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					                                                                   Board 22.03.07: Part 1: Att. 22




Title of Document:             SERIOUS UNTOWARD INCIDENTS (SUI) POLICY

Aims:          To detail the revisions made to the above policy.


Summary:

These revisions reflect the following:

   •    Changes in the reporting mechanism for SUIs – both internal to the PCT and London-
        wide.

   •    New national guidelines to be referenced.

   •    Additional advice with the aim of clarifying the reporting and investigative process.

   •    Amendments suggested by the Integrated Governance Committee at its meeting on
        the 14th March 2007.



However, in light of other recent developments, this revised policy is intended as an interim
measure only.
Following a meeting of London Trusts on the 2nd March 2007 – arranged and facilitated by
NHS London - it has been agreed that Anne Douse (NHS London, Head of Clinical
Governance) will review all current policies in the light of current needs and produce, within
six-to-eight weeks, a single policy for use NHS London-wide.



Recommendations: To agree the revised Policy


Date, author details: Tony Foote – Complaints Manager         15th March 2007
                                                         Board 22.03.07: Part 1: Att. 22(i)




                     Policy and Procedure For
                    Reporting and Investigating
                    Serious Untoward Incidents
                              (SUIs)




Date:        March 2007
Approved by Integrated Governance Committee:
Review Date: Three yearly (dependant upon legislation)




1
        SERIOUS UNTOWARD INCIDENT POLICY & PROCEDURE


INDEX                                                   PAGE NO.

Introduction                                               2-3

1. Definition of an SUI and its application                3-4
2. Procedure for reporting an SUI                          4-5
3. Procedure for reporting an SUI                          6
   received “out of hours”
4. Procedure for reporting an SUI by another Trust         6
   providing services on behalf of PCT
5. Procedure for reporting an SUI by an                    6-7
   independent contractor
6. Investigation of an SUI                                7
7. Handling Media Interest                                 7-8
8. Support for Staff                                       8
9. General Reporting                                       8
10. Miscellaneous                                          8-9

Appendices

Appendix 1- Definition of an SUI                          10-11
Appendix 2 – Incident Reporting Form                      12-13
Appendix 3 – SUI Reporting Form                           14
Appendix 4 – Reporting form for notifying appropriate     15-16
             PCT Officers and external bodies.
Appendix 5 – SUI Reporting Checklist                      17
Appendix 6 – Flow Chart for reporting process             18
Appendix 7 – Flow Chart for reporting process (OOH)       19
Appendix 8 – SUIs reportable to external bodies.          20
Appendix 9 – SUIs relating to the National Cervical       21
             & Breast Screening Programmes




2
Introduction

Aim of the Policy

An incident fitting the criteria of a Serious Untoward Incident (SUI) warrants
particular reporting and investigation. This document sets out the policy and
procedure for managing SUIs within the Sutton & Merton Primary Care Trust
(PCT) and in organisations from which it commissions services.

Policy Statement

The PCT will do its reasonable best to prevent injury, ill-health and harm to
patients, staff and visitors or loss and damage of NHS assets through timely
reporting, effective investigation of, and learning from, all adverse events and
near misses.

To ensure this all staff must report any incident, whether serious or not, in
accordance with the PCT’s Adverse Incident Policy. All SUIs will be subject to
thorough investigation.

The PCT believes that it is important to establish the root cause of an incident
and investigations of incidents will focus on establishing this.

The reporting and investigation of SUIs is not to apportion blame.

The ultimate aim of any investigation must be to ensure that lessons are
learnt from SUI’s and prevent any similar incident re-occurring in the
future.

Scope

This policy shall apply to all staff employed by Sutton and Merton PCT
(including bank and agency staff) students and volunteers. This policy also
applies to all organisations from which the PCT commissions services and
provides a framework that can be adopted by independent contractors.

This policy should be read in conjunction with the following:
        Whistle blowing policy
        Major incident plan
        Complaints policy
        DOH Guidelines for investigating patient safety incidents (Nov. 2006)
        Disciplinary policy
        Openness policy
        Fair blame statement
        PCT Adverse Incident Policy
        South West London NHS London SUI policy



3
       Vulnerable Adult policies of relevant local authorities
All the above are located on the PCT’s website or available from the PCT’s Risk Management
Department.
For the most serious incidents – those involving unexpected death and/or
serious untoward harm - the following documents should also be considered:

       Memorandum of Understanding: Investigating Patient Safety Incidents
       Involving unexpected death or serious untoward harm.
       A Protocol for liaison and effective communications between the
       National Health Service, Association of Chief Poli
       ce Officers and the Health and Safety Executive.

