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Incident Reporting Policy _Including Serious Untoward Incidents_

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					       Incident Reporting Policy
(Including Serious Untoward Incidents)




Lead Person: Clinical Governance/Risk Manager




                           Date Printed: July 2004

                         Date Reviewed:July 2005
              Birkenhead and Wallasey Primary Care Trust

                          Incident Reporting Policy
                   (Including Serious Untoward Incidents)

Contents                                                         Page
Policy Statement                                                  1
Legal Requirements and Guidance                                   1
Definitions                                                       2
Risk Profile matrix-consequence                                   3
Risk Profile matrix-likelihood                                    3
Incident Management Matrix                                        5
Senior Managers Responsibilities                                  9
Line Managers Responsibilities                                   10
Employees’ Responsibilities                                      11
Training Requirements                                            11
Health & Safety Advisor’s Responsibilities                       12
Local Security Management Specialist                             12
Finance Department Responsibilities                              13
Head of Corporate Services & Communication Responsibilities      13
Clinical Governance/Risk Manager’s Responsibilities              14
Incident Information Co-ordinator’s Responsibilities             14
Safety Alert Broadcast System Liaison Officer’s Responsibility   14
Health & Safety Committee Responsibilities                       15
Weekly Risk Management Group                                     15
Serious Untoward Incidents & Complaints Review Group             15
Root Cause Analysis Group                                        15
Risk Sub Committee Responsibilities                              16
Occupational Health Department Responsibilities                  16
Staff Support Services Responsibilities                          16
Referral to Disciplinary Process                                 17
Serious Untoward Incidents                                       17
Document on Data Control                                         17
Accident/Incident Reporting Form                     Appendix 1
Accident/Incident Report – Witness Statement         Appendix 2
Accident/Incident Management Protocol                Appendix 3
Reporting of Incidents to Relevant External Bodies   Appendix 4
Media Policy                                         Appendix 5
RIDDOR                                               Appendix 6
Risk Management Process                              Appendix 7
Root Cause Analysis Procedure                        Appendix 8
Useful contacts                                      Appendix 9
BIRKENHEAD & WALLASEY PRIMARY CARE TRUST (P.C.T.)
            INCIDENT REPORTING POLICY
        (Including Serious Untoward Incidents)
1.0 POLICY STATEMENT

Birkenhead & Wallasey Primary Care Trust will ensure that all accidents and incidents
are formally documented and thoroughly investigated. Remedial action will be based on
the investigation findings and recommendations. The goal will be to promote the
prevention of injury, loss and damage through the development of safer working
practices that will benefit all. The thrust of reporting and investigation procedures is to
promote safety performance not to apportion blame.

This policy relates to employed staff of Birkenhead & Wallasey, however in line with the
Risk Management Strategy independent contractors will be supported and encouraged
to report incidents through a centralised system to enable them as independent
contractors and the PCT an opportunity to consider trends and eliminate risks which are
occurring on a regular basis. To support this, the policy will be reviewed on a regular
basis to enable further discussion with independent contractors as to the best way
forward. In the event of a serious untoward incident both employed staff and
independent contractors are required to report centrally through StEIS, which is
managed by the PCT as outlined in the matrix.

2.0 LEGAL REQUIREMENTS AND GUIDANCE

Health & Safety at Work Etc. Act 1974
Management of Health and Safety at Work Regulations 1992
Reporting of Injuries, Diseases and Dangerous Occurrences Regulations RIDDOR 1995
Standing Financial Instructions
Losses and Special Payments Guidance FDL (98) 02
Social Security (Claims and Payments) Regulations 1979
Clinical Negligence Scheme for Trusts (CNST) Standards
Controls Assurance Standards (RPST)
DOH Reporting Guidance for Serious Untoward Incidents
National Patient Safety Agency Guidance
Strategic Executive Information System Guidance (StEIS)
CHI — Advice for the NHS Establishing and running rapid response NHS help lines
Management of Fire & Health Care Practices
Code of Conduct
Root Cause Analysis Procedure
Freedom pf Information Act
Health Records Policy
Counter Fraud and Security Management Services Guidelines (CFSMS)
Making it work – Guidance for Clinical Governance/Risk Managers on Designing &
Using a Risk Matrix (HCSU)

