PROCESS FOR REPORTING AND LEARNING FROM
SERIOUS INCIDENTS REQUIRING INVESTIGATION
Note: Yeovil District Hospital NHS Foundation Trusts
Incident Reporting Policy refers to this SIRI policy
Version:
Final
Ratified by:
Governance Committee
Date Ratified:
15 May 2013
Name of Originator/Author:
Liz Jagelman, Assistant Risk Manager
Name of Responsible
Committee/Individual:
Patient Safety and Quality Assurance
Committee
Date issued:
May 2013
Review date:
May 2016
Target audience:
All staff employed by the
commissioner and all Services
Commissioned by the commissioner
PROCESS FOR REPORTING AND LEARNING FROM SERIOUS INCIDENTS
REQUIRING INVESTIGATION
CONTENTS
Page
CONTENTS
VERSION CONTROL .................................................................................
i
IMPACT ASSESSMENT ............................................................................. ii
1
INTRODUCTION ........................................................................................ 1
2
DEFINITION OF A SERIOUS INCIDENT REQUIRING
INVESTIGATION (SIRI) .............................................................................. 2
3
REPORTING OF SERIOUS INCIDENTS ................................................... 4
4
COMMUNICATING WITH PATIENTS, CARERS AND FAMILIES ............. 6
5
SAFEGUARDING INCIDENTS ................................................................... 6
6
ROLES AND RESPONSIBILITIES ............................................................. 8
7
RESPONSIBILITIES OF THE COMMISSIONER ....................................... 8
Investigating Serious Incidents ................................................................... 10
Management of Investigations for Grade 2 Incident and Never
10
Events……………………………………………………………………….
Standards for Management of Serious incidents ........................................ 10
8
BLACK ALERT STATUS - ESCALATION FRAMEWORK
11
9
CATEGORIES AND INCIDENTS THAT SHOULD BE NOTIFIED ............ 12
Abuse of Adults ........................................................................................... 12
Blood Transfusion ....................................................................................... 12
Emergency Plan Invoked ............................................................................ 13
Health Protection ........................................................................................ 13
Serious Incidents Occurring in Independent Provider Organisations
14
Regulation ...................................................................................................
Information Governance ............................................................................. 14
Information Technology .............................................................................. 15
Major Incidents ............................................................................................ 15
Maternity Serious Incidents - Maternity, Infant and Child Incidents….
15
Media Issues ............................................................................................... 15
Medical Devices .......................................................................................... 16
Adverse Drug Reactions ............................................................................. 16
Medico-Legal Incidents/Litigation ................................................................ 16
Mental Health, Substance Misuse and Incidents Involving Learning
Disabilities ...................................................................................................16
Mortality/Morbidity/Care Incidents ...............................................................17
Never Events ..............................................................................................18
Nursing Home – SIRI / Patient Safety Incidents ………………………
19
Premises/Equipment Incidents ....................................................................19
Prison Healthcare .......................................................................................20
Professional Misconduct ..............................................................................20
Radiology ....................................................................................................20
Screening Programmes…………………………………………………
20
Staff-Related Incidents ................................................................................21
Terrorism and Chemical, Biological, Radiological or Nuclear (CBRN)
Incidents .....................................................................................................21
Unexpected Death, Serious Harm or Injury ................................................22
Violence towards Health Care Staff ............................................................22
10
MONITORING AND COMPLIANCE ...........................................................22
Rapid Responsive Review………………………………………………..
23
Risk Summits …………………………………………………………….
24
11
DISSEMINATION OF LEARNING ...............................................................24
12
COMMUNICATION BETWEEN ORGANISATIONS ...................................25
13
MEMORANDUM OF UNDERSTANDING: INVESTIGATING
PATIENT SAFETY INCIDENTS INCLUDING UNEXPECTED
DEATH OR SERIOUS UNTOWARD HARM ...............................................26
14
ACKNOWLEDGMENTS ..............................................................................27
APPENDICES
APPENDIX 1
APPENDIX 2
APPENDIX 3
APPENDIX 4
APPENDIX 4a
APPENDIX 5
APPENDIX 6
APPENDIX 7
APPENDIX 8
APPENDIX 9
APPENDIX 10
APPENDIX 11
APPENDIX 12
Out of Hours Reporting and Media Relations .............................................
29
Flowchart for Provider Organisations and Lead
Commissioners on the Management of Grade 2 Serious
Incidents .....................................................................................................
31
Serious Incident Requiring Investigation (SIRI) 72 Hour
Report .........................................................................................................
32
Guidance for Maternity reportable incidents on STEIS …
33
Guidance for Infant and Child Incidents reportable on
STEIS ………………………………………….
34
Flowchart for the Management of Mental Health Homicide
Incidents ......................................................................................................
39
Root Cause Analysis Template ……………………………...
41
Adult Safeguarding Flow Chart ....................................................................
43
Child Deaths and Child Safeguarding Flowchart ........................................
44
Incident and Risk Rating .............................................................................
45
Pressure Ulcer Investigation Template ........................................................
47
Protected Groups Form ………………………………………
49
Independent Contractors Pathway ………………………….
50
APPENDIX 13
APPENDIX 14
APPENDIX 15
NHS III SIRI Flowchart ………………………………………
SIRI Communication Template ……………………………...
Serious Incidents / Patient Safety Incidents reportable for
Nursing Homes………………………………………………...
51
52
53
REPORTING AND LEARNING FROM SERIOUS INCIDENTS REQUIRING
INVESTIGATION
VERSION CONTROL
Number assigned to document:
Document Status:
Final
Version:
2.0
DOCUMENT CHANGE HISTORY
Version
Date
Comments
1.0
01 June 2010
First Draft
1.1
27 October 2010
Amendments following publication of the
revised South West Strategic Health Authority
Process for Serious Untoward Incidents in
September 2010.
1.2
2 November 2010
Amendments following the Patient Safety and
Quality Assurance Committee
1.3
11 January 2011
Ratified by the Patient Safety and Quality
Assurance Committee
1.4
15 March 2011
Policy further updated in light of revised Never
Events from Department of Health
1.5
12 October 2012
Revised following comments from Associate
Director of Nursing and Patient Safety
1.6
23 October 2012
Revised following comments from Director of
Nursing and Patient Safety
1.7
01 November
2012
Revised following update from Deputy Director
of Nursing and Patient Safety and Designated
Nurse for Safeguarding Children
1.8
15 January 2013
Ratified by the Patient Safety and Quality
Assurance Committee
1.9
15 March 2013
Revised to reflect the NHS reforms and policy
amended to reflect the responsibilities of
Somerset Clinical Commissioning Group
2.0
23 March 2013
Revised to reflect updated guidance from the
NHS Commissioning Board
i
Sponsoring Director:
Author(s):
Lucy Watson, Director of Quality and Patient
Safety
Liz Jagelman, Assistant Risk Manager
Jo, Howarth, Head of Patient Safety and Risk
Management
Document Reference:
ii
CONFIRMATION OF EQUALITY IMPACT ASSESSMENT FOR THE
COMMISSIONER DOCUMENTS/POLICIES/STRATEGIES AND SERVICE
REVIEWS
Main aim of the document:
This document sets out the commissioner’s policy for the Reporting and Learning
from Serious Incidents Requiring Investigation (SIRI’s).
Outcome of the Equality Impact Assessment Process:
Neutral impact identified
If relevant, outcome of the full impact assessment:
Actions taken and planned as a result of the equality impact assessment, with details
of action plan with timescales/review dates as applicable:
Review of Policy in Three years (2016)
Groups/individuals consulted with as part of the impact assessment:
The commissioner staff
iii
PROCESS FOR REPORTING AND LEARNING FROM SERIOUS INCIDENTS
REQUIRING INVESTIGATION
1
INTRODUCTION
1.1
This policy sets out the arrangements by which organisations provide
NHS Funded care as commissioned by Somerset Clinical Commissioning
Group (CCG) will report, investigation and evidence learning from Serious
Incidents Requiring Investigation (SIRI’s).
1.2
This Policy for Reporting and Learning from Serious Incidents Requiring
Investigation (SIRI) follows the National Framework for Reporting and
Learning from Serious Incidents, published by the National Patient Safety
Agency, in March 2010. The approach encourages openness, trust and
continuous learning, and provides a consistent approach to the
management of serious incidents, and sets clear standards for
investigation and partnership working with relevant bodies.
1.3
Promoting Patient Safety by reducing harm or error is a key priority for the
NHS, particularly since the publication of ‘An Organisation with a Memory’
(Department of Health, 2000) which emphasises the need for learning
from adverse events and sets out a series of recommendations. ‘Building
a Safer NHS for Patients’ (Department of Health, 2001) describes the
implementation of these recommendations, including plans to establish a
national reporting system to record, analyse, and learn from adverse
incidents, ensuring that lessons learnt in one part of the NHS are properly
shared across the whole health community.
1.4
The Area Team for the NHS Commissioning Board is required to receive
notification of all serious incidents from all NHS Trusts and commissioned
services within its boundary. In addition the reporting of SIRI’s is a
requirement of the national contract for acute, community and mental
health providers together with a statutory ‘Duty of Candour’
1.5
Grade 1 SIRI’s - As lead commissioner, Somerset Clinical Commissioning
Group is responsible for the management, on-going review and
monitoring of serious incidents from organisations providing NHS funded
Care in Somerset. All Grade 2 incidents as defined in the National
Framework for Reporting and Learning from Serious Incidents 2010,
Never Events and incidents requiring independent investigation are
monitored jointly by the commissioners and the Area Team for the NHS
Commissioning Board.
1.6
This policy should be read in conjunction with the following Somerset
Clinical Commissioning Group policy documents:
Incident Reporting Policy
Major Incident Plan
Trust Risk Management Strategy
1
Complaints Procedure
Raising a Concern policy
Safeguarding Children and Adults Policies
Checklist for Reporting, Managing and Investigating Information
Governance Serious incidents (DH Gateway Ref: 13177)
Department of Health – Never Events List 2012/2013
NHS South of England – Process for reporting and learning from
serious incidents requiring investigation
National Patient Safety Agency – Information resource to support
the reporting of Serious Incidents
Serious Incident Framework - an update to the 2010 National
Framework for Reporting and Learning from Serious Incidents
Requiring Investigation
2
DEFINITION OF A SERIOUS INCIDENT REQUIRING INVESTIGATION
(SIRI)
2.1
A serious incident requiring investigation is defined as an incident that
occurred in relation to NHS-funded services and care resulting in one of
the following:
unexpected or avoidable death or severe harm of one or more
patients, staff, visitors or members of the public
a scenario that prevents or threatens to prevent a provider
organisation’s ability to continue to deliver healthcare services, for
example, actual or potential loss of personal/organisational
information, damage to property, reputation or the environment, or IT
failure
allegations or incidents of abuse
loss of confidence in a service as a result of adverse media
coverage or public concern about healthcare or an organisation
a never event - all never events are defined as SIRIs although not
all never events necessarily result in severe harm or death
2.2
Reporting serious incident ‘near misses’ may also be necessary, due to
potential media attention, or to facilitate the dissemination of lessons
learnt. Within the severity grading used by the National Patient Safety
Agency, ‘near misses’ are split into two categories, rather than one, as
previously, and are referred to as:
prevented incidents; (previously classed as a ‘near miss’) such as
those that did not impact on the patient because of factors other than
intervention, an example of which could be where a patient was
given a prescription for the wrong dose of a medication, but the error
was noticed and corrected by the pharmacy
2
no harm incidents; an example of which could be a patient was
supplied a drug by a pharmacist which was meant for a different
patient. The drug had no ill effect on the patient
2.3
From the 1 April 2010, as part of the new registration requirements arising
from the Health and Social Care Act 2008, NHS providers are required to
notify the Care Quality Commission (CQC) about events that indicate, or
may indicate risks to ongoing compliance with registration requirements,
or that lead, or may lead to changes in the details about the organisation
in the CQC register. Reports about serious incidents and deaths are
defined in the CQC’s guidance, Essential Standards of Quality and Safety.