       Guidelines for the NHS – In Support of the Memorandum of
       Understanding

Both the above can be accessed via the Department of Health website – www.dh.goz.uk

Confidentiality

The reporting of SUIs according to the following procedure should minimise
any unnecessary compromise to the Trust’s duty of confidentiality. “Safe
haven” arrangements for the communication of confidential information should
always be utilised where these are in place.

Reports should be anonymised; initials rather than names of persons involved
and designations of staff should be used.


1.     DEFINITION OF AN SUI

1.1   A definition of an SUI is:

An accident or incident when a patient, member of staff, or a member of the
public suffers serious injury, major permanent harm or unexpected death and
where the actions of health service staff are likely to cause significant public
concern. Also, where there is serious damage and/or loss of health care
property.

1.2    An SUI can be broadly described as “any incident, either on PCT
       premises or involving PCT business, which:

       •   Causes unexpected death (including suicide) or serious injury or
           was life threatening where foul play is suspected.

       •   Involves a hazard to the public health e.g. outbreak of infection
           such as salmonella or legionella, radiation incidents.

       •   Involves an incident that may give rise to serious criminal charges.
       •   Involves a serious attack on a patients, staff member or visitor.



4
       •   Involves serious damage to NHS assets.

       •   Involves an allegation of serious misconduct.

       •   Involves the suspicion of large-scale theft or fraud or impending
           litigation.”

       Also:

       •   Any incident involving the Vulnerable Adults or Child Protection
           Policy should be given consideration as a potential SUI but will not
           automatically qualify as one.

This list is not exhaustive and a fuller definition of what constitutes an SUI is
shown at Appendix 1.

1.3    Applying the definition

In deciding whether or not you are dealing with an SUI it may help to consider
the possible impact the incident could have upon the PCT, including any likely
in the media interest. If it could be damaging to the PCT, the incident needs
to be reported. The best approach is one of “better safe than sorry” and, if
you are unsure whether or not an issue needs reporting, please check with
the Complaints Manager, or Head of Integrated Governance, Director or Out
of Hours on-call Manager. Advice can also be sought from the SHA’s
Communications Manager.

1.4    Other Options

When declaring an SUI it should also be borne in mind that certain incidents
may also require investigation under separate procedures and should be
reported accordingly.

Such incidents would include those involving fraud, child protection and
vulnerable adults issues.


2.     PROCEDURE FOR REPORTING – DURING OFFICE HOURS – AN
       SUI CONCERNING SERVICES PROVIDED BY THE PCT.

2.1    It is the responsibility of the senior manager to whom the incident is
       reported to ensure that both the Trust incident form (Appendix 2) and
       the serious untoward incident report form (Appendix 3) are completed
       on the day of the incident and at the very earliest opportunity. This form
       should then be emailed or faxed immediately to the Complaints
       Manager (or named deputy). Contact details are as follows:
       Complaints Manager          Tel.          020 8251 0143
                                   Email         tony.foote@smpct.nhs.uk
                                   Fax           020 8715 2776


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2.2   As soon as practicable, but on the day incident occurs, the Complaints
      Manager (or named deputy) should telephone NHS London
      Communications Team on 020 7016 9674 or 020 7016 9675 or out of
      hours on 08700555500 and ask for pager Lon 01. This contact should
      include brief details of the incident and the responsible investigating
      officer.

2.3   Within 24 hours an SUI form (Appendix 4) should be completed by the
      Complaints Manager (or named deputy) and sent to
      anne.douse@london.nhs.uk


2.4   Upon receipt of notification the Complaints Manager (or named deputy)
      will also inform, via the appropriate reporting form (Appendix 4), the
      following:

      Obligatory:
      •   The PCT Chief Executive (who will, in turn, inform the PCT’s
          Chairman).
      •   The relevant Director(s).
      •   Communications Lead.
      •   NHS London

      Optional: (depending upon nature of SUI)
      •   The Head of Human Resources (where an Incident may result in
          disciplinary action against a member of staff or immediate
          suspension is necessary to ensure a thorough investigation).
      •   The IMT/Facilities/PHI Director.
      •   The London Health & Social Care Directorate (where incident is
          deemed likely to result in media coverage).

      •   The PCT’s Patient Advice & Liaison Service (to ensure a
          consistency of approach to any queries from the public.)
      •   National Patient Safety Agency (NPSA) (where an incident involves
          a patient.)
      •   Health and Safety Executive (where an Incident has resulted in
          death or significant injury to staff, patients or visitors).
          More detailed criteria for reporting to the HSE is contained in the
          Trust Adverse Incident Procedure.
      •   The Police (where an Incident has resulted in death or significant
          injury to staff, patients or visitors).