                                                                                         1
Major Incident Plan
Alert Cascade Procedure



3.0 DEFINITIONS

3.1.1 Accident/Incident — Any event that occurs which results in (or has the potential
      to result in) damage, loss or harm, to persons, property, equipment, assets etc.
      Serious untoward incidents are those defined in the incident management matrix
      and are subject to additional reporting requirements as described in the matrix.
      This is also summarised in the matrix within the document.

3.1.2 Clinical Event — An untoward clinical event is any occurrence involving the
      patient/client, resulting in (or with the potential to result in) an adverse patient
      care outcome.

3.1.3 Non Clinical Event — Any other type of event which results in (or has the
      potential to result in) loss, damage, injury or harm.

3.2    Near Miss — Any event that occurs that does not result in loss, damage or injury
       but had the potential to do so.

3.3    Hazard — Anything with the potential to cause harm, loss, damage or injury.

3.4    Risk — The likelihood of harm, loss, damage or injury occurring.

3.5    Risk Profile — The relationship between the hazard, the risk and the severity of
       the outcome of the accident/incident. The risk profile is graded on a risk matrix,
       which is shown in 3.6.




                                                                                             2
3.6    Grading of Incidents – Should occur as soon as possible after the incident and a
       review of grading should take place after the investigation has concluded.

       a) Risk Profile Matrix Consequence


 Risk Rating         1              2                    3                          4                       5
  Grading         Minimal         Low               Moderate                      Major              Catastrophic
Description    No injury    No medical       Medical treatment            Attempted suicide     Death
               Minimal      treatment or     required                     Serious injury        Severe loss of
               financial    intervention     Reduced capacity to          Serious property      confidence in the
               impact       required         deliver service(s)           damage                organisation
               No service   First Aid        Admission of suicidal        Litigation/Major      Extended service
               disruption   treatment        intent/self harm             financial loss/cost   closure substantial
                            delivered        Litigation                   >£500k-£1m<           disruption of service
                            Minimal or no    High financial               Increased length      provision
                            disruption to    loss/cost £500k              of stay and           Extensive Injuries
                            service          Moderate impact on           increased level of    Litigation >£1m
                            delivery         length of stay/level of      care National         Substantial financial
                            <£50k>           care Local Adverse           adverse publicity     impact
                            Litigation/      publicity/moderate           Major loss of         International/national
                            Low medium       loss of confidence in        confidence in the     adverse publicity
                            financial loss   the organisation             organisation
                            or cost                                       Temporary
                            Minor impact                                  service closure
                            on length of
                            stay/level of
                            care


         b) Risk Profile Matrix Likelihood

 Risk Rating            1                2               3                     4                        5
  Grading             Rare            Unlikely        Possible               Likely              Almost Certain
 Description    The event may      The event       The event           The event is        The event will occur
                only happen in     could occur     may well            expected to         (recur) in most
                exceptional        (recur) at      occur (recur)       occur (recur) in    circumstances
                circumstances      some time       at some time        most
                                                                       circumstances

The greater the risk rating value, the greater the risk issue for the Trust and the more
detailed the risk management response required.

The measuring of severity and likelihood are then multiplied to provide the Risk
Grading.




                                                                                                             3
Risk Rating Chart

Likelihood of                              Risk Level/Consequence and Weighting
Reccurrence
                       Catastrophic        Major           Moderate         Low             Minimal
                           (A)              (B)              (C)             (D)              (E)
Almost certain (5)   25               20              15               10               5
Likely (4)           20               16              12               8                4
Possible (3)         15               12              9                6                3
Unlikely (2)         10               8               6                4                2
Rare (1)             5                4               3                2                1

Risk Profile Grading Level/Management of Risk

In terms of grading the risks the following categories are then applied.

