Incident reporting and management policy and procedure ... · • The incident reporting ‘pick...

APPENDIX 1

Incident reporting and management policy and procedure; including the management of Serious Untoward Incidents Reference Number:

213/2008

Author / Manager Responsible:

Alexandra Lucas, Head of Patient Safety

Deadline for ratification: (Policy must be ratified within 6 months of review date)

Review Date:

June 2009

Ratified by:

Trust Board

Date Ratified:

Related Policies

• Strategic Framework for Risk Management • Major Incident policy • Complaints Policy and Procedure • Policy and Procedure for the Management of

Claims • Health and Safety Policy • Whistleblowing policy & procedure • Managing Conduct policy and procedure • Managing Performance policy and procedure • Code of Expectations of Employees • Managing Stress and Well-being at Work

policy and procedure

V.2 April 2009

Document name: Incident reporting and management policy and procedure; including the management of Serious Untoward Incidents

Ref.:

Issue date: Status: Final of 57

Contents

Section Page

Incident reporting summary 5

1 Introduction 7

2 Purpose 7

3 Scope of Policy 8

4 Definitions used within this Document 8

5 Responsibilities 9

5.1 Role Responsibilities 9

5.2 Committee Responsibilities 12

6 Category of Incident 12

6.1 Low Risk Category 13

6.2 Moderate Risk Category 13

6.3 High Risk Category 14

6.4 Extreme Risk Category 14

6.5 Near miss Incidents 15

7 Reporting Incidents 16

8 Investigating Incidents 16

9 The Management of Serious Untoward Incidents 17

10 Roles and responsibilities for the Management of Serious Untoward Incidents 18

10.1 Involved Staff 18

10.2 Most senior staff member/ senior manager on duty 18

10.3 The Head of Patient Safety 19

10.4 Director of Nursing 19

11 Reporting Serious Untoward Incidents 19

11.1 Reporting cascade 19

12. Other Actions 20

13 Investigation and Root Cause Analysis 21

14 Reporting on the Investigation 22

15 Analysis of Incident Data 23

16 Sharing Learning 23

17 Preventing Reoccurrence 24

18 Staff, Patient, Carer, Visitor and Contractor Support 25

19 Communication Strategy 26

19.1 Informing Staff 26

19.2 General Practitioners 26

19.3 Media Contact 27

19.4 Informing Stakeholders 27

19.5 Notifying the Lead Commissioner/Strategic Health Authority 27

19.6 ‘Help-line/Hotline’ Arrangements 28

19.7 Being open with patient’s and relatives 28

20 Links with Other Policies 29

20.1 Whistleblowing Policy 29

20.2 Disciplinary Policy 29

20.3 Complaints Procedure 30

20.4 Safeguarding Adults Procedure 30

20.5 Safeguarding Children 30

20.6 Counter Fraud 31

21 Training 31

22 Monitoring 31

23 References 32

Document name: Incident reporting and management policy and procedure; Ref.: including the management of Serious Untoward Incidents Issue date: Status: Final

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Appendices

Appendix 1 Consultation schedule 35

Appendix 2 Classification of Incidents Types 36

Appendix 3 Risk Assessment Matrix 37

Appendix 4 Incident Report form Procedural Guidelines 40

Appendix 5 Action for Line Managers 45

Appendix 6 Three levels of RCA Investigation - Guidance 46

Appendix 7 Serious Untoward Incident Identification 48

Appendix 8 Serious Untoward Incident Procedure Flow Chart 49

Appendix 9 Quick Reference Guide to Being Open 50

Appendix 10 Guidelines for Preparing and Writing Statements 52

Appendix 11 Trust Leaflet of Psychological Responses to Extremely Stressful Events

53

Appendix 12 Equality Impact Assessment 55

Appendix 13 Ratification checklist 56


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INCIDENT REPORTING SUMMARY

Page 1 of 2 What? Who? How? When?

Identification of an incident

Person involved, either directly or indirectly

By reference to: • Classification of incidents at appendix

2 • The incident reporting ‘pick list’ (section

6), available in all wards and departments.

Immediately

upon identification of

the incident

▼

Reporting an incident

(low/moderate)

Person involved, either directly or indirectly

Reporting to the most senior person on duty Completing an incident report (IR) form Entry in the patient’s health records (patient safety incident)

Immediately upon

identification of the incident

▼

Reporting an incident

(high/extreme)/ SUI

Most senior member of staff notified at the time of occurrence

By calling: • the Director on Call • the Director of Nursing • the Head of Patient Safety Completing an incident report (IR) form

Immediately upon

identification of the incident

▼

Grading an incident

Person involved/line manager

Completing section J of the incident report (IR) form

when completing

incident form

▼

Incident investigation

(low/moderate)

Ward/department manager

Using root cause analysis techniques and tools

Within 7 days of the incident

▼

Incident investigation

(high/extreme)

Nominated investigator

Using root cause analysis techniques and tools


▼

Central recording of incident data

Risk Management team

Incident reporting database entry following receipt of the incident report (IR) form

Within three days of receipt of the incident

▼

Reporting investigation information


Brief: Section J of the incident report (IR) form Concise: Using the level 1 NPSA RCA report proforma (section 14), Comprehensive: Using the level 2 NPSA RCA report format (section 14),


▼

Feedback to staff


Individually, or via meetings, following completion of investigation

As soon after the incident as practical


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of 2 What? Who? How? When?

Analysing incident data

(local)

Ward or department manager/risk leads

Analysing incident data reporting produced by the risk management team or locally.

Each quarter

▼

Analysing incident data (Trust-wide)

Head of Patient Safety/Head of Health & Safety

Analysing incident reporting data quarterly and submitting to Trust assurance committee meetings

Each quarter

▼

Sharing learning (local)

Ward or department manager/risk leads/governance groups

Analysis of incident feedback to staff in the department

following the

specialty governan

ce meeting

▼

Sharing learning (Trust-wide)


Production of regular incident analysis reports to governance and Trust assurance committees

each quarter

▼

Sharing learning (Externally)


• Submission of incident reporting data to external stakeholders

• Submission of RCA reports to external stakeholders (section 16.2)

Ongoing

▼

Monitoring of incident

investigation action plans

(local)

Divisional/Directorate governance groups

Documented review of progress against action plans

Each Governa

nce meeting

▼

Monitoring of incident

investigation action plans (Trust-wide)

Divisional/Directorate governance groups

Operational Governance Committee/Health & Safety Committee documented review of progress against action plans

Each governan

ce meeting


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Ref.:


1 INTRODUCTION The Royal United Hospital NHS Trust (the Trust) recognises the importance of reporting all accidents and incidents as an integral part of its risk identification and risk management strategy. The Trust is committed to improving the quality of care to patients, and the safety of staff and members of the public, through the consistent monitoring and review of incidents that result, or had the potential to result in injury, damage or other loss. The investigation of an incident forms part of a wider strategy for risk management, which advocates the use of root cause analysis to understand why an incident has occurred. The emphasis is upon critical exploration of the underlying and contributory factors, which if allowed to persist, could create the potential for the same error to be repeated again. Organisational learning and remedial action must be at the heart of any risk management approach. The NHS recognises the importance of learning lessons from incidents. Through the introduction of standardised reporting and management arrangements the NHS wishes to ensure that where incidents occur in one organisation the lessons learnt are shared across all NHS organisations, key stakeholders and our consumers of care. The Trust has a statutory duty to report certain kinds of accidents, violent incidents, dangerous occurrences and occupational ill health under the Health and Safety at Work Act 1974 and more specifically in accord with the Reporting of Injuries, Diseases and Dangerous Occurrences Regulations (RIDDOR) 1995. It is also a requirement to report certain incidents to a national body (e.g. Medicines and Healthcare products Regulatory Agency, NHS Estates, Department of Health, the South West Strategic Health Authority (SW SHA) and in the National Patient Safety Agency (NPSA) within a specific timeframe. 2 PURPOSE It is the policy of this Trust to record all incidents that have resulted in injury or loss or have the potential to do so, to report these incidents to the appropriate person and in a timely manner. This applies to incidents affecting patients, directly employed staff and others including visitors, contractors and volunteers who are visiting or working on our premises. This policy describes the Trust’s approach to the recording, reporting and the management of incidents. It also defines the types of incidents that may occur, clarifies the process of classification of incident severity and the data analysis used to highlight any trends which may uncover a need for further intervention. The Trust approach to incident management is designed to achieve the following objectives:

• a standardised approach to incident management across the Trust; • to ensure that learning from incidents is an integral part of the organisation’s culture; • analysis of trends which may identify the further need for intervention; • to improve patient and staff safety by addressing systematic errors; • to promote a culture of accountability without ‘blame’.

In doing so, the aim of the Trust is to promote a positive and non-punitive approach towards incident reporting, so long as there has been no flagrant disregard of the Trust Policies, fraud or gross misconduct.

3 SCOPE OF THE POLICY This policy applies when:

• the person is working on official Trust business, either as a permanent employee, a temporary employee on short term contract, a placement student, an agency nurse or locum, or as a subcontractor or volunteer;

• an incident occurs in a patient’s/client’s home whilst a member of directly employed Trust staff (including temporary nurses and healthcare professionals) is involved in providing care;

• when the a patient/client is undergoing treatment; • when the person is in a hospital, health centre or clinic for the purposes of health

care or for the purpose of visiting another. This policy relates solely to the incident reporting requirements of directly employed staff using the Incident Reporting (IR) form system of reporting, as detailed in appendix 3. 4 DEFINITIONS USED WITHIN THIS DOCUMENT 4.1 An incident An Incident is defined as an untoward event which has happened to, or occurred with, a patient(s), staff or visitor(s), the result of which might be harmful or potentially harmful, or which does cause or lead to harm. This definition also encompasses all “near misses”. Examples of incident types can be found at Appendix 2. 4.2 Serious Untoward Incident There are a variety of terms in current usage in the UK and internationally which provide similar definitions of a Serious Incident. These include:

• serious clinical event; • major clinical incident or event; • major or serious, adverse or untoward, event or incident.

The Trust will adopt and use Serious Untoward Incident to cover all of these common terms. For the purposes of this policy, the Trust will define a Serious Untoward Incident as one in which the consequences are:

• catastrophic - contributing to, leading to or causing death; or • major - contributing to, leading to or causing permanent injury; or • moderate - contributing to, leading to or causing semi-permanent injury which might

take up to a year to resolve; or • minor - relatively minor accident or injury to each individual, but a number of people

are involved; or • defects in plant, equipment, drugs or devices causing harm to patients, staff or

visitors; or • the incident or individual involved may have a high media profile.

These criteria are not exhaustive. For further guidance see section 6 and Appendix 7. 4.3 Hazard

A Hazard is something, i.e. an object, an unsafe act, an unsafe process, that has the potential to cause harm, loss or damage.


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4.4 Risk

Risk is the chance or likelihood of harm, loss or damage.

4.5 Near miss Those incidents that did not lead to harm, but could have, are referred to as a near miss, or patient safety incident (prevented).

4.6 Harm This can consist of both physical injury and/or mental damage.

4.7 Risk Grade The Risk Grade is calculated by multiplying the likelihood of an adverse event occurring by the severity of the harm loss or damage. This Trust utilises the standard NPSA 5x5 matrix (see section 6 & Appendix 3).

4.8 Factual Investigation A factual investigation is a careful search or examination of the incident/event, in order to discover facts. Some level of investigation must be applied to every incident.

5 RESPONSIBILITIES

5.1 Role responsibilities 5.1.1 The role of the Chief Executive The Chief Executive is responsible for overseeing the effective execution of a plan to achieve quality and safety improvement and harm reduction aims.

5.1.2 The Role of the Director of Nursing The Director of Nursing is the designated director with responsibility for the implementation of governance frameworks and risk management and for ensuring that appropriate systems are in place to identify and respond to incidents reported within the Trust.

On notification of Extreme Risk Incidents occurring in the Trust, the Director of Nursing is responsible for:

i. invoking the Serious Untoward Incident (SUI) procedure (section 9); ii. to advise on the appropriate person to lead the investigation; iii. to monitor progress and advise the Chief Executive in all matters

pertaining to the investigation; iv. to ensure the Trust complies with external reporting requirements; v. ensure all relevant stakeholders are informed, as appropriate. vi. to assess the potential for any public relations implications and agree

an approach liaising with the Chief Executive and the Communications Manager.

