Policy for the Management of Adverse Incidents and Near
Misses
Version
3
Name of responsible (ratifying) committee
Serious Incident Review Group
Date ratified
28 January 2014
Document Manager (job title)
Head of Risk Management
Date issued
07th February 2014
Review date
January 2016 (unless requirements change)
Electronic location
Management Policies
Related Procedural Documents
Risk Management Strategy
Management
of
Serious
Incidents
Requiring
Investigation
Investigation of Incidents, Complaints and Claims.
Management of Complaints, Concerns, Comments and
Plaudits
Being Open Policy
Management of Claims, Clinical Negligence Liabilities
to Third Parties and Property Expenses Scheme
Disclosure of Information to the Police Policy
How to Report an Adverse Incident
Key Words (to aid with searching)
Incident; Serious Incident; Adverse Incident
In the case of hard copies of this policy the content can only be assured to be accurate on the date of issue marked on the
document.
For assurance that the most up to date policy is being used, staff should refer to the version held on the intranet
Version
Date Ratified
3
Jan 14
Brief Summary of Changes

Alignment to NRLS definitions

Inclusion of Duty of Candour requirements

Addition of screening incidents

Update to responsibilities

Changes to monitoring

Removal of Guidance on Grading Incidents replaced
by NRLS definitions
Adverse Incident and Near Misses
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(Review date: January 2016 unless requirements change)
Author
A Green
Page 1 of 23
CONTENTS
QUICK REFERENCE GUIDE ............................................................................................................. 3
1.
INTRODUCTION.......................................................................................................................... 4
2.
PURPOSE ................................................................................................................................... 4
3.
SCOPE ........................................................................................................................................ 4
4.
DEFINITIONS .............................................................................................................................. 4
5.
DUTIES AND RESPONSIBILITIES .............................................................................................. 5
6.
PROCESS ................................................................................................................................... 6
7
TRAINING REQUIREMENTS ...................................................................................................... 9
8
REFERENCES AND ASSOCIATED DOCUMENTATION .......................................................... 10
9
EQUALITY IMPACT STATEMENT ............................................................................................ 10
10 MONITORING COMPLIANCE - As a minimum, the following elements will be monitored.......... 11
Appendix A: Reportable incidents ..................................................................................................... 12
Appendix B: Guidance on grading incidents ...................................................................................... 14
Appendix C: How to Report an Adverse Incident .............................................................................. 15
Appendix D: Reporting to External Agencies..................................................................................... 20
Appendix E: Informing external agencies: when, why and by whom ................................................. 21
Appendix F: VTE Reporting and Investigation Process ..................................................................... 22
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QUICK REFERENCE GUIDE
For quick reference the guide below is a summary of actions required. This does not negate the need
those involved in the process to be aware of and follow the detail of this policy.
PROCESS FOR THE REPORTING AND MANAGEMENT OF AN ADVERSE
INCIDENT
INCIDENT OCCURS
1. Address the immediate health needs of the person(s) involved
2. Grade the incident (ref: NRLS guidance in Appendix B)–
Red(Severe/Death)/Amber(Moderate)/Yellow(Low)/Green/Near miss(No Harm) NB:
incident may be re-graded following review by your Manager or the Risk Management
Department, following further investigation
3. Report the incident onto DatixWeb using the on-line electronic adverse incident
reporting form (guidance in Appendix C)
4. Consider the level of required communication with the patient
5. Any VTE Incident follow the process at appendix F
Severe/Death