For CQC registered providers most of these requirements are met by
reporting via the NRLS who will forward relevant information to the CQC.
2.4
In certain instances, there will also be a need to inform other agencies, in
accordance with national guidance, such as the Medicines and Healthcare
Products Regulatory Agency (MHRA) in the case of medicines equipment
failure, and the Counter Fraud and Security Management Service
(CFSMS) in the case of fraud and violence towards staff. NHS
Foundation Trusts are also required to report specific incidents to the
Health and Safety Executive and Monitor.
2.5
There is in place a protocol for liaison and effective communication
between the National Health Service, the Health and Safety Executive,
and the Association of Chief Police Officers, with regard to investigating
patient safety incidents (unexpected death or serious untoward harm) to
agree arrangements for investigations of health services to proceed when
a criminal investigation or HSE investigation is being undertaken. This is
set out in the Memorandum of Understanding: Investigating Patient Safety
Incidents Involving Unexpected Death or Serious Untoward Harm’,
published by the Department of Health, in February 2006.
3
3
REPORTING OF SERIOUS INCIDENTS
3.1
The organisation, where the serious incident requiring investigation
occurred, has overall responsibility for reporting the incident and for the
investigation and implementation of subsequent action plans. The lead
commissioner is responsible for monitoring the management of serious
incidents requiring investigation, reported by providers of NHS funded
care. Where an incident relates to a patient whose treatment has been
commissioned by the Specialist Commissioner, the commissioner has in
place a process of communication whereby such incidents are required.
Reference - South West Specialist Commissioning Group - Process for
Handling and Learning from Serious Incidents.
3.2
When an incident is reported by an organisation, and the Commissioner
who is responsible for the care of the patient is not the Lead
Commissioner (Associate Commissioner) the Lead Commissioner will
liaise with the Associate Commissioner, and involve them in the sign off
process.
3.3
A Serious Incident will be identified as an incident through the use of the
incident reporting risk management matrix. Incidents that are graded
against the consequence and likelihood score which result in a combined
risk score of greater than 16, will be classed as a Red Serious Incident,
and consideration will be given as to whether these incidents meet the
requirements for SIRI reporting, as shown in appendix 9.
3.4
SIRI’s should be reported on the Strategic Executive Information System
(STEIS) within two working days of the organisation identifying the
Serious Incident. In the majority of cases, the date of the incident
occurring is the same as the date in which the reporting organisation
identifies the incident. In some cases, the date that the organisation
identifies the incident may differ from the actual incident date. An
example of this is when an incident comes to light, following a
retrospective case note review. In these cases, the date of knowledge the
organisation identifies the incident becomes the incident date for
monitoring purposes. The commissioner will make the final decision on
which date applies in consultation with the reporting organisation.
3.5
When an organisation does not have access to the Strategic Executive
Information System (STEIS), for example independent contractors and
Treatment Centres, the commissioner will input the details of the SIRI and
sign off the report. In these cases, oversight of the reporting and
investigation process detailed in this process remains in place.
3.6
Where there is an unavoidable delay in investigating an incident, NHS
providers should update STEIS and inform the Patient Safety Team as the
commissioner, at the earliest opportunity.
4
Grading and Monitoring of Incidents
3.7
Serious incidents are graded as either 0, 1 or 2. Definitions can be found
in the National Framework for Reporting and Learning from Serious
Incidents Requiring Investigation (page 17). The commissioner will review
all incidents reported on STEIS within 2 working days of the report being
made and agree the grading for the incident with the NHS provider.
3.8
All Never Events are graded as Grade 2 serious incidents. There may
need to be discussion between the NHS provider, commissioner and the
Local Area Team for the NHS Commissioning Board, to agree that an
incident meets the criteria for a Never Event, and the associated grading.
The relevant commissioning manager, quality lead and lead GP will be
informed when incidents of this nature are reported.
3.9
The on-going monitoring of Grade 1 incidents will be managed by the
Somerset Clinical Commissioning Group).
3.10
Where serious incidents occur across organisational boundaries,
Somerset Clinical Commissioning Group will agree with other relevant
commissioners arrangements for leading and coordinating the
investigation, and oversee the management of the process.
3.11
When an incident occurs where a number of organisations are involved in
the patient pathway e.g. NHS III, Ambulance services and Hospital, the
Lead Commissioner will facilitate the investigation, to ensure that all
stakeholders are involved.
Confidentiality
3.12
It should be noted that, in the interests of confidentiality, all reports should
contain anonymised information. The content of any report relating to
serious incidents should not contain the names of practitioners, patients or
information, which could lead to the identification of practitioners or
patients. Investigation reports may be disclosable under the Freedom of
Information Act 2000.
3.13
Where Somerset Clinical Commissioning Group or the Local Area Team
for the NHS Commissioning Board, consider the serious incident to be of
a nature where patient (and practitioner) identifiable information is
necessary in order to protect patient safety, the Trust may release this
information in line with Caldicott principles and agreement with the
relevant Caldicott Guardian
3.14
If a patient is transferred to an organisation and clinical staff report that
the patient may have previously been involved in a serious incident in the
originating organisation, the incident should be reported by the receiving
organisation. The receiving organisation should also advise their Lead
Commissioner, who may negotiate transfer of the incident and
responsibility for investigation to the originating organisation. An example
5
of this may be the identification of a suspected safeguarding incident, or
where a pressure ulcer is deemed to have been present on admission.
4
COMMUNICATING WITH PATIENTS, CARERS AND FAMILIES
4.1
In November 2009, the National Patient Safety Agency issued an alert
strengthening its 2005 Being Open safer practice notice. The alert
requires all organisations to adopt the Being Open principles of
transparency, involvement and engagement with patients and their
families. The detail of the approach and involvement with the patients,
family and/or carers should be included in all investigation reports as set
out in the Somerset Clinical Commissioning Group Being Open Policy.
4.2
Where statutory instruments deem contact with the patient / relatives is
not indicated for example in safeguarding incidents or where a criminal
investigation is in progress, the statutory instrument should be adhered to
following discussion with the relevant agencies within the framework of
the memorandum of agreement.
4.3
In accordance with the ‘Duty of Candour’ providers must within 10
operational days after reporting a reportable patient safety incident notify
the Relevant Person that the reportable patient safety incident has
occurred or is suspected to have occurred.
5
SAFEGUARDING INCIDENTS
Adults
No Secrets (Department of Health 2000)
5.1
The No Secrets guidance (Department of Health, 2000) forms the basis
for multi-agency activity to protect adults who are at risk of harm. No
Secrets is not legislation itself but rather statutory guidance issued under
Section 7 of the Local Authority Social Services Act 1970. Councils are
thus obliged to follow such guidance.
5.2
Under the No Secrets guidance, local authorities have the lead role in
coordinating work to safeguard adults at risk; however, the main focus of
the guidance is the need for effective multi-agency working arrangements
to protect vulnerable people.
Safeguarding Adults: the role of Commissioners (DH, 2011)
5.3
The Department of Health published Safeguarding Adults; the role of
Commissioners in March 2011highlighting the need to ensure that
responsibilities for safeguarding adults are safely managed and
maintained through the transition period and into the new organisational
commissioning arrangements by Clinical Commissioning Groups, the
NHS Commissioning Board and the Local Authority and
6
5.4
This guide sets out that safeguarding adults is integral to safeguarding
care or patients using health services as follows:
Patient Care:
Achieving high quality care for patients. Safeguarding is particularly
relevant to domains 4 and 5 of the NHS Outcomes Framework –
patient experience and protecting people from avoidable harm
Regulation:
Safeguarding is a fundamental requirement for registration and
complying with the Care Quality Commission, Essential Standards for
Quality and Safety
Legislation:
Commissioners duty to comply with legislation including the Human
Rights Act; Equality Act; Mental Capacity Act and Safeguarding
Vulnerable Groups Act
Cost effectiveness:
Quality Innovation Productivity and Prevention – harm neglect and
abuse cost the NHS millions each year in avoidable admissions and
care
Safeguarding thresholds in health
5.5
The commissioner, in liaison with Somerset County Council, continues to
work to strengthen reporting of safeguarding incidents in health settings.
5.6
As part of monitoring arrangements the commissioner will review all SIRIs and
consider if there are safeguarding concerns and whether a referral should be
made to the Safeguarding Adults Board if this has not been actioned by the
reporting organisation or service.
5.7
The SIRI investigation will contribute to any serious case review instigated as
a result of a safeguarding concern.
5.8
Details of the Adult Safeguarding process can be found at Appendix 7 of this
document.
Children
5.9
Health Commissioners and NHS Trusts have a statutory duty to safeguard
and promote the welfare of children (Children Act 2004). As part of that duty
they must have arrangements in place to identify, report, investigate, as well
as implement and manage any remedial action required in situations where it
is believed that an incident has occurred that could have adversely affected
the health or welfare of a child. This also includes ‘near misses’.
5.10 A small subset of adverse incidents will fall into the category of safeguarding
7
children SIRIs, see attached appendix 4 for the reporting guidance on
Maternity, Infant and Child SIRIs
5.11
A number of Safeguarding Serious Incidents may also meet the criteria,
outlined within Working Together (2010) statutory guidance for a Serious
Case Review (SCR). It is the decision of the Local Safeguarding Children
Board as to whether or not an SCR will be commissioned. Any child protected
in care subject to an SCR will meet the threshold for reporting as a
safeguarding Serious Incident.
6
ROLES AND RESPONSIBILITES
6.1
The NHS has a responsibility to ensure that when a serious incident does
happen, there are systematic measures in place for:
safeguarding people, property, the service’s resources and its
reputation
understanding why the event occurred
ensuring that steps are taken to reduce the chance of a similar
incident happening again
reporting to other bodies, where necessary, and
sharing the learning with other NHS organisations and providers of
NHS-funded care
7
RESPONSIBILITIES OF THE COMMISSIONER
7.1
The commissioner is responsible for ensuring that the following are in place:
processes for reporting the event to other local agencies, such as
the police, local authority and other NHS Trusts
clear requirements for responding to serious incidents are specified
and agreed within contracts with all providers
procedures and relevant skills and resources, to receive and
appropriately manage and monitor follow up of serious incidents
requiring investigation
mechanisms in place to ensure that necessary follow-up action is
taken including monitoring of actions plans that have a clear
trajectory with named responsibility leads.
access to independent investigators and experienced clinical
advisors, in addition to suitably qualified and experienced
commissioning staff, to undertaken investigations when required
8
local procedures agreed with LSAB/LSCB, that set out the
arrangements for notification and management of serious case
reviews, including action planning and learning from incidents
arrangements are in place to be satisfied that providers are
operating an open and just culture were staff are encouraged to
report incidents without fear of inappropriate or unjust blame and
where patients are informed and involved in investigations when they
have been affected by an incident.
quality assure investigations, including internal investigations, to
ensure they are robust and demonstrate use of recognised principles
such as root cause analysis or Significant Event Audit.
ensure timely and transparent closure of serious incidents
underpinned by effective communication with providers.
