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Incident reporting, analysing, investigating and learning policy and procedures of 45 Ratified by: Safety and Risk Committee Review date: Jan22

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The priorities were agreed by the Trust Board in December 2017 to support the Trust’s vision. The priorities listed below will ensure there is a shared understanding about what needs to be delivered.

Monitoring Information Our Priorities

Patient Experience Delivering safe and high quality care

Assurance Framework People, attract, develop and retain

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Incident reporting, analysing, investigating and learning policy and procedures

Post holder responsible for Procedural Document

Head of Governance

Author of Policy and Procedure Head of Governance

Division/ Department responsible for Procedural Document

Corporate Governance

Contact details Telephone:

Email:

Date of original document December 2018

Impact Assessment performed Yes

Ratifying body and date ratified

Incident Review Group October 2019 Safety and Risk Committee: October 2019

Review date

October 2022

Expiry date October 2022

Date document becomes live October 2019

Controlled document This document has been created following the Royal Devon and Exeter NHS Foundation Trust Development, Ratification & Management of Procedural Documents Policy. It should not be altered in any way without the

express permission of the author or their representative.


Full History:

Status: Final

Version Date Author (Title not name)

Reason

1.0 December 2018 Head of Governance Adoption of policy provided by RD&E

1.1 June 2019 Head of Governance Revision from feedback.

1.2 July 2019 Head of Governance Revision of tables after feedback from Consultants.

1.3 September 2019 Head of Governance Comments added to draft policy

2.0 September 2019 Head of Governance Policy Approved at IRG 09.09.19

2.0 October 2019 Head of Governance Approved at S&RC

2.1 October 2019 Head of Governance Slight Amends from S&RC

2.2 November 2019 Head of Governance Amendments added – Safeguarding, Information Governance and flowchart.

Associated Trust Policies/ Procedural documents :

Safeguarding Children Policy

Raising Concerns and Complaints Policy

Disciplinary & Procedures Policy

Incident Response Plan

Fire Safety Policy

Health and Safety Policy

Standard Infection Control Precautions Policy

Safeguarding Adults Policy

Risk Management Policy

Supporting Staff in an Incident, Complaint or Claim Policy

Raising Concerns Policy Incorporating Freedom to

speak up and Whistleblowing

Information Governance Policy and Framework

Key Words: incident, incident report, reporting, DATIX

In consultation with and date: Incident Review Group – July 2019 Trained Investigators – July 2019 Senior nurses July 2019 Governance Staff July 2019 Safety and Risk Committee July 2019

Contact for Review: Head of Governance

Executive Lead Signature Chief Nurse


1. CONTENTS

1. CONTENTS ............................................................................................................... 3

2. INTRODUCTION ........................................................................................................ 4

3. PURPOSE .................................................................................................................. 4

4. DEFINITIONS............................................................................................................. 4

5. DUTIES AND RESPONSIBILITIES OF STAFF ......................................................... 6

6. INCIDENT REPORTING, ANALYSIS, INVESTIGATION AND LEARNING ............. 11

7. STAFF...................................................................................................................... 18

8. TRAINING REQUIREMENTS FOR STAFF .............................................................. 18

9. ARCHIVING ARRANGEMENTS .............................................................................. 18

10. PROCESS FOR MONITORING COMPLIANCE WITH AND EFFECTIVENESS OF THE POLICY ...................................................................................................................... 19

11. REFERENCES ......................................................................................................... 19

12. APPENDIX 1: DEFINITION OF A SERIOUS INCIDENT WITHIN THE NHS FRAMEWORK .................................................................................................................... 21

13. APPENDIX 2: CORE LIST OF NEVER EVENTS 2018 ........................................... 22

14. APPENDIX 3: INCIDENT REPORTING – WHAT SHOULD BE REPORTED? .......... 26

15. APPENDIX 4: GRADING MATRIX – DEFINITIONS FOR CONSEQUENCE OF INCIDENT (ACTUAL AND FUTURE POTENTIAL) ............................................................ 28

16. APPENDIX 12: PROCEDURE FOR REPORTING INCIDENTS INVOLVING MEDICAL DEVICES ........................................................................................................... 33

17. APPENDIX 13: PROCESS FOR REPORTING AND INVESTIGATING SUSPECTED MISAPPROPRIATION OF MEDICINES .............................................................................. 34

18. APPENDIX 14: DUTY OF CANDOUR PROCESS ................................................. 35

19. APPENDIX 15: DUTY OF CANDOUR STICKER .................................................... 36

20. APPENDIX 16: DUTY OF CANDOUR LETTER TEMPLATE ...................................... 37

21. APPENDIX 17 CARDIAC ARREST REPORTING FLOWCHART ........................... 38

22. APPENDIX 18: REPORTING ................................................................................... 39

23. APPENDIX 19 Just Culture guide .......................................................................... 42

24. APPENDIX 20: EQUALITY IMPACT ASSESSMENT TOOL .................................... 43


2. INTRODUCTION

2.1. The Northern Devon Healthcare NHS Trust (hereafter referred to as the Trust) is committed to delivering quality patient care, ensuring high standards of health and safety, and minimising loss by providing a system of incident reporting which allows all staff to record any incident which causes harm, damage or loss or has the potential to do so.

2.2. Incident reporting presents an important opportunity to learn from past events

and ensure steps are taken to minimise recurrences.

2.3. There is overwhelming evidence that NHS organisations with a high level of incident reporting are more likely to learn and subsequently increase safety for patients, staff and visitors.

2.4. Failure to comply with this policy could result in disciplinary action.

3. PURPOSE

3.1. This policy sets out the Trust 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 reporting to external agencies.

Process for investigating incidents according to level of harm and future harm /

risk. Process for involving and communicating with internal and external

stakeholders to share safety lessons.

Process for the aggregated analysis of incidents, complaints and claims. Process by which the organisation ensures local and organisational learning

and changes in practice resulting from individual incidents and aggregated analysis.

Process for ensuring communication is open, honest, occurs as soon as possible and is well documented and that our legal duties for Duty of Candour are applied and monitored.

Training requirements for staff.

3.2. Compliance with this policy will ensure that incidents are systematically identified, recorded, reported to management and appropriately investigated. This will result in learning and thus improving safety for patients, staff and visitors.

4. DEFINITIONS

4.1. Incident / Accident An Incident / Accident is defined as an occurrence or unplanned event (act or omission), where there is injury, loss of life, loss or damage to persons or property. Examples of an incident / accident: patient safety / clinical incident, personal accident, security, fire, theft, vandalism, staff shortage.

4.2. Near Miss

A near miss is defined as any event or circumstance that was prevented or narrowly avoided injury or harm, which had it occurred, could have had a detrimental impact. A near miss also encompasses the failure of clinical policy where no harm has come to the patients.


4.3. Serious Incident (SI) A serious incident in the SI Framework is defined as: ‘events in healthcare where the potential for learning is so great, or the

consequences to patients, families and carers, staff or organisations are so

significant, that they warrant using additional resources to mount a

comprehensive response. Serious incidents can extend

beyond incidents which affect patients directly and include incidents which may

indirectly impact patient safety or an organisations ability to deliver ongoing

healthcare.

For a full definition setting out the circumstance in which a serious

incident must be declared, go to Appendix 1. The incidents would be

StEIS reportable.

4.4. Serious Harm

Serious harm would relate to incidents where permanent harm has occurred.

4.5. Never Event Never events are serious, largely preventable patient safety incidents that should

not occur if the available preventative measures have been implemented (a full list

of never events is attached in Appendix 2).

4.6. Others Students, trainees, visitors, contractors, agency staff, volunteers, general public, and

undertakings sharing the premises with the Trust.

4.7. Datix

Datix is the electronic incident reporting system that enables reporting, analysis

and collation of incident, complaints, risk and claims data.

4.8. Incident Investigation

An incident investigation is the act or process of examination or enquiry and

analysis into an adverse event in order to understand, how and why it occurred

as well as identify mitigating actions to prevent future occurrence.

4.9. Levels of investigations

The level of investigation should be proportionate to the individual incident.

The national framework describes these levels as concise and

comprehensive.

Informal Managers Investigation – suited to no harm / minor incidents which are

managed within the team by the local manager.

Concise investigation – suited to less complex incidents which can be

managed by individuals or a small group of individuals at a local level.

Comprehensive – suited to complex issues which should be

managed by a multidisciplinary team involving experts and fully

trained investigators.

Independent – suited to incidents where the integrity of the internal investigation is

likely to be challenged or where it will be difficult for an organisation to conduct an

objective investigation internally.


4.10. Complications

Complications are any deviation from the normal course. Medical complications are

an unfavourable evolution or consequence of a disease, a health condition or a

therapy. A complication may be iatrogenic. However if a complication is a direct

result of human error, negligence, poor system or equipment design or unnecessary

treatment it is a clinical incident.

4.11. Human Factors

Enhancing clinical performance through an understanding of the effects of teamwork, tasks, equipment, workspace, culture and organisation on human behaviour and abilities and application of that knowledge in clinical settings.

5. DUTIES AND RESPONSIBILITIES OF STAFF

5.1. Chief Executive

The Chief Executive has overall responsibility, on behalf of the Trust Board, for ensuring the implementation of this policy throughout the organisation.