Moderate
Low
No Harm
No Harm
RED (including ‘Never Events’)
AMBER
YELLOW
GREEN
NR MISS
Must
be
reported
immediately, will require
an initial investigation
panel
arranged
and
managed in accordance
with the Trust Policy on
the
Management
of
Serious
Incidents
Requiring Investigation
Issues reported to /
monitored via:
 CSC Governance
Teams
 Serious Incident Review
Group
 Pressure Ulcer Review
Group
 Governance & Quality
Committee
 Trust Board
 CSC Performance
Reviews
 CCGs
 PSSG
 Complete an on-line electronic
adverse incident form
 Inform appropriate senior member of
staff
 Risk Advisors will be automatically
alerted to the incident and notified
via email
 Line Managers will be automatically
alerted to the incident and notified
via email
 Senior member of staff to ensure
appropriate type, level and
ownership of investigation (to be
investigated by CSC in which
incident occurred) is completed and
risk management advised of the
outcome of the investigation.
 The incident must then be closed on
DatixWeb
 Complete an on-line electronic
adverse incident form
 Inform appropriate senior member of
staff
 Senior member of staff must review
the incident within 5 days, complete
details of any long-term action and
close the incident on DatixWeb
within a further 5 days
Issues reported to / monitored
via:
 CSC Governance Committees/CSC
SIRG
 Governance & Quality Committee
as part of CSC reporting
Issues reported to / monitored
via:
 CSC Governance
Committees/CSC SIRG
 Patient Safety Working Group
 Governance & Quality Committee
as part of CSC reporting
 VTE weekly panel
It is essential that staff receive feedback via their line management route, on
reported incidents and actions taken.
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1. INTRODUCTION
In a service as large and complex as the NHS, things will sometimes go wrong. When they do,
the response should not be one of blame and retribution, but of learning and a drive to reduce
risk for future patients, visitors and staff. Therefore, the Trust is committed to developing a just
culture and to encouraging a willingness to admit mistakes without fear of punitive measures. In
support of this, the Trust accepts that completion of an incident form does not constitute an
admission of liability and will not result in automatic disciplinary action. There are occasions, of
course, when it may be necessary to take action against individuals which will be governed by
appropriate HR policies: acts of maliciousness or criminal or gross/repeated professional
misconduct.
The policy has been formulated in response to the Department of Health publications An
Organisation with Memory, Building a Safer NHS, Doing Less Harm and the National Patient
Safety Agency publications Building a memory: preventing harm, reducing risks and improving
patient safety, Seven Steps to Patient Safety and Being Open: Communicating Patient Safety
Incidents with Patients and their Carers. The policy is also designed to ensure compliance with
the requirements of external agencies. However, the ultimate aim is to reduce the risk of harm
to patients, staff and other users of Trust premises through improving the safety and quality of
services and the environment.
2. PURPOSE
This policy sets out the processes for the appropriate identification and reporting of adverse
incidents and near misses.
3. SCOPE
This policy applies to all permanent, locum, agency, bank and voluntary staff of Portsmouth
Hospitals NHS Trust, the MDHU (Portsmouth) and Carillion, whilst acknowledging that for staff
other than those directly employed by the Trust the appropriate line management or chain of
command will be taken into account
‘In the event of an infection outbreak, flu pandemic or major incident, the Trust recognises
that it may not be possible to adhere to all aspects of this document. In such circumstances,
staff should take advice from their manager and all possible action must be taken to
maintain ongoing patient and staff safety’
4. DEFINITIONS
Adverse incident: an event or omission relating to a patient, visitor or staff member or any
event or circumstances arising during NHS care that could have or did lead to unintended or
unexpected harm, loss or damage. See Appendix A for more information on incidents that
should be reported.
Patient safety incident: any unintended or unexpected incident which could have, or did, lead
to harm for one or more patients receiving NHS-funded healthcare.
Serious incident requiring investigation (SIRI): (commonly classified as a ‘red’ incident)
an incident that occurred during NHS funded healthcare (including in the community) which
resulted in one or more of the following:



unexpected or avoidable death or severe harm of one or more patients, staff or
members of the public
a ‘never event’ – all never events are defined as a SIRI although not all necessarily
result in severe harm or death.
a scenario that prevents, or threatens to prevent, an organisation’s ability to continue to
deliver healthcare services, including data loss, property damage or incidents in
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

population programmes like screening and immunization where harm potentially may
extend to a large population
allegations or incidents of physical abuse and sexual assault or abuse
loss of confidence in the service, adverse media coverage or public concern about
healthcare or an organisation
If in doubt, it is better to report an incident as a potential SIRI, as this can then be confirmed by
the Clinical Service Centre (CSC) or at the Initial Investigation Panel meeting. All grade 3 and 4
pressure ulcers, death attributable to either C Diff or MRSA (part 1 of death certificate), death
or major harm attributable to VTE ,and ‘Never Events’ – as defined by the Department of Health
(Appendix A) – must be reported as SIRIs
Never Event: a largely preventable patient safety incident that should not occur if the available
preventative measures have been implemented
Near miss: a situation in which an event or omission, or a sequence of events or omissions,
arising during clinical care fails to develop further, whether or not as a result of compensating
action, thus preventing injury to a patient
Harm: an injury (physical or psychological), disease, suffering, disability or death to patients,
staff or members of the public. In most instances, harm can be considered to be unexpected if
it is not related to the natural course of the patient’s illness, treatment or underlying condition.
Root Cause Analysis: A well recognised way of investigating incidents, claims and complaints,
which offers a framework identifying what, how and why the event happened. Analysis can then
be used to identify areas of change, develop recommendations and look for new solutions.
DatixWeb: A Patient Safety & Risk Management System that provides a comprehensive
picture of our organisation’s risks by collating information from incidents affecting patients, staff
& visitors
5. DUTIES AND RESPONSIBILITIES
Deputy Director of Nursing/Head of Patient Safety
The Deputy Director of Nursing/Head of Patient Safety, has responsibility for ensuring the
strategic implementation of this policy.
The Head of Risk Management
The Head of Risk Management has responsibility for the operational and day-to- day
implementation of this policy.
Risk Management Team
The Risk Advisors are responsible for supporting and advising staff at all levels across the
Trust, to ensure that this policy is implemented across the Trust and for ensuring external
agencies (Appendices D and E) are informed, if required.
Risk Analyst
The Risk Analyst has responsibility for ensuring that the database of incidents is maintained,
providing reports for CSCs and Trust Board.
Clinical Service Centre (CSC) Governance Leads
The Governance Leads are responsible for ensuring that all adverse incidents and near misses
are reported and managed in line with this policy and are discussed at CSC Governance
Committees or CSC SIRG and shared with staff.
All Managers
Managers are responsible for ensuring their staff are released for training, are fully assisted
and supported throughout the reporting and handling of an adverse incident or near miss and
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receive feedback on the outcome of any investigation. Where staff experience particular
difficulties associated with an adverse incident or near miss, managers should consider
referring the staff member or members to the Occupational Health Department or the AQUILIS
counseling service, in accordance with the Human Resources Policy for Supporting Staff
The Reporter of any incident must:
 Ensure the immediate safety of those directly affected by the adverse event or near
miss
 Complete an on-line electronic adverse incident form
 Immediately inform the appropriate senior member of staff/line manager
6. PROCESS
6.1
Near Misses (No harm to patient, impact prevented)
The reporter must:
 Ensure the immediate safety of those directly affected by the incident
 Complete an on-line electronic adverse incident form
 Inform the appropriate senior member of staff / line manager
The senior member of staff must:
 Review the incident within 5 days, and confirm the grading.
 Complete details of any long-term actions necessary, on the electronic form and
close the incident on DatixWeb within a further 5 days
 Ensure feedback is provided to the reporter
Note: consideration should be given to the potential severity of the near miss had it actually
impacted upon a patient, staff member or visitor and the appropriate level of investigation
pursued.
6.2 Incidents graded Green (No harm to patient, impact not prevented) or Yellow (Low
harm)
The reporter must:
 Ensure the immediate safety of those directly affected by the incident
 Complete an on-line electronic adverse incident form
 Inform the appropriate senior member of staff / line manager
The senior member of staff must:
 Review the incident within 5 days and confirm the grading
 Complete details of any long-term actions necessary, on the electronic form and
close the incident on DatixWeb within a further 5 days
 Ensure feedback is provided to the reporter
6.3 Incidents graded Amber (Moderate harm)
The reporter must:
 Ensure the immediate safety of those directly affected by the incident
 Complete an on-line electronic adverse incident form
 Inform the appropriate senior member of staff/line manager
 Risk Advisors and Line Managers will be automatically notified of the incident via
email
The senior member of staff must:
 Review the incident within 5 days and confirm the grading;
 Ensure an amber investigation is instigated, in conjunction with the CSC
Governance Lead/Head of Nursing;
 As part of the ‘Amber’ investigation process, complete a Root Cause Analysis
(RCA), make certain a member of staff is identified to communicate with the
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