7.2
Somerset Clinical Commissioning Group is responsible for ensuring
prompt reporting of adverse incidents and reactions, and defective
products relating to medical and non-medical equipment and supplies,
food, buildings and plant (Health Service Guidance 93, 13).
7.3
Somerset Clinical Commissioning Group is responsible for ensuring that
there are effective arrangements in place, for dealing with major incidents
(Health Service Guidance 93, 24) and infection control (Health Service
Guidance 93, 56). The commissioner has the responsibility of assuring
the quality of commissioned services.
7.4
The responsibility for ensuring that major outbreaks and incidents are
appropriately managed, lies with Public Health England and NHS England
respectively. These organisations will be responsible for notifying national,
regional and the local health and multi-agency partners, where
appropriate.
7.5
In the event of an actual, or possible, terrorist threat, the Ambulance
Service will be notified by Police and will act as the gateway to health.
They will notify Public Health England and NHS England who will activate
locally agreed major incident notification cascades. Public Health England
will also work closely with the police and fire and rescue service, on any
health risks posed by suspect packages that might contain a biological or
chemical substance/hazard.
7.6
All serious incidents that involve controlled drugs must be reported to the
Somerset Clinical Commissioning Group Accountable Officer, who will
oversee the arrangements for investigation of the incident, and manage
the shared learning through the Local Network for Accountable Officers
for controlled drugs.
9
Investigating Serious Incidents
7.7
If a Serious Incident has occurred within a commissioned service the
Somerset Clinical Commissioning Group Patient Safety Team will ensure
that an appropriate process is followed to ensure that a full investigation is
undertaken using root cause analysis techniques, lessons learned are
identified and recommendations for improvement made. This will ensure
that the necessary action has been taken and lessons learned are shared
across the Somerset Health Community. The commissioner will review
and monitor action plans from commissioned services through the Patient
Safety and Quality Assurance Committee.
7.8
If a Serious Incident occurs within a service commissioned from an
Independent Care Contractor, a full investigation will be undertaken led by
the appropriate professional lead for the service, and supported by the
Patient Safety Team. Investigations involving General Practice will be led
by a GP Patient Safety Lead. The pathway for the investigation process
for independent care contractors can be found at appendix 12.
Management of Investigations for Grade 2 Incidents and Never
Events
7.9
The arrangements for monitoring and managing Grade 2 Incidents and
Never Events will involve Somerset Clinical Commissioning Group
agreeing Terms of Reference for the investigation with the Trust and
regular telephone monitoring calls will be held to oversee the
management of the investigation and to ensure immediate and on-going
assurance of patient safety.
Standards for Management of Serious Incidents
7.10
The commissioner will monitor the time taken to close a Serious
Incident on the STEIS system from the date the incident is notified, in line
with the National Framework as follows:
within 45 days, for a Grade 0 or 1 incident (RCA level 2
Investigation)
within 60 days, for a Grade 2 incident (RCA Level 2 Investigation
within 60 days the internal investigation should be completed for
Grade 2 incident. Where an independent investigation must be
conducted for mental health homicides (where there has been recent
contact with mental health services) that meet Department of Health
guidance, 26 weeks will be given
a 72 hour management report should be made to the commissioner,
and the Local Area Team for the NHS Commissioning Board, for all
Grade 2 incidents, and can be found at appendix 3.
10
7.11
On rare occasions exceptions to the above timescales can be agreed with
the commissioner for Grade 1 incidents, and with the agreement of the
Local Area Team for the NHS Commissioning Board for Grade 2
incidents. The circumstances for an extension will be outside of the usual
working arrangements, for example where the outcome of an inquest is
still awaited or where the family have not been available for interview but
wish to participate in the investigation process. The reason for the
extension must be recorded on STEIS in the further information section.
7.12
A request can be made to the commissioner ‘to stop the clock’ on
investigations involving the Police where this prevents the SIRI
investigation proceeding, incidents incident which are subject to an
external review, where it is known that the investigation will exceed the
reporting timeframes. These requests must be made to the commissioner
for approval.
7.13
In order to close a serious incident on STEIS, the commissioner will
require a robust investigation report, generated following a full root cause
analysis, to include root causes, lessons learned and a time bounded
action plan. The action points need to address each root cause and the
timescales and named lead for implementation. This will provide
assurance to the commissioner of actions to learn to improve patient
safety and enable sharing of lessons learned, and identify key themes
across the health community of the improvements made within Trusts, as
result of the investigation.
7.14
The commissioner will report Serious Incidents and Never Events, to the
Somerset Clinical Commissioning Group Governing Body and in the
annual report.
7.15
The commissioner will publish quarterly reports on Grade 2 incidents,
Never events and incidents that have led to an independent investigation,
or that are considered to be high risk.
7.16
The Patient Safety and Quality Assurance Committee for Somerset
Clinical Commissioning Group has responsibility for monitoring the
management and follow up of serious incidents, implementation of action
plans and identification of themes and trends and reports to the
Governance Committee.
8
BLACK ALERT STATUS – ESCALATION FRAMEWORK
8.1
A framework has been designed for managers and clinicians involved in
managing capacity and patient throughput at a time of excess demand on
NHS emergency and acute care services. The document provides a
practical working reference tool for all parties, thereby aiding coordination, communication and implementation of the appropriate duties in
each organisation. Reference - the NHS South of England, Escalation
Framework, August 2012.
11
9
CATEGORIES AND INCIDENTS THAT SHOULD BE NOTIFIED
9.1
The following are potential criteria for reporting serious incidents requiring
investigation. It is not an exhaustive list and is intended as a guide only.
However, in deciding whether or not you are dealing with a serious
incident requiring investigation, consider the possible impact the incident
could have, including what lessons might be learned from it. Even if the
initial judgement is that the issue is/was unavoidable, or had no adverse
impact, it is important that the public perception is considered. If it could
be damaging to an organisation, or the wider NHS, the incident needs to
be reported.
9.2
Where a director of the commissioner has any doubts about the reporting
of a serious incident requiring investigation, the Director of Quality and
Patient Safety, their Deputy or the Head of Patient Safety and Risk
Management can be contacted for advice, during working hours.
9.3
Potential criteria for reporting serious incidents requiring investigation
include:
Abuse of Adults
9.4
The abuse of adult described in “No Secrets”. This includes:
death or injury to a vulnerable adult, where abuse or neglect is
suspected to be a factor
where a vulnerable adult has suffered harm, as a result of staff
failing to follow agreed procedures, or acceptable practice
when a vulnerable adult has suffered significant injuries, suspected
to be as a result of abuse
Blood Transfusion
9.5
Serious incident involving blood transfusions:
serious adverse reaction: any unintended response in a donor, or in
a patient that is associated with the collection, or transfusion of
blood, or blood components that is fatal, life-threatening, disabling or
incapacitating, or results in or prolongs hospitalisation or morbidity
serious adverse events: any untoward occurrence associated with
the collection, testing, processing, storage and distribution, of blood
or blood components, that might lead to death or life-threatening,
disabling, or incapacitating conditions for patients, or which results in
or prolongs hospitalisation or morbidity
12
microbiological contamination of transfusion, leading to major
morbidity or death
incorrect blood component transfused leading to serious incident or
death
Emergency Plan Invoked
9.6
Adverse incident that would invoke an emergency plan (affecting business
continuity including multiple ward closure due to infection, serious damage
to occupied NHS property through fire, flood or criminal damage, IT failure
(for terrorist activity – see separate section).
wilful damage to property, destruction and vandalism
Health Protection
9.7
Major outbreaks, serious incidents of communicable disease, or exposure
to environmental hazards caused by healthcare failures, or other NHS
system failures that have put patients/staff at harm/risk of harm, or restrict
service delivery e.g:
outbreaks of infection that involve presumed transmission within
healthcare settings (acute, community) e.g. Norovirus, Clostridium
difficile, Panton-valentine leukociden (PVL) positive, Methicillin
resistant staphylococcus aureus (MRSA) etc
cases/outbreaks of infection with an NHS-attributable food, water or
environmental source e.g. nosocomial legionnaires' disease,
salmonella outbreak etc
case of blood borne virus (hepatitis B, C, HIV), TB etc. infection in a
healthcare worker that necessitates consideration of a look-back
exercise
case of infection in a patient to whom others have been exposed that
necessitates consideration of a look-back exercise
failed vaccination cold chain
failed sterilisation of instruments
an outbreak e.g. of viral gastroenteritis, necessitating ward closures
to new patients and resulting in significant restrictions of hospital
activity
a confirmed death of a patient due to hospital acquired infection
including MRSA and C. difficile
13
exposure to chemical agents or radiation caused by failures in
healthcare settings
an outbreak/health protection incident that is poorly managed,
resulting in harm
9.8
From February 2007, the Department of Health has required mandatory
reporting by Acute Trusts of each case of Methicillin-Resistant
Staphylococcus Aureus (MRSA) bacteraemia as a serious incident. The
mechanism for this is separate from STEIS.
Serious Incidents Occurring in Independent Provider Organisations
Regulation
9.9
Under Regulation 28 of the Care Standards Act (2000), independent
provider organisations registered with the Care Quality Commission
(CQC) must report the following to the Commission:
the death of a patient and the circumstances of death
−
in an establishment
−
during treatment provided by an establishment or agency, or
−
as a consequence of treatment provided by an establishment
or within the period of seven days prior to the date of death
any serious injury to a patient
the outbreak in an establishment of any infectious disease, which in
the opinion of any medical practitioner employed in the
establishment, is sufficiently serious to be so notified
any allegation of misconduct resulting in actual or potential harm to a
patient by the registered person, any person employed by the
establishment or by an agency on behalf of the employer, or any
medical practitioner with practising privileges
Information Governance
9.10
Serious incident involving Information Governance:
major breaches of confidentiality, such as the loss or theft of
personal identifiable records, or information, (including missing
notes)
an 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
14
Information Technology
9.11
Serious incident involving Information Technology:
systems failure leading to serious outcomes
data loss resulting in severe breach of confidentiality
Major Incidents
9.12
Serious incident involving major incidents:
any circumstance which necessitates the activation of an NHS Trust,
Primary Care Trust or wider community Emergency Plan
Maternity Serious Incidents
9.13
See attached appendix 4 for the reporting guidance on Maternity SIR’s
and appendix 4a for reporting and guidance on infant and child SIRI’s.
