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The Newcastle upon Tyne Hospitals NHS Foundation Trust

Management and Reporting of Accidents and Incidents Policy

Version No.: 10.0

Effective From: 5 August 2015

Expiry Date: 5 August 2017

Date Ratified: 11 May 2015

Ratified By: Corporate Governance Committee

1 Introduction

The Newcastle upon Tyne Hospitals NHS Foundation Trust actively supports the creation of an open and learning culture in which staff understand that reporting and investigating incidents, including near misses, is pivotal to reducing risk and improving patient safety

Errors, incidents and accidents in all areas of clinical and non-clinical activity can result in serious harm to patients, staff and other personnel as well as to Trust property and reputation. It is therefore essential that learning from accidents, incidents or near misses is appropriately disseminated across the organisation.

Our intention is to create a just culture in which all staff feel confident that the reporting of incidents and accidents is welcomed and valued.

It is essential that all possible steps are taken to minimise the risk of initial incident occurrence and subsequent recurrence and that when an incident, accident or near miss occurs, that an incident report is completed. The Trust operates a web-based incident reporting system (DatixWeb) to facilitate the incident reporting and investigation process.

2 Policy scope

This policy covers the reporting of all incidents, accidents and near misses and the process for investigation of such incidents (clinical and non-clinical). Please refer to Appendix 1.

3 Aim of policy

This policy aims to minimise the risk of incident occurrence and subsequent recurrence and to ensure that when an incident, accident or near miss occur, that an incident form is completed, the incident is appropriately investigated with the emphasis on learning where lessons are learned and shared across the organisation where relevant.

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4 Duties (Roles and responsibilities) Roles and responsibilities of the following: 4.1 Trust Board

The Trust Board is responsible for implementing a robust system of risk management within the organisation. This includes having a system of incident reporting and investigation.

4.2 Chief Executive

The Chief Executive is ultimately accountable for Risk Management within the Trust and for ensuring that the Trust meets all of its obligations under Health and Safety legislation and NHS Directives.

4.3 Ward / Department Managers/Supervisors (Lead Investigators)

All staff must be made aware of the existence and content of this Policy.

All managers, or those acting in that capacity, have the responsibility for ensuring that all incidents and near misses are reported according to the procedure indicated in this policy and that an on-line incident report is completed within 24 hours of the incident or near miss occurring.

All managers are responsible for the initial investigation of incidents and near misses to the degree appropriate to the severity of the incident and for the identification of action required to prevent recurrence.

Where appropriate this will involve liaison and consultation with managers in other areas, senior managers and specialist staff e.g. Risk Management, Health & Safety Advisors, Infection Prevention and Control Team, Fire Officers, Security, Moving and Handling, Safeguarding Adults, Falls Coordinator.

All managers and supervisors must be aware that an incident may progress to a claim of negligence and as such must ensure that the process of incident investigation is followed as outlined within this policy.

4.4 Senior Managers, Directorate Manager or Heads of Department (Lead

Investigator and/or Final Approvers) Senior Managers are responsible for ensuring that incident investigation is completed in a timely manner and where necessary actions are implemented following investigation. Where an action is outstanding the manager must ensure that where appropriate this is reported on the risk register and risk reduction measures identified.

Senior Managers are responsible for undertaking trend analysis to ensure that where there are potential “hot spots”, appropriate action plans are in place to reduce the level of risk of recurrence of such incidents.

Senior Managers are responsible for ensuring organisational learning through the dissemination of Directorate incident data and aggregated

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data to the Directorate Clinical Governance or Risk Groups and via department/ ward level meetings.

4.5 Clinical Directors

In addition to ensuring that all incidents and near misses are reported through the incident reporting mechanisms, the Clinical Director has a responsibility to ensure that issues highlighted through investigation are addressed within the Directorate and that potential Serious Incidents are reported via CGARD to the Medical Director.

4.6 All staff

Every employee has a responsibility to maintain safe systems of work, to take care of their own safety and that of colleagues and all other persons who may be affected by their acts or omissions. Any incident or near miss should be reported to the person in charge, supervisor or senior manager as soon as possible. The person in charge, supervisor or senior manager is the person with responsibility for the area concerned at the time that the incident or near miss takes place. An incident report should be completed as soon as possible after the event.

In the case of a member of staff suffering an incident or near miss whilst in the course of their duties, on the premises of another organisation, the reporting procedures for that organisation should be followed in addition to the Trust procedure.

Reporting of incidents does not absolve responsibility to identify action and prevent recurrence; there is a duty of care on the part of all staff to report any situation which they think is potentially dangerous or harmful.

4.7 Head of Patient Safety and Risk

It is the responsibility of the Head of Patient Safety and Risk to maintain a central database of all reported incidents and near misses on behalf of the Medical Director.

This responsibility functions in order to:

Ensure that information from incident and near miss reports informs the Trust Risk Management priorities as outlined within the Trust Risk Management Strategy and that issues arising are addressed within the overall Risk Management function.

Monitor Trust wide incident data including trend and statistical analysis as part of the systematic aggregation of incidents, complaints and claims.

Provide appropriate and timely reports for the Trust Board and associated committees in order to facilitate effective risk management.

Provide support to managers and clinicians in identifying and addressing specific risks arising from either individual incidents or from analysis of

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wider trends.

Ensure that appropriate reports are submitted to external agencies as detailed in section 9 in relation to reportable incidents.

The Head of Patient Safety and Risk is also responsible for the provision of incident investigation training to all staff designated as Lead investigators or Final approvers.

4.8 Health and Safety Lead & Advisors

Advising investigators in relation to incidents involving or potentially presenting a health and safety risk.

Advising managers on current Health and Safety Legislation and Trust Policy and Procedure for accident prevention purposes.

Providing appropriate and timely reports to the Trust Health and Safety Committee.

