V2.FINAL. MPCT Incident Reporting Policy incorporating reporting arrangements for SUIs Sept2009 by stariya

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									Ref No GEN006                               v.2                      September 2009




                          General Policy and Procedure




                              INCIDENT MANAGEMENT

                             Including management of
                            serious untoward incidents




                                    Version: 2




                      Date approved: September 2009




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                                  Document Control


Document Reference                                 GEN006

Title of document                                  Incident Management including the
                                                   management of serious untoward
                                                   incidents

Author‟s name(s)                                   Christine Garratt
                                                   Judith Strobl

Author‟s job title(s)                              Operational Risk Manager
                                                   Public Health Consultant

Directorate                                        Corporate Affairs

Document status                                    v.2

Supersedes                                         Incident Management including the
                                                   management of serious untoward
                                                   incidents V.1 (Jan 2008)
Clinical approval                                  Not applicable

MPCT (Committee) approved by                       Governance Committee

Date of approval                                   9 September 2009

Publication/issue date                             September 2009

Review date                                        15 July 2011

Distribution                                       MPCT web site
                                                   Chief Executive
                                                   All Directors
                                                   Independent Contractors




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                                        Contents


                                                                                     Page
                                                                                      No.
                  POLICY

       1          Introduction                                                          5

       2          Policy Objectives                                                     5

       3          Definitions                                                           6

       4          Scope of the policy                                                   8

       5          Independent Contractors                                               8

       6          Commissioned Services                                                 9

       7          Key Points                                                           10

       8          Duties and Responsibilities                                          13

       9          Feedback to Staff                                                    17

      10          Supporting Staff following traumatic and /or stressful               18
                  incidents

                  PROCEDURES

      11          How the Incident reporting process operates                          18
                  (including the level of investigation) and reporting
                  arrangements for Withington Community Hospital

      12          Grading an incident                                                  22

      13          Medical Devices                                                      23

      14          Serious Untoward Incidents                                           23
                  - including specific categories such as MRSA bacteraemia

      15          Reporting to External Agencies (including RIDDOR)                    27

      16          Major Incidents                                                      29




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      17          Monitoring Compliance and Effectiveness                              29

      18          Key Performance Indicators                                           30

      19          Review                                                               30


      20          Linked Policies and Procedures                                       30

      21          References                                                           31

      22          Appendices:-                                                         32

                  1 Glossary of Terms                                                  33

                  2 Governance Committee Terms of Reference                            35

                  3 Incident Reporting and Management Flowchart,                       37
                    including diagram of groups & committees

                  4 Reporting Structure for Committees                                 38

                  5 Risk Matrix                                                        39

                  6 Guidelines for investigation following an incident                 41

                  7 Guidance on writing a statement                                    42

                  8     Supporting Staff following Traumatic or Stressful              43
                        Incidents
                                                                                       44
                  9     Reporting Injuries, Diseases and Dangerous
                        Occurrence Regulations (RIDDOR)

                  10 Key Performance Indicators                                        45

                  11 Reportable Incidents                                              47

                  12 Never Events                                                      49

                  13 Investigation of an Serious Untoward Incident                     51

                  14 Being Open                                                        53

                  15 Details of staff who can offer help                               56




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         POLICY
  1      Introduction
         When referring to Manchester Primary Care Trust – this includes both the
         commissioner and provider elements (NHS Manchester and Manchester
         Community Health)

1.1      The effective reporting and management of incidents in Manchester
         Primary Care Trust (MPCT), is a key component of risk management
         and governance. It is essential for ensuring that MPCT achieves the
         highest standards of care for patients, and keeps the working
         environment as safe as possible for staff.

1.2      The success of managing incidents is dependent on a well developed
         safety culture within the organisation, and staff having the knowledge
         and confidence that all incidents will be treated in an open and fair
         manner.

1.3      Risk is an inherent part of day to day activity. All staff can contribute
         to the identification of risk by reporting incidents or near misses. The
         actual cause of an incident is usually the result of a combination of
         events or system failures. The purpose of this policy is to learn from
         investigating these events, and put preventative measures in place to
         stop a recurrence. It is not to attribute individual blame (see section
         7.1), unless the action or omission was deliberate/wilful or malicious
         (see section 7.9)

1.4      MPCT will share the lessons learned from reported incidents, through
         quarterly board reports, best clinical practice system, team meetings,
         and the web site. This information will also be shared with staff
         through the Health and Safety Committee.




  2      Policy Objectives

2.1               Ensure that all staff respond and learn from incidents. This
                   includes bank, agency and locum staff, volunteers, students
                   and staff on secondment.

2.2               Ensure that all incidents and near misses are reported in a
                   timely manner.

2.3               Ensure that all staff, contribute to the identification of risk, by



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                   reporting incidents and near misses, thus allowing preventative
                   controls to be put in place.

2.4               Ensure MPCT has an open and honest approach to incidents
                   affecting patients/relatives/carers, and a commitment to sharing
                   lessons learned.

2.5               Ensure compliance with national reporting requirements.


2.6               Support staff throughout an incident, and not attribute blame,
                   unless the action or omission is found to be deliberate or
                   malicious.

2.7               To manage and investigate incidents based on their severity.


2.8               Ensure lessons learned from reported Incidents and trends are
                   shared across the organisation and fully implemented.

                  Enhance learning and development through the application of
2.9                good performance management principles.



  3      Definitions


3.1      Incident
         An event or circumstance arising during NHS care, or while visiting an
         NHS site, that led to unintended or unexpected harm, loss or
         damage, and contains one or more of the following components:-

                  Contrary to specified/expected standard of patient care/service
                  Placed staff/patients/contractors/members of public at
                   unnecessary risk
                  Puts MPCT in an adverse legal and/or media position with the
                   potential for loss of reputation
                  MPCT property or assets are put at risk of loss or damage


3.2      Clinical Incident
         An event or omission arising during clinical care and causing physical
         or psychological injury to a patient.


3.3      Near Miss
         A situation during clinical care or non clinical activities, fails to develop
         further, whether or not, as the result of intervening action, but carried
         with it, the potential to cause harm. (i.e. “it almost happened”)


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3.4      Serious Untoward Incident (SUI)
         An incident or accident where a member of staff/patient/member of the
         public suffers unexpected death, major permanent harm or serious
         injury (or risk of serious injury), including healthcare associated
         infections, either where healthcare services are provided or whilst in
         receipt of healthcare, or where actions of health service staff are likely
         to cause significant public concern. (Further information, including a
         detailed breakdown of types of incident, can be found in Section 14
         and Appendix 13).


3.5      Never Events
         Never Events are serious, largely preventable patient safety
         incidents, that should not occur, if the available preventable measures
         have been implemented by the healthcare providers.

         Never Events will be managed in the same way as serious untoward
         incidents. A list of locally and nationally agreed Never Events for
         MPCT is included in Appendix 12.

3.6      Hazard
         The potential of something to cause harm to people or property


3.7      Risk
         The likelihood that the harm from the hazard will be realised, and it‟s
         level of severity.
         (i.e. Risk = Likelihood X Severity)


3.8      Accident
         An unintentional event which can, but not always, cause physical
         harm.




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  4      Scope of Policy

4.1      The purpose of this policy is to ensure that the organisation is able to
         effectively manage all incidents, and incorporates the management of
         serious untoward incident reporting. This applies to both non-clinical
         and clinical Incidents.     This policy will also ensure that the
         management and investigation of incidents is consistent throughout
         MPCT.

4.2      This policy shall apply to all staff employed by Manchester Primary
         Care Trust, and includes bank/agency/locum staff, staff seconded
         from other organisations, students and volunteers. This policy should
         be read in conjunction with the policies and procedures listed in
         Section 20 of this document.

4.3      This policy also includes reference to the roles and responsibilities of
         contractors and commissioned services.


  5      Independent Contractors

5.1      MPCT commissions services from General Practitioners, General
         Dental Practitioners and Optometrists, who are all on the Performers
         List. Community Pharmacists are admitted on to a pharmaceutical list
         for MPCT. MPCT will seek to assure itself of the effectiveness of
         incident management systems in independent contractor services.
         MPCT have mechanisms in place to identify significant concerns and
         respond accordingly.

5.2      Independent contractors are expected to have in place their own
         effective reporting and management procedures for incidents
         occurring in their services. These should be in line with Health and
         Safety legislation, Healthcare Standards and National Patient Safety
         Agency requirements. (See Appendix 15 for details of MPCT staff
         who can provide advice).

5.3      Independent contractors are however, encouraged to notify MPCT
         Primary Care Commissioning Team, who will in turn notify the Medical
         Director, of the following:-

                  All Serious Untoward Incidents (SUI) – see section 14
                  All significant trends in incidents
                  Incidents with significant learning opportunities for other
                   independent contractors.

5.4      Independent contractors who wish to report a serious untoward
         incident affecting their services or staff should contact the Associate
         Director (AD) for Primary Care Commissioning, who will in turn notify
         the Director of Commissioning, as the responsible director for the
         purposes of the incident. The AD for Primary Care Commissioning


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         will notify the SUI to the Operational Risk Manager (to enable the
         Strategic Health Authority Executive Information System (StEIS), to be
         completed), as well as the Medical Director, if the incident is of a
         clinical nature.     For clinical incidents, the most appropriate
         investigation lead may be the relevant clinical advisor. MPCT expects
         to be actively involved in the investigation of SUIs within independent
         contractor services.


5.5      Independent contractors should also report patient safety incidents
         and near misses directly to the National Patient Safety Agency, at
         www.npsa.nhs.uk


  6      Commissioned Services


6.1      All providers of commissioned services are expected to have effective
         incident management policies and procedures in place and MPCT
         seeks assurance of this fact.

6.2      NHS Manchester has a specific policy for performance managing the
         management of SUIs within commissioned services (“Performance
         Management in provider organisations of serious untoward incidents
         and issues of performance breach”).


6.3      MPCT will agree mechanisms with service providers by which MPCT
         will receive adequate assurance of the quality and extent of the
         investigation and subsequent actions.      This may be through peer
         review of the investigation or participation in scrutiny panels of the
         provider organisations.

6.4      MPCT respects the role of the service provider in investigating their
         own serious untoward incidents, but reserves the right to review the
         quality of an investigation and request amendments to investigations
         or action plans, if this is judged necessary, in the interest of safety and
         prevention of further incidents.

6.5      Where MPCT is not the lead commissioning PCT, it will seek
         assurance from the lead commissioning PCT or service provider that
         any SUIs affecting Manchester patients will be notified to MPCT.

6.6      Commissioned service providers are also required to share with
         MPCT all significant trends in incidents.




