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Document Number: POL/AD/WCN/681        Title: INCIDENT REPORT POLICY


Version Number: 3                      Document Type: Policy


Application: Trust Wide                Content: Administrative


Author/Originator and Title: Karen Dawber, Director of Nursing &
                             Modernisation
                             David Melia, Deputy Director of Nursing

Date of Issue: December 2008           Replaces: Version 1 2004

                                       Description of Amendments:
                                        SABS changed to reflect CAS
                                        STEIS Reporting arrangements
                                         added
                                        Board statement re: patient safety
                                         included in Introduction


Approved By:                           Approval Information:

Clinical Strategy    &    Performance Name: Dr T P Enevoldson
Committee
                                       Signature   original held in Clinical Governance Dept


                                       Date: signed 17th December 2008
                                             (approved October 2008)

Review Date: October 2009              Responsibility Of: Head of Risk



Training Required: YES                 Name of Trainer/s:
Induction/Mandatory                    Head of Risk
                                       Health and Safety Advisor

CHECK LIST:

Completion of Distribution Information Page                     YES

Completion of Training Information Page (if required)           YES

Incident Report Policy
Ratified: October 2008
To Be Reviewed: October 2010
                               Page 1 of 79
                     Training Information Page
Document Title:          Incident Report Policy
                         POL/AD/WCN/681

Trainer/s Name & Title: Head of Risk and Health & Safety Advisor

Training Commencement Date (provisional):          Mandatory - Ongoing

Training Completion Date (provisional):            Mandatory - Ongoing


              Name                                Department

Trust Wide




Incident Report Policy
Ratified: October 2008
To Be Reviewed: October 2010
                               Page 2 of 79
                   Distribution Information Page

Document Title:          Incident Report Policy
                         POL/AD/WCN/681



          Trainee Name                            Department

Trust Wide




Incident Report Policy
Ratified: October 2008
To Be Reviewed: October 2010
                               Page 3 of 79
                            Equality and Diversity Checklist

Document Name:                   Incident Report Policy
                                 POL/AD/WCN/681

                                                                        Yes/No   Comments
1.   Does the policy/guidance affect one group less or more
     favourably than another on the basis of:

      Race or ethnicity (including gypsies or travellers)                No

      Age                                                                No

      Nationality                                                        No

      Gender (Male, Female, Transsexual)                                 No

      Culture                                                            No

      Religion or belief                                                 No

      Sexual orientation including lesbian, gay and bisexual people      No

      Physical Disability                                                No

      Cognitive Impairment                                               No

      Learning Difficulties / Disability                                 No

      Sensory Impairment                                                 No

      Mental Health Problems                                             No
2.   Is there any evidence that some groups are affected differently?     No
3.   If you have identified potential discrimination, are any             N/A
     exceptions valid, legal and/or justifiable?
4.   Is the impact of the policy/guidance likely to be negative?          No
5.   If so can the impact be avoided?                                     N/A
6.   What alternatives are there to achieving the policy/guidance         N/A
     without the impact?
7.   Can we reduce the impact by taking different action?                 N/A
If yes is answered to any of the above items the policy may be considered
discriminatory and requires review and further work to ensure compliance with
legislation

If you have identified a potential discriminatory impact of this procedural document,
please refer it to Mr. Andrew Maloney, Head of Human Resources, together with any
suggestions as to the action required to avoid/reduce this impact.

For advice in respect of answering the above questions, please contact:
Mr. Andrew Maloney,
Head of Human Resources,
2nd Floor, The Walton Centre



Incident Report Policy
Ratified: October 2008
To Be Reviewed: October 2010
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CONTENTS                                                                                                PAGE
CONTENTS                                                                              PAGE................4
1  Introduction ..............................................................................................6
2  Purpose....................................................................................................7
3  Scope of Policy ......................................................................................11
4  Incident Reporting Policy and Procedure...............................................12
   4.1      Definitions of Incident Types.....................................................12
            4.1.1       Clinical Incident......................................................................12
            4.1.2       Medical Device or Medication Incident.............................12
            4.1.3       Accident...................................................................................12
            4.1.4       Ill Health ...................................................................... 12
            4.1.5       Security Incident....................................................................12
            4.1.6       Information Security Incident..............................................12
            4.1.7       Fire Incident............................................................................13
            4.1.8       Environmental Incident ........................................................13
            4.1.9       Radiation Incident .................................................................13
            4.1.10 Near Miss................................................................................13
            4.1.11 Complaints..............................................................................13
            4.1.12 Claims ......................................................................................13
   4.2      Reporting of Incidents/Near Misses..........................................13
   4.3      Local Reporting at Directorate/Departmental Level ..................14
   4.4      Local Preventative Action/Investigation ....................................14
            4.4.1       Preventative Action...............................................................14
            4.4.2       Local Investigation ................................................................15
   4.5      Action Plan Management .........................................................16
   4.6      Central reporting to the Risk Management Department ...........16
            4.6.1       IR1 Completion......................................................................16
            4.6.2       DIR1 Completion...................................................................17
   4.7      Central Action ...........................................................................18
   4.8      Incident Grading Criteria...........................................................18
   4.9      Distribution of Incident Report Forms to Internal Stakeholders.19
   4.10     Serious Untoward Incidents......................................................21
   4.11     Serious Untoward Incident Reporting Procedure......................21
   4.12     Functions of the Serious Untoward Incident Team ...................23
   4.13     Action Timescales ....................................................................23
   4.14     Support for Serious Untoward Incident Team (SUIT) ...............24
   4.15     Major Incident and Public Health Hazards................................24
   4.16     Internal Reviews or Inquiries ....................................................25
   4.17     Rapid Response Help Line.......................................................25
   4.18     Reporting to External Agencies ................................................25
   4.19     Reporting Lessons learned Locally...........................................27

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To Be Reviewed: October 2010
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     4.20      Analysis of aggregated incident data and learning of lessons ..27
     4.21      Action Plan Follow Up ..............................................................28
     4.22      Support for staff involved in Serious Untoward Incidents .........28
     4.23      Reporting and Whistleblowing ..................................................25
5    Duties.....................................................................................................30
     5.1       All personnel (including contractors) working on Trust ................
               premises)..................................................................................30
     5.2       Line Managers/Ward Managers/Persons in Charge /
               Supervisors...............................................................................30
     5.3       Divisional General Manager/ Clinical Directors/Divisional
               Medical Risk Leads ..................................................................30
     5.4       Medical Lead for Risk ...............................................................31
     5.5       Head of Risk /Project Assistant ................................................31
     5.6       Project Assistant.......................................................................32
     5.7       Lead Radiation Protection Supervisor (Chair of the Radiation
               Safety Committee)....................................................................32
     5.8       Radiation Protection Adviser ....................................................32
     5.9       Medical Physics Expert (MPE) .................................................32
     5.10      Health and Safety Advisor/Head of Risk...................................32
     5.11      Estates Manager ......................................................................32
     5.12      Transfusion Practitioner (TP)....................................................32
     5.13      Local Security Management Specialist.....................................33
     5.14      On Call Managers.....................................................................33
6    Associated documentation and references ............................................34
7    Training and Resources.........................................................................35
8    Monitoring and Audit..............................................................................36
9    Incident Form (Appendix 1)....................................................................37
10   Definitions of Reportable Incidents (Appendix 2) ...................................39
     Near Miss...............................................................................................39
     Accident .................................................................................................39
     Clinical Incident......................................................................................39
     Ill Health.................................................................................................39
     Fire Incident ...........................................................................................39
     Radiation Incident ..................................................................................39
     Security Incident ....................................................................................39
11   List of Trust Advisors (Appendix 3) ........................................................40
12   Risk Categorisation and Incident Grading Criteria (Appendix 4)............41
13   Guidance for staff on writing statements as part of an investigation
     (Appendix 5)...........................................................................................45
14   Incident Investigation Form (Appendix 6)...............................................47
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To Be Reviewed: October 2010
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15   RIDDOR Reporting (Appendix 7)...........................................................48
16   Template for Serious Untoward Investigation Report (Appendix 8) .......50
17   Investigation Process Flow Chart (Appendix 9)                                  48Error!
     Bookmark not defined.
18   Operational Policy for the performance management of Serious
     Untoward Incidents - Sefton PCT (Appendix 10)                                           49




Incident Report Policy
Ratified: October 2008
To Be Reviewed: October 2010
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1       Introduction

The Walton Centre for Neurology and Neurosurgery NHS Trust (WCNN) is
committed to the health, safety and welfare of its patients, visitors, contractors
and staff.

Accurate and appropriate reporting of incidents/near-miss is essential in order
to reduce risks and avoid untoward incidents.

Incident reporting is a fundamental tool of risk management, the aim of which
is to collect information about adverse incidents, including near misses, ill
health and hazards, which will help to facilitate wider organisational learning.
If incidents are not properly managed, they may result in a loss of public
confidence in the organisation and a loss of assets.

The chief executive and directors (including the non executives) have made
their support for patient and staff safety transparent by their actions, when
setting the Trusts overall strategy.

It is unacceptable to reach other objectives at the expense of patient / public
and staff safety; a robust policy will enable effective monitoring and
management of this.

Therefore, the Trust requires its employees and contracted staff to comply
with the incident reporting policy and procedures as outlined within this
document. The Trust will adopt a fair blame culture that encourages
openness and organisational learning from errors or incidents. The focus of
incident reporting and investigation is on the identification of system failures
and not to apportion blame. (Incident form appendix 1)

The Trust aims to develop a culture of openness and non-punitive discipline
throughout the organisation by continuous support of, and feedback to, staff
involved in incidents and it is therefore important that all staff are aware that:

       The purpose of any incident reporting system is not to apportion blame
        to any individual or group but to identify and correct problems.
       There may though be clearly defined situations where further action,
        including disciplinary action, may need to be taken. For example this
        may be where there is a breach of law, professional misconduct or
        malicious intent.

For optimal effect, all clinical and non-clinical incidents, or near misses,
involving, witnessed by or reported to a member of staff, need to be formally
reported in line with this policy.

Incidents should be reported immediately it is safe to do so and certainly
within 24 hours of the event.




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To Be Reviewed: October 2010
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2      Purpose

The key objectives of this policy are to ensure that:-

      All staff and contractors are aware of their duties to report incidents that
       affect patients, visitors, contactors and staff.
      Managers are aware of their duties in the investigation of incidents and
       the monitoring of findings and implementation of action plans.
      Key personnel are aware of their duties of reporting incidents to
       external bodies as appropriate.
      The Trust is compliant with the National Patient Safety Agency Seven
       Steps to Patient Safety
      Qualitative and quantitative data analysis will be used to highlight any
       trends which may be occurring and uncover any further need for
       intervention.
      All incidents must be reported in writing on a paper Incident Report
       form (Appendix 1) or electronically using the Trust web based incident
       form. Incident reporting will be undertaken in an accurate and
       consistent way. All paper incident forms should be forwarded to the
       departmental manager, Divisional General Manager and to the Risk
       Management Department as soon after the event has been recorded
       and in line with timescales identified in paragraph 4.7.2
      Where an incident illustrates unsafe practice, appropriate corrective
       measures should be taken immediately and a risk assessment
       undertaken (see Risk Strategy)
      Where equipment contributed to the incident, this must be removed
       from use and held for examination during the investigation process.
       Biomedical Engineering at University Aintree Hospitals NHS Trust and
       Head of Risk should be informed immediately of any clinical equipment
       involvement (out of hours will be reported the next morning).
      Reports must be made to external agencies and stakeholders as
       described within this policy.
      Central records must be kept and held within the Risk Management
       Department.
      Analysis of data from incidents will be made and reports produced and
       distributed in line with the Trust’s governance arrangements.

All incidents (clinical and non-clinical) should be reported both locally and
centrally using the Trust’s Incident Report Form (IR1) or web base reporting
DIR1 (See Appendix 1).

Where the incident involves a member of staff, then the incident should be
verbally reported locally to their immediate line manager and the incident form
completed by the staff member involved in the incident. However, if the
member of staff is unable to complete the incident form due to a disability or
the effect of the incident, then the person to whom the incident was verbally
reported should complete the incident report form.



Incident Report Policy
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To Be Reviewed: October 2010
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If the incident involves a patient or visitor, then the staff member who
witnessed or to whom the incident is reported must complete the incident
report form. Again if the person who witnessed or to whom the incident is
reported is unable to complete the incident form due to a disability then this
should be delegated locally.

An incident form must be completed and distributed as follows:
        During the pilot and cascade of electronic reporting, paper forms will
          continue to be input to the Datix system by the Risk team
        Yellow copy to Divisional General Manager
        White copy to Clinical Governance (Risk Team)

Electronic reports will be copied automatically to
        Clinical Incidents the departmental manager (for local
          investigation), Divisional General Manager/Clinical director/Clinical
          Risk Lead/Modern Matron/Risk Team and the specialist manager
          e.g. an infection control issue will be copied to the Tissue Viability
          and Infection Control Nurse Specialist
        Health and Safety Incidents Departmental Manager/Divisional
          General Manager/Head of Risk/Health and Safety Advisor

Incident Report Forms are held in Clinical Governance




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To Be Reviewed: October 2010
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3.       Scope of Policy

This policy applies to all staff and contractors of WCNN.

This policy should be read in conjunction with

           Whistleblowing policy

           Being Open Policy

           Policy and Procedure for the Management of Claims

           Model of Best Practice and Procedure for Handling Complaints

           Guidelines for Supporting Staff Involved in Traumatic/Stressful
            Incidents,

           Complaints or Claims

           Risk Strategy

           Health and Safety Policy

           Security Policy

           Information Security Policy

           Major Incident Policy




Incident Report Policy
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To Be Reviewed: October 2010
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4     Incident Reporting Policy and Procedure

4.1   Definitions of Incident Types

4.1.1 Clinical Incident
This is a clinical event or circumstance that could have or did lead to
unintended or unexpected harm, loss or damage; including any such
circumstances where patients are participating in clinical research *.

Clinical incidents can be subdivided into two categories:
        Adverse Event – where the clinical incident actually results in harm,
           loss or damage.
        Near miss – where the clinical incident has the potential to result in
           harm, loss or damage but which was avoided as a result of the
           vigilance of staff, or good fortune.

*Additionally, the Trust has an obligation under the Research Governance
Framework (2001) to ensure that all potential research related incidents are
actively investigated, in order that causal links are identified and appropriate
action taken to reduce or manage future risk or abandon research where the
risk is deemed to outweigh the benefits. The Head of Risk is also required to
notify the approving Research Ethics Committee immediately any Serious
Adverse Event occurs.

4.1.2 Medical Device or Medication Incident
An incident involving a Medical device or medication, which gives rise to, or
has the potential to produce unexpected or unwanted effects involving the
safety of patients, users or other persons.

4.1.3 Accident
Any unplanned or unexpected non-clinical event, which results in personal
injury, loss or damage to property.

4.1.4 Ill Health
Any medical condition that the employee believes is either caused by, or
worsened by the work environment or working conditions.

4.1.5 Security Incident
Any incidents involving theft, damage, violence or other security related issue.
Security incidents must also be reported verbally to the Local Security and
Management Services (see Security Policy)

4.1.6 Information Security Incident
Any incident involving the misuse of patient/staff information, e.g. unapproved
removal of hospital notes or patient/staff information by a member of staff,
which must be reported to the Data Protection Officer, including the
unscheduled use of patient information in research which has not been
formally approved by Research Governance and Ethics Committees


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To Be Reviewed: October 2010
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4.1.7 Fire Incident
Any incident that requires the attendance of the Fire Safety staff, whether a
fire was detected or not.