5.2. Chief Nurse

Has delegated responsibility from the Chief Executive for Risk Management and

therefore has Executive responsibility for the development and implementation of

incident reporting processes.

5.3. The Senior Information Risk Owner (SIRO)

The SIRO is the Senior Management Board Member responsible for Information

Governance (IG) in the Trust and ensures IG incidents are reported and

investigated in line with the Trust incident reporting processes. In the Trust the

SIRO is the Medical Director.

5.4. The Caldicott Guardian The Caldicott Guardian is a senior clinician who oversees the arrangements for

the use and sharing of clinical information and advises on options for the lawful

and ethical processing of information as required and represents confidentiality

issues at Board level.

5.5. Head of Governance

Provide leadership of the Governance processes within the Trust.

To lead on the risk management systems, ensuring routes for risk identification and reporting are clearly articulated and implemented:

Responsible for ensuring the functioning of the corporate systems detailed

within the policy and support the identifying, recording, reporting to

management, appropriately investigating and learning from incidents.

Undertake the corporate collation and analysis of incidents, liaise with external and

internal stakeholders where necessary, generate trend reports of incident

types/themes.

Ensure reporting in line with the Care Quality Commission (CQC) regulatory framework.


5.6. Head of Quality and Safety Provide clinical leadership of the investigation and incident reporting:

Undertake the clinical collation and analysis of incidents, liaise with external and internal stakeholders where necessary, generate trend reports of incident types/themes.

Provide a source of advice and support for investigation leads when investigating and preparing the reports

Ensure Duty of Candour requirements are fulfilled

Undertake regular meetings with the CCG

5.7. Medications Safety Officer All medicines incidents will be reported to the Trust Chief Pharmacist who currently holds the Medications Safety Officer role, Clinical Pharmacy Manager, Medicines Governance and Safety Pharmacist and relevant Pharmacist/s via DATIX for screening and onward prioritisation, investigation and / or escalation, following the medicines incidents procedure for investigating and escalation.

5.8. Controlled Drug Accountable Officer

All incidents involving controlled drugs must be notified to the Trust’s Chief Pharmacist (MSO), the Clinical Pharmacy Manager who will inform the Trust’s Accountable Officer for Controlled Drugs in line with the Controlled Drugs Policy.

5.9. Information Governance (IG) Manager

The Information Governance Manager and the Information Governance team have delegated responsibility from the SIRO and are responsible for ensuring IG Serious Incidents (SI) are reported and investigated in line with National NHS Guidance on reporting, managing and investigating IG SI’s.

5.10. Associate Directors of Operations / Associate Medical Directors/Divisional

Nurses Are responsible for ensuring the Divisional structures support the systems for identifying, recording, reporting to management, appropriately investigating and learning from incidents. They are also responsible for the timely Duty of Candour to be undertaken with their divisions.

5.11. Risk Lead

The Risk Lead will act as gatekeeper for incidents, review all potential incidents for escalation. The Risk Lead will have oversight of the Incident and Investigation process, leading the Risk and Incident team.

5.12. Serious Incident Lead

The SI Lead will manage the SI reporting process. Notify the Commissioner via StEIS of reportable incidents, and the Commissioner

will have a process in place for informing Specialist Commissioners where an

incident relates to a patient’s treatment commissioned by them.

Ensure quality reports are produced and written within the specified time frames.

Support the lead investigators to complete their investigations and write the reports


Make the decisions as to whether an incident is a SI using the relevant criteria

Set appropriate terms of reference for each SI Investigation

Liaise with external stakeholders

Produce Status and ad-hoc reports as required

Maintain accurate records of the investigation and ensure all archiving of documentation is undertaken appropriately.

5.13. Investigations Administrator

Escalate Incidents as appropriate

Review all investigation reports to ensure quality is maintained and all other advisors are provided with the report for their input

Reports are anonymised appropriately

The administration of investigations on DATIX is completed

Provide administrative support for the Incident Review Group

Liaise with external stakeholders – Clinical Commissioning Group Safety team for Quality Reviews on SI Reports

Produce reports on investigations on themes, trends and key issues for Groups and Committees as required

5.14. Responsible Managers

Ensuring the Incident Management Policy is implemented

Ensure staff report incidents;

Escalate or investigate incidents according to the incident categorisation and take immediate action to reduce risk of reoccurrence;

Acting as ‘Responsible Manager’ for the incidents recorded on DATIX.

To ensure you review the grading as soon incident recorded

Ensuring action taken and learning identified from their local incident investigations are recorded on the DATIX system.

In the case of an incident involving a patient, informing the patient and their carer or relatives of any incident as soon as possible in line with the Duty of Candour Policy.

Acting in an open and transparent way with relevant persons in relation to care and treatment provided under Duty of Candour in line with the Duty of Candour Policy.

Regularly reviewing incident reports with staff to identify these and implement changes that may be required to avoid a recurrence of the incident.

Maintaining the ‘Current Status’ of the incident investigation on the DATIX system.

Providing feedback to staff of the outcomes of the local incident investigation.

Ensuring the severity of the incident is correct.

Promote patient safety and a just culture towards incident management

Notify the Facilities Clinical Services Manager of any of reportable medical equipment incidents who will notify the Medicines and Healthcare products Regulatory Agency (MHRA).

5.15. DATIX & Incident Team

Will maintain the database on which all incident reports will be stored (Datix).

Support staff to report and manage incidents.

Ensure each incident report form is screened upon submission to ensure a consistent approach to the coding to maintain data quality and to ensure information is passed to relevant clinical and non-clinical staff.

Ensure the procedures for managing the incident report information on DATIX


are robust and effective.

Identifying and escalating high risk incidents to the Investigations Team for further investigation in line with this policy.

Ensure patient safety incident data is routinely upload to the National Reporting and Learning System (NRLS) held by NHS Improvement.

Support staff to run routine and ad-hoc reports as appropriate.

5.16. Lead Investigator

Must be fully trained in undertaking investigations using Root Cause Analysis (RCA) techniques.

Undertakes an investigation using RCA tools and techniques which establishes how an incident has occurred, the root cause of that incident and establish how recurrence may be reduced or eliminated.

Formulate recommendations to manage care and service delivery issues.

Provide an investigation report within the allotted timeframe as a record of the investigation process that sets out clearly the investigation findings, recommendations and actions agreed by the operational team.

To keep a full investigation pack of all documents used for the investigation, including all statements taken, photographs and notes relied upon to formulate the report.

5.17. Divisional Governance Co-ordinators

Promote consistent, accurate and timely categorisation and grading of incidents on Datix within the Division by ensuring teams responsible for the reviewing and categorisation of all incidents within timescales.

Ensure compliance with required timescales and escalate concerns of non-compliance.

Are responsible for ensuring that all actions are monitored via the Divisions governance processes thus ensuring timely completion.

Co-ordinate the dissemination of Trust wide learning at specialist level.

Ensure there is compliance with Duty of Candour, and establish responsibility for contact for the patient/carer during the investigation process.

5.18. Staff

Are responsible for reporting and escalating incidents in accordance with this policy and co-operating where appropriate in any subsequent investigations.

Are responsible for application of duty of candour when appropriate

Engage in learning and outcomes from investigations.

Staff concerned about the delivery of care/service to patients have a duty to express their concerns to their line manager, through the incident reporting system or as outlined within the Raising Concerns Policy Incorporating Freedom to Speak Up and Whistleblowing

Staff concerned about the safety of their environment have a duty to raise their concerns, in line with the Health and Safety Policy.

5.19. Health and Safety manager/LSMS

Notify the Health and Safety Executive of reportable incidents under the Reporting and Injuries, Diseases, Dangerous Occurrence Regulations (RIDDOR).

Ensure all RIDDOR investigations are investigated in line with the investigation process.

5.20. Legal Claims Manager

To act as liaison between Trust staff and the Legal Team that we have an


agreed Service Level Agreement with to undertake our legal advice and activities with.

To ensure draft SI reports are sent to the Trust Solicitor as required i.e. those where an Inquest is required or those where a claim has been made.

5.21. Specialist Advisors

Specialist Advisors such as Tissue Viability, Falls, Pharmacy and Health and Safety leads may identify incidents for escalation through themes or specific issues whilst validating any incidents.

Will provide expert input into investigations where required.

5.22. Staff Side Safety Representatives

Under the Terms of the Safety Committees and Safety Representatives

Regulations 1977, the Trust recognises the right of Staff Side Safety

Representatives to investigate health and safety related incidents and dangerous

occurrences.

5.23. Safety and Risk Committee

Will receive reports from the Incident Review Group in relation to compliance with

undertaking investigations, subsequently implementing actions and exploring

themes arising from investigations

Will receive the full reports of never event investigations and give assurance to the

Governance Committee that the investigation is robust.

5.24. Incident Review Group (IRG)

Will review all investigations of incidents, inquests, claims and complaints

categorised as meeting the SI criteria or are externally reported, where harm and a

lapse in care is identified.

The Group will:

Monitor whether the incident was notified correctly and in a timely manner.

Monitor the use of root cause analysis tools within the investigation.

Monitor the quality and timeliness of the investigation process.

Review the appropriateness and completion of planned actions of reports scrutinised through IRG.

Review the correct level of communication and consultation with relevant parties/forums has been undertaken.