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  7      Key Points


7.1      A Fair Blame Culture

         MPCT supports a „fair blame‟ culture. The notion of fair blame comes
         from the National Patient Safety Agency, and encourages incidents to
         be reported and discussed in an open and constructive manner,
         without fear of recrimination, so that MPCT can learn and introduce
         measures to prevent a recurrence.

         However, if during the investigation of the incident, it becomes clear
         that due to actions or inactivity of the staff involved, this led to a clear
         breach of professional standards/conduct or contract, it may be
         appropriate to refer to disciplinary procedures.

         To assist in this process, the National Patient Safety Agency have the
         incident decision tree, to help enable staff investigating an incident
         ascertain whether disciplinary procedures need to be instigated.
         (www.npsa.nhs.uk/nrls/improvingpatientsafety/patient-safety-tools-
         and-guidance/incidentdecisiontree)




7.2      Disciplinary Action

         There may be circumstances, particularly when a serious untoward
         incident occurs, and following an investigation, in which there may be
         a need to consider disciplinary action in accordance with MPCT‟s
         Human Resources Policies and Procedures. The reasons for this are
         explained below:-

         Disciplinary proceedings might be considered appropriate when there
         are grounds for believing an employee has acted in one of the
         following ways:-

                  Intending to cause harm
                  Recklessly taking an unjustifiable risk
                  Negligently bringing about a consequence which a reasonably
                   competent person with his/her skills should have foreseen and
                   avoided
                  Illegally, by committing a criminal act, including circumstances
                   resulting in a Police investigation or prosecution
                  Breach of confidentiality
                  Inappropriately or deliberately failing to comply with policies,
                   procedures, or protocols applicable to MPCT.




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7.3      Capability Procedure

         The Capability Policy relates to an employee‟s capability to undertake
         the duties and responsibilities of their job. Capability is different from
         conduct, which relates to action that is wilful, careless, or negligent.
         Matters of conduct will be dealt with in accordance with the
         disciplinary procedures.


7.4      Support to patients & members of the public (Being Open)

         MPCT supports an open and honest approach to any incidents and
         subsequent investigation, and a commitment to sharing the lessons
         learned with patients, relatives, carers, members of the public and
         staff. Information regarding incidents affecting patients must be
         provided to them as soon as practicable after the event and where
         appropriate, to relatives/carers. See Appendix 14 for guidance on
         how to do this. If a patient feels that they need further information or
         support they should be provided with contact details for the Patient
         Advice Liaison Service (PALS) and/or the PALS manager (see
         Appendix 15 for contact details).


7.5      Whistle-blowing Policy (Reporting in confidence)

          Staff should be aware of the MPCT Whistle Blowing Policy if they
          have any concerns about reporting incidents. There is a procedure
          clearly explained in the policy on how to report in confidence. Staff
          should also be aware of the MPCT Disagreement Procedure, the
          Capability Policy and the Dignity and Respect at Work Policy. Staff
          should feel confident in reporting incidents without fear of retribution.

          However, this commitment will not prejudice any further investigation
          of the Incident and any subsequent disciplinary action, where
          breaches of law, professional misconduct or unacceptable repetitious
          incidents have occurred.


7.6       Confidentiality (Breach of information Security)

          Any breach of information security involving the maintenance of
          confidentiality, or the integrity/availability of personal data must be
          reported by all staff. This includes theft, loss or compromise of all
          removable media such as memory sticks/CDs/floppy discs,
          computers and lap-top computers. This includes incidents involving
          the systems/servers for the IT department. This applies to both hard
          copy/electronic data containing either clinical or non-clinical
          information. The line manager responsible for investigating the
          incident must, in addition to the submission of an incident report form,


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          notify the Information Governance Manager (See Appendix 15 for
          contact details). Staff who identify potential weaknesses in systems
          which could lead to an incident should raise them with their line
          manager in the first instance, who in turn, can seek advice from the
          Information Governance Manager.

7.7       Contact Point

          All users of the ContactPoint system for children have a duty to report
          all types of security beach to the Child Health Manager, in addition to
          the submission of an incident report form. The Child Health Manager
          will investigate the incident with the line manager of the staff member
          concerned, and decide on appropriate action.

7.8       All incidents will be notified to the ContactPoint Management Team,
          led by Manchester City Council. A separate policy document on the
          Management of Security Incidents for Contact Point supplements this
          overarching policy.


7.9       Financial Irregularities

          Financial irregularities will be dealt with in accordance with the
          Standing Financial Instructions. Incidents can be reported through
          the Counter Fraud Procedure. The Counter Fraud service is provided
          by Deloittes (Internal Audit), who can be contacted locally on the
          following number: (0161) 455-6715. Alternatively, the NHS National
          Fraud and Corruption Line is available on 0800 028 4060.

7.10      Volunteers, Students and Seconded Staff

          Volunteers, secondees from other organisations and students who
          are on work experience, should complete an incident form if they are
          involved in an incident whilst carrying out their duties on behalf of the
          MPCT or on MPCT premises.


7.11 Contracted Staff

         Contracted staff are required to report and complete an incident form
         for any incidents that occur during the course of their work.

7.12 Liability

         Completion of an Incident form does not constitute an admission of
         liability of any kind on any person.




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  8      Duties and Responsibilities



8.1      Chief Executive and The Board

         The Chief Executive and the Board have overall responsibility for risk
         management and patient safety within the MPCT. Through the
         reports and minutes from the above committees and groups, the Chief
         Executive and the Board receives assurance that the process of
         incidents, complaints and claims investigation, and the learning and
         application of lessons learned, is working efficiently and effectively.



8.2      Directors

         It is the duty of all directors to ensure that staff within their directorate
         comply with the incident reporting process and all of its associated
         procedures, and taking appropriate action if this does not occur.
         Directors are also responsible for ensuring that they have a full
         working knowledge of the serious untoward incident procedure, and
         that the final decision for instigating a full root cause analysis rests
         with them.

         Directors are also responsible for ensuring that relevant Governance
         Committee and Board reports provide assurance that actions resulting
         from clinical incidents and any relevant lessons have been
         implemented and shared.


8.3      All Staff

         It is the duty of every member of staff (including bank, agency, locum,
         secondees and students), to inform their line manager promptly (within
         24 hours or as soon as possible thereafter) of any incident or near
         miss, in which they are involved. Each member of staff should be
         aware of the reporting procedure, and must co-operate with any
         investigation into an incident (this includes students and
         volunteers).Investigations of incidents may affect more than one
         organisation. Failure to report an incident could lead to disciplinary
         action. (Details of the incident reporting procedure are set out in
         Section 11 of this document).


8.4      Staff based in non PCT sites

         Staff who are based in sites which do not belong to MPCT, such as
         hospitals, schools, Manchester City Council buildings etc, need to
         report incidents to MPCT and the host site, in line with the host site‟s


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         reporting requirements. To avoid completing two forms, it will be
         acceptable for staff to send a copy of the host organisation‟s
         completed incident form to the Risk and Compliance Administrator
         (based in the Corporate Governance and Risk section, 2nd floor,
         Parkway 3). However, if access is made available to the Datix on-line
         reporting system, then staff would be required to complete both
         systems. If this causes a problem within the service, then advice
         should be sought from the Operational Risk Manager.


8.5      Line Managers (including Heads of Service)

         The manager with supervisory responsibility for the member of staff
         involved in the incident is responsible for:-

                  Managing the incident – promptly implementing any identified
                   action to prevent a reoccurrence of the incident. See section
                   20 on linked policies to assist with this process.
                  If the incident involves equipment or a medical device failure –
                   arrange isolation of the item, and put on a notice that is it not to
                   be used until cleared by the Operational Risk Manager
                  Ensuring that the incident form (DIF 1) has been completed
                   correctly
                  Notifying the Head of Service/General Manager (or equivalent),
                   of a serious untoward incident immediately (Summary of
                   process in Appendix 3)
                  Grading the incident according to severity of risk using the Risk
                   Matrix (Appendix 5)
                  Investigate the Incident/near miss using the investigation
                   guidelines in Appendix 6 (Incidents scoring a risk level of 1-6)
                  Fully completing the DIF2 section of the Incident form, ensuring
                   that a full record is kept of all their actions in the appropriate
                   section of the form.
                  Complete a RIDDOR report if appropriate. A copy of the
                   RIDDOR report must also be sent to the Operational Risk
                   Manager (See Appendix 9 for further information).
                  Complete a Risk Assessment and action plan when appropriate
                  Notifying their own line manager when appropriate
                  Assist in root cause analysis of incidents (risk level 8-12)
                  Keeping copies of records and written accounts which are
                   stored securely, and ensuring that they are legible and dated.
                   Guidance on writing a statement for formal use i.e. for the
                   police or coroner etc is given in Appendix 7.
                  Ensuring that feedback is given within 20 working days to
                   the person reporting the incident.
                  Share lessons learned (and implemented), at team meetings.




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8.6      General Managers (or equivalent post)

         The General Manager (or their equivalent), with supervisory
         responsibility for the line manager involved in the incident, is
         responsible for:-

                  Supporting the line manager with ensuring that all necessary
                   action has been taken to manage the incident, and
                   documenting any specific actions they have taken.
                  Working with line manager to investigate the incident and
                   complete a local root cause analysis (incidents scoring a risk
                   level of 8-12)
                  Agreeing a risk assessment and action plan to resolve issues
                   raised
                  Submit identified risks for addition to the Divisional and where
                   appropriate, Directorate Risk Registers
                  Ensure that lessons learned are shared at division/department
                   meetings.
                  Actions identified from the lessons learned are implemented.


8.7      Associate/Assistant Directors

         The Associate/Assistant Director with supervisory responsibility for
         the Head of Service / General Manager (or equivalent) involved in the
         Incident is responsible for:-

                  Supporting the General Manager (or equivalent) with ensuring
                   that all necessary action has been taken to manage the
                   Incident, and documenting any specific actions they have
                   taken.
                  Working with General Manager / Head of Service (or
                   equivalent), and the Operational Risk Manager (non clinical
                   incidents), to investigate the incident and complete a local root
                   cause analysis (incidents scoring a risk level of 15-25/ SUIs).
                  Agreeing a risk assessment and action plan to resolve issues
                   raised
                  Submit risks identified for addition to Directorate Risk Register,
                   and if appropriate, the Risk Assurance Framework for either the
                   PCT or Manchester Community Health.
                  Ensure that lessons learned are shared at MPCT directorate
                   meetings, and appropriate external bodies. Implementation of
                   actions identified from the lessons learned, which may include
                   change of practice.




