incident reporting and investigation policy · 2018-11-19 · incident/near miss reporting and...

Incident/near miss reporting and investigation policy v 8.0

Policy no: RM04

Version: 8.0

Name of policy: Incident/near-miss reporting and investigation

policy.

Effective from: 18/01/2018

Date ratified 08/11/2017

Ratified Quality Governance Committee

Review date 01/11/2019

Sponsor Director of Nursing, Midwifery & Quality

Expiry date 07/11/2020

Withdrawn date

Unless this copy has been taken directly from the Trust intranet site (Pandora) there is no

assurance that this is the most up to date version

This policy supersedes all previous issues

Incident/near miss reporting and investigation policy v8 2

Version control

Version Release Author/

reviewer

Ratified by /

Authorised by

Date Changes

(Please identify

page no.)

1.0 December

1998

Trust Policy Forum 09/12/1998

2.0 May 2002 Trust Policy Forum 08/05/2012

3.0 February

2003

Risk Management

Committee Clinical

Improvement

Group

February

2003

4.0 November

2006

Clinical

Improvement

Group

November

2006

5.0 January

2009

Head of

Corporate Risk

PQRS January 2009

6.0 September

2009

Risk Facilitator September

2009

Formatted to

OP27 policy on

development,

management and

authorisation of

policies

6.1 January

2013

S A Gair Risk

Management

Facilitator

Head of Nursing,

Midwifery &

Quality

January 2013

7.0 H&S Risk and

Assurance

Manager

PQRS June 2014 Updated SI Panel

ToR. Internal

audit report

comment

8.0 18/01/2018 SafeCare Lead –

Patient Safety

and Incident

Management

Risk and Safety

Council

08/11/2017 Full review, changes

in process and

Committee

Structure


Incident/near-miss reporting and investigation policy

(Including never events and serious incidents)

Contents

1. Executive Summary ........................................................................................................... 4

2. Introduction ....................................................................................................................... 4

3. Policy scope ....................................................................................................................... 5

4. Aim of policy...................................................................................................................... 5

5. Duties – roles and responsibilities .................................................................................... 5

6. Definitions ......................................................................................................................... 8

7. Incident/near miss reporting and investigation process .................................................. 12

7.1 How to report an incident including timescales ................................................... 12

7.2 Review and investigation of incidents .................................................................. 13

7.3 Levels of investigation ........................................................................................... 15

7.4 Serious incidents and ‘Never events’ .................................................................... 16

7.5 Re-grading of incidents ......................................................................................... 16

7.6 Organisational learning ......................................................................................... 16

7.7 Raising concerns .................................................................................................... 16

7.8 RM67 Supporting staff involved in an incident, complaint or claim .................... 17

7.9 Involving patients and their families in investigations ......................................... 17

8. Training ............................................................................................................................. 17

9. Diversity and inclusion ...................................................................................................... 18

10. Monitoring compliance with the policy ............................................................................ 18

11. Consultation and review ................................................................................................... 19

12. Implementation of the policy ........................................................................................... 19

13. References......................................................................................................................... 19

14 Associated documentation ............................................................................................... 19

Appendices (hyperlinks provided) ....................................................................................... 20

Appendix 1 Flowchart: Process for the reporting and management of incidents

Appendix 2 Datix system: Flowchart for investigating an incident

Appendix 3 Incident grading matrix

Appendix 4 Levels of harm/actual severity

Appendix 5 Guidance for notifying external agencies

Appendix 6 Guidance for Root Cause Analysis

Appendix 7 Guidance for writing statements

Appendix 8 Guidance for interviews

Appendix 9 Hotline arrangements

Appendix 10 Serious Incident Framework

Appendix 11 Never Event Policy and Framework


GATESHEAD HEALTH NHS FOUNDATION TRUST

Incident/near-miss reporting and investigation policy

1. Executive Summary

This policy sets out the process to be followed in relation to incident management across

the Trust. This includes:

• Identifying and reporting an incident

• Review and investigation of incidents

• Reporting of incidents

• Levels of investigation

This document also takes account of existing statutory reporting requirements including:

• Medicines and Healthcare Products Regulatory Agency (MHRA)

• Health and Safety Executive(HSE)

• Medicines Control Agency (MCA)

• Serious Hazards of Transfusion Enquiry (SHOT)

2. Introduction

Gateshead Health NHS Foundation Trust recognises that in a service as large and complex

as the NHS things can go wrong. It actively supports the promotion of a positive and fair

blame approach to incidents and near miss reporting in a culture of openness and learning

which is fundamental to effective risk management.

The Trust supports the view that the response to incidents should not be one of blame but

of organisational learning to encourage participation in the overall process. The Trust is

committed to developing a just culture, encouraging a willingness to admit mistakes

without fear of punitive measures.