4.1.8 Environmental Incident
Any incident that is caused by environmental factors, such as lighting, noise,
heat, atmosphere, flooring etc. or an incident that would affect the
environment such as chemical spillage, waste disposal.

4.1.9 Radiation Incident
Any of the above situations that involve the use of ionising or non-ionising
radiation.

4.1.10 Near Miss
An unplanned or unexpected event of a clinical or non-clinical nature which
had the potential to result in an injury to a person and/or damage to
equipment or property, but was avoided as a result of the vigilance of staff, or
good fortune. It is vital that near miss incidents are reported:
        as the potential for a further incident will remain unless appropriate
          action is taken.
        to ensure, where appropriate, lessons are learned across the
          organisation

4.1.11 Complaints
Where an incident is likely to become a complaint, the Risk Management
Department will forward a copy of the incident report to the Trust’s Complaints
Team. Complaints must be dealt with in accordance with the Trust’s Model of
Best Practice and Procedure for Handling Complaints.

4.1.12 Claims
Claims must be dealt with in accordance with the Trust’s Policy and
Procedure for the Management of Claims. Where an incident is likely to
become a claim, the Risk Management Department will forward a copy of the
incident report to the Trust’s Legal Department.

4.2    Reporting of Incidents/Near Misses
This reporting procedure covers a wide range of situations. In general all
members of staff must report:
         Something that has happened that is contrary to the Trust’s
          accepted standards of patient care.
         An accident in which a member of staff or the public has been, or
          could have been, injured
         An incident that places, or has placed, patients, visitors, contractors
          or staff at unnecessary risk.
         An incident that could put the Trust in an adverse legal or an
          adverse media interest position.
         In a research project, using a procedure or intervention that has not
          been sanctioned in the approval protocol or on an approved
          protocol amendment by a Research Governance Ethics Committee
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To Be Reviewed: October 2010
                                 Page 13 of 79
       General examples of reportable incidents or near misses are given in
       Appendix 2.



4.3    Local Reporting at Directorate/Departmental Level
A verbal report must be made to the immediate line manager as soon as an
incident becomes apparent to ensure:
        immediate action is taken to prevent further harm.
        the earliest possible remedial action, i.e. care of the patient or
          injured party
        the appropriate clinical/departmental manager on duty at the time of
          the incident uses their professional judgement whether to inform a
          clinician or a more senior manager. If so, the clinician/senior
          manager should make comment on the incident report form as well
          as in the patient’s notes.
        There is an open and frank communication with the patient and/or
          relatives, as soon after the incident as is possible, about the
          incident and the potential impact to them. Advice should be sought
          from the patient’s Consultant, Ward Manager or Line Manager on
          who is most suitable to take on this role, depending on the severity
          of the incident. Patients and/or their relatives should be told of what
          happened and why (if known at that stage), and what will be done
          next, including measures to try to prevent recurrence and any future
          investigation which may be thought necessary. Depending on the
          severity of the incident, the Being Open Policy may need to be
          activated for more serious events.
        The Divisional General Manager/Clinical Director/ Modern
          Matron/Head of Risk are informed immediately, when a serious
          untoward clinical incident has occurred.
        The Divisional General Manager/Head of Risk/Health and Safety
          Advisor must be informed immediately of all serious Health and
          Safety Incidents.

4.4    Local Preventative Action/Investigation

4.4.1 Preventative Action
The responsible line manager must ensure that wherever possible appropriate
immediate action is taken to prevent further harm or recurrence. Where there
is difficulty or doubt about preventative action, this must be discussed with the
Divisional General Manager and advice sought from the appropriate Trust
advisor. (See appendix 3 for a list of Trust advisors)

If a medical device or other piece of equipment, either clinical or non-clinical,
is involved then it must be impounded until it can be examined. If this is not
possible, the state of the device/equipment at the time of the incident must be
documented on the incident report form, including the reason why the device
or piece of equipment could not be impounded, as this mayl be required in
subsequent investigations. It is important to note that similar devices/pieces
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To Be Reviewed: October 2010
                                 Page 14 of 79
of equipment may be in use within other areas of the hospital, therefore if a
problem occurs, all areas will need to be notified as soon as possible via
Medical Engineering, Line Managers, On-Call Managers, Risk Management
or Health and Safety Management.

A description of the device, its make, model, serial number/asset number
must all be recorded on the incident report form, together with details of
whether the device has been removed from service and where it is being held.

Local preventative action must be recorded on the incident form before it is
distributed as above.

4.4.2 Local Investigation
The immediate line managers must investigate all incidents locally in
conjunction with the medical lead of risk.

Details contained within the Incident Grading Criteria (See Appendix 4) must
be followed during a local investigation.

The investigating managers must:
            Interview and obtain written statements from any persons
             involved in the incident or those who witnessed the incident.
             (Statements must be written in accordance with the guidelines
             identified within this policy – see Appendix 5)
            Identify system failures/causes that led to the incident
            Identify corrective action required to prevent further harm or
             recurrence
            Complete the Trust’s Investigation Form with additional
             information gathered from the investigation and include a
             detailed action plan of corrective measures (see Appendix 6)
            Retain all records, medical device/ piece of equipment relevant
             to the incident. (The appropriate notes within Medical Records
             should be photocopied for investigation purposes if the original
             Medical Record is required for the ongoing treatment of the
             patient)
            Keep the patient and/or relatives informed during the
             investigation and implementation of action plans.
            All documentation relating to an incident will be scanned to the
             Datix risk management system and held with the details of the
             incidents

On completion of a local investigation the investigating manager must:
           Provide verbal feedback to personnel involved in the incident,
            including the patient and/or relatives if possible and in every
            case where the Being Open Policy has been activated ( see
            Being Open When Patients are Harmed Policy)
           Forward original documentation gathered during the
            investigation to the Clinical Governance (risk team) for review
            and central record keeping. (Copied Medical Records should
            also be sent if applicable)
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To Be Reviewed: October 2010
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            Together with the Divisional General Manager and Medical Risk
             Lead, ensure local action plans are implemented and monitored
             within agreed timescales.
            Together with the Divisional General Manager and Medical Risk
             Lead, consider wider sharing of the investigation outcome to
             ensure lessons are learned.

4.5   Action Plan Management
           The management of action plans and recommendations from
            investigations will be monitored for implementation and
            completion. Clinical Services Committee will monitor all patient
            related incidents and the Health and Safety Committee will
            monitor the non patient related incidents. Risk assessments will
            be monitored by the Divisional General Managers/Medical
            Leads for Risk and will be added to the DATIX risk management
            system.

4.6    Central reporting to the Risk Management Department
Following local reporting the incident must be reported centrally using the
Trust’ Incident Report Form (IR1) or Datix Incident Report form (DIR1) (See
Appendix 1) in accordance with this policy.

A verbal report must be made to Risk Management for any incidents graded
as Red: Serious Risk. If there is any doubt a telephone call should be made
for advice and support. Out of hours, the On Call Managers must be
contacted, and they will report to the Risk Management Department any
issues raised and the actions taken the next working day.

When completing the IR1 or DIR1, only factual statements must be made, not
opinions.

4.6.1 IR1 Completion
When reporting an incident:
           only an Incident Report Form may be used
           writing must be legible and in black ink
           this must be done as soon as possible after the event, after local
            preventative action has been taken, but no later than the end of
            the working day on which the incident became apparent.
           it must be recorded on the incident form that an investigation
            has been commenced if appropriate.
           The appropriate line manager should initiate the risk grading
            criteria (according to the grading criteria outlined under
            paragraph 4.9 Incident Grading and Appendix 4) before
            countersigning the form.
           The white copy of the incident form must be forwarded to the
            Risk Management Department, the yellow copy to the Divisional
            General Manager. The Risk Management Department will
            ensure copies of the incident form are distributed accordingly to


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To Be Reviewed: October 2010
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             the relevant internal and external stakeholders as detailed in
             4.10
            Once the line manager is satisfied that appropriate local action
             has been taken and/or a full investigation has been initiated or
             undertaken, then the yellow copy with all appropriate
             documentation must be forwarded to the Divisional General
             Manager /Head of Department for local record keeping purposes
             as detailed in paragraph 4.6.2.

If an incident report form is spoiled, then the white copy must be sent to the
Risk Management Department with the word VOID clearly written through it
and the yellow copy sent to the Divisional General Manager/Head of
Department for record keeping purposes.

The use of further incident report forms can be misleading in terms of whether
a second incident has occurred.

Further incident report forms must not be used to add or bring up to date
information on the patient’s condition. Such additional information should be
provided by a typed report, clearly indicating the incident details, date, time
and location together with Incident Report Number (if known) and sent to the
Risk Management Department with a copy to the Divisional General
Manager/Head of Department.

Only one incident form must be completed for each separate incident.

4.6.2 DIR1 Completion
When completing the DIR1 form the following steps must be followed:
           The staff member involved or witnessing the incident will
            complete the form as soon as safe to do so after the incident
            and will select the line manager for that department before
            submitting the form.
           If for any reason the staff member does not wish their line
            manager to be included in the circulation of this incident then
            another manager may be selected or for confidentiality reasons
            the Head of Risk.
           The form should be completed as soon as possible after the
            event, after local preventative action has been taken, but no
            later than the end of the working day on which the incident
            became apparent
           The reporter of the incident must offer a categorisation of the
            severity of the incident. This may be altered during further
            consideration of the incident
           The appropriate line manager must ensure that all parts of the
            DIR1 form have been completed and initiate the risk grading
            criteria before the form is countersigned. Incidents must be
            graded according to the grading criteria outlined under
            paragraph 4.9 Incident Grading and Appendix 4.


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To Be Reviewed: October 2010
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            The DIR1 will automatically be distributed accordingly to the
             relevant internal stakeholders and the Head of Risk will
             distribute to external stakeholders upon submission of the DIR1
            The line manager will then complete the DIR2 which includes
             the risk grading and investigation of the incidents. The incident
             will be graded according to the grading criteria outlined under
             paragraph 4.9 Incident Grading and Appendix 4.
            Once the line manager is satisfied that appropriate local action
             has been taken and/or a full investigation has been initiated or
             undertaken, then the incident can be submitted. The incident
             should take no longer than 7 days to be submitted by the line
             manager. An investigation taking longer than seven days will be
             agreed with the Divisional General Manager and Head of Risk.
            All documentation must be copied/scanned into the
             documentation area of the DIR1

4.7   Central Action
Upon receipt of an incident form the Risk Management Department will
undertake the following measures:
       Assess the incident report form in terms of its severity and ensure
         that appropriate action has been or is being taken locally in
         accordance with the incident grading criteria.
       Assess the grading of the incident and seek further clarification from
         the division/department if there are concerns. This may result in an
         incident being regarded at a central level.
       Ensure that incident report forms are shared with the appropriate
         internal stakeholders as described under distribution with internal
         stakeholders.
       Initiate the Serious Untoward Incident Reporting Procedure where
         appropriate and in accordance with the incident grading criteria.
       Ensure all incidents are recorded on the Trust’s Database, together
         with immediate actions taken and investigation details, within 10
         working days of receiving the incident form or investigating findings.
       Ensure reporting and communication to external stakeholders,
         where appropriate, is full and open and in line with external
         stakeholders requirements.
       Ensure that safety lessons are shared with internal and external
         stakeholders.

4.8    Incident Grading Criteria
It is necessary to grade incidents systematically and accurately using a
standard methodology, so that they can be placed into one of the three
categories below:
            Green:               Acceptable Risk
            Yellow – Orange:     Manageable Risk
            Red:                 Serious Risk.

By grading incidents in this manner, prioritisation of remedial action to be
taken and the depth of investigation required can be established.
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Incidents must be graded in two ways: -
              Actual Harm to person involved (performed by staff
               completing DIF1) – The incident outcome will be graded in
               terms of outcome for the individual concerned from Insignificant
               (no harm to the person) to Catastrophic (Death or adverse
               publicity) see table below:

           1               2               3              4              5
           Insignificant   Minor           Moderate       Major          Catastrophic


           Green           Yellow          Orange         Red            Red




              Assessment of recurrence (performed by person competing
               DIF2) - The assessment of recurrence requires a little more
               consideration than grading of actual harm. The assessment
               should take into account past experiences and the views of
               others.

       The tool described here provides a simple way of rating the potential
       risk associated with the incident or hazards identified. It requires the
       assessment of rating the potential consequences of harm and the
       likelihood of recurrence of harm from the hazard.
               Risk Grading =
               Consequence x Likelihood = Risk Categorisation
       See Appendix 4 for grading methodology, categorisation of risk and
       identification of further action required.

4.9     Distribution of Incident Report Forms to Internal Stakeholders
      Incident Report forms will be copied and distributed throughout the
      Trust, by the Risk Management Department, as detailed below, to
      ensure that safety lessons are shared.

              Clinical Governance/Risk/Health and Safety Advisor
               Receive complete copies of all incidents that relate to the
               Health, Safety and Welfare of staff, patients, visitors and
               contractors.
               Receive complete copies of all incidents that are reportable
               under Reporting of Injuries, Diseases and Dangerous
               Occurrence Regulations (RIDDOR) (See Appendix 7).
              Pharmacy Department
               Receive complete copies of all incidents that relate to medicines
               management within the Trust.
              Medical Engineering Department
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            Receive anonymous copies of all incidents that relate to medical
            devices within the Trust.
           Fire Safety
            Receive complete copies of all incidents that relate to fire safety
            within the Trust.
           Security (Clinical Governance Department)
            Receive complete copies of all incidents that relate to violence
            and abuse, theft, security breaches, loss or damage to Trust
            assets.
           Hotel Services/Contractors
            Receive anonymous copies of all incidents that relate to the
            services that they provide. Staff and/or patient details will only
            be provided through Risk Management with prior consultation of
            the individuals concerned.
           Estates Manager
            Receive anonymous copies of all incidents that relate to the
            hospital estate. Staff and/or patient details will only be provided
            through Risk Management with prior consultation of the
            individuals concerned.
           Tissue Viability/Infection Control Nurse Specialist
            Receive complete copies of all incidents that relate to infection
            control within the Trust, both for patients and staff
           Resuscitation Advisor
            Receive anonymous copies of all incidents that relate to
            resuscitation practices within the Trust.
           Blood Transfusion Group
            Receive anonymous copies of all incidents that relate to blood
            transfusion within the Trust.
           NHS Professionals
            Receive complete copies of all incidents that relate to Bank and
            Agency nursing Staff within the Trust.
           Clinical Director for Radiology/Divisional General Manager
            Receive complete copies of all incidents that relate to radiation
            safety within the Trust, and will give advice to the Chief
            Executive if an incident needs to be reported to an External
            Agency (e.g. HSE for the Ionising Radiations Regulations, 1999;
            Department of Health for Ionising Radiation (Medical Exposure)
            Regulations, 2000 and the Environment Agency for The
            Radioactive Substances Act, 1993).
           Information Governance Manager
            Receive complete copies of all incidents that relate to
            information security within the Trust.
           Complaints and Legal Services Manager
            Receive complete copies of all incidents where the injured
            person is likely to make a complaint or a claim against the Trust.
           Serious Untoward Incident Team (SUIT)
            Receive complete copies of all incidents where a SUIT is
            investigating the incident.