They will provide a forum for sharing organisational learning from investigations, incidents, complaints and claims and aggregate analysis, both qualitative and quantitative feeding into the Divisions as well as to the Safety and Risk Committee.

Sample concise investigation reports each quarter to ensure adherence with this policy,

Commission a lessons learnt newsletter to disseminate learning from investigations.

Monitor all overdue actions for moderate and major incidents, complaints and claims.

Monitor all overdue investigations which are moderate and above to understand the delay

Monitor compliance with duty of candour.

Review quarterly audits of completed actions and their effectiveness.


Through the above monitoring provide assurance to Safety and Risk Committee.

5.25. Safety Huddle

The safety huddle meets on a weekly basis and consists of the Chief Nurse, Deputy Chief Nurse, Head of Quality and Safety, Deputy Medical Director and Risk Lead.

Will review 72 hour investigation reports to identify whether escalation to SI is required.

Will identify appropriate leads for the investigation lead and relevant clinical investigator to support and advise the SI Lead.

Will support Investigation leads with any issues or blockages raised through the

investigation process.

5.26. Health and Safety Group

Receive reports on RIDDOR investigations to ensure learning is identified.

Analyse trend data to ensure learning is being put into place to reduce the likelihood of RIDDOR incidents occurring.

5.27. Information Governance Steering Group (IGSG)

The IGSG is the senior group in the Trust responsible for ensuring Trust

compliance with Information Governance. This includes legal and NHS policy

requirements. The IGSG will ensure: -

That IG Incidents are notified to the ICO, NHS Digital, DHSC and other regulators through the DSP Toolkit correctly and in a timely manner

The timeliness of the investigation process

Ensure appropriateness and completion of planned actions

Information Governance training is mandatory for all staff annually

5.28. Divisional Groups (Divisional Governance / Specialty Governance)

Will review Divisional concise and comprehensive reports, formulate action plans for these investigations and monitor them to completion ensuring completion is met within timeframes.

Will review Trustwide SI, and Divisional quarterly trend graphs to ensure appropriate learning and feedback to all staff at Divisional level

6. INCIDENT REPORTING, ANALYSIS, INVESTIGATION AND LEARNING

6.1. Reporting of Incidents

All incidents will be reported on the Trust Electronic Incident Reporting system (Datix) immediately or as soon as safe to do so (link via Trust Intranet).

The information reported on the incident form must be factual and accurate. No opinions or guesswork should be included. This is a legal document and must be factual.

Staff who intentionally fail to report an incident will be subject to management processes..

Incidents cover a wide range of events and may affect patients, staff and others both clinical and non-clinical. For a non-exhaustive list of incident types see Appendix 3.


Incident reports should, wherever possible, be completed by the member of staff who first becomes aware of the incident. If that person is unable to do this due to personal injury or other circumstances the form must be completed by another person on their behalf.

Any incident that relates to an external organisation will be forwarded by the DATIX & Incident Team to ensure they are made aware of the incident and refer that incident to the external body for appropriate action.

Any incident received from an external organisation including General Practitioner (GP) practices and CCG Yellow Cards will be entered onto the Datix system by the DATIX & Incident Team and allocated to the relevant department to investigate.

Any unexpected death arising from the Trust’s Mortality Review Process will be subject to a full mortality review. The outcome will be reviewed by the Deputy Medical Director and Associate Medical Director (AMD) for consideration of further escalation in line with this policy.

In some circumstances allegations can be raised through other forums, such as Whistleblowing or the Freedom to Speak up Guardians where it is alleged that an incident has occurred. Where allegations have been made an incident form must be completed and consideration must be given to whether they meet the StEIS reportable criteria.

6.2. Immediate Response to the Incident

The initial response to any incident must be to make the situation safe thus preventing further harm to patients, visitors and/or staff/ others.

Incidents resulting in unexpected death (catastrophic), serious injury (major) or suspected never events must always be reported immediately to the Chief Nurse, Head of Quality and Safety and/or Duty Manager out of hours who will escalate as appropriate.

For incidents which involve medical devices do not disassemble, clean, decontaminate or alter control settings. Clearly identify defective item(s) and attach a yellow decontamination label and contact the Medical Equipment Manager (see Appendix 12 for the process).

For medication incidents where patient harm has been identified or is suspected the medication must be retained if possible and the batch number (lot number) and manufacturer must be recorded on the Datix Form and the Medication Incidents – Standard Operating Procedure must be followed.

Where medication is suspected to be defective e.g. clouding or particulates in an intravenous (IV) fluid product this must also be retained, taken out of use and an incident form completed including batch (lot) number and manufacturer.

For incidents where misappropriation of medication is suspected the procedure outlined in Appendix 13 will be followed.

Where appropriate photographs of defective equipment or to show the


environment can be taken and uploaded to the incident form, to help inform any investigation.

6.3. Police Involvement

The police are likely to investigate incidents where there is evidence, or suspicion of, a criminal offence having been committed, for example if an incident has arisen from or involves criminal intent, or gross negligence.

The incident must be escalated as set out in section 5.2 and reported to the commissioning body, plus informing the Health and Safety Manager.

Referral to the police should be undertaken by the Health and Safety Manager/LSMS senior member of staff, on-call Manager or on-call Director.

In circumstances of unexpected death or serious harm requiring investigation by the police, the incident should be managed in accordance with the Memorandum of Understanding. This protocol should be activated when an incident requires investigation by the police and the Health and Safety Executive jointly. Wherever possible, SI investigations should continue alongside criminal proceedings but this should be considered in discussion with the police. In exceptional cases (i.e. following a formal request by police, Coroner or judge) the investigation may be put on hold and this should be discussed with those involved.

6.4. Hidden Incidents

Occasionally an incident may be reported which is sensitive or confidential which needs to be hidden from view on the system. Any request to undertake the hiding of incidents must be made via the Head of Governance through the DATIX system.

6.5. Duty of Candour - Being Open when Patients are Harmed

When moderate, severe harm or death incidents occur or prolonged pain or Psychological harm ie experienced by the patient, the Duty of Candour process must be followed as set out in the Duty of Candour Section in Appendices 15,16 & 17. This is a contractual duty as well as being a legal duty under the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014: Regulation 20.

If an incident occurs which does not result in moderate or above harm the patient should still be offered an apology and an explanation given in line with being open principles. Organisations are said to be open when the prevailing culture visibly encourages key behaviours. These include honesty, openness, appropriate sharing of information and a willingness to learn from experiences to change how the organisation functions. Any letters associated with the Duty of Candour should be linked to the incident on DATIX.

6.6. Incident Grading, and Escalation

Not all incidents need to be investigated to the same extent or depth. Categorising incidents according to the actual impact and the potential future risk to patients/visitors/staff/others and the organisation establishes the level of local investigation and causal analysis that should be carried out.


All incidents categorised as major or catastrophic (See Appendix 4) or in the Red area of the matrix will be escalated immediately to the Chief Nurse, Deputy Medical Director, Head of Midwifery, Head of Governance, SI Lead, DATIX and Incident Team and Divisional Senior Management team both via automated email but also via the internal escalation process for serious incidents. (Follow the flowchart Appendix 5).

A decision must be made by the SI Lead or the Safety Huddle as to whether an incident is reportable to the Commissioners as a Serious Incident (SI) meeting StEIS criteria; where possible this will be within 48 hours of the incident. Where appropriate, the SI Lead will:

Inform the Chief Nurse and Medical Director (if appropriate) at an early

stage. Ensure, though the Divisional Governance Co-ordinators that there is

compliance with Duty of Candour, they will establish responsibility of contact for the patient/carer during the investigation process.

The on-call Director needs to consider whether the incident is a significant or major incident as defined in the major incident plan and consider evoking the plan.

The Head of Communications will be required to advise and provide support on internal and external communications.

All incidents are reviewed by the DATIX Support Administrator prioritised by severity. Responsible Managers/Ward Managers or their deputy will review their incidents within 48 hours and escalate for investigation where appropriate.

6.7. Reporting of Information Governance incidents

Information Governance incidents are incidents in which information held by the Trust could have been, or has been, compromised. They can result in regulatory action by the Information Commissioner‘s office (ICO) including Civil Monetary Penalties (fines) of up to £17.7 million, as well as claims against the Trust.

All incidents of Information Governance breaches will be recorded using DATIX. Advice must be sought from the IG Team on whether an IG event is reportable to the ICO and DHSC. Any incident reported to the ICO is automatically StEIS reportable. All IG SI incidents will be fully investigated in accordance with this policy and graded as moderate or above. The Information Governance Manager will report a summary of Information Governance incidents to the Information Governance Steering Group (IGSG). Detailed reports will be produced on individual Information Governance related Serious Incidents (IG SI). An IG SI is detailed as failures in the security, integrity, accuracy or availability of information often described as data loss and/or information governance related issues to include:

a. Any incident which involves actual or potential failure to meet the requirements

of the Data Protection Act 2018.

b. This includes unlawful disclosure or misuse of confidential data, recording or

http://www.legislation.gov.uk/ukpga/1998/29/contents


sharing of inaccurate data, information security breaches and inappropriate invasion of people‘s privacy and/or the Common Law of Confidentiality.

c. Such personal data breaches which could lead to identity fraud or have other significant impact on individuals.

d. Applies irrespective of the media involved and includes both electronic media and paper records

It is a legal obligation to notify personal data breaches of the GDPR under Article 33 within 72 hours, to the ICO, unless it is unlikely to result in a risk to the rights and freedoms of individuals. The DSP Toolkit Incident Reporting Tool must be used for reporting as this will report IG SI incidents to NHS Digital, DHSC, ICO and other regulators.

