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Definitions
The definition of a SI in this context extends beyond those which impact directly on
patients. The NPSA has suggested the following definition which we would wish to adopt
in NHS Wales:
A SI requiring investigation is defined as an incident that occurred in relation to NHS
funded services and care resulting in:
permanent harm to one or more patients, staff, visitors or members of the public or
where the outcome requires life-saving intervention or major surgical/medical
intervention or will shorten life expectancy (this includes incidents graded under the
NPSA definition of severe harm);
adverse media coverage or public concern for the organisation or the wider NHS;
basis.
For
Complete a revised SI notification form (form 1) for the reporting of all serious
incidents (attached at appendix 1) or complete form 2 for the reporting of no
surprises (attached at appendix 2). Please note the forms are protected so that the
title of the form and the text prompt boxes can not be altered. The field boxes in
bold that are completely grey are for Welsh Assembly Government use only;
Ensure that each notification form is signed off by the CEO or an Executive
Director. An electronic signature should be attached to the form.
Please note: Notification forms will be sent back to the organisation if there is no
executive sign off or if it is not password protected.
Within 24 hours of receipt, the Assembly Government will respond to the notification by
returning an electronic copy of the SI form which will confirm:
The initial grading of the incident which will indicate the timescale of investigation
(as defined below); and,
The Assembly Government reference number, which will be the number used in all
future correspondence relating to the incident.
For incidents that potentially may attract national or significant media attention, please
immediately contact a member of the Improving Patient Safety Team (IPST), who will
liaise with the Assembly Government Press Office. Appendix 3 indicates the contacts
2
detail of Assembly Government officials within the IPST for your organisations. Direct
contact should only be made with the Assembly Government Press Office out of usual
working hours. The out-of-hours press office number is 029 2089 8099 and the answer
phone will give the contact number of the duty press officer.
Grading of Incidents
The initial grading of a SI is undertaken on a case by case basis and will clarify the level of
investigation required and monitoring approach by the Assembly Government. All
incidents submitted to the Assembly Government are reviewed on a weekly basis. If
during these review meetings it is decided that the initial grading is inappropriate, it will be
revised and you will be informed of this change, plus any further action or information that
we may require.
Should an organisation wish to discuss the grading assigned to an incident they should
contact the relevant Assembly Government official (as shown on appendix 3). A table
summarising the grading, expected response and timescales is attached at appendix 4.
This has been adapted to suit the Wales context from the NPSA National Framework for
Reporting and Learning from Serious Incidents Requiring Investigation.
It is expected that the level of investigation is consistent with the triggers and levels of
RCA investigation published by NPSA (see appendix 5).
Definitions of grading
Grade 0
Concerns currently and commonly referred to as a no surprise and/or where it is initially
unclear whether a serious incident has occurred will be graded 0. Unless further
information is received, Assembly Government will automatically close the incident after 3
days and no further correspondence with the Assembly Government is required. However
organisations will wish to assure themselves of a proportionate and appropriate response
and ensure arrangements are in place to reduce the risk of re-occurrence.
If following initial notification it becomes clear that the issue is an SI then further
information should be sent to the Assembly Government and the grading will be reviewed.
Grade 1
It is expected that a comprehensive investigation (RCA level 2 investigation) will need to
be completed by the organisation within 2 calendar months. In order to close this
incident we will require confirmation that an appropriate SI investigation has been
undertaken; has been reported to an appropriate committee; an action plan developed and
where relevant has identified any actions for wider learning and dissemination. A
closure/update report form should be completed for this purpose as attached at appendix
6. This should also be sent to improvingpatientsafety@wales.gsi.gov.uk. The report will
be reviewed by the relevant Assembly Government officials. They will confirm that they
are content will all actions undertaken and close the incident or seek further
information/action before confirming closure.
If an incident investigation cannot be completed within the timescale agreed the
organisation should complete the closure/update form as far as is possible and seek an
extension to the timescale.
