Incident Management Policy

DOCUMENT CONTROL:

Version: 17

Ratified by: Clinical Policies Review and Approval Group

Date ratified: 3 September 2019

Name of originator/author: Deputy Director of Nursing and Allied Health Professions & the Head of Patient Safety

Name of responsible committee/individual:

Executive Director of Nursing and Allied Health Professionals

Unique Referenced Number: 325

Date issued: 21 January 2020

Review date: October 2021

Target Audience All staff

Description of Change Incidents are now not closed within 10 days but 21, 28 or 60 days agreed at OMM, EMT and QC

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CONTENTS

TITLE PAGE

1. INTRODUCTION 5

2. PURPOSE 5

3. SCOPE 6

4. RESPONSIBILITIES, ACCOUNTABILITIES AND DUTIES 6

5. PROCEDURE/IMPLEMENTATION 15

5.1 What is an incident? 15

5.2 Who is responsible for reporting incidents? 16

5.3 How to report an incident 16

5.4 Incident grading 17

5.5 Who receives notification of an incident? 18

5.6 What to do when you receive e-mail notification of an incident occurrence

18

5.6.1 Designated Incident Manager. 18

5.6.2 The Subject Matter Expert. 19

5.7 What are the Time Periods for Incident Management? 20

5.8 Duty of Candour 20

5.9 The Trusts External Reporting Arrangements. 21

5.9.1 Health and Safety Executive (HSE) 21

5.9.2 National Reporting and Learning Systems 22

5.9.3 NHS Estates 22

5.9.4 Medicines and Healthcare Products Regulatory Agency (MHRA). 22

5.9.5 NHS Resolution 22

5.9.6 Environmental Health Office and Food Standards Agency. 22

5.9.7 Police 23

5.9.8 NHS Improvement. 23

5.9.9 Care Quality Commission (CQC)- Mental Health Act Notifications. 23

5.9.10 Regulatory Professional Bodies 24

5.9.11 National Clinical Assessment Service (NCAS). 24

5.9.12 NHS England (via STEIS). 24

5.9.13 NHS Counter Fraud Authority 24

5.9.14 Information Commissioner 25

5.9.15 Coroner’s Office. 25

5.9.16 Death of a Person with a Learning Disability 25

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TITLE PAGE

5.10 Investigation Process. 25

5.10.1 Mortality Reviews. 25

5.10.2 Review of Pressure ulcers graded at level 3 or above. 26

5.10.3 Incidents rated Low which don’t reach the Duty of Candour threshold.

26

5.10.4 Incidents rated Moderate or above which meet the Duty of Candour Threshold

27

5.10.5 Serious Incident Investigations 29

5.10.6 Very Serious Incidents. 31

5.10.7 Guidance on the preservation/ recording of evidence. 32

5.10.8 Action to take if during the course of a Serious Incident Investigation concerns are identified in relation to a staff member’s clinical practise, behaviour or attitude.

33

5.10.9 Undertaking a Serious Incident Investigation which is also subject to a Police investigation.

33

5.10.10 Conducting Investigations when other health care providers are also involved

34

5.10.11 Management of a Serious incident Investigation which is also subject to a formal complaint

34

5.10.12 Serious Health and Safety Incidents 35

5.11 Serious Incident Action Plans. 35

5.11.1 Action Plan Development. 35

5.11.2 Monitoring of Action Plan Implementation 35

5.11.03 Reporting of Action Plan Implementation. 36

5.11.4 Process for the sign off of Homicide Action Plans. 36

5.12 Involving Relatives and Carers in Investigations. 37

5.13 Support to Staff involved in an incident. 37

5.14 Support to other Service Users who may be affected by the Incident.

38

5.15 Support to Relatives and Carers. 38

5.16 Learning from Incidents. 39

5.17 Incident Reporting and Monitoring Arrangements. 39

5.18 Dealing with Media Enquiries. 40

5.19 Staff Who Wish to Raise a Concern 40

6. TRAINING IMPLICATIONS 40

7. MONITORING ARRANGEMENTS 41

8. EQUALITY IMPACT ASSESSMENT SCREENING 42

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TITLE PAGE

9. LINKS TO ANY ASSOCIATED DOCUMENTS 43

10. REFERENCES 43

11. APPENDICES 44

App. 1 Mortality reporting and review process 45

App. 2 Categories for reporting death on the Ulysses IR1 System 46

App. 3 Definition of Never Events ( 2018) 47

App. 4 Quick reference flow chart for Incident over sight and how the organisation learns from incidents

48

App. 5 RIDDOR reporting process for serious non-clinical incidents 49

App. 6 Quick reference guide to incident reporting / investigation 50

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1. INTRODUCTION

Responding appropriately to incidents or circumstances that have caused or may cause harm to Patients, Staff, including contracted staff, or Visitors is a key part of the way that the Trust will continually improve the safety of the services that it provides. An incident reporting, management and investigation process is essential to ensuring that the Trust responds to and learns from incidents ,and this policy lays out the process which facilitates the recognition, management and investigation of incidents and enables learning and the minimisation of future harm or loss within the Trust . When an incident has caused moderate (or more severe) harm or loss to patients and/or staff, the Trust will respond to and investigate these following the National Serious Incident Framework (NHS England March 2015). This policy includes the principles of ‘Being Open’ and the ‘Duty of Candour’ (see the Trust’s Being Open and Duty of Candour Policy & Procedure) which ensures that effective communication with Patient and/or their carers is central to our incident management and investigation. It also recognises the importance of the Trust supporting learning rather than blaming culture to promote patient safety.

2. PURPOSE

The purpose of this policy is to outline the procedure by which all Incidents and Serious Incidents (SIs) within the Trust will be reported, and managed. In outlining this procedure the policy sets out the Trust’s systems, processes and expectations in relation to incident reporting and learning to include the:

Process for reporting all incidents involving staff, patients and others

Process for ensuring communication is open, honest, occurs as soon possible and is well documented.

Process for reporting to external agencies

Process for investigating incidents according to level of risk

Support available to staff who are involved in or witness to a serious incident

Interface with the Trust Learning from Deaths policy, medical devices group and pressure ulcer review panel.

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

Process by which the organisation ensures local and organisational learning and changes in practice resulting from individual incidents and aggregated analysis

Process for the aggregated analysis of incidents, complaints and claims

Governance in place and process for providing assurance to the Board

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of Directors that appropriate actions are being taken, that lessons are being learnt, shared and improvements made to both care and service delivery following the occurrence of an incident.

Training requirements for staff An overview of the pathway of how different incidents, including serious incidents are managed is provided in the flowchart in Appendix 1

3. SCOPE

The policy applies to all staff employed within the Trust (permanent, temporary or honorary), students, volunteers, contractors and employees of other organisations working on the Trust’s estate.

4. RESPONSIBILITIES, ACCOUNTABILITIES AND DUTIES

4.1 The Chief Executive and Board of Directors

The Chief Executive, delegates through the Board of Directors the overall responsibility for the provision of adequate systems for the management of Health & Safety, including the reporting and managing of incidents, accidents and near miss events.

4.2 Director of Nursing and Allied Health Professions

The Director of Nursing and Allied Health Professions is the designated Board of Directors’ lead for incident reporting via the Ulysses Risk Management System and the implementation of Being Open and the Duty of Candour where appropriate. Also, as the lead director for clinical quality assurance, the Director of Nursing and Allied Health Professions is responsible for ensuring that there is a framework for SIs to be effectively managed, investigated and that organisational learning is taking place. In addition the Director of Nursing and Allied Health Professions is responsible for the formal sign off of all SI investigation reports prior to submission to the relevant Clinical Commissioning Group (CCG).

4.3 Head of Patient Safety

The Head of Patient Safety is responsible for the operational management of the incident and SI process including:

Ensuring all incidents and SIs are managed and investigated both appropriately and within required time frames

Ensuring robust and timely action plans are produced

Line management of the Trust’s central Investigation Team

Monitoring incident and SI themes across the Trust and the

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implementation of action plans and reporting to the Board of Directors and Executive Management Team

Supporting attendance of the relevant lead investigator at the CCGs’ SI Committees, and responding to commissioning requests

Supporting the Trust in its dissemination of learning from serious incidents across the Care Groups, and where relevant none clinical services.

4.4 Care Group Directors

The Care Group Directors are responsible for ensuring that :

All staff within their sphere of responsibility are aware of the need to complete the Electronic Incident Reporting Form (IR1), and if required the F2508 RIDDOR report forms.

For incidents rated as moderate harm or above, as appropriate in line with this policy one of the following is undertaken.

o Mortality review. o Structured review. o Referral to Pressure Ulcer panel.

The Being Open and Duty of Candour Policy is implemented.

A band 7 or above is allocated to coordinate and lead a structured review of incidents which meet the required criteria.

Any structured reviews undertaken in the Care Group are reviewed by the Care Group Triumvirate/Senior Management Team. On completion of this review the Care Group Director will sign the structured review off on behalf of the Triumvirate/ Senior Management Team.

All incidents requiring a detailed investigation are reported to the Patient Safety Investigation Team.

A quality check of the SI report is completed within the Care Group before it is provided to the Trust internal SI review panel.

Sign off the SI report on behalf of the Care Group Triumvirate.

As required the relevant staff receive a debrief immediately following a serious incident having occurred, and putting in place any additional ongoing support a staff member may require.

Action plans arising from the investigation are :

o Specific

o Measurable

o Achievable

o Realistic

o Timely.

Action plans are fully implemented, and completed within the agreed time frames.

If absent from work, they delegate their responsibilities under this policy

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to their nominated deputy.