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8.8      Operational Risk Manager (NHS Manchester)

                  The Operational Risk Manager is responsible for the MPCT
                   Incident reporting system. The software used to facilitate
                   incident reporting is Datix. Incidents are reported by all staff on
                   Datix Incident Form 1 (DIF1) and followed up by line managers
                   using the Datix Incident Form 2 (DIF2).
                  Liaising with all management levels and staff to ensure all
                   incidents are properly investigated and incorporated into the
                   database.
                  Support the management when dealing with serious untoward
                   incidents.
                  Responsible for providing incident statistics which are taken to
                   the Board and Health and Safety Committee every quarter.
                  Responsible for providing incident statistics to the Manchester
                   Community Health Governance Group.
                  Reporting patient safety incidents to the NPSA via the National
                   Reporting and Learning System (NRLS).
                  Responsible for providing evidence for the Annual Health
                   Check
                  Responsible for reporting to external agencies.
                  Lead on training on Incident Reporting & Risk Management,
                   including how to use the Datix system
                  Support the management of clinical serious untoward incidents
                   as required.
                  Analysing and learning from clinical serious untoward incidents
                   across the local health economy and beyond.
                  Ensuring the development of a system for organisational
                   learning and implementation of identified actions from incidents
                   reported.


8.9      Head of Communications

                  Advising the Director on appropriate communications, when it is
                   necessary to notify patients, relatives, staff and the public of
                   their involvement in a serious incident.
                  Provide media and communications support as identified within
                   the serious untoward incidents procedure


8.10 All Management Levels

         All managers must ensure that their staff are aware of deputising
         arrangements when on annual leave or unavailable.

         All incidents are potentially stressful for staff directly involved. MPCT
         expects all line managers to ensure appropriate support is discussed
         and made available to staff (eg counselling). (See section 10)


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8.11 Confidentiality when investigating incidents

         Incidents are of a confidential nature. Staff involved in the handling of
         information, or investigations concerning incidents must not divulge
         information without authorisation.



8.12 Safety Group

         The Safety Group reports to the Manchester Community Health
         (MCH) Governance Sub Group and is responsible for reviewing all
         MCH incidents, complaints, PALS and legal claims. The Safety Group
         will responsible for the following:-
              Gathering statistics on all reported Incidents/complaints/PALS
                 and legal claims
              Interpret data for trends
              Produce reports on the statistics and trends for the Board,
                 Health & Safety Committee, Information Governance Group,
                 Medical Devices Group and the MCH Governance Sub-Group
              Scrutinise the data to ensure actions taken are sufficient and
                 decide on whether any further action is required over and
                 above that already taken (eg RIDDOR report).
              Monitor the reporting to all external agencies.
              Identify potential claims for onward reporting to the NHSLA.
              Ensure all high risk incidents are following the Serious
                 Untoward Incidents procedures, as identified in this policy.
              Ensure compliance for incident reporting with the following:-
                     NHS Litigation Authority Risk Management Standard
                     Healthcare Commission Standards for Better Health
                     Health and Safety Legislation

8.13
         Governance Committee & MCH Governance Sub-Group

         The Governance Committees have responsibility for the operational
         management of risk and patient safety within the MPCT.




  9      Feedback to staff

9.1      It is recognised that feedback to staff is a vital element of the
         incident reporting procedure. Line managers (at all levels) must
         ensure that they have systems in place, to provide feedback to
         staff that have reported Incidents within 20 working days.



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9.2      Staff are encouraged to approach managers for feedback if not
         given within the above timescale, as there maybe a valid reason
         for this. Managers and staff alike are expected to use discretion
         of the types of incidents for which feedback is expected.


 10      Supporting staff following traumatic and/or stressful incidents

10.1 MPCT will support staff following traumatic or stressful incidents, and
     following complaints or claims made against them.

10.2 The MPCT recognises, that the counselling support that is normally
     available through Occupational Health, may need to be augmented,
     following a traumatic incident and will engage with appropriate
     external bodies in the case of such an event.

10.3 To this end, MPCT has a specific procedure note (Appendix 8), which
     supplements this policy and covers the following areas :-

         Roles and responsibilities
         Protocol for handling traumatic/stressful incidents
         Supporting staff who have been identified in legal claims
         Attendance at Tribunals/Court/Coroner‟s Count
         Bullying and Harassment




         PROCEDURES
 11      How the incident reporting process operates, including actions
         for specific types of incidents.


11.1 The following steps should be followed when an incident or near miss
     occurs. A guideline summary of reportable incidents can be found in
     Appendix 11. (The list is not exhaustive).


                  A member of staff who is directly involved, or witness to
                   an incident or near miss, must report the event.


                  SERIOUS UNTOWARD INCIDENT (SUI): If the Incident in
                   question involves sudden expected death, major permanent
                   harm, serious injury, or major loss/damage to assets, this must
                   be reported by telephone to the line manager immediately (or
                   the on-call manager if out of hours – 0161 276 6246). All staff
                   and managers need to be sure that they are aware of the SUI


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                   process. (Details in section 14). The line manager in turn,
                   needs to alert the General Manager/Associate Director. The
                   Director should be notified by the GM/AD as soon as possible

                  ANY      DEATH       ASSOCIATED        WTH       HEALTHCARE
                   INFECTION,        INCLUDING       C.DIFFICILE      &    MRSA
                   BACTERAMIA: All of these categories of incident are classed
                   as serious untoward incidents (SUI). The SUI process must be
                   followed. See Section 14 and Appendix 13 for details. The
                   details of the incident are to be recorded on Datix (or paper
                   based DIF1 if the service is not connected to the PCT web).

                  If an incident is serious, but does not meet the criteria of a
                   serious untoward incident, then the line manager should be
                   notified by telephone, prior to completing an incident form.

                  As soon as possible after the incident or near miss, (within 24
                   hours or as soon as possible, thereafter), an incident form
                   (DIF1) should be completed and sent to the member of staff‟s
                   line manager. (This is done automatically when using Datix).

                  As much information as possible should be recorded about the
                   Incident or near miss, and, as near to the time of the event.
                   This should include any action taken to initially investigate the
                   event. A record should be made of any advice or treatment
                   given.


                  If appropriate to the incident, diagrams and legible written
                   accounts from witnesses (with full contact details), should be
                   taken and stored securely.

                  If a formal statement is required, for example, at the request of
                   the Coroner or the Police etc, guidance on writing statements
                   is given in Appendix 7.

                  Only record facts – not opinions

                  The line manager will investigate the incident or near miss and
                   ensure appropriate follow up actions are taken to prevent a
                   reoccurrence. This includes seeking advice from colleagues
                   and notifying other departments of the incidents where
                   necessary (eg Health & Safety Advisor or Infection Control
                   Team). See Appendix 15 for contact details.

                  If a hazard is identified, immediate action should be taken to
                   remove it, or where this cannot be done, make the area as safe
                   as possible.




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                  If the outcome of the incident/accident is a physical injury to a
                   member of staff, the line manager should ensure that
                   appropriate medical treatment is sought (e.g. Walk-In Centre,
                   A&E or GP).

                  If the Incident/accident involves patients, relatives, contractors
                   or members of the public, medical aid should be given (from
                   medical staff, as appropriate to their injury), or an ambulance
                   called. Where appropriate, the injured person‟s next of kin
                   should be informed and further communication should be made
                    after 24 hours, to enquire as to the injured person‟s welfare
                    and thereafter, until the extent of the injury is known.

                  Clinical incidents should be documented in the patient‟s record
                   and any ill effects noted. All clinicians are responsible for
                   disclosing that the patient has been involved in an incident, and
                   that this will be documented on an MPCT incident form.

                  The line manager should document any information given to
                   staff, patients or the public.

                  The line manager to grade the risk on the incident form – DIF2,
                   which will in turn, determine the level of investigation.
                   Managers should note that any incidents that meet the category
                   of “Moderate – permanent harm”, which may only score a risk
                   level of 3, may still require a root cause analysis investigation.

                  National Reporting Learning System (NRLS): Any incident
                   which led to a patient being harmed by an action or omission by
                   a member of staff, will be reported to the NRLS, as required by
                   the National Patient Safety Agency.        (The actual report is
                   made by the Operational Risk Manager via the completed Datix
                   form)

                  SECURITY and/or PHYSICAL ASSAULT: If the member of
                   staff has been physically assaulted or subjected to a robbery,
                   the Police should be called in the first instance, followed by the
                   line manager. Incidents should be notified to the Local Security
                   Management Specialist (LSMS) (based in the Facilities
                   Division), by the line manager. Where the security incident
                   has already been reported to the Police and a crime number
                   issued, this along with the Police Officer‟s name (or shoulder
                   number) must be given. If the LSMS is not available, the
                   information should be given to the General Manager for
                   Facilities.

                  The exception to the above applies to the Learning Disabilities
                   Partnership, where each reported assault will be reviewed,
                   subject to any specific clinical and management plans or
                   assessments, for complex behavioural needs. Please refer to


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                    to MLDP policy: “Responding to Aggression and Violence”.



                  NEEDLESTICK INJURY: The wound should be bled, washed
                   and Occupational Health contacted immediately.             See
                   Appendix 15 for contact telephone numbers. The Accident
                   Book should also be completed, as well as an incident form. If
                   the incident involves a patient with a known blood borne virus,
                   then a RIDDOR form must also be completed. See Appendix
                   9 for further details.

                  CONTROLLED DRUGS: Incidents involving Controlled Drugs
                   need to be reported to the Medical Director, who is the
                   Accountable Officer, as well as the relevant line manager.

                  FIRE incidents should be notified to the Fire Safety Manager
                   (based in the Facilities Division), by the line manager. If the
                   Fire Safety Manager is not available, the information should be
                   given to the General Manager for Facilities.

                  MEDICAL DEVICES – see Section 13 for the procedure for
                   staff and line managers.

                  STAFF ABSENCE - If a member of staff is absent from work
                   for 3 days or more, as a direct result of an incident, the line
                   manager should complete a RIDDOR form for submission to
                   the Health and Safety Executive. A copy of the RIDDOR form
                   should be sent to the Operational Risk Manager. The line
                   manager should also notify the ORM by telephone or email of
                   the event.      (RIDDOR:      Reporting Injuries, Diseases &
                   Dangerous Occurrence Regulations 1996 – see Appendix 9).
                  EXTERNAL REPORTING: The line manager to ensure the
                   named person for reporting is notified of any incident which has
                   to be reported to an external agency. See Section 15.

                  FEEDBACK must be given to the member of staff who reported
                   the incident within 20 working days. If this is not forthcoming,
                   the staff member should approach the line manager for the
                   information.

                  The fully completed incident form (DIF1 and DIF2) is reviewed
                   by the Operational Risk Manager, and if necessary further
                   information sought.

                  All MCH incident forms reviewed by the Incident Review Group
                   (IRG) to ensure no further actions above and beyond those
                   already taken are required. The IRG will also complete trends
                   analysis and link with complaints, legal claims and PALS
                   enquiries.