Grade 2
This will follow a similar process to the above. A comprehensive investigation is required,
and in some cases the incident may be referred for independent external review by HIW or
3
other regulatory bodies etc. Grade 2 incidents will be subject to ongoing monitoring by
Assembly Government and final agreement through its Patient Safety Committee that the
incident has been investigated appropriately and thoroughly before closure.
Examples of such incidents could include mental health homicides, maternal deaths,
clusters of similar incidents and never events.
Appendix 1
FORM 1
NOTIFICATION OF SERIOUS INCIDENT
TO WELSH ASSEMBLY GOVERNMENT
WAG Reference
Grading
Internal Ref or
Datix No.
Date reported
to Risk
Management
Organisation
Reporters Name,
Designation and
contact details
Name:
Job title:
Contact details:
E- mail:
Date:
Local Authority
Area
Age of
patient(s) if
known
Brief description of
what happened
Brief description of
immediate action
taken
Media interest
(actual or potential)
Has this SI been
reported to the
NPSA?
What other external
agencies have
been informed
about this incident?
Any other relevant
information
Chief Executive /
Executive Sign off
Signature:
Print Name:
Title:
Date:
Appendix 2
FORM 2
WAG Reference
Grading
Organisation
Reporters Name,
Designation and
contact details
Name:
Job title:
Contact details:
E- mail:
Brief description of
issue
Brief description of
any action and
media handling
Chief Executive /
Executive Sign off
Signature:
Print Name:
Title:
Date:
Appendix 3
Marion Andrews-Evans
Jenny Sanger
Natalie Harris
Ann-Marie Carpanini
Taryn Ramsay
Sarah Wiltshire
01495 761434
01495 761414
01267 225278
02920 823218
02920 825113
02920 801147
marion.aevans@wales.gsi.gov.uk
jenny.sanger@wales.gsi.gov.uk
natalie.harris@wales.gsi.gov.uk
annm.carpanini@wales.gsi.gov.uk
taryn.ramsay@wales.gsi.gov.uk
sarah.wiltshire@wales.gsi.gov.uk
The contact details for the following organisations are:Betsi Cadwaladr University HB
Hywel Dda HB
Powys Teaching HB
Welsh Ambulance Services NHS Trust
Andrea Hughes
Clare Reece-Archer
Teresa Bridge
John Barnes
Carol Clarke
01352 706951
01352 706956
02920 826797
02920 825857
02920 823825
andrea.hughes2@wales.gsi.gov.uk
clare.reece-archer@wales.gsi.gov.uk
teresa.bridge@wales.gsi.gov.uk
john.barnes@wales.gsi.gov.uk
carol.clarke@wales.gsi.gov.uk
Grade 2
Grade 1
Grade 0
Action required:
Notification only for no surprises e.g media coverage of an issue, temporary capacity issues, or if it is unclear if
a serious incident has occurred at this stage.
The organisation must update the Improving Patient Safety Team (IPST) with further information within three
working days of a grade 0 incident being notified.
If within three working days it is found not to be a serious incident, it will be closed by WAG. Should any further
issues arise the HB/Trust should send a further updated report to IPST.
A CAMHS admission to an adult ward should always be notified. This will be graded according to the details of
each individual case
If a serious incident has occurred it will be regraded as a grade 1 or 2.
Examples of cases:
Monitoring required:
Action required:
The HB or Trust will
IPST will close the incident when Unexpected/unexplained death,
investigate the case and
including primary care
it is satisfied that:
report to the IPST findings,
o the investigation,
Mental health attempted suicides as
recommendations,
recommendations and
inpatients
associated action plans and
action plan is satisfactory
Mental Health deaths in the
learning.
and lessons have been
community
HBs and Trusts are
learnt and shared, and
HCAI outbreaks resulting in the death
responsible for informing
o local monitoring
or harm to patients
IPST of any further issues
arrangements are in place
Patient fall resulting in harm/death
that may arise during the
and working efficiently.
Ambulance delays resulting in
course of the investigation
harm/death to patient
e.g. media attention
Data loss and information security
Grade 3 or above hospital acquired
pressure ulcer develops
IRMER reportable incidents
Misidentification/ delay in diagnosis /
treatment or misdiagnosis resulting in
harm / death
Serious medication, blood or device
error
Comprehensive
Investigation
Root Cause Analysis (RCA)
required Level 2
Investigation)
Action required:
Case will be monitored by the
WAG.