5.1.3 Role of the Head of Patient Safety

i. To ensure the review of incidents report forms, monitoring their compliance with the guidance given in Appendix 4, including appropriate grading.

ii. To immediately alert the Director of Nursing of the occurrence of all high and extreme risk incidents (SUIs)


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iii. To ensure all information on incidents is collected on the incident reporting database and that patient safety data is reported to the NPSA via the NRLS

iv. To provide quarterly and annual statistical reports to the Governance Committees of the Trust, identifying incident trends across the organisation.

v. The production of divisional, directorate or specialty specific incident data

vi. To support Divisions and Directorates in ensuring that appropriate action is taken as a result of incident reporting.

vii. To ensure that Trust-wide risk issues are brought to the attention of the appropriate committee.

viii. To report SUI’s, where appropriate, to the Strategic Health Authority and the Commissioning PCT within 3 days of the incident occurring.

ix. To ensure notification of the Medicines and Healthcare products Regulatory Agency of any reportable incidents involving equipment.

x. To liaise with the Complaints and Claims Manager when there has been an incident that has the potential to result in a claim.

xi. To facilitate a formal investigation into incidents classified as Extreme Risk (Red Category) incidents, and where appropriate High Risk, utilising root cause analysis.

xii. As per the Serious Untoward Incident Procedure (section 9), present a summary and action plan to the Governance Committees, of any incident formally investigated.

xiii. To highlight the occurrence of incidents involving external stakeholders (e.g. PCTs, ambulance Trusts, Acute/Foundation Trusts, pharmacists etc.) to those organisations.

5.1.4 Role of the Head of Health & Safety

i. To provide quarterly and annual statistical reports to the Governance Committees of the Trust, identifying incident trends across the organisation.

ii. To support Divisions and Directorates in ensuring that appropriate action is taken as a result of incident reporting.

iii. To ensure that Trust-wide risk issues are brought to the attention of the appropriate committee.

iv. To ensure any RIDDOR reportable incidents are reported to the Health and Safety Executive within the appropriate timeframe.

v. To liaise with the Complaints and Claims Manager when there has been an incident that has the potential to result in a claim.

vi. To facilitate a formal investigation into incidents classified as Extreme Risk (‘red’ category) incidents, and where appropriate High Risk, utilising root cause analysis.

5.1.5 Role of the Divisional Managers and Directors Divisional Managers and Directors are responsible for the safety of all patients and directly employed staff and others including visitors, volunteers and contractors, who may be affected by the actions of the team within their sphere of responsibility. Specifically they are responsible for:

i. co-ordinating the actions required for the Trust to address all risk

management issues in relation to the incident; ii. ensuring all incidents are communicated to the Head of Patient Safety

and in accordance with this policy; Document name: Incident reporting and management policy and procedure; Ref.: including the management of Serious Untoward Incidents Issue date: Status: Final

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iii. ensuring temporary staff, contractors and volunteers are aware of the incident reporting policy and procedures;

iv. ensuring that any statutory reporting is carried out and reporting timeframes are met. This includes ensuring that incidents reportable in accordance with the Reporting of Injuries, Diseases and Dangerous Occurrences Regulations 1995 (RIDDOR) are reported to the Health and Safety team within the required time frame;

v. reviewing all summary reports provided by the Risk Management Team pertaining to their Division or Directorate and ensuring that the review of these are included in their Division or Directorate governance meetings;

vi. initiating management action and where appropriate any Root Cause Analysis investigations required following an incident including the allocation of sufficient resources and follow-up;

vii. ensuring that support is provided for staff involved in an incident; viii. ensuring that all Extreme Risk Incidents are managed in accordance

with the Serious Untoward Incident Procedure.

5.1.6 Role of the ward and department (line) managers All managers, team leaders and supervisors (or deputy) are responsible for:

i. ensuring that all staff within their sphere of responsibility are familiar with this policy and the procedure for incident reporting and investigation;

ii. ensuring that all incidents within their sphere of responsibility are reported and recorded on the Incident Report (IR) form, in compliance with Appendix 4, including:

• monitoring of information reported on the incident forms for accuracy and completeness and taking steps to improve performance where omissions are identified

• completing the Risk Evaluation section (section J) of the IR form • ensuring that a copy of the incident record is retained in accordance

with Appendix 4, section 13. • ensuring that the top (blue) copy of the IR form is submitted to the

Risk Management Team within 2 days of the date of the incident • ensuring that management follow-up action is notified to the Risk

Management Team within 7 days of the date of the incident; iii. reviewing the incident grading as soon as possible after the incident, using

the severity matrix. Any alteration to the grading should be clearly indicated on the IR form, with a clear explanation of the alteration;

iv. ensuring all Extreme Risk Incidents (serious untoward incidents) are brought to the immediate attention of their Line Manager/Head of Department (On-Call Manager out-of-hours) and the Head of Patient Safety. Securing the health records and ensuring an IR form is completed;

v. for High Risk incidents, identified on the IR form, instigating a preliminary investigation utilising root cause analysis. Completing the relevant section of the Incident report form (section J);

vi. informing, where appropriate, the senior clinician responsible for the patient’s treatment/care;

vii. following discussion with the lead clinician and Divisional Management team, ensuring that the patient and/or family/carer are aware of any incidents categorized as medium or high risk (see section 19.7, being open);

Document name: Incident reporting and management policy and procedure; Ref.:

viii. in conjunction with the Occupational Health Department and the Employee Assistance Programme team, initiating a support mechanism for staff involved in any incident;

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ix. ensuring that incidents reportable in accordance with the Reporting of Injuries, Diseases and Dangerous Occurrences Regulations 1995 (RIDDOR) are reported to the Health and Safety team within the required time frame;

x. ensuring that all staff concerned are debriefed after the incident; xi. providing feedback to directly employed staff on trends, serious incidents,

results of investigations, learning opportunities and any necessary risk reduction activities required within their area;

xii. ensuring that any procedures within their area take account of incidents that have been brought to their attention;

xiii. ensuring that recommendations arising from the investigation are implemented and monitored accordingly;

xiv. making safe any area or equipment following an accident, isolating and retaining equipment for inspection where required

5.1.7 All staff Every member of staff is responsible for being aware of the requirements of this policy, reporting an incident when it occurs and participating in incident investigation processes.

5.2 Committee responsibilities

5.2.1 The role of the Clinical Governance Committee To provide the Trust Board with assurance on the effective reporting and management of patient safety incidents, including organisational learning to prevent reoccurrence. 5.2.2 The role of the Non-Clinical Risk Committee To provide the Trust Board with assurance on the effective reporting and management of health and safety incidents, including organisational learning to prevent reoccurrence. 5.2.3 The role of the Operational Governance Committee To review the local implementation of recommendations for action from the analysis of patient safety incidents, complaints, PALS and claims. To identify areas of risk, to the organisation; highlighted through the analysis of patient safety incidents, complaints and claims. 5.2.4 The role of the Health & Safety Committee To review the local implementation of recommendations for action from the analysis of health and safety related incidents, complaints, PALS and claims. To identify areas of risk, to the organisation; highlighted through the analysis of health and safety incidents, complaints and claims. 5.2.5 The role of the Trust Board The Trust Board is responsible for ensuring it is aware of and receives adequate assurance on the management of incidents, as identified in the Standards for better health core standard C1a.

6. CATEGORY OF INCIDENT Incidents are categorised into nine broad categories:

• Patient Safety Document name: Incident reporting and management policy and procedure; Ref.: including the management of Serious Untoward Incidents Issue date: Status: Final

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• Personal accident • Ill Health (Work related only) • Fire Incident • Violence, abuse or harassment • Vehicle • Security • Miscellaneous

Information on these categories are given in more detail in appendix 2. The different types of incidents within these categories are identified in the incident reporting ‘pick lists’ available in each ward and department with the incident reporting (IR) form book. These lists are also available on the intranet and will be updated on a regular basis, in order to reflect the incident reporting categories identified in incident analysis. The classification of incidents can be defined numerically, using a simple risk quantification matrix. The matrix used by the Trust has been adapted from an International Risk Management Standard (Australian Standard/New Zealand Standard 4360:2004).

Severity None (1) Minor (2) Moderate (3) Major (4) Catastrophic (4)

Likelihood Rare (1) Unlikely (2) Possible (3) Likely (4) Very Likely (5)

All incidents will sit on a sliding scale of severity that will determine the actions to be taken at either ward, department, divisional, directorate or organisational level. The significance of the incident is determined by two factors:

the consequence or outcome of the incident; the probability or likelihood of the incident reoccurring.

Both of these factors can be assigned a numerical score ranging 1 – 5. A detailed description of the numerical scoring is illustrated in table Appendix 3. It is important to note that all incidents should be reported and investigated in accordance with the procedures as detailed in section 13 (including, where appropriate in accord with the Serious Untoward Incident procedure). The category of an incident will dictate the level of resultant management action and investigation. The severity score can be identified using the scoring matrix at Appendix 3 and will place the incident into one of the four following categories. 6.1 Low Risk Category Low Risk Incidents are incidents where immediate simple action only is necessary. Incidents that fall into this category must be risk scored by the individual reporting the incident and/or by the manager of the team/department concerned. They should be reported immediately on an incident report (IR) form, including brief details of the investigation, contributory factors, root causes and actions taken to prevent reoccurrence and forwarded to the Risk Management team within two working days utilising the IR form, as per the procedure detailed in Appendix 4. Such incidents may include:

a needle-stick injuries with a clean needle b fall with no injury to patient/staff/visitor c increased level of care, <5 days.


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6.2 Moderate Risk Category Moderate Risk Incidents involve incidents where only local management investigation and follow-up is required. An action plan may arise, which should be presented to the Divisional/Directorate meeting. Types of incidents that fall into this category must be risk scored by the individual reporting the incident and reviewed by the Ward/Department/Divisional/Directorate Manager. They should be reported to the Risk Management team within two working days utilising the IR form. Such incidents may include:

a minor injury requiring first aid, injury/ill health/damage/lessening of bodily function (sensory, motor, physiological or intellectual) not related to the natural course of the patient’s illness or underlying condition (i.e. acts of commission or omission)

b increased level of care, >5 days c failure of the Trust servers.

A concise level of investigation is required, including the information identified in Appendix 6. Guidance on undertaking a root cause analysis investigation can be obtained from the Head of Patient Safety, in addition guidance is also provided by the National Patient Safety Agency (NPSA), from the Root cause analysis investigation and report tools, which can be obtained at: http://www.npsa.nhs.uk/nrls/improvingpatientsafety/patient-safety-tools-and-guidance/rootcauseanalysis/rca-investigation-report-tools/

6.3 High risk category These incidents will require a comprehensive investigation, with the development of a full report identifying root causes, lessons learned and an action plan to prevent reoccurrence by the designated lead and/or the Divisional/Directorate manager. Details of the scope of the investigation is identified in Appendix 6.

A summary of this report will be presented to the Operational Governance Committee or the Health and Safety Committee. High Risk incidents must be reported verbally within one working day to the Head of Patient Safety during working hours or to the On-Call Manager out-of-hours. A completed incident report (RM) form (including risk scoring and follow-up action) must be forwarded to the Head of Patient Safety within two working days. Incidents that may fall into this category include:

a extensive injury/ill health/damage/loss of function (sensory, motor, physiological, or intellectual) not related to the natural course of the patient’s illness or underlying condition (i.e. acts of commission or omission);

b local adverse publicity; c temporary service closure (up to one week); d increased level of care for more than 15 days; e injury resulting in sickness absence for greater than 3 days as defined under

RIDDOR 6.4 Extreme Risk category This category of incidents will invariably be identified as a Serious Untoward Incident (SUI) and managed as per the procedure detailed in section 9. All Extreme Risk incidents are initially considered to be serious incidents and will require immediate action by senior members of the Trust and will be managed in accordance with the Serious Untoward Incident Procedure (section 9). They must be verbally reported immediately to the relevant Divisional/Directorate Manager, the Director of Nursing and to the Head of Patient Safety. Out-of-hours the incident must be reported to the On-Call Manager.


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http://www.npsa.nhs.uk/nrls/improvingpatientsafety/patient-safety-tools-and-guidance/rootcauseanalysis/rca-investigation-report-tools/


These incidents will require a comprehensive investigation and may, on occasion, be subject or require an independent investigation. Details on the investigation requirements can be found in Appendix 6. The outcome of extreme risk incident investigations will be presented to the Clinical Governance Committee or the Non-Clinical Risk Committee.