□ Green                                       Managed by Service Area

□ Amber                                       Managed by Senior Managers

□ Red                                         Managed by Director Level
                                              Immediate Action required (see Incident
                                              Management Matrix)

All incidents graded 1-14 will be recorded on the Service Area Risk Register
All incidents graded 15 and above will be recorded on the Corporate Risk Register




                                                                                              4
3.7        Accident/Incident Management Protocol – The action to be taken will be related
           to the risk profile grading level.

           (c) Incident Management Matrix

This matrix should be used to guide staff on how to manage an incident as it occurs.

Incident        Definition            NHS                Other               Review             Investigation
Type            Examples              Notification       Notifications &                        Procedure
                (Guidance)            (immediate)        Management
                                                         issues (Good
                                                         Communications
                                                         should be
                                                         between)
Catastrophic                          External:          Service             Root Cause         Identification of
    (A)         Extreme sustained                        Manager (GP-        Analysis           competent lead
                disruption to         Department of      Consultant)         Review may be      investigation
Red             objectives/           Health             Relatives/carers/   convened by PCT    manager –
                business of                              Staff prior to      Board              Trained in Root
                organisation          NPSA               media – As          Refer to Route     Cause Analysis –
                Unexpected death                         appropriate         Cause Analysis     See Appendix on
                of a patient under                       Police              Procedure          Procedure on
                direct care of a                         External                               Root Cause
                health care                              Agencies as                            Analysis
                professional          Strategic Health   appropriate                            Full and thorough
                Unexpected death      Authority via                                             investigation of
                of a patient on GP    StEIS                                                     circumstances of
                premises or other                                            Post Incident      event
                health care           Independent        Other PCTs &        review will be     Preparation of
                premises              Contractors        Trusts              convened by        investigation
                Known or              (where             Social Services     relevant service   report indicating-
                suspected             appropriate)       MHRA                area               Timetable for
                healthcare                               HSE                                    implementation of
                associated                               Area Child                             remedial action
                infection which                          Protection                             Improvement
                may result in death                      Committee                              monitoring
                eg hospital                              Public Health                          mechanisms
                acquired              Internal           Laboratories                           Report concerns
                legionellossis                           Legal Advisors                         & action plan to
                Suicide (sudden       PCT Board          Also remember                          PCT Board
                death)                CE/Exec on call    staff support
                Attempted                                issues
                Homicide causing
                bodily harm, injury   Service Manager
                eg shooting           Clinical
                Stabbing              Governance/Risk
                Rape                  Manager
                Death due to
                medication error
                Death due to          Head of
                neglect               Corporate
                Death due to          Services and
                patient abuse         Communication
                Sudden                GP (where

                                                                                                       5
        Unexpected Death       appropriate)
        Infancy (SUDI)*
        “Rogue” staff
        including staff
        without appropriate
        qualifications
        Serious Infection
        Control Event
Major   Serious disruption     External           Relatives/Carers
 (B)    to                                                            Internal Review    Clarification &
        objectives/business                                           may be convened    review of event
Red     of organisation                                               by PCT Board       circumstances
        Major or               NPSA                                                      Develop & deliver
        permanent harm                                                                   appropriate
        including              Strategic Health   Also remember                          remedial action
        procedures             Authority via      staff support                          recommendations
        involving wrong        StEIS (most        issues                                 Monitor event
        patient or body part   serious only)                                             trends
        Retained                                                                         Report concerns
        instruments or                            Again all           Post incident      & action plan to
        other material after                      informed prior to   review will be     PCT Board
        surgery requiring                         media               convened by
        reoperation                               involvement         relevant service
        Known or               Internal                               area
        suspected case of
        health associated      PCT Board
        infection which        CE/Exec on call
        may result in major
        permanent harm
        eg Hep.C
        Infant abduction or
        discharge to wrong     Service Manager
        family
        Attempted Suicide      Clinical
        – act time so          Governance/Risk
        intervention in        Manager
        unlikely,
        precautions taken
        to avoid being
        found, preparation,
        note left.
        Actual bodily harm
        Serious sexual
        assault
        Attempted rape
        Wrong medication
        given, wrong dose
        given, major
        adverse effects,
        possible
        hospitalisation
        Serious
        illness/injuries,
        hospitalisation due
        to abuse
        Fraudulent Activity