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4.10 Serious Untoward Incidents
A degree of judgement is required as to when to treat an incident as serious
and therefore to implement the serious untoward incident procedure. A first
indicator is when an incident has been graded Red. Other indicators would
be following:
         A death or life threatening event involving a patient, visitor, staff or
           other persons on Trust premises
         Any incident which exposes the Trust to potential litigation or
           adverse media coverage or regional or national interest
         Any event involving a hazard to the public health e.g. major toxic
           contamination or radiation hazard
         Incidents significantly damaging to the reputation of the Trust, its
           staff or assets.

The Head of Risk together with the Medical Director or the Director of Nursing
and Modernisation are authorised by the Chief Executive to decide when an
event should trigger the Serious Untoward Incident Procedure. Where doubt
exists, the Chief Executive will be invited to adjudicate.

Where appropriate, and after discussion with the Chief Executive (deputy/MD
in absence of CEO) the Risk Management Team will initiate the Memorandum
of Understanding Procedure for Police and Health and Safety Executive joint
investigations (see 4.19)
       The procedure described must not interfere with existing lines of
       accountability nor replace the duty to inform the Police, Coroner or
       other authorities where appropriate.

The Trust has separate arrangements for dealing with Major incidents in
accordance with HSC98/127.

The procedure for dealing with serious incidents is totally separate from any
disciplinary action which may be taken and from complaint handling, reviews
or inquiries.

In devising the Serious Untoward Incident Procedure, as recommended by the
Redfern Report, the Trust has noted that depending on the nature of the
serious incident, it may consider the need for a serious untoward incident
team independent of the Trust to investigate.

Some Serious Untoward Incidents straddle other organisations, that the Trust
has no managerial responsibilities for. Therefore it may be necessary to
undertake joint Serious Untoward Incident Investigations or to ensure that
other organisations are aware and updated on the Trust’s investigation and its
findings and safety lessons are shared

4.11 Serious Untoward Incident Reporting Procedure
The immediate priority in the case of serious incidents is to take steps
necessary to secure the safety of patients, staff and other people involved.
Subsequently, serious untoward incidents should be reported as follows:

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             The Chief Executive must be informed immediately of any such
              event, by the Head of Risk/Director of Nursing and
              Modernisation (Monday to Friday during office hours) or On Call
              Managers (out of hours) via the on call Executive as soon as
              possible and be given regular updates. At the discretion of the
              Chief Executive the Trust Board will be informed and updated.
             A nominated senior manager/clinician must inform all patient(s)
              and relatives as soon as possible after the event. Where this is
              not possible an Executive Director will be nominated by the
              Chief Executive to do this. Full and open communication must
              be maintained throughout the investigation and treatment of the
              patient (see Being Open When Patients are Harmed Policy).
             Comments or responses to the press or other media enquiries
              must only occur following reference to the Chief Executive and
              only after the patient/relatives have been informed
             The Chief Executive, or nominated Deputy, is to deal with press
              enquiries and this must be the only source of contact other than
              agreed statements.
             Sefton PCT will be advised briefly of the nature of the incident
              and that an initial report will follow.
             A Serious Untoward Incident Team (SUIT) will be convened
              comprising of:
                    Chief Executive or deputy
                    Medical Director or deputy
                    Director of Nursing and Modernisation
                    Lead Clinician (Clinical Director or Medical Lead for Risk)
                    Head of Risk or deputy
                    Complaints and Legal Services Manager
                    Appropriate Divisional General Manager or deputy

The membership of the Team will be increased to include representation from
the areas affected, according to the nature of the incident.
             An investigating officer (lead Investigator) must be appointed to
              manage the investigation, gather the facts of the incident, co-
              ordinate     all    statements     and      documentation,      keep
              contemporaneous notes of the investigation meetings and
              ensure that the timescales set out in paragraph 4.14 are
              adhered to.
             The lead investigator will be a member of staff who has attended
              an RCA course using the NPSA toolkit. This is to ensure that
              each investigation is undertaken consistently, using root cause
              analysis methodology and that unbiased judgements are made.
             The lead investigator will require the full support of the SUIT and
              the divisional\departmental manager concerned to collect all
              statements from staff involved, copy the patient’s case notes
              (where applicable) and assist in producing a timeline of events
              that led up to the incident and the effects after the incident.
             The Chief Executive will be updated regularly by the Lead
              Investigator
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              The Head of Risk/Complaints and Legal Services
               Manager/Matron will be nominated to take responsibility for
               arranging counselling support for the staff involved in the
               incident and in its aftermath e.g. staff involved in operating help
               lines as well as for identifying those staff in need of support.
              Consideration will be given as to whether it is appropriate to
               report the incident to the relevant professional or statutory body
               (e.g. Nursing and Midwifery Council, General Medical Council,
               Health and Safety Executive, Medicine and Healthcare Related
               Products Agency or National Patient Safety Agency) including
               the outcome of the SUIT investigation.

4.11.1         StEIS
               Any serious untoward incident must be reported (within 72
               hours) using the StEIS database. If the electronic system is not
               available then contact should be made to Sefton PCT via the
               telephone. For further guidance see Appendix 10 Operation
               Policy for the performance management of Serious Untoward
               Incident (Sefton PCT July 2008)

4.12 Functions of the Serious Untoward Incident Team
The principle functions of the team include the following:
             Investigation of the incident to identify, as rapidly as possible,
              the facts and consequences, using root cause analysis
              methodology. A timeline will be produced based on the patient’s
              case notes and written statements.
             Inform relevant external bodies as appropriate including
              professional and statutory organisations
             Co-ordinate information, communication and press coverage as
              well as establishing efficient means of dealing with enquiries
              from press, media, relatives and members of the public
             Organise appropriate counselling and support through
              Occupational Health Department for staff affected by the
              incident
             Production of an action plan designed to correct or limit the
              consequences, minimise the chance of recurrence in the future
              and allow lessons to be learned
             Production of a preliminary and final written report in a timely
              fashion against the criteria under Action Timescales.

4.13     Action Timescales
              The CEO will be informed of a Serious Untoward Incident
               immediately it is safe to do so.
              The CEO, Director of Nursing, Medical Director and Head of
               Risk will decide if a Serious Untoward Incident Team is to be
               established and if appropriate an investigation will commence
              The CEO will be informed that the Serious Untoward Incident
               Team has been convened following a serious untoward incident.
               They will be updated on progress of the investigation of the

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              incident and on follow-up action taken. Timescales for updates
              will be agreed between the lead investigator and the CEO
             A summary report will be made within a week of the Serious
              Untoward Incident Team Meeting and all witnesses and
              personnel involved in the incident must give written statement in
              accordance with ‘Statement Guidelines’ (Appendix 5).
             The Lead Investigator will write a final report which will be
              approved by the Divisional General Manager and the Divisional
              Medical Lead for Risk. The final report will clearly state the
              findings, recommendations and action plan agreed by the
              Serious Untoward Incident Team. The final report will be
              produced against the template shown in Appendix 8. The final
              report will be ready within 28 days
             The Executive Team and any other Trust Committee/Group
              relevant to the investigation will ratify the final report.
             The Chief Executive will inform the Board of the outcome of the
              Serious Untoward Incident Team Report and a final report will
              be sent to the Regional Strategic Health Authority usually within
              four weeks of an incident except where it has been decided to
              hold an external inquiry.
             The Trust will ensure that the outcome of the investigation
              influences future practice, recognising that a Serious Untoward
              Incident provides an opportunity to learn for the future
             Action plans will be followed up by Clinical Services Committee
              (CSC) or a nominated committee
             A further evaluation of the incident and response must be
              undertaken six months following the incident and entered on the
              Trust’s Incident Database for additional analysis. The aftermath
              of serious untoward incidents may continue over a prolonged
              period of time and regular update reports to the Trust Board and
              Regional Strategic Health Authority may be necessary.

4.14 Support for Serious Untoward Incident Team (SUIT)
The SUIT will require accommodation or a control room and there may be
further accommodation required for help lines, where appropriate – see
paragraph 4.18 Rapid Response Help line.

Adequate staffing to support the SUIT and the investigation including staffing
for routine administrative and clerical support, medical records support and
specialist assistance may be required. The final responsibility for allocation of
staff resource will lie with the Chief Executive who will determine from which
departments staff should be drafted, recognising that other work may be
compromised, particularly if the incident is prolonged.

4.15 Major Incident and Public Health Hazards
The Trust has a separate Major Incident Procedure for dealing with external
major incidents, including chemical and radiation incidents, together with
Service Recovery Plans to deal with major incidents within the Trust. These
procedures are distinct and separate from the Serious Incident Reporting
Procedure.
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4.16 Internal Reviews or Inquiries
In some cases following a serious untoward incident, the Trust may decide to
hold a formal internal review (undertaken by internal management) or an
internal inquiry (an internal investigation conducted by an external
organisation). A decision as to whether such procedures need to be
implemented will be taken following discussion between the SUIT, Chief
Executive and the Trust Board.

4.17 Rapid Response Help Line
The Trust has a dedicated Rapid Response Help Line that can be utilised and
staffed when deemed necessary.

4.18 Reporting to External Agencies
The Trust is responsible for ensuring incidents are reporting in a timely
manner to external agencies as detailed below and that safety lessons are
shared. The Trust will work within the terms of the protocol for the
Memorandum of Understanding between the DH, HSE and the Police
     Police
      Incidents must be reported to the Police promptly when there is:
          Evidence or suspicion that the actions leading to harm were
           intended
          Evidence or suspicion that adverse consequences were intended
          Evidence or suspicion of criminal activity
          Evidence or suspicion of gross negligence and/or recklessness in
           a serious safety incident, including where gross negligence and/or
           recklessness involves a failure to follow safe practice or
           procedures or protocols

Memorandum of Understanding Protocol (Memorandum)

      Coroner
Untoward patient death must be reported to the Coroner by the medical team.
The Complaints and Legal Services Manager must also be informed of
untoward patient deaths. A report to the Coroner must be recorded in the
patient’s case notes

      National Patient Safety Agency (NPSA)
All patient incidents are reportable to the NPSA. This is managed on a
monthly basis, through Risk Management, by the electronic transfer of data
from the Trust’s Incident Database to the NPSA database (National Reporting
and Learning Systems) using their agreed datasets.

The Trust may share a more detailed account of Serious Untoward Incidents
in order to disseminate learning to other NHS Organisations and in order for
the NPSA to initiate further work.

The NPSA use such data to provide to Trusts, comparative data for incident
reporting analysis across the NHS and as a framework for their activity on
learning lessons and the issuing of Patient Safety Alerts.
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     Regional Strategic Health Authority (RSHA)
The PCT manage the process for Serious Untoward Incidents on behalf of
NHS North West. Serious Untoward Incidents will be reported to the Sefton
PCT by the Risk Management team. Investigation Reports will be shared with
the PCT on completion of the investigation and within their timescales of 60
days.

      Medicines and Healthcare products Regulatory Agency MHRA)
These are incidents involving a medical device or medication, which gives rise
to, or has the potential to produce unexpected or unwanted effects involving
the safety of patients, users or other persons. Such incidents will be reported,
by the Trust to the Medicines and Healthcare Products Regulatory Agency
(MHRA) when they did or could have led to:

       Death, life threatening illness or injury
       Deterioration in health
       The necessity for medical or surgical intervention
       Unreliable tests results leading to inappropriate diagnosis or treatment.

Incidents involving medical devices/medicines must be reported to the MHRA
by the Medical Engineering Department / Pharmacy Department respectively.

     Health and Safety Executive (HSE)
Many incidents will be reportable to the HSE under the “Reporting of Injuries,
Diseases and Dangerous Occurrences Regulations (RIDDOR).

Appendix 7 gives examples of reportable and non-reportable incidents as a
guide only. The following are examples of reportable incidents under
RIDDOR:
       Incidents which result in an employee or a self-employed person dying,
        suffering a major injury, or being absent from work or unable to perform
        their normal duties for more than three days.
       Incidents which result in any person suffering an injury and being taken
        to hospital, or if an incident happens at a hospital suffering a major
        injury.
       An employee or self-employed person suffering one of the specified
        work related diseases.

The Health and Safety Advisor/Risk Team on receipt or further investigation of
an incident report will undertake reporting to the HSE.
       Serious Hazards of Transfusion (SHOT) via Serious Adverse
        Blood Reactions and Events (SABRE)
Incidents where there is an unintended response to a donor or patient that is
associated with the collection, or transfusion of blood or blood components
that is fatal, life-threatening, disabling or incapacitating, or which results in or
prolongs hospitalisation or morbidity will be reported by the Transfusion
Practitioner.


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       Reporting of radiation exposures “greater than intended” to
        External Agencies
If a patient (or volunteer, in the case of a research study) has received a
radiation dose "greater than intended" or there has been a failure to follow a
written protocol resulting in a dose being received where no dose was
intended, the Trust must notify either the Department of Health or HSE
depending on the circumstances. Dose "multiplier guidelines" have been
published and these give advice on what constitutes "greater than intended".
Clinical Director for Radiology/Divisional General Manager must be informed
of the incident and they will liaise with the Chief Executive on sending out the
letter of notification.

4.19 Reporting Lessons learned Locally
The Head of Risk or deputy will attend the Risk Management Network Forum.
This is a venue for local sharing of lessons learned from incidents and
investigations. This forum will be attended by an NPSA representative.
Divisional Risk Bulletins are collated and circulated regularly.

4.20 Analysis of aggregated incident data and learning of lessons
The Clinical Governance Department under the remit of the Head of Risk and
Complaints and Legal Services Manager, will produce and report on a four
monthly basis, the aggregated data on Incidents, Complaints and Claims.

The Head of Risk and the Complaints and Legal Services Manager, will
undertake a Risk Assessment of all Incidents, Complaints and Claims
aggregated data and will produce a single report for the Clinical Governance
Annual Report on the following:

            All data received during the financial year on Incidents, including
             Serious Untoward Incidents, Complaints and Claims
            Breakdown of trends both Trust wide and by Divisions
            Risk Assessment undertaken of above during financial year on
             Incidents, Complaints and Claims. This will be analysed to
             identify trends across the organisations as a whole, breaking
             down the impact on each division.
            An assessment of how these Risk Assessments have lead to
             actions to reduce future risk, with illustrative significant examples

The Risk Assessment will analyse numbers, outcomes, grades, action plans,
monitoring and review.

The report on the findings from the Risk Assessment will form part of the
Trust’s Clinical Governance Reporting Structure.

Following ratification of the report by the Clinical Services Committee, the
report and its recommendations will be discussed by the Trust Board and will
then be in the public domain.

The results of the analysis will be considered for inclusion in the Risk
Register. See Risk Strategy for further information.
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Each Division will have access to incident data via the web based incident
report system so that they can produce specific reports for analysis and risk
identification at Divisional meetings.

4.21 Action Plan Follow Up
All action plans from incidents, complaints and claims will be monitored
through Clinical Services Committee or a designated committee until the
committee is satisfied that all revenant action has been taken. Lessons
learned from incidents and investigations will be shared throughout the Trust
to relevant areas though the divisional risk management groups Divisional
Risk Bulletins are collated and circulated on a monthly basis.

4.22 Support for staff involved in Serious Untoward Incidents
The Trust has a Staff Support Policy to help and support staff who have been
or who are involved in a Serious Untoward Incident, Inquest, Complaint,
Clinical Negligence Claim, Public and/or Employer Liability Claim, PES and
who may have to provide witness statements and/or attend court to give
evidence. The policy describes the team who will offer support including
senior medical and nursing staff, together with senior managers, who have
extensive experience in handling/dealing with such sensitive issues.

The Trust offers a qualified confidential Counseling Service, to which staff
can self refer. This information is given to all employees at staff induction
and reiterated to all staff at mandatory training. The contact number is also
available from Human Resources and widely publicized throughout the Trust.