They will review findings,
recommendations and
associated action plans and
learning.
Comprehensive
Investigation
(RCA level 2 investigation)
(as above) or Independent
Investigation (RCA level 3
Investigation)
Monitoring required:
Incidents involving an
independent investigation or
review or those considered high
risk will continue to be monitored
by WAG officials until evidence is
provided that each action point
has been implemented and there
is evidence of learning
Incidents involving adult or child
abuse are referred to local
safeguarding arrangements
Example of cases:
Maternal deaths
Inpatient suicides (including following
absconsion)
Homicides following contact with
mental health services
Never Events
Safeguarding serious harm or death
following allegations of abuse or
neglectful behaviours (including sexual
abuse)
Some incidents listed in grade 1 above
may be graded 2 depending on the
severity, numbers affected, similar
previous incidents etc
Appendix 5
Level
2+3
Contents page
2+3
CONTENTS
Executive summary
2+3
EXECUTIVE SUMMARY
2+3
2+3
2+3
2+3
2+3
2+3
2+3
2+3
2+3
Detection of Incident
10
2+3
2+3
Contributory Factors
2+3
Root Causes
2+3
Lessons Learned
2+3
Recommendations
2+3
Main Report
1, 2 +3
MAIN REPORT
1, 2 +3
Incident date
1, 2 +3
Incident type
1, 2 +3
1, 2 +3
1, 2 +3
1, 2 +3
Pre-investigation risk
assessment
2+3
Incident date:
Incident type:
Specialty:
Effect on patient:
Severity level:
B
Likelihood of recurrence
at that severity (1-5)
2+3
2+3
Terms of reference
C
Risk Rating
(C = A x B)
Investigation team
1, 2 +3
2+3
11
1, 2 +3
2+3
2+3
Chronology of events
1, 2 +3
Detection of incident
Chronology of events
See table below
1, 2 +3
Detection of incident
Notable practice
2+3
Notable practice
Example only (please delete and add your own findings)
12
Contributory factors
1, 2 +3
Recommendations
Example only (please delete and add your own findings)
Distribution list
Lessons learned
Example only (please delete and add your own findings)
Root causes
Example only (please delete and add your own findings)
Contributory factors
Distribution list
2+3
Appendices
Appendices
Include key explanatory documents. e.g.
Tabular timeline, Cause + effect chart,
Acknowledgements to patients, family, staff
or experts etc.
Author:
Job Title:
Date:
13
Event
14
Detection of incident
Notable practice
.
Contributory factors
Root causes
Lessons learned
Recommendations
15
Event
16
MAIN REPORT
Incident description and consequences
Incident date:
Incident type:
Specialty:
Effect on patient:
Severity level:
Pre-investigation risk assessment
A
Potential Severity
(1-5)
B
Likelihood of recurrence
at that severity (1-5)
Terms of reference
17
C
Risk Rating
(C = A x B)
Detection of incident
Notable practice
.
Contributory factors
Root causes
Lessons learned
Recommendations
Appendices
Author:
Job Title:
Date:
18
Event
19
Appendix 6
FORM 3
CLOSURE / UPDATE FOLLOWING SERIOUS INCIDENT
TO WELSH ASSEMBLY GOVERNMENT
WAG Reference
Grading
Organisation
Date of
incident
Summary of
incident
Summary of
investigation
findings and
recommendations
Confirmation of
Actions to be
implemented
Timescale
20
Any outstanding
issues
Any additional
information
attached
Yes: [
Disclaimer
I confirm that this incident has been thoroughly investigated and the
findings and recommendations have been agreed by the appropriate
committee and acted upon
No: [
Or
The information provided on this form summarise the action to date and we
request an extension of ____ weeks to complete this investigation.
Signature
WAG Officials
sign off
Further
action
required
Yes: [
No: [
Signature:
Date:
21