Liaison with the Health and Safety Executive with regard to reportable incidents (Appendix 4).

4.9 Fire and Security Officers

The Trust Fire and Security Officers are responsible for monitoring incident data for all fire and security incidents in conjunction with the relevant Directorate Manager and providing appropriate and timely information to the Health and Safety Committee.

The list above is not exhaustive and there may be occasion where additional stakeholders/specialist personnel with a specific role and or responsibility should be listed (See section 6.16 external agency reporting responsibilities). 5 Definitions For the purposes of this policy the following definitions apply:

Accident/Incident :- An unexpected, unplanned event which causes an injury (either physical or psychological) to staff patients, visitors, volunteers, or contractors or which results in damage to equipment, buildings, assets or structures. The ‘event’ is not consistent with the desired operation of the organisation and may lead to a formal complaint and/or litigation.

Adverse Event: - an incident/accident which results in actual harm.

DatixWeb: The trust incident reporting and management system.

Duty of Candour: - patients and their families are to be told about patient safety incidents that affect them, receive appropriate apologies, are kept informed about investigations and are supported to deal with the

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consequences. The contractual Duty of Candour applies to patient safety incidents that occur whilst a person is receiving care under the NHS Standard Contract and that result in moderate harm, severe harm or death (using NPSA definitions2)

Harm: - An injury (physical or psychological), disease, suffering, disability or death including all instances of potentially preventable harm.

Hazard: A hazard is something (e.g. an object, a property of a substance, a phenomenon or an activity) that can cause adverse effects.

Near Miss: - An unplanned or uncontrolled event, which did not cause injury to persons or damage to property, but had the potential to do so.

Person: - A member of staff or patient in any location and visitors, contractors, or any member of the public whilst on Trust premises.

Root Cause Analysis- A systematic process whereby the factors that contributed to an incident are identified. As an investigation technique for patient safety incidents, it looks beyond the individuals concerned and seeks to understand the underlying causes and environmental context in which an incident happened.

Serious Incidents: - Incidents that are categorised as moderate, major or catastrophic on the incident grading matrix should be considered as potential Serious Incidents and be managed in accordance with the Trust policy - Reporting and Management of Serious Incidents (SIs) Policy”.

N.B. For the purposes of this Policy the word incident will apply to incidents and accidents unless specifically stated otherwise. 6 Incident Reporting and Investigation Procedure 6.1 Promoting effective reporting

6.1.1 Errors, incidents and accidents in clinical practice can result in serious harm to patients, staff and visitors and it is therefore essential to ensure that all possible steps are taken to minimise the risk of their occurrence.

6.1.2 The first step in this process is to ensure that all incidents, accidents and near misses are reported promptly by the employees involved.

6.1.3 When incidents do occur, it is vital in the first instance that prompt action is taken to minimise their potentially harmful effects. In addition, it is necessary to consider carefully the circumstances in which the incident occurred, so that we can learn from the events and take action to reduce the risk of recurrence.

6.1.4 All staff should report incidents, accidents or near misses as soon as possible following the procedure outlined below.

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6.2 Incident reporting process and initial response

A flowchart of the incident and near miss reporting process can be found in Appendix 1.

6.2.1 On becoming aware of an incident the employee concerned must take

the following actions:

Arrange immediate treatment for any injured person.

Summon emergency services if appropriate.

Take action to remove the hazard or to protect others from it, if it is safe to do so. Occasionally the site of the incident will require cordoning off to ensure that staff and visitors do not put themselves at risk.

Retain any equipment involved in an incident in a safe place to allow testing/checking (See section 6.4 below).

Complete any notation required in the patient’s clinical record.

Complete an on-line incident report via DatixWeb. In the event of system downtime or unavailability of IT systems a paper incident form must be completed and the appropriate procedure for investigation followed as outlined in Appendix 1.

Inform the person in charge of the area or department or senior manager immediately, particularly where a serious incident has occurred. Out of normal working hours the Patient Services Coordinator should be contacted.

If the incident is a potential Serious Incident the Head of Patient Safety and Risk or Patient Safety Advisor, should be contacted by telephone to ensure the incident is reported to the Executive Team as soon as possible.

If it is decided that an incident should be reported as a Serious Incident (SI) it will be reported and investigated as per the Trust policy and procedure on “Serious Incidents- Reporting and Management Policy”.

6.2.2 Reporting of incidents retrospectively Occasionally an incident or injury comes to light a considerable length

of time after it occurred. Where this is the case the incident should be reported via the online incident reporting system as usual, although the manager should note clearly any time delay in the report and the reason for the delay.



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If a complaint or claim highlights an incident or near miss occurrence, an incident report should be completed via the Trust online incident reporting system, DatixWeb. The information should include reference to the complaint; however the complaint or claim itself should be managed through the Trust’s Claims Management Policy or the Concerns and Complaints Policy .

6.2.3 There may be occasions when an incident may raise concerns about

malpractice or inappropriate behaviour. The “Whistleblowing: Policy on voicing concerns about malpractices, misdemeanours, inappropriate behaviour or actions ”, should be referred to in such circumstances.

6.3 Incident Investigation

The level of investigation will differ dependent on the severity of the incident; (see Appendix 1), however, the following general principles apply.

6.3.1 The initial investigation of incidents should be undertaken by staff who are trained as Lead Investigators, this is usually the relevant Ward or Department Manager or designated deputy, in consultation with specialist personnel, and professional leads, as appropriate.

6.3.2 Once informed of the incident, the Lead Investigator will take the

following actions:-

Visit the scene and establish the facts of the incident.

Check that any injured person has received treatment and that any hazard has been made safe.

In the case of an incident involving a patient, ensure an entry has been made in the clinical notes.

