Serious Untoward Incidents Policy

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					Serious Untoward
 Incidents Policy




      July 2008
                           Contents
  1. Introduction

  2. Definition of a serious untoward incident

  3. Reporting responsibilities

  4. Reporting process

  5. Role of the commissioner

  6. Role of the Strategic Health Authority

  7. Special Circumstances

        7.1 Maternal deaths
        7.2 Information security incidents
        7.3 Healthcare associated infections
        7.4 Mental Health Settings (including homicides)
        7.5 Safeguarding Children
        7.6 Death in custody
        7.7 Placement of children on adult psychiatric wards

Appendices

A - Flowchart for EOE SUI Process

B – SHA SUI Assessment Levels

C – SHA SUI Closure Form Template

D – SHA Quarterly Reporting Form Template

E – Maternal Deaths – definitions

F - Confidentiality and Data Loss DH Guidance

G - Flowchart for Homicide Investigations (mental health
    services)

H – Flowchart Safeguarding Children Investigations




                      Page 2 of 25
Document control



Name: Gt Yarmouth and Waveney PCT Serious Untoward Incident Policy

Version: Final

File location: W: Risk Management/SUI/Policy Documents/GYW SUI Policy 2008

Date of this version: July 2008

Produced by: Andy Peck, Head of Estates and Risk Management

Reviewed by: Integrated Governance Committee
             PCT Board

IGC approval at meeting on: 11/08/08

Board Approval: **/09/08

To be distributed to: All Directors for distribution to all staff and all Commissioned or
Contracted Service Providers
Copy Available on Harbourlights, PCT intranet site


Due for review: July 2008


Enquiries relating to this Policy to:
Andy Peck, Head of Estates and Risk Management or
Jackie Nemrova, Head of Integrated Governance




                                     Page 3 of 25
1. INTRODUCTION
This policy establishes a clear procedure to be adhered to following a Serious
Untoward Incident (SUI) in people’s health care. It is designed to help NHS
organisations take appropriate steps in the best interests of their
patients/clients/service users, staff and the NHS as a whole. It contains the
minimum reporting requirements expected in the East of England. Individual
PCTs will in the first instance, receive all SUIs reported by their commissioned
services and may also have set additional requirements through their
commissioning and quality monitoring processes. The PCT will then ensure
that the SHA is made aware of the SUI that has been raised with them.

The role of the Commissioning PCT in dealing with serious untoward incidents
is to ensure that:

      SUIs are thoroughly investigated

      Action is taken where necessary, to improve clinical quality and patient
       safety

      Lessons are learned in order to minimise the risk of similar incidents
       occurring in the future and that learning is shared across the wider
       health community

      Commission independent investigations if there is a statutory
       requirement to do so
Whilst Foundation Trusts are not obliged to report SUIs to the SHA we seek
voluntary agreement that they should do so. There is an expectation that all
SUIs must be robustly investigated and associated action plans implemented.
The SHA does expect that SUIs will be reported to their commissioning PCT.
PCT contracts with providers, including Foundation Trusts and independent
providers of NHS funded care should be drawn up to reflect this practice.

The Standard NHS Contract for Acute services in the East of England states:-
The Parties shall comply with the arrangements for notification and
investigation of Serious Untoward Incidents agreed between the Provider and
the Co-ordinating Commissioner and as set out in Schedule 12 (Serious
Untoward Incidents and Patient Safety Incidents). (15.2)

2. DEFINITION OF A SERIOUS UNTOWARD INCIDENT

2.1 The principle definition of a SUI is any incident on an NHS site, or
elsewhere, whilst in NHS-funded or NHS regulated care involving:

      NHS patients/clients/service users, relatives or visitors or

      Staff, including students undertaking clinical or work experience and/or
       their tutors, or

      Contractors, equipment, building or property



                                 Page 4 of 25
2.2 Which meet one or more of the following criteria:

   1. Causes death or serious injury or was life threatening.

   2. Contributes to a pattern of sustained reduction in standards of care that
      the provider or commissioner identifies as being below agreed
      minimum safe standards.

   3. Involves a hazard to public health, including major toxic contamination
      or radiation hazard.

   4. Involves the absconding or escape of a detained mental health patient
      who is considered at risk to themselves or others in that they:
            May cause death and serious injury.
            May pose a significant risk to the public.
            May seriously disrupt service delivery.
            May generate significant negative publicity.
            May be a risk to themselves
   5. Causes significant disruption to services.

