. Think about the risk to the Trust as well as to the individual patient.

14 Sharing Lessons Use this section to show how the report and the learning points should be shared. Good practice will require that there be staff briefing and that the report be discussed at the Business Division’s ‘Leadership and Quality Committee Meeting’ and key learning points disseminated to staff. Report and learning points should also be shared with:

• The Patient Safety Team • Chief Operating Officer and • Organisational Learning Forum

15 Monitoring Arrangements In this section explain the monitoring arrangement in place. This usually will be through the Business Division Leadership and Quality Committee Meeting and the Patient Safety Team for full implementations of the action plans.

16 Acknowledgements Please kindly use this section to acknowledge all those who assisted and or contributed to the investigation.

17 Dissemination List You need to agree the appropriate dissemination for your Business Division and also consider the list below:

• Business Divisions Leadership and Quality Committee • Patient Safety Team • Chief Operating Officer • The Lead Commissioners (NHS Doncaster)

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18 Conclusion This section is for a brief summary of the report showing: • What happened • The investigation process employed • Summary of the findings • Key learning points • Conclusions and recommendations • Likelihood of recurrence • Remedies or solutions

SI Number:

Recommendation 1 State here the theme around which the recommendation is based on e.g. Non adherence to ‘Record Keeping Standards’

Recommendation(s) to address root causes

State here the specific recommendation that you identified in section 11.

Action(s) to achieve recommendations

List the specific actions that you are proposing in order to achieve the recommendation.

Level of recommendation(s) State here the category and extent of the recommendation e.g. local to the Business Division or Trust wide

Implemented by State here who is responsible for the implementation of the recommendation, name and title

By when The date or the deadline for the implementation of the recommendation, remember to be realistic about timescales.

Resource required (time) E.g. within normal work time, 2hr protected time. If none required, state Nil.

Resource required (money) As requested

Resource required (other) As requested

Evidence of completion Please state here the evidence that will indicate that the action(s) has been completed.

Monitoring arrangements E.g.

• Business Divisions Leadership and Quality Committee

• Patient Safety Team

Review and sign-off by: Name: Name of Assistant Director or Designate Title: Assistant Director Date: The date of sign off

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SI Number:

Recommendation 2 Recommendation(s) to address root causes

Action(s) to achieve recommendations

Level of recommendation(s)

Implemented by

By when

Resource required (time)

Resource required (money)

Resource required (other)

Evidence of completion

Monitoring arrangements

Review and sign-off by: Name:

Title: Date:

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APPENDIX 7 INVESTIGATION CHECKLIST AND HELPFUL INVESTIGATION PLANNING

TEMPLATES Step 1 Level of investigation identified. 2 Investigation lead identified. 3 If the investigation is commissioned by a Director, Manager or other party (the

commissioner) they should agree the terms of reference with the lead investigator, reporting intervals and timescales for any specific information requirements. The discussion may include consideration as to how far the Investigating Officer’s diary can be cleared to allow a timely completion of the investigation.

4 Prioritise the issues to be investigated. 5 Consider what information is needed. 6 Consider how this information will be collected 7 Consider what, if any, support is needed, practical and emotional 8 Set up an investigation team, if necessary. This may include input from HR where

appropriate 9 The lead investigator will need to keep a diary/schedule of investigation events, e.g.

records of meetings, timescales given 10 If a service user or carer is involved in the investigation, the Lead Investigator may

wish to involve the service user’s consultant 11 Remember to keep all the parties involved informed of the progress of the

investigation on a regular basis 12 Tell interviewees about the issue under investigation and inform them of their rights

and responsibilities 13 Where a potential interviewee is from another area or organisation, ensure their line

manager is informed 14 Prepare for interviews. Re-visit the issue in order to structure the questions and

ask, ‘what information am I looking for from this interview’. 15 Consider whether additional supporting documentation is required at an early stage.

You may need to photocopy documents that will continue to be used or to avoid any changes being made to them

16 Review the information gathered: 17 Is it enough? 18 Is more needed? (Check point 5) 19 If necessary go back to 10 and 11 20 Ensure updates to investigation ‘commissioner’. Delays and the reasons for them

must be recorded. 21 Consider whether an update is necessary to any parties involved 22 Compare what happened with good practice 23 Check against procedures/policy

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24 Check against the allegation and any perception of what happened 25 Is any further investigation necessary? 26 Make decisions about the way forward, preferably with the team 27 Is any further investigation necessary? 28 Check draft with team, particularly the recommendations, if appropriate 29 Using the appropriate pro-forma prepare and present the final report to the

‘commissioner’ of the investigation 30 Ensure that the appropriate Director/Manager is aware of the investigation and

outcomes to share as ‘Lessons Learnt’ 31 Ensure the investigation report and action plan is copied to all interested parties 32 Reach agreement as to who will give feedback to all the parties involved See Investigation Planning Templates

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INVESTIGATION PLANNING TEMPLATES

INTERVIEWS WHO?