4.23 Reporting and Whistleblowing
All incidents need to be investigated promptly as soon as possible after the
incident and all employees should be treated with respect using a fair
approach. Staff need to be encouraged to report mistakes and other incidents
as soon as possible even if they are not directly involved in the incident. All
employees are responsible and accountable for the impact of their own
actions and omissions on patient care and service delivery. The Trust
recognises that at times staff members may be aware of an incident that has
not been reported and involves another member of staff. In this case, staff
may find it difficult to report such incidents themselves and should consider
using the following approaches:

      The incident can be reported anonymously by telephone to the Head
       of Risk, ext 8906, Complaints and Legal Services Manager, ext 5530,
       or to the Clinical Governance Department, 8437.
      The member of staff involved in the incident should be encouraged
       and supported in reporting the incident either by completing a form,
       reporting it anonymously or discussing it with their line manager.
      The staff member who is aware of the incident but not involved in it
       can use the Whistle Blowing Policy. This policy allows concerns to be
       raised which may have an effect on the safety of patients and the
       public in general. This policy will allow you to raise concerns without
       fear of retribution.

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4.24 Media
Any serious untoward incident will be fully discussed with the Communications
Manager to assess for potential media impact.




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5     Duties

5.1   All personnel (including contractors) working on Trust premises)
            Must comply with this Policy and its reporting procedures
            Must inform their immediate Manager verbally, as soon as they
             become aware, of a Serious Untoward Incident
            Assist with any incident investigation
            Provide written statements on request
            Take all reasonable steps to minimise risks.

5.2   Line Managers/Ward Managers/Persons in Charge/ Supervisors
           Must comply with this Policy and its reporting procedures
           Ensure that all staff are aware of their responsibilities and that
            they adhere to the reporting procedures
           Receive copies of all incident reports and ensure that an
            appropriate investigation is made of each incident in accordance
            with the incident grading criteria
           Must inform their immediate Manager verbally, as soon as they
            become aware, of a Serious Untoward Incident
           Must take immediate action to prevent recurrence
           Ensure Incident Report Forms are completed within the
            identified time period.
           Must follow the correct reporting procedure
           Ensure local investigations are carried out to a satisfactory and
            prompt conclusion no greater than 28 days
           For clinical incidents – check that the appropriate details have
            been recorded in the patient’s case notes.
           Retain all appropriate records, materials and equipment (Clinical
            and non-clinical) involved in the incident
           Inform the relevant Divisional/Departmental Managers and/or
            Clinical Director or out of hours On Call Manager
           The On Call Manager should make a decisions whether the
            incident should be reported to the On Call Executive
           Ensure that the patient, relatives or other persons responsible
            for the patient (with patients consent if available), who need to
            have details of the event, receive timely and adequate
            explanations from the appropriate member of staff.
           In the event of a radiation incident, ensure that the Radiation
            Protection Advisor (RPA) is informed and to take appropriate
            action following the RPA’s advice.

5.3   Divisional General Manager/ Clinical Directors/Divisional Medical
      Risk Leads
            Must comply with the Policy and its reporting procedures
            Must inform the Head of Risk/ deputy, as soon as they become
             aware of, a Serious Untoward incident
            Liaise the Risk Management Department when investigating
             Serious Untoward Incidents
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            Ensure that Divisions/Departments analyse incident reports and
             trends through the use of the web based incident report system
             and their local Governance Structures
            Manage the process of local incident investigations with
             particular emphasis on adherence to timescales and appropriate
             use of recognised investigation techniques
            Ensure that following all investigations action plans are
             implemented within Divisions/Departments through the
             Performance Review Framework and local Governance
             Structures.
            Ensure lessons are learned across the Division and/or
             organisation.

5.4   Medical Lead for Risk
          Review all serious clinical incidents in liaison with the Head of
           Risk
          Implement the Serious Untoward Incident Reporting Policy
           where appropriate
          Ensure investigations of Serious Incidents are undertaken and
           advice on appropriate management plans are established
          Ensure lessons are learned across the organisation and by
           educating clinical staff

5.5   Head of Risk /Project Assistant
          Ensure that incident data collection is complete and appropriate
          Implement the Serious Untoward Incident Reporting Policy
           where appropriate
          Inform the Chief Executive and/or Director of Nursing and
           Governance of reported incidents according to their significance
          Inform the National Patient Safety Agency and Sefton PCT in
           accordance with their requirements
          Ensure incidents that require immediate action are followed up
          Compile records of incidents
          Assist with the investigation of clinical and non-clinical incidents,
           where appropriate
          Review all incidents
          Support Clinical Directors/Medical Risk Leads, Divisional
           General Managers and Heads of Departments to interrogate
           incident data so that reports are tailored to individual department
           needs
          Provide reports for appropriate Trust Committees or Groups
          Forward copies of incident reports to internal stakeholders as
           outlined in paragraph 4.12.
          Undertake analysis of aggregated incident data for inclusion in
           the four monthly and yearly Risk Management reports quarterly
          Ensure lessons are learned across the organisation and by
           educating staff.


Incident Report Policy
Ratified: October 2008
To Be Reviewed: October 2010
                                Page 31 of 79
5.6    Project Assistant
            Ensure data from incident reports are accurately input on the
             Trust Database against departmental procedures, within 10
             working days of receiving the incident form.
            Request an investigation of the incident on the instruction of the
             Divisional General Managers/Project Lead/Medical Lead for
             Risk/Divisional Medical Lead for Risk/Head of Risk, within 2
             working days of receiving the incident form.
            Check daily for CAS alerts and disseminate hazard and safety
             notices appropriately and follow up actions required using a
             proforma.

5.7    Lead Radiation Protection Supervisor (Chair of the Radiation
       Safety Committee).
       Ensure that on a regular basis the radiation safety requirements as
       defined in the Ionising Radiations Regulations 1999 (IRS) (IR1999) and
       in the Trust’s own Local Rules relating to radiation safety are complied
       with. Each appointed Radiation Protection Supervisor provides reports
       to this committee to assure that rules are complied with in each area of
       responsibility.

5.8    Radiation Protection Adviser
       Regulation 13 of the Ionising Radiations Regulations 1999 requires the
       Trust to appoint a Radiation Protection Adviser for the purposes of
       advising the Trust as to the observation of those Regulations. The
       Trust’s appointed Radiation Protection Advisor is IRS limited,

5.9    Medical Physics Expert (MPE)
       The Walton Centre does not offer a nuclear medicine service. IRS
       provide the necessary Medical Physics expertise to enable the Trust to
       use radioactive Isotopes for laboratory testing, advising on compliance
       with IRR regulations.

5.10   Health and Safety Advisor/Head of Risk
            Make external reports as appropriate e.g. to the HSE/MHRA etc.
            Make reports available to the Health and Safety Group and other
             committees as required.
            Support Managers in investigating Health and Safety Incidents
            Promote a positive Health and Safety Culture.
            Ensure lessons are learned across the organisation and by
             educating staff.

5.11   Estates Manager
            Will investigate all fire incidents

5.12   Transfusion Practitioner (TP)
        Located in Aintree Blood Transfusion Laboratories and works under
          the terms of a Service Level Agreement
        Will make transfusion incidents to the appropriate body
Incident Report Policy
Ratified: October 2008
To Be Reviewed: October 2010
                                  Page 32 of 79
5.13   Local Security Management Specialist
            Will report security incidents to external agencies as appropriate
            Will maintain an ongoing dialogue with the police with regard to
             crime reduction activities
            Ensure lessons are learned across the organisation and by
             educating staff.

5.14   On Call Managers
           Will take immediate action following the report of a serious
            incident out of hours, as per policy
           Report actions taken following a Serious Untoward Incident to
            the Risk Management Team the next working day.
           Provide advice to staff out of hours on incidents.




Incident Report Policy
Ratified: October 2008
To Be Reviewed: October 2010
                                 Page 33 of 79
6     Associated documentation and references


     National Health Service Litigation Authority (NHSLA) Risk Management
      Standards for Acute Trusts (derived from the former Clinical
      Negligence Scheme for Trusts (CNST) and Risk Pooling Scheme for
      Trusts (RPST) Standards)
     Memorandum of Understanding
     National Patient Safety Agency
     Medical Healthcare Related Products Agency
     Health and Safety Executive
     Research Governance Framework (2001)
     Redfern Report
     Safety Alert Broadcasting Scheme Policy
     CHI Setting up of Rapid Response Help lines




Incident Report Policy
Ratified: October 2008
To Be Reviewed: October 2010
                               Page 34 of 79
7     Training and Resources

All new staff will be made aware of the Trust’s Incident Reporting Policy and
Procedure via the Trust’s Induction Programme.

All existing staff will be made aware/reminded of the Trust’s Incident
Reporting Policy and Procedure via the Trust’s Mandatory Training
Programme.

The Incident Reporting Policy and Procedure will be made available to all staff
through the Trust’s Intranet Site.

All staff will be made aware of local arrangements via Line Managers, Heads
of Departments, Divisional General Managers or Clinical Directors.

Divisional General Managers/Heads of Departments will receive training in
Root Cause Analysis by the Risk Management Team.




Incident Report Policy
Ratified: October 2008
To Be Reviewed: October 2010
                                Page 35 of 79
8 Monitoring and Audit

The implementation of this policy is integral to the management of risk within
the organisation. Compliance with the policy will be monitored by the Clinical
Services Committee (CSC) at a Trust wide level and by Divisional General
Managers and Medical Leads for Risk at divisional level. Compliance will be
measured by the following:
           Numbers of incidents reported from all divisions/departments
              (reported four monthly to CSC)
           Evidence of Incidents reported by all professional groups within
              each division/department (reported four monthly to CSC)
           Each division will hold a risk register and can demonstrate
              actions taken against the risks identified
           Evidence that analysis of incidents across the organisation has
              been undertaken and appropriate action taken (reported four
              monthly to CSC)
           Evidence that the Trust Risk Register contains risks derived
              from analysis of incidents
           Serious incidents are investigated using a root cause analysis
              approach and that action plans derived from investigations are
              followed up demonstrating that lessons are being learnt
           Evidence that staff undertake training related to incident
              reporting and complaints and claims management appropriate to
              their grade

The quarterly Risk Management and Complaints and Claims report on
progress against serious untoward incidents will demonstrate compliance with
this policy. Any areas not compliant will be followed up by CSC. The Head of
Risk and the Complaints and Legal Services Manager are responsible for
producing a four monthly risk, complaints and claims report which will be
submitted to the Board of Directors through CSC.




Incident Report Policy
Ratified: October 2008
To Be Reviewed: October 2010
                                Page 36 of 79
9 Incident Form (Appendix 1)




Incident Report Policy
Ratified: October 2008
To Be Reviewed: October 2010
                               Page 37 of 79
Incident Reporting Flowchart



                           When an incident occurs,
                           assess the situation, take
                         immediate action to prevent
                          further harm and treat any



                             Report the Incident
                             verbally to your line
                            manager immediately




                      Is this a Serious Incident where
                    Death or Serious Harm has or could
                                have occurred




        YES                                                            NO

  You must make an oral report                        Fill in the Incident Report Form
 for the Chief Executive through
    the Head of Risk or On-call                        (If you need more space use a
   Manager immediately as per                            separate sheet of paper and
  the Serious Untoward Incident                       attach original to the White copy
       Reporting Procedure.                           and photocopy to Yellow Copy)



                                                   White copy of Incident form must be
 CEO/DoN&G/MD/Head of Risk                          forwarded to Risk Management
    will decide if a Serious                       Yellow copy of Incident Form must
  Untoward Incident Team will                      be forwarded to Divisional General
     be established and if                          Manager or Head of Department
  appropriate investigation will
          commence


  Investigation will be completed and                  Risk Management or Division
  forwarded to Risk Management for                     will decide if local investigation
  inclusion on the Incident Reporting                        is required and where
               Database                                 appropriate investigation will
                                                                   commence


Incident Report Policy
Ratified: October 2008
To Be Reviewed: October 2010
                                   Page 38 of 79
10      Definitions of Reportable Incidents (Appendix 2)

The table below is for illustrative purposes only and does not include all
incidents that are reportable using the Trust Incident Report Form.

Near Miss                                 Accident
(Can be Clinical Or Non-Clinical)
 A ceiling tile falls off and narrowly      A syringe driver is dropped and
   misses a member of                         broken
   staff/patient/visitor/contractor          A member of staff hurts their back
 The wrong medication is about to            whilst moving a patient/object
   be administered, but the mistake          A member of the public falls in the
   is realised and the correct                car park injuring themselves
   medication is given

Clinical Incident                         Ill Health
(Adverse Event)

    The wrong patient is operated on        A member of staff suffers a
    The wrong dose of medication is          reaction after wearing latex of
     prescribed and given                     other type of gloves
    An unexpected complication in a         An existing back injury is made
     procedure                                worse by further manual handling
                                              tasks

Incident involving a medical device       Fire Incident
 A medical device develops a fault          Any time a fire is suspected,
   in use                                     whether it can be seen or not, e.g.
 A patient is injured by a faulty            smell of smoke but no flames
   medical device

Radiation Incident                        Security Incident

    A Member of staff or the public is      Verbal or physical assault, abuse
     over exposed to a radiation dose         or harassment of any member or
    A patient receives the wrong             staff, patient or visitor
     radiation dose due to either            The theft of any staff, patient,
     equipment failure or a procedure         visitor or Trust property
     being followed incorrectly              Burglary of any office or premises
    The loss or theft of a radiation        Criminal damage to any property,
     source                                   equipment or item
    The accidental release of               Lost or found property
     radioactivity                           Any confidentiality breach of
    A road traffic accident involving        patient of staff information
     radioactive sources being
     consigned by the Trust


Incident Report Policy
Ratified: October 2008
To Be Reviewed: October 2010
                                   Page 39 of 79
11    List of Trust Advisors (Appendix 3)

The table below provides details of Personnel who can assist with advice on
preventative measures to be taken following an incident.


Medical Director                            Director of Nursing & Modernisation
0151 529 5533/5726                          0151 529 5521


Head of Risk                                Project Assistant (Risk)
0151 529 8906                               0151 529 8437


Fire Safety Advisor/Estates Officer         Local Security Management Specialist
0151 529 5529                               0151 529 5664


Resuscitation Training Officer/Outreach Manual Handling Co-ordinator
Team                                    0151 529 2986
0151 529 5649


Tissue Viability and Infection Control Consultant Microbiologist/Director of
Specialist Nurse                       Infection Prevention and Control
0151 529 5599                          0151 525 4922


Head of Clinical Effectiveness and Audit    Complaints and Litigation Manager
0151 529 8583/5436                          0151 529 5533


Head of Human Resources                     Health and Safety Advisor
0151 529 5515                               0151 529 8377


Transfusion Practitioner                    Consultant Neuro-anaesthetist
                                            0151 529 5767




Incident Report Policy
Ratified: October 2008
To Be Reviewed: October 2010
                                 Page 40 of 79
12     Risk Categorisation and Incident Grading Criteria (Appendix 4)

Risks identified through incident reporting, must reflect the urgency and
degree of action, if any, required to eliminate or reduce the risk and further
occurrences of incidents. The guidance below indicates the three broad
categories of risks, which the Trust uses as its framework for action. The
categories include risks that the Trust considers to be ‘acceptable’,
‘manageable’ or ‘serious’. Guidance on actions are set out below.