   6. Causes significant damage to the reputation of an NHS organisation or
      its staff.

   7. Relates to fraud or suspected fraud (the procedure in HSC (99) 062
      must also be observed in parallel).

   8. May, or did, give rise to a significant claim for damages or to legal
      proceedings.

   9. Has involved the exclusion (suspension) of a member of clinical staff,
      or a student on clinical attachment, for reasons associated with patient
      care, which are potentially high impact.

   10. Raises concern following an inquest OR is likely to cause significant
      interest at an inquest.
   11. Involves an episode of restraint, which does not comply with National
      and Trust policy, and results in trauma to patients or staff.

   12. Involves significant health care associated infections, as defined by
      Health Protection Agency, for example, an outbreak of infection, failure
      in decontamination or infected healthcare worker. An individual
      bacteraemia would not be classified under this policy as a SUI unless
      another criterion from this list also applies.

   13. Is a death in custody e.g. prison, probation hostels and immigration
      detention accommodation. Including expected deaths natural causes.
      Guidance on clinical reviews undertaken in those circumstances and
      the responsibilities of the NHS are available from the regional Health
   and Social Care in Criminal Justice Team amanda.hawkins@eoe.nhs.uk.



                                Page 5 of 25
2.3 Excluded from this definition are adverse outcomes reasonably associated
with routine NHS activity such as major surgical procedures or radiotherapy
treatment.

A near miss in relation to any of the above should also be recorded by NHS
organisations and potential trends analysed. Any emerging trends, which
constitute a significant risk in any of the above categories, should be reported
using this protocol.
Organisations are advised to err on the side of caution. Advice can be sought
from the PCT commissioner of the service and/or the Clinical Quality and
Patient Safety Team at the East of England SHA (01223 597624).


3. OTHER RESPONSIBILITIES RELATED TO REPORTING SUIs

Reporting an incident to the PCT commissioner which is then raised with the
SHA does not remove any responsibility to comply with national guidance
issued by the Department of Health or other organisations such as the
National Patient Safety Agency (NPSA). In such circumstances, the
procedures in this document should be followed in conjunction with the
relevant guidance.

This policy must not interfere with existing lines of accountability and does not
replace the duty to inform the police and/or other organisations or agencies
where appropriate. Further guidance can be obtained from the Department of
Health publication “Memorandum of Understanding - Investigating Patient
Safety Incidents, June 2004” and accompanying NHS guidance of December
2006.
http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPo
licyAndGuidance/DH_4129918

Reporting managers must comply with the Caldicott principles of
confidentiality when reporting SUIs and must not refer to patients or
staff by name or by any other identifiable information. A reference code
should be utilised on all forms/reports or associated correspondence to
the PCT and/or SHA but this should NOT be the patients NHS Number or
include their initials.

Managers should be aware of Department of Health guidance that may
exempt details of individual serious untoward incident reports being made
available to third parties, under either or both Sections 31(2) and Section 40
(2 & 3) of the Freedom of Information Act 2000.

When an incident or incidents are of such a serious nature that an external
and/or independent investigation is required, it will need to be established in
line relevant national guidance for example HSG (94) 27 and associated
amendment. The responsibility for commissioning an external investigation
depends on the nature of the incident. Such incidents are expected to be
discussed with the SHA prior to establishing the investigation.



                                 Page 6 of 25
4. REPORTING PROCESSES FOR SERIOUS UNTOWARD INCIDENTS
Once an organisation providing NHS care has decided that a SUI fits the East
of England reporting criteria, the SUI should be reported within 1 working day
using the East of England Excel SUI Electronic Report Form (separate
attachment), which should be completed by the relevant member of staff
within the NHS organisation. When completed, it should be emailed to the
Lead Commissioner of the Service.

                            gyw-pct.sui@nhs.net

The Commissioner will then immediately forward a copy via its own secure
e-mail account, to the Clinical Quality and Patient Safety Team at the
Strategic Health Authority via its secure e-mail address only:

                            eoesha.SUI@nhs.net
The SHA will assess whether the situation requires further escalation and if so
they will agree any action that needs to be taken with the relevant NHS
organisation. Where there is a communication component to the incident
information will be shared with the SHA communications team, to enable any
confidential briefing to the Department of Health Media Centre to be made.
Therefore organisations should be prepared to provide further details required
for this purpose at short notice.

                    Incidents reported during office hours.

Where the incident has very significant implications for the NHS in terms
of clinical, managerial or media issues, the Trust and/or PCT are expected
to contact the SHA Clinical Quality and Patient Safety team directly.

SHA Clinical Quality and Patient Safety Team: 01223 597624/782

                     Incidents occurring out of office hours

Where the incident has very significant implications for the NHS in terms of
clinical, managerial or media issues, the organisation providing NHS care
must contact the On-Call Director for the Commissioner who will contact the
On-Call SHA senior manager.