                                                                                               6
Moderate   Semi permanent                            Relatives/Carers   May be reviewed      Record event
  (C)      harm                                      Staff              by PCT Board         details
           Known care              Directorate                                               Review safety
 Amber     associated              Manager           External           Reviewed at          performance
           infection which                           Agencies as        Service Level        against policy,
           may result in semi      Service Manger    appropriate                             procedure &
           permanent harm                                                                    process
           Admission of                                                                      requirements
           suicidal intent. self                                                             Monitor event
           harm, alerted                                                                     trends
           helpers after act                                                                 Report policy,
           Verbalise homicidal                                                               procedure,
           intent                                                                            process
           Causing minor                                                                     shortcomings to
           injury                                                                            manager
           Medical errors                                                                    Take appropriate
           (wrong dose given,                                                                remedial action
           minor adverse
           effects)
           Sexual or racial
           harassment
           (groping touching)
           Serious accidental
           injuries
           Assaults causing
           injury
           Major property
           damage
           Obvious physical
           deterioration due to
           neglect, lack of
           fluids, food etc
           Sustained verbal
           abuse & physical
           intimidation
           Problems
           regarding consent
           to treatment
           Slips, trips, falls
           with injury
  Low      Non permanent                             Relatives/Carers   Most serious
  (D)      harm including                            Staff              incidents/repeated
           know or suspected                                            patterns may be
 Green     health care             Service Manager   External           reviewed by PCT
           associated                                Agencies as        Board or Service
           infection which                           appropriate        area
           may result in non
           permanent harm
           Verbalise suicidal
           intent
           Harbouring
           ideas/plans but no
           attempt made
           Violent attack – no
           injuries caused
           Continued sexual

                                                                                                   7
            harassment
            Wrong medication
            given, wrong dose
            given, wrong dose
            given with no ill
            effects
            Deterioration in
            condition due to
            neglect
            Slips,trips, falls
            which cause low
            injury
            Verbal Abuse

 Minimal    Near miss                Service Manager   Relatives/Carers
   (E)      Verbalise suicidal                         (if appropriate)
            intent
  Green     Verbalise threats to
            harm e.g punch
            Sexual remarks
            Wrong medication
            Wrong dose,
            noticed before
            administration
            Poorly identified
            physical/mental
            health needs of
            patient
            Slips, trips, falls no
            injury


*Sudden Unexpected Death Infancy (SUDI) refer to Merseyside Joint Protocol
Agency Protocol.

3.8    External Agencies/Personnel — These include bodies such as the Health and
Safety Executive, the Medical Health Care Regulatory Agency (MHRA), Local Authority,
Fire Services, Independent Contractors, NHS Direct, Police.




                                                                                   8
4.0   SENIOR MANAGERS RESPONSIBILITIES

4.1   Senior managers will be responsible for ensuring that their staff are fully aware of
      the procedures for reporting and formally recording all accidents and incidents
      that arise from the work activity.