The completion of an incident report does not constitute an admission of liability. The Trust

believes that incident investigation and reporting should only trigger or contribute to any

disciplinary procedure where there is a criminal act or where a member of staff has wilfully

and/or negligently, exceeded their professional boundaries.

The Trust contributes to the NHS Commissioning Board’s National Reporting and Learning

System (NRLS).

The recommendations of the Department of Health publications “An Organisation with

Memory”1, “Building a Safer NHS”

2, “Doing Less Harm”

3, Culture Change in the NHS –

applying the lessons of the Francis Inquiries” 4,

National Patient Safety Agency publication

“Building a memory: preventing harm, reducing risks and improving patient safety” 5

and

“Safety First”6, the Health and Safety at Work Act 1974, the “Report of the Mid

Staffordshire NHS Foundation Trust Public Enquiry (Francis report 2013)”7,

“Freedom to

speak up: an independent review into creating an open and honest reporting culture in the

NHS”8

(Francis February 2015) and “Investigating Clinical Incidents in the NHS”9

(Public

Administration Select Committee March 2015) have been taken into account in the

development of this policy.


We will make sure that we share the learning from incidents both internally and externally

where appropriate and possible.

3. Policy scope

This policy applies to all staff working within the Trust, all patients treated and all visitors,

contractors, volunteers and members of the public visiting the premises.

4. Aim of policy

This policy outlines how the Trust will report, manage, analyse and learn from all clinical

and non-clinical incidents and near misses to reduce the risk of harm to patients, staff and

other users of Trust premises through improving safety, quality of services and the

environment by providing an effective incident reporting and investigation system.

5. Duties - roles and responsibilities

Trust Board

Trust Board has overall responsibility for effective risk management, the safety of patients,

staff and visitors within the Trust and to ensure the Trust complies with its statutory

obligations.

Chief Executive

The Chief Executive has ultimate responsibility for safe care, including risk management,

but delegates this responsibility to the Director of Nursing, Midwifery and Quality and the

Medical Director.

Medical Director

The Medical Director will chair any Serious Incident Review panels and ensure external

reporting of serious incidents where appropriate.

Director of Nursing, Midwifery and Quality

The Director of Nursing, Midwifery and Quality is responsible for ensuring governance

arrangements are in place to provide the leadership and support necessary to manage the

provisions of this policy. Management of the incident reporting process is delegated to the

Assistant Director of Quality.

Assistant Director of Quality

The Assistant Director of Quality is responsible for the development, implementation and

maintenance of a robust Trust-wide incident reporting and investigation system. As the

lead for Quality Governance the Assistant Director of Quality is responsible for ensuring

that the incident management process satisfactorily supports the Trust Quality Governance

agenda, and that the Clinical Business Units (CBU’s) ensure adequate resources are

deployed to ensure continual improvement through the analysis of reported incidents and

lessons learned.


Head of Corporate Risk

The Head of Corporate Risk is responsible for providing specialist advice, support and

leadership on clinical and non-clinical Risk Management, incident management and

investigations to all levels of staff across the Trust.

Patient Safety Manager

The Patient Safety Manager will manage the Serious Incident Reporting Procedure and be

the nominated officer for SI reporting through the Commissioners, coordinating the

collection of information required to submit initial and final reports.

Patient Safety and Incident Management Team

It is the responsibility of the Patient Safety and Incident Management team to:

• Provide the systems and training to support incident recognition, reporting and

investigation.

• Train staff in the use of Datix and other tools to support risk management.

• Review all incidents reported and undertake further enquiries as required.

• Escalate all significant incidents to the Head of Corporate Risk if it appears to fulfil

Serious Incident (SI) criteria.

• Quality control data.

• Export data as required to NHS Protect and the National Reporting & Learning

System.

• Notify incidents in accordance with CQC requirements in regulations 16, 17 & 18 of

the CQC (registration) regulations 2009.

• Monitor the incident reporting process and ensure that the wider context of risk or

any trends apparent from separate incidents are brought to the attention of senior

managers and /or committees for review.

• Monitor the incident reporting process and report trends to the Risk and Safety

Council or Health & Safety Committee.

Handler

The handler is the person who is responsible for managing the investigation of an incident.

They are not necessarily responsible for investigating the incident themselves (though they

may do); the handler’s job is to make sure that somebody investigates the incident.

The Handler will be selected on Datix by the reporter from a list of names in a field at the

end of the incident reporting form. The names from which the reporter can select the

handler depend on the Business Unit and Service that has been selected for the

investigating area e.g. if Medical Directorate is selected, only Datix users who are agreed

handlers and are linked to Medical Directorate will appear in the list of Handlers to choose

from.