Incidents within this category must comply with the reporting timeframes:

drafting of the final report within 45 days notifying the Lead commissioner Primary Care Trust, the South West Strategic

Health Authority and the National Patient Safety Agency; initial report of the incident within 3 days and a completed investigation within 60 days;

notifying the Health and Safety Executive – reportable incidents (e.g. death or major injury as a result of a work related accident) should be reported within 48 hours to the HSE Incident Contact Centre. The Health & Safety Advisor must submit a written report within 10 days of the incident.

National Health Service Litigation Authority – once an incident is considered to result in a potential claim.

Examples of the type of incident considered to be in this category can be found in appendix 7. The list is not exhaustive. 6.5 Near miss incidents Those adverse events that did lead to harm are referred to as incidents. Those incidents that did not lead to harm, but could have, are referred to as a near miss. Those clinical/patient safety incidents that did not lead to harm, but could have, are referred to as a near miss, or patient safety incident (prevented). These refer to any situation that did not result in injury/ill health or property loss/damage, but had the potential to do so (e.g. medication prescribing error, incorrect theatre list, scaffold collapse, etc.) and are not to be confused with actual incidents that resulted in no harm. Incidents of this nature will also fall within the identified categories listed in section 5 and 6 and should be investigated as such. It is the responsibility of all staff to report incidents using the definition detailed in this document. In addition, any person who feels that an event which, had it happened, could have given rise to an Incident should report it as a “near miss”.

Incident

YESAdverse

event

Did the event result

in harm, loss or damage?

“Any event or

circumstance that could have or did lead

to unintended or unexpected harm, loss

or damage”

NO

Near Miss

The Trust does not distinguish between incidents and accidents/or potential incidents and accidents. In this policy, all events are referred to as incidents and they should all be reported on the same form.


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7 REPORTING INCIDENTS 7.1 Patients, directly employed staff and visitors The process for reporting incidents is identified in Appendix 4. All incidents must be reported at the time of occurrence, or as soon as possible afterwards, to the line manager/Supervisor/Team Leader on duty. In the case of incidents that are discovered in retrospect, this still applies. For all patient safety (clinical) incidents, the incident occurrence and any follow-up actions taken to reduce further exposure to risk must be documented clearly in the patient’s health records. All staff involved in, or made aware of an incident, must complete an incident report (IR) form, for submission to the Risk Management team within two working days of the incident. The incident reporting database has the functionality for direct entry of information on incidents and their follow-up, from any Trust computer, and this may be the alternative method of reporting chosen by staff. As per section 5, the ward/department/team manager, or investigating manager must complete section J of the incident report (IR) form and forward to the Risk Management department within seven days of the incident. 7.2 Contractors The contractor is responsible for managing all incidents involving their staff and reporting any that require notification under RIDDOR to the Enforcing Authority. The Trust contracting officer must be made aware of all RIDDOR incidents as soon as practicable and may also require, through the formal contract progress, meeting details of the contractor health and safety performance. The contracting manager should complete a Trust incident report (IR) form for any contractor RIDDOR incident, so that the Trust is formally notified and can undertake any necessary investigation. Any incident involving Trust staff, patients, visitors or affects the Trust activities, but occurs as a result of contractor activity, then the contracting manager must be informed as soon as possible. The contracting manager will investigate, carry out any necessary actions to minimise the impact of the incident on the Trust activities and provide a summary report to the Health and Safety Committee. 8 INVESTIGATING INCIDENTS


The purpose of an investigation is to determine the facts concerning the incident and to identify whether any deficiencies in the standard of care provided or in the application of Trust policies or procedures contributed to the incident. This process applies equally to all complaints and claims.

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It is important that all facts are looked at. It is rarely due to one person’s actions that an incident has occurred, but usually results from a combination of events. The purpose of the investigation is to establish what actually happened and what actions need to be taken to prevent reoccurrence, but not to allocate blame. However in some cases the investigation may identify that the disciplinary processes may need to be invoked (section 20.2). The line manager with responsibility for the area in which the incident occurs is responsible for ensuring an initial assessment and investigation into the incident is undertaken, utilising the root cause analysis approach. The level of investigation will be determined by the severity of the incident (refer to section 6). Guidance on undertaking a root cause analysis investigation can be obtained from the Head of Patient Safety, in addition guidance is also provided by the National Patient Safety Agency (NPSA), from the Root cause analysis investigation and report tools, which can be obtained at: http://www.npsa.nhs.uk/nrls/improvingpatientsafety/patient-safety-tools-and-guidance/rootcauseanalysis/rca-investigation-report-tools/ Further advice and assistance in the investigation process can be provided by the Head of Patient Safety, the Head of Health & Safety or the Complaints, Litigation and Claims Manager. Following the investigation, information on the cause of the incident, including associated factors, the area/line manager is responsible for notifying the risk management team of this information and details on actions to be taken locally to prevent reoccurrence. The investigator will be responsible for ensuring that all staff concerned are debriefed and that recommendations arising from the investigation are implemented and monitored in accordance with the action plan. In the event of an incident involving a patient, they are responsible for securing the health records and arranging for a copy to be made, where appropriate; Where staff need to be interviewed as part of the investigation process, it is necessary to document the details of all discussions and any information given to staff members. 9 THE MANAGEMENT OF SERIOUS UNTOWARD INCIDENTS It is essential that there is a procedure in place for the rapid identification and follow-up of all serious untoward patient safety (clinical) and non-clinical incidents. When things go wrong the Trust must respond quickly and positively to mitigate the consequences and to demonstrate that its main concern is the patients’ best interests and well being. This section covers this requirement and is complementary to the normal incident reporting procedures and the Trust’s formal reporting obligations to any statutory or regulatory organisation/agency. This includes guidance on conducting an internal investigation. Any incident that is classified as a ‘high’ risk or ‘extreme’ risk within the risk evaluation matrix (section 6) will be identified as a serious untoward incident. Examples of incident types that would constitute a SUI are identified at appendix 7. The list of examples is not exhaustive, but should assist in clarifying under what circumstances an Document name: Incident reporting and management policy and procedure; Ref.: including the management of Serious Untoward Incidents Issue date: Status: Final

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incident should be reported. If staff are in any doubt about whether or not an incident is serious or not, they should contact their line manager or the Head of Patient Safety immediately. 10 ROLES AND RESPONSIBILITIES FOR THE MANAGEMENT OF SERIOUS

UNTOWARD INCIDENTS In addition to the responsibilities for managing incidents, as identified in section 5, in the event of a serious untoward incident and for the purpose of this document, the following titles roles and responsibilities will apply: 10.1 'Involved staff'

All ‘involved staff’ are responsible for normal standards of professional expertise and care; in order to make the situation or patient safe and ensuring those involved come to no further harm, by:

minimising any further risk to the person(s) involved (this includes instituting appropriate resuscitative measures and enlisting senior clinical and managerial help, where appropriate).

informing senior staff member (where not already involved) completing an incident report (IR) form ensuring that a factual account of the incident is entered in the health records

(patient safety incident). This should include a detailed record of all those present at the time of the event.

supporting family members, where appropriate. From the time that the incident is discovered, a contemporaneous record must be kept of the management of the incident, the investigation and the resulting action taken. 10.2 'Most senior staff member/senior manager on duty'

This includes: Senior nurse (e.g. team leader, Matron, ‘ward or department manager) Senior manager (e.g. Manager On-Call, Clinical Lead) Director On-Call.

Should ensure that all appropriate steps have been taken (i.e. resuscitation performed, risk removed/reduced), appropriate personnel are involved (i.e. clinical and/or managerial expertise), and relevant documentation is completed. Thorough contemporaneous documentation of the event is essential.

The most senior staff member on duty at the time of the incident is directly

responsible for the immediate management of the incident and reporting to the Head of Patient Safety and will:

produce the initial report (see investigation procedure). The report will be no longer than two pages in length. Copies will be sent to the designated person responsible for the management of the incident, and the Head of Patient Safety;

secure all relevant documents, including vital signs recordings, laboratory results, assessment forms. It is important that shortly after the incident that a decision is made whether it is necessary to remove all documents relating to the relevant service user/staff. All removed health records documentation will


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be stored securely away from the clinical area after all necessary entries concerning the incident have been completed. Where records have been removed, they will be copied and returned to the work area as soon as possible. This must be handled with sensitivity. N.B. In the case of death, health records must be removed immediately and a copy made;

ensure that support and assistance is provided when staff are completing any records;

advise staff on the need to complete a written statement; ensure all staff are supported.

10.3 The Head of Patient Safety The Head of Patient Safety is responsible for ensuring that the incident is managed and controlled appropriately, by reviewing the situation with senior staff members and then informing the relevant Director as soon as is practical, and in line with the severity of the incident (see section 6). 10.4 Director of Nursing The Director of Nursing is responsible for ensuring an appropriate investigation is set up into all serious or potentially serious untoward incidents, and for designating a single individual responsible for managing the incident and co-ordinating the incident review investigation. They are also responsible for informing the Chief Executive of the incident. The Director of Nursing is responsible for liaising with other external agencies and stakeholders (see section 19.4). 11 REPORTING SERIOUS UNTOWARD INCIDENTS During normal working hours staff are required to report all such serious incidents immediately to the Head of Patient Safety, or the Director of Nursing if the Head of Patient Safety is not available. The Head of Patient Safety must be notified at the earliest opportunity. The Head of Patient Safety is expected to notify the Director of Nursing or On Call Director immediately. An Incident Report (RM) form, or direct entry of the incident details onto the incident reporting database will be completed in all cases after the immediate action to manage the incident has been taken. 11.1 Reporting cascade

This structure can be seen in Appendix 8. 11.1.1 In normal ‘working hours’ (i.e. 08.00 - 1730 Monday-Friday)

If the patient's lead clinician has not been present at the incident the senior staff member present should inform them as soon as possible.

It would normally be the lead clinician’s responsibility to inform the family about the incident, as per the principles of ‘Being Open’ (DoH 2004) (section 19.7).

The senior staff member completing the incident report form is also responsible for informing the Head of Patient Safety about the incident and this should be as soon as possible after the event.


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The Head of Patient Safety will assess the incident and be directly responsible for informing the Director Nursing, with a view to instigating a serious untoward incident investigation. If and where appropriate, the Chief Executive should also be informed when the decision to investigate is made. It is their responsibility to ensure the patient’s lead clinician has been informed of the intention to formally investigate the incident.

The decision to investigate an incident in line with the Serious Untoward Incident process rests with the Director of Nursing, or Director on Call.

As part of the process, the relevant Divisional Manager and/or Director must also be informed. If it is possible that legal action could result, the Trust’s legal advisors should be consulted, through the Complaints and Claims Manager.

11.1.2 ‘Out of hours’ (i.e. 17.30-08.00 hrs, weekends, Bank Holidays)

As above, with the following adaptations: The On Call manager replaces the Head of Patient Safety in the cascade,

and assumes the same responsibility. The On Call manager will inform the relevant Director on Call as soon as

is practical after the event (i.e. first normal working day); though where he/she judges senior executive input to be necessary the Director on call should be contacted out of hours (e.g. where the incident may attract significant press interest, or require urgent senior executive action).

The On Call manager will inform the Head of Patient Safety as soon as is practical after the event (i.e. first normal working day).

12 OTHER ACTIONS The patient and their family/carers must be informed before any information is given to the media. The lead clinician will inform any other clinicians involved in the patient's care, as appropriate. Incidents involving the death of a patient should be reported to the Coroner's office, in line with existing procedures (e.g. death within 24 hours of surgery and anaesthetic; other unexplained or suspicious deaths). The lead clinician responsible for the case will undertake this. The Head of Patient Safety or the Director on Call (out of hours) will ensure that the Communications Manager is informed if the media are, or are likely to become, involved. In the event of a patient safety (clinical) incident, all relevant health records must be kept in a secure place, in order to ensure that important evidence is preserved and not destroyed and to maintain confidentiality. The health records must be readily available to key personnel to investigate the incident. The decision on whether to retain records will be made by the Head of Patient Safety. Where records are required for continuing care, a duplicate set will need to be made and retained, in order to ensure that contemporaneous health records are maintained.