6.3.3 Incident Grading

Each incident must be graded according to the damage caused, based on the criteria listed in Appendix 3. These consequences are listed in three columns based on: Impact on the individual, impact on the organisation and the number of people affected by the event. Using the listed criteria the investigator identifies a description that matches most closely the consequence of the incident, reviewing each column individually. The overall consequence of the incident is based on the highest level scored in each column. For example, should an incident have a major impact on an individual, a moderate impact on the organisation and only one person was affected, the consequence of the incident would be major.

In the event of a catastrophic, major or moderate injury or dangerous occurrence, consider the Trust’s Policy on the “Serious Incidents (SUIs) Reporting and Management Policy”.



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6.4 Obtaining statements from staff

6.4.1 The investigator should obtain statements from witnesses where appropriate and attach to the on line incident report (Appendix 5 for guidance). Where a paper form is used (as in the case of system downtime or unavailability of IT systems) the statements should be attached to the form.

6.4.2 Where possible staff members should write statements immediately

following an incident. All statements must be dated and signed with the name clearly printed in black ink on Trust headed paper. Statements can be marked draft until the staff member is satisfied with the content.

6.4.3 If staff are unable to write a statement, interviews should be arranged

and the record of the interview should be agreed by the member of staff. Prior to the interviews the investigating officers should meet to agree the areas of information to be obtained and the methods of discussion. An interview preparation form may be used.

6.4.4 Ensure staff members are supported and that they are informed that

they may bring a colleague, union or professional organisation representative to the interview if they wish.

6.5 Incidents involving medical devices

6.5.1 Any equipment that was involved in the incident should be isolated until

it has been reviewed by either the EME Services Officer in the Estates Department or Health and Safety Advisor. Photographs should be taken to support analysis of the incident. Health and Safety Advisors, Risk Management and Patient Services Coordinators all have access to digital cameras.

6.5.2 Where an incident involves a piece of bio-medical equipment:

Do not alter any dials or settings

Record the settings for future reference

Retain any disposables e.g. giving sets, in a yellow biohazard bag within a sealed and clearly labelled clear polythene bag

Quarantine the equipment in an area where it cannot be accessed by staff who may inadvertently put the equipment back into service

Do not allow the kit to be returned to the manufacturer without the clear agreement of either the Medical Electronics, Estates Department, Supplies, or Risk Management (See Appendix 2 )

Ensure that there is a secure environment to store any evidence to prevent loss or tampering

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6.6 Record keeping

6.6.1 Case notes should be reviewed in the case of a clinical incident to ensure that all records are completed appropriately. Staff should not record the reasons for any incident within the clinical record. The clinical record exists to record the clinical care of the patient and all other information should be recorded in the appropriate incident report and supplementary documentation.

6.6.2 Where a patient death or injury could be perceived as suspicious the police may seize the records. To allow the Trust to start its own investigation the senior officer on site at the time should obtain a photocopy of the records at the outset and retain in safe keeping for future reference.

6.6.3 Copies of all documentation relating to the incident will be retained by

the Trust for 10 years, with the exception of serious incident reports which are kept for 30 years, in accordance with the Trust procedure for document retention.

6.7 Supporting Staff

6.6.4 Involvement in a critical incident can be extremely upsetting for staff and the emotional state of the employee must be considered at all times. Support by Staff Counsellors can be arranged through Occupational Health if required. Please refer to Trust document “Supporting Staff Involved in Traumatic/Stressful Incident or Claims Policy’. Early implementation of this process will demonstrate strong support for staff involved.

6.8 Individual incident arising from systems failures

6.8.1 In a highly pressurised environment such as a hospital ward or department, incidents, accidents and near misses can occur as a result of systems failures and Trust managers must recognise this.

6.8.2 Every incident and its consequences will need to be considered individually. The intention is to understand what happened, potentially to discuss the practice issues informally, and ensure that lessons have been, learned both by the employee and the organisation as a whole. This discussion may in turn, result in the identification of a systems problem that will require a full root cause analysis investigation.

6.9 Situations where more formal action under Trust policies may be required

6.9.1 Concerns may emerge if an individual employee's practice has contributed to a clinical incident or accident. In such circumstances, the

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Clinical Director or manager and professional lead should discuss this in detail with the individual involved to identify any underlying causes and support required to prevent recurrence. In some circumstances it may be appropriate to further consider such issues with the individual under the appropriate Trust policy. In addition, where incidents and accidents are not promptly reported and appropriate action not taken to protect patients, visitors or staff from harm, this will be viewed as a serious breach of the terms and conditions of employment and professional registration.

6.10 Incidents requiring further investigation

6.10.1 Occasionally the initial investigation may highlight the need for further investigation by a designated lead investigator. This will include incidents such as: Suspected fraud - this would be carried out in line with the Fraud, Bribery and Corruption Policy and Response Plan. Possible complaint or claim against the Trust Situations in which the conduct of staff may require investigation under the capability or disciplinary procedures

6.10.2 These further investigations will only be initiated following discussion

with the Director of Quality and Effectiveness, the Medical Director, Nursing and Patient Services Director or designated operational/professional lead.

6.11 Communication with patients and/or next of kin

Being Open - ‘Duty of Candour’ must be considered for all patient incidents graded as moderate of above. Where appropriate an initial discussion should take place with the patient and the family in accordance with the Being Open (Duty of Candour) policy and the discussion recorded in the clinical notes.

6.12 Root Cause Analysis

6.12.1 The following documentation may be required to ensure a comprehensive analysis and report is completed:

Datix Incident report and relevant appendices

Other relevant written documentation as appropriate or available at the time (e.g. case notes, written policy documents)

Statements from all relevant staff immediately following incident (availability will depend on nature of incident).

Contributory factors framework to aid discussion (Appendix 6) N.B. Some categories of incident have specific RCA tools i.e. MRSA

bacteraemia, Clostridium difficile; Falls resulting in fractures; trust acquired pressure ulcers (category III or IV) and sharps/needle-stick injuries.