patient or relatives and ensure compliance with Duty of Candour requirements.
Further guidance is available in the Trust’s Being Open Policy
Ensure feedback on decision to investigate is given to reporter;
Inform Risk Management of the outcome of the investigation and close the incident
on DatixWeb
6.4 Incidents graded Red (severe/permanent harm or death)
Incidents graded red should be managed in accordance with the Trust Policy for the
Management of Serious Incidents. But briefly
Within office hours (08:30 – 17:00)
The witness to the SIRI will:
 Ensure the immediate safety of those directly affected by the SIRI;
 Complete an on-line electronic adverse incident form; and
 Immediately inform the appropriate senior member of staff/line manager
 Risk Advisors, Line Managers and relevant specialist members of staff (eg
Risk Management Pharmacist) will be automatically notified of the incident via
email
The senior member of staff will:
 Inform the CSC Management Team;
 Inform the patient’s consultant;
 Determine who will speak to the patient or relatives and ensure compliance
with Duty of Candour requirements see Being Open Policy
 Preserve the scene of the incident, if necessary e.g. retention of equipment;
 Request statements; and
 Ensure the appropriate support is provided to staff
 Inform the on-call Supervisor of Midwives if applicable
Out of hours (With the exception of pressure ulcers and VTEs)
The senior member of staff will inform:
 Hospital duty manager (for clinical incidents only)
 On-call consultant
 On-call duty Director
 On-call duty Director to inform CCG/Comms Team (if necessary; depending on
type/severity/scale of SIRI) e.g. an incident potentially causing high media
interest or disruption to service provision
 Inform the on-call Supervisor of Midwives if applicable
 Determine who will speak to the patient or relatives and ensure compliance with
Duty of Candour requirements see Being Open Policy
All confirmed SIRIs must be subject to a panel, investigated using full RCA and be signed
off through the Serious Incident Review Group (SIRG) see SIRI Policy
6.5 Guidance on grading can be found at Appendix B. Advice can also be sought from the
Risk Management Department
6.6
All incidents must be documented in the patient’s health records, including a note of the
incident number
6.7
Safeguarding
6.7.1 If a concern is regarding the welfare of an adult patient and a suspected
safeguarding incident, staff should refer to the Adult Safeguarding policy,
complete the reporting form and contact the Safeguarding Adults Office
6.7.2 If a concern is regarding the welfare of a child, and a suspected safeguarding
incident, staff should refer to the Child Safeguarding policy, complete the reporting
form and contact the named nurse or midwife for safeguarding children.
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6.8 Screening Incidents
Incidents relating to national screening programmes must be discussed with the Regional
Quality Assurance Director in line with local and national guidelines and escalated to
Commissioners as appropriate.
PHT currently participates in the following national screening programmes:

Breast Cancer

Bowel Cancer

Cervical Cancer

Diabetic retinopathy (managed by Care UK)

Newborn screening
6.9 The Investigation
Adverse incidents and near misses are subject to an appropriate level of investigation and
root cause analysis and where relevant an improvement strategy prepared. Not all events
need to be investigated to the same extent or depth and the investigation and analysis
should be relative to the seriousness, complexity of the event and/or whether it resulted in
actual harm and the potential for learning, such as those which are high frequency but
may be of low severity. Further detail can be found in the Trust Policy for the Investigation
of Incidents, Complaints and Claims.
Red Incidents (Severe harm or Death)
Any red or potential red incident will be subject to an initial investigation panel. Once
confirmed the incident must be managed as set out in the Trust Policy on the
Management of Serious Incidents Requiring Investigation, this includes full RCA
investigation, sign off at SIRG and is subject to external reporting requirements. Duty of
Candour requirements must be followed to ensure the patient/family are fully aware of the
event and subsequent investigation
Amber Incidents (Moderate harm)
Investigations into amber incidents will be carried out by only one or two key staff, e.g.
local manager and clinician with advice from the Risk Management Department, if
required. Whilst these investigations may require less input than investigations into red
incidents it is essential to establish the root cause(s), lessons to be learned and to comply
with the Duty of Candour requirements.
All incidents in this category will be subject to review and monitoring by the relevant CSC
Governance Committees, to ensure learning and the implementation of any required
changes in practice.
Yellow (Low harm) / Green (No harm, impact not prevented) / Near Miss (No harm,
impact prevented) Incidents:
It is the responsibility of the CSC Management Team to ensure that all incidents in this
category are investigated with the appropriate thoroughness and subject to aggregated
review and monitoring by the relevant CSC Governance Committees, to ensure learning
and the implementation of any required changes in practice. They are unlikely to warrant
individual investigation, but root cause analysis of trends should be undertaken, perhaps
as part of a working group, and a preventative risk management strategy established to
prevent recurrence.
6.10 Central recording of adverse incidents and near misses
All adverse incidents and near misses and the outcome of any investigations are
automatically inputted onto the electronic database (DatixWeb) which is maintained within
the Risk Management Department, to support analysis and feedback, identification of key
themes and organisational learning.
6.11 Organisational Learning
No adverse event policy will be effective unless there is organisational learning and
feedback on the lessons learned and any required changes in practice implemented. The
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Trust has introduced a number of processes to enable learning and feedback, which
include:
Internal








A systematic approach to the recording and trending of incidents through the use
of an electronic reporting system and database;
Monthly Quality Exception reports to the Trust Board;
Monthly Business Intelligence reports to the Trust Board;
Quarterly Quality Report to the Trust Board and Governance and Quality
committee. The report provides an aggregated view of issues concerning patient
safety, patient experience and clinical effectiveness
Presentation of quarterly information to the Patient Safety Steering Group;
Production of reports specifically tailored to the needs of various groups e.g.
pressure ulcer review group, falls group;
Monitoring of incidents at the monthly CSC Governance Committees; and
A Risk Management intranet site that can be accessed by all staff and that holds
all relevant documents and reports, including: incident reports; legal updates
from solicitors; NRLS updates.
External