4.5 Role of Ward /Service / Department Managers.

Ward/ Service and Department Managers are responsible for:

Ensuring that staff within their wards/ services/ departments are able to recognise an incident and know how to report it (on Ulysses IR1 System)

Ensure that the staff they manage are aware of the following:

o The escalation process to senior managers both in and outside

of normal working hours. o If they are the designated person in charge at the time of the

incident they are responsible for ensuring the immediate safety and wellbeing of those involved in an incident.

o The need to ensure that any equipment implicated in an incident is retained, (including any associated non-disposables), for the investigation

o Where possible and if appropriate, photos are taken of the incident scene.

o Where relevant, in the case of a serious incident, a record is made as to the location of staff at the time of the incident.

o Staff on duty at the time of the incident are asked to make a written record of the events of their working day.

Ensuring that, when required, witness statements are taken and staff are supported to do this and to attend investigation interviews if requested

Reviewing (and finally closing, where possible within the required time frame) all reported incidents for their service, verifying that an appropriate level of investigation has taken place and been recorded and that the incident details, categorisation and severity are recorded correctly

Ensuring that senior managers are informed of any incidents that may meet the criteria of a Serious Incident within 12 hours of the incident occurring

Leading on a service structured review, as requested by the Care Group Director, or their nominated deputy.

Liaising with the Health and Safety Lead regarding any member of staff who is unable to perform their normal job for more than seven days as a result of an accident or incident at work and about any other potential RIDDOR reportable incident.

Liaising with other relevant staff as necessary, such as Subject Matter Experts, Child and Adult Safeguarding Leads etc.

Ensure that vulnerable adult procedures are followed where the incident involves any allegation or suspicion of abuse of an adult in the Trust’s care

Ensure that staff are referred to the Occupational Health (OH) department following the reporting of any OH related incidents

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Learning from Experience by ensuring that :

o Incidents in area of responsibility are investigated according to the severity of the incident (see section 5.4), to identify what happened and why

o Incident information relating to their service is regularly reviewed and analysed to identify any patterns or trends that need to be investigated

o Necessary actions and changes are implemented based on the findings of incident investigations and reviews

o Feedback from the review of an incident is provided to those staff involved

4.6 Patient Safety Investigation Team

The Trust Patient Safety Investigation Team is responsible for supporting

the Head of Patient Safety in the day to day operation of SI management including:

Ensuring the Chief Executive and Directors are aware of any serious incident

Liaising with commissioners

Logging SIs onto the Strategic Executive Information System (STEIS)

Facilitating the Corporate Review of the structured reviews undertaken in the Care Groups and providing feedback to the relevant Care Group Director

Allocating the investigation of incidents that require a more in-depth level than is provided by a structured review

Ensuring that a 72 hour report is provided and that the investigation report is submitted within the 12 week (60 Working Day) timescale to the relevant Commissioning Group.

Production of reports to relevant groups including an Annual Report on patient safety to the Trust.

Completing the root causes and lessons learned boxes on the STEIS system following investigation

Supporting Care Groups with advice on the SI and RCA process

Report ‘Never Events’ – assisting the National Reporting and Learning System (NRLS) to identify these incidents by adding the text ‘Never Event’ within the incident description free text field on Ulysses/e-Form prior to submission.

The Team will also;

Be responsible for the day-to-day operation of the incident reporting system.

Submit the relevant patient safety incident information through the e-form to the National Patient Safety Agency (NPSA).

Make readily available to individuals who have rightful access, copies of completed incident report forms.

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Collate and analyse incident data regularly, producing summarised reports identifying trends and demonstrating a Trust-wide overview of all reported incidents for the Health and Safety Forum.

Provide Care Group specific reports to facilitate detailed consideration of any required policy and practice changes to support organisational learning.

Provide the Trust with relevant patient safety incident data in respect to the care and treatment of service users.

The Trust Patient Safety Team includes dedicated Lead Investigators and it is these staff who undertake the investigation of incidents where the structured review has identified that further investigation is required. Lead Investigators are responsible for undertaking a full investigation as set out in this policy and using the tools and techniques outlined in the RCA training provided. They are also responsible for:

Working with staff with appropriate expertise e.g. Accountable Officer for Controlled Drugs (Chief Pharmacist), Head of Information Governance etc.

Complying with the Being Open and Duty of Candour Policy in communicating with the patient or Relevant Person as dictated within the ‘Being Open & Duty of Candour Policy’. This will include working with the Designated Incident Manager to ensure that the incident has been effectively managed and that the Duty of Candour requirements are complied with, and closing Duty of Candour once their investigation has concluded.

Seeking the views of any relatives/carers as part of their investigation.

Providing feedback to relatives/cares in relation to their investigation findings.

Attendance at the local CCG SI panel meetings to present investigation reports and answer any queries that may arise.

Supporting Staff involved in the incident in line with the ‘Supporting Staff Involved in a Traumatic/Stressful Incident, Complaint or Claim Policy’ throughout the process.

Using the Trust NPSA approved Root Cause Analysis methodology in their investigation process.

Using the approved Trust reporting template (see SI forms and templates on the intranet).

Timely submission of the investigation report to the Care Group Director.

Debriefing staff teams on the outcome/s of their investigation focussing on identified good practice and areas for improvement.

Benchmarking findings against Trust policies and procedures, national guidelines and standards and current evidence base to determine good practices and areas for improvement. Feedback will be provided to the Care Groups via the monthly Dashboards.

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4.7 Designated Incident Manager

Unless otherwise delegated, the line manager or Service Manager of the person reporting the incident will be the Designated Incident Manager (DIM). The DIM will;

Ensure that all incidents regardless of type, damage or injury are accurately reported, using the Electronic Incident Form (IR1) via the Trust’s Ulysses electronic incident reporting system, as soon as is reasonably practicable, but within 12 hours of the incident (or becoming aware of the incident).

Report all potentially serious incidents to their manager or duty manager within 12 hours of the incident occurring (or becoming aware of the incident).

Log on to the system on receipt of a web incident notification being automatically emailed to them and complete and submit the ‘Manager’s Form.’

Comply with the Being Open for all patient safety incidents, and the Duty of Candour for all incidents which are classified as a Notifiable Safety Incident and have a level of harm of moderate or higher.

Complete an investigation into the cause of the incident, and put in place mitigating actions to manage the incident and prevent its reoccurrence.

For Serious Incidents, Work with the Lead Investigators to ensure that the Duty of Candour requirements are complied with and their investigation progresses effectively.

4.8 Health and Safety Lead.

The Reporting of Injuries, Diseases and Dangerous Occurrence

Regulations (RIDDOR) 2013 requires a named ‘Responsible Person’ on behalf of the Trust to report to the local office of the Health and Safety Executive (HSE). The Health and Safety Lead has been designated as the ‘Responsible Person’ on behalf of the Trust. The Health and Safety Lead will:

Be responsible for ensuring the statutory notification of those specified incidents to the Health and Safely Executive (HSE).

Receive and manage the process of RIDDOR reportable incidents, checking that the forms are completed correctly and sent to the relevant office of the HSE in the prescribed timescale, normally 15 working days .

4.9 Accountable Officer for Controlled Drugs

The Accountable Officer for Controlled Drugs is responsible for:

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Recording, assessing and investigating concerns expressed about incidents that may have involved improper management or use of such drugs.

Ensuring that appropriate action is taken for the purpose of protecting service users or members of the public in cases where such concerns appear to be well-founded.

In this Trust the role of the Accountable Officer is undertaken by the Chief Pharmacist.

4.10 Safeguarding Team

It is the responsibility of the Designated Nurse for Safeguarding Children and Adults to have oversight of any safeguarding themes emerging from SIs, and that where a statutory safeguarding notification or response is required; this is actioned in a timely manner. The Designated Nurse for Safeguarding will also act as the link between the Trust SI investigation process and any statutory/learning lessons review processes undertaken by the relevant Local Safeguarding Children or Adult Boards (LSCB/SAB). In relation to any SI investigations which are also subject to safeguarding investigation processes the Lead Investigator and Safeguarding team will work together to reduce duplication and minimise the number of interviews staff may be required to attend.

4.11 Local Counter Fraud Specialist

The Local Counter Fraud Specialist will report to NHS Counter Fraud Authority incidents of fraud and corruption. They will also undertake investigations into fraud, bribery and corruption’.

4.12 Local Security Management Specialist (LSMS)

The LSMS will assist in, or lead on investigations into crime, violence and aggression and other security-related issues as required. They will also keep the Security Management Director and Board up to date with any serious incidents that may impact on the Trust’s reputation.

4.13 Mental Health Act Manager

The Mental Health Act Manager is responsible for reporting to the Care Quality Commission ( CQC) :

The death of a detained patient.

The outcome of any application made to a supervisory body in relation to depriving a service user of their liberty. See Mental Capacity Act 2005 – Deprivation of Liberty Policy.

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The admission of a child or young person (under the age of 18) to an adult psychiatric ward or unit.

Any absence without leave (AWOL) of a person who is detained or liable to be detained under the Mental Health Act 1983 in a hospital designated as low, medium or high security. (Including patients failing to return from s.17 leave of absence from hospital, or absenting from escorted leave or detention under short-term powers of s.5, 135 or 136.)

4.14 Human Resources.

The Human Resources department is responsible, in line with relevant

employment policies, for external reporting to regulatory bodies for professionals including the General Medical Council (GMC), Nursing and Midwifery Council (NMC), Health and Care Professions Council (HCPC) in conjunction with the relevant senior manager, and Director /Deputy Director of Nursing and Allied Health Professions. Referrals to the National Clinical Assessment Service (NCAS), whose role is to help resolve performance concerns about dentists, doctors and pharmacists, will also be dealt with under the employment policies route by the Human Resources department in conjunction with the relevant senior manager.

4.15 Learning Disability Registered Home Managers /Supported Living Manager

In accordance with the relevant Regulations of the Care Quality Commission (Registration) Regulations 2009, the Registered Manager for the relevant home or supported living service is responsible for sending relevant notifications directly to the CQC within the required timescales.