6.12.2 Following incident investigation an Action Plan for remedial action may be necessary.


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6.13 Closing or approving the Investigation

6.13.1 Following the investigation the investigating officer must complete all relevant mandatory sections of the on line incident report form before changing the status to ‘awaiting final approval’.

6.13.2 It is the responsibility of the trained ‘Final Approvers’ from the

department/s involved to agree the factual basis of the report and any remedial action required.

6.13.3 It is the responsibility of the Clinical Director of the department where

the incident occurred to ensure, with the support of the Directorate Manager and Matron, that remedial action is implemented and that where appropriate learning from the incident is shared throughout the organisation.

6.13.4 It must be remembered that the report can be disclosed during

litigation. 6.13.5 Where necessary ongoing audit of the proposed changes should be

agreed.

6.14 Feedback and Learning from Incidents 6.14.1 Staff who report incidents should receive feedback on the outcome of

the investigation and any lessons learnt. To facilitate this process there is an automatic feedback function in the Datix system but this should be supplemented by anonymised feedback shared via Directorate Governance meetings and Newsletters.

6.14.2 All staff involved in the incident should be informed that the

investigation is closed; bearing in mind that this is likely to be a difficult time for some and that support may be required. Ideally lessons learned should be shared with the group of staff directly involved.

6.14.3 Where there is thought to be an opportunity for Trust wide learning the

issue should be discussed at the Clinical Risk Group and/or presented at a Patient Safety Briefing for wider dissemination.

6.14.4 Clinical Educators and Educational Supervisors also play a key part in

providing feedback, sharing and dissemination of learning from incidents and near-misses.

6.15 Review of risk after an incident

6.15.1 Following some incidents the investigating officer will identify that there is a residual risk to the organisation. To ensure that this risk is managed correctly the risk should be added to the Trust Risk Register.

6.15.2 It is the responsibility of the Directorate or Department manager with

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access to the Risk Register to ensure that the hazard or threat is recorded.

6.15.3 To ensure that the risk is managed correctly the Trust policy on “Risk

Register – Management and Use ” should be followed. 6.16 Reporting Incidents to External Agencies

6.16.1 All NHS organisations are expected to communicate with the relevant external bodies in accordance with appropriate reporting requirements. There are a number of external bodies to which certain incidents should be reported as and when they occur; these are included in Table 1.

6.16.2 Incidents involving the Cervical Screening Programme (NHSCSP)

should be handled in accordance with protocol documentation to Interim Guidelines for Managing Incidents in the NHS Cervical Screening Programme “NHSCSP Publication No. 11 Dec 2010”



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Table 1: Key External Stakeholders / Reporting Schemes

Incident Type External Agency Reported

Frequency Person/Department Responsible for Reporting to External Agency

Internal Reporting Committee

Patient Safety Incidents

National Reporting Learning Service (NRLS)

Fortnightly as a minimum. On-going rolling programme

Head of Patient Safety and Risk

Clinical Risk Group, Trust Board

Serious Incident/Serious Adverse Event

NRLS As above Head of Patient Safety and Risk

Corporate Governance Committee, Clinical Risk Group, Trust Board

Strategic Executive Information System (STEIS) CCGs

As they occur


Trust Board

Radiation Protection

Care Quality Commission Health and Safety Executive

As they occur

Director of Quality and Effectiveness

Radiation Committee, Trust Board

Reporting of Injuries, Diseases & Dangerous Occurrences Regulations (2013) RIDDOR

Health & Safety Executive

As they occur

Health and Safety Lead (NB: Occupational Health required to inform manager and Health and safety re reportable diseases- App 4- section 4)

Trust Health and Safety Committee

Medical Devices Medicines and Healthcare products Regulatory Agency (MHRA)

As they occur

Head of Patient Safety and Risk & EME Managers

Medical Devices Steering Group

Adverse reactions to medication

MHRA As they occur

Clinicians and/or Pharmacists

Blood products Serious Adverse Blood Reactions and Events (SABRE)

Within 24 hours and investigated within 5 days

Transfusion Practitioner/Blood Bank Manager

Hospital Transfusion Committee.

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Incident Type External Agency Reported

Frequency Person/Department Responsible for Reporting to External Agency

Internal Reporting Committee

Human tissue, organ transplantation

Human Tissue Authority

As required Designated individuals Cellular Pathology and Histopathology

Cellular Pathology Management meetings & Lab Medicine CG & Q meetings

Fertilisation and Embryo

Human Fertilisation and Embryology Authority

As required Quality Development Manager, Newcastle Fertility Centre

7 Training 7.1 The Trust will ensure that appropriate training is provided on the reporting and

investigation of incidents and near misses, using the web-based incident reporting system, DatixWeb. All staff receive basic training on incident reporting as part of the Trust Induction Programme. A prospectus detailing the programme of training sessions for various staff groups is available on the Trust Intranet on the Clinical Governance and Risk Department webpage and on the Learning Zone.

7.2 All designated investigators and final approvers must have completed the

Trust training for Lead Investigators. Training on Incident Investigation will be delivered on a nominated person basis to staff identified by their Directorate Management team before being given access to the Datix Investigation Module.

7.3 Additional training materials related to incident investigation is available from NHS England and originally developed by the National Patient Safety Agency at https://www.england.nhs.uk/ourwork/patientsafety/root-cause/

8 Equality and Diversity The Trust is committed to ensuring that, as far as is reasonably practicable, the way we provide services to the public and the way we treat our staff reflects their individual needs and does not discriminate against individuals or groups on any grounds. This policy has been appropriately assessed.