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In the event of s Serious Untoward Incident, staff are advised to prepare a written statement at the earliest opportunity. Guidance on writing statements can be found at Appendix 10. Further advice on writing statements can be obtained from the Complaints and Litigation manager and the relevant Trade Union. Line managers or clinical leads should ensure that staff involved in the incident are offered support as soon as possible after the event. 13 INVESTIGATION AND ROOT CAUSE ANALYSIS As identified in section 8, all incidents, complaints and claims require investigation at some level; either concise or comprehensive. As per section 6, all Serious Untoward Incidents require a comprehensive root cause analysis investigation. The purpose of the investigation is to determine the facts concerning the incident and to identify whether any deficiencies in the standard of care provided or in the application of Trust policies or procedures contributed to the incident. It is important that all facts are looked at. It is rarely due to one person’s actions that an incident has occurred, but usually results from a combination of events. The purpose of the investigation is to establish what actually happened, the underlying causes and what needs to be done to prevent reoccurrence, but not to allocate blame. However, in some cases disciplinary processes may need to be invoked (section 20.2), following discussion with the Human Resources team. The Director of Nursing will appoint a lead investigator within three working days of the decision to investigate being made. The lead investigator would ideally be a member of staff of a different professional group or Division/Directorate. The team lead investigator must have been appropriately trained in root cause analysis, can take an independent and unbiased perspective, i.e. who have not been involved in the care of the patient, and must also have appropriate professional input. The lead investigator may have to consult with Heads of Professional Services to clarify issues of professional practice. Individuals should only participate in one investigation at any one time. The Head of Patient Safety will liaise with the lead investigator and co-ordinate the investigation. The Head of Patient Safety will create an investigation file that will document:

The affected individual’s/patient’s name, address, telephone number, date of birth and (if applicable) date of death.

Details of the individual’s/patient’s next of kin and contact telephone numbers. General Practitioner, health authority contact (if appropriate) and other relevant

clinician contacts. Names of all individuals involved in the incident including work and home

addresses and contact telephone numbers. A photocopied set of the relevant patient health care records or other documents

(non-clinical). All other notes and communication made regarding the incident and subsequent

investigation The lead investigator will undertake a root cause analysis of the incident and will review all written statements and be required to keep a written record of interviews/discussions that have taken place as part of the investigation. Where individuals involved in investigations are interviewed, they have the right to be accompanied by a friend or Trade Union Representative.


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Guidance on undertaking a root cause analysis investigation is provided by the National Patient Safety Agency (NPSA), from the Root cause analysis investigation and report tools, which can be obtained at: http://www.npsa.nhs.uk/nrls/improvingpatientsafety/patient-safety-tools-and-guidance/rootcauseanalysis/rca-investigation-report-tools/ It is good practice for the lead investigator to meet with service users’ family and carers as part of the investigation (Section 19.7). The Lead Clinician will inform the patient’s family, where relevant, of the intention to investigate the incident.

The reasons for the investigation should be explained in full, a contact person for the family established (e.g. principal investigator, PALS representative) and a method of feedback agreed. N.B. Any discussions with the family must be documented in full, in the patient’s health records. The investigation should include information gathered from all staff involved in the incident. This may take the form of a written statement, but this is not a requirement for evidence gathering. Any completed statement should be typed and then signed and dated on every page by the individual concerned who will also be given a copy for his or her own records. Advice with writing statements can be seen in Appendix 10. All staff are encouraged to obtain further support in writing statements from their relevant trade union. The lead investigator may interview all individuals concerned although this may be supplemented by a panel interview. The initial investigation, including collection of statements and conduct of interviews, should ideally be conducted within 14 days, unless otherwise agreed with the Director of Nursing. 14 REPORTING ON THE INVESTIGATION The final report of an investigation must document the circumstances involved and make recommendations to address any problems identified. The investigation report should follow the format given in the guidance on undertaking a root cause analysis (RCA) investigation provided by the National Patient Safety Agency (NPSA), from the root cause analysis investigation and report tools, which can be obtained at: http://www.npsa.nhs.uk/nrls/improvingpatientsafety/patient-safety-tools-and-guidance/rootcauseanalysis/rca-investigation-report-tools/

It is the responsibility of the lead investigator to provide a feedback report to the Head of Patient Safety and the Director of Nursing as soon as possible after the incident. The lead investigator is responsible for completing the RCA investigation and producing a draft report to the Head of Patient Safety within 30 days of the incident. The Head of Patient Safety will review the report, to ensure it includes all elements of the required NPSA reporting format, identifies of root causes and recommendations. The Trust Assurance Committees will be notified verbally of the occurrence of a SUI, the timescales for investigating and report writing, by the Head of Patient Safety, or nominated investigation lead. The final comprehensive root cause analysis report, including recommendations and an action plan for implementation, will be presented to either the Operational Governance Committee or the Health and Safety Committee for review, approval and agreement for


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implementation in relevant areas. Progress against the action plan will be monitored regularly by the relevant committee, until all agreed actions have been implemented. The final comprehensive root cause analysis report will also be presented to the Clinical Governance Committee or the Non-Clinical Risk Committee, for approval and agreement to disseminate both internally and externally. Progress against the action plan will be monitored regularly by the committee, until all agreed actions have been implemented. An executive summary and action plan will be disseminated to the Division/Directorate management teams for discussion, implementation, where relevant, and review at their governance meetings.

The Director of Nursing will determine how the final report and its recommendations are transmitted to the family. Direct communication with the family will usually be undertaken by the Head of Patient Safety. A copy of all documentation including witness statements, the preliminary report, supporting documents and the final report will be retained by the Head of Patient Safety. 15 ANALYSIS OF INCIDENT DATA It is the responsibility of the Head of Patient Safety to collate all documentation and reports arising from the investigation of the incident(s). All relevant investigation information will be entered on to the incident reporting database with the initial incident information. The Head of Patient Safety is responsible for producing regular quarterly and annual reports on the analysis of incident data, to include the aggregation of incidents, complaints and claims. These reports will be presented to the Divisional Governance meetings, the Operational Governance Committee and the Clinical Governance Committee.

As a minimum, the reports will contain information on:

• Types/categories • Incident trends • Top 10 incident types • Recommended actions to prevent reoccurrence • Links between claims and complaints • Available benchmarking (NPSA/NRLS/HSE/SHOT) • Activity data comparison

The Head of Health and Safety is responsible for producing regular reports on the analysis of occupational health & safety related incident data, to include the aggregation of incidents, complaints and claims. These reports will be presented to the Divisional/Directorate Governance meetings, the Health and Safety Committee and Non-Clinical Risk Committee. 16 SHARING LEARNING 16.1 Internally It is the responsibility of the Head of Patient Safety to ensure the collation all information and reports arising from the investigation of incidents. All relevant investigation information will be retained and details entered on to the incident reporting database with the initial incident information.


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Incident reports are sent to the following groups and leads within the organisation:

• Medical Records Group • Blood Transfusion committee • Hospital Thrombosis Committee • Medicines Advisory group • Safeguarding adults lead • Safeguarding children lead • Caldicott Guardian • Information Governance manager • Tissue Viability Nurse

As per their Terms of Reference, these groups are responsible for analysing incident data and trends, determining learning outcomes and identifying areas of risk and the necessary action plans to manage the risk to the operational committee within the organisation to which they formally report. Quarterly specialty specific reports on incident data, including actions taken, will be produced for review at Divisional and Directorate governance meetings, in order to share learning and identify progress against identified actions. The Divisions and Directorates are responsible for identifying and agreeing the implementation of any actions plans that may have an impact on more than one service area. The completion of action plans will be monitored by the Divisional or Directorate Governance meetings and reported to the assurance committees through the normal reporting procedure. The Relevant Division/Directorate management team is responsible for monitoring the local implementation of the action plan and any recommendations identified from the investigation of SUI’s, as identified in the final report. A summary of the investigation of SUI’s and actions taken will be included in the Risk Management Reports provided to the Trust governance committees. 16.2 Externally All patient safety incident information is reported directly to the National Patient Safety Agency (NPSA) via the incident reporting database through the National Reporting and Learning System (NRLS). This includes information on key lessons learned and actions taken to prevent reoccurrence. This information provides the data to contribute to the national data collection on incidents and their management. The NPSA provides regular Patient Safety Observatory reports on identified key topics and individual benchmarking reports for each healthcare organisation. The Head of Patient Safety will communicate the findings of SUI investigation to the NHS Bath and North East Somerset (NHS BaNES) the Lead Commissioner, and the South West Strategic Health Authority (SW SHA), by means of the nominated database, as per the regional SUI procedure. The Head of Patient Safety will also forward a copy of the root cause analysis findings to the Lead Commissioner. Information on clinical incident analysis and management, including RCA and lessons learned, is shared across the local health community via the SHA Patient Safety Network, facilitated by the SHA Patient Safety Action Team.


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The relevant Director, Head of Patient Safety and the Communications Manager will advise on the process for release of information arising from the investigation (Section 19). A strategy for the release of information where appropriate to the patient, the relatives and the media will be developed on a case by case basis and discussed with the Chief Executive. 17 PREVENTING REOCURRENCE As per the terms of reference of the Operational Governance Committee and the Health and Safety Committee, the committees have responsibility for ensuring lessons learned from the investigations into incidents, complaints and claims are identified and required changes incorporated into practice, where appropriate, by the relevant Division or Directorate. The committees will monitor the implementation and achievement of organisational learning from recommendations and subsequent action plans identified through the investigation of incidents, complaints and claims. The Head of Patient Safety will be responsible for identifying key risks to the organisation, as identified in incident investigation reports, and ensuring these are captured on the organisation-wide risk register, with an identified responsible lead/s and agreed actions to reduce the risk/s. 18 STAFF, PATIENT, CARER, VISITOR AND CONTRACTOR SUPPORT While the trust is aware that intense events occur within hospitals all staff need to be aware of the effects of involvement in or witnessing incidents. While not all individuals respond to an event in the same manner, it is important to recognise that staff, patient, carer, visitor and contractors may require immediate and ongoing support. 18.1 Staff All staff, including temporary staff, involved in incidents, complaints and claims will need support from their peers, colleagues and managers (Kaplan C & Hepworth S, 2004) and should be kept informed of the progress of an investigation at regular intervals. They may also require external support such as bereavement counselling. Help line numbers should be given to all staff and arrangements should be made for de-briefing meetings. Staff support is available through the Chaplaincy and the Employee Assistance Programme (EAP) and all staff must be provided with details of the programme for direct referral, or through their line manager. In some instances, for their own benefit, staff involved may require to be off work, usually in the form of special leave on full pay, or the possibility of working in a different area of the Trust for a period. Efforts will be made to meet these needs. 18.2 Patients/carers/visitors Central to the Trust’s strategy to improve patient safety is its commitment to improving communication between healthcare professionals and patients and/or carers when a patient is harmed as a result of a patient safety incident. Section 19.7 identifies the Being Open process further. Other patients, both inpatients and outpatients and their families, who are either closely affected by the incident or receive notice of the incident via the hospital network or the media, also require support and information. As part of the Major Incident Plan, the Welfare Plan identifies the process for those involved in such events. Document name: Incident reporting and management policy and procedure; Ref.: including the management of Serious Untoward Incidents Issue date: Status: Final

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Following the occurrence of an incident, in the event of a critical incident, the Matron or Senior Sister of the unit should visit each of the patients that witnessed the event to ensure that they are not experiencing any acute anxiety reaction or might be at risk of developing a post-trauma-stress reaction. Staff should also consider involving chaplaincy in helping to provide ongoing support for patients, carers and visitors following such an incident. Where it is recognised that patients and/or carers may have witnessed an event that has affected them, it is recommended that the specialty Matron contact the individual approximately three months after the event, in order to check on any ongoing affects and reiterate the sources of support available. 18.3 Contractors Contractors are responsible for managing all incidents involving their staff, including the ongoing need for support. Appendix 11 details the Trust leaflet on Psychological Responses to Extremely Stressful Events. This leaflet can be provided to and used by any individual involved in an incident. 19 COMMUNICATION STRATEGY Staff involved in the incident should be aware of the importance of maintaining confidentiality. Additionally, that disclosure of information may breach the Trust’s obligations under the Data Protection Act. The overall focus is to ensure that communication lines are clear, concise and kept to a minimum. Advice on this matter may be sought from the Information Governance Manager or the Caldicott Guardian (Medical Director). Where staff, patients or the members of the public are involved in a serious untoward incident, it is essential that the staff, patient(s), the members of the public and/or relatives are informed as quickly as possible by an appropriate person. The responsibility for ensuring that this early notification happens will rest with the Relevant Director. It is equally important that other interested parties should be informed as soon as possible e.g. the Chief Executive of the Strategic Health Authority. This will be undertaken by the Chief Executive or designated individual under their instruction. There may be a need to inform and include other agencies such as the Medicines and Health products Regulatory Agency (MHRA) or the Health and Safety Executive (HSE), or other interested parties such as GP’s, other PCT’s, other provider Trusts/organisations, the NHS Litigation Authority (NHSLA), Police, Coroner, Social Services or Trust Legal Advisors. The Head of Patient Safety, with the agreement of the Chief Executive, may undertake this. The information given to staff, patients and/or to the Public and external agencies must be documented. The Individual designated to manage the incident will ensure that this information is recorded. The relevant Director will ensure that Trust Board members are informed and updated as the investigation progresses. 19.1 Informing staff It is recognised that staff involved in an incident need to be kept fully informed of the progress of the investigation (Kaplan C and Hepworth S, 2004). Such information will be provided through regular briefings and access to the completed investigation report will be