Incidents or events that have a significant impact on the continuity of essential services (under the NIS Regulations) must also be reported within 72 hours. Any incident reportable under the NIS Regulations may also be reportable as a personal data breach under the GDPR reporting requirements (above).

The IG Manager will investigate and prepare a report in consultation with the Caldicott Guardian, Data Protection Officer (DPO) or Senior Information Risk Owner (SIRO) to ensure that IG SIs are reported in accordance with Trust policy and National NHS guidance. All Level 2 reportable ICO incidents will also be StEIS reported.

6.8. Investigation Appropriate to the Severity of the Incident

Major, Catastrophic (Actual Harm) or SI incidents (future potential) on the grading matrix The greatest effort should be concentrated on serious incidents where major or

catastrophic harm has occurred. To identify whether the incident is reportable on

StEIS a 72 hour report will be completed. If the incident meets the criteria it is

reported on StEIS and an SI investigation report is completed. For non-reportable

incidents, the screening tools are completed and a Concise Investigation report is

completed (Appendix 10). StEIS incidents must be the subject of a comprehensive

investigation using Root Cause Analysis (RCA) methodologies completed within 45

working days on the Investigation Template (Appendix 11). A full evidence pack

must be kept of any documentation supporting the findings in the report including

any notes taken and investigative tools used. These will be returned to the SI Lead

(either as a hard copy or electronically) where they will be stored and made

available if further investigation or legal action arises.

The Safety Huddle, SI Lead or Head of Midwifery for Maternity Incidents, will

identify trained investigators to co- ordinate the review of each comprehensive

incident; 1 investigator and a subject matter expert will be appointed, where

necessary 2 investigators may be assigned. At this point the Terms of Reference

(TORs) for the investigation must be given to the investigator. The investigators

will be trained in undertaking investigations using RCA techniques and

independent of the specialty where the incident occurred, a subject matter expert

will be allocated as required.


Investigation Process The investigation should confirm the facts using the incident, falls or Information Governance screening tool around:

What happened?

How did it happen?

Why did it happen?

Moderate incidents (Actual Harm)

A concise investigation using the concise investigation tool must be

undertaken within the Division, and any resulting investigation must be

completed within 45 working days on the investigation template. (Appendix

10).

No harm or minor incidents It is the responsibility of the person in charge of an area to undertake the

informal managers investigation within 45 working days and ensure that all

necessary immediate remedial action is taken and documented in the

management section on the electronic incident report.

The managers investigation section is sent to the reporter once the investigation

is closed on the system if the reporter has requested feedback.

Externally reportable Incidents Certain incidents require reporting to external agencies, detail of such incidents and responsibilities for reporting are included in Appendix 18. All externally reported incidents will be graded as a minimum of moderate due to the potential reputation risk, however, this may be higher against another domain. The report will be reviewed by the Incident Review Group where it is StEIS reportable or where there has been harm and lapses in care. Redacting Reports Including the patients names that they have asked to be known by, makes the report more personal so this should be include if we have consent from patient / relative it is fine to us to use the preferred name and to not redact this at the end. Professionals names and experts used should just state job titles and not names or initials. In the appendix there should be a table with job titles and names of individuals so this can be easy identified if needed, however when sharing with the patient / family this page will be removed. Sharing Reports The patient or relative will be consulted on how they would like to be referred to in the report (Mr/Mrs/name or possibly initials), this will be the name used throughout the report. The patient or relative must be made aware of how far this report may be shared, it could go to the CCG and other organisations and be seen by many different people or it could go through a legal process. The patient may wish for the report to be redacted if the report is to be shared outside this organisation.

6.9. Templates

There are a range of templates available for varying different investigations, the most relevant template should be used to suit the investigation.

• Incident Screening Tool Template


• Falls Investigation Screening Tool Template • Information Governance Screening Tool Template • Concise Investigation Tool Template • 72 Hour Report Template • SI Reporting Template • Safeguarding 72 hour template • Safeguarding Concise Report Template

6.10. Ensuring Local and Organisational Learning

Root Cause Analysis Investigations All investigation reports will include an action plan which will link to the causative

factors and recommendations identified during the investigation.

The Incident Review Group, will routinely review outstanding concise and SI actions and receive exception reports via the Governance Co-ordinators/Maternity Risk Manager. The Governance Co-ordinators/Maternity Risk Manager are in turn responsible for working through open actions in the Division with the senior management teams to ensure the timely closure of actions through local governance processes.

The Risk Lead will undertake spot checks of implemented action plans, and report findings to the Incident Review Group and subsequently to the Safety and Risk Committee which will advise the Governance Committee and thereby the Board of Directors.

6.11. Lessons Learnt Newsletter The Incident Review Group will produce a lessons learnt newsletter setting out key themes, trends and learning from investigations. This will give information on key learning and topics of interest, highlighting key information staff need to be aware of. This newsletter will be disseminated through the Divisions by the Governance Co-ordinators posted on the Trust Intranet.

6.12. Aggregated Analysis Reporting

Aggregate Analysis Reports of Incident, Complaint, Claim and other Patient Feedback Quarterly aggregated trends, will be produced for the Incident Review Group and Divisions setting out both quantitative and qualitative analysis of these elements. The report will include: - Quantitative Analysis The report will include a quantitative summary of complaints, claims and incidents identifying trends where possible. The content will include the following information: Complaints Overview. Number of complaints per rolling year. Total number of complaints received per month. Top 5 complaints by main subject. Total number of complaints received by severity. Summary analysis and lessons for learning. Claims Overview. On-going claims.


New claims this quarter. Claims closed this quarter. Inquest details. Summary analysis and lessons for learning. Incidents Overview. Total number of reported incidents. Breakdown of incident type. Top 10 reported incidents Trustwide. Total number of reported incidents by severity. Concise report trends/ SI Summaries Summary analysis and lessons for learning. Qualitative Analysis Where specific trends are identified the contributors to the report will be responsible for providing an explanation (if possible) for the trend. This may require making reference to external data sets and/or a comparison to previous quarterly figures.

7. STAFF

7.1. It is recognised that incidents can have a significant impact on staff who were involved or who may have witnessed the incident.

7.2. Staff involved in the investigation process should have the opportunity to access professional advice to ensure that support is offered to all staff involved promptly. Further guidance can be found in the Supporting Staff involved in an incident, complaint or claim Policy.

7.3. The Just Culture Guide (Appendix19) should be used to promote fair and

consistent staff treatment. In the very rare circumstances where a member of staff has committed a criminal or malicious act, the staff member should be advised at an early stage to enable them to obtain separate legal advice and/or representation.

7.4. Further support may be arranged if required through staff support or occupational health.

8. TRAINING REQUIREMENTS FOR STAFF

8.1. All staff will receive training on incident reporting via their line management at local induction and through periodic risk updates.

Staff leading investigations will receive training in Root Cause Analysis methodology. Training is facilitated by the Investigation Team as required. A record of staff trained to lead investigations is held within the Investigations team.

9. ARCHIVING ARRANGEMENTS

The original of this policy will remain with the Governance team. An electronic copy will be maintained on the Trust Intranet. Archived electronic copies will be stored on the Trust's Governance Department/policies and procedural documents, and will be


held indefinitely. A paper copy (where one exists) will be retained for 10 years.

10. PROCESS FOR MONITORING COMPLIANCE WITH AND EFFECTIVENESS OF THE POLICY

10.1. In order to monitor compliance with this policy, the auditable standards will be monitored as follows:

No

Minimum Requirements

Evidenced by

1. Incidents are validated by the responsible managers within 48 hours.

Incident Review Group (IRG) Reports

2. Incidents are investigated and c losed within 45 working days.

IRG Reports

3. Triangulation Reports are presented quarterly to IRG.

Schedule of reports IRG

Minutes

4. IRG are meeting their terms of reference and reporting to Safety and Risk Committee.

Schedule of reports S&RC

Reports

5.

Divisional Governance Groups (DGGs) / Divisional Management Groups review SI and Concise investigations and monitor action plans to completion.

Schedule of reports to DGG / IRG / SGG

DGG / IRG Minutes

6. Overdue actions are reviewed at IRG and exception reports produced.

IRG Reports

10.2. Frequency

In each financial year, the Risk Manager will audit to ensure that this policy has been adhered to and a formal report will be written and presented at the Incident Review Group.

10.3. Undertaken by Risk Manager.

10.4. Dissemination of Results This is undertaken at the Incident Review Group, which is held 2 weekly, and reports to the Safety and Risk Committee.

10.5. Recommendations/ Action Plans Implementation of the recommendations and action plan will be monitored by the Safety and Risk Committee, which meets monthly.