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9 Monitoring compliance with the policy

Standard / process / issue

Monitoring and audit

Method By Committee Frequency

Monitoring of reporting of all incidents and near misses

Incidents overdue for investigation


Corporate Governance Committee

Bi-monthly

Serious Incidents management process



Bi-Monthly

Quality Account Director of Quality and Effectiveness

Board Monthly

Monthly Incident Report

Datix Administrator

Women’s Services Clinical Improvement Risk Group (CIRG)

Monthly

Aggregated learning from incidents, complaints and claims


Clinical Risk Group Bi-monthly

Monitoring of how effectively incidents are reported to external agencies

Annual review of all external reporting to be included in Annual risk management report



Annual

Monitoring of incident investigation process

Audit of incidents, claims and complaints investigations



Annual

10 Consultation and review This policy will be formally reviewed by the Head of Patient Safety and Risk on a two yearly basis or when changes in practice warrant updates to this policy. Ongoing review will be carried out by the Head of Patient Safety and Risk. The content of this policy has been discussed with relevant stakeholders via the Clinical Risk Group and agreed by the Corporate Governance Committee prior to ratification. 11 Implementation of policy (including raising awareness) All staff should be made aware of this policy as part of local induction and a link to the policy is attached to the DatixWeb Incident Reporting Form. 12 References

NHS England (formerly National Patient Safety Agency) ‘National Framework for Reporting and Learning from Serious Incidents Requiring Investigation’

Health and Safety Executive- HSIS1

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NHSLA Standards 2012 13 Associated documentation

Being Open (Duty of Candour) Policy

Capability Procedure (Non-medical and dental staff)

Capability Procedure Medical and Dental staff

Claims Management Policy

Concerns and Complaints Policy

Risk Register – Management and Use

Serious Incidents: Reporting and Management Policy

Supporting Staff Involved in Traumatic/Stressful Incident or Claims Policy

Whistleblowing: Policy on voicing concerns about malpractices, misdemeanours, inappropriate behaviour or actions

Policy Author: Head of Patient Safety and Risk, Clinical Governance and Risk Department












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Appendix 1

Flowchart on the Management of Incidents within the Trust

N.B. It is the joint responsibility of the line manager and the affected person to ensure that any events notifiable under the Reporting of Injuries, Diseases, Dangerous Occurrences Regulations (1995) (RIDDOR) are report to the Health and Safety Lead / Advisor

Major

Follow policy on the Management and Reporting of Accidents and Incidents

Appropriate level of investigation and implementation of any required actions

Support staff

Identify significant risks outstanding

Action planning and recommendations for risk reduction

Inform relevant external agencies as required

Insignificant Moderate

Lead Investigator Action: Grade the incident according to the actual consequence of the incident at time of occurrence Level of investigation to be determined by appropriate Director – Line Manager in liaison with the Clinical Governance and Risk Department / other appropriate staff members

Catastrophic Minor

Employee Action:

1. Address immediate needs of the individual(s) involved

2. Inform the person in charge of area/department / senior manager particularly when there is a serious incident (Out of Hours – contact Patients Services Co-ordinator, (PSC))

3. Complete an on-line incident form via the Trust Incident Reporting System (DatixWeb)

Incident Occurs

Level of investigation to be determined by appropriate Director – Line Manager in liaison with the Clinical Governance and Risk Department / other appropriate staff members Consider Policy on Reporting and

Management of Serious Incidents

Report incident immediately to person in charge / senior manager

Contact the Head of Patient Safety and Risk / Director of Quality and Effectiveness / Patient Safety Advisor

Duty Manager / PSC (Out of Hours)

Inform patient / relatives / carers of investigation Being Open (Duty of Candour)

Gather relevant statements / supporting evidence

Carry out Root Cause Analysis / Critical Incident Review

Support staff

Identify significant risks outstanding

Action planning and recommendations for risk reduction

Inform relevant external agencies

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This flowchart outlines the responsibilities and actions needed to be taken by staff in the event of a equipment/products

being involved in an incident or use, due to defect or failure. (Management for Reporting of Accidents and Incidents Policy)

This flowchart is not to be used for routine service/repair or decontamination. Refer to:

(Decontamination Status of Healthcare Equipment Following Patient Use and/or Prior to Service or Repair Policy)

Defective Equipment/Products

Defective Medical Electronic Device

Report to Electronics & Medical

Engineering Department.

FH 31197 / RVI 24069

Defective Product

Inform Supplies Department FH

Colin Smith 37592

(Do not contact manufacturer or

company reps)

Contact Risk Management

RVI Ext 20548 or via email

[email protected]

Estates/Environmental Issues

Report to Service Desk 21000

or via Intranet Home Page.

Remove defective device, clearly label and

quarantine on ward. Electronics & Medical

Engineering Department will initiate

investigation and provide Defect & Failure

report.

Complete a Declaration of Decontamination

Status of Healthcare Equipment Following Patient

Use and/or Prior to Service or Repair Form.

Remove defective equipment, clearly label

and quarantine on ward or isolated area

affected. Estates Department will initiate

investigation and provide report.

V1 March 2012 CGARD

Complete an incident form on

Datix ensuring all device details

including fault, ref, batch, lot No,

Asset No, Manufacturer etc are

completed.Complete an incident form on

Datix ensuring all device details including

fault, ref, batch, lot No, Asset No,

Manufacturer etc are completed.

Complete an incident form on

Datix ensuring all product details including

fault, ref, batch, lot No, Manufacturer etc

are completed.

Remove defective products, clearly label

and quarantine on ward.

Supplies will contact the manufacturer for a

exchange of goods or recall.