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11.2 Investigating Incidents

         Incidents should be investigated in relation to the grade of risk. See
         Appendix 6 for a summary and details of investigation procedures in
         relation to the seriousness of the incident. Investigations will be
         guided by documentation produced from the National Patient Safety
         Agency (NPSA). NPSA guidance recommends that investigations fall
         into the category of Concise, Comprehensive or Independent. See
         Section 15 for reporting to external agencies and the identified
         reporting officer.



11.3 Withington Community Hospital

                  All staff working within Withington Community Hospital (WCH)
                   will follow the MPCT incident management policy and
                   procedures.

                  All incidents will be reported using the Datix system where
                   accessible. Where this is not possible, provider trusts must
                   provide information about incidents to the assistant hospital
                   manager, at WCH, where it will be transferred on to the Datix
                   system.

                  The incident will be investigated and appropriate action taken
                   by the named line manager.



 12      Grading an incident

12.1 Line managers are required to grade all incidents using the risk matrix
     as defined in the MPCT Risk Management Policy (Appendix 5). The
     grading will be reviewed by the operational risk manager. The initial
     grading may be amended to a more appropriate level of risk.

         Likelihood X Severity = Risk

         Likelihood = the likelihood of a reoccurrence of a similar incident
         Severity   = the severity (consequences) of the actual outcome of
                      the incident


12.2 If a manager is uncertain as to the grade of risk – they should seek
     advice from the Operational Risk Manager




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 13      Medical Devices

13.1 A medical device incident may also fall into the category of a serious
     untoward incident. The SUI procedure should be followed, and will
     include the actions listed below. Medical Devices are also covered in
     the Medical Devices in Practice Policy.

13.2 All defects or potential hazards involving medical devices. should be
     reported to the line manager, including any relevant information,
     make, model, manufacturer‟s name, batch number etc.

13.3 In the event of a medical device failing to operate, or causing an injury
     to the patient, a member of staff or both, the defective item should be
     taken out of use immediately and isolated. A notice should be placed
     on the equipment stating it is not to be used until authorisation is given
     from the operational risk manager.

13.4 If is possible not to significantly affect the service, or safety, the
     equipment should be left undisturbed and the immediate area
     quarantined until such time as readings, positions of equipment,
     controls switches and photographs can be recorded.

13.5 The line manager must report the incident to the Medical Devices
     Liaison Officer (MDLO), who will notify the Medicines Healthcare
     Regulatory Authority (MHRA). A cross check will also be made with
     RIDDOR to see if the incident also falls under these regulations. The
     MDLO for MPCT is the operational risk manager.

13.6 The MDLO will liaise with the line manager on the investigation that
     will be conducted by the MHRA. Manufacturers of the medical device,
     may only inspect the equipment, once express permission has been
     given by the MHRA, and confirmed by the MDLO. The MDLO should
     be informed when an inspection date has been arranged.

13.7 Offers from the manufacturer to exchange a suspect or defective item
     must not be accepted and should be directed to the MDLO.

13.8 The MDLO will liaise with the Facilities Division to carry out a check of
     the Medical Devices Asset Register for identical or similar items of
     equipment, and arrange for safety inspections to be carried out.



 14      Serious Untoward Incidents (SUI)

14.1 As described in section 3.4, a Serious Untoward Incident (SUI) is
     when an incident or accident involving a member of staff, patient or
     member of the public, suffers sudden unexpected death, major
     permanent harm, or serious injury, (or risk of serious injury), either
     where healthcare is provided, whilst in receipt of healthcare, or where


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         actions of health service staff are likely to cause significant public
         concern.

         In practical terms these can be described as “any incident, either on
         MPCT premises or involving MPCT services , which:-

                  Causes unexpected death (including suicide, suspected suicide
                   or homicide)
                  Causes unexpected death or serious infection due to MRSA
                   bacteraemia or C.Difficile or any other healthcare associated
                   infection, including outbreaks leading to unit closures
                  Home Oxygen Service
                  Causes serious injury
                  Classed as a Never Event
                  Contributed to a pattern of reduced standard of care
                  Caused serious disruption to service delivery
                  Is considered life threatening, where foul play is suspected
                  May involve vulnerable adults
                  May involve Child Protection / Safe Guarding Children
                  May involve a hazard to public health (eg Legionella)
                  May cause significant damage to the PCT reputation
                  May give rise to serious criminal charges
                  Involves a serious attack on staff/patients/public
                  Loss of patient data
                  Breach of confidence and/or Data Protection Act
                  Involves loss or serious damage to NHS assets
                  Involves suspicion of large scale theft/fraud/litigation
                  Involves an allegation of serious misconduct
                  Absconsion of mental health patient detained under the Mental
                   Health Acts 1983/2007 and/or where patient poses a significant
                   risk to themselves or others.

         It is the responsibility of line managers to ensure that they are fully
         aware of the above statement, and the identified categories of what
         constitutes an SUI.



14.2 Serious Untoward Incidents with specific arrangements

         Incidents occurring in the following services are dealt with under
         separate policies or specific procedures in liaison with other
         stakeholders:-

                  Child Protection / Safeguarding Children Strategy

                  Deaths in custody (HMP Manchester): MPCT is responsible for
                   contributing to the Prison and Probation Service Ombudsman‟s
                   investigations into deaths in custody in HMP Manchester.


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                   Investigations are conducted in compliance with PSO 1301
                   (2004), and in line with the guidance “Undertaking a clinical
                   review following a death in custody” (July 2009), produced by
                   the Prison and Probation Service Ombudsman, Department of
                   Health and the National Patient Safety Agency.


14.3 Procedure for reporting a Serious Untoward Incident (SUI)

         During office hours:-

                  When an incident has taken place it is reported immediately to
                   the relevant Line Manager, (who will in turn, notify the General
                   Manager or equivalent).
                  The Line Manager will grade the incident and agree the level of
                   risk with the General Manager or equivalent post. (Risk Score
                   15-25 = SUI)
                  The General Manager, or equivalent, considers the seriousness
                   of the SUI and confirms whether it meets the criteria, in
                   consultation with the relevant Associate Directorate (AD), or re-
                   grade the incident to a more suitable level. This may include
                   incidents with a grade of 3 (moderate), where there has been
                   serious harm.
                  The Associate Director notify the Director (or designated
                   deputy) who will make the final decision.

                  If the incident is of a clinical nature, the Director will liaise
                   with the Medical Director on how the matter is to be
                   followed up and subsequently investigated.

                  The Lead Director will then:-
                      a) Inform the Chief Executive (who will brief the Board)
                      b) Inform the Head of Communications
                      c) Authorise an investigation team with terms of reference,
                         and an identify a lead investigator.

                  Notify the Operational Risk Manager for entry onto the StEIS
                   system for the Strategic Health Authority.

14.4 Out of Hours:-

                  If a potential SUI occurs out of office hours, the on-call
                   manager must be contacted, who will request that the director
                   on-call decide whether the incident is an SUI or not. In every
                   case the decision must be taken as soon as possible,
                   preferably within less than 24 hours of the incident occurring.




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14.5 Immediate Actions by Line Manager

                      Ensure any immediate potential risk of injury/loss to people or
                       property is addressed
                      In the case of an incident involving a patient, ensure a record
                       is made in their notes about the event/omission having
                       occurred, its consequences, and immediate action take to
                       stabilise the situation or reduce the likelihood of further harm.
                       The records should be secured, as they will form part of the
                       follow-up investigation
                      Ensure affected staff are supported
                      Arrange support for others involved (relatives, carers etc)
                      Take witness statements from all those involved in the
                       incident who are non PCT staff.
                      Retain and isolate any medical devices involved in the
                       incident
                      Keep a record of all actions taken and information gathered
                      Incident Form fully completed, including a comprehensive
                       description of the event, by each member of PCT staff, who
                       were either directly involved, or witness to the incident.


         Role of the Lead Director / Medical Director
14.6
         The Director will take responsibility for the further management of the
         SUI. In the case of a clinical SUI, the Medical Director may take on
         this role, in agreement with the appropriate director.

         The agreed Lead Director will:-

                     Inform and maintain communication with the Chief Executive
                      (who will brief the Board).
                     Inform and maintain communication with the head of
                      communications.
                     Authorise a sufficiently experienced or trained staff member to
                      act as the investigating officer, having considered the need for
                      Police or other external agency involvement.
                     Receive an interim report after 45 days from the investigating
                      officer, if the investigation is still ongoing. This will be shared
                      with the SHA.



14.7 Role of the Investigating Officer
         The investigating officer will:-

                     Receive terms of reference from the Lead Director
                     Keep the lead director informed and involved in key decisions.


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                  Identify a team to undertake an appropriate investigation.
                  Identify who needs to be informed both internally and externally
                  Liaise with Medical Director for advice on reporting to the
                   National Patient Safety Agency for clinical SUIs. Only the
                   Medical Director can make the decision to escalate outside the
                   organisation
                  Liaise with the ORM for reporting to the Strategic Health
                   Authority Executive Information System (StEIS), and
                   subsequent follow up reports.
                  Keep a portfolio of documentation showing details of the
                   investigations, dates, times, personnel involved and decisions
                   made by whom.
                  Produce an action plan including specified deadlines
                  Produce progress reports for the director to keep the Chief
                   Executive informed, and relevant external agencies
                  Provide an interim report to the Lead Director after 45 days,
                   from the date of the incident, if the investigation is still ongoing.
                   If an extension is required, this must be agreed with the
                   Director.
                  Provide a final report to the Director within 45 days, if
                   investigation is complete.
                  Provide support and feedback to staff involved in the incident.
                  Provide information and support to patients/family/carers in line
                   with “Being Open”
                  Activate the MPCT “Hot Line” arrangements where it is
                   necessary to provide a point of contact for the public, in liaison
                   with the Emergency Planning Manager.
                  Produce a final report which includes any identified learning
                   which will require sharing across MPCT.



14.8 Investigation Process for Serious Untoward Incidents

              See Appendix 13 for details of the following:-
               How a Serious Untoward Incident is investigated, reported to
                the Board and the rest of the MPCT
               Details on how the MPCT “Hot Line” operates
               How the identified lessons learned are to be shared and
                implemented across the organisation.


 15      Reporting Procedures for external agencies


15.1 The MPCT has a duty to report various categories of incidents to
     external agencies, within their respective specified timescales. This
     will apply in the main to Serious Untoward Incidents, but there are
     circumstances when a report is still required, but the incident does not


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         fall into the category of SUI.