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made available to those concerned. This is particularly important if there is potential media interest where every possible effort will be made to inform the staff, patient/s and/or relatives prior to the media. Counselling and staff support will be organised by the Occupational Health department and the Employee Assistance Programme team. 19.2 General Practitioners In some situations it maybe appropriate to inform the General Practitioner (GP) before the patient, parent/guardian, as the GP may be an integral element of the support system for the patient(s) involved. The lead consultant is responsible for identifying the need for communication with the GP and ensuring contact is made. 19.3 Media Contact The Trust must expect that any incident may attract media attention, resulting in a media presence on site. It is essential that where appropriate, the patient and/or their carers should be informed of the incident before the media (although it is recognised that this may not always be achieved). The Communications Manager will take responsibility for dealing with the press and agree with the Chief Executive any press release to be issued. If appropriate, the Chief Executive or the Director on-call will liaise with the communications and a press statement will be prepared. The press statement will be updated on a regular basis as appropriate. In exceptional circumstances, the Chief Executive may convene a special group to co-ordinate the Trust’s media response. Under no circumstances should any member of staff discuss an incident with the media, without receiving express permission from the Chief Executive or Director on Call. 19.4 Informing stakeholders The Communications team, in partnership with the Director of Nursing, the Head of Patient Safety and Trust leads, will manage the associated communications, ensuring that all stakeholders have been appropriately reported to. These stakeholders may include:

public press General Practitioners (GP’s) Strategic Health Authorities, PCT’s and other Trusts* Care Quality Commission NHS Litigation Authority* The Police* HM Coroner Social Services* Commission for Social Care Inspection (CSC)* The Medicines and Healthcare Products Agency (MHRA)* Health & Safety Executive* Other healthcare organisations Public Health Department* Trust Legal Advisors Elected Representatives County Council Environmental Protection Agency*

*External agencies that may wish to come in and assist with investigations when deemed appropriate.


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http://www.idea.gov.uk/idk/core/page.do?pageId=1092323

All contact with the media during an incident is to be done through the Communications Office under the direction of the Chief Executive. Members of staff may not discuss any element of an incident with the media unless expressly authorised to do so by the Chief Executive or Director on Call. 19.5 Notifying the Lead Commissioner/Strategic Health Authority The Head of Patient Safety (or deputised staff member), in consultation with the Director of Nursing, will inform the South West Strategic Health Authority (SW SHA) and NHS Bath and North East Somerset. Notification will be made electronically to the both organisations, within 48 hours, using the designated database notification system for Serious Untoward Incidents. 19.6 ‘Help-line/Hotline’ arrangements In the event of a serious untoward incident involving multiple individuals a “Help line/hotline” service may need to be established. As per the Major Incident Plan, the Trust has procedures in place to establish an “incident hotline” at short notice to provide information to patients, their carers’ and the general public, in the event of a serious incident. It is the responsibility of the Chief Executive Officer, or in their absence, the Senior Director to decide if a ‘hotline’ needs to be established for the incident concerned. 19.7 Being Open with patient’s and Relatives Central to the Trust’s strategy to improve patient safety is its commitment to improving communication between healthcare professionals and patients and/or carers when a patient is harmed as a result of a patient safety incident. This communication is known as Being open (NPSA 2005). Being open involves apologising and explaining what happened. It ensures communication is open, honest and occurs as soon as possible following an incident. Being open about what happened and discussing incidents promptly, fully and compassionately can help patients cope better with the after-effects. Openness and honesty can help prevent such events becoming formal complaints and litigation claims. Many patients and/or their carers will often only make a litigation claim when they have not received any information or apology from the healthcare team following the incident (Crane M 2001, DoH 2003). Being open will help to:

Establish an environment where patient and/or their carers receive the information they need to enable them to understand what happened and the reassurance that everything possible will be done to ensure that a similar type of incident does not recur;

Create an environment where patients and/or carers, healthcare professionals and managers all feel supported when things go wrong.

The principles of being open are fully supported by the Royal Colleges and professional organisations (GMC 2001). If a patient has suffered serious harm, immediate action should be taken to provide prompt and appropriate clinical care and prevention of further harm, if that is possible. When appropriate, an apology should be offered. What has happened should be explained fully and accurately to the patient and/or carers, including information on the likely long and short-term effects. A verbal apology allows face-to-face contact between the patient and their carers and the healthcare team. This should be given as soon as the staff are aware an incident has occurred.


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It must be recognised that information on an incident that has resulted in serious harm may cause added stress to the patient and/or their carers and potential loss of confidence in the standard of care. Continued and open discussion with the patient and carers is essential. Communication should be timely; patients and/or their carers should be provided with information that is based solely on the facts known at the time. It should be explained that new information may emerge as an incident investigation is undertaken and they should be kept up-to-date with the progress of an investigation. Patients and/or their carers should receive clear, unambiguous information and be given a single point of contact for any questions or requests they may have. They should not receive conflicting information from different members of staff. The use of medical jargon should be avoided at all times. Further guidance on Being Open is identified in Appendix 9 and when undertaking such open discussions with the patient and carers, it is important that the criteria detailed in the Appendix are met. It is essential that all communication with the patients and/or their carers is clearly documented in the patient’s health records. The inclusion of the patients and/or their carers in incident investigations should be identified in the Serious Untoward Incident investigation report proforma, as created by the NPSA. Sometimes, despite the best efforts of staff or others, the relationship between the patient, their carers and the healthcare professional may breakdown as a result of the incident. The patient and family may not accept the information provided and may not wish to participate in the process of being open. Consideration should be given to utilising PALS as a mechanism to support the patient/relatives during this process. Information provided should be clear, concise and consistent. Consideration should also be given to the need to use an interpreting service for families’ whose first language is not English. It is important to ensure the patient and/or their carers are aware of the formal complaints procedure. 20 LINKS WITH OTHER POLICIES 20.1 Whistleblowing Policy and Procedure The Trust has a culture of openness and dialogue and encourages staff to raise concerns about raising genuine concerns about crime, failure to comply with legal duty, miscarriages of justice, danger to health and safety or the environment and the cover up of any of these sensibly and responsibly without fear of victimisation. The Trust expects the co-operation of staff at all levels to maintain this culture. The Trust will, so far as is reasonably practicable, pay particular attention to:

providing a clear commitment that staff concerns will be taken seriously and fully

investigated. guaranteeing that staff who raise concerns responsibly and reasonably will be

protected against victimisation. providing guidance to help staff who have concerns about malpractice to do so

reasonably and responsibly with the right people. The Trust will not tolerate the harassment or victimisation of any member of staff raising a genuine concern. Victimisation and harassment of any sort are considered serious disciplinary offences and will be dealt with accordingly. Document name: Incident reporting and management policy and procedure; Ref.: including the management of Serious Untoward Incidents Issue date: Status: Final

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20.2 Managing Conduct Policy and Procedure The Trust encourages the reporting of all incidents in order for action to be taken to prevent any recurrence. The reporting of near misses will be dealt with fairly and directly employed staff given support where required.

No disciplinary action will be taken against directly employed staff that have followed agreed policies and procedures and exercised reasonable judgment. The Trust aims to ensure that all directly employed staff are open and honest in reporting incidents and are provided with support where required. All members of staff are actively encouraged to openly report incidents where a mistake has occurred and will be fully supported through this process. Disciplinary action will not be taken as a result of incident reporting, except in cases of misconduct and gross misconduct, e.g. Fraud, physical assault, corruption, breach of confidentiality, recklessness, criminal behaviour or where the incident is repeated on many occasions.

The need for disciplinary action will have to be considered in line with the Trust’s existing policies and procedures (including special leave as an interim measure). In line with these policies and procedures, if appropriate, disciplinary proceedings will be commenced once the findings of an internal investigation are clear.

The NPSA Incident Decision Tree (IDT) will be used to contribute to the decision making process. The Incident Decision Tree has been created to help NHS managers and senior clinicians decide whether they need to suspend (exclude) staff involved in a serious patient safety incident and to identify appropriate management action. The aim is to promote fair and consistent staff treatment within and between healthcare organisations. The IDT is an on-line tool and can be accessed from: http://www.npsa.nhs.uk/nrls/improvingpatientsafety/patient-safety-tools-and-guidance/incidentdecisiontree/ Wherever possible, preventative action such as retraining will be undertaken rather than disciplinary action. All decisions of potential professional involvement in the disciplinary process must involve the Director of Nursing or Medical Director and the identified professional lead. 20.3 Complaints Procedure All complaints must be handled in accordance with the Trust complaints’ procedure. If an incident is being investigated in accordance with the procedure for incident reporting and management and a complaint is subsequently received, any investigation underway will continue and the relevant information used to inform both processes. Advice on this matter should be sought from either the Complaints Manager or the Head of Patient Safety. 20.4 Safeguarding Adults Procedure In the event of an incident requiring management according to the vulnerable adult policy, the nominated vulnerable adult lead and the Director of Nursing must be informed and the Trust Vulnerable Adults procedures adhered to. This will be in partnership with the incident reporting and Serious Untoward incident reporting procedures. The nominated vulnerable adult lead will, if appropriate, inform the police, following discussion with the Director of Nursing. The nominated vulnerable adult lead will be the contact point on behalf of the Trust for any Police investigation of the incident.


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http://www.npsa.nhs.uk/nrls/improvingpatientsafety/patient-safety-tools-and-guidance/incidentdecisiontree/

http://www.npsa.nhs.uk/nrls/improvingpatientsafety/patient-safety-tools-and-guidance/incidentdecisiontree/

Relevant incidents and learning outcomes are shared across the local health economy, as per the Local safeguarding Adults procedure. 20.5 Safeguarding Children If a child protection issue is suspected, the Trust Child Protection policy and procedures (ID: 221.2007) must be followed. Any child protection issue must be dealt with as a matter of urgency. The paediatric registrar should be contacted for ongoing management and advice. The Named Nurse and/or Doctor must be informed of all referrals made to Social Services, through either a copy of the ‘cause for concern’ form or via the Named Nurse Child Protection form. Relevant incidents and learning outcomes are shared across the local health economy, as per the Local Safeguarding Children procedure. 20.6 Counter Fraud Where incidents are identified by the Risk Management Team that identify fraud or may leave the Trust vulnerable to the risk of fraud; they will communicate with the Local Counter Fraud Specialist (LCFS) at the earliest opportunity, in order to enable early agreement in relation to the level of involvement each party will hold in each specific case. This will minimise any risk of compromise of any subsequent criminal or civil action against any appropriate party in relation to the investigation. 21 TRAINING All staff receive an overview on incident reporting and risk management as part of the Trust induction process, updates are provided through various staff briefings. Further role specific learning, such as root cause analysis investigations, will be arranged by the Education Centre Team. Employees who identify a need for specific training should seek this through their line manager. 22 MONITORING The implementation of this policy will be under regular review by the Head of Patient Safety, to assess the timeliness and quality of incident reporting, review and feedback. The Clinical Governance Committee will review this policy every two years, on behalf of the Trust Board.