At the time the incident is reported, the handler is notified by email. The immediate job of

the Handler is to log into the system and select an appropriate Investigator from the

department in which the incident originated (as identified by the reporter).


Investigators

Investigators are identified within the Datix system dependent on the nature and location

of the incident. Investigators are responsible for investigating incidents fully in accordance

with this policy including the development and follow up of action plans.

Specialist Advisers

Specialist advisers e.g. Information Governance Officer, Medical Devices Manager, Health

and Safety Manager/Adviser are automatically notified of specific incidents within their

sphere of knowledge. They are responsible for reviewing the incident and either giving

advice about the investigation of the incident or investigating and reporting on it

themselves depending on the level of harm/level of risk. They will be responsible for any

external reporting necessary (see appendix 7)

Health & Safety Manager/Health & Safety Adviser

The Health & Safety Manager and/or Adviser is responsible for overseeing that all Health &

Safety incidents are investigated and RIDDOR reportable incidents are investigated fully

and reported within the Health and Safety Executive timescales.

Associate Directors

Associate Directors are responsible for promoting effective risk management; ensuring

operational systems are in place to meet the requirements of this policy. They have a

responsibility to make sure there is a robust culture of reporting and that all incidents

within their business unit are reported in accordance with this policy and that serious

incidents are reported to the Patient Safety Team who will coordinate the reporting to the

Chief Executive or Director on Call in normal working hours or the Acute Response Team

(ART) night site manager out of hours.

Business unit risk managers/risk representatives

Are responsible for the effective and efficient management of the incident reporting

process within their business unit including making sure that the appropriate levels of

investigation are completed and incidents and action plans (where appropriate) are signed

off in a timely manner.

Acute Response Team (ART) night site manager

The ART night site manager may receive reports of serious incidents and will ensure that

the necessary arrangements are in place to ensure the immediate safety of the patient and

individuals involved, the quarantining of equipment and notifications required at that time.

The ART night site manager will notify the senior nurse on call of any such incidents.

Manager on call/Out of hours

The Manager on call may receive reports of serious incidents and will ensure that the

necessary arrangements are in place to ensure the immediate safety of the patient(s) and

individual(s) involved, the quarantining of equipment and notifications required at that

time. He/she will ensure that the incident and actions taken are reported to the Patient

Safety Team as soon as possible for the on-going coordination of the Serious Incident

process.


Service Line Managers/Heads of Departments/All managers

Managers are responsible for promoting effective risk management; ensuring operational

systems are in place to meet the requirements of this policy. This includes making sure that

incidents (including near misses) are investigated in accordance with this policy. In

addition, they have a responsibility to make sure that their staff receive appropriate risk

management training by attending induction, mandatory training and other appropriate ad

hoc training.

All staff

All staff should be aware of what is an incident, near miss or serious incident and the

process for reporting and management of such incidents as part of their own accountability

to safe care, reporting incidents as they arise.

Quality Governance Committee

The Quality Governance Committee receives assurance regarding incident reporting

findings and analysis. The Chair will report on an exception basis any matters relating to

incident reporting, including Never Events to the Trust Board.

Risk and Safety Council

The Risk and Safety Council takes assurance in relation to all incidents and reviews

incidents moderate and upwards, following up actions taken in respect of incident reports

SafeCare Council

The SafeCare Council identifies areas for improvement in respect of incident themes and

ensure appropriate action is taken.

Serious Incident Panel (SIP)

The panel co-ordinates the investigation and reporting of serious incidents and near-misses

and ensures organisational lessons are learnt where relevant and that appropriate external

reporting in completed.

Health and Safety Committee

The Health and Safety Committee is responsible for monitoring non clinical incidents and

near misses, reviewing trends and monitoring any action plans developed as a result of

individual incidents or trends.

Integrated Learning Group

The aim of the Integrated Learning Group is to ensure that the Trust has an integrated

approach to the management and investigation of complaints, claims, incidents, research

and development, audit and issues reported to the Patient Advice and Liaison (PALS)

service including learning and sharing lessons as appropriate.

6. Definitions

Abuse, violent, disruptive or self-harming behaviour: Untoward events that cannot be

reasonably said to be accidental in motive and include physical assaults by any person,

deliberate self-harm, aggressive incidents and other incidents involving verbal abuse,

sexual or racial harassment, or intimidation or threatening behaviour. These may be face to

face or over the telephone.


“Being open” refers to the process for communicating adverse events with patients and

their carers, staff and visitors.

Duty of Candour: Candour is defined in Robert Francis’ report as: “The volunteering of all

relevant information to persons who have or may have been harmed by the provision of

services, whether or not the information has been requested and whether or not a

complaint or a report about that provision has been made.”