15.2 Details of the required reporting and the designated post required to
     do this, are listed below. This table is not definitive and will be
     amended as and when required. The Glossary of Terms in Appendix
     1 gives further information on each organisation listed. The named
     person will act as the liaison officer if the organisation states they will
     become involved in the investigation into the incident

15.3 There maybe other external official bodies which need to be contacted
     depending on the incident or issue to be reported. Examples of these
     are the General Medical Council or the Nursing and Midwifery Council.
     (these examples are not exhaustive).

15.4 The same applies to other external stakeholders which may need to
     be contacted. Examples of these are General Practitioners, Social
     Services, neighbouring PCTs. (these examples are not exhaustive)




15.5             Organisation           Reporting Timescale            Named Person
           Fire and / or Police         Immediate                  Person involved in
                                                                   incident (and line
                                                                   manager for follow-up)

           Health & Safety              Death – Immediate          Operational Risk
           Executive                                               Manager (ORM)



                                        RIDDOR – within 10         Line Manager
                                        days for over 3 day
                                        absence or when facts
                                        have been established
                                        (eg exposure to disease)

           National Patient Safety      Red Incident – 3 days      Medical Director
           Agency                       (Full report: 45 days)

                                        Non-urgent incidents       Operational Risk Mgr
                                                                   (ORM)
           Medicines Healthcare         Immediate                  Medical Devices Liaison
           Regulatory Authority                                    Officer

           Serious Hazard Of            Immediately to the         Line Manager on duty
           Transfusion Incident         hospital transfusion
                                        laboratory
           NHS Litigation Authority     When facts of a incident   Claims Manager
                                        have been established
                                        which may lead to a
                                        claim or when in receipt
                                        of a claim

           Strategic Health Authority   Immediate category red:    ORM after consultation
           (SHA Executive               actual harm resulted       with lead director


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           Information System –
           StEIS)                     Immediate by telephone      ORM after consultation
                                      for specific incidents.     with lead director
                                      Within 3 days on StEIS
                                      (includes Home Oxygen)
           Security Management        Physical Assault – within   Local Security
           Service                    24 hours                    Management Specialist

           Counter Fraud Service      Fraud – within 24 hours     Director of Finance

           Contact Point              Immediate                   Child Health Manager
           NHS Estates (including     Within 24 hours for         Fire Safety Manager
           Fire incidents)            emergencies

           Environment Agency         Within specified time       General Manager for
                                      lines dependant on          Facilities
                                      nature of incident

           Health Protection Agency   Within specified time       Clinical Lead for Infection
                                      lines dependent on          Control
                                      nature of incident
           Food Standards Agency      Within specified time       Associate Director Adult
                                      lines dependent on          Services
                                      nature of incident

 16      Major Incidents

16.1 A major incident is one where the usual services, and/or resources
     cannot adequately respond to the need.

16.2 The Executive Director responsible for the major incident plan is the
     Director of Public Health.

16.3 The MPCT major incident plan will become operational when a major
     incident affects the MPCT. Alternatively, the PCT may activate the
     major incident plan as a result of a request from an external body such
     as the Local Authority or another NHS organisation.

16.4 The major incident plan includes the procedure for responding to
     incidents that happen during office hours or out of hours. Once the
     Executive Director for Public Health has declared that the major
     incident plan is in operation, specific management responsibilities (eg
     cascading of information/instructions to MPCT staff), become active
     and these are detailed in the major incident plan document


 17      Monitoring Compliance and Effectiveness

17.1 Monitoring procedures must be geared towards continuous
     improvement through learning, and provide the MPCT with assurance
     that appropriate control procedures are operational, and that they are
     being adhered to. In areas of non compliance effective actions must
     be put in place to rectify the situation and demonstrate changes have
     been implemented.


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17.2      The monitoring compliance and effectiveness role in respect of MCH,
          will be carried out by the Safety Group, and will cover incidents,
          complaints, PALS and legal claims against MCH. This group will
          report to the Governance Sub-Group for Manchester Community
          Health.

          The monitoring compliance and effectiveness role for non MCH
          incidents will be carried out by the Governance Committee for MPCT.



 18      Key performance indicators

         Key performance indicators that cover both process and outcome will
         be used to measure the effectiveness of this policy. The usefulness of
         these indicators will be reviewed by the Incident Review Group, and
         updated/amended to reflect the work of the MPCT (Appendix 10).

 19      Review

         The policy will be reviewed bi-annually and/or when procedure, best
         practice or organisational changes occur.




 20      Linked strategies and policies

         This policy is linked to the following Manchester MPCT strategies,
         policies, procedures, protocols and plans, which are located on the
         MPCT web site, under “About Us”:-

         Best Clinical Practice Policy
         Capability Policy
         Care of individuals who are violent or abusive
         Claims Management Policy
         Community Nursing Controlled Drugs Policy
         Complaints Policy
         ContactPoint (Management of Incidents)
         Counter Fraud
         Dignity and Respect at Work Policy
         Disagreement Policy
         Disciplinary Policy
         Health and Safety Policy
         Infection Control Procedures
         Lone Worker Policy
         Learning and Development Strategy
         Major Incident Plan
         Medical Devices Policy


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         Performance management in provider organisations of serious
         untoward incidents and issues of performance breach
         Raising concerns under the public interest disclosure Act 1998
         (Whistle Blowing)
         Records Management Strategy/Policy
         Responding to Aggression & Violence – for MLDP staff
         Risk Management Policy
         Risk Management Strategy
         Standing Financial Instructions


 21      References

         Data Protection Act 1998   London Office of Public Sector Information

         Department of Health (2000) An Organisation with a Memory: Report of an
         Expert Group on Learning from Adverse Events in the NHS London
         Department of Health

         Department of Health (2001)       Building a Safer NHS for Patients:
         Implementing an Organisation with a Memory    London  Department of
         Health

         Department of Health & National Patient Safety Agency (2001) Doing Less
         Harm: Improving the safety and quality of care through reporting, analysing
         and learning from Incidents involving NHS patients. Key requirements for
         healthcare providers London Department of Health

         Department of Health (2006) Safety First: A report for patients, clinicians
         and healthcare managers London Department of Health

         Department of Health (2004) 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 London Department of Health

         Freedom of Information Act 2000 London Office of Public Sector Information

         Healthcare Commission (2005) Criterion for Assessing Core Standards
         2006/2007 London Healthcare Commission

         NHS Litigation Authority (2007) Risk Management Standards for Primary
         Care Trusts London NHS Litigation Authority

         National Patient Safety Agency (2005) Seven Steps to Patient Safety –
         Primary Care London National Patient Safety Agency

         Management of Health and Safety at Work Regulations 1999 London HSE
         Books

         Reporting of Incidents, Diseases and Dangerous Occurrence Regulations
         1995 London HSE Books



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 22      Appendices


         Appendices 1 – 15 are attached to the rear of this policy




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                                                                    APPENDIX 1

Glossary of Terms

CF: Counter Fraud Services - a Special Health Authority that has
responsibility for all policy and operational matters relating to the
prevention, detection and investigation of fraud and corruption in the NHS.

SMS: Security Management Services - a Special Health Authority that has
responsibility for all policy and operational matters relating to the
management of security in the NHS.

Grade: A position in a scale of size, quality or intensity. The grade is
determined by looking at the likelihood and severity.

HSE: Health and Safety Executive – are responsible for the regulation of
almost all the risks to health and safety arising from work activity in the UK.

Investigation: Detailed enquiry or systematic examination

Major Incident: An unexpected event which overwhelms the normal
resources of the service. Examples are:-
    A serious threat to the health of the community
    Health Service is disrupted
    Special arrangements are necessary to deal with the number of
      casualties

MHRA: Medicines and Healthcare Regulatory Authority – an executive
agency of the Department of Health which protects and promotes public
health and patient safety by ensuring that medicines, healthcare products
and medical equipment meet appropriate standards of safety, quality,
performance, and are used safely.

NHSLA: National Health Service Litigation Authority – a Special Health
Authority who indemnifies NHS bodies in respect of both clinical negligence
and non-clinical risks, and who manages claims under both headings.

NPSA: National Patient Safety Agency – a Special Health Authority
created to collate and co-ordinate patient safety reports and initiate
preventative measures, so that the whole country can learn from each
incident, and patient safety throughout the NHS can be improved.

NRLS: National Reporting and Learning System – the system used to
report patient safety incidents to the NPSA.

RIDDOR: Reporting of Incidents, Diseases and Dangerous Occurrence
Regulations (1995) -requires employers to report certain occupationally
acquired injuries and diseases to the Health and Safety Executive.



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Risk Assessment: A structured way of looking at a particular task or part
of the organisation and ascertaining where hazards could, or have
occurred, and minimizing them.

Risk Matrix: The 5 x 5 table used by MPCT to determine the risk score.
This is done by scoring the following two together:_

    A) Measure the Severity (consequence) of harm if the hazard
       happened: scores range from 1-5
    B) Measure the Likelihood (probability) of the risk occurring: scores
       range from 1-5


Risk Assessment Score: multiplying the two scores above determines the
risk assessment score (from 1-25). This assists the MPCT in managing
risks appropriately. (1= insignificant 25 = catastrophic)

Serious Untoward Incident: An incident or accident where a member of
staff/patient/member of the public suffers serious injury, major permanent
harm or unexpected death (or risk of serious injury), either where healthcare
services are provided or whilst in receipt of healthcare, or where actions of
health service staff are likely to cause significant public concern.


Strategic Health Authority Executive Information System (StEIS) – the
electronic system for reporting serious untoward incidents to the Strategic
Health Authority.




Incident Reporting & SUI Policy   Page 34 of 57           Christine Garratt & Judith Strobl
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                                                                          APPENDIX 2
                          MANCHESTER PRIMARY CARE TRUST

               GOVERNANCE COMMITTEE TERMS OF REFERENCE

       1. Title

The Board hereby resolves to establish a Committee of the Board to be
known as the Governance Committee (“The Committee”)

       2. Purpose and Duties

The purpose and duties of the Committee shall be to:

              a)        Ensure the establishment and maintenance of an effective
                        system of integrated governance, risk management and
                        internal control, across the organisation‟s activities (both
                        clinical and non-clinical), that support the achievement of the
                        organisation‟s objectives.
              b)        Provide an assurance to the Audit Committee, and ultimately
                        the Board, that there are robust structures, processes and
                        accountabilities in place for the identification and
                        management of significant risks facing the organisation.
              c)        Ensure the PCT is able to submit risk and control related
                        statements, in particular the Statement on Internal Control
                        and declarations of compliance with the Standards for Better
                        Health. This will entail initiation and monitoring of action to
                        meet these Standards, by means of an annual plan.
              d)        Ensure that the organisation has policies for ensuring
                        compliance with relevant regulatory, legal and code of
                        conduct requirements, and to approve such policies.
              e)        To identify and review lapses in quality and make
                        recommendations for improvements
              f)        Receive and monitor progress against reports from external
                        agencies, including the Healthcare Commission and Health
                        and Safety Inspectorate.
              g)        Work collaboratively to identify and promote “Best Practice”,
                        the sharing of experience, expertise and success across the
                        PCT and with key stakeholders.