4.2   Senior Managers will review all reports graded up to Amber Level (see incident
      management matrix) and will be responsible for the security of all documentation.

      a) Staff should be aware that in the event of Serious Untoward Incident
         contemporous record keeping is an essential component of incident
         management. In addition to informing patient/relatives/staff and the public of
         any incidents that involve them, all communications must be accurately
         documented.

      b) A lead investigating officer is identified who is fully conversant with
         investigation procedures, including root cause analysis and has relevant
         expertise in the area of work relating to circumstances of the incident. Refer
         to root cause analysis investigation team (Appendix 8).

      c) A full examination of the circumstances of the incident is undertaken and a
         report is prepared indicating the root cause/s of the event and identifying the
         remedial action.

      d) All evidence including witness statements, training records, risk assessment
         documentation, photographic material and equipment information is gathered,
         reviewed and kept secure as part of the investigation procedure.

      e) A management response is agreed and remedial action timetable is
         implemented.

      All Red graded incidents will be referred to Director level.

      They will be charged with the responsibility of ensuring that the action response
      promotes improved safety performance minimising loss, damage and injury.

      Trends will be monitored for all accidents/incidents and risk profile levels will be
      audited.

4.3   Senior managers must ensure that all levels of staff receive training appropriate
      to their responsibilities for accident/incident management and reporting.

4.4   Senior managers must ensure that, in the event of a serious accident/incident
      (graded red level), the Chief Executive Officer/Executive on call of the Trust is
      notified immediately.


                                                                                           9
4.5   If it seems probable that a serious adverse event may result in media interest,
      the Director of Communications or other Executive Director will ensure that
      patients and their families have been fully informed before the media.

4.6   All media enquiries must be referred to the PCT’s Public Relations experts
      through the switchboard. (Also refer to Media Policy Appendix 5).

4.7   If a serious clinical adverse event affects several patients or patient groups, local
      media may be used to alert the general public to the issue. This will be actioned
      only by an Executive Director and consideration will be given to implementing the
      major incident plan and/or the establishment of telephone advice/helplines.


5.0   LINE MANAGERS

5.1   Line managers must ensure that their staff report all accidents/incidents and the
      area is made safe and that calls are put through to other emergency services as
      appropriate. Other immediate actions line managers must take would include
      removing equipment from service, review of risk assessments, referral of staff to
      Occupational Health, taking witness statements, conduct incident investigation
      as soon as possible etc. Details should be recorded accurately and promptly on
      the PCT documentation (Appendix 1 and 2). The documentation must be
      forwarded within 5 days to the Incident Information Co-ordinator for processing
      within the PCT. Where the nature of the accident/incident involves serious injury,
      loss or damage managers will be responsible for immediately advising their
      manager and/or the on-call duty manager, the Health and Safety Advisor, Clinical
      Governance/Risk Manager, Local Security Management Specialist (LSMS) as
      appropriate.

      Line Managers will be responsible for ensuring that risk information is shared
      with all others who may be affected by the accident/incident. This may include
      staff from other organisations e.g. PCT, Social Services, Probation Services. A
      record of the information shared should be noted by the Line Manager. The
      Incident Information Co-ordinator will be responsible for formally sharing risk
      information with other organisations as appropriate.

5.2   Line Managers will be responsible for grading the risk profile of the incident,
      investigating and reviewing risk level, Amber level and below accidents/incidents.
      All Red/Amber incidents must be thoroughly investigated. This will be lead by
      Director or Senior Management.

      Line Managers will be responsible for clarifying and reviewing event
      circumstances, developing and delivering appropriate remedial action
      recommendations, monitoring event trends and ensuring appropriate debriefing
      support. Low risk events will be reviewed using the accident/incident
      management protocol (Appendix 3). Shortcomings identified in the systems,

                                                                                        10
      procedures and working practices will be subject to remedial action aimed at
      eliminating or minimising the likelihood of recurrence of such events.

5.3   Line managers will work closely with the Health and Safety Department Advisors,
      Clinical Governance/Risk Manager, the Security Advisor, other health specialist
      advisors and the Finance staff to ensure that accidents/incidents are effectively
      managed and appropriately investigated. Managers will be responsible for
      liaising with external agencies in particular circumstances and will be supported
      by the aforementioned Advisors and Finance staff as appropriate (appendix 4).
      Incidents involving medical devices will be managed in accordance with the
      Trust’s Management of Medical Devices Policy.