Process for Reporting of Defective Equipment

Appendix 2

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Appendix 3

Incident Grading Matrix

Level Impact/

consequences Risk Matrix

Descriptor

Actual Impact on Individuals

Actual/ Potential Impact on Organisation

Number of persons affected at one time

5 CATASTROPHIC

Suicide or homicide or a death that would generate immediate media attention Any alleged rape or other serious violent assault on an NHS patient or member of staff Infant abduction

National adverse publicity NHS Investigation STEIS Care Quality Commission Visit Criminal Prosecution, RIDDOR Extended service closure Cost greater that £500K

Excess of 50 e.g. cervical screening disaster, mass evacuations

4 MAJOR

Invasive procedures being carried out on the wrong patient or body part. Any unexpected death of a patient whilst under the direct care of a health care professional or within one month of being seen by a health care professional Haemolytic transfusion reaction; Removal of wrong body part. Infant discharge to the wrong family Permanent injury Loss of body part, Mis-diagnosis – poor prognosis. Patient receiving radiation dose much greater than intended whilst undergoing a medical exposure

Service closure, H&S Investigation reportable, Long term sickness. Claim expected – indefensible. Temporary service closure. Increased Pt. Stay >15 days Cost greater than £250K RIDDOR reportable major injury MHRA reportable STEIS reportable

16 - 50 Moderate number – e.g. loss of specimens, vaccination problem

3 MODERATE

Semi-permanent Injury/ Damage e.g. injury takes up to one year to resolve Injury leading to short term staff sickness more than 7 days

Needs careful PR, Local Adverse publicity RIDDOR reportable MHRA reportable Hospital stay increased < 15 days

Small number 3-15

2 MINOR (LOW)

Short term Injury/ Damage e.g. injury that has been resolved within one month

Minimal risk to the organisation

One

1

INSIGNIFICANT

No injury or adverse outcome Near Miss

No Risk at all to the organisation

None

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Appendix 4 Reporting of Injuries, Diseases, and Dangerous Occurrences Regulations

(RIDDOR)

All RIDDOR reportable incidents will be submitted to the Health & Safety Executive through the Clinical Governance & Risk Department. 1. The following are reportable, if they arise ‘out of or in connection with work’:

i. the death of any person, whether or not they are at work ii. accidents which result in an employee or a self-employed person dying,

suffering a specified injury, being absent from work or unable to do their normal duties for more than seven days

iii. accidents which result in a person not at work (eg a patient, service user, visitor) suffering an injury and being taken directly to a hospital for treatment, or if the accident happens at a hospital, if they suffer a specified injury (see Section 2);

iv. specified dangerous occurrences, which may not result in a reportable injury, but have the potential to do significant harm (see Section 3)

v. an employee or self-employed person has one of the specified occupational diseases or is exposed to carcinogens, mutagens and biological agents

vi. (see Section 4); For the purposes of reporting the regulations define specified injuries and dangerous occurrences as indicated below. 2. Specified Injuries The list of ‘specified injuries’ in RIDDOR 2013 (regulation 4) includes:

i. a fracture, other than to fingers, thumbs and toes; ii. amputation of an arm, hand, finger, thumb, leg, foot or toe; iii. permanent loss of sight or reduction of sight; iv. crush injuries leading to internal organ damage; v. serious burns (covering more than 10% of the body, or damaging the eyes,

respiratory system or other vital organs); vi. scalpings (separation of skin from the head) which require hospital treatment; vii. unconsciousness caused by head injury or asphyxia; viii. any other injury arising from working in an enclosed space, which leads to ix. hypothermia, heat-induced illness or requires resuscitation or admittance to

hospital for more than 24 hours. 3. Dangerous Occurrences 3.1 The collapse, overturning, or failure of a load bearing part of a lift, hoist,

crane, derrick, forklift truck or mobile platform, or an excavator, or a pile-driving frame with an operating height of over seven metres.

3.2 The collapse or failure or a load bearing part of a passenger carrying

amusement device or any safety arrangement connected with it.

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3.3 The explosion, collapse or bursting of any closed vessel. 3.4 Electrical short-circuits or overload causing fire or explosion. 3.5 Any explosion or fire resulting in the suspension of normal work for more than

24 hours. 3.6 The collapse or partial collapse of any scaffold over five metres high. 3.7 Any unintended collapse of any building or structure under construction,

alteration or demolition involving a fall of more than five tonnes of material or of a wall or floor in a place of work.

3.8 An uncontrolled or accidental release or escape of any pathogen or substance

from any apparatus or equipment. 3.9 Any unintentional ignition or explosion of explosives. 3.10 Failure of any freight container or a load bearing part thereof. 3.11 Bursting, explosion or collapse of a pipeline. 3.12 Any incident in which a road tanker overturns or suffers serious damage

catches fire or causes the release of dangerous substances.

3.13 Any incident in which a dangerous substance being conveyed by road is

involved in a fire or where there is an uncontrolled release of escape of the dangerous substance.

3.14 Any incident where breathing apparatus malfunctions in such a way as to

deprive the wearer of oxygen. 3.15 Any incident in which plant or equipment comes into contact with overhead

power lines exceeding 200 volts. 3.16 Any accident or incident which resulted or could have resulted in the release or

escape of a biological agent likely to cause severe human infection or illness. 4. Occupational Diseases Where, in relation to a person at work, the responsible person receives a diagnosis of—

i. Carpal Tunnel Syndrome, where the person’s work involves regular use of percussive or vibrating tools;

ii. cramp in the hand or forearm, where the person’s work involves prolonged periods of repetitive movement of the fingers, hand or arm;

iii. occupational dermatitis, where the person’s work involves significant or regular exposure to a known skin sensitizer or irritant;

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iv. Hand Arm Vibration Syndrome, where the person’s work involves regular use of percussive or vibrating tools, or the holding of materials which are subject to percussive processes, or processes causing vibration;

v. occupational asthma, where the person’s work involves significant or regular exposure to a known respiratory sensitizer; or

vi. tendonitis or tenosynovitis in the hand or forearm, where the person’s work is physically demanding and involves frequent, repetitive movements

5. Seven Day Absence Any employee requiring seven days or more absence from work following a work related incident must be reported under the RIDDOR rules. This rule applies even if the absence does not take place immediately following the incident.