4.16 Head of Information Governance / Data Protection Officer

The Head of Information Governance / Data Protection Officer is responsible for reporting Level 2 Information Governance Serious Incidents (SIs) to the Information Commissioner. Staff should refer to the IG Tool Kit for guidance on the categorising of IG incidents. A copy of which can be viewed at https://www.igt.hscic.gov.uk

4.17 The Trust Caldicott Guardian

The Trust Caldicott Guardian is responsible for ensuring that any patient identifiable information which may be used during the course of both the reporting and investigating of any incident is used and presented in a way which is proportionate and maintains the patients right to privacy.

4.18 Incident Reporters

All Staff are responsible for reporting all incidents on the Trust Electronic

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IR1 form via the Ulysses electronic incident reporting system e.g. accidents, incidents, health and safety issues, security issues, alleged clinical negligence or malpractice and alleged abuse of patients, staff and property. Staff also need to be mindful of the fact that some incidents will require prompt and specific action to deal with the problem. This may include the following:

Summon emergency medical care if required

Summoning assistance from others if required

Ensuring that patients, staff, visitors and others, are protected from the risk if required

Notifying senior members of staff on duty

If equipment / machinery is involved, removing it from service (marking it clearly ‘out of order’) and arrange its repair or removal.

Recording the action taken in the patient’s care records. Records might not be at hand, but they should be found and either tracked or made secure.

If necessary, request that all those who observed what happened prepare a witness statement as soon after the event as possible

4.19 Corporate SI Review Panel

The Corporate SI Review Panel is responsible for the review of all SI investigation reports to assess the quality against its Commissioner’s report criteria and advising Lead Investigators and the relevant Care Group Director of changes/clarifications required prior to submission.

4.20 Mortality Surveillance Group

The mortality surveillance group meets monthly to review Mortality and victims of or perpetrators of homicide data across the Trust, benchmark against published data and identify areas for investigation. The Group aims to review all deaths that occur whilst in Trust care or within a six month period following discharge. The groups terms of reference are to;

Review Mortality and victims of or perpetrators of homicide data across the Trust, benchmark against published data and identify areas for investigation.

Reduce suicide rates by using mortality data to identify key risk groups or situations for suicide with the aim of targeting those groups or situations more effectively and thus reducing suicide rates.

Reduce deaths in physical health patients contributed to by mental health difficulties by improved mental health screening in patients with long term conditions.

Review community hospital deaths in order to reduce rates of

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avoidable deaths. Review community deaths in order to reduce the rates of avoidable

deaths.

4.21 Executive Management Team

The role of the Executive Management Team is to:

Review themes and trends in incident and serious incident reporting.

Monitor compliance with action plans arising from serious incident investigations, and seek assurance of risk mitigation for any actions not achieved in the agreed time frame.

Provide assurance to the Board of Directors in relation to incident management, sharing of lessons leant, and action taken to mitigate any identified risks.

This information is also provided to the Quality Committee through a monthly serious incident report, and the quarterly patient safety Dashboards.

5. PROCEDURE/IMPLEMENTATION

It is essential that all incidents of all types (including near misses) are reported via the Trust Ulysses incident reporting system (IR1), including any that the Trust is required to report to external bodies. If staff are in any doubt about the reporting of an incident they should seek advice without delay to confirm reporting requirements from their Manager/ Health and Safety Lead/ Directors.

5.1 What is an incident?

An NHS incident is described as: “any event which has given rise to potential or actual harm or injury, to patient dissatisfaction or to damage/ loss of property”.

A patient Safety Incident is;

“Any unintended or unexpected incident that could have, or did, lead to harm for one or more patients receiving NHS-funded healthcare.”

A non-person incident is;

“Any unintended or unexpected incident involving Trust property or private property whilst on Trust premises. Any unintended or unwanted situation not directly related to staff, patient, visitor or contractor, any unintended or unwanted situation involving environmental issues.”

A near miss is defined by the NPSA as ;

Any patient safety incident that had the potential to cause harm but was prevented. However it can also encompass situations where an

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unexpected event had the potential to cause harm to someone, but by chance or design did not result in loss or injury.

All deaths of people receiving NHS care, whether expected or not, are considered untoward occurrences and require reporting. It also includes incidents resulting from negligent acts, deliberate or unforeseen. For example:

Unexpected / unexplained death

Absconsion by a detained patient

A member of staff hurts his/her back

A member of staff subject to verbal or physical abuse

A member of the public falls in the car park

Fire on work premises

Theft, loss or damage to organisation or personal property. All untoward and unexpected occurrences should be reported on the Ulysses Incident Reporting System (IR1).

5.2 Who is responsible for reporting incidents?

Ideally, the member of staff involved in the incident should report it, both to a senior manager and on the incident reporting system. However, it is the responsibility of the senior person on duty at the time to ensure that it is reported. Once the occurrence of the incident is made known to the service manager, it is their responsibility to ensure that the incident has been reported on the incident reporting system if not yet done so.

5.3 How to report an incident

The Ulysses Risk Management System (IR1 system) is an online, web based, incident reporting system that is used across the Trust for all types of incidents, unexpected occurrences and concerns. All staff have access to the system for reporting, and to enter the system staff need to click on the Safeguard (IR1) link then enter the user name and password they have for general logging on. The system is user friendly and a number of guides are available to assist. http://nww.intranet.rdash.nhs.uk/health-and-safety-fire-and-security/ulysses-safeguard-ir1/ For any queries or if seeking support, email the Statistics Co-ordinator who is part of the Patient Safety Team at RDASH.incidents@nhs.net

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If a member of staff feels that an incident requires a more urgent response or is of a serious nature, the Manager or Duty Manager is to be contacted to discuss the incident, an IR1 report is to be entered as soon as practicable. Incidents should be reported as soon as practicable, but within 12 hours of the incident occurring or staff becoming aware of it.

5.4 Incident Grading

All incidents need to be screened to identify the appropriate level of investigation required to ensure that adequate fact finding, conclusions and, if necessary, action plans, are produced. To aid the decision the Incident Reporting System has a risk matrix which calculates the risk from the severity and the likelihood of the incident repeating. This presents the risk as a grade and a colour. There is also the ability for the Trust to examine other parameters and decide that a particular level of investigation would be more suitable. For some incidents the level of investigation is determined by the requirements of external influences, for example the Serious incident investigation process, never events, Commissioner directives etc.

1 - Rare

2 - Unlikely

3 - Possible

4 - Likely

5 - Almost Certain

1 - Non Harm

1 - LOW 1 - LOW 1 - LOW 2 - MODERATE

2 - MODERATE

2 - Minor Harm

1 - LOW 2 - MODERATE

2 - MODERATE

3 - HIGH 3 - HIGH

3 - Moderate Harm

1 - LOW 2 - MODERATE

3 - HIGH 3 - HIGH 4 - EXTREME

4 - Major Harm

2 - MODERATE

3 - HIGH 3 - HIGH 4 - EXTREME 4 - EXTREME

5 - Catastrophic Harm / Death

2 - MODERATE

3 - HIGH 4 - EXTREME 4 - EXTREME 4 - EXTREME

The incident reporter is able to enter the criteria for this matrix, and the Designated Incident Manager is able to enter their assessment of the criteria. The final entry is the risk factor which is to be used to assess the level of investigation required. However, the risk factor is not the only consideration, the Designated Incident Manager or Subject Matter Experts can use other considerations when deciding the level of investigation required. The main considerations when making decisions about the investigation

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level are:

The level of actual harm suffered

The level of potential harm even if prevented

The likelihood of the incident reoccurring

The development of a trend of similar incidents

Whether the cause is suspicious

Whether the incident may lead to reputational damage

If there is a possibility that the staff were negligent in their duties

Is there some other cause for concern which would benefit from a more in-depth investigation?

5.5 Who receives notification of an incident?

On successful submission of an electronic form, a summary of the IR1

report is automatically emailed to:

Any pre-designated Manager for the service/location

The designated subject matter expert

The Statistics Co-ordinator

The incident holding file For all incidents rated as resulting in moderate harm of above a summary is also emailed to the:

Relevant Care Group Triumvirate and Heads of Service in the Doncaster Care Group.

Trust Serious Incident Officer.

Head of Patient Safety.

Deputy Director of Nursing and Allied Health Professions.

5.6 What To Do When You Receive Email Notification Of An Incident Occurrence

5.6.1 Designated Incident Manager

The Designated Incident Manager will log on to the system using their desk computer user name and password, which will enable them to access their services’ Manage Incidents list. When an incident on the list is clicked onto, brief details of the incident are opened and the Managers Form icon is available for the manager to click on to open the full incident form. The manager can then check all the details of the incident, amend where relevant, complete the Severity and the Incident Outcome and submit. If any other changes are required, staff can contact the Statistics Co-ordinator. The Designated Incident Manager is responsible for the management and closure of the incident report.

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The Designated Incident Manager is to consider the incident and appraise whether it has reached the criteria for a Serious Incident. If they are unsure, they are to seek advice from the Patient Safety Investigation Team. If the incident is a Patient Safety Incident, and the actual harm is of a moderate level or higher, then the Duty of Candour applies. For incidents which do not reach the threshold for Serious incidents, the manager should carry out an investigation of a scale and scope which is proportionate to the incident to ensure that resources are effectively used and conducted to identify;

The cause of the incident

Whether the incident can be prevented from occurring again

The action taken to manage the incident

Whether the actions taken were suitable and sufficient to manage the incident effectively

Any post incident actions, including further management, learning and changes to systems and practices which may prevent or mitigate a future occurrence.

Any investigation should be of a suitable thoroughness to achieve the aims above. The investigation should be based upon the Root Cause Analysis process, and may range from simple fact finding to a full investigation. The manager is to summarise the findings of the investigation in the Outcomes and Recommendation sections of the incident reporting system.