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2.5   The initial report is should be followed by an update – by the
      investigating officer - within the first week of the incident to the
      Complaints Manager (or named deputy) who will, in turn, forward this
      onto anne.douse@london.nhs.uk

2.6   The investigation report - including confirmation of any actions required
      - should be completed within ninety 90 days of the incident and
      submitted to the Complaints Manager (or named deputy) who will, in
      turn, forward this onto anne.douse@london.nhs.uk

A flow chart showing this process is attached at Appendix 6.


3.    PROCEDURE FOR REPORTING – OUTSIDE OF OFFICE HOURS –
      AN SUI CONCERNING SERVICES PROVIDED BY THE PCT.

3.1   Process as contained with Section2, with the exception that the senior
      manager to whom the incident is reported will inform the on call
      manager who will then establish the facts. The on call manager will
      then agree with the on call director if the incident is an SUI and the
      immediate action to be taken. The on call manager will then contact
      the on call press lead and ensure that the Complaints Manager is
      informed at the earliest opportunity.

3.2   Upon receipt of notification, the Complaints Manager will inform, via the
      appropriate reporting form (Appendix 4) the contacts as listed
      previously.

A flow chart showing this process is attached at Appendix 7.


4.    PROCEDURE FOR REPORTING BY ANOTHER TRUST PROVIDING
      SERVICES ON BEHALF OF THE PCT

4.1   All Trusts are required to have policies and procedures for the handling
      and reporting of SUI’s.

4.2   All Trusts providing services on behalf of the PCT are obliged to inform
      the PCT of any relevant SUI. The “responsible” Trust will also inform
      all appropriate external agencies (NHS London, NPSA, etc).

4.3   Upon receipt of notification of such an SUI the Complaints Manger will
      inform, by forwarding on a copy of the “responsible” Trust’s notification,
      the following:

      •   The PCT Chief Executive (who will, in turn, inform the PCT’s
          Chairman).
      •   The relevant Director(s).




7
      •   Communications Lead.

4.4   The investigation of such SUIs is also the duty of the “responsible”
      Trust but the PCT should be kept informed of all developments and
      receive the final investigation report.

5.    PROCEDURE FOR REPORTING AN SUI BY AN INDEPENDENT
      CONTRACTORS/DENTISTS/PHARMASISTS/OPTICIANS

5.1   All independent contractors are expected to have procedures for
      identifying and handling SUI’s, and should report any SUI’s, using the
      appropriate form (Appendix 3), immediately to the PCT.

5.2   For SUIs arising from GP Services the report should be sent to the
      PCT’s Associate Director of Primary Care who will advise the
      Complaints Manager of the SUI. The Complaints Manager and the
      Associate Director will agree action to be taken with the appropriate
      Director.

5.3   SUIs arising from Dental, Community Pharmacy or Ophthalmology
      Services should be sent to the Complaints Manager who will, in turn,
      liaise with the appropriate person from the following:

      •   PCT Dental Lead
      •   PCT Community Pharmacy Lead
      •   PCT Ophthalmology Lead

6.    INVESTIGATION OF AN SUI

6.1   The PCT requires all SUIs to be subject to a full root cause analysis
      investigation. An investigation should include:

      •   Identification of any underlying failures in systems and/or process.
      •   Identification of any issues relating to staff performance.
      •   Identification of what should be learned from the incident.
      •   Recommendations arising from this learning.
      •   Action plan to implement/monitor of recommendations.

6.2   The above should be the primary responsibility of the lead investigating
      officer as indicated on the reporting form (appendix 3).


7.    HANDLING MEDIA INTEREST

7.1   Every SUI has potential for media interest and for this reason the Press
      lead must be notified as quickly as possible of the relevant details.

7.2   Out of Hours, the director on call will contact the Communications
      Manager on call, who will then liaise with NHS London Communication
      on 08700555500 and ask for pager Lon 01.


8
7.3   The Communications Manager will advise the Trust on the appropriate
      action required in the following areas:

      •   The need to issue a press release or prepare a holding statement
      •   The need to set up a panel to handle the media and to arrange a
          media briefing
      •   The need to activate the dedicated Serious Untoward Incident
          telephone line.
      •   When the investigation manager should advise the patient/client
          and his/her relatives that the incident may cause media attention. If
          this is necessary the patient/client etc. will be offered support in
          dealing with the media. Patients/clients will be given the emergency
          help line number.
      •   Agree who will be spokesman for the PCT.
      •   Where there is a need for national co-ordination of the handling of a
          particular serious incident or where media have to be kept closely in
          touch, contact will be maintained with the press lead. He/she will
          liaise with the Department of Health.