Risk Categorisation as identified through the Grading Matrix

Acceptable Risk (Green)
Realistically it is never possible to eliminate all risks. There will be a range of
risks identified within the Trust that would require us to go beyond
‘reasonable’ action to reduce or eliminate them, i.e. the cost in time or
resources required to reduce the risk would outweigh the potential harm
caused. These risks would be considered ‘acceptable’ by the Trust.

Examples are:
 frequent, low consequence events such as minor property loss and
   damage,
 injuries requiring first aid only,
 or potentially serious events that are very unlikely to occur and for which
   reasonable preventative measures are in place.

Incidents graded Green (acceptable risk) should be analysed locally to identify
if there are lesson to be learnt, a formal written investigation is not required
centrally.

Manageable Risk (Yellow – Orange)
These risks can realistically be reduced within a reasonable timescale through
cost effective measures, such as training or new equipment purchase.

Examples are:
 manual handling injury,
 malicious damage,
 procedural failures and injury to staff or patients.

Action will be the responsibility of the Directorate/Department.

Incidents graded Yellow - Orange (manageable risk) must be formally
recorded and sent to Risk Management along with original copies of
investigation documents, such as statements and photographs (where
appropriate).

Serious Risk (Red)
The consequence of the event could seriously impact on the Trust and
threaten its objectives.

Incident Report Policy
Ratified: October 2008
To Be Reviewed: October 2010
                                  Page 41 of 79
Examples are:
 accidental death,
 major fire
 major disruption of services.

This category might include risks that are individually manageable but
cumulatively serious, such as series of similar injuries. Risk identified as
serious must be reported to the Chief Executive via the Head of Risk or
deputy.

Incidents graded Red (serious risk) must be investigated as a Serious
Untoward Incident in accordance with the Serious Untoward Incident
Investigation Procedure.

Obviously these are broad categories, and can only reflect a reasonable
estimate of potential risk. For instance a patient may fall and sustain no
injury, a laceration or a fatal skull fracture. When estimating risk, past
experience will often inform identification of the most probable outcome.

Risk Grading Criteria

It is necessary to rate risk systematically and accurately using standard
methodology, so that they can be placed into one of the three categories
above. This allows prioritisation of remedial action.

As detailed in paragraph 4.9 incidents should be graded in 2 ways.

   1. actual harm caused by the reported incident
   2. an assessment of recurrence.

The assessment of recurrence should take into account:

      the potential harm that could have been caused (measure of
       consequence – see table 1
      the likelihood that another similar incident will occur and how often this
       is likely (measurement of likelihood – see table 2)

By combining the two and referring to the matrix the risk categorisation is
identified.

i.e. a patient slipped on wet floor and has fractured their wrist.
Actual harm grading = 3. Moderate (Orange)
Assessment of recurrence: the patient could have fractured their hip, the floor
was wet because of a spillage. Spillages are normally cleaned up straight
away:

Measurement of consequence = 4. Major
Measurement of likelihood = D = Unlikely
Assessment of recurrence = ORANGE

Incident Report Policy
Ratified: October 2008
To Be Reviewed: October 2010
                                  Page 42 of 79
  Table 1 Measurement of Consequence


   Level          Descriptor         Description
   5              Catastrophic       Death; Adverse Publicity
   4              Major              Permanent Injury; RIDDOR reportable
   3              Moderate           Semi-permanent        Injury;    RIDDOR
                                     reportable
   2              Minor              Short Term Injury
   1              Insignificant      No injury or adverse outcome


  Table 2 Measurement of likelihood


   Level          Descriptor         Description
   5              Almost             Likely to recur on many occasions, a
                  certain            persistent issue
   4              Likely             Will probably recur but is not a persistent
                                     issue
   3              Possible           May recur occasionally
   2              Unlikely           Do not expect it to happen again but it is
                                     possible
   1              Rare               Cannot believe this will ever happen
                                     again




Incident Report Policy
Ratified: October 2008
To Be Reviewed: October 2010
                                  Page 43 of 79
     Risk Grading Matrix


                Consequence (if in doubt grade up, not down)
Likelihood      1                 2                   3          4        5
of              Insignifica       Minor               Moderate   Major    Catastrop
recurrence      nt                                                        hic
5 Almost
  Certain       Orange            Orange              Red        Red      Red


4 Likely
                Yellow            Orange              Orange     Red      Red


3 Possible
                Green             Yellow              Orange     Red      Red


2 Unlikely
                Green             Green               Yellow     Orange   Red


1 Rare
                Green             Green               Yellow     Orange   Orange




   Incident Report Policy
   Ratified: October 2008
   To Be Reviewed: October 2010
                                      Page 44 of 79
13      Guidance for staff on writing statements as part of an investigation
        (Appendix 5)

As a member of staff who comes into contact with the public, patients and
relatives, there may be times when a complaint is made about an event that
you have been involved with. On these occasions you may be asked to write
a statement on the events surrounding the incident. In other words, you may
be asked to describe your involvement.

It is understandable that at times like these you may feel worried. It is
important to remember that with any investigation our aim is to be
scrupulously fair to both the complainant and the staff involved. The aim of
the investigation is purely to establish the facts and find out what and why
something happened so that the Trust can provide the complainant with a full
explanation. It is not used to apportion blame to any individual and you
should not feel threatened in any way by this.


Your manager will be able to advise you and offer help in producing any
statement or account of your involvement. The following points will also help
you to write a clear and concise report of events.
    First remember that you are entitled to have access to any relevant
     records or documents whilst making your statement. So do make sure
     that you have access to the patient’s case notes.
    Before writing consider the following 5 principles:
    Who, where, when, how and why.
    Begin by stating who you are, your occupation/qualifications and length of
     experience. State how you came into contact with the person (patient or
     relative). Also refer to any witnesses by their full name and status.
    If you do not remember the patient/event say so and state that your
     statement is based upon the records you made at the time.
    Record events in chronological order being accurate with dates and times
     and refer to entries made within the nursing and medical notes where
     appropriate.
    Concentrate on the facts (what you saw, heard and did).
    Do not express opinions on what might have happened or what other
     people may have done. Also avoid hearsay or speculation.
    Write in the first person, e.g. at 16:00hrs I reviewed Mr Smith. I saw that
    Address any allegations made.
    If you refer to any supporting documentation e.g. guidelines followed,
     attach this to your statement.
    Always sign and date your statement and keep a copy.

Incident Report Policy
Ratified: October 2008
To Be Reviewed: October 2010
                                   Page 45 of 79
A vital part of any investigation of a complaint about a patient’s care is a
review of the patient’s records. When asked to prepare a statement in relation
to your involvement with the patient, you may have to rely entirely on what you
documented in the patient’s records at the time. For this reason, all entries
made in a patient’s case notes should provide a detailed, legible and
chronological account of the patient’s stay with all entries being signed, dated
and timed. Good record keeping will support any statement you are required
to produce.


For further information see Ten Commandments of Good Record Keeping
on the Trust’s Intranet.


For further advice: contact the Clinical Governance Department.




Incident Report Policy
Ratified: October 2008
To Be Reviewed: October 2010
                                 Page 46 of 79
         14    Incident Investigation Form (Appendix 6)
         Confidential                         To be forwarded to Head of Risk
            The Walton centre for Neurology and Neurosurgery NHS Trust
                             Incident Investigation Form
Incident Form No: _______ Length of Absence: __________hours/days/weeks/months


Additional Information of Incident:
___________________________________________________________________________
___________________________________________________________________________
___________________________________________________________________________
___________________________________________________________________________

Facts Brought Out By Investigation: (Give simple, clear, one sentence ‘good’ and bad’ facts.
Each sentence should contain only one specific fact).
1
2
3
4
Actions Taken By Investigator/Directorate/Department
no Description                Action Taken                               Timescal Complet
                                                                         e         e
1
2
3
4
Recommendations for the Risk Management Team to consider
     Description              Recommendations                            Timescale Complete
1
2
3
4
Investigator(s)
     Name                                    Designation                        Contact
                                                                                No:
1
2
3
Date of Completion of investigation: ___/___/___
Attachments:
Witness              Sketches           Photograph(s)         Other (specify):
Statements

For Office Use:
    No further action required, addressed by directorate/department

   Recommendations to be reviewed by Risk Management Committee.
   Date referred to Committee: _________________ Action Approved/Not Approved
         Incident Report Policy
         Ratified: October 2008
         To Be Reviewed: October 2010
                                         Page 47 of 79
Recommendations to be reviewed by Trust Board.
Date referred to Trust Board: _________________ Action: Approved/Not Approved

     15    RIDDOR Reporting (Appendix 7)

     Examples of Incidents that are or are not reportable under the Reporting
     of Injuries, Diseases and Dangerous Occurrence Regulations (RIDDOR)

      Reportable                                       Not reportable

      A confused patient falls down from a window A frail elderly patient falls
      or an upper floor and is badly injured           and breaks their leg; there
                                                       are no obstructions or
                                                       defects in the premises,
                                                       which contributed to the fall.
      A hospital patient is scalded by hot bath Minor scalds requiring first
      water and has to be moved to a burns unit aid
      for treatment
      Reportable Major Injuries:                       Fractures to the fingers,
      Fractures                                        thumbs or toes
      Amputations
      Loss of sight (temporary or permanent)
      Chemical or hot metal burn to the eye or any
      penetrating injury to the eye
      Acute illness requiring medical treatment or
      loss of consciousness resulting form
      absorption of any substance by inhalation,
      ingestion of through the skin, or exposure to
      a biological agent.
      Any other injury, which leads to hypothermia
      or     unconsciousness,       which    requires
      admittance to hospital for more than 24
      hours.
      Any other injury that leads to the person
      being absent from work or unable to perform
      their normal duties for more than 3 days.
      Reportable Diseases:                             A person who becomes
      Some skin diseases, such as occupational colonised with MRSA after
      dermatitis,     asthma        or     respiratory nursing patients with MRSA
      sensitisation.
      Infections such as hepatitis, tuberculosis,
      Legionellosis and tetanus.
      Any other infections reliably attributed to
      work with biological agents.
      Reportable Dangerous Occurrences:                Urine specimen container is
      A patient hoist falls, due to overload           broken and the contents
      Needlestick injury from a needle and syringe are spilt.
      known to contain Hepatitis B positive blood
      Spillage of formaldehyde

     Incident Report Policy
     Ratified: October 2008
     To Be Reviewed: October 2010
                                      Page 48 of 79
 Container of Tuberculosis culture is broken
 and releases its contents




Incident Report Policy
Ratified: October 2008
To Be Reviewed: October 2010
                               Page 49 of 79
16      Template for Serious Untoward Investigation Report (Appendix 8)

(It must be remembered that the report is disclosable in law, should a litigation
claim be made)

The final report should contain the following:

1.      Cover Sheet

2.      Contents Page

3.      Introduction
        Brief summary of what the incident involved and the outcome of the
        incident, not the outcome of the review
        Identify the members of the Serious Untoward Incident Review Team
        State the specific Terms of Reference for the investigation
        Outline the methodology of the investigation.
        List Statements taken
        List documentation used
        List staff/persons involved in the incident
        List staff/persons from whom statements were taken if different from
        above
        List interview information (timescales, how conducted, different
        interview methodologies, repeat interviews undertaken, type(s) of in
        depth causal analysis for all incidents involving death or serious harm,
        details of meetings/group discussions held with staff involved etc.)
        Provide details of internal/external expert reports requested if relevant.
        Identify level of involvement/communication with
        patient(s)/carers/relatives etc.

4.      Timeline
        Provide a detailed timeline of the sequence of events.

5.      Body of the Report
        Discussion of investigation findings of Serious Untoward Incident
        Investigation. Root cause analysis should be included as an appendix.
        In the discussion refer to any external expert report(s) undertaken as
        the Trust’s request.
        Detail any external reports made (e.g. NPSA, RSHA, MHRA, HSE)
        Detail actions taken since time of incident (changes to practice/service
        delivery)
        Detail lessons learned
        Detail impact on staff (according to NPSA data set)
        Impact of incident on service(s) (according to NPSA data set)

     6. Conclusions of the Report

     7. Recommendations

Incident Report Policy Sept 2008   Page 50 of 79
Review Date – Sept 2009
      8. Action Plans (as per template below) with timescales and monitoring
         arrangements.

Appendices: (These are examples only of what could be included in the
report)

1.       Index of contents of appendices
2.       Untoward incident form and appendices including lessons learned
         proforma
3.       Statements (list and actual statements in order of list) – typed and
         anonymous.
4.       Contact details of all persons involved
5.       Structured interview template(s) or other interview methodologies used
6.       Report from the clinical expert providing a specific clinical opinion
         about what happened with a view about the outcome of the incident
7.       Copy of relevant parts of the case notes (where applicable)
8.       Copy of photographs/floor plans etc if relevant
9.       Timeline: factual sequence of events from start to end of incident(s)
10.      Root cause analysis methodologies used and documented findings
11.      Action points of meetings held
12.      Copies of all correspondence relating to the case
13.      Information re Claim/Complaint status if applicable
14.       Copies /details of reports to external authorities
15.      Reports from external experts (where relevant)
16.      Incident Grading Matrix
17.      Summary for SHA in line with reporting requirements (NPSA data sets)
18.      Copy of summary report prepared for staff involved.
19.      The appendices may be lengthy for a Serious Untoward Incident. They
         should be listed in the report but may not necessarily be part of the
         report
20.      The final report and all documentation must be held in the Risk
         Management Department.

Note: The final report for disclosure will be anonymous of patient and staff
   details.




Incident Report Policy Sept 2008   Page 51 of 79
Review Date – Sept 2009
        17       Investigation Process Flow Chart (Appendix 9)

                                               Incident Identification
                                        Ensure patient or Environmental Safety

 Investigation Process Flow
 (incident, complaint or
                                                 Incident Reporting
 litigation)
                                       1-3Grade Report to departmental manger
                                                    immediately
                                           4 – 5 grade Immediate report to
                                                 Divisional Manager


                                        Reporting of Incident Forms

                                       As soon as safe to do so complete
                                               the incident form
                                        Report to be written before the
                                            end of the working day


                                        Incident Form Dissemination

                                          Departmental Manager to
                                        complete the local investigation
                                       area of report with instructions of
                                                  actions taken
                                           Departmental Manager
                                        responsible ensuring yellow and
                                       white form promptly to recipients




      Pink Forms                                 White Forms                           Yellow Forms
Retain within department                                                         Departmental Managers send
  Not in patients notes              Risk Team to input within 10 days             to Divisional Managers
                                   Assess and approve severity of incident              within 24hrs
                                   Assess need for internal review or RCA
                                              Report Concerns

                                                                                         Weekly Review
                                                                                  Divisional Manager, Clinical
                                               Categorisation                     Director and Medical lead for
                                   All incidents reviewed for severity and       Risk to review all yellow within
                                          aggregate or investigation
                                                                                              5 days
                                   Investigations decided at categorisation
                                      will be notified to the Divisional
                                       Manager for appointment of an             Notification of Investigation
                                              investigation team
                                                                                 Responsible manager to be
                                                                                 informed of incidents which
                                              Grade 5 Incidents                  affect their area or work e.g.
                                                                                 infection
                                     Ensure that appropriate executive,
                                     Director of Nursing and/or Medical          Risk Team to be notified of all
                                      Director informed immediately                 investigations pending and
                                                                                   investigation team members
                                                                                 and must include the Divisional
        Incident Report Policy Sept 2008    Page 52 of 79                             Medical Lead for Risk
        Review Date – Sept 2009
                                                                                  Investigation lead to be RCA
                                                                                     trained member of staff
18. Operational Policy for the performance management of Serious
    Untoward Incidents – Sefton PCT (Appendix 10)

This Policy is used as a working draft




      Operational Policy for the Performance
    Management of Serious Untoward Incidents


 Title:   Operational Policy for the Performance Management of Serious Untoward
          Incidents
 Scope: Trust wide                            Classification: Policy
 Identification No:                           Version No: 12
 Replaces: N/A
 Author/Originator: Jane Keenan, Project Manager
 In consultation with: Head of Corporate Performance & Risk, Deputy Director of
 Corporate Performance & Standards, Director of Corporate Performance &
 Standards
 Accountable Director: Director of Corporate Performance & Standards
 Authorised by: Governance Committee                 Date:
 To be read in conjunction with: NHS North West Serious Untoward Incident
 Reporting Protocol March 2008
 Issue Date: July 08                      Review Date:
                                          December 08
 Equality Impact Assessment carried out       Date




In considering the application of this policy, procedure or function the PCT will ensure
that staff or patients will not be discriminated against or treated differently on account
of any subjective bias in relation to the six pillars of equality and diversity: race,
disability, gender, age, sexual orientation, religion/belief.