   Commissioner Director On-Call contactable by ringing Medicom on
                           01603 481202
     SHA Senior Manager on Call Tel: 07699 732431 (on call pager).

A message should leave a message indicating that you have a serious
untoward incident that you need to alert the SHA to. You should provide
the contact details of the individual dealing with the SUI but no further
details of the incident itself on this messaging system.




                                Page 7 of 25
PCT Commissioner contact: Jackie Nemrova 01502 719522 or Andy
Peck 01502 719579.


Minimum reporting standards for SUIs are:

       1 working day for receipt of the Serious Untoward Incident form by the
        SHA - once the decision has been made to inform the PCT
        commissioner and SHA.
       Brief update in 72 hours for very serious SUIs (as indicated by the
        SHA) and within 7 days for others, to identify any immediate actions
        taken as a result of the incident and/or any additional relevant
        information that may have emerged during the trust’s immediate
        investigation.
       Root cause analysis (or a similar process to establish a chronology,
        identify underlying causes and what further action needs to be taken),
        with accompanying action plan within 45 days. This may be extended
        on a case-by-case basis where a delay is necessary for example whilst
        awaiting the results of criminal investigations or an inquest.

5. THE ROLE OF COMMISSIONERS

Through the commissioning arrangements and quality monitoring systems
within PCTs, all PCT commissioners will ensure that:

       The originating trust, or provider arm of a PCT, or other organisations
        providing NHS care, informs the Lead Commissioner of a SUI via the
        SUI reporting system.
       SUIs are monitored, reports and investigations scrutinised and
        appropriate actions are implemented by the reporting organisation.

       The SHA is fully briefed on SUIs within their commissioned services
        and provided with a quarterly update utilising the SHA template
        appended to this policy (Appendix D).

       Measures are in place to manage any potential press and media
        interest with briefings to the SHA communications team as required.

       The dissemination of wider learning takes place locally and in
        conjunction with SHA regional processes for sharing anonymised
        cases, trends and themes.


6. THE ROLE OF THE SHA

The role of the SHA in monitoring serious untoward incidents is to ensure that
they are properly investigated, action is being taken to improve clinical quality



                                 Page 8 of 25
and patient safety and lessons are learned in order to minimise the risk of
similar incidents occurring in the future. See Appendix A.
The SHA will:
      Ensure PCTs, through their commissioning arm are performance
       managing SUIs occurring in their commissioned service. Reviews will
       occur on a quarterly basis between the SHA SUI case manager and
       the PCT.

      Ensure all SUIs reported to the SHA are assigned a case manager who
       will assess the level of seriousness designated by the SHA and this will
       reflect their continued role in the SUI process (see appendix B).

      Maintain an overview of SUIs across the East of England and for the
       more high level SUIs (Level 3), decide with commissioners and the
       Trust concerned, what additional support/action may be required.

      Undertake thematic trend analysis across East of England

      Ensure that the wider implications and key learning points are
       disseminated across the East of England

      Undertake specific investigations as directed by national guidance or
       the SHA Board on those incidents (or clusters of incidents) that require
       further external investigation.

      Ensure measures are in place to manage any potential press and
       media enquiries and if necessary inform the Department of Health
       Media Centre and the Ministerial Briefing Unit.

7. SPECIAL CIRCUMSTANCES

Some serious untoward incidents require further attention in respect of the
process applied. These incidents are likely to be assigned as Level 3 SUIs
due to the nature of their severity and or sensitivity.

7.1 Maternal Deaths (Appendix E)

In order to comply with NMC Midwives Rules and Standards 2004 ALL
maternal deaths are to be reported to the Local Supervising Authority
Midwifery Officer (LSAMO). This will be via the LSA Coordinator on 01223
597568 or via their secure email address and sent from a secure e-mail
address to:
                     eoesha.matsui@nhs.net

CEMACH (Confidential Enquiry into Maternal and Child Health) reporting will
continue in the normal way.




                                Page 9 of 25
NB Although not all maternal deaths are classified as serious untoward
incidents the EOE electronic SUI reporting form should be utilised in all
cases being notified to the LSAMO.

7.2 Information security incidents (see appendix F)

The reporting of SUIs relating to breaches of confidentiality involving person
identifiable data and data losses should be reported to the SHA in accordance
with Department of Health Gateway letter 9571 dated 29 February 2008 and
refer to the definitions and risk assessment methods contained in Annex B
(see Appendix F). The SHA will utilise the risk assessment matrix in the DH
guidance to determine the SHA level of seriousness applied to the incident.
The SHA will publish a quarterly report of such incidents on its website in
accordance with the Gateway letter.