22.1 Duties The key responsibilities of the identified leads within this policy will be monitored as per the existing HR appraisal process. 22.2 Reporting Monitoring the reporting elements of this policy will be undertaken to ensure the Trust captures all relevant information on incident occurrence through the agreed process and shared learning. Any identification of failure to report incidents via the agreed process will be identified to the relevant line manager for investigation and onward reporting on identified barriers to reporting to the Divisional/Directorate governance meeting. This information can also be cross referenced with audit reports relating to identified triggers within the incident reporting ‘pick’ lists. Document name: Incident reporting and management policy and procedure; Ref.: including the management of Serious Untoward Incidents Issue date: Status: Final

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22.3 Level of investigation The appropriateness of the levels of incident investigation according to the level of severity of the event will be monitored by the Divisional/Directorate governance groups, by means of the risk scores presented in the quarterly specialty specific incident data provided to the 3 Divisional governance groups by the Risk Management Team. 22.4 Action plan follow-up As per section 16, the Division/Directorate will monitor progress against any action plans identified as required to prevent reoccurrence of incidents. 22.5 Aggregation of incidents & Minimum content The Operational Governance Committee and the Health and Safety Committee will monitor the content of the Risk Management reports, to ensure they contain the minimum requirements and meet the needs of the organisation. 22.6 Sharing externally As per section 16, the Lead Commissioner will monitor the externally shared information on learning from incident investigations. 22.7 Implementing risk reduction measures & Change in practice/culture As per the terms of reference, the Operational Governance Committee and the Health and Safety Committee will monitor the implementation and achievement of organisational learning from recommendations and subsequent action plans identified through the investigation of incidents, complaints and claims. 22.8 Training, Whistle-blowing & Staff support The management of all related HR policies, including the whistleblowing policy, will be reported to the Health and Safety Committee and the Non-Clinical Risk Committee, as per the agreed Terms of Reference. Use of the EAP is monitored by the Human Resources team and reviewed by the Health and Safety of staff at work group, in order to identify areas of concern. The review of SUI investigation reports will identify the referral to sources of support and the Risk Management reports will monitor trends in the process and areas of non-compliance, in order for the Health and Safety committee to identify actions required to improve compliance. 22.9 Communicating with external agencies Ensuring the Trust communicates appropriately to external agencies, as per legislative requirements, will be identified in the Risk Management reports, which are produced quarterly and annually. 22.10 Being Open The review of SUI investigation reports will identify the inclusion of patients and/or their carers. The Risk Management reports will monitor trends in the process and areas of non-compliance, in order for the Operational or Health and Safety committees to identify actions required to improve compliance. 23 REFERENCES


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Health & Safety Executive. (1995). Reporting of Injuries, Diseases and Dangerous Occurrences Regulations (RIDDOR Explained, Version 6), Suffolk: Health and Safety Executive. Available at: http://www.hse.gov.uk/riddor/index.htm. Public Interest Disclosure Act 1998, Chapter 23. London: The Stationery Office. Available at: www.opsi.gov.uk Department of Health. (1998). Health Service Circular 1999/198, The Public Interest Disclosure Act 1998: Whistle blowing in the NHS. London: Department of Health. Available at www.dh.gov.uk/Department of Health. (2000). An Organisation with a Memory: Report of an Expert Group on Learning from Adverse Events in the NHS. London: Department of Health. Available at www.dh.gov.uk/ Department of Health. (2001). Building a Safer NHS for Patients: Implementing an Organisation with a Memory. London: Department of Health. Available at www.dh.gov.uk/ National Patient Safety Agency. (2004). Seven Steps to Patient Safety. London: National Patient Safety Agency. Available at: www.npsa.nhs.uk/ National Patient Safety Agency. (2005). Building a Memory: Preventing Harm, Reducing Risks and Protecting Patient Safety London: National Patient Safety Agency. Available at: www.npsa.nhs.uk. National Patient Safety Agency. (2005). Patient Briefing - Saying Sorry When Things Go Wrong. London: National Patient Safety Agency. Available at: www.npsa.nhs.uk/ National Patient Safety Agency. (2005). Safer Practice Notice - Being Open When Patients are Harmed. London: National Patient Safety Agency. Available at: www.npsa.nhs.uk/ Healthcare Commission. (2008). The annual health check 2008/09 Assessing and rating the NHS. London: Healthcare Commission. Available at: http://www.healthcarecommission.org.uk/publicationslibrary. Department of Health. (2008). High Quality Care For All NHS Next Stage Review Final Report. London: Department of Health. Available at: http://www.dh.gov.uk National Patient Safety Agency (NPSA). (2009). Never Events – Framework for 2009/10: Process and action for Primary Care Trusts 2009/10. London: NPSA. Available at: http://www.npsa.nhs.uk Crane M (2001). ‘What to say if you made a mistake.’ Medical Economics. 78(16): 26–8, 33–6 Department of Health (2001). Building a safer NHS for patients. Department of Health (2003). Making Amends. London: The Stationery Office. (April 2004) Department of Health (2004). Safeguarding patients: lessons from the past - proposals for the future. Crown copyright. General Medical Council (2001). Good Medical Practice. (April 2004)


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http://www.hse.gov.uk/riddor/index.htm

http://www.opsi.gov.uk/

http://www.dh.gov.uk/



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




http://www.healthcarecommission.org.uk/publicationslibrary



Kaplan C and Hepworth S. Supporting health service staff involved in a complaint, incident or claim - an NHSLA initiative. NHSLA journal, 2004, issue 3, 11–13 National Health Service Litigation Authority (2002). Litigation Circular No: 02/02. Apologies and Explanations. Issued 11 February 2002. National Patient Safety Agency (2006). Seven steps to patient safety for primary care. Vincent CA and Coulter A (2002). ‘Patient safety: what about the patient?’ Quality and Safety in Health Care. 11(1): 76–80 Vincent CA, Pincus T and Scurr JH (1993). ‘Patients' experience of surgical accidents’ Quality Health Care. 2(2): 77–82


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APPENDIX 1 CONSULTATION SCHEDULE

Name and Title of Individual Date Consulted James Scott, Chief Executive James Carine, Chairman Francesca Thompson, Director of Nursing John Waldron, Medical Director Dr Tim Craft, Deputy Medical Director Howard Jones, Director of Estates and Facilities Brigid Musselwhite, Director of Planning and Strategic Development Catherine Phillips, Director of Finance Lynn Vaughan, Director of Human Resources Sharon Bonson, Assistant Director of Nursing Gareth Howells, Assistant Director of Nursing Jan Lyn, Assistant Director of Nursing, Surgery Jo Miller, Assistant Director of Nursing Peter Eley, Assistant Director of HR Moira Brennan, Non Executive Director Michael Earp, Non Executive Director Reverend Jonathon Lloyd, Non Executive Director Professor Peter Tomkins, Non Executive Director Stephen Wheeler, Non Executive Director Steve Hart, Divisional Manager, Surgery Clare O’Farrell, Divisional Manager, Medicine. John Travers, Divisional Manager, Specialty. Mr Chris Gallegos, Surgery Division Chair/Lead Lindsay Grant, Specialty Division Chair Eluned Higgs, Medicine Division Chair Dr William Hubbard, Medicine Division Chair Mike Osborn, Specialty Division Lead Mark Tooley, Specialty Division Lead Regina Brophy, Chief Pharmacist Geoff Cross, Head of IM&T Theresa Hegarty, Head of Patient Experience Viv McHale, Head of Clinical Effectiveness David Robinson, Head of Health & Safety Helen Robinson Gordon, Head of Communication and External Relations Amy Shortridge, Assistant Director of HR (Development) Alison Spears, Trust Board Secretary Alex Massey, Patient Access Team Manager Yvonne Pritchard, Senior Infection Control Nurse Kate Purser, Tissue Viability Specialist Nurse Jenny Evans, Recruitment Officer Peter Eley, Assistant Director of HR (Employee Relations) Stephen Roberts, Occupational Health Manager Sharon Bradley, Risk Management Assistant Simon Edwards, In formation Governance Manager Policy Group membership Matrons, Senior Sisters, Senior Nurses and Ward Managers (all) Consultants (all)

17 July 2009

Name of Committee/Group Date of meeting Clinical Governance Committee Non-Clinical Risk Committee Audit Committee


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APPENDIX 2 CLASSIFICATION OF INCIDENTS TYPES Patient Safety Incident: any incident directly related to patient treatment or care, which did or could have resulted in adverse outcome (e.g. medication error, medical equipment failure etc.) Personal accidental injury: any injury, no matter how small, to patients, staff and other persons. Ill Health (Work related only): any case of known or suspected work-related ill health e.g. infection, back injuries following moving and handling. Fire Incident: any incident, no matter how small, involving fire, fire fighting equipment or fire warning systems (including false alarms). Violence, abuse or harassment: any incident involving physical or non-physical assault, such as verbal abuse, unsociable behaviour, racial or sexual harassment or physical assault whether or not it results in injury. Vehicle Incident: Any incident involving a vehicle used for work purposes e.g. road traffic accident, excluding vandalism or theft, which would be considered as a security incident. Security Incident: any untoward incident involving theft, loss or other damage to organisation or personal property, intrusions, false alarms (not fire alarms), absconded patients and other security incidents. Other:

Accidental property loss or damage: any incident where equipment, buildings or other property is damaged (e.g. dropping a TV set, walls damaged by trolleys).

Information Management and Technology: any incident involving a breach in the security and confidentiality of patient information, Trust business information and equipment security.

Adverse incidents relating to equipment, supplies, food, buildings & plant: includes radiation incidents, spills (e.g. incorrect management of blood/body fluid spillages), floods, environmental incidents (e.g. accidental discharge to drains or to atmosphere etc.). Incidents relating to these issues should be brought to the attention of the Health and Safety Advisor, who will ensure that the Trust complies with the required reporting and management arrangements, as detailed in the associated policy.

Fraud and Corruption: If an incident involves actual or suspected fraud or corruption, then the Trust’s Fraud and Corruption Policy must be followed. Incident reporting in this case will take place only after conclusion of the relevant investigation.


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APPENDIX 3 INCIDENT CLASIFICATION MATRIX The Score is determined by Likelihood x Severity Likelihood

Score Descriptor Description 1 Rare Extremely unlikely to happen/recur – may occur only in exceptional

circumstances – has never happened before and don’t think it will happen (again)

2 Unlikely Unlikely to occur/reoccur but possible. Rarely occurred before, less than once per year. Could happen at some time

3 Possible May occur/reoccur. But not definitely. Happened before but only occasionally once or twice a year

4 Likely Will probably occur/reoccur. Has happened before but not frequently – several times a month. Will occur at some time.

5 Very Likely Continuous exposure to risk. Has happened before regularly and frequently – is expected to happen in most circumstances. Occurs on a daily basis

Severity/consequence

Consequence score (severity levels) and examples of descriptors

1 2 3 4 5 Domains Negligible Minor Moderate Major Catastrophic

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

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

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

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

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

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

Quality/complaints/audit

Peripheral element of treatment or service suboptimal Informal complaint/inquiry

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

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

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

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

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Human resources/ organisational development/staffing/ competence

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

Low staffing level that reduces the service quality

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

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

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

Statutory duty/ inspections

No or minimal impact or breech of guidance/ statutory duty

Breech of statutory legislation Reduced performance rating if unresolved

Single breech in statutory duty Challenging external recommendations/ improvement notice

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

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

Adverse publicity/ reputation

Rumours

Potential for public concern

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

Local media coverage – long-term reduction in public confidence

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

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

Business objectives/ projects

Insignificant cost increase/ schedule slippage

<5 per cent over project budget Schedule slippage

5–10 per cent over project budget Schedule slippage

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

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

Finance including claims

Small loss Risk of claim remote

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

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

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

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

Service/business interruption Environmental impact

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

Loss/interruption of >8 hours Minor impact on environment

Loss/interruption of >1 day Moderate impact on environment

Loss/interruption of >1 week Major impact on environment

Permanent loss of service or facility Catastrophic impact on environment


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Score – Likelihood x Severity

CONSEQUENCE

Likelihood 1 insignificant

2 Minor

3 Moderate

4 Major

5 Catastrophic

5 – Almost certain

5 10 15 20 25

4 - Likely 4 8 12 16 20 3 – Possible 3 6 9 12 15 2 – Unlikely 2 4 6 8 10 1 - Rare 1 2 3 4 5


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APPENDIX 4 INCIDENT REPORT FORM PROCEDURAL GUIDELINES

Page 1 of 5 1 Incident Reporting

All incidents are reported on the incident reporting (IR) form, contained within the Incident Reporting books, or directly on to the incident reporting database, available from all networked PC’s within the organisation. The incident reporting books are held in each Ward/department or Service area. Staff will be unable to enter incidents directly on to the database without prior training.

2 Who reports?

Any person who is directly employed by the Trust or who is working for the Trust on a temporary, locum, or agency basis, as a contractor or volunteer, including placement students, may complete an incident report form.

Ideally the person who was directly involved in the incident should report the incident as soon as possible after the event. Where this is not possible, a witness or supervisor may complete the incident report. If the incident is reportable under RIDDOR it is the responsibility of the individual’s line manager/supervisor and/or the Head of Service to ensure this incident has been reported as per guidance the Health and Safety policy.

3 Where do you report?

If using an IR form, ideally the incident should be reported on the IR form held by the ward/department where the incident occurred or at the nearest locality possible. Incidents can be reported directly on to the incident reporting database on any networked PC within the organisation.