10.6. Any barriers to implementation will be risk-assessed and added to the risk register.

10.7. Any changes in practice needed will be highlighted to Trust staff via the Governance process.

11. REFERENCES

NHS England Serious Incident Framework Supporting Learning to Prevent Recurrence

NHS England Serious Incident Framework 2018 frequently asked questions


NHS England Revised Never Events Policy and Framework

Reporting of Injuries, Diseases and Dangerous Occurrences Regulations 2013. London: Stationery Office. http://www.legislation.gov.uk/uksi/2013/1471/contents/made

National Patient Safety Agency Incident Decision Tree – NPSA

NHS Digital Guide to the Notification of Data Security and Protection Incidents. Reporting incidents post the adoption of GDRP 25 May 2018 and NIS Directive 10 May 2018.

https://www/dsptoolkit.nhs.uk/Help/29 Social Care Act 2012. London: Stationery Office.

http://www.legislation.gov.uk/ukpga/2012/7/contents/enacted

Safety Committees and Safety Representatives Regulations 1977. London: Stationery Office. http://www.legislation.gov.uk/ukpga/2012/7/contents/enacted

Data Protection Act 1998. London: Stationery Office. http://www.legislation.gov.uk/ukpga/1998/29/contents

Memorandum of Understanding

Managing Safety Incidents in NHS Screening Programmes https://www.gov.uk/government/publications/managing-safety-incidents-in-nhs-screening- programmes

http://www.legislation.gov.uk/uksi/2013/1471/contents/made

https://www/dsptoolkit.nhs.uk/Help/29





http://www.legislation.gov.uk/ukpga/1998/29/contents

https://www.gov.uk/government/publications/managing-safety-incidents-in-nhs-screening-%20programmes

https://www.gov.uk/government/publications/managing-safety-incidents-in-nhs-screening-%20programmes


12. APPENDIX 1: DEFINITION OF A SERIOUS INCIDENT WITHIN THE NHS FRAMEWORK

Serious incidents in the NHS include:

Acts and/or omissions occurring as part of NHS funded healthcare (including in the community) that result in: o - 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 o Unexpected or avoidable injury to one or more people that has resulted in

serious harm; o Unexpected or avoidable injury to one or more people that requires further

treatment by a healthcare professional in order to prevent: - o The death of the service user; or o serious harm; o 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. o This includes abuse that resulted in (or was identified through) a Serious

Case Review (SCR), Safeguarding Adult Review (SAR), Safeguarding Adult Enquiry or other externally led investigation, where delivery of NHS funded care caused / contributed towards the incident.

A never event – all never events are defined as serious incidents although not all never events necessarily result in serious harm or death. o 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 o Failures in 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 o Incidents in population-wide healthcare activities like screening and

immunisation o programmes where the potential for harm may extend to a large

population; o 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)

o 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)

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

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


13. APPENDIX 2: CORE LIST OF NEVER EVENTS 2018 1. Wrong site surgery

An invasive procedure performed on the wrong patient or at the wrong site (eg wrong knee, eye, limb, tooth). The incident is detected at any time after the start of the procedure.

Includes: Interventions that are considered to be surgical but may be done outside a surgical environment – for example, wrong site block (including blocks for pain relief), biopsy, interventional radiology procedure, cardiology procedure, drain insertion and line insertion (eg peripherally inserted central catheter (PICC)/ Hickman lines). This also includes teeth extracted in error that are immediately re-implanted.

Excludes:

removal of wrong primary (milk) teeth unless done under a general anaesthetic

interventions where the wrong site is selected because the patient has unknown/unexpected anatomical abnormalities; these should be documented in the patient’s notes

wrong level spinal surgery

wrong site surgery due to incorrect laboratory reports/results or incorrect referral

letters

contraceptive hormone implant in the wrong arm.

2. Wrong implant / prosthesis

Placement of an implant/prosthesis different from that specified in the procedural plan, either before or during the procedure. The incident is detected any time after the implant/prosthesis is placed in the patient.

Excludes: placed implant/prosthesis is intentionally different from that specified in the

surgical plan, based on clinical judgement at the time of the procedure specified implant/prosthesis is placed as planned but later found to be

suboptimal implant/prosthesis is different from the one specified due to incorrect pre-

procedural measurements or incorrect interpretation of the pre-procedural data – for example, wrong intraocular lens placed due to wrong biometry or using wrong dataset from correct biometry.

Includes: implantation of an intrauterine contraceptive device different from the one in the

procedural plan.

3. Retained foreign object post-operation

Retention of a foreign object in a patient after a surgical/invasive procedure.

‘Surgical/invasive procedure’ includes interventional radiology, cardiology, interventions related to vaginal birth and interventions performed outside the surgical environment – for example, central line placement in ward areas.

‘Foreign object’ includes any items subject to a formal counting/checking process at the start of the procedure and before its completion (such as for swabs, needles,


instruments and guide wires) except where items:

not subject to the formal counting/checking process are inserted any time before the procedure, with the intention of removing them during the procedure but they are not removed

subject to the counting/checking process are inserted during the procedure and then intentionally retained after its completion, with removal planned for a later time or date as clearly recorded in the patient’s notes

are known to be missing before completion of the procedure and may be inside the patient (eg screw fragments, drill bits) but action to locate and/or retrieve them is impossible or more damaging than retention.

4. Mis-selection of a strong potassium containing solution

Mis-selection refers to; When a patient intravenously receives a strong potassium solution rather than

an intended different medication.

5. Administration of medication by the wrong route The patient is given one of the following: Intravenous chemotherapy by the intrathecal route

oral/enteral medication or feed/flush by any parenteral route intravenous administration of an epidural medication that was not intended to be

administered by the intravenous route

6. Overdose of insulin due to abbreviations or incorrect device

Overdose refers to when:

a patient is given a 10-fold or greater overdose of insulin because the words ‘unit’ or ‘international units’ are abbreviated; such an overdose was given in a care setting with an electronic prescribing system

a healthcare professional fails to use a specific insulin administration device – that is, an insulin syringe or pen is not used to measure the insulin

a healthcare professional withdraws insulin from an insulin pen or pen refill and then administers this using a syringe and needle.

7. Overdose of methotrexate for non-cancer treatment

Overdose refers to when:

patient is given a dose of methotrexate, by any route, for non-cancer

treatment that is more than the intended weekly dose; such an overdose was

given in a care setting with an electronic prescribing system.

8. Mis-selection of high strength midazolam during conscious sedation

Mis-selection refers to when:

a patient is given an overdose of midazolam due to the selection of a high strength preparation (5 mg/mL or 2 mg/mL) instead of the 1 mg/mL preparation, in a clinical area performing conscious sedation

excludes clinical areas where the use of high strength midazolam is appropriate; these are generally only those performing general anaesthesia, intensive care, palliative care, or areas where its use has been formally risk-assessed in the organisation.

9. Failure to install functional collapsible shower or curtain rails (mental health only)


10. Falls from poorly restricted windows

A patient falling from poorly restricted window. This applies to:

windows ‘within reach’ of patients; this means windows (including the window sills) that are within reach of someone standing at floor level and that can be exited/fallen from without needing to move furniture or use tools to climb out of the window

windows located in facilities/areas where healthcare is provided and that patients can and do access

where patients deliberately or accidentally fall from a window where a fitted restrictor is damaged or disabled, but not where a patient deliberately disables a restrictor or breaks the window immediately before they fall

where patients can deliberately overcome a window restrictor using their hands or commonly available flat-bladed instruments as well as the ‘key’ provided.

11. Chest or neck entrapment in bedrails

Entrapment of a patient’s chest or neck between bedrails or in the bedframe or

mattress, where the bedrail dimensions or the combined bedrail, bedframe and

mattress dimensions do not comply with Medicines and Healthcare products

Regulatory Agency (MHRA) guidance.

12. Transfusion or transplantation of ABO-incompatible blood components or organs

Unintentional transfusion of ABO-incompatible blood components.

Excludes: where ABO-incompatible blood components are deliberately transfused

with appropriate management.

Unintentional ABO mismatched solid organ transplantation.

Excludes: situations in which clinically appropriate ABO-incompatible solid organs are

deliberately transplanted.

In this context, ‘incompatible’ antibodies must be clinically significant. If the recipient has donor-specific anti-ABO antibodies and is therefore likely to have an immune reaction to a specific ABO-compatible organ, the inadvertent transplantation of that organ without appropriate management is a Never Event.

13. Misplaced naso- or oro-gastric tubes

Misplacement of a naso- or oro-gastric tube in the pleura or respiratory tract that is not

detected before starting a feed, flush or medication administration.

14. Scalding of patients

Patient being scalded by water used for washing/bathing

Excludes:

scalds from water being used for purposes other than washing / bathing

(e.g. from kettles).


15. Unintentional connection of a patient requiring oxygen to an air flowmeter This applies when a patient who requires oxygen is connected to an air

flowmeter when the intention was to connect them to an oxygen flowmeter.

Excludes:

unintentional connection to an air cylinder instead of an oxygen cylinder

as robust barriers to prevent this have not yet been identified.

16. Undetected oesophageal intubation This Never Event has been temporarily suspended pending further clarification


14. APPENDIX 3: INCIDENT REPORTING – WHAT SHOULD BE REPORTED?

Incident Reporting – What should be reported?

An incident is defined as:

Any event that gives (or may give) rise to personal injury or to property loss or

damage. This covers a broad range of events, some examples of which are given

below.