The Duty of Candour is a legal duty on hospital, community and mental health trusts to

inform and apologise to patients if there have been mistakes in their care that have led to

significant harm. Duty of Candour aims to help patients receive accurate, truthful

information from health providers.

Clinical incident: A clinical incident is one which arises in the context of the duty of care

owed to patients by members of the healthcare professions (including medical/dental

practitioners, nurses and midwives, professions allied to medicine, laboratory staff and

relevant technicians) or by others consequent on decisions or judgements made by those

professions in their professional capacity or relevant work e.g. misdiagnosis, incorrect site

surgery, failure to act upon test results.

Causal factors/root causes: The prime reason(s) why an incident occurred. A root cause is

a fundamental contributory factor. Removal of these will either prevent, or reduce the

chances of a similar type of incident from happening in similar circumstances in the future.

Contributory factors/associated factors: Contributory factors are those which affect the

performance of individuals whose actions may have an effect on the delivery of safe and

effective care to patients and hence the likelihood of Care Delivery Problems (CDP) or

Service Delivery Problems (SDP) occurring. Contributory factors may be considered to

influence either the occurrence or outcome of an incident, or to actually cause it. Generally

speaking the removal of the influence may not always prevent incident recurrence but will

generally improve the safety of the care system; whereas removal of causal factors or ‘root

causes’ will be expected to prevent or significantly reduce the chances of recurrence.

Fire incident: Any incident that involves actual smoke/fire or suspected smoke/fire or fire

alarm.

Harm: Harm is defined as injury, suffering, disability or death. The NHS Commissioning

Board Special Health Authority definitions of levels of harm are:

No harm: Impact prevented – any patient safety incident that had the potential to cause

harm but was prevented, resulting in no harm to people receiving NHS-funded care. Impact

not prevented – any patient safety incident that ran to completion but no harm occurred to

people receiving NHS-funded care.

Low: Any patient safety incident that required extra observation or minor treatment and

caused minimal harm, to one or more persons receiving NHS-funded care.

Moderate: Any patient safety incident that resulted in a moderate increase in treatment

(e.g. increase in length of hospital stay by 4-15 days) and which caused significant but not


permanent harm, to one or more persons receiving NHS-funded care.

Severe: Any patient safety incident that appears to have resulted in permanent harm to

one or more persons receiving NHS-funded care.

Death: Any patient safety incident that directly resulted in the death of one or more

persons receiving NHS-funded care.

Incident: an event or circumstances involving patients, visitors or staff that could have or

did lead to unintended or unexpected harm, loss or damage. This harm can be identified as

physical or psychological.

Information Governance Serious Incident: Any incident involving the actual or potential

loss of personal information that could lead to identity fraud or have other significant

impact on individuals should be considered as serious. (This applies irrespective of the

media involved and includes both loss of electronic media and paper records).

Infrastructure/resources incident: Any incident/near-miss that is believed to be due to

inappropriate staffing/ facilities or environment should be reported in this category.

Reporter: Any person who reports an incident through the Datix incident reporting

module.

Handler: The person selected on Datix who is responsible for managing the investigation of

an incident.

Investigator: A person identified within the Datix system responsible for investigating

incidents in accordance with this policy

Medical device/equipment incident: Any incident/near miss involving medical

device/equipment including lack of availability or equipment failure should be reported in

this category.

Medication incident: Errors/near-misses in the prescribing, dispensing, administration or

recording of medications should be reported using this category.

Near miss: an unplanned event that did not result in injury, illness, or damage – but had

the potential to do so. Only a fortunate break in the chain of events prevented an injury,

fatality or damage; in other words, a miss that was nonetheless very near.

Negligence: Conduct that falls below the standards of behaviour established by law for the

protection of others against unreasonable risk of harm. A person has acted negligently if he

or she has departed from the conduct expected of a reasonably prudent person acting

under similar circumstances.

Never events: “Never events” are serious, largely preventable patient safety incidents that

should not occur if the available preventative measures have been implemented. These

are updated on an annual basis by the NHS Commissioning Board Special Health Authority.


Non-patient personal accident (staff/visitor/contractor): Non-patient personal accidents

are ‘accidental’ untoward events which affect/involve a person or persons (other than a

patient) and either resulted or could have resulted in injury.

Patient personal accident: Patient personal accidents are ‘accidental’ untoward events

which affect/ involve a patient and either resulted or could have resulted in injury e.g. slips,

trips and falls.

Security incident: A security incident is one in which there is fraud, theft, deception,

criminal damage, car crime, including all property belonging to the Trust. Patients

absconding from the Trust or becoming ‘missing’ are also included in this category.

Specialist adviser: Advisers within the Trust who have specialist knowledge in relation to

specific incidents e.g. Fire Officer, Information Governance Officer, Medical Devices

Manager, Health and Safety Manager/Adviser to offer advice and/or externally report the

incident.