PRIORITY? WHEN? WHERE? BY WHOM?

STATEMENTS FROM WHOM?

LOCATION* BY WHOM? BY WHEN

*including restrictions on availability (e.g. Night-worker)

DOCUMENTS REQUIRED TITLE

SOURCE BY WHOM BY WHEN? FROM WHOM?

INVESTIGATION DIARY DATE

RECORD OF ACTION TAKEN AND OUTCOME

FURTHER ACTION REQUIRED

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APPENDIX 8

GUIDANCE ON WITNESS STATEMENTS

The information gathering stage of an incident investigation will often involve the collection of statements from people who were involved in, or witnessed, the

incident. The guidelines below may be helpful to those people who are requested to provide such documentation for statements. The guidance also aims to ensure that

statements of consistent quality can be obtained as early on as possible.

Preparing a Witness Statement

This guidance is intended to assist you in preparing your statement regarding the Incident which occurred on _________ involving _______.

The information contained within your statement will enable the investigation team to build a complete picture of what happened and help them to understand how the incident occurred.

Any information you give will be treated as confidential and will be stored in a secure place. Disclosure of the content of your statement to anyone outside of the investigation team will not occur without your express permission.

It is important that your statement is an accurate and factual account of your involvement in the incident. It should be focused on:

what you said what you did what you saw what you didn’t do and why

GUIDELINES ON WRITING A WITNESS STATEMENT These guidelines are intended to assist any individual who has been asked or wishes to prepare a written statement. A statement may be required as part of an investigation into a complaint, incident, investigation or situation.

Purpose of a statement A written statement is intended to inform another party (usually the Investigatory Officers) of exactly what happened at the time of an incident or situation.

Presentation of a statement 1 A statement should be written in black ink or preferably typed onto Trust

headed A4 paper. The attached pro-forma may be used as a guide. 2 A statement should clearly state your name, designation, business address and

the full date your statement was written/typed. 3 The statement should always be signed with the date given when signed.

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4 If the statement runs to several pages, each page should be signed and dated.

5 The statement should be headed with a reference to the nature of the incident or situation, the date of the incident and any hospital reference number that may be available.

Content of a statement 1 The statement should be in the first person singular (e.g. “I saw …….”). 2 Set out the story, saying only what your involvement in the incident was - other

witnesses can explain their own involvement. 3 Record facts – actions, dates, and times – as clearly as possible. Only record

something if you can remember.

4 If you cannot be sure of a certain aspect of an incident or situation then state this. It might however be helpful to indicate what the normal practice would have been (e.g. I cannot remember this patient being told to walk unassisted on Friday 5 May 2000. Normal practice on the ward would be to ensure a patient was assessed as being capable of mobilizing independently, and was safe to do so”).

5 If an action or decision was made jointly this should be set out in your statement (e.g. “and I agreed that I should do this with………” it is not helpful to say “it was decided we should……” This neither explains who decided nor who was going to do the doing).

6 When referring to other people, state clearly their full names and designations. 7 The statement should not express opinions, particularly opinions about matters

outside your expertise (e.g. nursing staff should avoid expressing opinions about consultant’s clinical competence or vice versa).

8 If other documents (e.g. medical records) are relevant then it may be helpful to refer these in your statement. It is even more helpful to incorporate a transcript of notes into the statement.

9 If any shorthand notes or abbreviations are being referred to then these should be explained fully and a translation provided.

10 Dates and times should always be referred to in full (e.g. 16.30 on Tuesday 22 February 2000, not 4.30 on 22/2).

11 Incident Report: An incident report form will invariably need to be completed, however, if you are involved in an incident that may result in a complaint or a future claim it is advisable to write a statement following the above guidelines. Do not feel you need to wait until you are asked to prepare a statement.

Remember 1 Signed and dated statements are legal documents. 2 Always read and double-check a statement before submitting it. 3 Always keep a copy for you own records. 4 Give as much information as possible. 5 Prepare a statement as near to the time of the incident as possible. As time

passes, memory fades.

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6 Never place copies of statements in patient records. 7 Ensure the clinical Services Manager (or equivalent) is aware of the statement.

Further Help

If you need further help or support in preparing a statement, please contact any of the following for advice:

1 Your line Manager. 2 Human Resources Department. 3 Your professional organisation. 4 A Staff Association or Trade Union body.

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