Incidents not only cover events where harm has been caused but also those where a

hazard is identified but no harm has occurred, either due to luck or an error being realised

in time and measures being taken to prevent harm occurring. These are often referred to

as near misses. These are reported in the same way as incidents resulting in harm as it is

expected that for every incident where harm occurs there will be many where no harm is

caused, therefore, these incidents can provide a wealth of learning information.

Any incident identified retrospectively through either audit or mortality reviews will also be reported.

Clinical Incidents / Near Misses

Delays to treatment / care

Failure to obtain valid consent

Inadequate observations / checks undertaken

Medical devices failure / availability

Mislabelled samples / incorrect results

Significant or unexpected complications of a clinical procedure / treatment

Hospitalisation of patients undergoing research trials

Unexpected death*

Blood Transfusion Incidents

*Incidents resulting in unexpected death or serious injury must always be

reported immediately to a senior member of staff (on call manager and named or

on call Consultant as appropriate).

Medication Errors / Near Misses

Prescription error

Administration error

Omission

Inadequate storage

Missing drugs

Adverse Reaction

Personal Accidents / Near Misses

Slips, trips and falls

Needlestick / inoculation injuries (including bites / scratches)

Back injury / musculo-skeletal injuries

Occupational Health / Near Misses

Occupational acquired infection

Occupational acquired dermatitis


Infection Control / Near Misses

Infection control outbreaks

Infection control status not handed over

Transfer of patients with infections (C Difficile)

Hospital acquired wound infections Violence, Abuse, Harassment / Near Misses

Verbal abuse

Physical assault

Racial / sexual harassment or any other equality related

Threatening behaviour *All incidents involving an actual assault must be reported to Security who will inform the police

Security Incidents / Near Misses

Absconded / missing patients

Theft / damage to Trust or personal property (including fraud)*

Unsecured premises / windows

Suspicious persons *All incidents involving theft must be reported to Security who will inform the police

Documentation / Near Misses

Inadequate / incomplete health records

Misfiled documentation

Delay in obtaining documentation

Illegible / incorrect documentation

Information Governance / Data Security / Near Misses

Loss / theft inadequately protected electronic data i.e. laptop, unencrypted data stick

Loss / theft of confidential paper documents

Unauthorised access or disclosure of confidential information

Integrity of data is compromised

Capacity Issues

Bed shortages

Staff shortages

Inadequate access to equipment

Pressure Damage

Pressure Ulcers

Moisture Associated skin damage (Moisture Lesions)

Anything that is a cause for concern for patient safety.


15. APPENDIX 4: GRADING MATRIX – DEFINITIONS FOR CONSEQUENCE OF INCIDENT (ACTUAL AND FUTURE POTENTIAL)

Consequence Score (severity levels) and examples of descriptors

1 2 3 4 5

Domains None Minor Moderate Major Catastrophic

Impact on the safety of patients, staff or public (physical/ psychological harm)

Minimal injury requiring no/minimal intervention or treatment.

No time off work

Minor injury or illness, requiring minor intervention

Requiring time off work for less than 7 days

Increase in length of hospital stay by 1-3 days

Moderate injury requiring

professional intervention

Requiring time off work for

over 7 days

Increase in length of hospital stay by 4-15 days

Externally reportable incident

An event which impacts on a

small number of patients

Major injury leading to

long-term

incapacity/disability

Requiring time off work for >14 days

Increase in length of

hospital stay by >15 days

Mismanagement of patient

care with long-term effects

Incident leading to death Multiple permanent injuries or irreversible health effects

An event which impacts on a large number of patients

Quality/ complaints/ audit

Peripheral element of treatment or service suboptimal

Informal complaint/ inquiry

Overall treatment or service suboptimal

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

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

Non-compliance with national standards with significant risk to patients if unresolved

Multiple complaints/ independent review

Low performance rating

Critical report

Totally unacceptable level or quality of treatment/service

Gross failure of patient safety if findings not acted on

Inquest/ombudsman inquiry

Gross failure to meet national

standards

Patient experience

Patient Experience

Unsatisfactory patient

experience not directly

related to patient care

Unsatisfactory patient

experience – readily

resolvable

Mismanagement of patient

care – short term effects

Mismanagement of patient care – long term effects

Totally Unsatisfactory patient outcome or experience

Human resources/ organisational development/ staffing/ competence

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

Low staffing level that reduces the service quality

Late delivery of key objective/

service due to lack of staff

Unsafe staffing level or

competence (>1 day)

Low staff morale

Poor staff attendance for mandatory/key training

Uncertain delivery of key objective/service due to lack of staff

Unsafe staffing level or

competence (>5 days)

Loss of key staff

Very low staff morale

No staff attending

mandatory/ key training

Non-delivery of key objective/service due to lack of staff

Ongoing unsafe staffing

levels or competence

Loss of several key staff

No staff attending mandatory training /key training on an ongoing basis

Statutory duty/ inspections

No or minimal impact or breach of guidance/ statutory duty

Breach of statutory legislation

Reduced performance rating if unresolved

Single breach in statutory duty

Challenging external

recommendations/ improvement notice

Enforcement action

Multiple breaches in

statutory duty

Improvement notices

Low performance rating

Critical report

Multiple breaches in stat.duty Prosecution Complete systems change required Zero performance rating Severely critical report

Adverse Rumours Local media coverage Local media coverage – National media coverage National media coverage with publicity/ reputation

Potential for public concern

short-term reduction in public confidence

Elements of public expectation not being met

long-term reduction in public confidence

with <3 days service well below reasonable public expectation

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

Business objectives/ projects

Insignificant cost increase/ schedule slippage

<5 per cent over project budget

Schedule slippage

5–10 per cent over project budget

Schedule slippage

Non-compliance with

national 10–25 per cent

over project budget

Schedule slippage

Key objectives not met

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


Finance including claims

Small loss Risk of claim remote

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

Loss of 0.25–0.5 per cent of budget

Claim(s) between £10,000 and £100,000

Uncertain delivery of key objective/Loss of 0.5–1.0 per cent of budget

Claim(s) between £100,000 and £1 million

Purchasers failing to pay

Non-delivery of key objective/ Loss of >1 per cent of budget

Failure to meet specification/ slippage

Loss of contract / payment by results. Claim(s) >£1 million

Service/ business

Loss/interruptio

n of >1 hour

Minimal or no

Loss/interruption of >8 hours

Minor impact on

Loss/interruption of >1 day Moderate impact on environment

Loss/interruption of >1 week

Permanent loss of service or facility

interruption Environmental impact

impact on the environment

environment Major impact on environment

Catastrophic impact on environment

Information Governance

No personal data lost

Limited demographic data Less than 10 people

Celebrity /VIP involved. Basic demographic data Limited clinical information 10-50 people

Sensitive personal data, high level of stress / financial loss, 51 – 100 people

Highly sensitive personal data, multiple occurrences of loss, 100 + people

Likelihood Score

1 2 3 4 5

Descriptor Rare Unlikely Possible Likely Almost certain

Frequency How often might it/does it happen

Might happen or recur occasionally

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

Will undoubtedly happen/recur, possibly frequently

This will probably never happen/recur (< once per year)

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

Examples of frequency

Not expected to occur for years or <once/year

Expected to occur at least annually

Expected to occur at least monthly

Expected to occur at least weekly

Expected to occur at least daily

Grading Matrix

Action guidance summary

For Red incident / near misses – Inform the Chief Nurse, Risk Lead, Head of Quality and Safety, and Patient Experience Matron, On-call Senior Manager. Carry out full root cause analysis investigation; formulate action plan and remedial actions. Full investigation / report required

For concise incidents / near misses – Inform Head of Quality and Safety, Risk Manager within 48 hours via automated trigger at grading stage. Carry out a moderate screening tool to ascertain whether a full investigation is required, within 45 days, formulate action plan and remedial actions.

For green incidents – Incident form to be completed and graded within 48 hours. Person

in charge of area to discuss with staff involved. Document any remedial actions on the

electronic copy of the incident form.

Rare 1 Unlikely 2 Possible 3 Likely 4 Almost certain 5

5 Catastrophic 5 10 15 20 25

4 Major 4 8 12 16 20

3 Moderate 3 6 9 12 15

2 Minor 2 4 6 8 10

1 None 1 2 3 4 5


Incident Grading Step Guide Stage 1 Actual Impact - The actual impact of the incident is selected from the

consequence table.

The consequence table identifies harm to patients / visitors / staff, number

of persons affected at one time and the impact to the organisation. The

most serious consequence rating (None – Catastrophic) across the three

columns is picked. For example if semi-permanent harm has been caused

and it has affected 25 people the incident would be judged as Major

impact.

Stage 2 Future Potential - The chance of recurrence of a similar incident within

the Trust is selected from the likelihood table (choice of Rare – Certain).

The most likely consequence of a similar incident if it does happen again is

selected (choice of 5 as in stage 1).

This may be different to the actual impact identified in Step 1, for example

the incident may have resulted in no harm occurring on this occasion

because an error was identified and rectified, however, in other

circumstances it would probably have resulted in semi-permanent harm.

Plot the likelihood and consequence on the 5 by 5 matrix to ascertain grade.

In practice categorisation at both stages is subjective and will depend on the

knowledge of the ward/ department manager/ supervisor.