RIDDOR reportable incidents: It is a statutory requirement that all RIDDOR (Reporting of

injuries, diseases and dangerous occurrences regulations) reports are submitted to the

Health and Safety Executive (HSE) within15 days of the event. An incident is RIDDOR

reportable if:

• An accident connected with work results in death or major injury;

• A member of the public is killed or taken to hospital;

• An accident connected with work results in an injury which requires more than 7

consecutive days absence from work;

• Work related disease; or

• Dangerous occurrence

The Trust is required to keep a record of an incident if a worker has been incapacitated for

more than three consecutive days.

Root Cause Analysis (RCA): the process by which the underlying cause(s) of an incident are

established. This is often a multi-disciplinary meeting of the individuals who were involved,

chaired by an individual who was not involved in the incident. It can also be a

comprehensive investigation using the principles and tools e.g. timeline, of root cause

analysis by one or more people.

Any recommendations made arising from a RCA must be detailed within an action plan

recorded in the actions module within Datix, followed up and signed off by the

investigator.

Serious Incident (SI): An incident/near miss occurring on health service premises or in

relation to health services provided, resulting in death, serious injury or harm to patients,

staff or the public, significant loss or damage to property or the environment or otherwise

likely to be significant public concern. This shall include ‘near misses’ or low impact

incidents which have the potential to contribute to serious harm. The definition also

applies to any incident involving the actual or potential loss of personal information that

could lead to identity fraud or have significant impact on individuals.


Wilful: intentional; deliberate

7. Incident/near miss reporting and investigation process

7.1 How to report an incident including timescales (see also flowchart at Appendix 1-

Process for the reporting and management of incidents”).

When a member of staff witnesses an incident they should:

• Take all necessary action to attend to the needs of the person(s) affected by

the incident and minimise the risk of further harm.

• Where an item of equipment is involved, label and quarantine the item

(documenting asset, batch, lot) and retain all evidence where possible.

• Where the level of harm is moderate, severe or death and could, therefore,

constitute a “Serious Incident” must be reported verbally (by the reporter)

to the person in charge/senior manager or the nominated investigator for

immediate action. That person will initiate the “Serious Incident” process.

(Please refer to the Serious Incident Policy`)

• Complete a web based Datix incident report form which is accessed through

the staff intranet “home” page”. Click on the Datix icon to the left of the

screen:-

• This will open up the following menu to the right of the screen and click on

“Report Incident”:

• Report immediately if possible, but within a period of 24 hours from the

time of witnessing the event. However, where there are exceptional

circumstances incidents can be reported out-with this timescale rather than

not being reported at all. (NB within domestic services and catering services

a paper Datix form is completed by the member of staff then input into the

electronic Datix system by the managers. The signed paper copy of the Datix

form is filed in the department).

• When completing the Datix incident report form the reporter should:


• include only facts (not opinion)

• write in sentence case in free text boxes – not write in block capitals

as this affects the national reporting

• not include any names or personal information of either staff or

patients in the free text boxes – this information should be included

in the contacts section. Again this affects the national reporting

• nominate a handler – this would normally be the ward or

department manager. See screenshot section 1a below

7.2 Review and investigation of incidents

When a handler (as identified by the system see appendix 2) receives notification of

an incident they must open and review the incident. Any serious harm incidents

should be opened within 24 hours with no harm, low harm and moderate harm

being opened within 48 hours to:

• Confirm that the correct investigator has been identified. See authorised

levels of investigation below. If not, it is the responsibility of the nominated

investigator to redirect the incident to the correct investigator using the

message field within the incident (See below) and also changing the name of

the investigator within section 1a (see above section 6.1) on Datix.

• Message field:

• The investigator will review the details of the incident including the accuracy

of the level of harm and all other coding making amendments if necessary.

The investigator will also assess and enter the risk grading.

• The investigator will identify the level of investigation required for the

incident. (Where the incident is a “Serious Incident” please refer to the

Serious Incident Policy)


Actual

Severity

Investigator Final Approver Level of

Investigation

Timescales

See further guidance

in 6.3 below

Opened

Within

Final Approval

Within

No harm or

low harm

Sister/Ward manager Sister/Ward

manager

Brief review 48 hours 14 working days

Moderate

harm

Handler or their nominated

person

Handler Concise

investigation*

48 hours 28 working days

Severe or

death (SIs)


person

SI Panel Comprehensive*

investigation

24 hours 28 working days

Near miss –

no harm

incidents

The risk grading of near miss incidents may identify potential significant risks to the organisation and

consideration should be given to carrying out either a concise or comprehensive investigation where this is

the case

Risk

grading

Investigator Final Approver Level of

Investigation

Timescales

Opened

within

Final approval

Within

Very low

risk and

low risk

Sister/Ward manager Sister/Ward

manager

Brief review Will have

been

opened

according

to level of

harm

above

14 working days

Moderate

risk


person

Handler Concise

investigation*

28 working days

High risk Handler or their nominated

person

SI Panel Comprehensive

investigation*

28 working days

All individual C.Diff, MSSA, MRSA, bacteraemia incidents require an RCA within 7 days