5.6.2 The Subject Matter Expert

Each incident report is forwarded to a relevant subject matter expert, for example:

Security – Trust Security Advisor

Violence – Reducing Restrictive Interventions Team

Falls – Trust Falls Prevention Lead

Sudden Collapse – Trust Resuscitation Officer The Subject Matter Expert is to read the incident report and provide assistance, guidance or other support as required to the Designated Incident Manager and/or people involved in the incident. This may include providing support or seeking further information / clarification or carrying out an investigation. Where possible this should be within 21 days of staff having received the notification for incidents of near miss – minor harm, 28 days for moderate incidents and within 60 days for severe and death incidents. The Subject Matter Expert should ensure that any learning from the

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incident has been taken and managed effectively. The Subject Matter Expert is not too close any incident other than those for which they are also the nominated manager. They should assist in any investigation which may take place into the causes and management of the incident.

5.7 What are the Time Periods for Incident Management?

Upon receipt of the email notification of an incident occurrence, the subject matter expert should review the incident and contact the manager to discuss the incident, or to provide advice on how to proceed, within 10 working days. The completion of the investigation and closure of the incident on the reporting system by the Designated Incident Manager should take no longer than 21 working days for near miss to minor harm, 28 days for moderate harm and 60 for major harm and/or death. The closure targets can be extended if the incident investigation is complex, or there is a delay in obtaining information. In cases where the incident becomes subject to any of the following:

Serious Incident process

External investigation

Investigation by the Police or Coroner

Investigation by some other statutory body. As there is no further action that the manager can take they are to close the incident making a note of the fact that the incident is now subject to one of the above. Investigation outcomes will then be subject to monitoring and reporting as detailed in section 5.11 of this policy.

5.8 Duty of Candour

In order to meet this duty the Trust must:

Act in an open and transparent way with the relevant person in relation to care and treatment provided to people who use our services in carrying out a regulated activity.

Tell the relevant person, in person, as soon as reasonably practicable after becoming aware that a notifiable Patient Safety Incident (PSI) has occurred, and provide support to them in relation to the incident, including when giving the notification.

Provide an account of the incident, which to the best of its knowledge is true, of all the facts that it knows about the incident as at the date of notification.

Advise the relevant person what further enquiries it believes are

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appropriate.

Offer an apology.

Follow this up by giving the same information in writing, and providing an update on the enquiries.

Keep a written record of all communication with the relevant person. The Trust’s Being Open and Duty of Candour Policy is available on the website and details the policy and procedures required for meeting the duty, information on offering an apology and a process flowchart to assist decision making following a patient safety incident. Further information on the Duty of Candour can be found in the Being Open and Duty of Candour Policy.

5.9 The Trust’s External Reporting Arrangements

The Trust is required to report certain types of incident to a range of external agencies. All incident reports are scrutinised by the Health and Safety Lead in order that the relevant external reporting requirements are met. The main external agencies to which the Trust reports incidents are listed below (please note this is not an exhaustive list, and advice will be taken by the Health and Safety Lead in conjunction with other relevant managers, on particular issues).

5.9.1 Health And Safety Executive (HSE)

Reporting Of Injuries, Diseases And Dangerous Occurrence Regulations (RIDDOR) 2013

RIDDOR requires the reporting of incidents of a specified nature to the Health and Safety Executive (HSE), using standard forms F2508 and F2508A.

The most common report is for injuries to staff which result in an absence from duty of more than 7 consecutive days. This requires completion of form F2508.

Dangerous occurrences such as failure of lifting equipment, explosion, and failure of supporting structures also require completion of form F2508.

The reporting of diseases requires completion of form F2508A. The disease has to be diagnosed by a Medical Practitioner.

The guidance to the regulations has appendices, which list the types of injury, diseases and dangerous occurrence that need to be reported.

The manager of the area where the incident took place is responsible for completing the RIDDOR report and forwarding it to the Statistics Co-ordinator who submits it to the HSE and copies it to the Health & Safety Lead. The Health & Safety Lead will assist and advise if required.

If there is any doubt, reference should be made to the guidance, or the

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Health and Safety Lead contacted for advice.

5.9.2 National Reporting And Learning System (NRLS)

The Statistics Co-Ordinator within the Patient Safety Investigation Team submits the relevant patient safety incident information through the e-form to the National Reporting and Learning System (NRLS). This includes the notifications which are required by law to be reported to the NRLS who will then notify the Care Quality Commission.

5.9.3 NHS Estates

The Trust is required to report incidents relating to Fire, buildings, plant and non-medical equipment to NHS Estates. Managers dealing with such incidents must contact the Head of Estates and Facilities with all the relevant information to enable the Health and Safety Lead to complete the required report form.

5.9.4 Medicines and Healthcare Products Regulatory Agency (MHRA)

Any incident relating to medical equipment should be notified formally to the MHRA using the relevant form supplied by that office. Managers in those areas affected can report directly to the MHRA. Incidents relating to adverse drug reactions are reportable on the yellow forms. Reporting can be done electronically via https://yellowcard.mhra.gov.uk/

5.9.5 NHS Resolution

Incidents where there are likely to be civil claims require, where practicable, to be notified to NHS Resolution as early as possible. Managers should inform the Patient Safety Investigation Team for Clinical Claims and the Health & Safety Lead for non-clinical claims, supported by the submission of an Electronic Incident Form (IR1) to enable as much information to be gathered prior to reporting. The Trust Claims Manager will contact NHS Resolution as appropriate.

5.9.6 Environmental Health Office And Food Standards Agency

Incidents relating to food will, in addition to being notified internally using the Electronic Incident Form (IR1) be notified to the Local Environmental Health Office of the Local Authority and the Food Standards Agency by the Catering Manager.

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5.9.7 Police

Criminal incidents will, by their nature, be reported to the police. These may include assaults, actual or threatened, theft, vandalism, suspicious activity or deaths. It is the responsibility of the person affected, or the manager on behalf of the Trust, to report the incident to the police via 101, or 999 if an emergency. If necessary the Health & Safety Team can advise and assist a member of staff or manager to report. An Electronic Incident Form (IR1) must be completed for all incidents reported to the police.

5.9.8 NHS Improvement

NHS Improvement has a statutory duty to assess, authorise and regulate NHS Foundation Trusts. Incidents of concern are highlighted to NHS Improvement by the Chief Executive Officer, Deputy Chief Executive or Trust Board Secretary as required.

5.9.9 Care Quality Commission (CQC) – Mental Health Notifications

Incident to be reported to CQC

Trust policy to be referred to for full detail of reporting requirements.

Detail of Regulation under which this reporting requirement falls.

The death of a patient detained or liable to be detained under the Mental Health Act 1983.

Learning from Deaths Policy

Regulation 17 of the Care Quality Commission (Registration) Regulations 2009.

The unauthorised absence of a patient detained or liable to be detained under the Mental Health Act 1983 from a secure ward.

Policy for Service Users who are Absent Without Leave (AWOL).

Regulation 17 of the Care Quality Commission (Registration) Regulations 2009.

Any application and outcome made to a supervisory body in relation to depriving a service user of their liberty.

Deprivation of Liberty Safeguards Policy

Regulation 18 of the Care Quality Commission (Registration) Regulations 2009.

The admission of a child or young person to an adult psychiatric ward or unit.

Policy for the Care and Treatment of Children under the age of 18 on Adult Acute Mental Health Inpatient Areas.

Regulation 18 of the Care Quality Commission (Registration) Regulations 2009

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The following must be reported directly to the CQC without delay:

For deaths of detained patients and the admission of a child or young person to an adult psychiatric ward or unit, the Mental Health Act Manager is responsible for notifying the CQC. For service users who are absent without leave from a secure ward, the Nurse in Charge is responsible for notifying the CQC. See Patients who are Missing or Absent Without Leave (AWOL) Policy.

5.9.10 Regulatory Bodies For Professionals

Reporting to regulatory bodies for professionals including the:

General Medical Council (GMC)

Nursing and Midwifery Council (NMC)

Health and Care Professions Council (HCPC) are dealt with under the employment policies route by the Human Resources Department in conjunction with the relevant senior manager, Medical Director or Director /Deputy Director of Nursing and Allied Health Professions.

5.9.11 National Clinical Assessment Service (NCAS)

Referrals to the National Clinical Assessment Service (NCAS), whose role is to help resolve performance concerns about dentists, doctors and pharmacists, are dealt with under the employment policies route by the Human Resources Department in conjunction with the relevant senior manager.

5.9.12 NHS England (Via STEIS)

Serious Incidents (SIs) are reported via the Strategic Executive Information System (STEIS). Incidents are reported to the Serious Incident Officer who is part of the Patient Safety Investigation Team. Please refer to section 5.10.5 of this policy for guidance on serious incidents which may meet the criteria for STEIS reporting.

5.9.13 NHS Counter Fraud Authority (Formerly NHS Protect) In accordance with NHS Counter Fraud Authority requirements, incidents

of fraud, corruption, and security breaches should be reported via the Local Counter Fraud Specialist. For further guidance see the Counter Fraud, Bribery and Corruption Policy. The Local Security Management Specialist (LSMS) will report incidents of and theft, damage, security breaches and violence and aggression against staff to NHS Counter Fraud Authority.

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5.9.14 Information Commissioner

Level 2 Information Governance Serious Incidents (SIs) are required to be reported to the Information Commissioner by the Head of Information Governance / Data Protection Officer. For further guidance see the Checklist for Reporting, Managing and Investigating Information Governance Serious Incidents (DoH, 2010) contained within the Standard Operating Procedure for the management of Information Governance Serious Incidents Requiring Investigations (IG SIRI).

5.9.15 Coroner’s Office

In the following cases if the death has not already been reported to the coroner by another agency such as the police there is a statutory duty on healthcare providers to refer the death to the local coroner :

Suicide of an inpatient

Suicide of a person within 6 months of discharge from service

If the deceased was subject to detention under MHA 1983 including Community Treatment Orders.