Expert advice (usually by consulting more senior staff or specialist e.g. Infection Control,

Manual Handling Trainer, Occupational Health) should be sought when necessary and

wherever practicable a consensus view should be arrived at by two or more persons with

relevant knowledge.

For additional advice/ support consult the DATIX and incident team.

The initial categorisation of an incident should be undertaken quickly, it is not necessary

for the assessor to be in possession of all the facts at the time of grading. It is always

possible to re- categorise as the facts and issues emerge.

The level of investigation and analysis required for individual events must be dependent

upon the incident categorisation of potential future risk and not whether the incident

resulted in harm or not.


15.1. APPENDIX 5A: INVESTIGATION PROCESS (FLOWCHART)

Investigation Process Flow Chart

None Minor Catastrophic Major Moderate

Grade against grading matrix

Informal Managers investigation

What happened?

Why it happened

Mitigation / Actions

Lessons learnt

Further investigation required?

Feedback/ Sharing

Personal/ Team/ Reporter

Speciality Governance Process

Trend & theme reports

Concise investigation

tool. Completed within

45 working days

Further investigation required

(Significant lapses)

IRG (Externally reportable)

Feedback/ Sharing

IRG Lessons Learnt Newsletter

Discussions at Audit, Team,

Governance and Departmental

Meetings

Escalate immediately

Complete 72 hour report

StEIS reporting decision

Investigation using root cause

analysis methodology and

completed within 45 working

days

Incident Review Group

Commissioners

Feedback/ Sharing

IRG Lessons Learnt Newsletter

Discussions at Audit, Team, Governance

and Departmental Meetings

External / Family sharing

More

Info

YES

NO

YES

YES

NO YES

NO

NO

Use screening tools for incident

Divisional Action planning

Speciality Governance

Divisional Sign Off Legal Review

Complete Duty of Candour within 48 working hours

Local Management Speciality/ Divisional

Management

Divisional/ Organisational Management


15.2. APPENDIX 5B: INVESTIGATION TEAM INTERNAL PROCESS FOR INVESTIGATIONS

Incident escalated to Divisional Co-ordinators

Divisional Co-ordinators appoint report leads to ensure report is completed and closed within 45 days

Completed report returned to Divisional Co-ordinators

Report to investigations to tidy/ anonymise/ update

Is further info / expert

review required?

Updated report returned to

investigations

Report to Risk Lead and Divisional Co-ordinators (to pass to Divisional

Nurses) for decision

Is further information

requested?

Investigation to request further info/

expert review

Investigations to request further info

Closure agreed within 45 days - Investigations to add

actions, close incident on Datix and send out closure e-mail

Divisional co-ordinators to monitor actions

Updated report returned to

investigations No

Yes

No

Yes

Report completed within timescale

Escalate to Chief Nurse after 2 reminders

(reminders at 15 & 20 days, then escalate so

can be sorted for completion in timescale)

NO

Yes


Safeguard the safety of the person affected and ensure all necessary treatment is

given

15.3. APPENDIX 5C: MATERNITY/GYNAE INVESTIGATION FLOWCHART

16. APPENDIX 12: PROCEDURE FOR REPORTING INCIDENTS INVOLVING MEDICAL DEVICES

Medical Device: Any healthcare product, excluding drugs, used in the diagnosis, treatment,

prevention or alleviation of illness, injury or handicap.

The following action should be taken immediately you become aware of an incident

involving a medical device or consumable including NG Tubes, syringes etc

Safeguard patients, staff and others by preventing further use of medical device

that may be defective

Notify the senior person present within the ward / department / GP or senior nurse on

call in community and inform the named Consultant.

Do not disassemble, clean or decontaminate the device. Do not alter controls or settings.

Store in a secure location with a yellow decontamination label

Contact EMBE and inform them of the incident

Record details on DATIX including the serial numbers, lot numbers etc in the section on Equipment/Consumables


17. APPENDIX 13: PROCESS FOR REPORTING AND INVESTIGATING SUSPECTED MISAPPROPRIATION OF MEDICINES

Process for Reporting and Investigating Suspected

Misappropriation of Medicines

Detection of an Incident

If a staff member has a suspicion that drugs have been misappropriated from any area and cannot be accounted for, a DATIX incident report form should be completed.

Any incident that is reported through any other route including the internal security crime reporting line will be recoded on DATIX and the procedure below will be followed.

When completing the incident form the following categories should be selected: -

Incident Type – Patient Affected/Clinical incident

Category - Security Sub-category – Controlled drug issue

These incidents will automatically trigger to the following people only will only be visible to them: -

Chief Nurse/Deputy Director of Nursing

Chief Pharmacist/Plus 2 nominated individuals from pharmacy

Head of Quality and Safety,

Risk Manager

Chief Pharmacist

Deputy Chief Nurse

Health, Safety Manager and LSMS

Deputy Head of Estates

Fire and Security Advisor

Relevant Matron

Relevant Divisional Nurses Investigation On receipt of the incident form the Deputy Chief Executive / Chief Nurse or Deputy Chief Nurse in conjunction with the Chief Pharmacist will initiate an investigation into the missing drugs. The investigation will be undertaken in line with this policy and procedure using root cause analysis techniques. This will include the use of the Incident Decision Tree (IDT) contained as appendix 19. Should the IDT or investigation identify any HR issues in relation to staff then the usual HR Policies will be followed.

Should any criminal activity be identified or suspected by the investigator, this will be discussed with either the Chief Pharmacist, the Deputy Chief Executive / Chief Nurse or their deputy at the earliest opportunity. They will decide whether to inform the police.


18. APPENDIX 14: DUTY OF CANDOUR PROCESS

Process to be followed for Duty of Candour

This is a contractual duty as well as being a legal duty under the Health and Social Care Act 2008

(Regulated Activities) Regulations 2014: Regulation 20. The legal duty of candour applies to patient safety

incidents that occur during care provided and that results in moderate harm, severe harm or death,

Prolonged pain or Psychological Harm. However, low / no harm incidents should still be reported to the

patient if appropriate and an apology given.

Verbal

Apology

as soon as

practically

possible

Written Apology

Within 10 working

days of incident

Immediate mitigating actions

1. Escalation – to line manager

2. Ascertain level of harm

(Moderate, Major or Catastrophic impact)

As outlined in the GMC/NMC Guidance 2015

3. Tell the patient* something has gone wrong.

4. Apologise to the patient and give them the duty of candour information leaflet.

5. Offer an appropriate remedy or support to put things

right (if possible).

6. Explain fully to the patient the short or long- term

effects of what has happened.

7. Identify a point of contact for the patient to use

during the investigation process and document these

in the patient information leaflet. This would usually be

the manager of the service/department

8. Invite the patient to be involved in the

investigation process.

9. Document the conversation in both the medical

and nursing notes. In an inpatient setting populate

the Duty of candour sticker (Appendix 15) and

apply to the medical and nursing notes. In the

community setting, chose the duty of candour

assessment in RIO, populate with the relevant

information and add to the patients progress notes.

10. On a daily basis the divisional co-coordinators for each division will access the medium and high harm incident Datix dashboard. Once patients have been identified the medical record will be accessed to determine the patients involvement in the investigation. A template letter (Appendix 16) will be populated by the divisional coordinators and signed by the divisional nurse.

11. Outline the Trust's investigation process.

12. Signed copy of letter to be uploaded to DATIX and initial Duty of Candour action closed.

*Patient: or, where appropriate, the patient's advocate, carer or family

INCIDENT


19. APPENDIX 15: DUTY OF CANDOUR STICKER


20. APPENDIX 16: DUTY OF CANDOUR LETTER TEMPLATE

Private and Confidential NAME ADDRESS ADDRESS ADDRESS ADDRESS POSTCODE DATE

North Devon District Hospital Raleigh Park

Barnstaple, Devon EX31 4JB

Direct line: 01271 XXXXX

Our ref: XXXXX

Dear NAME I am writing further to our telephone conversation on date, and would like to thank you for taking the time to speak with me regarding your mother’s/father’s, etc care and treatment. I would like to take this opportunity of sending you my sincere condolences on the sad loss of your mother/father, etc (if appropriate). As explained in our discussions the main reason for my call was to advise you that there were aspects of your mother’s/father’s, etc care and treatment which the Trust would wish to review. This review is called a 72 hour report/a Concise Investigation)/a SI (serious incident requiring investigation). This investigation is a formal framework where particular events are revisited, simply with the aim of identifying what happened, why it happened and if there is anything which could be put in place to reduce the chance of it happening again. The Trust is required to advise you of this review, and I would also like to reassure you that the Trust would want to advise you of the process, in the spirit of openness and honesty. As discussed in my telephone call once the 72 hour report/Concise Investigation/SI (serious incident requiring investigation) is finalised, hopefully in date (month/year), I will send you a copy, and should you wish to meet with the staff involved in the investigation I would be happy to arrange this, if you would feel it beneficial. However in the meantime please do not hesitate to call me on my direct line (01271) XXXXXX or via email on [email protected] should you wish to discuss any aspect of the investigation or report.

Yours sincerely NAME Divisional coordinator on behalf of the Divisional Nurse

mailto:[email protected]


21. APPENDIX 17 CARDIAC ARREST REPORTING FLOWCHART


22. APPENDIX 18: REPORTING

REPORTING ‘SIGNIFICANT EVENTS’ / INCIDENTS EXTERNALLY AND INVOLVING OTHER STAKEHOLDERS IN INVESTIGATING

The Commissioners

The Investigations Team will report incidents to the CCG via the StEIS reporting system.