       3. Membership
         Two Non-Executive Directors
         Medical Director
         Director of Corporate Affairs
         Workforce/HR representative*
         Director of Performance or representative*
         Director of Operations
         AD Corporate Governance and Risk Management


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         Clinical Governance representative*
         AD Patient and Public Involvement
         AD Service and Professional Development

       4. to be clarified once structural arrangements for these directorates are
          agreed

One of the Non-Executive Director Members of the Committee shall also be a
member of the Audit Committee.

       5. Chair

The chair shall be a Non-Executive Director. In the absence of a Non-
Executive Director the meeting shall appoint a Chair.

       6. Lead Director

The Lead Director shall be the Director of Corporate Affairs who shall ensure
administrative arrangements to support the committee are in place.

       7. Meeting arrangements

The Committee shall meet not less than five times a year.

       8. Quorum

The quorum shall be four members.

       9. Agenda Items

The agenda shall be prepared by the Director of Corporate Affairs in
conjunction with the Chair and shall have standard items as determined by the
Committee. The agenda and papers for meetings shall be distributed five days
in advance of the meeting.

       10. Links to other Committees and Groups

The Committee shall establish sub-committees and task groups to take
forward particular areas of work. These shall be reviewed annually to ensure
they remain effective in delivering the objectives of the organisation

       11. Accountability and Reporting Arrangements

The approved Committee minutes shall be submitted to the next available
Board and the Audit Committee.

       12. Review of Terms of Reference

The terms of reference of the Committee shall be reviewed at least annually
by the Board.


Incident Reporting & SUI Policy   Page 36 of 57            Christine Garratt & Judith Strobl
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                                                                                              APPENDIX 3

           Incident Reporting and Management Process



                                          ORM assesses risk.
                                          Identifies & follows
            Line Manager                   up any appropriate                         Incident closed
            Investigates and                   action plan
            grades risk




                                                                            Reports if
                                                                            appropriate to:
                                          Reports to
                                          MHRA,                             MHRA
                                          RIDDOR,                           NRLS
                                          If appropriate                    Police
                                                                            *and other
                                                                            appropriate external
         Incident rated                                                     bodies
         Non-serious

                                                                                                        CE               Director co-
                                                                               Appropriate              informed        ordinates team
                                                                               Director                                      and
                                                                               informed                                 communication
                                                                                                        Comms
                                                                                                        Manager
                                                                                                        informed
                                                                               Non Clinical




       START HERE                                   Line Manager
                               Incident            contacts General               Director          Director                            Final
       Staff complete          rated               Manager, who in                 Lead             requests                          incident
       Incident Report         serious               turn contact                identified         advice on                          report
       Form (paper or                                Associate or                                   STEIS\NRLS                       signed off
       Datix) and pass                                 Assistant                                    report                           & incident
       to Line Manager                             Director. AD to                                                                     closed
       immediately                                   notify their                 Clinical
                                                       director




                                                                                                                         Agreed Lead
                                                                                                    CE                      Director
                                                                                                    informed              coordinates
                                                                               Lead
                                                                                                                         investigation
                                                                               Director
                                                                                                                           team and
                                                                               &
                                                                                                                        communication
                                                                               Medical              Comms
                                                                               Director             Manager
                                                                               informed             informed
                                                                               Agree
                                                                               who is the
                                                                               lead
                                                                               director


                                                                         Reports if
                                                                       appropriate to:
                                                                                                               * If out of working hours
                                                                         MHRA                                  please contact the on-call
                                                                         NRLS
                                                                         Police                                       manager on
                                                                         STEIS                                       0161 276 6246
                                                                        and other
                                                                   appropriate external
                                                                         bodies




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                                                                        APPENDIX 4

             Reporting Structure for Committees and Groups




                                  Governance Committee


       Clinical Governance Group                      MCH Governance Sub-Group



                                                          MCH Safety Group




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                                                                                                        APPENDIX 5
SIMPLE RISK QUANTIFICATION
Risk management defines risk as “the chance of something that will have an impact on objectives. It is
measured in terms and consequences and likelihood”.

A simple approach to quantifying risk is to define qualitative measures of consequences and likelihood such as
the exemplars given below. This allows construction of a risk matrix, which can be used as the basis of
identifying acceptable and unacceptable risk.


                                                              Organisational/
 Score and                                 Personal
                   Risk to patients                           Financial                     Reputation / Publicity     Score and Probability
 Descriptor                                Injury
                                                              Impact


                                                                                            International adverse
                                                              Entire Trust unable to
                                                                                            publicity / reputation     5 Almost certain
                                           Death              function for sustained
                 Death                                                                      irreparably damaged.         Is expected to
 5. Catastrophic                           Multiple           period. Interruption to all
                 Multiple fatalities                                                        CEO or ministerial           occur in most
                                           Death              Trust activity. Huge
                                                                                            resign / removal             circumstances
                                                              financial loss


                                           HSE defined
                   Extensive injuries.                        Major part of the Trust                                  4 Likely
                                           major injury
                   Permanent severe                           unable to function for        Adverse national             Will probably occur
 4. Major                                  inc
                   outcome to multiple                        sustained period. Major       publicity                    in most
                                           amputation,
                   patients                                   financial loss                                             circumstances
                                           fracture

                   Permanent service
                                                              Suspension of some
                   out come to single      Serious injury                                                              3 Possible
                                                              operational activity for      >3 days local media
 3. Moderate       patient. Severe         to one or more                                                              Might occur at
                                                              sustained period. High        publicity
                   recoverable injuries    persons                                                                     some time
                                                              financial loss
                   to multiple patients

                                                              Suspension of some
                                                              operational activity for
                                         Minor injury to      limited period.                                          2 Unlikely
                   Minor injuries to one                                                    <3 days local media
 2. Minor                                one or more          Disruption of some                                         Could occur at
                   or multiple patients                                                     publicity
                                         persons              activity for sustained                                     sometime
                                                              period. Medium
                                                              financial loss


                                                              Disruption of some                                       1 Rare
                                                              activity for limited                                       May occur only in
 1. Insignificant No injuries              No injuries                                      Not Applicable
                                                              period. Low financial                                      exceptional
                                                              loss                                                       circumstances




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                         Likelihood
                       Rare           Unlikely           Possible   Likely               Almost
                        1                2                  3         4                  Certain
                                                                                           5

1                     1 Low             2                   3         4                   5
Insignifi                              Low                 Low      Medium              Medium
cant


2                       2               4                   6         8                    10
Minor                  Low            Medium              Medium     High                 High


3                       3               6                   9         12                  15
Moderat                Low            Medium               High      High               Ex High
e


4                      4                8                   12        16                  20
Major                Medium            High                High     Ex High             Ex High


5                      5                10                  15        20                  25
Catastro             Medium            High               Ex High   Ex High             Ex High
phic

Consequence




Classified                                              Action
Extremely High
                                                        Stop
                                                        Avoid
                                                        Act now
                                                        Transfer

High
                                                        Reduce
                                                        Transfer
                                                        Accept
                                                        Avoid

Medium
                                                        Reduce
                                                        Accept

Low
                                                        Accept




Incident Reporting & SUI Policy          Page 40 of 57              Christine Garratt & Judith Strobl
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                                                                APPENDIX 6

Summary of Guidelines for Investigation following an Incident


                                  INCIDENT OCCURS

(1)     If the incident meets the criteria of a Serious Untoward Incident (SUI),
         notify your line manager by telephone (or On-Call Manager if OOH)*
         Complete an Incident Form within 24 hours or as soon as possible
         thereafter.

(2)           Line Manager grades the level of risk for the incident
  (This includes incidents notified by telephone) Please note, any incident
 graded moderate, and involved in causing serious injury or permanent
           harm, should be considered for a root cause analysis.

(3)      If the incident is an SUI or scores 15-25, the Director must be notified




(4) To assist managers with the investigation process, and to
    decide the depth of investigation that is appropriate to the
    event, the NPSA have produced a series of tools:-

       Incident Decision Tree
       Triggers for root cause analysis investigation
       Three levels of root cause analysis investigation – guidance


        All three documents are available from the National Patient
        Safety Agency web site (see below) or the Operational Risk
        Manager

        www.npsa.nhs.uk/nrls
        Go to resources and select Toolkits
        Select from Root Cause Analysis reporting tools and
        templates, which also includes RCA investigation tools –
         Guidance (Triggers)
        Alternatively select the Incident Decision Tree




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                                                                         APPENDIX 7

Guidance on writing a statement for formal purposes
These notes have been prepared to assist staff in writing a statement. It is important
to note that statements will form part of a claims file and will be made available to the
NHS Litigation Authority, Legal representatives and the Court.

    1. You must assume that the reader of your statement knows nothing of the
       facts of the case, including the patient‟s medical history or community/hospital
       routines. The statement will need to tell a lay person the circumstances of an
       incident as you remember them.

    2. If you cannot remember much about the particular patient or situation, say so.
       It may help to refresh your memory by referring to the patient‟s records before
       writing the statement.

    3. The statement must be typed.

    4. Begin your statement by stating your name, post held and base.

    5. Be clear about the times you were on/off duty on the days in question and
       about what you saw and heard. Put events in the order in which they
       happened giving precise dates and times. It is important that you differentiate
       between day and night by using the 24-hour clock. If the incident occurred
       during a night shift, ensure you refer to the correct date.

    6. When describing service procedures explain what they are. Avoid general
       statements such as “routine observations were made”. If normal procedures
       were not followed explain first what is normal and then why there was a
       departure from the usual procedure.

    7. Avoid abbreviations. If you have used abbreviations in the patient‟s records,
       explain what it means in your statement. Always refer to the patient by their
       full name, e.g. Mrs Clarke.

    8. When referring to other people be precise and give their full names, grades
       and job titles. For example, the title of “DN” is not sufficient; you must put the
       “district nurse” (and give the name).

    9. Always stick to facts and avoid expressing opinions. Do not “repeat rumours”,
       only give first hand accounts. Do not use derogatory or detrimental
       comments.

    10. Write your statement in simple terms and avoid jargon or officious language;
        be as brief as possible whilst covering essential points.

    11. Double-check your statement before signing it. Make sure you keep a copy
        as you might be required to give additional information.

    12. You should advise your line manager that you have been requested to give a
        statement and they will be able to give you support and advice.

    13. Always sign your statement and give your full name and job title below your
        signature, together with the date on which it was signed.