If the deceased was under 18

If the death was due to occupational injury/disease

If the death is due to homicide

If the death is unexplained.

This list is not exhaustive, and if there is any doubt advice should be sought from the local Coroner’s office.

5.9.16

Death of a Person with a Learning Disability Deaths of patients with a diagnosis of Learning Disability are the be reported by the Service Manager to the LeDeR programme via the online reporting tool at; http://www.bristol.ac.uk/sps/leder/ A local review is to be completed as soon as practicable using the Mortality Review

5.10 Investigation Process

5.10.1

Mortality Reviews Concern about patient safety and scrutiny of mortality rates has intensified with investigations into NHS hospital failures that have taken place over the last few years. As a result there is an increased drive for NHS Trust boards to be assured that deaths are reviewed and appropriate changes made to ensure patients are safe, and the Trust has in place a Learning from Deaths Policy to which staff are to refer for detailed guidance on undertaking mortality reviews.

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All deaths of patients for whom we are the main provider (as defined in the Learning from Deaths Policy, see quick ref flow chart in appendix 2) are to be reported using the IR1 online reporting form. It is required whether a patient is an inpatient or out patient, and includes all patients who die within 6 months of discharge from our services. In brief the review requirements under the Learning from Deaths Policy are as follows:

Unexpected deaths, or deaths which meet the criteria of the Coroner – Staff are to follow the structured review process as set out in this policy. Expected deaths due to natural causes - IR1 to be reviewed by at least a Band 7 manager to ensure the death was expected, and that the care provided by the Trust was suitable and sufficient.

No concerns noted – IR1 to be closed down by the Manager.

Issues identified – Structured review to be undertaken.

Unexpected deaths, but due to natural causes - Structured review to be undertaken. The Trust has in place a mortality reporting and review process to identify any shortcomings in care provision or systems, and provide assurance to the Trust board that deaths are effectively reviewed.

5.10.2 5.10.3

Review of Pressure Ulcers Graded at level 3 or above. For full guidance staff are to refer to the Trust Pressure Ulcers: Detection, Prevention and Treatment Policy but in brief when a pressure ulcer is categorised as a level 3 or above a full review undertaken and recorded on the Root Cause Analysis pressure ulcer form. Once completed the pressure ulcer RCA form is submitted to the Trust pressure ulcer review panel. Pressure ulcer reviews are reported to the Care Groups via the monthly patient safety DASH Boards. Incidents rated Low which don’t reach the Duty of Candour threshold. These are usually the least serious and the most frequently reported incidents. They will usually be reviewed and managed within the Service. The Designated Incident Manager (or nominated deputy) of a team will:

Review the grading and actions already taken identified on the Incident Report Form (IR1), check the accuracy and completeness of the report.

Complete the Risk Matrix to ascertain the suggested level of

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investigation.

In most cases the incident will have been effectively managed and adequate actions taken by the staff present at the time as recorded on the Incident Report Form. The manager is to make an entry in the Managers outcome section confirming that the incident was effectively managed and what, if any, further actions are required.

If further investigation or actions are needed the manager will nominate a member of staff (if not themselves) to carry out this task and report back.

Seek advice and support from Subject Matter Experts as necessary.

Ensure any further investigation is completed and that any necessary changes are implemented.

Complete the manager’s outcome section on the IR1 with the outcome of the investigation.

Record any additional learning.

Inform the senior manager for the service of any significant learning or service improvement for sharing with other teams and services.

Escalate any risks/issues to Service Manager.

Feedback to any staff members involved. However if any themes or trends are identified from low rated incidents a thematic structured review should be undertaken by the Trust central investigation team.

5.10.4. Incidents rated Moderate or above which meet the Duty of Candour Threshold All incidents rated at this level which are not subject to review via :

Mortality review

Pressure Ulcer review panel Will have a structured case review completed. The incident is to be reported on the IR1 system in the usual way. Within 3 working days the Care Group Director will allocate a minimum of 2 case reviewers at band 7 or above, one of whom must be from outside the team directly involved in the incident to undertake a structured case review. Staff leading the Structured Review will be trained in RCA, and/or have a high level of investigating experience. The structured review tool is an excel workbook which is available on the L Drive as follows:

Access the L drive.

Click on the SI file.

Once in the SI file click on Structured Review.

In this file you will find a folder for each Care Group.

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Save a copy of the Master structured review workbook in the relevant year folder under the incident number and it is this copy that the review details are to be entered onto.

Review outcomes. The outcome of the structured review will determine if any further investigation is required and the reviews will be rated as follows:

A – No areas of concern found in relation to care delivery, or acts/ omissions of staff.

B – Some low level concerns identified which can be addressed through individual or team reflection with the ward/team manager.

C - Concerns identified which whilst not felt to have directly impacted on the outcome of the incident are felt to require a table top review with an external facilitator. In these cases the review will be facilitated by one of the Trust Lead Investigators.

D - Significant concerns have been identified which require a full Serious Incident Review to be undertaken.

Sign of process for the Structured Reviews. Once the structured review has been completed it is to be reviewed and signed off by the Modern Matron/ Team Manager who will then inform the Care Group Director that it is ready for them to review and sign off. If the Care Group Director is satisfied that the Structured Review has considered all issues and a robust decision made they are to sign it off and notify the Serious Incident Officer that they have signed it off for review by the central investigation team. In the event of the Care Group Director having any queries or feeling information is missing in relation to the structured review they are to contact the Modern Matron / Service Manager who did the first stage of the sign off to discuss their findings and agree what steps need to be taken and the time frame for completion in relation to addressing any queries or gaps in information. The structured review should be fully completed and signed off by the Care group within 28 days of the incident having occurred unless it is a severe incident which is within 60 days. In the event that the required days are to be breached for any reason the Care Group Director is to notify the Serious Incident Officer. Once the Structured Review has been signed off by the Care Group Director it will be reviewed by the Central Investigation Team at their morning meeting. The result of this review can be:

Decision of Care Group felt to be proportionate with the right level of action/ learning taken. In this case no further action will be required.

That further information is needed in relation to some aspects of the Structured Review. In this case a full Serious Incident Investigation will

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be undertaken. However the remit of the Serious Incident Investigation will be to concentrate on the aspects of the Structured Review where gaps in information or concerns had been identified.

Identification of themes or cluster incidents occurring across more than one Care Group which require a Serious Incident Investigation.

5.10.5 Serious Incidents

The occurrence of a Serious Incident may demonstrate weaknesses in a system or process that need to be addressed to prevent future incidents. Serious Incidents may lead to avoidable death or serious harm to patients or staff, future incidents of abuse to patients or staff, or future significant reputational damage to the organisations involved. Serious Incidents therefore require investigation in order to identify the factors that contributed towards the incident occurring and the fundamental issues (or root causes) that underpinned these. Serious Incidents can be isolated, single events or multiple linked or unlinked events signalling systemic failures within a commissioning or health system.

There is no definitive list of events/incidents that constitute a Serious Incident (and lists should not be created locally as this can lead to inconsistent or inappropriate management of incidents). Where lists are created there is a tendency to not appropriately investigate things that are not on the list even when they should be investigated, and equally a tendency to undertake full investigations of incidents where that may not be warranted simply because they seem to fit a description of an incident on a list. The definition below sets out circumstances in which a Serious Incident must be declared.

Every incident must be considered on a case-by-case basis using the description below. Inevitably, there will be borderline cases that rely on the judgement of the people involved. Serious Incident Definition Acts and/or omissions occurring as part of NHS-funded healthcare (including in the community) that result in:

Unexpected or avoidable death of one or more people. This includes; o suicide/self-inflicted death; and o homicide by a person in receipt of mental health care within the

recent past

Unexpected or avoidable injury to one or more people that has resulted in serious harm;

Unexpected or avoidable injury to one or more people that requires further treatment by a healthcare professional in order to prevent:

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o the death of the service user; or o serious harm;

Actual or alleged abuse; sexual abuse, physical or psychological ill treatment, or acts of omission which constitute neglect, exploitation, financial or material abuse, discriminative and organisational abuse, self-neglect, domestic abuse, human trafficking and modern day slavery where:

o healthcare did not take appropriate action/intervention to safeguard against such abuse occurring, or

o where abuse occurred during the provision of NHS-funded care.

A Never Event - all Never Events are defined as Serious Incidents although not all Never Events necessarily result in serious harm or death. ( please refer to appendix 3 for the current list of never events)

An incident (or series of incidents) that prevents, or threatens to prevent, an organisation’s ability to continue to deliver an acceptable quality of healthcare services, including (but not limited to) the following:

o Failures in the security, integrity, accuracy or availability of information often described as data loss and/or information governance related issues

o Property damage; o Security breach/concern;

Incidents in population-wide healthcare activities like screening and immunisation programmes where the potential for harm may extend to a large population;

Inappropriate enforcement/care under the Mental Health Act (1983) and the Mental Capacity Act (2005) including Mental Capacity Act, Deprivation of Liberty Safeguards (MCA DOLS);

Systematic failure to provide an acceptable standard of safe care (this may include incidents, or series of incidents, which necessitate ward/ unit closure or suspension of services); or

Activation of Major Incident Plan (by provider, commissioner or relevant agency)

Major loss of confidence in the service, including prolonged adverse media coverage or public concern about the quality of healthcare or an organisation

For further detail and explanation, please see the NHS England Serious Incident Framework. At the time of writing this policy, the Framework can be found on the NHS England website: https://www.england.nhs.uk/ . Once identified as a Serious Incident it then becomes the responsibility of the Director of Nursing & Allied Health Professions, and any further investigation beyond the Structured review will be undertaken by a Lead Investigator based in the Patient Safety Investigation Team. In some cases an investigation team may need to be established consisting of suitable

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specialists, a medical advisor etc. to ensure the investigation is thorough and encompassing. These are defined in the Serious Incident Framework as Grade 2 - Level 2 Comprehensive RCA Investigations. For all serious incident investigations the investigation terms of reference will be clearly defined and in all cases include the following:

For inpatient services the staffing levels at the time of the incident (please note this will be for all disciplines)

Staffing levels and caseload numbers for community services.