Media Issues
9.14
Serious incident involving media issues:
matters likely to attract interest from local, regional or national
newspapers, TV or radio
all incidents reported to or involving the police, which are considered
serious or may have adverse media interest
any Health and Safety Improvement Notices or convictions being
served upon an NHS or Primary Care Trust
matters involving high profile patients likely to attract media interest
any other sudden unexpected incidents: including apparently trivial
incidents which lead to something more serious including those
which could attract media attention
cancellation of surgery by the Trust for a patient, on more than three
occasions
serious fraud or security-related media matters (to be reported to
NHS SMS)
15
Medical Devices
9.15
Serious incident involving blood transfusions:
any serious harm to staff or patients involving medical equipment,
whether due to human error, or due to equipment found to be, or
suspected of being faulty, or to have failed e.g. hoist collapsing,
defibrillator failing
any medical device-related incident that causes, or has the potential
to cause, unexpected or unwanted effects, involving the safety of
device users (including patients) or other persons
Medicines and Serious Adverse Drug Reactions
9.16
Suspected or actual serious side effects or adverse drug reactions (ADRs)
from a medicine, be it:
prescription medicines
herbal remedies
over-the-counter (OTC) medicines
Medico-Legal Incidents/Litigation
9.17
Serious incident involving medico-legal issues:
suspicion of large scale theft or any incident which might give rise to
serious criminal charges
potential legal claims against the hospital regarding a serious
incident
potential legal claims against the hospital or Department of Health
that may affect national policy
impending court hearing, or out of court settlement, in cases of large
scale litigation, including negligence claims (as defined by the NHS
Litigation Authority (NHSLA) large scale claims are considered to be
those over £250,000)
Mental Health, Substance Misuse and Incidents Involving Learning
Disabilities
9.18
Serious incident involving mental health, substance misuse and incidents
involving learning disabilities:
16
a serious offence including homicide committed by an individual in
receipt of mental health and/or learning disability services
patients detained under the Mental Health Act 1983, who are absent
without leave from health services, and who present a serious risk to
themselves and/or others. Specific national guidance governs
incidents, such as homicides and other serious incidents, involving
mentally ill people (Health Service Guidance 94, 27). Arrangements
for dealing with major incidents (Health Service Circular 98, 197)
the criteria set out below will at times duplicate the criteria already
stated but they are included to remind those delivering mental health
services of the need to report them:
−
the absence without leave of a patient detained under the
Mental Health Act 1983, where there is serious cause for
concern
−
patient/s receiving inpatient care in secure accommodation,
who go missing (but not detained under the Mental Health Act
1983)
−
homicide, or suspected homicide, by a patient who has
received mental health services. NB if it occurs within six
months of receiving treatment, this triggers the setting up of an
independent inquiry, as described in Chapter 3.4: Investigation
−
all deaths within secure settings (to be dealt with as a death in
custody)
−
all deaths of persons who are subject to the Mental Health Act
1983, or equivalent legal restriction who has, or is receiving
care and treatment from the mental health services
-
any serious criminal acts involving patients
-
an incident that causes serious harm, or injury, or places life in
jeopardy, whether by a patient, staff or visitor in mental health
and learning disability services
-
admission of a child under 18 to an adult mental health ward
-
an inpatient who is missing from the ward, who is considered a
risk to themselves or others
-
an episode of restraint that does not comply with national or
local trust policy
Mortality/Morbidity/Care Incidents
9.19
Serious incident involving mortality/morbidity/care incidents:
17
clusters of unexpected or unexplained deaths
where the death results in adverse comments from a coroner
maternity: maternal deaths, neonatal deaths and unexpected
stillbirths
the suicide of any person currently in receipt of NHS services on or
off NHS premises, or who has been discharged within the last twelve
months. Suicide is defined as death:
-
where there is obvious evidence or strong suspicion of self
harm
-
where the above does not apply initially but emerges later from
a clinical review of the case, or discussion at the incident
monitoring group
-
where the Coroner’s verdict is Suicide (or open verdict)
death or injury where foul play is suspected
situations when a patient requires additional intervention(s) as a
result of failures in the diagnosis process
the accidental death of, or serious injury to, a patient, a member of
staff, or visitor to NHS or primary care premises, or involving NHS
staff or equipment:
-
out of county critical care transfers or any other transfer that
could have resulted in a serious incident
-
abuse which has been perpetrated within the remit of the
organisation; this may be abuse by a member of staff, visitor or
member of the public
-
Grade 3 and above pressure sores
-
Falls which result in a fractured neck of femur, subdural
haematoma or death
Never Events
9.20
Never Events are serious, largely preventable patient safety incidents that
should not occur if the available preventative measures have been
implemented.
18
9.21
The list of core Never Events which should be reported are listed below,
which are updated on annual basis. For further guidance please refer to
the Department of Health, Never Events Framework 2012/2013, published
18 January 2012
-
Wrong site surgery
Wrong implant/prosthesis
Retained foreign object post-operation
Wrongly prepared high-risk injectable medication
Maladministration of potassium-containing solutions
Wrong route administration of chemotherapy
Wrong route administration of oral/enteral treatment
Intravenous administration of epidural medication
Maladministration of Insulin
Overdose of midazolam during conscious sedation
Opioid overdose of an opioid-naïve patient
Inappropriate administration of daily oral methotrexate
Suicide using non-collapsible rails
Escape of a transferred prisoner
Falls from unrestricted windows
Entrapment in bedrails
Transfusion of ABO-incompatible blood components
Transplantation of ABO incompatible organs as a result or error
Misplaced naso- or oro-gastric tubes
Wrong gas administered
Failure to monitor and respond to oxygen saturation
Air embolism
Misidentification of patients
Severe scalding of patients
Maternal death due to post partum haemorrhage after elective
caesarean section
Nursing Home - SIRI / Patient Safety Incidents
9.22
See attached appendix 15 for the reporting guidance on SIRI/Patient
Safety Incidents for Nursing Homes.
Premises/Equipment Incidents
9.23
Serious incident involving premises/equipment incidents:
serious damage which occurs on the premises of NHS or
independent sector premises providing NHS work; serious damage
to property belonging to NHS, or any incident which results in
serious injury to any individual or serious disruption to services (such
as evacuation of patients due to fire)
failure of equipment, so serious as to endanger life, whether or not
injury results
19
suspicion of malicious activity, such as tampering with equipment
circumstances that lead to the provider no longer being able to
provide an element of service and not reportable through SITREP
(such as closure of caseloads to new referrals)
Prison Healthcare
9.25
Serious incident involving prison healthcare:
death of prisoner in custody, prison, probation hostels and
immigration detention accommodation. The local NHS as the
provider organisation of prison health care must work closely with
the PPO to ensure appropriate investigation of clinical aspects of
death in custody
Professional Misconduct
9.26
Serious incident involving professional misconduct:
allegations of serious professional misconduct.
Radiology
9.27
Serious incident involving radiology:
severe equipment failure leading to harm or death
Screening Programmes
9.28
An actual, or possible, failure of the screening service that has
consequences for the clinical management of patients, e.g. loss of test
results, failure to detect cancers, incorrect notification of results to a
patient or groups of patients.
9.29
The screening programmes which are covered are:
−
−
−
−
−
−
−
−
−
−
breast cancer
cervical screening
bowel cancer
diabetic retinopathy
abdominal aortic aneurysm
fetal anomaly
infectious diseases in pregnancy
sickle cell and thalassaemia
newborn blood spot
newborn hearing
newborn and Infant Physical Examination
20
The full guidance on the national screening programme SIRI guidance
can be found at www.screening.nhs.uk/getdata.php?id=9902
Staff-Related Incidents
9.30
Serious incident involving staff related incidents:
serious complaints about a member of staff, or primary care
contractor, or any incident relating to a staff member, where adverse
media interest could occur
any serious criminal acts involving patients, or staff
suspicion of a serious error, or errors, by a member of staff, primary
care contractor, or other healthcare contractor
where a member of staff is suspected of harming patients
a serious drug error, such as mal-administered spinal injections
where professional competence is in questions (see NPSA incident
decision tree)
a serious breach of confidentiality
where a member of staff is suspected of committing serious fraud
the exclusion of employed doctors, or dentists, under the NHS Trust
disciplinary procedures, that refer to ‘High Professional Standards in
the Modern NHS: a framework for the initial handling of concerns
about doctors and dentists in the NHS’ (HSC 2003/12)
significant disciplinary matters of other staff
serious verbal and/or physical aggression
where a member of staff shows gross disrespect for the dignity of a
patient/deceased patient
Terrorism and Chemical, Biological, Radiological or Nuclear (CBRN)
Incidents
9.31
Any act of terrorism is normally covered under the Major Incident Policy
and will therefore have a comprehensive list of definitions. Generally, the
following incidents must be reported:
terrorist threats/incidents, which include incendiary devices, or the
use of other weapons, including chemical, biological, radiological or
nuclear agents (CBRN)
21
potential, or confirmed, accidental chemical, biological, radiological
or nuclear agents (CBRN) incident
Unexpected Death, Serious Harm or Injury
9.32
Serious incident involving unexpected death, serious harm or injury:
patients, individuals, or groups of individuals, suffering serious, or
catastrophic harm, or unexpected death, whilst in receipt of health
services, including screening and immunisation/radiation errors and
equipment failures
serious injury, or unexpected death of any individual, to whom the
organisation owes a duty of care, including staff, visitor, contractor,
or any other person
Violence towards Health Care Staff
9.33
Counter Fraud and Security Management Service (CFSMS) in the case of
fraud, and violence to staff. In such circumstances, this serious incident
framework should be followed in conjunction with the national guidance.
serious violence/death of healthcare worker
10
MONITORING AND COMPLIANCE
10.1
In order to comply with the requirements of the National Patient Safety
Agency, National Framework for Reporting and Learning from Serious
Incidents Requiring Investigation, Providers and Commissioners should
monitor trends in serious incident reporting. This trend analysis should
include not only a quantitative report, but also a qualitative analysis of
those incidents, where root causes and lessons learned have been
identified.
10.2
Feedback from staff utilising the policy when a serious incident occurs will
be sought and the policy amended as necessary.
10.3
The commissioner will monitor the performance of all NHS providers in
managing serious incidents through quarterly reports on the status of all
incidents on STEIS to the Patient Safety and Quality Assurance
Committee. The Patient Safety Team will evaluate the quality of all
investigation reports at its Serious Incident review meeting and ensure
that these are robust and include the lessons learned and include a timed
action plan. Where there are further recommendations raised at the
Serious Incident Review, this will be feed back to the Trust, for inclusion in
the report.
22
10.4
The commissioner will monitor the implementation of all action plans from
serious incidents, through the Clinical Quality Review meetings with NHS
providers. All action plans for Grade 2 incidents will be monitored through
Patient Safety and Quality Assurance Committee.
10.5
The commissioner will report on performance in managing serious
incidents and trends in incident reporting, and key themes from lessons
learned on a quarterly basis to the Governing Body. Never events will
also be reported to the Governing Body in the quarterly report.
10.6
Somerset Clinical Commissioning Group is committed to providing equal
access to healthcare services, to all members of the community. To
achieve this, gathering information is essential to help ensure that we
deliver the most effective and appropriate healthcare. Attached at
appendix 11 are the nine protected groups, which where possible, should
be included in all root cause analysis investigation reports.
RAPID RESPONSIVE REVIEW
10.7
A rapid responsive review provides commissioners with a means by which
they can carry out a structured and purposeful visit to a trust or other
provider as part of their routine assurance monitoring of the quality of care
being delivered. The process can also be used where issues have been
raised that could potentially impact adversely on an n aspect of the quality
of care, including patient safety and/or experience. A rapid response
review can be used both on a planned basis and as an immediate
response to a problem or crisis.
10.8
A rapid responsive review may be considered where there have been a
cluster of SIRIs or failings that may lead to the requirements of a rapid
responsive review. Reference: National Quality Board –
How to: Organise and Run a rapid Responsive Review: 2012/2013.
RISK SUMMITS
10.9
A risk summit is a meeting of high-level leaders called to shape a
programme of action which is focused on sharing information willingly to
help achieve a consensus about the situation under scrutiny and the
actions required to mitigate the identified risks. Normally the risk summit
will need to continue over several says or even weeks before the SHA
and stakeholders can be satisfied that matters under review can be safely
handed over to routine operational management systems, which is the
ultimate goal.