8.    SUPPORT FOR STAFF

8.1   The PCT recognises that SUIs are potentially stressful for all
      employees, both for those directly involved and those not. It is the
      PCT’s expectation that line managers will ensure appropriate support is
      discussed and made available to staff such as access to support and
      counselling services.

8.2   Staff concerns regarding the delivery of care or services or the running
      of the Trust’s business will be dealt with under a separate procedure.


9.    GENERAL REPORTING

9.1   The Complaints Manager will advise Part Two of the Trust Board and
      the Integrated Governance Committee of all new and on-going SUI’s
      on a monthly basis, in the form of a confidential report, and provide an
      annual analysis of all SUI’s.

9.2.1 The Complaints Manager will also keep the Trust Board and the
      Integrated Governance Committee informed on the progress and
      outcomes of SUI investigations.

10.   MISCELLANEOUS
The following are PCT obligations in less standardised circumstances:




9
10.1   Where an untoward incident results from a clinical intervention,
       the investigating manager or appropriate professional (after
       discussion with the Director) will:
10.1.1 Inform the patient/client or his/her relative(s) of the incident as soon as
       possible. It may not be appropriate to inform the patient immediately
       the Director will make this decision. The patient/client or his/her
       relatives must be informed before the media.
10.1.2 Record the incident and all subsequent treatment given as a result of it,
       in the patient’s/client’s clinical notes.
10.1.3 Offer appropriate care and counselling

10.1.4 Inform the patient/client’s GP.
10.2 Where a patient or client is exposed to clinical risk through an
       indirect untoward incident, the investigating manager or
       appropriate professional will:

10.2.1 Inform the patient/client or his/her relative(s) of the incident within 8
       hours. In some circumstances it may be appropriate to delay informing
       patients; this decision will be made by the Director

10.2.2 Offer appropriate care and counselling.

10.2.3 Record the incident and all subsequent treatment given as a result of it,
       in the patients/client’s clinical notes.

10.3   Where an untoward incident affects a large number of
       patients/clients, then the SLA with NHS Direct will be activated by
       the press lead. The Director will ensure that NHS Direct have
       been given all the necessary information and are clear as to the
       advice for patients.

10.3.1 For communicable disease/environmental health issues
       communication will be from the health Protection Teams to relevant
       people. The team will respond to public enquiries. Press Conference
       will be via Press lead.

10.4   For other Trusts who have services on Sutton & Merton PCT
       premises; any SUI occurring on these premises are reported to
       the Complaints Manager or in their absence the IM&T/facilities/PHI
       Director.

10.5   Where Sutton & Merton PCT are providing services in premises
       owned by any other organisation; any SUI should also be reported
       to the Chief Executive or Risk Manager of that organisation.

11.    REVIEW




10
        This policy will be reviewed three yearly or when national reporting

                                                                                 APPENDIX 1
        guidelines change.




CRITERIA FOR APPLYING THE PROCEDURE

The following criteria apply when defining whether an incident should trigger
this procedure and be reported as a Serious Untoward Incident: These
examples are guidelines to assist the staff and are not intended to serve as
exhaustive or all-inclusive listings. If in doubt about whether an event is a
“serious untoward incident” seek advice from your Director. If out of office
hours, call the on-call director.

•    Death or serious injury where foul play is suspected or there has been a
     breakdown of Trust procedures or contractors.

•    Unexpected/unexplained deaths or unexpected child death and residential
     death in PLD or Elderly long stay.

•    Management and/or clinical failures which harm patients and put them
     at risk

•    Suspicion of large scale theft or fraud or any incident which might give rise
     to serious criminal charges (please note that this policy should be read in
     conjunction with the Trust’s Fraud Policy).

•    Impending large scale litigation (including negligence claims).

•    The suicide of any person on NHS premises.

•    Serious damage that occurs on NHS premises or any incident which
     results in serious injury to any individual or serious disruption to services.

•    Serious attack on a member of staff or visitor.

•    Absconsions by patients detained under the mental health act, 1983 who
     present a serious risk to themselves or to others.

•    Major damage to structures, equipment or other NHS property.

•    Apparently trivial incidents, which may have disproportionate ramifications,
     including those, which could attract media attention.

•    Incidents of major toxic, contamination or radiation hazard.



11
•    Repeated serious complaints about a member of staff or primary
     care contractor.

•    Incidents which may create public or media incident.

•    Serious breach of confidentiality.

•    Suspicion of a serious error or errors by a member of staff or primary care
     contractor which would give rise to public concern or arouse national or
     very significant local media interest.