Reporting of all patient safety incidents to the National Reporting and Learning
System (NRLS). The reports produced by the NRLS, are then used for both
benchmarking and learning across the Trust;
Reporting of all patients safety incidents to the Care Quality Commission, via the
NRLS;
Reporting onto STEIS
Receipt by the Commissioners of the quarterly Quality Report and the monthly
Quality Exception and Business Intelligence reports, used to inform the
Commissioner’s targets for the Trust;
A monthly meeting with the Commissioners at which various aspects of incidents
are discussed, to provide assurance on organisational learning;
Reporting of any relevant incident to external agencies, as required (Appendix E)
6.12 Staff are also able to raise concerns in line with the Trust’s Whistleblowing Policy. This
policy enables staff to raise concerns about wrongdoing at work in a way which protects
their interests, and which ensures at the same time, that instances of wrongdoing, alleged
wrongdoing or apparent wrongdoing are properly investigated and dealt with. The policy
is designed to:




Provide a way for members of staff concerned about the care or safety of
patients to speak out in the event of other procedures failing or being exhausted.
Provide an effective and confidential process to enable staff to challenge
practices or behaviours if they believe others are acting in an unlawful and/or
unethical way
Ensure victimisation or retribution against staff will not be tolerated
Protect staff if they speak out appropriately
7 TRAINING REQUIREMENTS
7.1 Training forms part of the Trust’s Essential Skills and Training Requirements; as identified in
the Training Needs Analysis. It is included in mandatory Corporate Induction and in
Essential Updates
7.2 Staff undertake Essential Update refresher training via the Electronic Staff Record (ESR)
system every two years
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7.3 All training is recorded on the ESR from which the Learning and Development Team provide
a monthly heat map to each CSC, to enable monitoring of compliance
7.4 Compliance is further monitored through the CSC performance reviews with the Executive
Team
8 REFERENCES AND ASSOCIATED DOCUMENTATION
External
 National Patient Safety Agency, July 2005. Building a Memory: preventing harm,
reducing risks and improving patient safety www.npsa.nhs.uk
 National Health Service Litigation Authority, April 2011, Risk Management Standards
www.nhsla.com
 National Health Service Litigation Authority, April 2010, Clinical Negligence Scheme
for Trusts - Clinical Risk Management Standards – Maternity www.nhsla.com
 Hampshire County Council Protecting People from Abuse guide
Internal
 Management of Serious Incidents Requiring Investigation
 Investigation of Incidents, Complaints and Claims.
 Management of Complaints, Concerns, Comments and Plaudits
 Management of Claims Clinical Negligence Liabilities to Third Parties and Property
Expenses Scheme
 Being Open Policy
 Risk Management Strategy
 Maternity Risk Management Strategy
 Trust Policy and Protocol on Whistleblowing Policy
 Health & Safety Policy
 Disclosure of Information to the Police
9 EQUALITY IMPACT STATEMENT
Portsmouth Hospitals NHS 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 assessed accordingly
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10 MONITORING COMPLIANCE - As a minimum, the following elements will be monitored
Minimum requirement
to be monitored
Lead
Tool
Frequency of Report
of Compliance
95% of incidents/ near
misses are reported in
accordance
with
this
policy
Internal Audit
Audit of random
selection of 50
DatixWeb reports
Annually
95% of relevant incidents
will
be
appropriately
reported
to
external
agencies
Head of Risk
Management
Audit of random
selection of 20
SIRIs
Annually
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Reporting arrangements
Policy audit report to:

Head of Risk Management
Patient Safety Steering Group
Policy audit report to:

Lead(s) for acting on
recommendations
Head of Risk Management
Patient Safety Steering Group
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Appendix A: Reportable incidents
Reportable Incidents
Whilst it is not possible to cover every eventuality, the following incidents must always be reported:
some of which will be considered to be Serious Incidents Requiring Investigation (SIRIs) and
investigated in accordance with that policy.
For ease of reference the incidents have been loosely grouped into: clinical care; information
governance; accident/damage/theft/loss; other; and never events
Clinical Care
 Absence of consent form / incomplete consent form
 Unmarked / incorrectly marked surgical site
 Inappropriate surgery performed
 Unexpected outcomes
 Unexpected death
 Any major clinical incident e.g. failure to diagnose a serious illness
 Medication incidents
 Patient slips/trips/falls
 Pressure ulcers
 Unexpected patient moves (more than 4 moves)
 Any incident involving multiple patients e.g. cervical screening incidents
 Absconding patient
 Suicide / serious self-harm
 Incidents relating to radiology regulations (IRMER)
 Death related to Clostridium Difficile (C Diff)
 Death related to Methicillin Resistant Staphylococcus Aureus (MRSA)
 VTE/PE
Information Governance
 Breach of confidentiality
 Loss of person identifiable data
 Incidents relating to health records, including unavailability
 Breach of security
Accidents / Damage / Theft / Loss
 Involving any person on Trust premises
 Incidents involving any vehicle on Trust premises
 Theft of property: Trust, staff or patient
 Loss of property: Trust, staff or patient
 Damage to Trust property: premises; fixtures; equipment etc
 Injury or ill-health suffered as a result of handling patients or inanimate object
 Contact with bodily fluids – needlesticks
 Contact with harmful chemicals or spillages
 Fire: actual or false alarm
Other
 Expression or act of violence or aggression
 “Rogue” staff
 Procedure or protocol related incidents, including failure to follow
Never Events (as defined by the DoH)
 Wrong site surgery
 Wrong implant/prosthesis
 Retained foreign object post-operation
 Wrongly prepared high-risk injectable medication leading to death or severe harm
 Maladministration of potassium-containing solutions leading to death or severe harm
 Wrong route administration of chemotherapy
 Wrong route administration of oral/enteral treatment leading to death or severe harm
 Intravenous administration of epidural medication leading to death or severe harm
 Maladministration of insulin leading to death or severe harm
 Overdose of midazolam during conscious sedation leading to death or severe harm
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