10.10
Potential triggers for when a risk summit might be called by Somerset
Clinical Commissioning Group with the Area Team for the NHS
Commissioning Board include:
Care Quality Commission issues a warning notice(s), applies material
conditions on a provider or serve notice to withdraw registration
23
Serious failings in the provision of care such that patients are at
imminent or immediate risk. For example;
-
-
-
Quality, patient safety / experience metrics causing alarm
Clinical services poorly performing, missing targets and the
serious incidents / never event profile suggests / confirms there
to be an unsafe or failing service
Serious and sustained safety breaches indicative of a more
systemic quality failure within a single provider or across a
health and social care system
Death of a patient(s) which is unexpected and avoidable and
which raises specific alarms about clinical practice
Significant safeguarding breaches and breakdown in systems
which compromise the protection of vulnerable adults and
children (statutory and other formal processes apply)
Soft intelligence, which when triangulated against the quantitative data,
including trend analysis, clearly identifies a serious problem
Patients / carers speak out at a level beyond that which would be
expected to be addressed by the provider and local commissioners
Monitor raises serious concerns about the governance and/or
leadership of an FT
One or more of the professional regulators raises concerns about the
appropriateness of trainees /students remaining on clinical placements
in a provider and are considering / intend withdrawing them
An independent report, such as a Royal College report, raises serious
concerns about patient safety which cannot be managed locally
through routine service improvement
Reference: National Quality Board – Organise and Run a Risk
Summit: 2012/2013.
11
DISSEMINATION OF LEARNING
11.1
The NHS has a responsibility to ensure that when a serious event or
incident occurs, there are systematic measures in place for safeguarding
people, property, NHS resources and reputation, for understanding why
the event occurred, and ultimately to ensure steps are taken to reduce the
chance of a similar incident happening again.
11.2
Provider organisations should have systems in place, to ensure that
learning is disseminated within their organisation.
24
11.3
The commissioner has processes in place to share learning more widely
within the local health community, through the SafetyNet Newsletter, and
through the quarterly quality monitoring meetings with NHS providers.
12
COMMUNICATION BEETWEEN ORGANISATIONS
12.1
When there is an SIRI involving more than one provider, it is essential that
there is robust communication between these organisations. Somerset
Clinical Commissioning Group has developed a communication template,
to share patient details and contact details at appendix 14.
12.2
Contact details for each organisation are listed below:
Somerset Clinical Commissioning Group – Patient Safety Team
Telephone Number
E-mail Address
01935 384185
[email protected]
Somerset Partnership NHS Foundation Trust
Telephone Number
E-mail Address
01278 432169
[email protected]
Taunton and Somerset NHS Foundation Trust – Governance Support
Unit
Telephone Number
E-mail Address
01823 344864
[email protected]
Yeovil District Hospital NHS Foundation Trust – Clinical Governance
Department
Telephone Number
E-mail Address
01935 384590
[email protected]
South Western Ambulance Services NHS Foundation Trust
Telephone Number:
E-mail Address:
01392 261574
[email protected]
NHS III
Telephone Number
E-mail Address
01908 689866
[email protected]
25
13
MEMORANDUM OF UNDERSTANDING: INVESTIGATING PATIENT
SAFETY INCIDENTS INCLUDING UNEXPECTED DEATH OR SERIOUS
UNTOWARD HARM
13.1
In 2006, the Department of Health produced ‘Guidelines for the NHS: In
support of the Memorandum of Understanding- Investigating Patient
Safety Incidents Involving Unexpected Death or Serious Untoward Harm’
(DH Guidance 22/11/2006). These guidelines may be referred to provide
practical advice about what to do, when faced with a patient safety
incident that may require investigation by the police and/or Health and
Safety Executive (HSE).
13.2
It will sometimes be immediately obvious that the police and/or the Health
and Safety Executive should be contacted, but in other cases, the need
may not come to light until the organisation, coroner or other body, such
as the Medicines and Healthcare Products Regulatory Agency has carried
out its own investigations. The decision to report an incident to the police
should be made at a sufficiently senior level, for example, by either the
chief executive, or another executive director.
13.3
Once such a decision has been taken, representatives of the organisation,
police and, where appropriate Health and Safety Executive, should
arrange an initial meeting. The meeting of this ‘Incident Coordination
Group’ should be called, as soon as practicable, following the referral and,
in any case, the group should meet within five working days of the referral.
All three organisations are entitled to call an Incident Coordination Group
meeting, but responsibility for organising the meeting rests with the CCG.
13.4
The police, and/or the Health and Safety Executive may also call an
Incident Coordination Group meeting, in response to a complaint, referral
from a coroner, or in response to other concerns.
13.5
Until the first meeting of the Incident Coordination Group, the organisation
should continue to deal with concerns about patient safety, but not
undertake any activity that may compromise any subsequent
investigations conducted by the police and/or the Health and Safety
Executive. If in doubt about this matter, the organisation should seek
legal advice and consult the police, the Health and Safety Executive, or
where appropriate, other investigating bodies.
13.6
It is also critical that any relevant physical, scientific and documentary
evidence is secured and preserved.
13.7
Some patient safety incidents may result in the police, or Health and
Safety Executive investigating possible offences by individual employees
and/or the employer. Investigation of the NHS employer will normally
involve the Health and Safety Executive, because health and safety
legislation places the primary responsibility on the employer. In such
cases, it may not be appropriate for those who may be investigated, or
could be defendants in a criminal case, to be members of the Incident
26
Coordination Group. When this issue arises, it should normally be
discussed, at the outset, by the agencies involved, and if necessary, the
Strategic Health Authority should take on the role of liaising with the police
and Health and Safety Executive, on behalf of the Trust.
14
ACKNOWLEDGEMENTS
National Patient Safety Agency, National Framework for Reporting
and Learning from Serious Incidents Requiring Investigation
NHS South of England for the Serious incident Reporting Process
September 2010
NHS South of England Guidance on Managing Serious Incidents
Reported by NHS Organisations Through the Strategic Executive
Information System (STEIS) 2008
NHS South of England Guidance on Process for Reporting and
Learning from Serious Incidents Requiring Investigation
National Quality Board – How to: Organise and Run a rapid
Responsive Review: 2012/2013
National Quality Board – Organise and Run a Risk Summit:
2012/2013
Department of Health, Never Events Framework 2012/2013,
published 18 January 2012
Care Quality Commission: Guidance about compliance Essential
standards of quality and safety March 2010
Managing Serious Incidents in the English NHS National Screening
Programmes - Guidance on behalf of the UK National Screening
Committee (UK NSC) June 2010
27
28
APPENDIX 1
Out of Hours Reporting and Media Relations
1. Introduction
1.1
Serious incidents requiring investigation should be reported on the Strategic
Executive Information System (STEIS), within two working days. If a reporting
organisation, or Lead Commissioner (Specialist Commissioning Group where
relevant) needs to verbally inform the NHS Commissioning Board Area Team
contact should be made via the Patient Safety Team at BNSSSG Area Team.
The reporting organisation should also inform the Lead Commissioner
(Specialist Commissioning Group where relevant).
1.2
During out-of-hours, the senior manager or director on-call in the NHS trust or
Lead Commissioner will be responsible for the reporting of any serious
incidents requiring investigation.
1.3
All incidents falling into any of the serious incident categories, listed below, or
where there is any doubt over the matter must be notified to the Area Team
senior manager on call including:
incidents which necessitate activation of the NHS Trust or Area Team
Major Incident Plan, where the Area Team needs to take action.
incidents which will give rise to significant media interest, or will be of
significance to other agencies, such as the police, or other external
agencies
incidents which will be of significant public concern
1.4
Having advised the Area Team senior manager on-call, the reporting
organisation must complete the web-based Strategic Executive Information
System (STEIS) form by 12:00pm, on the first working day. Once the on-line
form has been completed and saved, an automatic e-mail alert will be sent to
nominated personnel.
1.5
If the serious incident does not fall within the categories listed above, the NHS
Area Team on-call manager need not be notified, but the Strategic Executive
Information System (STEIS) form should be completed, as soon as possible,
by the Trust, certainly within two working days.
29
2.
Media Relations (Also See Pages 28-29 of National Framework)
2.1
In many cases, serious incidents requiring investigation can lead to a high
level of media attention, not only in the immediate aftermath.
The
management, investigation and learning from incidents can all be triggers for
media coverage for months, and in some cases years after the incident itself.
Somerset Clinical Commissioning Group has media relations policies in place,
which include the appropriate action to be taken, in relation to serious
incidents, including protocols with other local organisations and agencies on
media handling and strategies for on-going, and longer term management of
media coverage.
2.2
Communication regarding serious case reviews (child abuse) will be managed
by the Chair of the Local Children’s Safeguarding Board (LCSB).
2.3
The communications leads in NHS organisations will work closely with the
communications team at the Area Team, on agreeing appropriate media
handling strategies, working alongside the relevant colleagues responsible for
the wider management of the incident. The Area Team and responsible
Director of NHS South of England will brief the Department of Health Media
Centre as necessary.
In forensic/criminal cases, the police lead all
communications with the media.
2.4
Media coverage itself can also be the incident. Where adverse media
coverage becomes the issue (and where it is not triggered by an adverse
event as such) it is expected that the communications lead for the NHS
organisation would be in direct contact with the NHS South of England
Communications Team, to discuss handling and reporting strategies
accordingly.
2.5
If the serious incident has occurred within an acute, community, mental health
or ambulance trust, that trust will take the responsibility for advising the Lead
Commissioner (Specialist Commissioning Group where relevant).
2.6
All incidents automatically receive a unique log number when entered within
the Strategic Executive Information System (STEIS) system. To maintain
confidentiality this number will be used in all communication with Trusts.
2.7
Somerset Clinical Commissioning Group will implement its communication
plan to ensure relevant colleagues, both internally and externally, are
informed to support effective management of the serious incident.
30
APPENDIX 2
Flowchart for Reporting and Management of Grade 2 Serious Incidents
Serious incident requiring investigation
is reported within 2 working days of
occurrence or date of knowledge
Incident is graded a 2 following national
framework and local process with
agreement from the CCG/AT
72 hour management report undertaken
by provider and received by the
commissioner and sent to NHSCB AT –
see appendix 3
Completed Root Cause Analysis report
is sent to the commissioner and NHS
South of England within 60 working days
NHSCB AT and the commissioner will
provide feedback to Provider within 20
working days
Agreement to close incident between
NHSCB AT and the commissioner. If
the incident is a Never Event, the
commissioner will apply the penalties in
accordance with national contract
requirements
Where appropriate, lessons learned are
disseminated across the local health
economy and NHSCB AT
31
APPENDIX 3
Serious Incident Requiring Investigation (SIRI) 72 Hour Report
SIRI Reference Number:
STEIS Identification Number:
Patient Initials
Date/Time/Location of
Incident including hospital /
ward / team level information
Incident type
Description of incident
including reason for
admission and diagnosis (for
mental health please include
Mental Health Act status and
date of referral and last
contact)
Details of any police or media
involvement/interest
Details of contact with or
planned contact
patient/family or carers
Immediate actions taken
including actions to mitigate
any further risk
Details of other
organisations/individuals
notified
Lead Commissioner
Report completed by
Designation
Date / time report completed
Does this constitute a further
full view?