5.4   When an adverse event occurs involving a patient the line manager must inform
      the patient or carer, where appropriate, of the nature of the adverse event and
      any actions taken. The line manager is responsible for ensuring that the adverse
      event, side effects, injury and any treatment given are recorded in the patient
      records.


6.0   EMPLOYEES’ RESPONSIBILITIES

6.1   Employees have a responsibility to report any accident/incident they are involved
      in, or are aware of, to their manager IMMEDIATELY. This includes hazard
      concerns and near miss situations that have the potential to cause injury, loss or
      damage.

6.2   Employees will be required to co-operate fully with accident/incident investigation
      procedures providing written statements as appropriate to their involvement in
      the accident/incident event.

6.3   Employees may be supported by their Safety Representative throughout the
      accident/incident review process.

6.4   The Occupational Health Service will provide confidential care to staff. Staff
      support may provide input as required in Post Critical Incident Management.


7.0   TRAINING REQUIREMENTS

7.1   The Primary Care Trust will ensure that all staff are appropriately trained to
      enable them to carry out their responsibilities with regard to accident/incident
      management. Managers who are responsible for investigating the circumstances
      of accidents/incidents will be trained in investigation techniques (including root
      cause analysis skills) together with reporting and recording skills.




                                                                                      11
8.0   HEALTH & SAFETY ADVISOR’S RESPONSIBILITIES

8.1   The Health and Safety Advisor will manage health & safety accident/incident
      reports.

8.2   The Health and Safety Advisor will support managers in their investigation
      procedures and the development of post event action plans to promote safer
      working in relation to health & safety incidents/accidents.

8.3   Regular data reports will be prepared and shared with managers, the Health and
      Safety Committee and Safety Representatives.

8.4   The Health & Safety Advisor will manage compliance with the RIDDOR
      Regulations on behalf of the PCT. This will involve liaison with the Health &
      Safety Executive.

8.5   The Health & Safety Advisor will support training and other requirements arising
      from remedial action plans and strategic development plans.

8.6   The Health and Safety Advisor will support managers in their responsibilities to
      liaise with external agencies as required in particular circumstances e.g.
      reporting to Medical Health Care Regulatory Agency (MHRA).

       *See Management of Medical Devices Policy. Records of all external reports
      prepared by the Trust will be managed by the Health & Safety Department (see
      appendix 4).Managers must ensure that there is an identified deputy to
      undertake the reporting on their behalf during any period of the manager’s
      absence e.g. annual leave.

9.0   LOCAL SECURITY MANAGEMENT SPECIALIST

9.1   The Local Security Management Specialist will receive and manage security
      incident information.

9.2   The Local Security Management Specialist will support managers with security
      incident investigation and remedial action planning.

9.3   Regular data reports will be prepared and supplied to managers, the Health &
      Safety Committee and the PCT Board.

9.4   The Local Security Management Specialist will liaise with security staff, police,
      NHS Estates and others as appropriate (appendix 4).

9.5   The Local Security Management Specialist will support training initiatives arising
      from the remedial action plans and the strategic development plans.

                                                                                     12
10.0   FINANCE DEPARTMENT RESPONSIBILITIES

10.1   The Finance Department will receive and manage incident information detailing
       events that have or are likely to have a financial implication for the Trust.

10.2   Financial reports will be prepared and supplied to managers, Health and Safety
       Committee, PCT Board, auditors and appropriate external bodies (appendix 4).

10.3   The Finance Department will support training initiatives to enable the appropriate
       management and response to situations of loss and damage.