Review and analysis of staffing levels at the time of the incident (all clinical staff not just nurses).

For inpatient services the level of clinical activity on the ward at the time of the incident and consideration of general patient dependency and acuity.

Determination as to whether or not the staffing levels were sufficient to meet patient /service need.

Analysis of any impact staffing levels had on the incident.

5.10.6 Very serious incidents These will include but may not be restricted to incidents such as homicides. In these cases an internal serious incident investigation will be undertaken by one the Trust Lead Investigators, which will be followed by an independent investigation managed by the Director of Nursing and Allied Health Professions and the CEO Office on behalf of the Trust Board. The requirement for an independent investigation will be decided by NHS England, the CCG or the Chief Executive Officer. NHS England, the CCG, the Trust and other organisations should come to local agreement with respect to arrangements for funding and supporting independent investigations. An early meeting with all the stakeholders involving the senior manager should take place to agree a common approach to:

The timing of investigation

Sharing of information, including issues of confidentiality

Communication with families, carers, staff and media. The Trust would be responsible for obtaining service users’ consent for release of their notes to the investigation team. These incidents are classed as Grade 2 – Level 3 Independent Investigations within the Serious Incident Framework (2015).

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5.10.7 Guidance on the Preservation / Recording of Evidence. When undertaking any level of investigation it is important that all evidence used to inform decision making is obtained as close to the event having taken place as is possible. Whilst the evidence used will vary dependent on the nature of the event and type of investigation undertaken steps must be taken to ensure that the evidence is well documented and accurate. Below are examples of evidence types, but this is not an exhaustive list. Scenes of Crime. In any incident which is suspected to be as a result of a crime the area is to be immediately secured, and nothing touched, or moved until Police permission is given to do so. Memory Capture. This differs from a statement in that it is where staff are asked to make a written record of a whole shift and the event that took place, not just the actual incident. There is no structure to it as it is important that the staff member records their memory of the shift and things that stood out to them. It needs to be as soon as possible following the event .and is a useful way for an investigator to gain a wider understanding of what was happening leading up to an incident. Photos. The use of photos is useful as it enable a visual presentation of key aspects of an investigation. However when using photos it is important that:

The photos are taken with a camera that records the date it was taken.

If measurements are to be included in the investigation report the photos should be taken with a ruler or tape measure in place to show size, depth etc.

Devices. Where any incident involves the failure of any equipment, medical device, furniture or fabric of a building, where possible, and if safe to do so photos should be taken and the item/area must be immediately cordoned off, access controlled and advice sought from the Trust Health and Safety Lead/Team. Staff statements. If staff are asked to provide a written statement in relation to an incident :

The investigator must be clear as to why the statement is being requested, the parameters of the statement content, and how the information in the statement will be used.

The staff member is to be reminded to only state fact in their statement and not to relay on hearsay or opinions that cannot be backed up by clinical evidence.

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All statements used in an investigation must be signed by the staff member and dated.

Staff interviews. Interviews are useful in that they enable the investigator to question for further detail and clarify verbal statements or reasons for actions having been taken. At all interviews a record is to be made of the discussion that takes place. These notes are to be typed up and a copy sent to the staff member for them to check the content accuracy. The staff member should then be asked to return a signed copy to the investigator. Should any amendments be requested the staff member is to make these on the copy they received, sign the amendments and return to the investigator. If the investigator agrees with the amendments these are to be made and a new copy of the interview records issued to the staff member for them to sign and return. The copy of the interview notes with the staff member’s amendments on will be scanned into the investigation file. In the event that the investigator does not agree that the requested amendments reflect the discussion which took place at the interview the investigator should in the first instance speak with the staff member to agree the amendments. If agreement cannot be reached advice is to be sought from HR.

5.10.8 Action to take if during the course of a Serious Incident Investigation concerns are identified in relation to a staff members clinical practise, behaviour or attitude. In these circumstances the Lead Investigator must immediately inform the persons line manager so that a decision can be made in relation to any clinical risk posed and required action to mitigate any identified risk. In the absence of the staff members line manager the Care Group Director or Associate Nurse Director are to be informed. If the concerns relate to a member of medical staffing the Associate Medical Director for the Care Group is to be contacted or in their absence the Trust Medical Director. If it is an agency staff member contact must be made with the employing agency to inform them of the concerns that have been identified.

5.10.9 Undertaking a Serious Incident Investigation which is also subject to a Police investigation. There will be some incidents which the Trust needs to investigate that are also subject to a criminal investigation by the Police. In these cases it is important that no action is taken by the Trust which could be seen as

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tainting / interfering with evidence and as a result potentially jeopardise any future court trail. However it is also not acceptable for no action to be taken due to the incident being subject to a police investigation as following any incident the Trust is responsible for ensuring its policies and processes promote safe service delivery. Therefore the Lead Investigator must :

Undertake a clinical records/document review.

Establish contact with a named police officer with whom they can liaise as to the progress/timeframes of the police investigation. A record is to be kept of all contact with the police, including what was asked and the response provided.

Establish if there are any staff they can interview as part of the Trust investigation who are not part of the police investigation.

Ascertain with the police if they are able to undertake staff interviews within the parameters of a pre agreed set of interview questions.

5.10.10 Conducting Investigations when other health care providers are also involved. In cases where more than one organisation is involved in the care and service delivery the organisation which initially identifies the serious incident is responsible for alerting other providers, commissioners and partner organisations and initiating a discussion about any required investigation and subsequent action. Where possible and appropriate all organisations and agencies involved in care delivery should work together to undertake a single investigation. If due to the complexities of the case a single investigation is not possible separate investigations will be undertaken by each organisation. However in this case it is important that investigators inform partner organisations of any issues identified which are as a direct result of their processes or staff actions.

5.10.11 Management of a Serious incident Investigation which is also subject to a formal complaint. In these cases the Lead Investigator will undertake one investigation, the findings of which will inform both the Serious Incident report and complaint response. Where appropriate the Lead Investigator will also agree with the complainant how much of their complaint will be answered as part of the SI investigation and subsequent report, and what aspects will require a separate response due to being outside the remit of the SI investigation. It will also be made clear to the complainant that the response to the compliant is unlikely to be issued within the 40 day time period as we won’t

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be in a position to fully answer their compliant until the SI investigation is concluded.

5.10.12 Serious Health and Safety Incidents All health and safety incidents must be reported via the Trust’s electronic IR1 form using the Ulysses incident reporting system. However, there is a legal requirement to report serious incidents externally to the Health and Safety Executive (HSE). Serious health and safety incidents include deaths, some types of serious injury, some occupational diseases and dangerous occurrences that arise as a result of or in connection with work activities. This would include injuries to staff as well as patients, visitors and any other person who is injured as a result of Trust work activities. For example, if a visitor falls over a wheelchair left in a corridor and is injured. If the person is taken directly to hospital due to the injury, this would be reportable to the HSE. However, if the person did not want to go to hospital, a report to HSE would not be required. The criteria for reporting to HSE would be that there was an injury and the injured person went directly to hospital from the location where the injury occurred.

5.11 Serious Incident Action Plans.

5.11.1 Action Plan development. For any investigation which is undertaken independently of the Care Group the investigator will make recommendations based on their investigation findings, and it is the responsibility of the Care Group Triumvirate to work in conjunction with the relevant ward/service manager to put in place an action plan to address the recommendations which meets the principles of being

SMART.

Specific

Measurable

Achievable

Realistic

Timely

5.11.2 Monitoring of Action Plan Implementation. The Care Group Director will be responsible for submitting a copy of the action plan to the Trust Central Investigation team. All action plans will be held on a central data base, and the Serious Incident Officer will be responsible for :

Alerting the relevant action lead of any actions they are responsible for which are due for completion.

Seeking an explanation as to why any actions will not be completed within the agreed timeframe.

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Escalating to the Head of Patient Safety any actions which will not be completed in the agreed timeframe so that there can be a review of any risk posed as a result of the slippage on completion.

Where required gathering and archiving evidence of action plan completion.

On a monthly basis undertaking a random audit of completed actions plans to test the evidence of completion

5.11.3 Reporting of Action Plan Implementation. Compliance of action plan completion is reported to the Quality Committee on a monthly basis in the Serious Incident report.

5.11.4 Process for the Sign off of Homicide Action Plans

All Homicide reports and associated action plans are filed centrally within

the Trust Investigation Team. A month prior to the date any action is due

for completion the Trust Investigation Team will liaise with the relevant

Group Director to collate evidence of completion against any due actions.

Once all the evidence has been logged onto the central data base against

each action on the plan the following steps will be undertaken:

Step 1 = The evidence will be reviewed by the central investigation team

and cross referenced to the relevant actions. Where gaps in evidence are

found a request will be made to the Care Group Director for further

evidence to be provided.

Step 2 = Service visits will be undertaken by staff from Nursing and

Quality in conjunction with an Associate Nursing Director from outside the

Care Group where the incident occurred to test the evidence in practice.

Step 3 = A briefing reports of the findings from Step 1 & 2 will be

prepared. The report will highlight assurance of completion of actions, gaps

and actions taken to mitigate any gaps in evidence.

Step 4 = Briefing report to be reviewed by the Medical Director and

Director of Nursing to determine if the evidence of action completion is

robust enough to recommend closure of the action plan. The relevant

Group Director and Chief Operating Officer will be notified of the outcome

from this review.

Step 5 = Report will be presented to the Quality Committee detailing the

review findings and recommendation that the action plan is either closed or

requires further work to be undertaken within the service.