Please insert below a brief chronology of key events
32
APPENDIX 4
Maternity Serious Incident (SI) Definition
Maternal death
A maternal death is defined as any death which occurs during or within 42 days of pregnancy,
ectopic pregnancy or abortion which is directly or indirectly related to these conditions.
Intrauterine death (antenatal)
Any intrauterine death at 24 weeks and above where service or clinical factors may have
contributed to the outcome.
Intrapartum death (during labour)
Unexpected intrapartum death during labour regardless of gestational age where service or
clinical factors may have contributed.
Intrapartum-related deaths: Deaths that are directly related to events occurring from the onset of
labour until birth.
Intrapartum-related stillbirth:A stillborn baby (shows no signs of life at delivery and weighs more
than 500g or is greater than 22 weeks of gestation) with intact skin and no signs of disintegration
in utero. The death is assumed to have occurred in the 12 hours before delivery and was most
likely due to an intrapartum hypoxic event. Babies with severe congenital abnormalities are not
included (based on Wigglesworth's classification).
Intrapartum-related neonatal deaths: (previously called “birth asphyxia” deaths):Neonatal deaths
of term babies with neonatal encephalopathy (see below) or who cannotbe resuscitated (or for
whom resuscitation is not available).Where possible, other causes should be excluded such as
lethal congenital malformations and preterm birth complications (less than 34 completed weeks
of gestation or birth weight b2000 g). Also includes a smaller group of babies who die from birth
injury without hypoxic brain injury.ture.
Unexpected Neonatal Death
Unexpected death of a baby aged 0-28 days. The requirement is to report unexpected death as
the death of a neonate that was not anticipated as a significant possibility 24 hours before the
death or where there was a similarly unexpected collapse leading to or precipitating the events
that led to the death. If there is any doubt the designated paediatrician for the unexpected death
should be consulted. If doubt persists, the incident should be reported as an SI until evidence
suggests otherwise.
Unexpected admission to NICU (Neonatal Intensive Care Unit)
Infants > 37 completed weeks of gestation that have a sudden and unexpected collapse
following delivery or in the early postnatal period of a previously well infant requiring intensive
care (positive pressure ventilator support).
Suspension of maternity services
Any time a decision is made to suspend maternity services regardless of outcome or when the
maternity services tries to suspend services and is unable to due to no other units being able to
accept transfers.
Maternal unplanned admission to ITUAn unexpected admission to ITU during pregnancy or within 28 days following birth (either flu or
pregnancy related)where service or clinical factors might have contributed.
Any other incidents that are considered locally as serious incidents.
33
APPENDIX 4a
Guidance for Infant and Child Incidents reported onto the Strategic Executive
Information System (STEIS)
When to report – the types of incidents that should be reported onto the
Strategic Executive Information System (STEIS)
The following types of maternity, infant and child incidents should be reported onto
the Strategic Executive Information System (STEIS). This is in line with the National
Patient Safety Agency National Framework for Reporting and Learning from Serious
Incidents Requiring Investigation and the NHS South of England Process for
Reporting and Learning from Serious Incidents Requiring Investigation.
Incident Category
Child Abuse (family)
(Grade 2 incident)
Child abuse (institutional)
(Grade 2 incident)
Child Abuse (multiple)
(Grade 2 incident)
Child Death
(Grade 2 incident)
Description
To be reported where a local multi agency
/organisational review has identified a failure in the
duty of care by a health professional or
organisation.
To be reported when this has been a factor in a
child death or a child has suffered significant
injuries either in the past as a missed opportunity
or currently.
Abuse or neglect of one or more children by one or
more perpetrators in an institutional setting where
there is a health professional linked to the
institution (this would include a school, nursery,
child minder etc) and children who are looked after
in a residential setting or an inpatient in a health
care setting.
Networked abuse of one or more children by one
or more perpetrators and where multiple complex
and abuse procedures are initiated, e.g.
paedophile ring, child trafficking etc.
All unexpected and/or unexplained child deaths up
to the age 4 years and 364 days.
Unexpected death of a child aged 5 to 17 years
and 364 days (where natural causes are not
suspected) should be reviewed within 48 hours if:
they are known to additional health care
providers;
or where it has been agreed, following the
initiation of the rapid response process, that
further exploration of the circumstances is
required urgently. This includes all children
in an institutional setting, e.g. school, youth
offenders setting, respite care or secure
unit.
34
Child Serious Injury
Maternity services intrapartum death
Maternity services intrauterine death
The death of any child on a child protection plan or
looked after child must be reported.
Where there is permanent harm or injury that
occurs in a healthcare setting or where healthcare
is delivered and the injury is related to the
healthcare delivery that does not involve
safeguarding or abuse.
Unexpected intrapartum death during labour
regardless of gestational age where service or
clinical factors may have contributed.
Any intrauterine death at 24 weeks and above
where service or clinical factors may have
contributed to the outcome.
Since April 1st 2008, there has been a statutory requirement for all Local
Safeguarding Children Boards (LSCB) to review the death of all
children under 18 years of age, who live within the LSCB area. The purpose of the
review is to identify any factors which could have contributed to a child’s death; to
learn lessons which might benefit children in the future; and ultimately to potentially
reduce the number of children who die. The deaths of all children who are resident in
Somerset are reviewed anonymously by the Somerset Child Death Overview
Panel.
A death which was originally believed not to be suspicious and not therefore reported
follows the Child Death Overview Panel (CDOP) process. The Child Death Overview
Panel (CDOP), with a fuller picture of the evidence, may decide that there are
safeguarding issues and that it should be referred to the Local Safeguarding
Children Board Serious Case Review Panel. The panel may then determine that the
incident meets the criteria for a Serious Case Review. In this case, the incident
should then be reported onto the Strategic Executive Information System (STEIS)
and the date of knowledge of the incident will be the date of the referral to the
serious case review panel of the Local Safeguarding Children Board.
Definitions
Neonate
A child aged between 0 to 28 days.
Unexpected death
Death of a child that was not anticipated as a significant possibility 24 hours before
the death or where there was an unexpected collapse or incident leading to or
precipitating the events which led to the death.
Unexplained circumstances
Factors in the environment, history or examination which may give rise to concern
about the circumstances surrounding the death. Examples: non-accidental injury,
environment which highlights issues of neglect.
35
Please note these examples are not exhaustive.
Scenarios detailing who should report an incident on to the Strategic
Executive Information System (STEIS)
The examples detailed below are not an exhaustive list. Each incident should be
dealt with on its own merits. Some examples illustrate specific scenarios, others are
more generic. If in doubt, contact the NHS South of England for further advice.
Scenario 1 – unexpected unexplained child death
All deaths of children are reported to the Child death Overview Panel. The rapid
response team will investigate the incident and review the care.
If the child is known to the health service (for example under the care of a health
visitor or an inpatient in an acute trust) then the organisation whose care the patient
was under at the time of the incident will report the incident on to the Strategic
Executive Information System (STEIS) as a child death and undertake the
investigation. Following the investigation, if there are no suspicious circumstances
and no safety lessons to be learned, the Primary Care Trust Commissioner will
request that the incident be deleted from the Strategic Executive Information System
(STEIS) by the Strategic Health Authority (paragraph 4.3 of this guidance also
applies).
N.B. If the child is under 5 years of age, they should be known to their health visitor
and as such all cases should be reported for this age group.
Scenario 2 – unexpected explained child death
Example A: a road traffic accident; meningococcal sepsis.
If there are no safeguarding concerns then the incident will be reported to the Child
Death Overview Panel but not to the Strategic Executive Information System
(STEIS). If there are safeguarding concerns then the Primary Care Trust
Commissioner will ensure that the incident is reported onto the Strategic Executive
Information System (STEIS) by the appropriate organisation.
N.B. If the child is under the age of 5 years, then this should be reported on the
Strategic Executive Information System (STEIS). If the child is over 5 years old an
investigation should be undertaken to check if the child is known to another health
provider for example CAMHS or disability services. The findings of this investigation
will determine if a report is made.
36
Example B: the (seemingly deliberate) suicide of an adolescent
If the child has been in contact with health services then the report to the Strategic
Executive Information System (STEIS) and subsequent investigation should be
made by the main provider of those services e.g. the relevant mental health trust.
If the child has not had contact with health services, then the Commissioner should
make the report onto to the Strategic Executive Information System (STEIS) and
investigate the circumstances of the death. If it subsequently transpires that there
are no safeguarding issues then a request will be made to the Strategic Health
Authority to delete the record from the Strategic Executive Information System
(STEIS)
Scenario 3 – expected and unexplained child death - for example a child
expected to die but the cause of death is not explained by the condition (e.g. a
malignancy) who dies earlier than is expected or in unexplained
circumstances)
In this scenario, the incident should be reported on to the Strategic Executive
Information System (STEIS) as a child death by the organisation whose care the
patient was under. Following the investigation, if there are no suspicious
circumstances and no safety lessons to be learned, the investigation is referred to
the Child Death Overview Panel and the Primary Care Trust Commissioner will
request that the incident be deleted from the Strategic Executive Information System
(STEIS) by the Strategic Health Authority (paragraph 4.3 of this guidance also
applies).
Scenario 4 – expected and explained child death - for example a child with
malignancy who dies in appropriate circumstances
In this scenario, the incident does not need to be reported on to the Strategic
Executive Information System (STEIS) as long as the assessed and agreed package
of care has been delivered appropriately.
Scenario 5 – unexpected child death pronounced within an emergency
department –
For example a child is brought into the emergency department of an acute
trust. The child either requires lifesaving treatment and subsequently dies or is
pronounced dead on arrival
Assumption
The care of the child by the attending staff is within guidelines and there is nothing to
suspect the care of the child in the emergency department was substandard (if the
standard of care is suspect, the acute trust will report as a patient safety incident).
Outcome
The child death is reported to the rapid response team by the emergency
department. The acute trust will report the death to the Child Death Overview Panel
and the primary care trust child protection lead who will ensure that the incident is
37
reported onto the Strategic Executive Information System (STEIS) by the primary
care commissioner. The primary care trust child protection lead will make enquiries
into the child’s situation and ensure that an investigation is undertaken. The
investigation will involve the acute trust; however the lead investigating authority is
the primary care trust commissioner. If there are child safeguarding issues, the
incident will be reported to the Local Child Safeguarding Board. Investigations by the
Primary Care Trust Commissioner can be undertaken in conjunction with any
reporting to other bodies unless specifically prohibited by the Police.
Following the investigation, if there are no suspicious circumstances and no safety
lessons to be learned, the investigation is referred to the Child Death Overview
Panel and the Primary Care Trust Commissioner will request that the incident be
deleted from the Strategic Executive Information System (STEIS) by the Strategic
Health Authority (paragraph 4.3 of this guidance also applies).
Scenario 6 – suspected child abuse whilst under the care of an NHS
organisation
The incident will be reported on to the Strategic Executive Information System
(STEIS) as Child abuse (institutional) by the organisation whose care the child is
under.
Scenario 7 – suspected child abuse in the community –
For example, not known to health services but has died or has suffered
significant injuries as a result of abuse
This is dependent on how the abuse is uncovered. If it has been discovered by a
health worker then it should be reported on the Strategic Executive Information
System (STEIS). Where a case is discovered by other agencies, a report on the
Strategic Executive Information System (STEIS) will not be necessary, unless either
a Serious Case Review is initiated (any Serious Case Review should be reported on
STEIS) or there are alleged failings by health agencies or there is media interest in
any healthcare provided.