4 Estates Incidents

Incidents involving the Estate should be completed by the Estates staff where they are present. If they are not in attendance it is the duty of the individual who first identified the incident to complete the form.

5 Legal Issues

Completion of the form does not constitute any admission of liability of any kind on any person. However, forms completed for actual incidents may be available to all parties in the event of legal proceedings and it is therefore essential that they are completed accurately and factually.

THE INCIDENT REPORT SHOULD IDENTIFY FACTS NOT OPINIONS AND SHOULD GIVE AN OBJECTIVE AND CLEAR ACCOUNT OF WHAT HAPPENED.

Any clinical opinion or professional judgement noted on the form should be clearly separated and identified from the factual evidence.

6 What should be reported? All incidents of a clinical and non-clinical nature as defined within the policy should be reported via the IR Incident Report form or the incident reporting database.

7 Where more than one person is involved

In the case of incidents involving more than one person, when reporting via the IR form, a form can be completed for each person affected. However, when reporting, each individual involved should be recorded in the appropriate section.


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8 Complaints

Where a complaint has been made following an incident, the potential for complaint should be recorded on the incident form. The individual involved should be advised of the Trust formal complaints process and the complaints procedure followed.

9 Defective Equipment

The following basic principles are taken from the guidance given by the Medical Devices Directorate at the Department of Health (RIDDOR, 1995): Ensure the patient is safe. Quarantine the device involved in the Incident, including packaging and

instructions, where appropriate, and secure safely. If it is a machine, try to leave all switches and controls as they were at the time of

the Incident, unless they have to be changed to make them safe. Complete an incident report form, giving details and the number of the device. Ensure the device is labelled with a warning sticker, giving the database ID/IR

form reference number before reporting and sending to the MEMS department Do not return the device to the manufacturer before an appropriate person, i.e.

medical engineer, examines it. If the item is part of a batch, check the remaining stock and ask if the defect has

arisen due to faulty storage. The batch may need to be withdrawn.

The Medications and Healthcare products Regulatory Agency (MHRA) will be notified of adverse Incidents involving devices, equipment or related procedures. This is undertaken by the Trust’s nominated Medical Devices Liaison Officer. If a serious incident involving defective equipment/products occurs, any witness to the incident should make a written report and notify the Health and Safety Advisor immediately.

Any device involved in an incident will only be released back into use following a full examination by the medical engineering team.

10 Delayed reporting The outcomes of many incidents are identified immediately e.g. broken bone, damaged equipment, fire. However, it is just as important to report incidents where the outcomes are identified at a later stage. For example a back sprain resulting from moving and handling may not be apparent for a few days, similarly a patient who develops unexpected pressure tissue damage or a complication whilst in the care of the RUH.

11 When should it be reported?

The person who first becomes aware of the incident should report the incident on the IR form, or incident reporting database, as soon after the incident as possible. The top copy of the form should be sent to the Risk Management team within 2 working days. The second copy of the IR form should then be forwarded to the line manager within 2 working days for all incidents except major or serious ones, which should be reported IMMEDIATELY by telephone, as per the Serious Untoward Incident Procedure and subsequently in writing via the IR form or incident reporting database within 24 hours. Flowcharts of the overall reporting procedures can be found in Appendix 4.


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12 Information to record

Instructions for completing the existing IR forms are: Section A The type of incident; Section B The date of the incident; Section C The location of the incident; Section D Details of the individual affected by the incident, including

contact details Section E Details of any actual harm or loss that occurred as a direct

result of the incident; Section F Details of the nature of any treatment given to address the

harm caused by the incident. Attention offered to the person if appropriate e.g. first aid. The details recorded in this section of the form for clinical incidents are in addition to clear and accurate documentation in the patient’s health records

Section G Details of documentation and equipment involved; Section H An outline of the circumstances of the incident; Section J Details of the individual completing the incident form; Section K To be completed by the most senior member of staff present at

the time of the incident, or ward/department manager following incident. Details of actions taken to reduce the risk if reoccurrence as a result of the investigation of the incident and the incident severity and likelihood scores.

Instructions on completing the revised IR forms are given on the inside cover of the revised Incident Reporting form book, held in each area.

The following sections are included: Section A The type of incident; Section B The individual affected by the incident; Section C Details of the location where the incident occurred and date

and time of the incident; Section D An outline of the circumstances of the incident; Section E Details of staff involved or witnesses where appropriate; Section F Details of the nature of any injury sustained as a result of the

incident, apparent cause, body part affected, nature of incident Section G Attention offered to the person if appropriate e.g. first aid. The

details recorded in this section of the form for clinical incidents are in addition to clear and accurate documentation in the patient’s health records

Section H details of equipment involved Section J Any immediate or remedial action that was taken following the

incident. This may include removing equipment from use, liaising with patients, relatives or phoning the police.

13 Where do the forms go?


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Following completion of an IR form, the top (blue) copy should be removed from the book and sent to the Risk Management team within 2 working days. The second (pink) copy should be sent to the ward/department/line manger within 2 working days, for review on content, review of grading, according to severity and likely hood of reoccurrence. Grading the incident will assist the manager to determine the level of investigation required. Details on the investigation should be documented in section J. The pink copy of the form should then be sent to the Risk Management team within seven working days of the date incident.

The IR form is a confidential document and should be treated accordingly, ensuring that it is secured and stored correctly in order to maintain confidentiality.

Note: previous IR forms and IR books should be treated as confidential, secured appropriately and only accessed for legitimate reasons. Alternatively the incident forms and books should be destroyed in accordance with the Records Management: NHS Code of Practice.

For major or serious incidents or death, the manager should be contacted immediately by phone in addition to the form being completed.

The third copy of the IR form should be retained in the IR book and secured as confidential information. The top copies should be forwarded as above. All IR forms received by the Risk Management team will be stored as confidential information and retained for 10 years unless the incident relates to:

1 Legal action in which case advice should be sought from the Complaints and Claims Manager

2 Exposure to hazardous substances or biological agents which may lead to disease (e.g. asbestos, latex and other respiratory sanitizers, noise) in which case they should be kept for 40 years from the date of entry.

It is important that any records retained are properly controlled, readily accessible and available for use to authorised persons, and eventually archived or otherwise disposed of in accordance with Records Management: NHS Code of Practice. Further advice may be sought from the Information Governance Manager.

14 Options for reporting

All directly employed staff are encouraged to report ‘near miss’ Incidents using the above system with completion of the incident forms. In circumstances where an individual feels awkward about reporting a sensitive incident or near miss (for example in cases of whistle-blowing), telephone contact can be made direct to the Head of Patient Safety to highlight the incident.

Directly employed staff must be aware that if the issue is serious the Head of Patient Safety may be required to discuss the situation with other Trust managers, to ensure that prompt action is taken. Reporting in this way may be applicable where the situation is sensitive and a member of directly employed staff requires advice on how to manage the incident. However situations where anonymous reporting would be appropriate are very rare.

15 Losses The form can be used to record losses of property that may also result in payment of compensation subject to the Trust’s Standing Financial Instructions. In addition to completing the relevant sections of the IR form, it is also necessary to include the


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owner of the property i.e. Trust or named individual, a full description of the item stolen with its purchase price and current value and any steps that have been taken to repair/replace items.

Completion of an incident report form in no way guarantees that a payment will be made to a claimant. Each report will be thoroughly investigated to determine whether or not the Trust was liable for the property, whether the Trust acted negligently and whether there was an actual loss.

16 Fire Incidents

In the case of fire incidents the information given on the form must include the following: false alarms or actual fire method used to raise the alarm whether evacuation occurred and to what extent any method used to fight the fire e.g. extinguisher, hose reel whether the Fire Service attended the materials that first ignited the cause and spread of the fire if known.

This reporting system does NOT affect the need to involve the Fire Safety Advisor. This must continue in line with the Trust’s Fire Policy.

17 Spoilt forms Incident report forms completed in error, or identified as a duplicate, should clearly be identified as such and are still required to be sent to the Risk Management team for recording.


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APPENDIX 5 ACTION FOR LINE MANAGERS



YES NO

Is an investigation required?

Manager informs head of service and undertakes an investigation, ensuring immediate action to prevent further harm has been taken. Follow-up/investigation report is sent to the Risk Management team within 7 days.

Top (blue) copy of the RM1 form sent to the Risk Management team within 2 working days

YES

Inform the H&S Advisor and involve in the investigation

Has the incident resulted in ill health, in accordance with the RIDDOR guidance?

YES

Inform the Moving and Handling Advisor and the Occupational Health Department and involve them in the investigation

Was this a moving and handling incident?

YES

Send equipment to MEMS, with a copy of the incident report, ensuring a hazard sticker has been secured to the device.

Was medical equipment involved?

YES

Inform the infection control nurse and involve in the investigation

Was there an infection control outbreak?

YES

Inform the Fire Safety Advisor and involve in the investigation

Was this a fire incident?

YES

Inform the estates Department and involve in the investigation.

Does the incident affect or involve the Estates Department?

YES

Send a copy of the incident report to the Finance Department.

Was there a loss of any Trust assets?

YES

Check the crime reference and include on the incident report form

Were the police called?

When satisfied that all details are complete, send the completed form to the Risk Management team within 7 working days of the incident, or complete the database entry

including the management of Serious Untoward Incidents


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of 2 APPENDIX 6 THREE LEVELS OF RCA INVESTIGATION – GUIDANCE Patient safety Root Cause Analysis (RCA) investigations should be conducted at a level appropriate and proportionate to the incident, claim, complaint or concern under review. This document provides guidelines for what might be considered appropriate and proportionate. Level 1 – Concise investigation

Level 2 – Comprehensive investigation

Level 3 – Independent investigation

Most commonly used for incidents, claims, complaints or concerns that resulted in no, low or moderate harm1 to the patient.

Commonly conducted for actual or potential ‘severe harm or death’1

outcomes from incidents, claims, complaints or concerns.

As per Level 2, but in addition:

Also useful as an executive summary to communicate findings from full, comprehensive or independent investigation reports, following actual or potential ‘severe harm or death’ outcomes.

Conducted to a high level of detail, including all elements of a thorough and credible investigation.2

Must be commissioned and conducted by those independent to the provider service and organisation involved.

Commonly involves completion of a summary or one page structured template.

Includes use of appropriate analytical tools (e.g. tabular timeline,contributory factors framework, change analysis, barrier analysis).

Commonly considered for incidents, claims, complaints or concerns of high public interest or attracting media attention.

Includes the essentials of a thorough and credible investigation,2 conducted in the briefest terms.

Normally conducted by a multidisciplinary team, or involves experts/expert opinion/independent advice or specialist investigator(s).

Conducted for mental health homicides which meet Department of Health guidance.3

Involves a select number of RCA tools (e.g. timeline, 5 why’s, contributory factors framework).

Conducted by staff not involved in the incident, locality or directorate in which it occurred.

Should be conducted where Article 2 of the European Convention on Human Rights is, or is likely to be, engaged.

Conducted by one or more people (with a multidisciplinary approach if more than one investigator).

Overseen by a director level chair or facilitator.

Often conducted by staff local to the incident (ward/department/ directorate/GP surgery).

Led by person(s) experienced and/or trained in RCA, human error and effective solutions development.

Should include person(s) with knowledge of RCA, human error and effective solutions development.

Includes patient/relative/carer involvement and should include an offer to patient/relative/carer of links to independent representation or advocacy services.

1 As defined in the RCA Toolkit: www.npsa.nhs.uk/rcatoolkit

If a patient is directly effected, they/relative/carer should be involved.

May require management of the media via the organisation’s communications department.

2 As detailed in the ‘RCA Investigation Report Template’ and ‘RCA Investigation Evaluation - thoroughness and credibility checklist’ www.npsa.nhs.uk/rca

Includes plans for shared learning – locally and/or nationally as appropriate.

Includes robust recommendations for shared learning, locally and/or nationally as appropriate.

3 Independent investigation of adverse events in mental health services. www.dh.gov.uk/en/ Publicationsandstatistics/Lettersandcirculars/Dearcolleagueletters/DH_076535

Includes a full report2 with an executive summary and appendices.