Further to this all SUIs involving data losses and breaches in confidentiality
should be published in the annual reports of all EOE NHS organisations from
2007/8 in accordance with Department of Health Gateway letter 9912 dated
20 May 2008 utilising the format at Annex A of the gateway letter.


7.3 Healthcare Associated Infections

Some incidents involving infections (including Healthcare Associated
Infections) should be reported to Commissioners/PCTs and the SHA via the
East of England SUI reporting process. The categories for reporting include:
         Outbreaks of healthcare associated infection (this includes the
           presumed transmission within a hospital and causes significant
           morbidity/mortality and/or impacts significantly on hospital activity)
         Infected healthcare workers (incidents which necessitate
           consideration of a look back exercise)
         Breakdown of infection control procedures/serious decontamination
           failures with actual or potential for cross infection
         Other high profile infection incidents that meet the general SHA SUI
           reporting criteria

The normal SUI reporting process should be followed and a full systematic
investigation (using Root Cause Analysis) must be undertaken and copy sent
to the PCT and SHA, together with any action plan. The PCT will ensure
ongoing monitoring of any action plan with the SHA ensuring that
implementation is assured and outcomes of actions are also monitored by the
PCT.

Epidemiological data fro reported SUIs will be shared with the HPA to allow
further epidemiological studies to take place. Trusts may therefore be required
to provide additional information in these circumstances.

The Trust/PCT will manage the SUI with advice and support from colleagues
in the Health Protection Agency; however the SHA has an identified team to



                                Page 10 of 25
provide additional advice, support and guidance to you both in the reporting
and management of ongoing infection incidents.

Their contact details are:

       Clinical Quality and Patient Safety Team (reporting of incidents): 01223
        597624/782
       Rosie Readman, SHA Infection Control Programme Manager: 01223
        597518, Mobile: 07977 437404
       Dr Linda Sheridan, NHS Head of Public Health (Consultant in Public
        Health Medicine), SHA Lead for Health Protection including Healthcare
        Associated Infection 01223 597507

    N.B. Root Cause Analyses on individual MRSA Bacteraemia should
    NOT be sent via the SUI reporting process but sent directly to the
    SHA Infection Control Programme Manager.


7.4 Mental health services incidents including homicides involving
service users (see appendix G)

7.41 In June 2005 Department of Health (DH) issued new guidance on the
independent investigations of serious patient safety incidents in mental health
settings. This aimed to improve investigations and to help ensure a consistent
approach across the National Health Service (NHS). It replaced paragraphs
33 –36 in HSG (94) 27 and (LASSL (94)4), concerning the conduct of
independent inquiries into mental health services1.

It is the responsibility of the Strategic Health Authority (SHA) to commission
independent investigations and there are clear criteria that determine the
need for one.
      When a homicide has been committed by a person who is, or has
         been, under the care, i.e. subject to regular or enhanced care
         programme approach, of specialist mental health services in the six
         months prior to the event. N.B. All homicide cases will be
         designated as SHA Level 3
      When it is necessary to comply with the State’s obligations under
         Article 2 of the European Convention on Human Rights. Whenever a
         State agent is, or may be, responsible for a death or where the victim
         sustains life threatening injuries, there is an obligation on the State to
         carry out an effective investigation. This means that the investigation
         should be independent, reasonably prompt, provide a sufficient
         element of public scrutiny and involve the next of kin to an appropriate
         extent.
      Where the SHA determines that a serious patient safety incident
         warrants an independent investigation, for example if there is concern
         that an event may represent significant systemic service failure,
         such as a cluster of suicides.

1 http://www.dh.gov.uk/assetRoot/04/11/35/74/04113574.pdf


                                       Page 11 of 25
7.42 The process needed for the three stages of the independent
investigation process are:

1. Initial service management review: an internal trust review within 72
   hours of the incident being known about in order to identify any necessary
   urgent action.
2. Internal NHS mental health trust investigation: using Root Cause
   Analysis (RCA) or similar process to establish a chronology, identify
   underlying causes and what further action needs to be taken. This would
   usually be completed within 45 days of the incident.
3. SHA independent investigation: Commissioned and conducted
   independently of the providers of care.

Further information can be sought from the NPSA guide on best practice
http://www.npsa.nhs.uk/patientsafety/alerts-and-directives/directives-
guidance/mental-health/


7.5 Safeguarding children (see appendix H)

As part of Commissioning a Patient Led NHS the SHA ceased to be a
member of all 10 Local Safeguarding Children’s Boards but it will discharge its
responsibilities in 2 key ways;
7.51 By holding PCTs to account for the delivery of their function and all other
organisations from whom they commission, in relation to Safeguarding
Children. The SHA would also use its Regional Partnerships and relationship
with the Inspectorates to both support and ensure NHS organisations deliver
their Safeguarding Children responsibilities.