38
APPENDIX 5
Flowchart for the management of mental health homicide incidents
Homicide occurs. Mental Health
Trust informed of arrest by police
Mental Health Trust Lead
identified
Serious Incident
Requiring
Investigation (SIRI)
confirmed by Mental
Health Trust
Mental HealthTrust identifies
police contact and police
confirm the record number
SI logged onto STEIS as
grade 2 homicide
2 working days
15 working days
Mental Health Trust
completes initial service
management review report
within 72 hours
Terms of reference for
internal investigation are
agreed
Internal investigation undertaken
and report received and agreed
by Trust, Lead Commissioner
and NHSCB AT
60 working days
Internal investigation report and
action plan considered by Lead
Commissioner and NHSCB AT
Homicide Review Group
90 working days
39
Mental HealthTrust and NHSCB AT
communications team updated with progress
of investigation by Mental Health Trust Lead
5 working days
Liaison with police and other key stakeholders
regarding investigation process
Trust communications lead
liaises with NHSCB AT
communications lead to
develop a media handling
strategy
Decision made at NHSCB AT Homicide
Review Group to commission an
independent investigation. Letter sent
from Chair of SHA Homicide Review
group and Lead Commissioner
60 working days
Yes
Independent investigation commissioned
26 weeks
Independent investigation reported
Time-framed action plan developed from
the recommendations of the independent
investigation monitored by Lead
Commissioner and NHSCB AT.
Close incident only when assurance
received that all actions contained within
the action plan have been implemented
40
No
Close incident
when
assurance
received that
robust action
plan is in
place and
monitoring
arrangements
confirmed
APPENDIX 6
Root Cause Analysis Investigation Report
Serious Untoward Incident no:
Incident form no:
Authors:
Date Investigation commenced:
Final Report date:
Incident date:
Incident type:
Healthcare specialty:
Actual effect on patient and/or service:
Actual severity of the incident:
Level of investigation conducted
Terms of reference:
1.
Involvement and support of the patient and/or relatives
Involvement and support provided for staff involved
Detection of Incident
Information and evidence gathered
Investigation type, process and methods used
Summary of events
Care and Service Delivery Problems
Notable practice
Contributory Factors
41
Root Causes
Lessons Learned
Recommendations
Arrangements for Sharing Learning
Distribution list (The following list is not exhaustive and may be amended as appropriate)
Appendices
Time line
Author
Job title
Date
Chronology (timeline) of events –
Date & Time
Event
42
APPENDIX 7
Adult Safeguarding Flow Chart
43
APPENDIX 8
Child death
All deaths
(but excluding
still born
babies)
Child Safeguarding
Suspicious?
Death of an infant or child
(or murdered
by mentally ill
parent)
Unexpected?
Information
collected on
child
Interagency
Child Protection /
Criminal
investigation
Interagency Rapid Response
Final case
discussion
Coroner’s
Inquest
Serious Case
Review
Child Death
Review Team /
Overview Panel
44
Injury to a child where
abuse or neglect is known
or suspected.
Impairment through abuse
or neglect
Serious sexual abuse
A parent has been
murdered and a homicide
review has begun
Case gives rise to concern
about inter-agency working
to protect children from
harm
APPENDIX 9
INCIDENT AND RISK RATING
Risk Consequence Score
Descriptor
Injury
Patient
Experience
1
2
3
4
5
Insignificant
Minor
Moderate
Major
Catastrophic
Over three days off “sick” =
Major injuries, or long term
Minor injury not requiring Minor injury or illness, first aid
RIDDOR reportable. 10 days to incapacity / disability (loss of
first aid
treatment needed
report to the HSE.
limb)
Unsatisfactory patient
experience not directly
related to patient care
Unsatisfactory patient
Mismanagement of patient care Mismanagement of patient care
experience - readily resolvable
– short term effects
– long term effects
Totally unsatisfactory patient
outcome or experience
Below excess claim. Justified
complaint involving lack of
appropriate care
Multiple claims or single major
claim
Justified complaint peripheral to
Complaint /
Locally resolved complaint
clinical care
Claim Potential
Insignificant cost increase /
schedule slippage. Barely
noticeable reduction in
scope or quality
< 5% over budget / schedule
slippage. Minor reduction in
quality / scope
Service / Business
Loss / interruption > 1 hour
Interruption
Loss / interruption > 8 hours
Objectives /
Projects
Human
Resources /
Organisational
Development
Short term low staffing
level temporarily reduces
service quality (< 1 day)
Ongoing low staffing level
reduces service quality
Financial
Small loss(> £100)
Loss > £1,000
Inspection /
Audit
Claim above excess level.
Multiple justified complaints
5 -10% over budget / schedule 10 - 25% over budget / schedule
slippage. Reduction in scope or
slippage. Doesn't meet
quality requiring client approval
secondary objectives
Loss / interruption > 1 day
Loss / interruption > 1 week
Rumours
> 25% over budget / schedule
slippage. Doesn't meet primary
objectives
Permanent loss of service or
facility
Late delivery of key objective /
Non delivery of key objective /
service due to lack of staff
Uncertain delivery of key
service due to lack of staff. Loss
(recruitment, retention or
objective / service due to lack of
of key staff. Very high turnover.
sickness). Minor error due to
staff. Serious error due to
Critical error due to insufficient
insufficient training. Ongoing
insufficient training
training
unsafe staffing level
Loss > £10,000
Loss > £100,000
Enforcement Action. Low
Minor recommendations.
Reduced rating. Challenging rating. Critical report. Multiple
Recommendations given. NonMinor non-compliance with
recommendations. Nonchallenging recommendations.
compliance with standards
standards
compliance with core standards Major non-compliance with
core standards
Adverse Publicity
/ Reputation
Death or major permanent
incapacity
Local Media - short term
Local Media - long term
Risk Likelihood Score
1
Rare
Only occurs in exceptional circumstances, <1%, 1 – 5 year strategic risk
2
Unlikely
Could occur at some time, 1- 5%, at least annually
3
Possible
Should occur at some time, 6 – 20%, at least monthly
4
Likely
Will probably occur, 21 – 50%, at least weekly
5
Almost Certain
Expected to occur, > 50%, at least daily
45
National Media < 3 Days
Loss > £1,000,000
Prosecution. Zero Rating.
Severely critical report
National Media > 3 Days. MP
Concern (Questions in House)
Risk Rating
•
Insert frequency and severity scores on the risk assessment form and consult matrix (D) below
•
If a risk falls in one of the boxes numbered 15 - 25, immediate action required, so far as is reasonably practicable
•
If a risk falls in one of the boxes numbered 8 - 14, prompt action required, so far as is reasonably practicable
•
If a risk falls in one of the boxes numbered 4 - 7, risk reduction required, so far as is reasonably practicable
•
If a risk falls in one of the boxes numbered 1 - 3, further risk reduction may not be feasible or cost effective.
Risk Matrix
1.1
1.
Consequence
LIKELIHOOD
1
Insignificant
2
Minor
3
Moderate
4
Major
5
Catastrophic
1 - Rare
1
2
3
4
5
2 - Unlikely
2
4
6
8
10
3 - Possible
3
6
9
12
15
4 - Likely
4
8
12
16
20
5 - Almost Certain
5
10
15
20
25
46
APPENDIX 10
Pressure Ulcer Investigation
Investigating Officers/Report Authors:
Designation
Date of Report:
Patient Details: (initials only)
Male/Female
DOB:
Date admitted to service/caseload:
Pressure Ulcer Details:
Type :
Grade:
Size:
Location:
For patients where there is more than one pressure ulcer – repeat the process above
Date Identified:
Is this a new pressure Ulcer?
YES/NO
Deterioration of Pressure Ulcer? From 1 2 3 (circle)
Present on admission to service
YES / NO
Where was the pressure ulcer acquired?
Detail of other services involved in care:
Describe approach taken with patient/and or carers
Brief Description of incident detection and background.
Immediate Actions taken:
Findings
47
– (see timeline, barrier analysis and/or fishbone)
Conclusions
Recommendations
1.
2.
3.
4.
Once the recommendations have been accepted these should be transferred to the
Action Plan with the relevant solutions for action
48
APPENDIX 11
Somerset CCG is committed to providing equal access to healthcare services to all members of the community. To achieve
this, gathering the following information is essential and will help us ensure that we deliver the most effective and appropriate
healthcare. Responding to these questions is entirely voluntary and any information provided will remain anonymous.
What is your age? please write in the box below
 Prefer not to state
What is your gender?
 Male
 Prefer not to state
 Female
Do you/have you ever identified yourself as trans or transgender?
 Yes
 No
 Prefer not to state
What is your status?
 Prefer not to state
 Single
 Married
 Widow(er)
 Separated
 Civil partnership (same sex partnership)
 Divorced
 Co-habiting (living together)
 Other
Are you a carer? for a relative or friend
 Yes
 No
 Prefer not to state
Are you pregnant or have you had a baby in the last six months?
 Yes
 No
 Not applicable
 Prefer not to state
Which of the following best describes how you think of yourself?
 Prefer not to state
 Heterosexual (attracted to the opposite sex)
 Bisexual (attracted to both sexes)
 Lesbian/Gay (attracted to the same sex)
 Other
Do you consider that you have a disability?
 Yes
 No
 I don’t know
If yes, how would you describe your disability?

 Sensory
 Learning
 Mental Health
 Physical
 Other ____________________________
 Prefer not to state
Prefer not to state

Prefer not to state
 No Religion
 Other Religion/Belief ______________
Do you have a religion or belief?
 Buddhism
 Islam
 Christianity
 Judaism
 Hinduism
 Sikhism
Please tell us your ethnic group

Prefer not to state
White
 British
 Irish
 Gypsy, Romany or other traveller heritage
Any other White background, please state
___________________________________
Dual-Heritage
 White and Black Caribbean
 White and Asian
 White and Black African
Any other Dual-Heritage, please state
___________________________________
Asian or Asian British
Indian
 Pakistani
 Bangladeshi
 Any other Asian background, please state
___________________________________
Black or Black British
 Caribbean 
African
Any other Black background, please state ___________________________________
Chinese or other ethnic group

Chinese
Any other ethnic background, please state ___________________________________
49
APPENDIX 12
Independent Contractor Pathway in respect of commissioned services
Incident/SEA/SIRI
received in the Patient
Safety Team
Details logged onto the
Datix Risk Management
System
Meeting to agree grading of incident,
level and scope of Investigation
Identify GP Patient Safety
Lead / Professional Adviser
to undertake RCA
Investigation and formally
notify including Terms of
Reference and RCA
Template
Notification to
the Local
Professional
Network
Agree Timescales and
Terms of Reference for
Investigation
Grade 1 – 45 working
days
Grade 2 – 60 working
days
Midpoint progress meeting with investigator and
Patient Safety Team member to review draft report
and if further escalation is required.