All medication errors to have a Medication RCA form completed (SI’s to be dealt with through the SI policy)

*Any serious incidents as reported to the Commissioners must be completed on the NHS Commissioning Board Special

Health Authority (NPSA) template

• Certain incidents are notified to specialist advisers e.g. Health & Safety

Advisor, Tissue Viability Nurse, Information Governance Officer

automatically through the electronic incident system depending on the

coding. Every incident notified to specialist advisers will be reviewed by

them within 5 calendar days of notification.

• For Information Governance incidents and incidents in the National

Screening Programmes the specialist advisers will be involved in ensuring

that the national guidance is implemented where necessary.

• Following investigation the investigator will attach all relevant

documentation to the Datix incident report and ensure completion of the

action plan within the agreed timescale and give feedback on the outcome

to the reporter of the incident.

• Final approval will be given by either the Sister/Ward Manager or the

Handler dependent upon severity and/or risk grading (see Tables above). NB

Serious Incidents will require final approval by the SI Panel.

• All actions identified from the incident are to be recorded within the actions

module which can be found within the Datix relating to the incident. This


will enable actions to be monitored. Once this is done the incident can be

closed even if there are actions outstanding.

• If there are any actions which cannot be completed for any reason e.g.

finance, cross business unit priorities, these need to be added to the risk

register.

External reporting

• NHS Commissioning Board Special Health Authority (previously NPSA) – All

patient safety incidents are reported to the NHS Commissioning Board

Special Health Authority through the National Reporting Learning Service

(NRLS). Reporting of incidents to the NRLS and CQC should not be delayed by

local investigation procedures. Grading of incidents can be changed if

necessary following the completion of local investigations.

• There are specific requirements for external notification of a variety of

incidents for example incidents relating to blood transfusions, information

governance incidents, screening incidents. The requirements for external

notification are detailed in appendix 7.

7.3 Levels of investigation

The table in paragraph 6.2 above identifies the various levels of investigations

required and timescales dependent on the severity or risk grading of incidents.

The description of the investigations can be classed as:

Investigation

Actual level of harm

Notes

Brief review

No harm/low harm/

very low risk/low risk

A brief review of the incident to check the

accuracy of the information, actions taken,

applying the risk grading and whether any more

detailed investigation is required. Can be finally

approved if no further action required.

Concise investigation Moderate

harm/moderate risk

No harm near miss

Detailed investigations including either:

o Multi-disciplinary RCA meeting which

involves all of the people involved in the

incident gathering to review the incident

using the RCA tools to identify the

contributory factors, root causes and

develop an action plan for

implementation and follow up

o The investigator (possibly with support)

carrying out a root cause analysis using

the relevant RCA tools to identify the

contributory factors, root causes and

develop an action plan for

implementation and follow up

(See appendix 7 for RCA guidance)

Comprehensive

investigation

Severe/death/high risk

Never Event


The following Root Cause Analysis (RCA) documentation is available on the

Datix incident module:

• Comprehensive RCA

• Concise RCA

Individual staff interviews may be necessary during an investigation: please refer to

appendix 11.

7.4 Serious incidents and never events

Serious incidents and never events will be reported and investigated in accordance

with the “Serious Incident” process flow detailed within appendices 10, the serious

incident framework detailed within appendix 11 and Never Event Policy and

Framework as detailed in appendix 12.

7.5 Re-grading of incidents

If appropriate, the investigator, handler, or staff within the Patient Safety Team may

re-grade the incident (either in terms of level of harm or risk grading) as further

facts and issues emerge during an investigation.

7.6 Organisational learning

To achieve organisational learning from incidents and near misses, the Integrated

Learning Report will be produced on a quarterly basis, identifying numbers, location

and trends (including SI investigations) are provided to the Risk and Safety Group,

and Council of Governors. Lessons learned are also shared at Business Unit

Safecare meetings, Trust wide Safecare events and included in publications e.g.

Safecare Alerts and Good Practice Bulletins. See also RM51 Learning from

experience Policy.

In addition the Trust reports all incidents reported via Datix to NHS Commissioning

Board Special Health Authority via the NRLS and serious unexpected incidents to the

Commissioners via STEIS (Strategic Executive Information Service). Relevant

reporting to the Care Quality Commission is achieved through the NRLS/ NHS

Commissioning Board Special Health Authority system. The Trust also notifies other

external agencies as identified in the Guidance for Notifying External Agencies (see

appendix 7).