This document can only be considered valid when viewed via the Sefton PCT
website or Department Policy Folder. If this document is printed into hard copy or
saved to another location, you must check that the version number on your copy
matches that of the one online.

This document is available in other formats on request


Incident Report Policy Sept 2008     Page 53 of 79
Review Date – Sept 2009
Contents

Introduction                                                              51
Purpose                                                                   51
Definition of Serious Untoward Incident                                   51
Procedures that NHS Organisations must have in place                      53
Reporting Serious Untoward Incidents                                      53
Initial Assessment of the Serious Untoward Incident                       54
PCT Roles and Responsibilities                                            55
Commissioning Responsibilities                                            55
Executive & Non-Executive Responsibilities                                55
Committee Responsibility                                                  56
PCT Serious Untoward Incident Performance Management Group
 – Constitution                                                           56
Quality Standards for the Review Process                                  56
Notification & Initial Review                                             56
Notification to Associate PCT                                             56
Criteria for assessing the 45 working day internal investigation report   57
Criteria for incident closure                                             57
Flow Chart – Overview of responsibilities and relationships
NHS Provider/ SHA/PCT Commissioner                                        58
Data Collection & Analysis                                                59
Learning from Experience                                                  59
Monitoring and Revision Arrangements                                      59
Appendix 1 - NHS North West Strategic Health Authority StEIS
Incident Areas & Examples                                                 60
Appendix 2 - Flow Chart for Reporting Serious Untoward Incidents          63
Appendix 3 - NHS North West Interim Criteria for SHA Action               64
Appendix 4 - Internal Incident Investigation Report Format for
Providers & Content                                                       66
Appendix 5 - Function / Terms of Reference of PCT Serious
Untoward Incident Performance Management Team                             70
Appendix 6 Serious Untoward Incidents Involving Children                  72
Appendix 7 Reporting Serious Untoward Incidents Involving Data            75




Incident Report Policy Sept 2008    Page 54 of 79
Review Date – Sept 2009
1 Introduction

In June 2008, North West Strategic Health Authority will transfer its responsibilities
for the performance management of Serious Untoward Incidents to the
commissioning arm of Sefton Primary Care Trust.

This policy outlines the responsibilities of the PCT in relation to performance
management of Serious Untoward Incidents in its commissioned and contracted NHS
services. Please note: this policy does not replace the systems and processes
associated with a Serious Case Review in the event of a death of a child or young
person below the age of 18.

2 Purpose

The purpose of this policy is to outline the PCT’s governance arrangements for the
performance management of Serious Untoward Incidents and ensure that patient
safety and other reportable incidents are appropriately managed within our
commissioned services in order to address the concerns of patients of the patients
and promote public confidence.

The policy describes the requirements for serious untoward incident reporting and
management within the Northwest of England and is in line with ‘NHS North West
Serious Untoward Incident Reporting Protocol March 2008’.

The PCT is expected to use patient safety intelligence, provider performance
knowledge and lessons learned to inform a commissioning process that actively
reduces the risk of harm to patients.

The role of the SHA and Commissioning PCT is to ensure incidents are investigated
properly, that action is taken to improve clinical quality and that lessons are learnt in
order to minimise the risk of similar incidents occurring in the future.

A further requirement of this new process will be that Foundation Trusts report SUIs
to the Commissioning PCT for the purpose of performance management.

Sefton PCT makes explicit in their contracts with all providers, their expectations
regarding incident reporting and management, and the indicators and the process for
performance management

3 Definition of a Serious Untoward Incident

3.1 The principal definition of a serious untoward incident (SUI) is any incident on an
    NHS site, or elsewhere, whilst in NHS-funded or NHS regulated care involving;

         Patients, relatives/carers or visitors
         Staff
         Contractors working for the NHS, equipment, building or property

And which may or has;

        Resulted in death (this includes deaths from suspected suicide/ suicide or
         homicide) or serious injury or was life-threatening
        Contributed to a pattern of reduced standard of care
        Involved a hazard to public health
Incident Report Policy Sept 2008       Page 55 of 79
Review Date – Sept 2009
     Involved the absconsion of a patient detained under the Mental Health Acts of
      1983 and 2007 and/or where a patient poses a significant risk to themselves or
      others
     Caused serious disruption to services
     Caused significant damage to the reputation of an NHS organisation or its staff
     Caused significant damage to NHS assets
     Involved fraud or suspected fraud (the procedure in HSC 1999/062 and the
      associated Memorandum of Understanding (NHS CFS and ACPO 2002) must
      also be observed in parallel)
     Given rise to a significant claim for damages
     Involved the suspension of a member of staff on care/clinical, professional or
      managerial issues / when a ‘healthcare professional alert’ notice has been
      issued (Healthcare Professionals Alert Notice Directions 2006) or referral to a
      Professional Regulatory Body
     Involvement of external investigation agencies (Police, HSE, Healthcare
      Commission, CSCI)
     Raised severe criticism by an external body e.g. Coroners’              Inquest,
      Parliamentary and Healthcare Ombudsman, Mental Health Commission
     Raises concerns regarding Article 2 European Convention on Human Rights /
      Human Rights Act 1998 (breach of duty to protect life)
     Involved significant healthcare associated infections e.g. outbreaks, unit/ward
      closures or Public Health issue, especially if the require the involvement of the
      Health Protection Agency
     A data related incident resulting in damage to service reputation resulting in
      either local or national media coverage as outlined in categories 3 to 5 (DoH
      Information Governance Assurance Programme Gateway Reference Number:
      9912). See Appendix 7
     A data related incident resulting in a serious breach of confidentiality,
      unintended release of sensitive data or a breach with the potential for identity
      theft as outlined in categories 3 to 5 (DoH Information Governance Assurance
      Programme Gateway Reference Number: 9912). See Appendix 7

Appendix 1 provides StEIS incident areas and examples

3.2    Adverse outcomes reasonably associated with routine NHS activity such as
       major surgical procedures, trauma interventions etc are excluded from the
       above list

3.3    Reporting managers need to exercise a degree of judgement in deciding a
       threshold for reporting an incident. Organisations are advised to contact the
       Corporate Performance & Standards Directorate at Sefton PCT if in doubt
       (please see page 8 of this policy for contact details).

3.4    This protocol must not interfere with existing lines of accountability nor
       replace the duty to inform the Police and/or other organisations or agencies
       as required.      Please refer to the joint publication ‘Memorandum of
       Understanding – Investigating Patient Safety Incidents (2006) issued by the
       Department of Health, the Health and Safety Executive and Association of
       Chief Police Officers and ‘Guidance for the NHS in support of the
       Memorandum of Understanding’ (2006) for further guidance. For serious
       incidents involving children and young persons under the age of 18, refer to
       Sefton Local Safeguarding Children Board Procedures, and the statutory
       guidance ‘Working Together to Safeguard Children’ (2006) – Appendix 6.
4      Procedures That NHS Organisations Must Have in Place
Incident Report Policy Sept 2008 Page 56 of 79
Review Date – Sept 2009
4.1       NHS organisations are responsible for identifying serious untoward incidents
          and taking effective action in each instance. It is expected that clear local
          procedures are in place at each NHS organisation for identifying, reporting
          and investigating SUIs.

4.2       Each NHS organisation should have an authorised named person who is
          responsible for deciding when an incident should trigger the serious untoward
          incident procedure. Chief Executives must ensure that local procedures are
          in place so that all staff know how to identify and report a serious untoward
          incident as outlined in this document. Arrangements must be in place to
          ensure responsibilities remain clear throughout any organisational changes.

4.3       The named person should involve their Communications lead in the
          assessment of incidents for potential media impact. The NHS Trust or PCT
          should prepare a press release to respond to media enquiries where media
          interest is anticipated. NHS North West’s Communications Team is available
          for advice and will offer support in media handling for high profile incidents.

4.4       The national guidance contained in HSG (94) 27 (revised June 2005) should
          be followed for mental health incidents.

4.5       When a child or young person under the age of 18 has died or is seriously
          injured and non-accidental injury, abuse or neglect is suspected then all local
          child protection procedures must be followed and the Designated Nurse for
          Sefton Local Safeguarding Children Team must be informed immediately the
          incident is identified. When cases fall under the authority of the local
          Safeguarding Children Board, a joint media strategy will be agreed – see
          Appendix 6.

5         Reporting Serious Untoward Incidents

5.1       NHS organisations must report any serious untoward incident to the PCT
          within a maximum of 72 hours or as soon as known following notification
          using the StEIS database. Care should be taken to ensure that all sections
          are completed and as much detail as possible is included in the initial StEIS
          report. Information should be provided in a manner, which maintains the
          anonymity of patients and staff involved, in line with Caldicott principles. In
          the event of StEIS reporting system being unavailable, contact with the PCT
          should be made via telephone (see appendix 2), and the incident entered
          onto StEIS once the system is back online.

      If relevant, the following information should also be provided in the ‘Further
      Information’ field on the StEIS electronic report form;

         Number of patients affected;
         Impact on patient(s);
         Designation of staff involved;
         Confirmation of which, if any, medical devices or equipment were involved;
         Confirmation of which, if any, medicines were involved;
         The impact of the incident on staff;
         Whether the patient’s family has been informed and if not ate there plans to
          do so; if a decision not to inform the family has been taken, has this been
          properly recorded – was the patient involved in this decision;
Incident Report Policy Sept 2008      Page 57 of 79
Review Date – Sept 2009
         If the family has been contacted- how is contact with the family being
          maintained, is there a named person for this purpose;
         Any other information deemed relevant by the reporting organisation

5.2 Having completed the initial StEIS report form, the reporting organisation must
    then take appropriate measures to investigate the SU. The onus of responsibility
    lies with the reporting organisation to inform the PCT of any problems or delays.
    The PCT will endeavour to ensure the investigative process is not hampered by
    unnecessary contact from the PCT. Please refer to the flowchart in Appendix 2
    for details of the recommended process for incidents which meet NHS North
    West’s escalation criteria and will therefore remain the responsibility of/ or be
    escalated for the SHA to performance manage following the new arrangements
    and the transfer of performance management to commissioning PCT's.

5.3 Where the authorised named individual in a Trust/PCT believes that the incident
    has significant implications for the NHS in terms of clinical, managerial or media
    issues, and warrants the immediate involvement of the SHA out of hours, the
    SHA on-call Executive Director can be contacted when the situation requires
    escalation. If so, they will agree any action that needs to be taken with the
    relevant NHS organisation. Please refer to the flowchart in Appendix 2 for the
    recommended process.

6         Initial Assessment

Once Sefton PCT has received notification of a serious untoward incident, an
assessment will be carried out in collaboration with NHS North West.

The following options will be considered;

6.1       Criteria for SUI Management

         The incident does not meet the StEIS reporting criteria and no further action
          is needed. Removal from StEIS would be requested following discussion with
          the reporting organisation
         NHS North West may declare a particular incident to be a major incident and
          involve the on-call Director of Public Health and/or Regional Director of Public
          Health in the incident management
         Sefton PCT undertakes performance management of the incident and
          advises NHS North West as appropriate. If NHS North West considers it
          necessary, NHS North West may retain the performance management of the
          incident and liaise with Sefton PCT, but in either case the reporting
          organisation will be requested to proceed with its internal investigation
          processes and provide Sefton PCT and/or NHS North West with an internal
          investigation report within 45 working days from the date the incident was
          reported onto StEIS
         The incident may meet NHS North West escalation criteria (Appendix 3) and
          will then be managed by NHS North West in collaboration with Sefton PCT.

On reporting an SUI, the PCT will determine the performance management process
within 24 hours and advise the provider to commence its internal investigation
immediately. The PCT will write to the provider organisation(s) to confirm this within
3 days.



Incident Report Policy Sept 2008      Page 58 of 79
Review Date – Sept 2009
In the event of escalation of an incident, NHS North West will brief the Department of
Health if/as appropriate and agree the level of involvement with the Trust/PCT.
Depending on the severity of the incident this could include;

         Submission of internal investigation report within 45 working days
         Agree terms of reference and investigation/review panel
         NHS North West commissions an independent investigation

7.        PCT Role and Responsibilities

7.1       Commissioning Responsibilities

Sefton PCT is the Lead Commissioner for:-

University Hospitals Aintree
Sefton PCT Provider Services
Southport & Ormskirk NHS Trust
The Walton Centre for Neurology & Neurosurgery

7.2       Executive & Non Executive Responsibilities

The Chief Executive has overarching responsibility for the management of the StEIS
system and has delegated responsibility for the performance management of SUIs to
the Director of Corporate Performance & Standards,

A core team of individuals have been established as initial contacts during office
hours for the notification of an SUI and can be contacted as below;

Vacant                  Patient Safety Manager
                        Tel: 0151 920 5056 extension 437 / 443

Sue Giles               Head of Corporate Performance & Risk
                        Tel: 0151 478 1291 (direct line)

Jan Snoddon             Deputy Director of Corporate Performance & Standards
                        Tel: 0151 478 1225 (direct line)

Vacant                  Assistant Head of Risk
                        Tel: 0151 920 5056 extension 437 / 443

Fiona Boyle             Head of Corporate Governance
                        Tel: 0151 920 5056 extension 214 / 427

Sue Williams            Head of Clinical Quality
                        Tel: 0151 478 1291 extension 437 / 443

Fiona Clarke            Director of Corporate Performance & Standards
                        Tel: 0151 920 5056 extension 427

For SUIs involving children and young persons under the age of 18 which may fall
under local Safeguarding Board Procedures, contact the Designated Nurse for
Sefton;

Jane Leather            Designated Nurse for Safeguarding Children

Incident Report Policy Sept 2008      Page 59 of 79
Review Date – Sept 2009
                      Tel: 077 667 63569 / 0151 920 5056 extension 447

7.3    Committee Responsibility

The Executive Team and the Governance Committee will receive performance
reports every two months as per meeting calendar unless a reported SUI warrants
more frequent reporting as determined by the Director of Corporate Performance &
Standards.

7.4    The PCT SUI Performance Management Group

On receipt of a notification of an SUI, the PCT will establish a PCT SUI Management
Group (SUI PMG)

Relevant expertise, knowledge and experience within the PCT will be utilised
dependent upon the type of service reporting the event and the type of event
reported. The PCT will ensure that the team has sufficient knowledge and
experience of the subject matter to enable an objective assessment of the adequacy
of the scope of the review, the subsequent review report and any recommendations
made and facilitate incident closure on receipt of assurance that recommendations
have been implemented.

The PCT will provide sufficient resources to support the performance management
process including administrative support for the StEIS system.