RCA Report to SI
Review and request
action plan if Grade 2
Final RCA Report to Patient Safety
and Quality Assurance Committee
Feedback to Reporting Organisation
including Action Plan
50
APPENDIX 13
SOMERSET NHS 111 REPORTING PROCESS FOR INCIDENTS, COMPLAINTS, CLAIMS AND HEALTH PROFESSIONAL FEEDBACK
Incident
Complaint
Claim
Health Professional
Feedback
NHS 111 Provider management systems
(response and feedback)
Immediate action
to mitigate risk
Weekly summary report
(all cases)
Assessment of
severity and type
of incident
Provider/Multi agency
investigation
Report of SIRI to Somerset CCG 111 Clinical
Lead within 2 hours
(Patient Safety Team)
Investigation and reports produced in
line with local agreement/National
Guidance
Somerset 111 Incident
Review Group convened
Report to Somerset 111 Clinical
Lead/Clinical Assurance Committee
Action Plans monitored by
Clinical Assurance Committee
Learning and recommendations
identified and implemented
51
Bi-monthly exception report to
Patient Safety and Quality
Assurance Committee
APPENDIX 14
SERIOUS INCIDENT REQUIRING INVESTIGATION
COMMUNICATION TEMPLATE
Patient Name:
……………………………………………………………………
………………………………………….
Patient Address:
……………………………………………………………………
……
……………………………………………………………………
……
Town …………………….. Post Code
Day _ / _ Month _ / _ Year _ / _ /
…………………………
_/_/
Date of Birth:
NHS Number:
…………………………………………………
…………………………
Date of Admission:
Day _ / _
_/_/
Month _ / _ Year _ / _ /
Patient in receipt of care, prior to admission:
If YES, which organisation:
YES/NO *delete as applicable
…………………………………
…………………..
Name of Professionals involved: ……………………………………………………
…………………………..
Incident type:
………………………………………………………………………
…………………………………….
Reported on STEIS:
If YES, STEIS Number:
YES/NO *delete as applicable
…………………………………
………………….
Contact Details:
Name:
……………………………………………………………………..
Email:
…………………………………………………………………….
Telephone:
………………………………………………………………
52
APPENDIX 16
Serious Incident/Patient Safety Incidents
Nursing Homes
A serious incident is defined in the NHS Standards Care Home Services Contract)
as follows: „means an incident or accident or near-miss where a patient (whether or not
a service user), member of staff, or member of the public suffers serious injury, major
permanent harm or unexpected death and where the actions of the provider, the staff or
the commissioner is likely to be of significant public concern‟ .
A patient safety incident is defined in the NHS Standards Care Home Services
Contract as follows: „means any unintended or unexpected incident which could have
led or did lead to harm to one or more service users receiving NHS funded care‟ .
This appendix focuses on how the care delivered in care homes with or without nursing
and other private providers where some or all of the care is funded by Somerset CCG
can be incorporated into the Serious Untoward Incident (SUI) policy for Somerset CCG.
It is recognised that one of the key elements is to ensure any SUI that occurs whilst the
care is being delivered by a private provider is reported in a timely way to Somerset
CCG if it applies to residents that are funded by Somerset CCG. .
A serious incident requiring investigation (SUI) is defined as an incident that occurred in
relation to NHS-funded services and care resulting in one of the following:
unexpected or avoidable death of one or more patients, staff, visitors or members
of the public
serious harm to one or more patients, staff, visitors or members of the public or
where the outcome requires life-saving intervention, major surgical/medical
intervention, permanent harm or will shorten life expectancy or result in prolonged
pain or psychological harm (this includes incidents graded under the NPSA
definition of severe harm)
a scenario that prevents or threatens to prevent a provider organisation’s ability
to continue to deliver healthcare services, for example, actual or potential loss of
personal/organisational information, damage to property, reputation or the
environment, or IT failure
allegations of abuse in relation to the provision of healthcare
adverse media coverage or public concern about the organisation or the wider
NHS
there is a local expectation that grade 3 and above pressure ulcers will be
reported as SUI‟ s as noted in the contracts where these relate to patients who
are in receipt of fully NHS funded care
there is a local expectation that C.Diff deaths which are reported in part 1 and 2
of the death certificate will be reported as a SUI, following the SHA C.Diff review
Mismanagement of patient’s condition (inappropriate management, lack of risk
assessments) that results in significant harm or places the person at risk of
significant harm
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Failure with medical equipment, leading to harm, including inappropriate
operation of equipment where the care provided for the patient and the
equipment is funded by NHS continuing care
Large number of low level harm incidents indicating poor level of Healthcare
service delivery that affects patient outcomes
Areas for reporting
Unexpected Death where the patient has been under active health care
management or intervention.
Complaint/concern/allegations about the standards of patient care where there
has been serious harm to the patient or a near miss
Unplanned admission where you would expect the needs to have been met by
the care provider
Failure to report significant changes in the patient’s condition
Medication error resulting in serious harm or a near miss
Pressure sore Grade 3 and above for patients who are in receipt of fully funded
NHS continuing health care or where these have developed under the provision
of NHS care.
MRSA bacteraemia
Falls that cause harm resulting in hospital admission where there they are
concerns about the risk assessment and management plans for those individuals.
Serious Untoward Incidents for Nursing Homes should be reported to the Patient Safety
Team at Somerset CCG as soon as is reasonably possible.
This does not affect the need to report to the regulatory body such as CQC or to make a
safeguarding referral under the Somerset Safeguarding Policy.
Once reported it will be agreed by all relevant organisations that are involved/concerned
who will undertake the necessary investigations and produce an overarching report,
through this process agreed timeframes will be built into the Terms of Reference for the
investigation. If the process also involves CQC and/or adult social care under
safeguarding then agreement will be sought with all relevant agencies as to who will lead
on the process and undertake the investigation, following the relevant safeguarding and
SUI procedures.
Feedback
It is important to share the lessons learnt from incidents and therefore a copy of the Root
Cause Analysis report will be shared with the nursing home and staff involved with the
incident. In accordance with the being open policy, Somerset CCG will ensure that
patients and their family are kept informed throughout the process. There will also be the
opportunity of a debrief meeting offered.
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All Never Events are graded as Grade 2 serious untoward incidents. There may need to
be discussion between the NHS provider, commissioner and strategic health authority to
agree that an incident meets the criteria for a Never Event and the associated grading.
Never Event investigations will be carried out by the NHS Commissioner.
The core list of never events published in 2012/2013 that are relevant to residents in
care homes are as follows;
The core list of Never Events
MEDICATION EVENTS
4. Wrongly prepared high-risk injectable medication
Description: Death or severe harm as a result of a wrongly prepared high-risk injectable
medication.
High-risk injectable medicines are identified using the NPSA‟ s risk assessment
tool. A list of high-risk medicines has been prepared by the NHS Aseptic
Pharmacy Services Group using this tool†. Organisations should have their own
list of high-risk medications for the purposes of the “never event” policy, which
may vary from the NHS Aseptic Pharmacy Services Group list, depending on
local circumstances.
A high risk injectable medicine is considered wrongly prepared if it was not;
- prepared in accordance with the manufacturer's Specification of Product
Characteristics;
- prepared in accordance with a protocol formally agreed by the local
organisation (for example for off-label or unlicensed product use);
- prepared in accordance with patient specific directions of a prescriber in an
urgent or emergency situation and supported by evidence or expert advice.
This event excludes any incidents that are covered by other “never events”.
Where death or severe harm cannot be attributed to incorrect preparation, treat
as a Serious Untoward Incident.
Setting: All healthcare settings
7. Wrong route administration of oral/enteral treatment
Description: Death or severe harm as a result of oral/enteral medication, feed or flush
administered by any parenteral route.
Setting: All healthcare settings.
9. Maladministration of Insulin
Description: Death or severe harm as a result of maladministration of insulin by a
health professional.
Maladministration in this instance refers to when a health professional
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uses any abbreviation for the words „unit‟ or „units‟ when prescribing insulin in
writing,
issues an unclear or misinterpreted verbal instruction to a colleague,
fails to use a specific insulin administration device e.g. an insulin syringe or
insulin pen to draw up or administer insulin, or
fails to give insulin when correctly prescribed.
Setting: All healthcare premises
11. Opioid overdose of an opioid-naïve patient
Description: Death or severe harm as a result of an overdose of an opioid given to a
patient who was opioid naïve. Specifically this means:
Where a dose is used that is not consistent with the dosing protocol agreed by
the healthcare organisation, or the manufacturer’s recommended dosage for
opioid-naïve patients*.
Where the prescriber fails to ensure they were familiar with the therapeutic
characteristics of the opioid prescribed.
Excluded are cases where the patient was already receiving opioid medication.
Setting: All healthcare settings
12. Inappropriate administration of daily oral methotrexate
Description: Prescription, supply or administration of daily oral methotrexate to a patient
for non-cancer treatment including supply to the patient with the instruction to take daily.
Excludes cancer treatment with daily oral methotrexate
Excludes where the error is intercepted before the patient is supplied with the
medication.
Setting: All healthcare settings
GENERAL HEALTHCARE
15. Falls from unrestricted windows
Description: Death or severe harm as a result of a patient falling from an unrestricted
window.
Applies to windows “within reach” of patients. This means windows (including the
window sill) that are within reach of someone standing at floor level and that can
be exited/fallen from without needing to move furniture or use tools to assist in
climbing out of the window
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Includes windows located in facilities/areas where healthcare is provided and
where patients can and do access.
Includes where patients deliberately or accidentally fall from a window where a
restrictor has been fitted but previously damaged or disabled, but does not
include events where a patient deliberately disables a restrictor or breaks the
window immediately before the fall.
Setting: All healthcare premises
16. Entrapment in bedrails
Description: Death or severe harm as a result of entrapment of an adult in bedrails that
do not comply with Medicines and Healthcare products Regulatory Agency (MHRA)
dimensional guidance.
Setting: All adult inpatient care premises
19. Misplaced naso or oro-gastric tubes
Description: Death or severe harm as a result of a naso or oro-gastric tube being
misplaced in the respiratory tract.
Setting: All healthcare premises
21. Failure to monitor and respond to oxygen saturation
Description: Death or severe harm as a result of failure to monitor or respond to oxygen
saturation levels in a patient undergoing general or regional anaesthesia, or conscious
sedation for a healthcare procedure (e.g. endoscopy).
Includes failure to physically have monitoring in place, and failure to act on
relevant information from monitoring oxygen saturation.
Excludes where action is taken in response to recorded adverse oxygen
saturation levels, but this fails to prevent death or severe harm for other reasons
(e.g. pre-existing problems with oxygenation that cannot be resolved).
Excludes incidents where the accepted limitations of monitoring equipment mean
that adverse readings may be artefactual (e.g. shock/vasoconstriction).
Setting: All healthcare premises
23. Misidentification of patients
Description: Death or severe harm as a result of administration of the wrong treatment
following inpatient misidentification due to a failure to use standard wristband (or identity
band) identification processes.
failure to use standard wristband identification processes means;
failure to use patient wristbands that meet the NPSA‟ s design requirements,
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failure to include the four core patient identifiers on wristbands – last name, first
name, date of birth and NHS number,
failure to follow clear and consistent processes for producing, applying and
checking patient wristbands,
printing several labels with patient details at one time.
This event excludes where the patient refuses to wear a wristband despite a clear
explanation of the risks of not doing so, or where it has been documented that the
patient cannot wear a wristband due to their clinical condition or treatment, or in
emergency care environments where high patient turnover, insufficient patient identity
information, or the need for rapid treatment can delay wristband use.
Setting: All healthcare premises
24. Severe scalding of patients
Description: Death or severe harm as a result of a patient being scalded by water used
for washing/bathing.
Excludes scalds from water being used for purposes other than washing/bathing (eg
from kettles)
Settings: All healthcare premises
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