Incident Reporting & SUI Policy    Page 42 of 57                Christine Garratt & Judith Strobl
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                                                             APPENDIX 8

Supporting Staff following Traumatic or Stressful Incidents


In line with NHS Litigation Authority requirements under the Risk
Management Standard for Primary Care Trusts – a new Procedure Note
document on “Supporting staff following Traumatic or Stressful
Incidents.” Until the guidance document is introduced, staff can get help
and support from Occupational Health.

The object of this procedure, is to recognise that when involved in traumatic
or stressful incidents, the usual mechanisms of the MPCT may not be
sufficient, and that additional support may need to be sought from external
agencies.

The procedure note will also seek to advise staff and mangers of how to
proceed when allegations have been made against them in
complaints/claims, and what to do when called upon to attend Court
(including the Coroner‟s Court).




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                                                             APPENDIX 9

Reporting of Incidents, Diseases and Dangerous
Occurrence Regulations (RIDDOR) (1995)
MPCT has a duty to report to the Health and Safety Executive, any Injury,
Disease or Dangerous Occurrence, as laid down in the Regulations (1995).
Whenever MPCT receives notification of an incident which falls into a
RIDDOR category, the HSE Incident Contact Centre at Caerphilly, must be
notified. The most common incident type, that has to be reported is when a
member of staff is absent for 3 days or more. In this instance the report must
be completed within 10 days. For any other category, the HSE web page can
be consulted or advice sought from the Operational Risk Manager or the
Health and Safety Advisor.

The Line Manager is responsible for completing the RIDDOR form and
submitting it to the Health and Safety Executive within the appropriate
time scale. A copy of the notification must then be sent to the
Operational Risk Manager.

The most common types of incidents that managers are likely to come across
are:-
      Lifting and Handling (Injury)
      Needlestick involving a patient with a known blood borne virus such
          Hepatitis or HIV (Dangerous Occurrence)
      Exposure to specified diseases, for example Tuberculosis or latex
           allergy (Disease)

These are just examples – managers should check the HSE web page for a
full listing.

Please be aware that if a member of staff is absent from work as a result of an
incident, the manager must check the length of absence in case it becomes
RIDDOR reportable at a later date.

Notification can be made by any of the following methods:-

         Telephone/Fax            Internet/E-mail            Post

Full details are available on the Health and Safety Executive web page
(www.hse.gov.uk). The HSE produce a leaflet which is specifically for
healthcare staff.


If you have any specific queries concerning RIDDOR, please contact the
Operational Risk Manager on 07968 901033, or the Health and Safety
Advisor on 07970 127981.




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                                                                              APPENDIX 10


Key Performance Indicators (to be reviewed every six months)


Key performance indicators will be used to measure the effectiveness of this
policy. The usefulness of these indicators will be reviewed by the Incident
Review Group on a quarterly basis, and updated to reflect the work of MPCT.



Key Area                          Details of KPI Target            Comments             Level of
                                                                                        Achievement
                                  Target Date:
                                                                                        Date:
INCIDENT REPORTING:               All Staff notifying line
Compliance with policy            manager and completing
and procedure                     incident form within stated
                                  timescales

INCIDENT REPORTING:               All Line Managers
Compliance with policy            providing feedback to staff
and procedure                     within the stated
                                  timescales
INCIDENT REPORTING:               All Identified personnel
Compliance with policy            meeting all reporting
and procedure                     deadlines to external
                                  agencies (eg HSE)
INCIDENT REPORTING:               Line Managers applying
Compliance with policy            grades to reported
and procedure                     incidents and recording on
                                  the incident form
INCIDENT REPORTING:               Staff and Line Managers
Compliance with policy            notifying the Assoc
and procedure                     Director and/or the
                                  Operational Risk Manager
                                  for SUIs

INCIDENT REPORTING:               SUI investigation lead to
Compliance with policy            provide a final report, if the
and procedure                     investigation is completed,
                                  within 45 days
INCIDENT REPORTING:               All staff levels complying
Compliance with policy            with procedure for
and procedure                     responding to a SUI

INCIDENT REPORTING:               Target areas of under
Compliance with policy            reporting of incidents.
and procedure                     Target areas to be agreed
                                  with the Health and Safety
                                  Committee
INCIDENT REPORTING:               Induction training to all
Roll out training for Datix       new staff on how to report
Form DIF1                         an incident on Datix Form
                                  DIF1



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Ref No GEN006                                      v.2                        September 2009



INCIDENT REPORTING:               Induction training to all
Roll out training Datix           new line managers on
Form DIF2                         how to follow up incidents
                                  reported on Datix Form
                                  DIF1 & completing DIF2
INCIDENT REPORTING                Training Programme to be
Training Programme for            agreed
Incident Reporting




Incident Reporting & SUI Policy           Page 46 of 57        Christine Garratt & Judith Strobl
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                                                                       APPENDIX 11

                       LIST OF REPORTABLE INCIDENTS

The following is a list of reportable incidents (including those
which will be deemed as serious). This list is not exhaustive and
is here to serve as a guide.

Incident Type                     Category

Abuse                             Verbal
                                  Racial
                                  Gender
                                  Sexual Assault (actual and alleged)
                                  Sexual Harassment (actual and alleged)
                                  Bullying and Harassment
                                  Staff Attitude inappropriate
                                  Patient inappropriate behaviour

Admission/Discharge               Delay in admission
                                  Delay in discharge
                                  Transfer problems

Information                       Deliberate breach of patient confidentiality
Governance                        Accidental breach of patient confidentiality
                                  Document error
                                  Incorrect information given (verbal or written)
                                  Records misfiled
                                  Records missing
                                  Records unavailable when needed
                                  Patient/staff records destroyed/damaged/stolen

Slips/Trips/Falls                 Fall from height (over 2 metres /6ft 6in)
                                  Suspected unobserved fall
                                  Witnessed fall
                                  Collapse
                                  Slip due to poor condition of flooring
                                  Slip due to wet floor (rain / domestic cleaning)
                                  Trip due to obstruction
                                  Trip due to poor condition of flooring

Fire                              Failure of fire detection system
                                  False fire alarm
                                  False fire alarm – intentional
                                  Rubbish bin fire
                                  Electrical fire
                                  Fire – cause unknown
                                  Arson

Home Oxygen                       Compromised supply of oxygen
                                  Delayed discharge/inappropriate readmission to
                                  hospital


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                                  Health and safety incidents, including fire
                                  Compromised care, including distress to service users
                                  and their carers
Infection Control                 Contact with needlestick/sharps – clean
                                  Contact with needlestick/sharps – dirty
                                  Clostridium Difficile infection
                                  Healthcare associated infection
                                  Hospital acquired infection
                                  Infection risk
                                  MRSA Bacteraemia
                                  TB
                                  Contact with bodily fluid
                                  Clinical area not clean
Medication Errors                 Error ordering medication
                                  Failure to administer medication
                                  Wrong dose given
                                  Dose administered through incorrect route
                                  Medication administered to wrong patient
                                  Medication not supplied when patient discharged
                                  Patient refuses medication
                                  Records not up to date/illegible
                                  Incorrect label on medication
                                  Prescription error
Medical Devices                   Failure of a medical device
                                  Incorrect use of medical device
                                  Lack of training when using a medical device
Never Events                      Locally agreed – See Appendix 12
Property                          Vandalism to property
                                  Break –in to property
                                  Break-in and theft from property
                                  System break-down (eg telephones/electricity)
Standards of Care                 Inadequate supervision of patient
                                  Inadequate supervision of staff/students
                                  Failure to follow up arrangements
                                  Pressure Ulcers (hospital or community acquired)
                                  Equipment from Community Equipment Store not
                                  delivered or unavailable
                                  Results or samples lost
                                  Case load management
                                  Staffing levels
                                  Unable to provide care to patients with dignity/respect
Violence/aggression               Physical assault (actual or attempted)
                                  Injury whilst restraining
                                  Assault on patient/public on another patient/public
                                  Threatening behaviour
                                  Presence of weapons
Death                             Unexpected Death




Incident Reporting & SUI Policy         Page 48 of 57               Christine Garratt & Judith Strobl
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                                                               APPENDIX 12
NEVER EVENTS

Surgical events:

    1. Surgery performed on the wrong part of the body
    2. Surgery performed on the wrong patient
    3. Wrong surgical procedure performed on a patient
    4. Unintended retention of a foreign object in a patient after surgery or
       other procedure
    5. Intra-operative or immediately post-operative death in an ASA Class I
       patient
    6. Artificial insemination with the wrong donor sperm or donor egg

Product or device events:

    7. Patient death or serious disability associated with the use of
       contaminated drugs, devices, or biologics provided by the healthcare
       facility
    8. Patient death or serious disability associated with the use or function of
       a device in patient care, in which the device is used or functions other
       than as intended
    9. Patient death or serious disability associated with intravascular air
       embolism that occurs while being cared for in a healthcare facility

Patient protection events:

    10. Infant discharged to the wrong person
    11. Patient death or serious disability associated with a patient absconding
        (disappearance)
    12. Patient suicide, or attempted suicide resulting in serious disability, while
        being cared for in a healthcare facility

Care management events:

    13. Patient death or serious disability associated with a medication error
        (e.g., errors involving the wrong drug, wrong dose, wrong patient,
        wrong time, wrong rate, wrong preparation or wrong route of
        administration)
    14. Patient death or serious disability associated with a hemolytic reaction
        due to the administration of ABO/HLA-incompatible blood or blood
        products
    15. Maternal death or serious disability associated with labour or delivery in
        a low-risk pregnancy while being cared for in a health care facility
    16. Patient death or serious disability associated with hypoglycemia, the
        onset of which occurs while the patient is being cared for in a
        healthcare facility




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    17. Death or serious disability (kernicterus) associated with failure to
        identify and treat hyperbilirubinemia in neonates
    18. Stage 3 or 4 pressure ulcers acquired after admission to a healthcare
        facility
    19. Patient death or serious disability due to spinal manipulative therapy
    20. Patient death or serious disability due to exposure to known allergen
        while the patient is being cared for in a healthcare facility

Environmental events:

    21. Patient death or serious disability associated with an electric shock
        while being cared for in a healthcare facility
    22. Any incident in which a line designated for oxygen or other gas to be
        delivered to a patient contains the wrong gas or is contaminated by
        toxic substances
    23. Patient death or serious disability associated with a burn incurred from
        any source while being cared for in a healthcare facility
    24. Patient death or serious disability associated with a fall while being
        cared for in a healthcare facility
    25. Patient death or serious disability associated with the use of restraints
        or bedrails while being cared for in a healthcare facility
    26. Patient death or serious disability associated with food-poisoning while
        cared for in a healthcare facility

Criminal events:

    27. Any instance of care ordered by or provided by someone
        impersonating a physician, nurse, pharmacist, or other licensed
        healthcare provider
    28. Any instance of care ordered by or provided by a health professional
        currently not registered with the appropriate professional body where
        such a registration would be expected
    29. Abduction of a patient
    30. (Alleged) sexual assault on a patient [or member of staff] within or on
        the grounds of the healthcare facility
    31. Death or significant injury of a patient or staff member resulting from a
        physical assault that occurs within or on the grounds of the healthcare
        facility




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                                                                APPENDIX 13

Investigation of a Serious Untoward Incident (SUI)

Incidents which meet the designated criteria or score a risk level of 15-25
are classed as Serious Untoward Incidents (SUI), and must be dealt with by
senior management within the MPCT.