7.52 Ensuring that the Serious Untoward Incident (SUI) reporting mechanisms
are used to report any alleged or actual non accidental death/serious injury to
children. Then through the performance management of the SUIs, ensure that
appropriate actions are taken by NHS organisations in response to the
findings of any serious case review panels.

This SUI policy incorporates best practice in investigations as part of any
serious case review process and the coordination of action plans to be
monitored by commissioners in PCTs. The Clinical Quality and Patient Safety
Team will assure that robust investigations are undertaken by NHS
organisations and all actions implemented via the performance management
of PCTs.


7.6 Death in custody

Where Deaths in Custody occur the appropriate guidance should be followed.
Guidance on clinical reviews undertaken in those circumstances and the
responsibilities of the NHS are available from the regional Health and Social
Care in Criminal Justice Team, amanda.hawkins@eoe.nhs.uk.


                                Page 12 of 25
7.7 Use of adult psychiatric wards for children aged 16 and under

In accordance with Department of Health Gateway letter 8390 dated 29 June
2007 where a child of 16 or under is placed on an adult ward the SHA should
be immediately notified, the notification should include how the child will be
moved to appropriate accommodation within 48 hours and in the intervening
time, how the ward and staffing have been made appropriate to the child's
needs. For 16/17 year olds placed on adult wards the SHA will need to be
assured that it is an appropriate placement (in line with best practice set out in
the NSF)

The SHA and Commissioning PCT have agreed that the most effective way of
alerting the SHA if you do have to place a child on an adult ward is to use the
SUI reporting mechanism and the East of England SUI reporting form. This
should be sent to the SHA and your PCT commissioner via the dedicated
secure SUI email address. You will need to provide an update by 48 hours to
demonstrate that plans have been implemented.




                                 Page 13 of 25
SERIOUS UNTOWARD                                                           APPENDIX A
INCIDENT PROCESS



                        Incident occurs in NHS organisation
                           Internal reporting mechanism
                     Decision to report to Commissioner & SHA


                             EoE SUI Report Form
                  completed and Trust investigation commences



            PCT Commissioner                         SHA informed
                informed


                            Assessment of severity level



        LEVEL 1                       LEVEL 2                        LEVEL 3
                                                                     (Highest
       SUI Process                 SUI Process                       Severity)
        Managed                     Managed &
       & monitored                 monitored by                        Joint
         by PCT                      PCT with                      monitoring &
                                   advice from                    management of
                                      SHA if                      SUI process by
                                    necessary                      SHA & PCT



       Requirement of Update/Interim Report in 72 hours (level 3) → 1 week
                      Update scrutinised by SHA and/or PCT
         Immediate action may be necessary to safeguard other patients


                    Completion of Investigation via RCA 45 days
                     (Dependent on criminal investigation etc.)


    Report scrutinised by SHA and/or PCT for robustness of investigation
                               & Action Plan


       LEVEL 1                       LEVEL 2                 LEVEL 3
     ACTION PLAN                   ACTION PLAN             ACTION PLAN
                                  PCT Monitors            PCT Monitors
     PCT Monitors                Overview by SHA          SHA Ensures
                                                         implementation
                                                                                   … continued
                                        APPENDIX A (Continued)




          Ensuring Action Taken and Lessons Learned




LEVEL 1                    LEVEL 2                  LEVEL 3




                                                Monitoring by
     Quarterly monitoring                        SHA & PCT
       of PCT by SHA



                                               Case Closed
          Case closed                         Lessons learnt

    Lessons learnt shared                   Individual, thematic,
     with SHA and locally                     trend analysis and
                                             learning shared via
                                                networks, web,
                                                  newsletter,
                                                 conferences,
                                            workshops, ‘Patient
                                             Safety Programme’




                        Page 15 of 25
                                                                 APPENDIX B



                      SHA SUI Assessment Levels



SHA LEVEL    MONITORING                       EXAMPLES OF CASES (NOT
                                              EXHAUSTIVE)
             PCT will monitor incident and       Mental Health – unconfirmed
             inform SHA when the case is           suicides
     1       being closed (using closure         Data loss and information
             template) sharing any learning        security (DH Criteria level 0-1)
             where appropriate

             PCT will monitor the case and          Staff members involved in
             report to the SHA findings and          incident – professional
             recommendations and                     competence or misconduct
     2       associated action plans. SHA           Mental health - attempted
             will monitor progress on a              suicides as inpatients
             quarterly basis with PCT               Data loss and information
             unless earlier discussion is            security (DH Criteria level 2)
             required or the SUI is re-
             graded.