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Appendix 5

Guidance for Preparing Statements and Reports 1. Introduction There are occasions when staff will be required to write a statement following a complaint and/or incident. Staff must be supported in statement writing following an incident. All statements must be dated and signed with the name clearly printed in black ink on Trust headed paper. As staff may be traumatised by having witnessed or being involved in an incident, it is not always possible to obtain statements immediately. In such cases they will need to undertake supported statement writing at a later time. In extreme cases it may be necessary to visit a member of staff at home, with their agreement, to assist in statement provision. If this is necessary it is essential that consideration is given to who should undertake this task. 2. Purpose of the Statement The aim of the statement is to establish the facts about the events which resulted in an incident. Accurate and concise reporting ensures that the organisation is in the best position to satisfy a complainant or deal with potential claims for negligence at the time or in the future. Good record keeping is of paramount importance in both complaints handling and incident reporting as many of the complaints received arise from failures in communication. The need for statements to amplify the clinical record is greatly reduced where the quality of clinical documentation is high. It is therefore in everyone’s interests to continually maintain a high standard of record keeping. 3. Content of Statements and Reports There are six main instances in which clinical staff may be requested to provide a written statement or report. These are:

to supplement the clinical record

to be used by the Trust for an internal enquiry or an independent review

requested by HM Coroner

to assist the Trust in relation to a complaint

to assist the Trust in relation to a legal claim

to assist the Trust in relation to an incident/accident report The core content of each of these types of statement is likely to be similar, but there are levels of detail which may be more or less appropriate for inclusion depending on the purpose for which the statement is being requested. Common to every type of statement is the need to record the facts and not to present opinion, belief or blame. Opinion and belief may need to be transmitted to

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other staff within the Trust, but initially this is best done verbally. If it becomes necessary to put it in writing, this should be done as a letter with a defined recipient and circulation and should not be part of a formal report or statement. Points to note:

Only the facts should be documented

The statement should be full, frank and honest

The statement should be clear and unambiguous

Statements relating to clinical care should be written with reference to the clinical notes

This makes it essential that in any statement opinions should not be included. Advice on the content of statements can be obtained from the Clinical Governance and Risk Department. 4. Writing the Statement 4.1 General Points:

The report does not form part of the medical record

Timing is important; write a statement as near as possible to the event

The final version of the report should retain the date of the first draft and state the date of the final version

The first page of the final version should be on Trust headed stationery

In a case involving a patient, the patient’s full name, date of birth and hospital record number should be stated. (In the case of a baby, this should include the baby’s full name, date of birth and hospital number followed by the words ‘Baby of’ and then the mother’s full name, date of birth and hospital number)

4.2 First Paragraph

This should state your full name, status and relevant qualifications. Professional staff should state their registration number and duration of employment with the Trust. It is helpful in addition to state dates, such as date of qualification and date of obtaining a postgraduate qualification, as well as the duration of work at your present grade. For example: “I am Dr Joseph Onions, MB BS, MRCOG. I qualified in 1992 and have worked as a specialist registrar for 2 years. I have worked in the Directorate xxxxxxxxxx at the xxxxxxx hospital for 5 months.

4.3 Second Paragraph

This should state who has requested the report or statement, and the purpose for which the statement or report has been requested. For example: “This statement has been prepared as a supplement to the clinical record at the request of ……..”.

4.4 Third Paragraph This should state the basis of your statement or report. The report might be based on the clinical record, relevant charts, your own observations, or relevant information from any other member of staff who should, where relevant, be

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named. For example: “This report is based on my own observations and the charts from the night of 9th /20th June which recorded observations made by A.N. Other (post).

4.5 Fourth Paragraph

This should state your role in relation to the patient and/or the incident in question. In the unlikely event of your being a personal friend or relative of the patient, this should also be stated clearly. Example: “I was involved in the care of this patient from the start of my shift at 2100 on 19th June 2011 until she was transferred to intensive care at 0300 on 20th June”.

4.6 Subsequent Paragraphs

All staff should state the names and grades of their colleagues on duty at the time

Events should be chronologically ordered, starting from when you came on duty or when you first took charge of the patient, as appropriate

Avoid abbreviations 4.7 Checking the Statement or Report

Check for correct spelling and grammar

Check that the information you have is accurate, objective and complete

Finish – “ I believe that the facts stated in this witness statement are true” (Not “to the best of my knowledge and belief”)

Sign and date the report 4.8 Reports for the Coroner

Unlike internal statements for use within the Trust, or reports or statements which may ultimately be cited in court proceedings, reports to the HM Coroner become public documents. It is therefore Trust policy that all reports requested by HM Coroner are seen by the Trust’s solicitors before the final report is submitted to HM Coroner. The presentation of such reports to the Trust’s solicitor will be coordinated by the Legal & Committee Services Officer on behalf of the Medical Director.

A Framework for Patient Safety Incident Investigation: Contributory Factors Framework

(CFF)

Prompting question Relevant to Incident?

CONTRIBUTORY FACTOR DOMAIN

Situational Factors

Did the staff involved function as a team? □ Yes □ Maybe

□ No

Team Factors - For example:

Conflicting team goals

Lack of respect for colleagues Poor delegation Absence of feedback

On the day of the incident, how did you feel? □ Yes □ Maybe

□ No

Individual Staff Factors - For example:

Fatigue Stress

Rushed

Distraction

Inexperience

Did the task features make the incident more likely? □ Yes

□ Maybe

□ No

Task Characteristics - For example:

Unfamiliar task

Difficult task

Monotonous task

Were there any reasons this incident was more likely to occur to this particular patient?

□ Yes □ Maybe

□ No

Patient Factors - For example:

Language barrier

Uncooperative

Complex medical history

Unusual physiology

Intoxicated



Local Working Conditions

Did staff provision match the expected workload around the time of the incident?