Summary of Procedure:-

        Incident occurs and is responded to by the member of staff and
         notified to their line manager .

        Line manager confirms the incident meets SUI criteria or scores a
         risk level of 15-25, and notifies general manager or equivalent and
         the appropriate Associate Director

        The Director is informed, who will make the final decision to proceed
         with full Root Cause Analysis investigation.

        If the SUI is a potential clinical event the Director will liaise with
         the Medical Director for a final decision, and agree who will be
         lead director.

        Director (or designated investigation lead) to notify Operational Risk
         Manager for entry on to the StEIS system for the Strategic Health
         Authority, and subsequent reports until the incident is closed.

        The Lead Director will notify the Chief Executive and Head of
         Communications and authorise an Associated Director or suitably
         experienced staff member to act as the Investigation Lead.

        The Director issues terms of reference for the investigation.

         The investigation lead will identify staff for the investigation team.

        If appropriate to the incident, the lead investigator should liaise with
         the Emergency Planning Officer, in order to activate the “hot line”, to
         enable the public to call the PCT for information.

        The investigation lead to ensure that the Director/Chief Exec/Board
         are kept briefed of progress throughout the investigation

        Investigation lead to provide updates, as appropriate to the
         Operational Risk Manager, for updating the StEIS system

        Once the investigation is completed (using the NPSA Root Cause
         Analysis tools – see Appendix 6), the final report of the team‟s



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Ref No GEN006                               v.2                             September 2009




         findings and recommendations will be submitted to the Governance
         Committee, and the MCH Governance Sub-Group if applicable.

        The Director is responsible for ensuring that identified learning is
         shared across the organisation

        Each Directorate responsible for implementing lessons learned, and
         where appropriate, changing practice.




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                                                            APPENDIX 14

BEING OPEN GUIDANCE NOTE

The PCT is committed to the principles of being open and honest with
patients who may have been involved in a safety incident.

Being open simply means apologising and explaining what happened to
patients, and/or their carers, who have been involved in a patient safety
incident.

Communicating effectively with patients and /or carers is a vital part of the
process of dealing with errors or problems in their treatment. In doing so,
NHS organisations can mitigate the trauma suffered by patients and
potentially reduce complaints.

The Department of Health‟s 2003 Making Amends consultation document
states, “The individual who has suffered harm as a result of the healthcare
they have received must get an apology”.

It is not a requirement of this guidance note to communicate patient safety
incidents that we prevented, or “no harm” incidents to patients and/or their
carers. The decision to do this will depend on local circumstances, and the
lead director or senior manager responsible for the investigation and/or
investigation team will need to consider the advantages of discussing these
incidents with patients. Benefits include raising awareness of incidents
amongst patients and/or their carers so that they can intervene to prevent
similar incidents happening again.

For low harm incidents, an apology and explanation should be given by
staff providing care locally. For serious patient safety incidents, a suitably
trained member of staff should seek and maintain communication with
affected patients and/or carers. It may be preferable for this person to be
different from the investigator.

Practitioners involved in communicating with patients and/or carers should
to be trained in doing so. Training for key senior staff is offered, but it is
also available through the NPSA website:
http://www.npsa.nhs.uk/patientsafety/improvingpatientsafety/beingopen/


National Patient Safety Agency quick reference guide to being open

Apologising and explaining when patients have been harmed can be very
difficult. You may have already considered some or all of the
recommendations below, but this guide will help ensure that you follow best
practice.



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Ref No GEN006                              v.2                           September 2009




Patients and/or their carers should receive an apology as soon as possible
after a patient safety incident has occurred and staff should feel able to
apologise on the spot. Saying sorry is not an admission of liability and it is
the right thing to do. Patients have a right to expect openness in their
healthcare.



Stage 1: Preliminary meeting with the patient and/or their carer

Who should attend?
   A lead staff member who is normally the most senior person
     responsible for the patient‟s care and/or someone with experience
     and expertise in the type of incident that has occurred.
   Ensure that those members of staff who do attend the meetings can
     continue to do so; continuity is very important in building
     relationships.
   The person taking the lead should be supported by at least one
     other member of staff, such as the nursing or medical director, or
     member of the healthcare team treating the patient.
   Ask the patient and/or their carers who they would like to be present
   Consider each team member‟s communication skills; they need to
     be able to communicate clearly, sympathetically and effectively.
   Hold a pre-meeting amongst healthcare professionals so that
     everyone knows the facts and understands the aims of the meeting.

 When should it be held?
   As soon after the incident as possible
   Consider the patient‟s and /or their carer‟s home and social
     circumstances
   Check they are happy with the timing.
   Offer them a choice of times and confirm the chosen date in writing.
   Do not cancel the meeting unless absolutely necessary.

Where should it be held?
   Use a quiet room where you will not be distracted by work or
     interrupted.
   Do not host the meeting near to the place where the incident
     occurred if this may be difficult for the patient and/or their carers.


Stage 2: Discussion

How should you approach the patient and/or their carers?
   Speak to the patient and/or their carers as you would want someone
     in the same situation to communicate with a member of your own
     family.
   Do not use jargon or acronyms: use clear, straightforward language.




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        Consider the needs of the patients with special circumstances, for
         example linguistic or cultural needs and those with learning
         disabilities.

What should be discussed?
   Introduce and explain the role of everyone present to the patient
     and/or their carers and ask them if they are happy with those
     present.
   Acknowledge what happened and apologise on behalf of the team
     and the organisation; Expressing regret is not an admission of
     liability;
   Stick to the facts that are known at the time and assure them that if
     more information becomes available, it will be shared with them.
   Do not speculate or attribute blame.
   Suggest sources or support and counselling
   Check they have understood what you have told them and offer to
     answer any questions.
   Provide a named contact who they can speak to again.


Stage 3: Follow-up

        Clarify in writing the information given, reiterate key points, record
         action points and assign responsibilities and deadlines.
        The patient‟s notes should contain a complete, accurate record of
         the discussion(s), including the date and time of each entry, what the
         patient and/or their carers have been told, and a summary of agreed
         action points.
        Maintain a dialogue by addressing any new concerns, share new
         information once available and provide information on counselling as
         appropriate.


    This quick reference guide is available to download as a separate
    document at www.npsa.nhs.uk/advice.


    If a patient feels that they need further information or support, they
    should be provided with contact details for the Patient Advice Liaison
    Service (PALS). See appendix 15 for contact details.




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                                                                          APPENDIX 15
        Details of useful staff contacts

Title                          Name            Service         Tel        Email
                                                               No
On-call Manager                OUT OF          5.00pm –        276        Not Applicable
                               HOURS           9.00am          6246
Operational Risk               Christine       Corporate       765        Christine.garratt@manc
Manager & MDLO                 Garratt         Governance      4171       hester.nhs.uk
                                               & Risk          07968-
                                               Team            901033
Health and Safety              Maureen         Corporate       765        Maureen.karmouta@ma
Advisor                        Karmouta        Governance      4173       nchester.nhs.uk
                                               & Risk
                                               Team
Complaints & PALS              Mark Carroll    Customer        219        Mark.carroll@manchest
Manager                                        Experience      9493       er.nhs.uk
                                               Team
Child Health                   Jeannette       Child Health    958        Jeannette.Beckett@man
Manager                        Beckett         Department      4090       chester.nhs.uk
Head of                        Tim             Communica       958        Tim.seamans@manche
Communications                 Seamans         tions Team      4123       ster.nhs.uk
Communications                 Karen           Communica       958        Karen.moore@manches
Manager                        Moore           tions Team      4148       ter.nhs.uk
Ass Director of                Karen           Commission      958        Karen.obrien@manches
Primary Care                   O‟Brien         ing             4023       ter.nhs.uk
Commissioning                                  Directorate
Infection Control              Leasa           Public          946        Leasa.benson@manche
Team                           Benson          Health          8242       ster.nhs.uk
                                               Directorate
Facilities General             David           Facilities      958        David.mcgarrigan@man
Mgr                            McGarrigan      Division        4047       chester.nhs.uk
Head of Clinical               Andrea          Manchester      219        Andrea.allcock@manch
Gov. (MCH)                     Allcock         Community       9419       ester.nhs.uk
                                               Health
Head of Clinical               Kim Gordon      Medical         217        Kim.gordon@manchest
Governance                                     Directorate     4445       er.nhs.uk
(Commissioning)
Occupational Health            Duty staff      Occupation      998
                                               al              7070
                                               Health          795
                                                               4567
Public Health                  Judith Strobl   Medical         217        Judith.strobl@manchest
Consultant                                     Directorate     4340       er.nhs.uk
Medical Director               Radjan          Medical         217        Rajan.madhok@manch
                               Madhok          Directorate     4339       ester.nhs.uk
Risk & Comp Admin              Vacant          Corporate                  datix@manchester.nhs.
(Datix)                                        Gov & Risk                 uk
                                               Team
Info Governance                Vacant          Corporate                  IG.Team@manchester.n
Manager                                        Gov & Risk                 hs.uk
                                               Team
Director of Finance            Vacant          Finance
                                               Directorate
Security                       Nick Brice      Facilities      958        Nick.brice@manchester.
Management                                     Division        4027       nhs.uk



        Incident Reporting & SUI Policy        Page 56 of 57            Christine Garratt & Judith Strobl
      Ref No GEN006                                 v.2                          September 2009



Fire Safety Manager          David         Facilities      958      David.mcgarrigan@man
                             McGarrigan    Division        4047     chester.nhs.uk
Local Counter Fraud          James         Internal        455      James.meadowcroft@d
Specialist                   Meadowcroft   Audit c/o       6715     eloittes.co.uk
                                           Finance
Chair of JCNC                Margaret      Community       205      Margaret.koller@manch
                             Koller        Practitioner    5063     ester.nhs.uk
Unison Convenor              Katy Legg     Information     237      Katy.legg@manchester.
                                           Directorate     2780     nhs.uk




      Incident Reporting & SUI Policy      Page 57 of 57          Christine Garratt & Judith Strobl

								
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