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5.12 Involving Relatives and Carers in Investigations. If the incident is subject to a full serious incident investigation the lead investigator will make contact with the person and or their family to offer them the opportunity to both contribute to the investigation and ask any questions they may have in relation to the incident. As it is likely that the patient/family will have already established a relationship with the nominated contact person from the clinical services it is advisable that at least in the first instance a joint visit is undertaken. Once the lead investigator has established the patient /family expectations of the investigation they will be responsible for :

Agreeing the level of contact they wish to receive.

Keeping them updated as to the progress of the investigation at the agreed times.

Ensuring that any questions they raised have either been answered, or that they have been provided with a full explanation as to why their queries could not be addressed as part of the investigation.

Feeding back the outcome of their investigation. If the initial or further contact is declined by the person or their family, further attempts at contact are to be made, and a record kept of when and how contact was attempted. This may be in the form of a letter on conclusion of the investigation to let them know that the Trust is now in a position to share the investigation outcome with them, and who to contact to make the necessary arrangements to receive this feedback.

5.13 Support to Staff involved in a serious incident

5.13.1 Immediate support. At the time of the incident the most Senior Person on duty will be responsible for identifying any immediate support needs that the staff may have this may include the following:

Attendance at the local accident and emergency department.

Administration of first aid.

Emotional support.

Support during any police interviews.

Arranging additional staffing from adjacent wards.

Enquiring if staff on the next shift can come in early.

Arrangements being made for them to leave duty.

5.13.2 Addressing longer term support needs.

As each individual staff member will respond differently to a traumatic event it is important that line managers are alert for any signs of stress that may be exhibited by staff. This can include but is not limited to :

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Tearfulness.

Expressed feelings of guilt.

Impaired concentration.

Expressed frustration/anger.

Increased sensitivity.

Avoidance of certain role responsibilities that the staff member had previously been confident to undertake.

Reported sleep disturbance.

Reported loss of appetite.

Reluctance to make clinical decisions. Regardless of whether a staff member involved in a serious incident is exhibiting any of the above they must be offered the following options for gaining support.

Formal incident debrief either on a 1-1 or team basis, or both with a facilitator external to the team.

Option of increased 1-1 supervision for a period of time.

Referral for counselling.

Changes to shift patterns on a fixed term basis

5.14 Support to other service users who may be affected by an incident. If an incident occurs on an inpatient ward it is likely that other patients may be distressed either as a result of having directly witnessed the incident or due to them having formed an acquaintance with the patient involved in the incident. In these circumstances it is important that ward staff:

Provide them with the opportunity to discuss how they feel, and ask any questions they may have.

Agree with them what ongoing support they may need,

Review the risk assessment.

Consider if the incident has any impact on the patients risk profile, including the potential risk of copying behaviour.

5.15 Support to Relatives and Carers.

Once the immediate response to an incident has been progressed (i.e. no later than on the following working day) a senior staff member should be confirmed by the Care Group Director as responsible for communicating with the person involved in the incident and or their family. The selection of this person should take into account the family’s feelings and any communication needs they may have and possess the skills to enable

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them to act with openness and empathy. In the event of the incident progressing to a full Serious Incident investigation the person nominated as the family contact person by the Care Group Director will work with the lead investigator to provide ongoing support and continuity. In the case of a patient death due to suspected suicide the relative is to be provided with a copy of the booklet “Support for Families and Carers following a sudden death.” It is also important that the patient / family are made aware of what additional support is available to them this can include:

Advocacy services.

Access to interpreters.

Access to local support groups.

Consideration as to whether or not the relative may require a referral into services for bereavement counselling /anxiety management.

In the case of a relative/ carer who is already in receipt of Trust services contact is to be made with their relevant Care Coordinator / clinical team to alert them to the fact that the person may require additional support and/or review of their risk assessment.

5.16 Learning from incidents. A key outcome from the investigation of incidents is for the organisation to critically evaluate the care provided and extract learning which can be shared to minimise the risk of a similar incident occurring . However it is recognised that this learning has to take place across all levels in the Trust and be provided flexibly to meet the needs of a diverse workforce. In addition learning needs to be shared with external agencies, including the local commissioners. Within the Trust there are number of ways in which learning form incidents is shared and these can be seen in appendix 4.

5.17 Incident Reporting and Monitoring Arrangements. All incidents reported on the IR1 system are monitored by the Patient Safety Team and the following data is included on the monthly Patient Safety Dashboards which go to each Care Group for discussion in their Governance meetings and at the ward/ clinical team meetings.

Total number of incidents reported by level of harm.

Number of unclosed incidents.

Compliance with the Duty of Candour requirements.

Number of serious Incidents by category.

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Number of action plans in place from SI investigations, and the number of actions that are overdue.

From the Care Groups the Dashboards go to the Quality Operational Management meeting, and are shared with the local commissioners at the monthly quality meetings, and amalgamated into a Trust wide quarterly patient safety Dashboard which is presented to the Trust Quality Committee. The Quality Committee also receives a monthly SI report, and as required outcome reports from table top reviews and deep dive reports.

In addition the following reporting arrangements are also in place:

Mortality reports are presented to the Mortality Review Group.

Pressure Ulcer data and review outcomes is included in the patient safety Dashboard, and presented to the Pressure Ulcer Harm minimisation steering Group.

5.18 Dealing with Media Enquiries. The Head of Communications will be briefed by the Head of Patient Safety or the relevant Care Group Director concerning incidents which may attract media interest. The Head of Communications or a team member will be responsible for the preparation of a “press statement” which will be approved by the relevant director/s. The Communication Team will work closely with organisational staff to determine the precise nature, frequency and content of such communication.’

5.19 Staff Who Wish to Raise a Concern. There may be occasions when a member of staff witnesses or becomes aware of something within the Trust that gives them cause for concern. In these circumstances the member of staff should:

Make an immediate note of their concern, recording relevant details such as what was said/ witnessed, date, time and details of other people involved.

Raise their concern with their Manager and/or refer to the Trust’s Freedom to Speak Up Policy which provides further guidance.

6 TRAINING IMPLICATIONS

It is important that all staff involved in the incident management process are familiar with this policy and that its purpose and principles are well understood and the associated procedures are rigorously applied. All Lead Investigators are required to have attended the Root Cause Analysis Training prior to undertaking an investigation.

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It is advantageous for all incident investigators, whether SIs or not, have had Root Cause Analysis training.

The Root Cause Analysis Methodology is a structured team based approach, which when used correctly, can benefit all stakeholders involved in providing care and treatment to patients. The objective of this approach is to develop learning and open culture where staff are proactive and committed to continuously improving safety. The Trust provides RCA training to equip staff with the right tools to:

Gather and organise information

Establish good clinical practice

Analyse and define the problem

Understand and locate the root cause of the problem

Put corrective action into place

Monitor progress

Learn and share experiences The key tools (see RCA Tools available on the Intranet) introduced are:

The Time and Tabular Timeline

The 5 Why’s

The Incident Decision Tree

Change analysis

The Nominal Group Technique and Ranking

The Fishbone

The Learning & Development Department delivers the Root Cause Analysis training and will provide bespoke training to groups and individuals on request.

7. MONITORING ARRANGEMENTS

Area for Monitoring/ Type of report

How Who By Reported to Frequency

SI Monthly Report

Report Head of Patient Safety

Care Group Quality Governance meetings.

Quality Operational management meeting.

Executive Management Team

Quality Committee

Monthly

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Area for Monitoring/ Type of report

How Who By Reported to Frequency

Performance Management Action Plans

Report Head of Patient Safety

As above. Monthly

Quarterly status update report

Report Head of Patient Safety

Commissioners - DCCG - RCCG

Quarterly Bi-monthly

Dashboard Report Head of Patient Safety

Care Group Quality Governance meetings.

Quality Operational management meeting.

Executive Management Team

Quality Committee

Monthly & Quarterly

8. EQUALITY IMPACT ASSESSMENT SCREENING

The completed Equality Impact Assessment for this policy is published on this Policy’s webpage of the RDaSH Website. 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

No issues have been identified in relation to this policy.

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

Indicate How This Will Be Achieved.

All individuals involved in the implementation of this policy should

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Therefore, the Trust is required to make sure that all staff working with individuals who use our service is 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.

do so in accordance with the Guiding Principles of the Mental Capacity Act 2005. (Section 1)

9. LINKS TO ANY ASSOCIATED DOCUMENTS

Being Open and Duty of Candour Policy

Claims Handling Policy

Clinical Risk Assessment and Management Policy

Complaints Handling Policy

Deprivation of Liberty Policy

Disciplinary Policy

Freedom to Speak Up Policy

Health and Safety Policy Statement

Healthy Workplaces: Staff Support and Stress at Work Policy

Mental Capacity Act Policy

Patients who are Missing or Absent Without Leave (AWOL) Policy

Risk Management Strategy

Safe and Secure Handling of Medicines Policy

Safeguarding Adults Policy

Safeguarding Children Policy

Standard Operating Procedure for the Management of Information Governance Serious Incidents Requiring Investigation (IG SIRI)

10. REFERENCES

Care Quality Commission, (2015). Guidance for providers on meeting the

regulations.

Dangerous Drugs, England and Scotland - Instrument No. 3148 The Controlled Drugs (Supervision of Management and Use) Regulations 2006 .

Department of Health, (2007). Safer Management of Controlled Drugs – A Guide to Good Practice in Secondary Care.

Department of Health, (2015).Checklist Guidance for Reporting, Managing and Investigating Information Governance and Cyber Security Serious Incidents Requiring Investigation. V 5.1.

Rotherham Doncaster and South Humber NHS Trust, (2017) Deprivation of Liberty Policy, v5.1.

Rotherham Doncaster and South Humber NHS Trust, (2017) Mental Capacity Act 2005 Policy, v4.

Institute for Healthcare Improvement, (2006). Leadership Guide to Patient Safety.