11.0   HEAD   OF     CORPORATE               SERVICES        AND      COMMUNICATION
       RESPONSIBILITIES

11.1   The Head of Corporate Services and Communication will ensure there are
       mechanisms in place to enable the management of StEIS to occur i.e. reflect the
       agreed arrangements within the attached Media Policy (appendix 6) approved by
       an Executive Director in hours and managed out of hours through the on-call
       rota, with the PCT communication team kept fully informed.

11.2   Although the Communications Lead for Cheshire and Merseyside Health
       Authority (CMHA) will be able to access the critical incident part of StEIS,
       telephone contact should be made with STHA as an additional measure. For
       detailed hotline arrangements cross-reference should be made with Major
       Incident Plan. Where the training room, 1st floor St Catherine’s Hospital will be
       designated as the major incident room, which will contain/have access to
       telephone points, handsets as dedicated telephone numbers for the
       duration of the incident. Internal/external telephone directories, answering
       machines, fax machines, networked computers/printers.

       Should the major incident involve St Catherine’s a backup alternative major
       incident room is situated in the Boardroom at Port Causeway. Names and
       telephone numbers of those calling the hotline should be documented, with a
       brief description of enquiry.

       Information to be given out about the incident will be decided by the Executive
       lead for the incident. Postal arrangements will be made for those who do not
       have access to a telephone. The PCT website will be updated with necessary
       information.




                                                                                           13
12.0   CLINICAL GOVERNANCE/RISK MANAGER’S RESPONSIBILITIES

12.1   The Clinical Governance/Risk Manager will co-ordinate all risk information to
       ensure it is fed in through the governance structure to the board, and where
       appropriate to the risk register.

12.2   Ensure there are systems in place to provide meaningful information to
       managers and the Board in relation to risks.

12.3   Work closely with the partnership trust as the centralised collating mechanism for
       risk information, and also the Health & Safety Department.

12.4   Will support training and other requirements arising from remedial action plans
       and strategic development plans.

12.5   Will undertake root cause analysis of serious incidents where appropriate to
       promote a learning culture within the PCT.


13.0   INCIDENT INFORMATION CO-ORDINATOR’S RESPONSIBILITIES

13.1   The Incident Information Co-ordinator will receive, review and input all incident
       forms completed working closely with the Clinical Governance/Risk Manager.

13.2   The Co-ordinator will liaise with managers and specialist advisors regarding
       incident information.

13.3   The Co-ordinator will produce incident information reports to assist the PCT in its
       risk management activity.

13.4   The Co-ordinator will be responsible for maintaining the incident information
       securely.

13.5   The Co-ordinator r will produce incident information reports to assist the PCT in
       its risk management activity.

13.6   The Co-ordinator will ensure that incident information is maintained securely.


14.0   SAFETY ALERT BROADCAST SYSTEM LIAISON OFFICER’S
       RESPONSIBILITY

14.1   The Safety Alert Broadcasting System Liaison Officer will receive all alerts issued
       by the Department of Health via the Safety Alert Broadcasting System (SABS).


                                                                                        14
14.2   The Safety Alert Broadcast System Liaison Officer will record all alerts and
       cascade to relevant identified service areas throughout the PCT and will monitor
       the progress of any actions taken as a consequence of the alerts as per the
       PCT’s Alert Cascade Procedure.


15.0   HEALTH & SAFETY COMMITTEE RESPONSIBILITIES

15.1   The committee will receive and consider accident/incident data reports. Trends
       will be reviewed and remedial and strategic action plans considered. The
       committee will actively support the promotion and implementation of
       improvements to safety performance in the workplace.

15.2   The committee will review the effectiveness of accident/incident management
       procedures and the training in place to support the development of safer working.


16.0   WEEKLY RISK MANAGEMENT GROUP

       The Main duties of the Group are to review all incidents and ensure that the
       appropriate risk grading has been applied.