             Case will be monitored by the          Homicides,
     3       SHA/PCT in conjunction with            Maternal Deaths
             the Trust. The SHA will review         In-patient Suicides
             findings, recommendations              Child protection
             and associated action plans.           Data loss and information
                                                     security (DH Criteria level 3-5)


This table is a guide to the severity levels assigned by the SHA, all
incidents are treated individually and therefore levels are applied
discretionally by the SHA case managers with advice where
appropriate from specialist sources.
                                                           APPENDIX C

                  Serious Untoward Incident Closure Form
                           East of England SHA
                              Level 1 Cases

SHA reference

PCT reference

Trust code

Incident Date

Investigation completed                  Yes/No

Has an action plan with deadlines and
responsible person identifiable been     Yes/No
provided?
Please state any future monitoring
arrangements.



Summary of key findings




Key lessons learnt




Date SUI closed by PCT

Additional information




Signed off by:
Designation:
Date:




                                Page 17 of 25
                                                         APPENDIX D
                   Quarterly Update Report Form

                      INSERT PCT NAME HERE

                 Reporting Period April 08 – June 08




1.    Insert PCT name here

SHA REF        SHA LEVEL     TRUST REF          Updated position/progress




2.    Insert NHS Trust name here

SHA REF        SHA LEVEL     TRUST REF          Updated position/progress




     Please complete and return to the SHA case Manager prior to
         discussion at the SHA/PCT Quarterly Review Meeting




                             Page 18 of 25
                                                                APPENDIX E


           Confidential Enquiry into Maternal and Child Health
                         Saving Mothers’ Lives:
    Reviewing maternal deaths to make motherhood safer -2003-2005.

The Seventh Report of the Confidential Enquiries into Maternal Deaths in the
                    United Kingdom December 2007


Definitions of maternal mortality

The ninth and tenth revisions of the International Classification of Diseases,
Injuries and Causes of Death, (ICD9/10) define a maternal death as “the
death of a woman while pregnant or within 42 days of termination of
pregnancy, from any cause related to or aggravated by the pregnancy or its
management, but not from accidental or incidental causes”. This means that
there was both a temporal and a causal link between pregnancy and the
death. When the woman died she could have been pregnant at the time, that
is, she died before delivery, or within the previous six weeks have had a
pregnancy that ended in a live or stillbirth, a spontaneous or induced
abortion or an ectopic pregnancy. The pregnancy could have been of any
gestational duration. In addition, this definition means the death was caused
by the fact that the women was or had been pregnant. Either a complication
of pregnancy or a condition aggravated by pregnancy or something that
happened during the course of caring for the pregnant woman caused her
death. In other words, if the woman had not been pregnant, she would not
have died at that time.

Maternal deaths are subdivided into further groups:

Direct maternal deaths are those resulting from conditions or complications
or their management which are unique to pregnancy, occurring during the
antenatal, intrapartum or postpartum period.

Indirect maternal deaths are those resulting from previously existing
disease or disease that develops during pregnancy, not due to direct
obstetric causes, but which was aggravated by physiologic effects of
pregnancy. Examples of causes of Indirect deaths include epilepsy,
diabetes, cardiac disease and, in the UK only, hormone dependent
malignancies. The Enquiry also classifies most deaths from suicide as
indirect deaths as they were usually due to puerperal mental illness although
this is not recognised in the ICD coding of such deaths. The UK Enquiry
assessors also classify some deaths from cancer in which the hormone
dependant effects of the malignancy could have led to its progress being
hastened or modified by pregnancy as Indirect although these also do not
accord with international definitions. Only Direct and Indirect deaths are




                               Page 19 of 25
counted for statistical purposes as discussed later in the section on
measuring maternal mortality rates.


ICD-10 also introduced two new terms related to maternal deaths. One of
them is pregnancy related death, defined as the death of a woman while
pregnant or within 42 days of the end of her pregnancy, irrespective of
cause. These deaths include deaths from all causes, including accidental
and incidental causes. Although the latter deaths, which would have
occurred even if the woman had not been pregnant, are not considered true
maternal deaths, they often contain valuable lessons for this Enquiry. For
example they provide messages and recommendations about domestic
abuse or the correct use of seat belts. From the assessments of these cases
it is often possible to make important recommendations. The ICD coding
classifies these cases as fortuitous maternal deaths. However, in the opinion
of the UK assessors, the use of the term fortuitous could imply a happier
event and this Report, as did the last, names these deaths as Coincidental.