This includes all incidents set out in Appendix 1.

The Health and Safety Executive

RIDDOR (Reporting of Injuries, Diseases and Dangerous Occurrences Regulations)

reportable incidents are notified to the HSE via the Health and Safety Manager. If the serious

incident requires joint investigation by the organisation and the HSE and the Police, the

Memorandum of Understanding will be activated.

The NRLS (National Reporting and Learning System)

All patient safety incidents / near misses are uploaded weekly from Datix by the DATIX and

incident Team.

The MHRA (Medicines and Healthcare Products Regulatory Agency)

The Facilities Clinical Services Manager report in conjunction with Medical Electronics

any significant events / concerns with Medical Devices.

Care Quality Commission [CQC]

The requirement to report incidents is typically met by reporting incidents to the National

Reporting and Learning System (NRLS). However, the Head of Governance will notify the

appropriate regulator, about incidents that indicate, or may indicate, risks to on-going

compliance with registration requirements, or that lead, or may lead to changes in the details

about the organisation in the regulators register according to the CQC regulatory framework.

Reporting Serious Adverse Blood Reactions and Incidents (SABRE)

The Trust Transfusion Team (Transfusion Practitioner, Blood Bank Manager, Blood

Conservation Specialty Doctor and Quality Manager) in line with the UK Blood Safety and

Quality Regulations 2005 and the EU Blood Safety Directive will report serious adverse

incidents and serious adverse reactions related to blood and blood components to the

MHRA, the UK Competent Authority for Blood Safety. This information is vital to the work

that the Serious Hazards of Transfusion (SHOT) uses to compile its reports.

IRMER (Ionising Regulations for Medical Exposure to Radiation) Reportable Incidents

IRMER incidents are reported by the Trust Radiation Protection Advisor. The Human Tissue Authority

Incidents relating to the collection or storage of human tissue for research should be reported

on Datix and the HTA indictor must be selected. The Trust’s HTA Lead will notify the HTA of

all incidents that are described in the HTA Reportable Incidents in the Post Mortem Sector

document http://www.hta.gov.uk/_db/_documents/Guidance_for_reporting_HTARIs.pdf

Early Notification Scheme for maternity incidents (NHS resolution)

NHS Resolution require all providers to report all maternity incidents that occur on or after 1

April 2017 which are likely to result in severe brain injury. These cases have the potential to

become high value compensation claims and are defined below:

Babies born at term (≥37 completed weeks of gestation), following labour, with a

severe brain injury diagnosed in the first seven days of life, namely babies that have

http://www.hta.gov.uk/_db/_documents/Guidance_for_reporting_HTARIs.pdf


one or more of the following:

Diagnosed with grade III hypoxic ischaemic encephalopathy (HIE);

Actively therapeutically cooled;

Have all three of the following signs: decreased central tone; comatose; seizures of

any kind.

The above criteria have been identified by the Royal College of Obstetricians and

Gynaecologists (RCOG) (Each Baby Counts Programme) as being potential markers for

avoidable severe brain injury at birth.

Healthcare Safety Investigation Branch (HSIB)

HSIB •conduct a portion of investigations each year to provide safety recommendations, they

provide thorough, independent, impartial and timely investigations into clinical incidents.

Sharing what they learn across the whole of the healthcare system for the benefit of everyone

who is cared for by it and works in it.

The HSIB investigate incidents that meet the Each Baby Counts criteria or their defined

criteria for maternal deaths. Each Baby Counts (RCOG) 1. Intrapartum stillbirth;

2. Early neonatal death: when the baby died within the first week of life (i.e. days 0–6) of any

cause; 3. Severe brain injury diagnosed in the first seven days of life.

• diagnosed with grade III hypoxic ischaemic encephalopathy (HIE)

OR

• Was therapeutically cooled (active cooling only)

OR

• Had decreased central tone AND was comatose AND had seizures of any kind

The Trust notifies the HSIB when an incident meets these criteria.

Screening

The Trust Hospital Based Programme Coordinator will follow the Guidelines for Managing

Safety Incidents in NHS Screening Programmes in the event of an incident.

Guidelines for Managing Safety Incidents in NHS Screening Programmes

Information Governance, Caldicott and Data Protection

Information Governance SIs will be reported via the DSP toolkit in line with NHS Digital Guide

to the Notification of Data Security and Protection Incidents by the Information Governance

Manager / Deputy. National NHS Reporting Guidelines.

Public Health England

Infection, Prevention and Control – where incidents have the potential to affect population

health, will seek advice from the local PHE Centre. Depending on the nature of the incident,

other public health organisations such as local authorities may need to be involved. Such

incidents will include those with a health protection component, such as failures in

decontamination. The PHE Centre health protection staff will provide a risk assessment and

advise on appropriate action.

If more than one organisation is involved in a significant event, the organisation that has

discovered the incident will make the initial report. A meeting will then be arranged to include

all key stakeholders. A lead professional will be identified to manage, lead and co-ordinate

the incident, procedure and investigation. All key stakeholders will contribute and work

together with the nominated lead and lessons will be shared with all stakeholders. The

Memorandum of Understanding Concordat Agreement outlines the arrangements for

https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/472611/Managing_Safety_Incidents_in_National_Screening_Programmes_gateway_291015.pdf

https://www.igt.hscic.gov.uk/KnowledgeBaseNew/HSCIC%20IG%20SIRI%20%20Checklist%20Guidance%20V2%200%201st%20June%202013.pdf


investigations involving the NHS, Police and HSE.

Defects and Failures

The Estates Management Team will report incidents that relate to a defect or failure involving

engineering plants, infrastructure and/or non-medical devices, a defect and failure report will

also be submitted to the Department of Health via the defect and failure portal


Page 42 of 45

23. APPENDIX 19 Just Culture guide

Incident reporting, analysing, investigating and learning policy and procedures of 45 Ratified by: Safety and Risk Committee – Review date: October 2022

24. APPENDIX 20: EQUALITY IMPACT ASSESSMENT TOOL

Name of document

Incident reporting, analysing, investigating and learning policy and procedures

Division/Directorate and service area Trustwide

Name, job title and contact details of

person completing the assessment

Julie Poyner, Head of Governance

Date completed: 20/09/2019

The purpose of this tool is to:

identify the equality issues related to a policy, procedure or strategy summarise the work done during the development of the document to reduce

negative impacts or to maximise benefit highlight unresolved issues with the policy/procedure/strategy which cannot be

removed but which will be monitored, and set out how this will be done.

1. What is the main purpose of this document?

This policy sets out the Trust systems, processes and expectations in relation

to incident reporting and learning

Compliance with this policy will ensure that incidents are systematically identified,

recorded, reported to management and appropriately investigated. This will result in

learning and thus improving safety for future patients, staff and visitors.

2. Who does it mainly affect? (Please insert an “x” as appropriate:)

Carers ☒ Staff ☒ Patients ☒ Other (please specify)

3. Who might the policy have a ‘differential’ effect on, considering the “protected characteristics” below? (By differential we mean, for example that a policy may have a noticeably more positive or negative impact on a particular group e.g. it may be more beneficial for women than for men)

Please insert an “x” in the appropriate box (x)


Protected characteristic Relevant Not relevant

Age X ☐

Disability X ☐

Sex - including: Transgender, and Pregnancy / Maternity

X ☐

Race X ☐

Religion / belief X ☐

Sexual orientation – including: Marriage / Civil Partnership

X

☐

4. Apart from those with protected characteristics, which other groups in society might this document be particularly relevant to… (e.g. those affected by homelessness, bariatric patients, end of life patients, those with carers etc.)?

End of life

5. Do you think the document meets our human rights obligations? ☒

Feel free to expand on any human rights considerations in question 6 below.

A quick guide to human rights:

Fairness – how have you made sure it treats everyone justly?

Respect – how have you made sure it respects everyone as a person?

Equality – how does it give everyone an equal chance to get whatever it is offering?

Dignity – have you made sure it treats everyone with dignity?

Autonomy – Does it enable people to make decisions for themselves?

6. Looking back at questions 3, 4 and 5, can you summarise what has been done

during the production of this document and your consultation process to

support our equality / human rights / inclusion commitments?

Discussion with equality lead on how incident reporting best benefits the monitoring and addressing of equality related incidents.

Inclusion of live reporting of equality related incidents


7. If you have noted any ‘missed opportunities’, or perhaps

noted that there remains some concern about a

potentially negative impact please note this below and how this will be

monitored/addressed.

“Protected characteristic”: None

Issue:

How is this going to be

monitored/ addressed in the

future:

Group that will be responsible

for ensuring this carried out:

All equality impact assessments will need the involvement of somebody beyond the policy author to provide insight and guidance. If you need help with any aspect of this assessment, please contact either (for patient related policies/procedures/strategies) or (for human resources). Both can be contacted via (if you are using the generic email please can you indicate whether you feel this is predominantly patient or staff related).

Please note: apart from seeking guidance during the development of the policy/strategy, etc., this impact assessment form also needs to be approved by an appropriate equality lead prior to final ratification of the policy.