Reports to analyse trends etc. can be produced via the Datix module. The Patient

Safety Team will be able to provide training in how to produce the report.

7.7 PP35 Freedom to speak up – Raising Concerns

Sometimes staff may find it difficult to report an incident/near miss perhaps due to

the sensitive nature of the circumstances in which the incident happened. In these

situations members of staff are encouraged to refer to “PP35 Freedom to Speak up

- Raising concerns at work policy” and follow the reporting routes outlined within

the policy.


7.8 RM67 Supporting staff involved in traumatic/stressful incidents

Whether or not a member of staff feels personally culpable for any events

surrounding an adverse incident the possibility of blame or criticism, whether public

or private, is extremely stressful. Involvement at any level in an adverse incident

gives rise to substantial anxiety.

“RM67 Policy for supporting staff involved in an incident, complaint or claim” gives

detailed guidance.

The guidance only relates to providing staff support and does not replace,

supersede or involve personnel guidelines or professional responsibilities,

circumstances in which there may be disciplinary action, issues relating to patient

protection or internal enquiries.

7.9 Involving patients and their families in investigations - Being open and Duty of

Candour

The level of patient/family involvement clearly depends on the nature of the

incident and the patient or family’s wish to be involved. Unless there are specific

indications to the contrary or the patient/their family request other arrangements,

these issues should be covered in a series of ongoing open discussion. The Trust

fully supports the ‘Being open’ principles of openness, honesty and transparency

and the policy. “RM49 Being open and Duty of Candour” gives information on the

processes involving the patient and their family.

8. Training

8.1 Training on the requirements of this policy will form part of the Trust’s mandatory

Training Needs Analysis.

8.2 Root Cause Analysis (RCA) Training

There is an ongoing programme of Root Cause Analysis training for those staff

members expected to carry out the multidisciplinary RCAs and are Datix handlers.

This training consists of a full day programme based on the NHS Commissioning

Board Special Health Authority (NPSA) Root Cause Analysis methodology.

The objectives of the course are to:

• Increase the understanding of the theory underpinning RCA

• Provide candidates with an overview of the RCA process

• Provide skills in some of the RCA Tools

• Demonstrate the advantages of using a systems based approach to patient

safety incidents

8.3 Datix training

Training on the use of the Datix incident reporting module will be provided to

investigators prior to gaining access to the system.


9. Diversity and Inclusion

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 staff reflects their individual needs and

does not unlawfully discriminate against individuals or groups on the grounds of any

protected characteristic (Equality Act 2010). This policy aims to uphold the right of all staff

to be treated fairly and consistently and adopts a human rights approach. This policy has

been appropriately assessed.

10. Process for monitoring compliance with this policy

Monitoring compliance with this policy will be carried out as follows:

Standard /

process / issue

Monitoring and audit

Method By Committee Frequency

All incident

reporting

Quarterly summarised

incident reports will be

produced in the form of a

CLIP report

Any resulting action plans

will be monitored by the

Integrated Learning

Group

SafeCare Lead

Patient Safety and

Incident

Management

SafeCare Lead

Patient Safety and

Incident

Management

Quality

Governance

Committee via

Risk and Safety

Council

Quarterly

Non clinical

incidents and

near misses

Trends will be highlighted

within the reports and the

Committee will take

responsibility for initiating

actions to address these

trends.



Health & Safety

Committee

Health & Safety

Adviser

Health & Safety

Committee

4 monthly

Timescales for

investigations in

incidents with

sign off of RCAs

and action plans

(excluding

serious

incidents)

Monitored on monthly

basis through the Board

to Board meetings for

each Business Unit and

the Integrated Learning

Group

SafeCare Lead –

Patient Safety and

Incident

Management

Board to Board

meetings

Risk and Safety

Group

Monthly

Reporting to

external agencies

Audit of compliance with

the external reporting

requirements



Quality Governance

Committee

SafeCare Lead –

Patient Safety and

Incident

Management

Quality

Governance

Committee

Annual


In addition, The Integrated Learning Group will monitor and analyse incident reporting

trends, subsequent investigations and root cause analysis as described in policy “RM51

Learning from experience.”

11. Consultation and review

This policy has been reviewed by members of the Patient Safety and Incident Management

Team with comments sought from a variety of staff across the Trust including associate

directors, service line managers, risk managers, head of service, modern matrons, specialist

staff

12. Implementation of policy

This policy will be implemented in accordance with OP27 Policy for the development,

management and authorisation of policies and procedures. It is also included in corporate

and mandatory training, the staff handbook and relevant staff education/training events.