□ Yes □ Maybe

□ No

Workload & Staffing issues - For example:

High unit workload

Insufficient staff

Unable to contact staff

Staff sickness

Did everyone understand their role? □ Yes

□ Maybe

□ No

Leadership, Supervision & Roles - example:

Inappropriate delegation

Unclear responsibilities

Remote supervision

Were the correct drugs, equipment & supplies available and working properly?

□ Yes □ Maybe

□ No

Drugs, Equipment & Supplies - For example:

Unavailable drugs

Equipment not working

Inadequate maintenance

No supplies delivery



Latent/Organisational Factors

Did the ward environment hinder your work in any way?

□ Yes □ Maybe

□ No

Physical Environment - For example:

Poor layout

Lack of space

Excessive noise / heat / cold

Poor visibility (e.g. position of nurses’ station)

Poor lighting

Poor access to patient

Appendix 6

Were there any problems from other departments? □ Yes □ Maybe

□ No

Support from other departments This includes support from IT, HR, porters, estates or clinical services such as radiology, phlebotomy, pharmacy, biochemistry, blood bank, microbiology, physiotherapy, medical or surgical sub- specialities, theatres, GP, ambulance…

Did any time or bed pressures play a role in the incident?

□ Yes □ Maybe

□ No

Scheduling & Bed Management - example:

Delay in the provision of care

Transfer to inappropriate ward

Difficulties finding a bed

Lack of out-of-hours support

AWere there any issues with staff skill or knowledge? □ Yes □ Maybe

□ No

Staff Training & Education - For example

Inadequate training

No protected time for teaching

Training not standardised

No regular/yearly updates

Did local policies & protocols help or hinder? □ Yes □ Maybe

□ No

Local Policies, Protocols & Procedures - e.g.

No protocol exists

Protocol too complicated

Lack of standardisation

Contradictory policies exist



Latent/External Factors

Is there any characteristic about the equipment, disposables or drugs used that was unhelpful?

□ Yes □ Maybe

□ No

Design of Equipment, Supplies & Drugs - e.g.

Confusing equipment design

Equipment not fit for purpose

Similar drug names

Ambiguous labelling & packaging Have any national policies influenced this incident? □ Yes

□ Maybe

□ No

National Policies - For example:

Commissioned resources

National screening policy

Interference by government organisations

National medical / nursing standards

4 hour Emergency Department target



General Factors

How would you describe the culture of your clinical area in relation to patient safety?

□ Yes

□ Maybe

□ No

Safety Culture - For example:

Patient safety awareness

Fear of documenting errors

Attitude to risk management Were the notes available, accurate & readable?

Did poor or absent verbal communication worsen the situation?

□ Yes

□ Maybe

□ No

Communication Written and Verbal Communication For example:

Poor communication between staff

Handover problems

Lack of communication/notes

Unable to read notes

Inappropriate abbreviations used

Unable to contact correct staff

Notes availability

With acknowledgement to the Yorkshire and Humberside Improvement Academy, Creative Commons, Bradford Teaching Hospitals NHS Foundation Trust

The Newcastle upon Tyne Hospitals NHS Foundation Trust

Equality Analysis Form A

This form must be completed and attached to any procedural document when submitted to the appropriate committee for consideration and approval.

PART 1 1. Assessment Date: 2. Name of policy / strategy / service:

Management and Reporting of Accidents and Incidents Policy

3. Name and designation of Author:

Jackie Moon, Head of Patient Safety and Risk

4. Names & designations of those involved in the impact analysis screening process:


5. Is this a: Policy x Strategy Service

Is this: New Revised x

Who is affected Employees x Service Users x Wider Community

6. What are the main aims, objectives of the policy, strategy, or service and the intended outcomes? (These can be cut and pasted from your policy)

This policy covers the reporting of all incidents, accidents and near misses and the process for investigation of such incidents

(clinical and non-clinical).

This policy aims to minimise the risk of incident occurrence and subsequent recurrence and to ensure that when an incident, accident or near miss occurs, that an incident form is completed and the incident is appropriately investigated.

7. Does this policy, strategy, or service have any equality implications? Yes No x

If No, state reasons and the information used to make this decision, please refer to paragraph 2.3 of the Equality Analysis Guidance before providing reasons:

The policy describes the process of incident reporting, investigation and monitoring of recommendations/actions required.

28/04/15

The process should not differ for incidents involving patients or staff with protected characteristics.

8. Summary of evidence related to protected characteristics Protected Characteristic Evidence, i.e. What evidence

do you have that the Trust is meeting the needs of people in various protected Groups

Does evidence/engagement highlight areas of direct or indirect discrimination? If yes describe steps to be taken to address (by whom, completion date and review date)

Does the evidence highlight any areas to advance opportunities or foster good relations. If yes what steps will be taken? (by whom, completion date and review date)

Race / Ethnic origin (including gypsies and travellers)

Sex (male/ female)

Religion and Belief

Sexual orientation including lesbian, gay and bisexual people

Age

Disability – learning difficulties, physical disability, sensory impairment and mental health. Consider the needs of carers in this section

Gender Re-assignment

Marriage and Civil Partnership

Maternity / Pregnancy

9. Are there any gaps in the evidence outlined above? If ‘yes’ how will these be rectified?

10. Engagement has taken place with people who have protected characteristics and will continue through the Equality Delivery

System and the Equality Diversity and Human Rights Group. Please note you may require further engagement in respect of any significant changes to policies, new developments and or changes to service delivery. In such circumstances please contact the Equality and Diversity Lead or the Involvement and Equalities Officer.

Do you require further engagement? Yes No

11. Could the policy, strategy or service have a negative impact on human rights? (E.g. the right to respect for private and family

life, the right to a fair hearing and the right to education?

No

PART 2 Name:


Date of completion:

28/04/2015

(If any reader of this procedural document identifies a potential discriminatory impact that has not been identified, please refer to the Policy Author identified above, together with any suggestions for action required to avoid/reduce the impact.)

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