•    Where it is suspected that a patient, patient’s relative/carer, could have
     been injured or is put at risk as a result of:

•    An action or lack of action by a member of the Trust’s staff, health service
     staff, employees of other agencies and contractors.

•    Faulty procedures or instruction, lack of, or failure to follow proper, laid-
     down procedures, instructions or clinical protocols.

•    Faulty equipment, including unexpected responses or evidence of
     tampering, drugs or unsafe environment where a patient significantly
     harms him/herself during clinical care.

•    A fire/explosion which involves a loss of service or significant injury.

•    Incidents which question the state of mind, competence or accreditation of
     any member of staff (for example, a person masquerading as a trained
     doctor, or damage to a patient/client resulting from the action of a member
     of staff affected by alcohol or drugs).

•    Any other incident, which seriously affects the workings of the Trust or its
     patient/client care.

•    Known, or suspected, case of health care associated infection, which may
     result in death, e.g. hospital acquired legionellosis.

Also:

•    Any incident involving the Vulnerable Adults or Child Protection Policy
     should be given consideration as a potential SUI but will not automatically
     qualify as one.




12
                                                                          AIR FORM
                                                                    Accident/Incident Report




         ACCIDENT/INCIDENT
A                                                                                Date:                                          Time:
 Locality:              Sutton /         Merton /          Both                                                      Incident Type:
 (Circle Use
Office if applicable)
DATIX No: _______________                                                                                                 Health and Safety APPENDIX 2
 Speciality:                                                                                                              Clinical
 (if applicable)
INCIDENT No: ____________
                                                                                                                          Near Miss
 Directorate :
(bearing responsibility for the patient or staff member affected)                                                         Serious Untoward Incident (SUI)

 Location of Accident/Incident                  (Unit/Site/Service Type and Site/Building must be supplied)
                                                   •      This form is to be completed for ALL accidents, injuries, incidents & ‘near misses’
 Unit / Site / Service Type:                       •      Fact only and not opinion must be recorded                                     Patient’s Home
       Orchard Hill                                • Unexpected death or serious injury must be reported immediately regardless of time of day
                                                                 Community Clinic/Health Centre                                          Public place / Street
       Osborne House                                                GP Practice                                                  The Wilson
       Other LDS site                                               Other Hospital Trusts                                        The Nelson
         Other:

 Site/Building :
 (eg. Robin Hood Lane, Garth House, Epsom & St Helier, Wilson Clinic)

 Actual Location :
 (eg. Hallway, carpark, kitchen, reception)


 Description of the incident / near miss, include type of injury/harm:                               (State fact not opinion)




 Immediate action taken following incident:




 Did problems with EQUIPMENT contribute to the incident?                                           Yes / No
 Type of equipment :
 (eg. Bed, hoist, IV equipment, wheelchair, vehicle)
 Manufacturer:                                                                                                                         Serial No:




         PERSON                                      No person was affected                  Person Type                        Employee:
B                                                 (Do not complete this section, go to C)
                                                                                             Patient:                                SMPCT
Title:            Surname:                                                                         Inpatient                         Agency/Locum
Given name(s):                                                                                     Outpatient                        Bank
Address:                                                                                           Residential Patient               Other NHS
                                                  Postcode:                                        Day Care Patient                 Visitor
                                                                                                   Respite Patient                  Other:
Gender: Male / Female                     DOB:
Contact Phone No:                                                                           If employee, Job Title/Occupation:
          13
Email Address:
Was a PATIENT harmed?                         Yes / No                         Is the person affected completing this form?                    Yes        /      No
                                                                                                                                             (Go to D)        (Go to C)
                                                                                         Did you witness the incident?           Yes / No
C        PERSON COMPLETING FORM
                                                                                                       SMPCT
Title:           Surname:                                                                                           Job Title/Occupation:
                                                                                                       Agency/Locum
Given name(s):                                                                           M / F         Bank
Based at:                                                                                              Other NHS
Contact Phone No:                                                             Email Address:

                               (Where applicable, identify any witnesses)                   Person Type                    Employee:
         WITNESS
D                                                                                           Patient:                          SMPCT
Title:           Surname:                                                                         Inpatient                   Agency/Locum
Given name(s):                                                                                    Outpatient                  Bank
Address:                                                                                          Residential Patient         Other NHS
                                               Postcode:                                          Day Care Patient           Visitor
                                                                                                  Respite Patient            Other:
Gender: Male / Female                   DOB:
Contact Phone No:                                                                          If employee, Job Title/Occupation:
Email Address:

         OTHER                PERSONS                  (eg. Staff member, perpetrator)      Person Type                    Employee:
E                                                                                           Patient:                           SMPCT
How involved ?                                                                                    Inpatient                    Agency/Locum
         Professional directly administering care                                                 Outpatient                   Bank
         Professional assisting with care delivery                                                Residential Patient          Other NHS
         Aggressor        Care giver                                                              Day Care Patient            Visitor
         Assailant        Other:                                                                  Respite Patient             Other:

Title:           Surname:                                                                  Given name(s):
Address:                                                                                                                     Postcode:

Gender: Male / Female                   DOB:                                              Contact Phone No:
Email Address:                                                                 If employee, Job Title/Occupation:

         LOCAL INVESTIGATION                                                                           Risk Rating    (Refer to the PCT Risk Matrix)
F        (To be completed by the manager / investigating officer / team leader)                        Consequence/Severit        Likelihood:
                                                                                                       y:                             Rare
Reported to Manager …                                                                                      Insignificant                  Unlikely
Date:                                                    Time:                                             Minor                          Possible
Name:                                                                                                      Moderate                       Likely
Job Title/ Position:                                                                                       Major                          Almost Certain
                                                                                                           C t t hi
Managers Actions / Lessons Learnt:                                                                                             Did the incident result
                                                                                                                               in staff absence ?
                                                                                                                               If so, how
                                                                                                                               many days
                                                                                                                               ?




Email:                                                                                           Contact Phone No:
Date:             14                                       Signature:
                                                                            APPENDIX 3



                   Serious Untoward Incident (SUI) and Potential
                        Serious Untoward Incident Briefing

This form to be sent by email or fax to Complaints Manager
                                  DETAILS OF INCIDENT
Brief Outline of Incident

Time/Date
Location
Police/Coroner’s
Involvement
Likely Media
Involvement
DETAILS OF CLIENT
Name
Date of Birth
Lead Health
Professional
Location of
Medical/Other Case
Notes
Investigation*
Brief Details of
Immediate Action
Taken
Level of Investigation
Required
Lead Director
Lead Investigator
Reporting        (Retain documentary evidence)
                                         By Whom/Signature   Time Date Method
Head of Integrated              Yes/No
Governance
Chief Executive Informed        Yes/No
NHS London informed             Yes/No
NPSA informed                   Yes/No
Board Informed                  Yes/No
If no to any of above give      Yes/No
reasons:
Investigation (Office use Only)
Date investigation set-up
Investigators
Target Date
Report received                          Yes/No                    Date
Investigation Completed (date)
Result reported to NPSA                  Yes/No
Result reported to Integrated            Yes/No
Governance
Any other relevant information


      15
                                                                                      APPENDIX 4



                                        Serious Untoward incident

Notification Form:


 Date of making report:                  Time (24 hour clock):

 Name of NHS organization(s)
 involved
 Trust/PCT incident reference
 number (to be used in all
 correspondence

 Names and contact details of            Name:
 lead manager/director
                                         Job Title:
                                         Telephone:
                                         E-mail:
 Name and contact details of             Name:
 communications contact:
                                         Job Title:
                                         Telephone:
                                         E-mail:
 When did the incident occur?            Date:                      Time (24 hr clock):
 Where did the incident occur?
 Location and, where relevant,
 specialty
 Information about
 patients/carers etc. involved
 (Patient description, initials only,
 NOT name(s); where possible
 include gender and age)
 Information about staff
 involved (Designations, NOT
 names)

 What happened? (Give a
 factual account of the incident,
 including a description of: any
 medical devices, medicines or
 equipment involved)




       16
  Other information not in the
  public domain (Provide a brief
  overview of any other material
  factors that are not and should
  not enter the public domain, or
  indicate whether other
  information is available)


  Describe any immediate
  action taken to protect and/or
  improve patient/visitor/staff
  safety



  Next steps




  Has, or will information on
  this incident be reported to
  any other agency/body?
  (Specify).


  Information about actual or
  likely media interest,
  including draft response/line
  to take




Form completed by:
Name:
Tel:

Copied to (eg. host PCT):



When completed, this form should be sent by fax or email to:

Anne Douse
NHS London

E-mail:        anne.douse@london.nhs.uk




          17
                                                                                     APPENDIX 5




ACTION CHECKLIST FOR REPORTING SERIOUS UNTOWARD INCIDENTS (SUI)

RESPONSBILITY           ACTION

PCT/NHS TRUST
                        •   Decide whether definition of SUI applies
                        •   If incident is of particular gravity report to SHA
                            immediately by telephone
                        •   Within 24 hours send initial report to SHA and if
                            appropriate, host PCT or PCT where patient resides
                        •   Provide relevant information to other relevant bodies
                            e.g. police, HSE, NPSA etc
                        •   Within 3 working days of incident occurring submit
                            more detailed report to SHA
                        •   Within 60 working days submit final report to SHA
                            with an action plan
                        •   Provide a quarterly update to the SHA on progress
                            with the action plan