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of 2 Investigation report section Level 1

(Concise) Investigation

Levels 2 & 3 (Comprehensive & Independent) Investigations

Cover page √ Contents page √ Executive summary

Executive summary including a summary of: • incident description and date

√

• incident type √ • healthcare specialty √ • actual effect on patient √ • actual severity of incident √ • Level of investigation (Level 1, 2 or 3) √ • Involvement and support of patient and/or relatives √ • Detection of incident √ • Care and service delivery problems √ • Contributory factors √ • Root causes √ • Lessons learned √ • Recommendations √ • Arrangements for sharing learning √

Incident description and consequences including: • concise incident description √ √ • incident date √ √ • incident type √ √ • healthcare specialty √ √ • actual effect on patient and/or service √ √ • actual severity of incident √ √ Pre-investigation risk assessment √ Background and context to the incident √ Terms of reference √ Investigation team details √ Scope and level of investigation √ √ Investigation type, process and methods used √ Involvement and support of patient and relatives √ √ Involvement and support provided for staff involved √ Information and evidence gathered √ Detection of incident √ √ Chronology of events √ √ Notable practice √ Care and service delivery problems √ √ Contributory factors √ √ Root causes √ √ Lessons learned √ √ Recommendations √ √ Arrangements for shared learning √ √ Distribution list √ Appendices √ Author and date √ √


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APPENDIX 7 SERIOUS UNTOWARD INCIDENT IDENTIFICATION This list is not exhaustive, but should assist in clarifying under what circumstances an incident should be reported. If staff are in any doubt about whether or not an incident is serious or not, they should contact their line manager or the Head of Patient Safety immediately. The following examples should be considered when determining whether or not an untoward incident is serious:

where there is suspicion that a patient was potentially at risk of serious harm as the result of possible negligence or error by a member of staff or service;

where a death or serious injury to a child has occurred which results in a Serious Case Review under Working Together to Safeguard Children 2006 (DOH);

where death or serious injury to a vulnerable adult has occurred which may result in a inquiry;

where there is suspicion that a patient may have suffered injury as the result of a deliberate act by a member of staff, another patient or member of the public;

where there is suspicion that a patient may have suffered serious harm as the result of faulty procedures, a lack of proper procedures, or failure to follow proper procedures;

where there is suspicion of serious harm to a patient, member of staff, or member of the public, resulting from faulty equipment, drugs or unsafe environment;

where a patient or member of staff attempts serious harm to themselves on Trust premises;

where there has been a physical assault resulting in a serious injury or death of a member of staff in the course of their duties;

temporary service closure increased level of care for more than 15 days; injury resulting in sickness absence for greater than 3 days as defined under

RIDDOR (Refer to 001.007. Guidelines for reporting incidents to the Health and Safety Executive).

a fire, where damage has occurred and where patients and staff have been put at risk and/or the circumstances are suspicious;

where incidents involve infectious diseases that cause profound difficulties; incidents that would be coded “RED” in line with the National Patient Safety

Agency guidance; where an incident poses or may pose a significant threat to public health and/or

safety including microbiological and chemical contamination incidents or releases into the environment;

where an incident is likely to lead to public concern and/or significant media attention;

thefts of computers, laptops or palmtop computers or memory sticks that contain patient sensitive material;

suspension of clinical or managerial staff in highly unusual circumstances; where an incident may seriously prevent the Trust from meeting its objectives

or compromise the provision of services; any other incident considered as being serious.


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APPENDIX 8 Serious Untoward Incident Procedure Flow Chart



* Where relevant

including the management of Serious Untoward Incidents


APPENDIX 9 QUICK REFERENCE GUIDE TO BEING OPEN Page 1 of 2

Apologising and explaining when patients have been harmed can be very difficult. You may have already considered some or all of the recommendations below, but this guide will help ensure that you follow best practice. Patients and/or their carers should receive an apology as soon as possible after a patient safety incident has occurred and staff should feel able to apologise on the spot. Saying sorry is not an admission of liability and it is the right thing to do. Patients have a right to expect openness in their healthcare.

Stage 1: preliminary meeting with the patient and/or their carer Who should attend?

A lead staff member who is normally the most senior person responsible for the patient’s care and/or someone with experience and expertise in the type of incident that has occurred.

Ensure that those members of staff who do attend the meetings can continue to do so; continuity is very important in building relationships.

The person taking the lead should be supported by at least one other member of staff, such as the risk manager, nursing or medical director, or member of the healthcare team treating the patient.

Ask the patient and/or their carers who they would like to be present.

Consider each team member’s communication skills; they need to be able to communicate clearly, sympathetically and effectively.

Hold a pre-meeting amongst healthcare professionals so that everyone knows the facts and understands the aims of the meeting.

When should it be held?

As soon after the incident as possible.

Consider the patient’s and/or their carer’s home and social circumstances.

Check that they are happy with the timing.

Offer them a choice of times and confirm the chosen date in writing.

Do not cancel the meeting unless absolutely necessary. Where should it be held?

Use a quiet room where you will not be distracted by work or interrupted.

Do not host the meeting near to the place where the incident occurred if this may be difficult for the patient and/or their carers.

Stage 2: discussion How should you approach the patient and/or their carers?

Speak to the patient and/or their carers as you would want someone in the same situation to communicate with a member of your own family.

Do not use jargon or acronyms: use clear, straightforward language.

Consider the needs of patients with special circumstances, for example, linguistic or cultural needs, and those with learning disabilities.

What should be discussed?

Introduce and explain the role of everyone present to the patient and/or their carers and ask them if they are happy with those present.

Acknowledge what happened and apologise on behalf of the team and the organisation. Expressing regret is not an admission of liability.

Stick to the facts that are known at the time and assure them that if more information becomes available, it will be shared with them.

Do not speculate or attribute blame.

Suggest sources of support and counseling.

Check they have understood what you have told them and offer to answer any questions.

Provide a named contact who they can speak to again. Stage 3: follow-up

Clarify in writing the information given, reiterate key points, record action points and assign responsibilities and deadlines.

The patient’s notes should contain a complete, accurate record of the discussion(s) including the date and time of each entry, what the patient and/or their carers have been told, and a summary of agreed action points.

Maintain a dialogue by addressing any new concerns, share new information once available and provide information on counseling, as appropriate.

This quick reference guide is available to download as a separate document for briefing staff at www.npsa.nhs.uk/advice


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

APPENDIX 10 GUIDELINES FOR PREPARING AND WRITING

STATEMENTS It is hoped that these guidelines may be helpful to staff who are asked to provide written statements which relate to:

Incidents complaints legal claims General At all times statements must be factual and exclude personal opinions, unless these

have been specifically requested, and emotional statements; they should follow the order in which the events occurred.

Recommended format 1 State your present:

name address or location in the hospital position relevant qualifications how long you have been in the post how you can be contacted most easily

2 If different from the above, give the following information as it applied when the

incident/events that are under investigation occurred: name address [if not still employed by the Trust] position relevant qualifications at the time how long you had occupied that post relationship to patient:

e.g. named nurse, ward manager, Consultant/doctor on take, Consultant in charge of patient, radiographer, physiotherapist etc.

3 Provide a narrative of the events - this does not need to be elaborate, just keep to the

facts and in date and time order state:

when and what you did and why where relevant, identify your contributions to nursing or medical notes - add an

explanation if you feel there is any doubt as to what you meant by the entries 4 Sign, date and time of writing statement

Remember:

STATEMENTS ARE NOT ABOUT ATTRIBUTING BLAME; THEY ARE ABOUT ESTABLISHING WHAT HAPPENED


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APPENDIX 11 TRUST LEAFELT OF PSYCHOLOGICAL RESPONSES TO EXTREMELY STRESSFUL EVENTS


INTRODUCTION This leaflet has been prepared to help you make sense of how you feel after a very stressful event- and how to understand and manage the reaction. Such events can happen to anyone, and can range from a big disaster, to something more private and personal in nature, like an acute illness or accident or being a witness to these events. These events are distressing for everyone and can produce strong reactions in people that they may never have had before. FEELINGS AFTER A TRAUMATIC EVENT At various stages following a traumatic incident you can experience many strong feelings, such as: flashbacks where you re-live the feelings from the event, shocked and numb, sad and tearful, helpless and hopeless, restless and wound-up, irritable, tearful, vulnerable, worried, angry, Fearful, guilty, bereaved – easily startled. RELATIONSHIPS

Traumatised people can withdraw and cut themselves off from others and you can feel that nobody understands what you are feeling. PHYSICAL FEELINGS The body also reacts to trauma, sometimes straight away and sometimes much later on. Some of the feelings you may experience are:

• Tiredness and fatigue; • Muscle tension; • butterflies and palpitations; • heart racing; • stomach churning; • hands shaking; • Sweating; • nausea, vomiting; • diarrhoea.

These reactions are all part of the normal reaction to a traumatic event- but they can be unhelpful and difficult to cope with. LONGER TERM REACTIONS You may experience a loss of interest, in self-care, in family and in social occasions. You may lose self-confidence in doing things. You may become emotionally detached, feeling cut off from people to whom you

are normally close, or become irritable or annoyed with them. THINGS YOU CAN DO Make sure you know what really happened. Hard facts help in the long run. Talk to others about what happened. Don’t bottle up your feelings- they may hurt, but it will help if you let them out. Try not to smoke or drink too much- the same with shopping- be careful you don’t go on too many spending sprees. Coming to terms with a traumatic, stressful event can take time, particularly if there is no neat explanation for what happened. Give yourself time. Be very careful – accidents happen more frequently after severe stress, especially in the home or on the road.

Document name: Incident reporting and management policy and procedure; Ref.: including the management of Serious Untoward Incidents

WHEN TO ASK FOR HELP The trauma feelings should improve quietly over the next 3-6 months. Sometimes events can be too severe, or too personal, for the reactions to fade as they might be expected to. If this happens you might want more help, particularly if: • Your bodily sensations remain

overwhelming. • Memories and flashbacks continue to

intrude and disturb you. • You remain exhausted or wound-up, or

sad. • You cannot function at work. • You have nightmares or sleep

problems. • You cannot relax. • You are constantly irritable. • You feel lonely and isolated. • You become accident prone, or cannot

concentrate. • Your relationships suffer, or other

people comment that you’ve changed. • You drink, eat or smoke much more

than usual.

WHO TO ASK FOR HELP Your GP will be able to advise you of the different sources of support available. “please remember that these feelings are a normal reaction to an extreme event - and that it is possible to get help”

Psychological responses to

extremely stressful events.

The normal reaction to trauma

and emergencies.



Ref.:


APPENDIX 12 EQUALITY IMPACT ASSESSMENT TOOL

To be completed and attached to any procedural document when submitted to the appropriate committee for consideration and approval

Initial Screening

1. Policy, service, strategy, procedure or function: Policy

Lead (e.g. Director, Manager, Clinician): Director of Nursing

2. Person responsible for the assessment:

Name: Alexandra Lucas

Job Title: Head of Patient Safety

3. Is this a new or existing policy, service strategy, procedure or function?

New Existing

4. Who is the policy/service strategy, procedure or function aimed at?

Patients Carers Staff Visitors

Any other Please specify: PCT, SHA

5. Are any of the following groups adversely affected by the policy:

If yes is this high, medium or low impact (see attached notes): Impact

Disabled people: No Yes H M L

Race, ethnicity & nationality: No Yes H M L

Male/Female/transgender: No Yes H M L

Age, young or older people: No Yes H M L

Sexual orientation: No Yes H M L

Religion, belief and faith: No Yes H M L

If the answer is yes to any of these proceed to full assessment. This applies whether the impact assessment is high, medium or low.

If the answer is no to all categories, the assessment is now complete.

6. Does the policy, service strategy, procedure or function include measures which promote equality? No Yes

7. If yes, what are these measures?

Identification of incidents that indicate a risk, for escalation through the organisation.


Ref.:


APPENDIX 15 RATIFICATION CHECK LIST Author; attach this to each copy of the policy being sent to a Committee for final ratification.

Dear Chairman

Please would you review this document at your next meeting and agree final approval and organisational ratification.

Title of meeting: Trust Board

Date of meeting: October 2009

Name of document: Incident reporting and management policy and procedure; including the management of Serious Untoward Incidents

Name of author: Alexandra Lucas, Head of Patient Safety

Yes No N/A

Are there any elements of this policy which present operational issues that require further discussion? If yes, please provide a contact name for the author.

X

Does the document include a training plan? X

Is the policy referenced? X

Are up to date National Guidelines included? X

If you are the appropriate forum, have the necessary resources been agreed to implement this document?

X

Is there a plan for policy implementation? X

Does your meeting recommend further consultation with groups or staff other than listed at the front of the policy?

What are the cost implications of implementing this policy?

Equipment £ 0 Staffing (additional) £ 0 Training Other

£ £

0 0

Document approved without further comment (Please circle): Yes / No

Further amendments to document suggested (Please circle)? Yes / No Name of Chair: ________________________________________________ Signature: ____________________________________________________ Date: ______________________________

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