NHS Yorkshire and the Humber Procedure for the management of Serious Incidents (SIs)-Version 6 – October 2010

NHS Yorkshire and the Humber Commissioning of Independent

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Investigations Policy Statement

NHS Yorkshire and the Humber learning the lessons from ‘extreme’ SIs: How do we ensure that it couldn’t happen here…? December 2009.

NHS Improvement, (2015). Serious Incident Framework March 2015.

NHS Improvement, (2018). Never Events Policy and Framework.

NPSA, (2009) .Being open – Communicating patient safety incidents with patients and their carers.

NPSA, (2010) .Information Resource to Support the Reporting of Serious Incidents.

NPSA, (2010). National Framework for Reporting and Learning from Serious Incidents Requiring Investigation

NPSA ,(2008).Independent Investigation of Serious Patient Safety Incidents in Mental Health Services; Good Practice Guidance

11. APPENDICES

App. 1 Mortality reporting and review process

App. 2 Categories for reporting death on the Ulysses IR1 system

App. 3 Definition of Never Events (2018)

App. 4 Quick reference flow chart for Incident oversight and how the organisation learns from incidents

App. 5 RIDDOR reporting process for serious non-clinical incidents

App. 6 Quick reference guide to incident reporting/ investigation

MORTALITY REPORTING AND REVIEW PROCESS

For all deaths of

under 18 years

Follow Safeguarding Children process detailed within the

Safeguarding Policy

For unexpected unnatural deaths (UU) or deaths which meet the

criteria of the coroner

Team manager logs an incident on the risk system and escalates to the Trust

Patient Safety Team within 24 hours

If notification form has not already been done, the coroner must be informed of the death if

patient is:

• Patient suicide • Suicide of a person within 6 months of

discharge from service • Subject to detention under MHA 1983

including Community Treatment Order (CTO)

• Subject to Deprivation of Liberty Safeguards

• Under 18 years • Deceased due to occupational

injury/disease

Full SI investigation to be undertaken =

Follow SI process and time frames

IR1 Closed

For expected deaths due to natural causes ( EN1 &

EN2)

IR1 to be reviewed by at least Band 7 manager to ensure

death was expected, and that the care provided by the Trust was suitable and

sufficient.

Issues identified

Manager to complete IR1 –

documenting the review.

Yes

No

Assessed that full SI

investigation needed?

Request to be made to Clinical Service

Manager for investigator to be nominated

Concise RCA to be completed within 4 weeks and completed form submitted to Trust

Patient Safety Team and attached to IR1

IR 1 to be reviewed by Mortality Review Group members (virtual review

with a minimum of 2

responses)

Death reported to the coroner,

other than industrial disease?

For unexpected deaths, but due to natural causes (UN1 & UN2)

and expected deaths due to unnatural causes (EU)

Yes

Yes

No

No

Clinical services receive notification of death for a

patient where we are the primary care provider IR1 form completed and manager informed

Appendix 1

CATEGORIES FOR REPORTING DEATH ON THE ULYSSES IR1 SYSTEM

Appendix 2

Clinical Services Receive Notification of Death for a

Patient Where We Are Primary Care Provider

CATEGORY DEFINITION GUIDE REVIEW GUIDE

Expected Natural (EN1) Deaths that were expected to occur in an expected

time frame. E.g. people with terminal illness or in palliative care services.

Reviewed by Band 7 Manager to ascertain that the categorisation is correct and no care issues are of

concern.

Expected Natural (EN2) Deaths that were expected but were not expected to happen in that timeframe. E.g. someone with cancer

who dies earlier than anticipated.

Reviewed by Band 7 Manager to ascertain that the categorisation is correct and that there are no suspicious

circumstances or care issues.

Expected Unnatural (EU) Deaths that are expected but not from the cause

expected or timescale e.g. some people on drugs or dependent on alcohol.

Reviewed by Mortality Review Group to ascertain that categorisation is correct and whether SI, RCA level or

local review is required.

Unexpected Natural (UN1) Unexpected deaths which are from a natural cause

e.g. a sudden cardiac condition or stroke.

Reviewed by Mortality Review Group to ascertain that categorisation is correct and whether SI or RCA level

review is required.

Unexpected Natural (UN2) Unexpected deaths which are from a natural cause

but which didn’t need to be e.g. some alcohol dependency and where there are care concerns.

Reviewed by Mortality Review Group to ascertain that categorisation is correct and whether SI or RCA level

review is required.

Unexpected Unnatural (UU) Unexpected deaths which are from unnatural causes

e.g. suicide, homicide, abuse or neglect. Reviewed by SI process

No Information Available Class as Unexpected Unnatural (UU) until clarification

obtained.

Reviewed by Mortality Review Group to ascertain that categorisation is correct and whether SI or RCA level

review is required.

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Appendix 3 Appendix 1

Never Events as defined by NHS Improvement 2018.

Surgical Wrong site surgery Wrong implant/prosthesis Retained foreign object post procedure Medication Mis selection of a strong potassium solution Administration of medication by the wrong route Overdose of insulin due to abbreviations or incorrect device Overdose of methotrexate for non-cancer treatment Mis-selection of high strength midazolam during conscious sedation Mental health Failure to install functional collapsible shower or curtain rails General Falls from poorly restricted windows Chest or neck entrapment in bed rails Transfusion or transplantation of ABO-incompatible blood components or organs Misplaced naso- or oro-gastric tubes Scalding of patients Unintentional connection of a patient requiring oxygen to an air flowmeter Undetected oesophageal intubation (temporarily suspended as a Never Event).

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Appendix 4 Quick Reference Flow Chart For Incident oversight and how the Organisation Learns from

Incidents How outcome/themes and lessons learnt are shared.

IR1 generated by staff member who witnessed the incident and severity of harm graded

Monthly Patient Safety Dash Boards Dash Boards discussed at the Care Service Quality meetings

Weekly patient

safety messages.

Staff supervision

Themes and

scenarios used to

inform staff

Staff Debrief/

Feedback sessions

Near miss – Minor (minimum harm) Minor (minimum harm) Moderate harm or above

The IR1 system automatically issues a copy of the IR1 Form to the relevant ward / service / department manager. In addition the system is programmed to also forward specific categories of incidents to designated leads within the Trust for example:

All incidents rated moderate or above

go to the members of the relevant

Care Group triumvirate, Trust Serious

Incident office, Head of Patient

Safety, Heads of Services for

Doncaster and the Deputy Director of

Nursing and Quality

Falls – Trust Designated lead

Medication – Chief Pharmacist

Pressure Ulcers – Trust lead for

Pressure Ulcer Reductions, Deputy

Director of Nursing and Quality, Head

of Patient Safety

Deaths – Trust Medical Director

(Mortality Lead)

Fire- Trust Fire Officer, Health and

Safety and Local Security Manager

Violence and Aggression – RRI

Trainers and Local Security Manager

Infection Outbreaks – Care Group

Triumvirates, Doncaster Head of

Services and IPC Team

Medical Devices – Medical Devices

Officer

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Non-clinical accident / incident – ‘An event or circumstance that could have (i.e. ‘near miss) or did cause unexpected or unwanted harm, loss or damage to any individual(s) involved including service users( but not related to clinical care), staff, visitors etc.) or damage to/loss of property/premises for which the Trust is responsible.

Fatalities (non-clinical) related to work activities.

Specified injuries – including bone fractures (except fingers, thumbs and toes), limb amputations, serious burns etc.

Fatalities (non-clinical) related to work activities.

Over 7 day injuries – staff absent from work for more than 7 days (including non-work days, but excluding the day of the accident)

Occupational diseases – Work-related and medically diagnosed.

Dangerous occurrences – e.g. Collapse of lifting equipment.”

Appendix 5

RIDDOR reporting process for serious non-clinical incidents where there is an injury

Notify HSE immediately by

telephone (person at incident

location)

Non-clinical incident occurs*

Who is injured?

Non-employee - visitor, contractor or patient (not as a

result of clinical treatment) injured on Trust premises or by

work under Trust’s control

Injured person absent from work for more than 7

days (inclusive of non-working days)

Employee

Safety Team to report to HSE within 15 days

Person involved in accident /manager / Patient Safety Team to contact Safety

Team as soon as possible with details of the incident

Specified injury Injured person taken from accident site directly to hospital

Fatality

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Appendix 6

IR1 submitted which is rated as moderate harm or above and meets the Duty of Candour threshold

Pressure Ulcer Grade 3 or above

Root Cause Analysis (RCA) undertaken by the service

OR ward manager

RCA presented to the Trust Pressure Ulcer SI panel by the

service OR ward manager

Pressure Ulcer panel review the findings of the RCA and determine

if the PU was avoidable or unavoidable

If unavoidable

If determined avoidable

Case de-logged

Does it meet threshold for safeguarding

alert?

Yes No

Fall Death due to: • Suspected suicide • Homicide • Another cause • Unexpected unknown

cause

Harm due to other reasons for example: • Patient accident • Equipment failure • Significant self-harm

Death due to natural causes

Incident logged on the risk system within 24 hours of the service becoming aware that a potential SI has occurred

Mortality Review to be undertaken (refer to the Trust Learning from Deaths policy

for detailed guidance)

Review to be undertaken within21 days for near miss to minor harm incidents 28 days for moderate incidents and 60 days for severe and above of the incident occurring

Issues found that case cannot be resolved within the team OR

there is wider organisational learning

from the incident

Full SI investigation to be undertaken

Findings of the service structure review to be

considered at the Investigation Team morning meeting

Discuss with Care Group Director and agree

Investigation Team disagrees with findings OR find out more

information is needed

No service delivery OR key care problem

identified from the reviews

Some low level individual issue

identified that can be addressed through reflective practice

Structured review to be signed off by the Care Group

• Team Manger or Modern Matron, then • Care Group Director

Signed off structured review to be forwarded to the Trust Patient Safety Team

Investigation Team agree with action

Case closed