SHA                     On receipt of:
                            -      Initial report
                            -      3 day report
                            -      60 day report with an action plan
                        If an incident is of particular gravity report to DH Media
                        Centre immediately
                        Prepare media alerts if necessary
                        Prepare Ministerial Briefings if necessary
                        Follow up on the action plan with the Trust/PCT
                        Collate information on themes and trends and feedback
                        into the Clinical Governance Network to aid future
                        learning

DH
                        Provide advice to SHAs/Trusts on managing the most
                        serious incidents
                        Advise Ministers on handling the most serious incidents
                        in consultation with the DH Investigations and Inquiries
                        Unit and the Healthcare Commission




18
                                                                           APPENDIX 6



       SERIOUS UNTOWARD INCIDENT REPORTING FLOWCHART

                         (DURING OFFICE HOURS)



                                     INCIDENT




                              Report to Director
                              decide if potentially                   NO
                              serious


                                        YES                 Follow Trust Adverse
                                                            Incident Procedure

                              Inform Comp. Manager

                        YES
     Inform Press                                                    NO
     Lead                            Agree SUI



                                        YES
     Inform LRO
     Press Team
     NPSA &
     NHS                    Arrange initial investigation
     London


                                 Report outcome
     All press                   of investigation
     enquiries
     forwarded
     to Press
     Lead                        Agree Action to
                                 be taken



       •   Director or Complaints Manager will inform Integrated Governance
           Committee and part 2 of Trust Board.
       •   Director or Complaints Manager will liaise with Trust press lead.
       •   Director or Complaints Manager will inform NPSA and NHS London



19
                                                                       APPENDIX 7




SERIOUS UNTOWARD INDIDENT PROCEDURE REPORTING FLOWCHART
                      OUT – OF – HOURS


                                   INCIDENT




                         Telephone on call manager
                          Decide if potentially serious         NO

                                      YES



                                                          Follow incident
                      TELEPHONE DIRECTOR ON CALL            reporting
                                                            procedure




                               Agree if untoward                NO
             YES               Incident is serious

                                                              YES



      Inform the                   Investigation
      press lead on                   Started             Inform HRM
      call



  Press Lead             Press Lead activates
  informs R.O.           SUI/Media phone line
  Press Office           and informs QMH
                         Switchboard



  All enquiries forwarded to
        Press on-call



 20
                                                                                        APPENDIX 8



               INCIDENTS REPORTABLE TO EXTERNAL AGENCIES

         Type of Incident                External agency               Responsible Manager
                                          Reportable to

All serious untoward incidents    DHSC Health & Social Care        Complaints Manager
                                  Directorate                      or
                                  Tel 020 7725 5472                Press Lead

                                  Out of hours 020 8345 6789
                                  Pager LRO 101

Serious untoward incidents        NHS London                       Complaints Manager
Involving patients                where the patient is resident    or
                                  020-8687 4655                    Director

Medical Devices                   Medical Devices Agency           Complaints Manager
                                                                   or
                                                                   Manager
Medical products – adverse        Medicine Control Agency          Pharmacist
Drug reactions
Non-medicinal equipment           NHS Estates Defect Office*       Head of Facilities

Special dietary and enteral       Medical Devices Agency*          Lead Director
food and ready to feed
preparations for hospital use
**Food contamination -            Environmental Health             Head of Facilities
microbiological or chemical

**Fire                            NHS Estates*                     Head of Facilities

**Accidents                       Health & Safety Executive        Head of Facilities

**Unexpected patient deaths       Coroner                          Medical Director/
                                                                   Consultant or Lead
                                                                   Clinician


 *          May also need reporting to the Health & Safety Executive under Reporting of
            Injuries, Diseases and Dangerous Occurrences regulations (RIDDOR)
 **         Normally reported and investigated via other procedures (e.g.
            Accident/Incident procedure/ fire policy etc.) unless particularly serious to
            qualify as a Serious Untoward Incident.

 Copies of Reports must be sent to Head of Integrated Governance

 SUI HOTLINE NUMBER :

 This should only be given out once the |PR lead confirms it has been activated.




 21
                                                                                    APPENDIX 9




NATIONAL CERVICAL & BREAST SCREENING PROGRAMMES

The responsibility for screening Quality Assurance rests with the Director of
Public Health for the London Health & Social Care Directorate (London
HSCD), and this is discharged through the London HSCD Quality Assurance
Team.