Membership of Sefton PCTs SUI Performance Monitoring Group can be found in
Appendix 5.

8      Quality Standards for the Review Process

8.1    Notification & Initial Review

       Following notification of an SUI the PCT will liaise with the reporting
       organisation to confirm the appropriate level of investigation and reports
       required and internal investigation reports will be required within 45 working
       days from the date the incident was reported onto StEIS system. If the
       organisation faces unavoidable delays in its investigation of an incident e.g.
       police investigation, the PCT should be notified of the reason for the delay
       and the anticipated delay period and a new reporting timescale will be
       negotiated on a case by case basis as required.

8.2    Notification & Involvement of Associate PCT’s

       An associate PCT will be notified within 24 hours of Sefton PCT being notified
       of the SUI. The associate PCT will also be provided with a copy of the final
       report into the SUI by the provider Trust. Depending on the circumstances of
       the SUI in question, there may be early implications for an associate Trust
       which may warrant their participation in the performance management
       process but this will be determined on a case by case basis.

8.3    Criteria for Assessing the 45 Working Day Internal Investigation Reports

       Sefton PCT will accept draft investigation reports at the provider’s
       consultation phase.

Incident Report Policy Sept 2008       Page 60 of 79
Review Date – Sept 2009
          The following criteria are used when appraising the 45 working day Internal
          Investigation reports (see Appendix 4);

         Has the report examined the workings of the risk management (including
          incident reporting and the related incident management systems) and clinical
          governance arrangements at the Trust / PCT. Has the report assessed
          whether these systems are fit for purpose;
         Have the authors of the report interviewed / sought information/ statements
          from the key workers / managers involved in the case (please note care
          should be taken to ensure staff do not feel intimidated if interviewed);
         Has the report adequately addressed all of the investigation terms of
          reference;
         Is the report internally consistent i.e. do the main conclusions follow from the
          body of the report;
         Are the main recommendations directed at the appropriate sector of the
          health community – i.e. primary care, secondary care, local authority
         Is there a robust action plan in place to meet the reports recommendations
         Do the recommendations address the root causes of the incident

Any further action will be agreed with the Trust / PCT Provider on a case by case
basis as required. Once completed the incident may be recommended for closure by
Sefton PCT SUI Performance Management Group.

8.4       Criteria for Incident Closure

      Closure of incidents reported on StEIS may be considered after submission of the
      internal investigation report and action plan (if appropriate). However if there are
      significant recommendations closure may be delayed until these
      recommendations or the associated action plan has been implemented. Closure
      of an SUI will depend on the severity of the SUI and will be decided on a case by
      case basis and will reflect the role and responsibility of the PCT as a
      Commissioning organisation. Sefton PCT will confirm in writing the closure of an
      SUI with the provider organisation. In general, the PCT will look to ensure;

         The report is robust and has fulfilled the terms of reference
         An action plan has been agreed between the relevant organisations, which
          addresses the recommendations and has been ratified by the Trust/PCT
          Board
         Evidence has been submitted that significant recommendations have been
          implemented




Incident Report Policy Sept 2008          Page 61 of 79
Review Date – Sept 2009
                   Overview of Responsibilities & Relationship, NHS Provider, SHA & PCT
                                Serious Untoward Incidents (SUI) Flowchart

                                             Serious Incident (SUI)
                                                     Occurs
                                           (as per guidance in Policy)

If the incident does not
 fit the criteria for SUI                         Enter onto STEIS                      Copy to
but may incur MEDIA                              Database within one                  Commissioners
          interest                                  working day


                                            Enter further details on                  Review against
                                             STEIS within three                       Major Incident’s
                                                working days                          criteria report to
                                                                                        RDPH DOH

                                           PCT write to Trust within
                                                 three days



                                     Further Action
                                       Needed?
                            Yes                               No


         PCT confirm action required                         Incident is now closed
          and type of report. Normally
        needs to be completed within 60
                 working days


              Report given to PCT
               (within 60 days)



           PCT review report within
             fifteen working days



       Further               PCT happy with
       action               actions completed.
       needed                Incident Closed


                                  PCT to disseminate lessons learned at 6
                                  monthly intervals
          Incident Report Policy Sept 2008 Page 62 of 79
          Review Date – Sept 2009
9      Data Collection & Analysis

       The Patient Safety Manager will have responsibility for maintaining accurate
       electronic records through the StEIS database.

       The use of performance management in terms of StEIS will remain entirely separate
       from the PCT Provider services reporting process.

       The StEIS database will assist the Patient Safety Manager in providing relevant and
       timely information as required by the SUI Performance Management Team.

       The Patient Safety Manager or appropriate senior manager will provide reports to the
       Governance Committee according to the meeting schedule and the Trust Board as
       requested.

10     Learning from Experience

       The Trust is committed to quality and safety in commissioned services.

       A systematic approach to the analysis of patient safety intelligence will be developed
       which supports the commissioning of safe services which meet the clinical quality
       requirements.

       The PCT will make explicit reference within contracts as to its expectation regarding
       incident reporting and management. The clinical quality reviews with provider
       services will enable local discussions on areas of concern or provide an opportunity
       to facilitate the sharing of good practice.

       It is acknowledged that providers will invoke their own arrangements for instigating
       remedial action following an SUI.

       In the interest of wider participation and the sharing of lessons, Sefton PCT will act
       as commissioning host and provide the forum to share experiences and enable
       lessons to be learned. As host commissioner, Sefton PCT will bring together parties
       to the SUI for a Post Incident Review (PIR). This review does not replace any
       internal mechanisms for review a provider organisation may have. The spirit of the
       review must be one of openness and learning – it is not about the allocation of
       blame. Through this process lessons learned will be tacitly shared with all involved,
       documented and shared with a wider audience. The PIR will take place as soon as
       possible after receipt of the SUI investigation report. The PIR will take place after the
       performance management process has concluded and following receipt of the
       internal investigation report from the provider organisation. It is anticipated the PIR
       will be facilitated by an individual who was not involved in the SUI and ideally an
       individual external to the organisations involved. It is anticipated that the PIR
       process may occur anytime from receipt of the SUI investigation report to no later
       than 8 weeks after receipt of the report.

11     Monitoring Review and Revision Arrangements

       This policy will be reviewed on an ongoing basis as the PCT assumes responsibility
       for the performance management of SUIs previously within the domain of NHS North
       West. Initially however, this policy will be reviewed no later than 6 months from its
       inception.

Incident Report Policy Sept 2008    Page 63 of 79
Review Date – Sept 2009
                                        Appendix 1

             NHS NORTH WEST STRATEGIC HEALTH AUTHORITY StEIS
                        INCIDENT AREAS & EXAMPLES


 INCIDENT           INCIDENT EXAMPLES


                    Acute and Primary Care Trusts

                     Death or serious injury, abuse or neglect of a child or young
                      person under the age of 18, which results in a Serious Case
                      Review (previously known as a Part 8 Review) under the
                      Children Acts of 1989 and 2004 in which health has a major
                      role.

                     Death leading to public concern and / or external inquiry
                      involving NHS service provision (including children, vulnerable
                      and other adults e.g. deaths in custody).

                     Homicide or serious injury to a member of staff (including
 Untoward death       Independent contractors) or patient in the course of their duties
   of patients,       or whilst on NHS premises.
      staff,
   contractors       Staff that may lead to the involvement of the criminal justice
 working for NHS      system.
        or           Serious injury of a person currently in receipt of NHS care such
                      as deliberate self-harm, accidental injury or injury inflicted by
 Serious risk or      another person.
     injury
                     Serious injury or harm, as a result of the actions of a health
                      care professional to a person currently in receipt of NHS care.

                     Serious injury to a vulnerable adult resulting in an investigation
                      under local adult protection arrangements.

                     Any instance of staff or patients being poisoned / infected in
                      the course of receiving treatment or as a direct result of NHS
                      employment.

                     Inpatient admissions of Under 18 year old CAMHS clients to
                      adult clinical units. NB for patients aged 16-18 years please
                      indicate if the admission location was based on clinical / risk
                      assessment and patient identified need (i.e. was the admission
                      to an adult placement a deliberate clinical decision / choice) or
                      due to lack of CAMHS beds / facilities availability.


                    Mental Health / Learning Disabilities Trusts

Incident Report Policy Sept 2008   Page 64 of 79
Review Date – Sept 2009
                      The unexpected death of a person currently in receipt of NHS
                       care where the death is as a result of suspected suicide, as a
                       result of a homicide or is likely to be of public concern, e.g. of
                       particular concern is any such death occurring on NHS
                       premises or potentially high profile patient suicides involving
                       bridges and railway lines.

 Untoward death       Death resulting from violence/aggression.
   of patients,
      staff,          Homicide or serious injury to a member of staff (including
   contractors         independent contractors) or patient in the course of their duties
 working for NHS       or whist on NHS premises.

        or            Staff actions that may lead to the involvement of the criminal
                       justice system.
  Serious risk or
      injury          Serious injury of a person currently in receipt of NHS care such
                       as deliberate self-harm, accidental injury or injury by another
                       person.

                      Serious injury or harm of a person currently in receipt of NHS
                       care as a result of the actions of a health care professional.

                      Serious injury to a vulnerable adult resulting in an enquiry
                       under local adult protection arrangements.

                      Patients detained under the Mental Health Act 1983 / 2007
                       who abscond from Mental health/learning disability services
                       and who present a serious risk to themselves and/or to others.
                       Of particular concern are those patients who absconds from
                       medium/high secure or specialist forensic services, those who
                       are likely to pose a risk to the public, attract media attention
                       and/or who commit an offence whist at large, were police are
                       informed of their absconsion and missing persons alerts are
                       issued. Informal admission patients who abscond but are
                       considered to be vulnerable / high risk should also be reported.

                      Any instance of staff or patients being poisoned / infected in
                       the course of receiving treatment or as a direct result of NHS
                       employment.

                      Inpatient admission of Under 18 year old CAMHS clients to
                       adult clinical units. NB for patients aged 16-18 years please
                       indicate if the admission location was based on clinical / risk
                       assessment and patient identified need (i.e. was the admission
                       to an adult placement a deliberate clinical decision / choice) or
                       due to lack of CAMHS beds / facilities.

 Corporate Risks     All Trusts

                      Any incident is likely to attract media attention, is high profile or
                       likely to be of public concern.

                      Serious breach of patient confidentially e.g. theft/loss of PC,
Incident Report Policy Sept 2008 Page 65 of 79
Review Date – Sept 2009
                     laptop or memory stick containing patient identifiable
                     information; inappropriate publication of sensitive data.


                     Removal of accreditation by an external body over major risk
                      issues/concerns e.g. NHSLA schemes, royal colleges,
                      university training establishments.

                     A pattern emerging that is causing local concern such as a
                      high number of complaints regarding a member of staff/team a
                      particular service and/or hospital/unit that may warrant further
                      investigation and action.

                     Serious fire or other serious damage / incident which occurs on
                      health service premises, practically if they result in death or
                      serious injury of patients or staff and / or would result in the
                      major disruption of service provision.

                     Incident which results in the loss of service provision and
                      impacts on patient or staff safety e.g. significant power
                      failure/loss of power, equipment failure, IT / communications
                      failure.

                     Any incident involving serious implications for patient to staff
                      safety – involving potential risk as opposed to actual risk to
                      patients to staff, which the wider health community needs
                      alerting to.




Incident Report Policy Sept 2008   Page 66 of 79
Review Date – Sept 2009
                                                Appendix 2
                        Flow Chart for Reporting Serious Untoward Incidents to PCT


                                          Serious Untoward Incident occurs in NHS
                                             initial StEIS / UNIFY alert Unit
                                         iveorganisation or NHS IS Provider / report
                                                                                                 OUT OF OFFICE HOURS
                                                                                                      IF IMMEDIATE
                                                                                                    INVOLVEMENT IS
                                                                                                 NECESSARY CALL (01704
 DURING OFFICE HOURS                                                                                538 970 and ask for
                                       If SUI is considered to be urgent or in event of          Manager on Call – Manager
Call 0151 920 5056 and ask                                                                         on Call reports SUI to
                                         StEIS system failure, ring PCT immediately
for initial contacts for SUI                                                                      Executive Director on call
          reporting                                                                                    immediately

                                        In all cases provider completes StEIS Report
                                          Form within 72 hours of incident & further
                                                 details entered within 3 days


                                                                                                       Liaise with
                                              PCT receive initial StEIS report                         PCT/Trust
                                                                                                       Communications
                                                                                                       Lead



                                       PCT SUI PMG convenes to agree performance
                                                 management process




                                       Agree actions to be taken by NHS Organisation




                                       PCT contact with NHS organisation requesting
                                          further information/actions if necessary




                                        NHS organisation to complete and send any
                                       incident review to PCT within 45 working days




                                               Review to be assessed by
                                                       SUI PMG




                                                                 Agree any further level of investigation and
                 Close Case                                    monitoring of procedures by NHS organisation
               Provider notified                              through SUI PMG and report to Trust Board and
         Post Incident Review format                                      Governance Committee.
            agreed with provider                                   Agree format for Post Incident Review.


        Incident Report Policy Sept 2008          Page 67 of 79
        Review Date – Sept 2009
                                        Appendix 3

                    NHS North West Interim Criteria for SHA Action



                 NHS North West Interim Criteria for SHA Action
 Mental Health      Inpatient suicides/attempted suicides

                     Homicides/attempted suicides

                     All absconds from Secure Accommodation, and all incidents
                      occurring in high secure hospital services as required in line
                      with DH guidance “Policy framework for the reporting and
                      briefing of incidents and issues in high security hospitals” (June
                      2007).

 General             Inpatient suicides/attempted suicides

                     Incidents involving police investigation or criticism from an
                      external organisation

                     Clusters and trends involving multiple incidents or patients

                     Evidence of organisational failure

                     Incidents where a safety alert has been in place

                     Incidents where a professional alert notice is in
                      place/requested

                     Incidents involving new or poorly understood areas of concern
                      e.g. adverse outcomes from new interventional procedures/
                      drugs

                     Incidents attracting high media attention

                     Prison service incidents involving NHS staff

                     Deaths in Custody involving NHS Staff

                     Incidents reported by Commissioning arm of PCT

                     A data related incident resulting in damage to service
                      reputation resulting in either local or national media coverage
                      (DoH Information Governance Assurance Programme
                      Gateway Reference Number: 9912)

                     A data related incident resulting in a serious breach of
                      confidentiality, unintended release of sensitive data or a breach
                      with the potential for identity theft (DoH Information
                      Governance Assurance Programme Gateway Reference
                      Number: 9912)

Incident Report Policy Sept 2008   Page 68 of 79
Review Date – Sept 2009
 SHA Priorities      Safeguarding children – Serious Case Reviews

                     Maternity unit closures

                     High Secure Unit SUIs (as identified in MH section above)

                     Health Care Associated Infections (HCAI) which constitute an
                      outbreak and/or cause ward closure/disruption to service
                      provision.

                     CAMHS admissions under the age of 18 into adult placement
                      areas. All admissions of children under 16s years of age
                      admitted to adult wards to be reported accordingly.
                      Adolescents aged 17-18 years admitted to adult placements
                      are requested to add clarification statement in the “further
                      information” box on the StEIS report form identifying if the
                      placement decision was made on clinical judgement or due to
                      lack of specialist CAMHS placement availability.