13. References

1. Department of Health, June 2000. An Organisation with a Memory

2. Department of Health, April 2002 Building A Safer NHS For Patients

3. Department of Health, August 2001. Doing Less Harm.

4. National Patient Safety Agency, July 2005. Building a Memory: preventing harm,

reducing risks and improving patient safety

5. Department of Health. December 2006 Safety first: A report for patients, clinicians

and healthcare managers.

6. Report of the Mid Staffordshire NHS Foundation Trust Public Enquiry (Francis report

2013)

7. Department of Health, July 2004. National Standards, Local Action, Health and Social

Care Standards and Planning Framework

8. National Health Service Litigation Authority, April 2006, General Risk Management

Standards-Pilot.

9. Medical Devices Agency, March 2002. Safety Notice MDA SN2002(01)

10. Health and Safety at Work Act 1974

11. Checklist for reporting, managing and investigating information

Governance serious untoward incidents – Gateway ref: 13177

12. Managing Serious Incidents in the English NHS National Screening Programmes

Guidance on behalf of the UK National Screening Committee (UK NSC) Version 4 June

2010

13. Serious Incident Framework March 2013 – NHs Commissioning Board

14. Associated documentation

It is important that other appropriate policies are read in conjunction with this policy and

all Trust policies are relevant.

Specifically the following policies are of prime importance:

Datix user guides

RM01 Risk management policy

RM02 Health and safety policy


RM21 Complaint and concerns policy

RM23 Claims management

RM49 Being open and Duty of Candour

RM51 Learning from experience

RM67 Supporting staff involved in an incident complaint or claim

PP35 Raising concerns at work

RM74 Mental Capacity Act 2005

RM68 Safeguarding children and young people in Gateshead

OP45 Safeguarding vulnerable adults

Police/Health & Safety (HSE) Investigations protocol

Checklist for reporting, managing and investigating information

governance serious untoward incidents – Gateway ref:13177

Managing Serious Incidents in the National NHS Screening Programmes interim Guidance

(September 2013)

15. Appendices

Appendix 1- Process for the reporting and management of incidents http://pandora/Departments/Quality-

Team/DOCUMENTS%20TEAM/Policies/Appendix%201.%20Process%20for%20the%20reporting%20and%20management%20of%20incidents.docx

Appendix 2 -Datix Risk Management System Guidance http://pandora/Departments/Quality-

Team/DOCUMENTS%20TEAM/Policies/Appendix%202%20Incident%20investigation%20process%20July%202017.docx

Appendix 3 - Risk Assessment Guide

.http://pandora/Departments/Quality-Team/DOCUMENTS%20TEAM/Policies/Appendix%203.%20Risk%20Assessment%20Guide%20A3%20-

A4%20print%20standard%20booklet.docx

Appendix 4 - The levels of harm as detailed within the Datix incident reporting module. http://pandora/Departments/Quality-

Team/DOCUMENTS%20TEAM/Policies/Appendix%204.%20The%20levels%20of%20harm%20as%20detailed%20within%20the%20Datix%20incident

%20reporting%20module.docx

Appendix 5 - Guidance for notifying external agencies http://pandora/Departments/Quality-

Team/DOCUMENTS%20TEAM/Policies/Appendix%205%20Guidance%20on%20notifying%20external%20agencies.docx

Appendix 6 - Root Cause Analysis Guidance (RCA) http://pandora/Departments/Quality-Team/DOCUMENTS%20TEAM/Policies/Appendix%206.%20Root%20Cause%20Analysis%20Guidance.docx

Appendix 7 - Guidance on writing statements http://pandora/Departments/Quality-Team/DOCUMENTS%20TEAM/Policies/Appendix%207.%20Guidance%20for%20writing%20statements.docx

Appendix 8 - Guidance on interviews http://pandora/Departments/Quality-Team/DOCUMENTS%20TEAM/Policies/Appendix%208.%20Guidance%20for%20Interviews.docx

Appendix 9 - Hotline Arrangements http://pandora/Departments/Quality-Team/DOCUMENTS%20TEAM/Policies/Appendix%209.%20Hotline%20arrangements.docx

Appendix 10 – Serious Incident process http://pandora/Departments/Quality-

Team/DOCUMENTS%20TEAM/Policies/Appendix%2010.%20Process%20for%20the%20reporting%20and%20management%20of%20a%20Serious%

20Incident.docx


Appendix 11 - Serious Incidents Framework http://pandora/Departments/Quality-Team/DOCUMENTS%20TEAM/Policies/Appendix%2011.%20serious-incidnt-framwrk.pdf

Appendix 12 – Never Event Policy and Framework http://pandora/Departments/Quality-Team/DOCUMENTS%20TEAM/Policies/Appendix%2012.%20never-evnts-pol-framwrk.pdf

incident reporting and investigation policy · 2018-11-19 · incident/near miss reporting and...

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