The PCT currently has an Acting Screening lead Dr Maggie Harding, Director
of Public Health for S&M PCT, who should be notified of any potential
screening related SUI. This role has responsibility for :-

     •   Establishing that this is an SUI
     •   Ascertaining whether this is an SUI following guidelines for Managing
         Incidents in the Cervical Screening Programme (NHSCSP publication
         No 11):
     •   A primary care contractor
         The Primary Care Support Service (PCSS)
         A trust from whom the PCT commissions services
     •   Notifying London HSCD (QA), the NHS London, the PCT Chief
         Executive accordingly.
     •   With the practice, Primary Care Support Service (PCSS), Trust and
         London HSCD (QA) ensuring that the appropriate investigation is
         instigated, reported (an early preliminary report, updates as appropriate
         and a final report) and lessons learned are widely shared.

In line with Shifting the Balance of Power and London Quality Assurance
HSCD guidance, there will be a :-

     •   South West London wide screening Commissioner accountable to the
         Director of Public Health for the Lead Screening PCT.
     •   PCT Screening lead. Preliminary discussion indicates that this role will
         be shared between the Director of Public Health as the responsible
         executive director and one or more PCT staff.

The above will take over the role presently fulfilled by the Screening
Commissioner, with the balance of responsibility depending on whether the
SUI preliminary relates to :-

     •   Primary Care - in which case the PCT would probably take the lead
         through the DPH in conjunction with the head of Integrated
         Governance.
     •   The PCSS - where the lead may be joint given that S&M PCT is the
         lead commissioner for the PCSS.
     •   An Acute Trust – in which case the sector wide Screening
         Commissioner would lead.

Though in all SUIs there would be close co-ordination and communication
between the PCT, Sector Wide Screening Commissioner and London HSCD.


22
                                                    Board 22.03.07: Part 1: Att. 22(ii)

REVIEW OF THE SERIOUS UNTOWARD INCIDENTS (SUI) PCT POLICY
AND PROCEDURE
An incident fitting the criteria of a Serious Untoward Incident (SUI) warrants
particular reporting and investigation. This policy, now reviewed in line with
changes to the reporting mechanism, sets out the procedure for managing
SUIs within the Sutton & Merton Primary Care Trust (PCT) and arising from
organisations from which it commissions services.
The significant amendments to the Policy are as follows:
Changes in reporting arrangements:
  • All SUIs to be reported directly to the PCT’s Complaints Manager.
   •   As soon as practicable, but on the day of the incident, the Complaints
       Manager (or named deputy) should telephone NHS London
       Communications Team.This contact to include brief details of the
       incident and the investigating officer.
New national guidelines to be considered:
  • Memorandum of Understanding: Investigating Patient Safety Incidents
     Involving unexpected death or serious untoward harm.
     A Protocol for liaison and effective communications between the
     National Health Service, Association of Chief Police Officers and the
     Health and Safety Executive.
   •   Guidelines for the NHS – In Support of the Memorandum of
       Understanding
Additional Guidance:
  • “Applying the definition” – advice on deciding whether an incident
      warrants being declared an SUI.
   •   Checklist for reporting SUIs
Integrated Governance Committee Suggested Amendments:

   •   “1.2 Definition of an SUI”
       “Involves Vulnerable Adult Policy” and “Involves Child Protection
       incident” replaced with:
       “Any incident involving the Vulnerable Adults or Child Protection
        Policy should be given consideration as a potential SUI but will not
        automatically qualify as one.”
   •   “1.4 Other Options”
       “When declaring an SUI it should also be borne in mind that certain
       incidents will also require notification/investigation under




                                       1
       complementary, but separate, reporting procedures, which also need to
       be followed.

       Such incidents would include those involving fraud, child protection and
       vulnerable adults issues.”

The IGC also highlighted the following requirements:

(i) To establish clear reporting mechanisms with those Trusts from whom the
PCT commissions services. This has already been accomplished with the
Mental Health Trust and discussions are also underway with the Royal
Marsden.

(ii) To promote the importance of reporting SUIs across independent
contractors. This will be pursued through dissemination and clarity of
expectations via the clinical governance route, and involving Local
Representative Committees in this process.

(iii) To confirm the SUI Policy reflects responsibilities in accordance with the
Scheme of Delegation and Reservation of Powers, approved by the Board in
November 2006. This is confirmed, but ‘Head of Risk Management’ post has
now been replaced with the ‘Head of Integrated Governance’, following PCT
organisational restructure (July 2006)

(iv) To ensure the SUI Policy is compatible with the Adverse Incident
Reporting Policy.




                                                                       Tony Foote
                                                               Complaints Manager
                                                                  15th March 2007




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