Incident Report Policy Sept 2008   Page 69 of 79
Review Date – Sept 2009
                                        Appendix 4

          Internal Incident Investigation Report Format for Providers & Content

The report of the internal investigation should normally be received by the PCT within 45
working days of the incident report date on StEIS and should include the following;

Title

    1.     Post Incident Review – Serious Untoward Incident – StEIS reference number

Contents Page

    2.     If a report is in excess of 4 pages, a contents page should be included –
           especially if the report contains appendices. Page and paragraph numbering is
           required

Background

    3.     A brief description of the matters and circumstances that have prompted the
           review, including the specific issues that need to be addressed within the report
    4.     Care should be taken not to include here information that should be placed in the
           body of the report
    5.     As this section is likely to set the tone of the document, particular care should be
           taken over use of language. In particular emotive language should be avoided

Review Team and Terms of Reference

    6.     The Trust should appoint a review team at the earliest opportunity. The team
           should be led by a Chair of the Review Team, who ideally is experienced in
           incident investigation and trained in root cause analysis. The chair of the Review
           Team should also have sufficient authority (delegated or otherwise) within the
           Trust to be able to report recommendations to the Trust Board and partner
           organisations
    7.     The other members of the review team should include appropriate clinicians,
           other health professionals, managers and others so that the review will be as
           balanced and as thorough as possible. The Trust should also consider including
           a lay person, patient or independent professional on the team, to provide an
           objective view of the circumstances
    8.     The terms of reference should closely reflect the contents of paragraphs 3-5
    9.     The terms of reference should be clear and free from ambiguity to permit
           focussed examination of the key issues
    10.    If appropriate the terms of reference should be amended in the light of a
           significant fact/issue emerging from the ongoing review
    11.    It may be that the new fact(s)/issue(s) would need to be addressed by a separate
           investigation. In this case this matter should be raised in the recommendations
           and/or in an appendix to the report

Process (Methodology)

    12.    The report should clearly state the methodology and/or the process adopted to
           undertake the review. The report should contain information on the following;


Incident Report Policy Sept 2008    Page 70 of 79
Review Date – Sept 2009
   (a) List of policies and documents examined by the reviewer(s);
   (b) Whether patient records were examined and if so by whom, was an internal expert
       asked to comment on the records;
   (c) List of persons who have provided written statements / interviewed with dates and
       times (including the length of individual interviews). It is recommended that the
       questions asked of the various interviewees should be included in an appendix and
       cross-referenced. It is also recommended that interview notes should also be
       included in the appendix;
   (d) Any anomalies in the process e.g. key witnesses being unavailable should be
       mentioned here.

Facts Established

   13.    A history of the service user’s treatment and care should be included. A
          chronological account of what is known to have happened – this should ‘tell the
          story’ of the unfolding of events relating to the matters under review. The report
          should carefully document the following;

   (a) Whether the relevant and accurate diagnosis was /were made at the earliest
       available opportunity
   (b) Whether the diagnosis was made in the most efficient and efficacious manner
   (c) Whether the care given to the patient was effective and optimal
   (d) Whether there are any outstanding issues related to consent and
   (e) The consequence(s) of any defects/shortcomings in (b) and (c)

   14.    The report should make specific reference(s) (if appropriate) to any individual
          professional performance issues. If the performance of a professional is at issue,
          the report should make reference to any previous instances of poor performance
          and conduct. The report should also make reference to the steps taken by the
          Trust/PCT to address poor performance and/or conduct
   15.    The report should detail (including any sanction taken by a body against a
          professional) any input from the professional regulatory bodies and the National
          Clinical Assessment Service (NCAS) in the case of a professional who played a
          role in the current incident
   16.    The above account should make explicit reference to any relevant existing
          policies (including clinical risk management and clinical governance policies),
          procedures and protocols. The report should also allude to the extent of
          dissemination / staff knowledge of these policies, procedures and protocols
   17.    The report should also make a reference to the extent to which the policies,
          procedures and protocols were adhered to in the management of the case under
          consideration (in relation to both the management of the care and treatment and
          the management of the incident).

Associated Relevant Factors

   18.    The report should include an examination of potential human error causal factors.
          Attention should be paid to;

             Staffing levels and skill mix at the time of the incident
             Pressure to achieve targets (e.g. A&E throughput, waiting list priorities,
              European Working Time Directive)
             Pressure to achieve targets (e.g. A & E throughput, waiting list priorities,
              European Working Time Directive)
             Fatigue or fitness of staff
Incident Report Policy Sept 2008   Page 71 of 79
Review Date – Sept 2009
              Communication difficulties between staff or with the patient
              Ability of staff to raise concerns (culture of organisation or team)
              Whether anyone raised a concern & if so how was it dealt with
              Whether minimum operating standards were complied with (e.g. equipment
               unavailable or faulty, mandatory training standards)
              Any confusion or misunderstandings about procedures or practices
              Clarity about each person’s role in any procedure or practice

NB. This list is not exhaustive

Points Causing Concern About the Evidence

   19.     This section should highlight any areas of conflict or ambiguity in the gathered
           evidence e.g. where people interviewed disagreed about significant matters or
           where there are important gaps in the evidence
   20.     The report should clearly state the criteria used to resolve conflict/inconsistencies
           in the evidence. The way in which the gap(s) in the evidence was /were handled
           should also be stated. The report should also give an indication as to how facts
           on which key conclusions are based / were established

Analysis / Conclusions

   21.     There should be logical and sequential connections between the facts and
           evidence.
   22.     The report should analyse and comment on any mismatch between what is
           believed to have happened in practice and what should have happened (given
           policy/procedures/protocols and/or professional judgement of review team or
           expert witnesses)
   23.     The authors should comment on the cause(s) of any such inconsistencies. The
           authors should support their views by the facts contained in the report and other
           evidence based on guidance and best practice.

Recommendations

The purpose of the recommendations is twofold: to minimise the impact of the present
incident and to reduce the likelihood of the incident occurring again.

   24.     The recommendations should be precise and targeted at the appropriate level(s)
           of the organisation and should reflect the ‘improvement’ philosophy behind the
           review
   25.     The recommendations should address any factor that is judged to have
           contributed to less than satisfactory service delivery (if latter is the case this
           should be made explicit). Such factors may be organisational, situational,
           procedural, resource related, or related to professional practice (personal style,
           communication, professional judgement, knowledge etc).
   26.     The recommendations made should be clearly listed in order of priority as
           deemed important by the review team. Please note if the Trust/PCT does not
           accept the recommendations, the SHA must be informed of the reasons for
           rejection and any proposed alternatives.
   27.     The recommendations should be strengthened if they can be related to examples
           of good and effective practice elsewhere.
   28.     The action points contained in the recommendations should clearly state
           timescales for completion


Incident Report Policy Sept 2008    Page 72 of 79
Review Date – Sept 2009
Actions

   29.    Each NHS organisation that reviews an incident should ensure that;

             The document is disseminated to relevant staff
             All relevant new staff are inducted in the resulting process changes
             Information is shared, where appropriate, across the health community
             There is evidence of how reports impact on future delivery of services and
              any changes made

Lessons Learned

   30.    The purpose of the lessons learned is twofold namely to highlight changes in the
          practices implemented since the incident and to ensure the information is readily
          accessible. Providers will be invited by Sefton PCT to participate in a wider Post
          Incident Review so that lessons can be shared.

Authorship / Membership

   31.    The report should be addressed to the relevant officer of the Trust and signed
          and dated by the chair of the review. Full details of the members on the review
          team should be included in the report. Membership designation should be
          identified.

Appendices

   32.    Copies of all interview notes, documents examined and working documents such
          as plans of the site of the incident should be included in the appendix. Also
          included should be a breakdown of the Review team, including experience /
          qualifications and job titles of each member.

   33.    Statement to the effect that the incident has been or is likely (if correct) to be
          subject to a formal complaint or claim should be included.




Incident Report Policy Sept 2008   Page 73 of 79
Review Date – Sept 2009
                                           Appendix 5


                       Corporate Performance & Standards Directorate

                  Serious Untoward Incident Performance Management Group

                                       Terms of Reference

Purpose of Group

The purpose of the SUI Performance Management Group is to;


             1.      Receive notification of all SUIs to the PCT
             2.      Review initial information provided
             3.      Identify and engage additional PCT expertise as required for the review
                     team
             4.      Cross reference detail of initial serious untoward report with provider’s
                     terms of reference for review
             5.      Identify potential gaps and make recommendations to be included or
                     excluded from review
             6.      Agree and monitor timescales for initial management report
             7.      Confirm lead for communications with provider
             8.      Review draft report against terms of reference
             9.      Accept / reject initial management report and review draft action plan
             10.     Agree any action the PCT requires to take as a Commissioner in terms of
                     performance / standards / governance contract review
             11.     Accept / reject action plan
             12.     Confirm update frequency on action plan to PCT
             13.     Monitor progress of action plan
             14.     Agree assurances and agree closure of incident
             15.     Identify opportunities for wider sharing of lessons learned in line with
                     Caldicott principles
             16.     Provide Performance Reports to Commissioning Committees
                     Handle poor performance issues with provider NHS

Principal duties

The SUI Performance Management Groups principal duties are to;


        1.            Monitor NHS Provider progress against protocol and facilitate
                      improvement
        2.            Monitor quality reports arising from SUI review and facilitate improvement
        3.            Monitor recommendations and             implementation       and facilitate
                      improvements to quality and safety
        4.            Define processes for ensuring intelligence gained is integral to
                      commissioning and contracting services
        5.            Define process for handling poor performance that feeds into
                      commissioning role of PCT, risk and quality agendas


Incident Report Policy Sept 2008       Page 74 of 79
Review Date – Sept 2009
Membership

Membership of the SUI Performance Management Group will be determined in the context
of the facts of the SUI but will in the main be drawn from;

      PEC Chair – if conflict of interest arises
      Professional Advisor
      Director of Public Health – will undertake a lead role where their expertise is required
      Director of Corporate Performance & Standards and/or Deputy Director of Corporate
       Standards & Performance – takes overall responsibility of ensuring the systems and
       processes put in place by the PCT are working effectively
      Patient Safety Manager – will co-ordinate the SUI Performance Management
       process, liaise with NHS North West and the Risk Managers of provider
       organisations. The Patient Safety Manager will manage the administrative support
       required within the process and ensure that the StEIS system is maintained.
      Head of Corporate Performance & Risk and/or Assistant Head of Risk– will maintain
       an overview and ensure the PCT works in line with the SUI protocol.
      The Lead Commissioner & Lead Nurse – the team will engage the support of the
       appropriate commissioning lead and other PCT expertise as dictated by the
       individual circumstances of each reported event
      PCT Communications Lead – will undertake an assessment of incidents for potential
       media impact and liaise with the NHS Trust or PCT regarding their press release to
       respond to media enquiries were media interest is anticipated. Liaison with the NHS
       North West Communications Team for advice on media handling for high profile
       incidents will be necessary.
      Any other such membership that reflects the degree of expertise required and
       as warranted by the nature of the incident whilst still preserving a distinct
       commissioning role.

Working arrangements

The SUI Performance Management Group will meet for each SUI as reported and from
thereon will determine the frequency of further meetings depending on the context and
circumstances of the SUI.

There must be a quorum of three members and of which must include a clinical lead or a
patient related SUI. It is envisaged that a core membership including the Patient Safety
Manager, Head of Corporate Performance & Risk and Deputy Director of Corporate
Performance & Standards.

Administrative support to the SUI Performance Management Group will be provided from
within the Corporate Performance & Standards Directorate.

Reporting Arrangements

The SUI Performance Management Group will report in via Sefton PCTs Governance
Committee according to the corporate calendar. There may be occasion depending on the
circumstances of the SUI that an extraordinary meeting of the Governance Committee be
called for.




Incident Report Policy Sept 2008    Page 75 of 79
Review Date – Sept 2009
                                        Appendix 6


Serious Untoward Incidents involving Children & Young Persons under the age of 18
                & Local Safeguarding Children Board Procedures

Local Safeguarding Children Board (LSCB) responsibilities for the child death review
processes – Chapter 7 Working Together (2006)

From 1st April 2008, a sub-committee of Sefton LSCB is responsible for reviewing
information on all child deaths and deaths of young persons up to the age of 18 years
(excluding those babies who are stillborn) in Sefton and is accountable to the LSCB Chair.
The disclosure of information about a deceased child is to enable the LSCB to carry out its
statutory duties relating to child deaths.

There are two inter-related processes for reviewing child deaths (either of which can trigger
a Serious Case Review;

1.     A rapid response by a group of key professionals who come together for the purpose
of enquiring into and evaluating each unexpected death of a child
2.     An overview of all child deaths (under 18 years) in the LSCB area undertaken by a
panel

Definition of an unexpected death

An unexpected death is defined as the death of a child which 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 which led to the death (Fleming et al 2000;
Royal College of Pathologists and Royal College of Paediatrics and Child Health). The
designated paediatrician responsible for unexpected deaths in childhood should be
consulted where professionals are uncertain about whether the death is unexpected.

Serious Case Reviews – Chapter 8 Working Together

When a child dies, and abuse or neglect are known or suspected to be a factor in the death,
organisations must consider immediately whether there are other children at risk of harm
who require safeguarding (for example siblings, other children in an institution where abuse
is alleged). Thereafter, organisations should consider whether there are any lessons to be
learned about the ways in which they work together to safeguard and promote the welfare of
children. Consequently when a child dies in such circumstances, the LSCB should always
conduct a serious case review into the involvement with the child and family of organisations
and professionals. The PCT should always inform its SHA of every case that becomes the
subject of a serious case review. Additionally LSCBs should always consider whether a
serious case review should be conducted:

      Where a child sustains a potentially life-threatening injury or serious and permanent
       impairment of health and development through abuse or neglect, or
      A child has been subjected to particularly serious sexual abuse, or
      Their parent has been murdered and a homicide review is being initiated, or
      The child has been killed by a parent with a mental illness, or
      The case gives rise to concerns about inter agency working to protect children from
       harm


Incident Report Policy Sept 2008    Page 76 of 79
Review Date – Sept 2009
Allegations of Abuse Made Against a Person Who Works with Children – Chapter 6 Working
Together (2006)

The guidance in Appendix 5 of Working Together should be followed in respect of any
allegation that a person who works with children has;

      Behaved in a way that has harmed a child, or may have harmed a child or
      Possibly committed a criminal offence against or related to a child or
      Behaved towards a child or children in a way that indicates s/he is unsuitable to work
       with children, in connection with the person’s employment or voluntary activity

If concerns arise about the person’s behaviour in regard to his/her own children, the police
and/or social care need to consider informing the person’s employer in order to assess
whether there may be implications for children with whom the person has contact at work.

Further advice & support

For further advice and support concerning SUIs involving children and young persons
please contact;

Jane Leather Designated Nurse for Safeguarding Children in Sefton on 077 667 63569 or Dr
Amanda Bennett Designated Paediatrician on 0151 228 4811.




Incident Report Policy Sept 2008   Page 77 of 79
Review Date – Sept 2009
Incident Report Policy Sept 2008   Page 78 of 79
Review Date – Sept 2009
                                                    Appendix 7

                        Reporting Serious Untoward Incidents Involving Data

    Extract from Department of Health Gateway Reference Number (9912) 20 May 2008

                          Information Governance Assurance Programme


Annex A – Reporting of Personal data Related Incidents

Incidents classified at a severity rating of 3-5 are those that should be captured as Serious
Untoward Incidents and should be reported to SHAs [and to the Information Commissioner].

Incidents classified at a severity rating of 1-2 should be aggregated and reported in the
annual report.

Figure 1

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




Incident Report Policy Sept 2008              Page 79 of 79
Review Date – Sept 2009

								
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