Opioid overdose of an opioid-naïve patient leading to death or severe harm
Inappropriate administration of daily oral methotrexate
Fall from unrestricted windows leading to death or severe harm
Entrapment in bedrails leading to death or severe harm
Transfusion of ABO-incompatible blood components leading to death or severe harm
Transplantation of ABO or HLA-incompatible organs leading to death or severe harm
Misplaced naso or oro-gastric tube leading to death or severe harm
Wrong gas administered leading to death or severe harm
Failure to monitor and respond to oxygen saturation in patient undergoing general/ regional
anaesthesia or conscious sedation and leading to death or severe harm
Introduction of intravascular air embolism leading to death or severe harm
Misidentification of patients as a result of failure to use standard identification processes and
leading to death or severe harm
Severe scalding of patients as a result of water used for washing/bathing and leading to death
or severe harm
Maternal death due to post-partum haemorrhage after elective C-section
If in doubt, it is always better to report than not, but advice can be obtained from your line manager or
the Risk Management Department
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Appendix B: Guidance on grading incidents
NRLS Definitions of Levels of Harm
No Harm (Near Miss):
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
No Harm (Green):
Impact not prevented – any patient safety that ran to completion but no harm occurred to people
receiving NHS-funded care.
Low (Yellow):
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 Harm (Amber):
Any patient safety incident that resulted in a moderate increase in treatment and which caused
significant but not permanent harm, to one or more persons receiving NHS-funded care
Severe (Red):
Any patient safety incident that appears to have resulted in permanent harm to one or more persons
receiving NHS-funded care
Death (Red):
Any patient safety incident that directly resulted in the death of one or more persons receiving NHSfunded care.
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Appendix C: How to Report an Adverse Incident
HOW TO REPORT
AN ADVERSE
INCIDENT
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DatixWeb for Incidents
Contents
1. Introduction
2. Accessing the Adverse Incident Reporting Form
3. Adding a new Adverse Incident
4. Additional Fields
5. Submitting the Adverse Incident Reporting Form
Any questions associated with this document or any DATIX related questions should
be addressed to:
Risk Analyst
Portsmouth Hospitals Trust
Room 0.23
De La Court House
Queen Alexandra Hospital
Cosham
Hants
02392 286000 x 3477
1. Introduction
DID YOU KNOW THAT …
All accidents, adverse incidents and near misses must be reported, even if they
appear to be minor
Serious adverse incidents (SIRIs)(RED) must be immediately reported to your line manager or duty
manager and the risk department by telephone.
Once you have been trained, you MUST use DATIX (our electronic report form) to report all adverse
events and near misses
1.1.
What is DATIX?
A Patient Safety & Risk Management System
Used by more than 75% of NHS organisations as well as private health care providers.
Provides a comprehensive picture of our organisation’s risks by collating
information from incidents affecting patients, staff & visitors
1.2. Things to REMEMBER
A question mark
on the form means that there is some helpful information
available which can be revealed by the clicking the button
A red star
denotes mandatory fields
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A down arrow
indicates that there are options available from the drop down box
If in any doubt when completing the form then refer to your line manager or direct any queries to the
risk management team.
Q. Are you uncertain whether to report an adverse incident?
A. If in doubt, report it!
2.
Accessing the Adverse Incident Report Form
Click on the button on the PHT intranet Home Page as shown below.
3. Adding a New Adverse Incident
The DIF1 form is available to all staff that have a PHT login. No user names or passwords are
required to access the DIF1 form.
The form is split into sections, each section focusing on a different aspect
of the adverse event being reported i.e.
Summary of incident
Additional information
Person reporting the incident
The first section of the form gives users some additional information to aid completion and answer
any initial questions they may have.
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REMEMBER:
Once an Adverse Event Form has been started it must be completed – if you close the form prior to
submitting, the information will not be retained and you will have to start again.
3.1. Summary of Incident
This section lets the reviewer know details of the incident and where it took place and who was
involved. A ‘question mark’ on the form means there is some helpful information available which can
be revealed by clicking the button and a red asterix indicates a mandatory field. Other fields might
open dependant on choice entered into previous fields.
3.2. Additional Information
Clicking on the drop down boxes reveals the ‘pick lists’ for reporters to choose from, this will then
open up extra sections to gather more detailed information.
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3.2.1
Was anyone one else involved in this incident?
Enter the details of anybody else involved, as with the above question, extra fields will open
dependant on the options selected. You can add additional names by clicking on the ‘Add
another‘ button.
3.2.2
What Category of incident is this?
Select from the dropdown box an option which fits the incident; this will open up additional
sections for further detailed information gathering.
3.2.3
Does this incident involve safeguarding?
If answering yes, a new field will open asking which team needs to be notified. A pop up will
give you the opportunity to open a safeguarding form to fill out on-line. You can save this form
to your own profile on the network and send to the team via e-mail.0
3.2.4
Tick the box it there are any documents to attach to this incident.
This will open up another section where you can browse and locate files to add to the incident
form. Additional or supporting documents relating to the incident will need to be scanned and
saved to the PC before they can be attached to the incident.
3.3.
Details of Person Reporting the Incident.
This is about you the reporter, fill in the relevant details. Populate ‘your e-mail address’ with
your PHT email address and you will get an acknowledgement from the Datix system once
your form has been submitted.
Once you are happy that all the information has been entered, click on the submit button
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Appendix D: Reporting to External Agencies
INCIDENT THAT MAY REQUIRE EXTERNAL REPORTING INCLUDING THOSE RELATING
TO A SUSPICION OF CRIME/ARRESTABLE/SERIOUS OFFENCE
IMMEDIATELY
REPORT THE INCIDENT/ISSUE TO
YOUR LINE MANAGER / SENIOR
PERSON IN THE DEPARTMENT /
WARD
Record that you
have reported it / to
whom
/
when.
Complete
on-line
electronic adverse
incident form
LINE MANAGER / SENIOR
PERSON ESCALATES
INFORMATION
Line manager / senior
to record to whom
escalated / when
CLINICAL SERVICE CENTRE MANAGEMENT TEAM
HOSPITAL DUTY MANAGER
DUTY EXECUTIVE
RISK MANAGEMENT DEPARTMENT ext 3475/6
Any of the above will be able provide further advice on who
needs to be notified
OTHER AGENCIES
POLICE
If there is a suspicion that a
crime or arrestable offence may
have been committed or you
have been requested by the
person affected to call the police
on their behalf
(Details of what constitutes a crime or
arrestable offence can be found in the
‘Disclosure of Information to the Police
Policy’ 2013 which can be found on the Trust
intranet under: policies and guidelines→
management
polices→
Disclosure
of
Information to the Police 2013)
These include but are not limited to:









Care Quality Commission
Coroner
Counter-fraud Agency
Disclosure and Baring Service
Environment Agency
Environmental Health Agency
Health and Safety Executive
Information Commissioner
Medicines and Healthcare Products
Regulatory Agency (MHRA)
 Professional Regulatory Bodies.
 Strategic Health Authority
IF IN ANY DOUBT PLEASE
TAKE ADVICE – DON’T
IGNORE ANY POTENTIALLY
REPORTABLE ISSUE
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Appendix E: Informing external agencies: when, why and by whom
The following are examples of the external agencies that may need to be informed in the event of an
adverse incident.
If you need any advice in this regard please do not hesitate to contact the Risk Management
Department
Agency
Circumstances
Reporter
Care Quality
Commission
Counter-fraud
Agency
SIRIs related to breach of radiology
regulations e.g. IRMER
Actual or suspected fraud
Environment Agency
Major contamination of the environment
Environmental Health
Agency
SIRI involving food poisoning originating in,
or being transferred through the Trust
Health and Safety
Executive
The Reporting of Injuries, Diseases and
Dangerous Occurrences Regulations 1995
(RIDDOR), place a legal duty on employers
to report work-related deaths[1], major
injuries[2] or over-three-day injuries[3], work
related diseases[4], and dangerous
occurrences (near miss accidents)[5].
When the Trust
1. Dismisses or withdraws permission for
an individual to engage in a regulated
or controlled activity, or would have
done so had that individual not
resigned, retired, been made redundant
or been transferred to a position which
is not a regulated or controlled activity
because
2. they think that the individual has:
 engaged in relevant conduct
 satisfied the Harm Test; or
 received a caution or conviction for a
relevant offence
All level 3 information governance SIRIs
Health and Safety Manager
Suspected safety problems with medicines,
medical devices, blood and blood
components.
Member of staff who discovers the
problem– guidance available on
Pharmacy intranet web site
Death or injury where it is considered there
are unusual or suspicious circumstances
Theft of / malicious damage to, Trust
property
Violent or aggressive incidents where it is
considered police involvement is required
Arson
Where there are concerns about the
practice of a healthcare professional.
Medical Director / Director of Nursing
Disclosure and
Baring Service
Information
Commissioner
Medicines and
Healthcare Products
Regulatory Agency
(MHRA)
Police
Professional
Regulatory Bodies.
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Radiation Protection Adviser
Deputy Director of Nursing/Head of
Patient Safety/Executive
Director of Finance/CSC
Management Team
Director of Human Resources and
Workforce
Head of Hotel Services – Carillion
Deputy Director of Nursing/Head of
Patient Safety
CSC Management Team / Head of
Human Resources
Information Governance Manager
Security Manager / Duty Director
Medical Director / Director of Nursing
/ Senior Manager
Deputy Director of Estates
Medical Director / Director of Nursing
of specific professional lead,
depending on healthcare professional
involved.
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Appendix F: VTE Reporting and Investigation Process
VTE Reporting and Investigation
Confirmed DVT or PE diagnosis
Department / ward complete
DATIX form
VTE Admin Support identify
PE’s from PACS reports – if
not already on DATIX
complete form
VTE Admin Support made
aware of DVT’s by Vascular
Lab – if not already on DATIX
complete form
Department / ward complete
DATIX form
Incident
closed/rejected and
logged as
COMMUNITY
NO
Risk / VTE Admin Support review
– Relevant hospital attendance
within 90 days?
No further PHT
investigation
YES
VTE Admin Support email CSC Management Team
- to inform of event, request IMR, give details of panel date / time
of attendance
CSC arranges for completion of
Initial Management Report (IMR ) and CSC
representative to attend VTE panel
IMR must include:
IMR completed and sent to VTE in-box
in time for scheduled Weekly VTE panel
VTE@porthosp.nhs.uk
•
•
•
CSC present IMR at Weekly
VTE Panel
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•
If patient had been an inpatient, had surgery
or attended ED with POP application within
previous 90 days.
If patient risk assessed and assessment
documented on admission to hospital.
If any thrombosis risk factor is identified, that
thromboprophylaxis (mechanical or chemical)
was prescribed in accordance with NICE
guidelines
Whether any prescribed prophylaxis was
delayed or omitted
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VTE Panel and ongoing Process
CSC representative presents IMR
at weekly VTE panel meeting
VTE panel grade incident
GREEN
Appropriate assessment
and prophylaxis followed
RED
AMBER
PHT/NICE assessment and
prophylaxis guidelines not
followed and
PHT/NICE assessment and
prophylaxis guidelines not
followed but no
DEATH OR MAJOR HARM
DEATH OR MAJOR HARM
SIRI process instigated
and reported to CCG
by Risk Dept
Investigator appointed to
complete RCA. Submit to
VTE@porthosp.nhs.uk
within 28 days
UNAVOIDABLE
Investigator appointed to
complete RCA. Submit to
VTE@porthosp.nhs.uk
within 28 days
CSC rep presents completed reports to
VTE Incident Review Group for sign off
Definition of MAJOR HARM:
Patient requiring Thrombolysis
DCCQ admission
Resuscitation
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Learning fed back to CSC / Trust wide
via Governance structure
CSC presents feedback of action plan
outcome to Thrombosis Committee
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