The other new term introduced in ICD-10 is late maternal death, defined as
the death of a woman from Direct or Indirect causes more than 42 days but
less than one completed year after the end of the pregnancy. Identifying late
maternal deaths enables lessons to be learnt from those deaths in which a
woman had problems that began with her pregnancy, even if she survived
for more than 42 days after its end. However, although this category has
only been recently recognised in the ICD 10 codes, and then only for deaths
from Direct or Indirect causes, the previous three UK Enquiry Reports had
already included all Late deaths notified to the assessors (including
Coincidental deaths) occurring up to one year after delivery or abortion, as
does this.




                              Page 20 of 25
                                                                                    APPENDIX F
Annex B of DH Gateway Letter 9571 (29/2/08)

REPORTING SERIOUS UNTOWARD INCIDENTS (SUIs) RELATING TO
ACTUAL OR POTENTIAL BREACHES OF CONFIDENTIALITY INVOLVING
PERSON IDENTIFIABLE DATA (PID), INCLUDING DATA LOSS.

It is essential that all serious untoward incidents that occur in the Trust are reported
appropriately and handled effectively. This document covers the reporting
arrangements and describes the actions that need to be taken in terms of
communication and follow up when a serious untoward incident occurs. Trusts
should ensure that any existing policies for dealing with Serious Untoward Incidents
are updated to reflect these arrangements.

Definition of a Serious Untoward Incident in relation to Personal Identifiable
Data
There is no simple definition of a serious incident. What may at first appear to be of
minor importance may, on further investigation, be found to be serious and vice
versa. As a guide, any incident involving the actual or potential loss of personal
information that could lead to identity fraud or have other significant impact on
individuals should be considered as serious.

Immediate response to Serious Untoward Incident
The Trust should have robust policies in place to ensure that appropriate senior
staff are notified immediately of all incidents involving data loss or breaches of
confidentiality. Where incidents occur out of hours, the Trust should have
arrangements in place to ensure on-call Directors or other nominated individuals
are informed of the incident and take action to inform the appropriate contacts.

Assessing the Severity of the Incident
The immediate response to the incident and the escalation process for reporting
and investigating this will vary according to the severity of the incident.

Risk assessment methods commonly categorise incidents according to the likely
consequences, with the most serious being categorised as a 5, e.g. an incident
should be categorised at the highest level that applies when considering the
characteristics and risks of the incident.

 0                  1               2                  3                 4                5
 No significant     Damage to       Damage to a        Damage to a       Damage to an     Damage to
 reflection on      an              team’s             services          organisation’s   NHS
 any individual     individual’s    reputation.        reputation.       reputation.      reputation.
 or body.           reputation.     Some local         Low key local     Local media      National
 Media interest     Possible        media interest     media             coverage.        media
 very unlikely      media           that may not       coverage.                          coverage.
                    interest, eg    go public
                    celebrity
                    involved
 Minor breach       Potentially     Serious            Serious breach    Serious          Serious
 of                 serious         potential          of                breach with      breach with
 confidentiality.   breach. Less    breach & risk      confidentiality   either           potential for
 Only a single      than 5 people   assessed high      eg up to 100      particular       ID theft or
 individual         affected or     eg                 people            sensitivity eg   over 1000
 affected           risk assessed   unencrypted        affected          sexual health    people
                    as low, e.g.    clinical records                     details, or up   affected
                    files were      lost. Up to 20                       to 1000
                    encrypted       people                               people
                                    affected                             affected



                                         Page 21 of 25
Reporting to SHA
The Trust should report the SUI, i.e. all incidents rated as 1 – 5, to the SHA through
the usual SUI process. The following information should be provided in each case:
     A short description of what happened, including the actions taken and
       whether the incident has been resolved
     Details of how the information was held: paper, memory stick, disc, laptop
       etc
     Details of any safeguards such as encryption that would mitigate risk
     Details of the number of individuals whose information is at risk
     Details of the type of information: demographic, clinical, bank details etc
     Whether a) the individuals concerned have been informed, b) a decision has
       been taken not to inform or c) this has not yet been decided
     Whether a) the Information Commissioner has been informed, b) a decision
       has been taken not to inform or c) this has not yet been decided
     Whether the SUI is in the public domain and the extent of any media interest
       and/or publication

Reporting to the SHA should be undertaken as soon as practically possible (and no
later than 24 hours of the incident during the working week). If there is any doubt as
to whether or not an incident meets the SUI reporting criteria, the Trusts’ Risk
Manager or the SHA should be contacted by telephone for advice. Early
information, no matter how brief, is better than full information that is too late.

The Trust should keep the SHA informed of any significant developments in
internal/external investigations, as appropriate. The SHA should continue to keep a
watching brief on developments including following up further details/outcomes of
the incident. The Trust’s communications team should contact the SHA
Communications team immediately if there is the possibility of adverse media
coverage in order to agree a media handling strategy. Where necessary, the SHA
Communications team will brief the Department of Health Media Centre.

Reporting to the Department of Health
The SHA will be responsible for notifying the DH of any category 3-5 incident
reported by forwarding details to the appropriate dedicated mailbox established
within the DH. Incidents should be notified to DH comms only if only the lighter
shaded risk areas in the top two rows in the table apply and to both DH Comms and
the Ministerial Briefing Unit if the significant risks in the darker shaded area at the
bottom right of the table apply. This latter, most serious category is the one that
should be referenced as a nationally reported SUI. Those reported to DH Comms
alone should be referred to as a comms alert derived from a local SUI. Once an
incident has been reported to DH any subsequent details that emerge relating to
the investigation and resolution of the incident should also be supplied.

The DH will review the incident and determine the need to brief Ministers and/or
take other action at a national level.

Reporting to the Information Commissioner or other Bodies.
The Information Commissioner should be informed of all Category 3-5 incidents.
The decision to inform any other bodies will also be taken, dependent upon the
circumstances of the incident, e.g. where this involves risks to the personal safety
of patients, the National Patient Safety Agency (NPSA) may also need to be
informed.




                                   Page 22 of 25
Informing Patients
Consideration should always be given to informing patients when person
identifiable information about them has been lost or inappropriately placed in the
public domain. Where there is any risk of identity theft it is strongly recommended
that this is done.




                                  Page 23 of 25
                                                                         APPENDIX G

Homicides committed by patients in receipt of mental health services

NHS Trust                     Primary Care Trust (lead        SHA
                              commissioner)
Raise SUI internally and      Notification of SUI received    Notification of SUI received.
report immediately via EOE                                    SHA immediate briefing to
SUI Process.                                                  Executive and
                                                              communications team.

Trust undertakes rapid 72     PCT assesses risks of SUI       SHA designates Level 3 SUI
hour service management       with trust and SHA              and reviews 72 hr report
review to assess risk to                                      jointly with trust and PCT to
patients, public and staff.                                   ensure that any immediate
Immediate clinical or                                         action to safeguard other
managerial actions taken                                      patients/public is taken
where necessary as a result
of 72 hour review.                                            Consider whether to evoke
                                                              memorandum of
Trust continues to work/co-                                   understanding during the
operate with police                                           SUI process to ensure
throughout investigation.                                     patient safety is maintained
                                                              and to agree communication
                                                              with perpetrator and victims’
                                                              family

                                                              SHA considers whether case
                                                              meets/likely to meet criteria
                                                              HSG (94) 27

Internal investigation        PCT receives Trust final        SHA receives final trust
completed as soon as          report of investigation.        report of internal
possible (usually within 90                                   investigation.
days).

Changes to policy and/or      PCT monitors internal trust     SHA monitors internal trust
practice to enhance patient   investigation and action plan   investigation and action plan
safety implemented.           jointly with SHA                jointly with PCT

                              .                               At the end of any legal
                                                              proceedings ( or earlier if
                                                              possible) and if criteria met,
                                                              SHA commissions the
                                                              independent investigation
                                                              proportionate to findings of
                                                              completed internal root
                                                              cause analysis.




                                   Page 24 of 25
           SAFEGUARDING CHILDREN FLOW CHART                                  APPENDIX H



                                   Suspected child protection incident




     Decision by LSCB to convene                           Decision to raise SUI incident form
         Serious Case Review                                  made by NHS organisation




   YES                      NO               PCT / Trust follows                  SHA maintains
                                                normal SUI                        contact as per
                                               Investigation                      protocol re risk
                                                  Process                          level 1 / 2 / 3



         NHS organisations
      Undertake single agency
      reports following robust
                                             PCT Commissioner maintain overview
   investigation process such as
                                                  of process to ensure robust
                RCA.
                                              investigations are undertaken from
   Populate templates as agreed
                                                       NHS organisations
             with LSCB




     Single agency report
      signed off by NHS
   organisation governance
  system prior to submission




 LSCB Serious Case Review
       Findings and
    Recommendations                          PCT responsible for
                                              ensuring all actions
                                             implemented in NHS
                                                commissioned                     SHA ensures actions
                                                organisations                    implemented via PCT
      LSCB Monitors                                                                commissioning
implementation of action plan
                                           Page 25 of 25

				
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Description: Serious Untoward Incidents Policy