17.0   SERIOUS UNTOWARD INCIDENTS & COMPLAINTS REVIEW GROUP

       The main duties of the Serious Incidents and Complaints Review Group are to
       ensure that there is a process to engage both employed staff and independent
       contractors in learning from serious events from inside the organisation and
       externally to the organisation and that there is a mechanism to stop similar
       serious events and complaints reoccurring. The membership of this Group
       recognises the important role the Local Health Directorates and other
       independent contractors have in supporting Birkenhead & Wallasey working
       towards becoming a learning organisation.


18.0   ROOT CAUSE ANALYSIS GROUP

       This Group’s main function is to review any incidents, which are referred to them
       and undertake root cause analysis to enable learning to occur across the PCT. It
       is responsible for ensuring that there is an ongoing training programme for key
       staff on root cause analysis.




                                                                                        15
19.0   RISK SUB COMMITTEE

19.1   The Risk Sub Committee will receive and consider all risk incident information
       and will agree, monitor and review any action plans, which have been produced.

19.2   The Committee will receive regular reports from the Health & Safety Committee,
       and other groups who have responsibility for any areas of risk management.

19.3   The Committee will inform the PCT Board via the Corporate and Clinical
       Governance Committee of any areas of concern from trends which have been
       identified and which may impact on the risk register.

19.4   The Committee will work closely with the Serious Untoward Incident &
       Complaints Review Group to ensure that lesions are learnt from serious
       incidents.

20.0   OCCUPATIONAL HEALTH DEPARTMENT RESPONSIBILITIES

20.1   The Occupational Health Department will support staff providing confidential care
       and advice relating to all accidents/incidents.

20.2   The Department will advise Managers and staff in the prevention of
       accident/incidents in the workplace.

20.3   The Department will receive and manage the documentation for staff related
       accidents/incidents.


21.0   STAFF SUPORT SERVICES RESPONSIBILITES

       The Service will provide confidential advice and support to staff post incident as
       required.




                                                                                        16
22.0   REFERRAL TO DISCIPLINARY PROCESS

22.1   The Manager should consider at any stage during the review of an incident
       whether or not there maybe a disciplinary case to answer. The manager should
       seek the advice of the HR department. This could be in circumstances were the
       following may be suspected

       •   Deliberate intent to cause harm or compromise patient or staff safety

       •   Professional or personal misconduct

       •   A criminal act has been committed

22.2   The review should cease immediately and the member of staff informed that the
       matter is going to be dealt with in accordance with the Trust’s disciplinary
       procedure and any statement taken during the review may be required as part of
       the disciplinary process.

22.3   Managers involved as part of the review team must not participate in the
       disciplinary process other than to refer their findings to the investigating officer
       appointed in accordance with the Trust’s Disciplinary Procedure.


23.0   SERIOUS UNTOWARD INCIDENTS

       For incidents relating to homicide, attempted homicide and/or patient death or
       incidents graded 15 or above, an Executive Director or an on call Director,
       together with member(s) of Learning From Experience Group/Risk Management
       Committee will meet within two working days of notification to agree and
       document any actions required.

       Action Plans from incidents will be monitored quarterly through the Learning
       From Experience Group/Healthcare Governance Committee, which reports to the
       PCT Board


24.0   DOCUMENT AND DATA CONTROL

       The completed incident accident reports and supporting documentation including
       witness statements, photographs and any other relevant documentation should
       be archived in a secure location as per NHS national guidance. Responsibilities
       for document and data control should be assigned to a nominated person as
       outlined in above within the policy and procedure.




                                                                                              17
                                                                                                                                                                                                                                                                                                                    Appendix 1
          Form No.                                                                                                         Health & Safety Dept. use only
                                                                                                                                                                           E.            EVENT INVENTORY
                                                                                                                           Ref. No.
                                                                                                                                                                       Was equipment involved                             Yes                 No            N/A
                                                                                                                           Date received:
                                                                                                                                                                       Was property Lost/Damaged                          Yes                 No            N/A
                                                    ACCIDENT/INCIDENT FORM                                                                                             Actual/estimated cost        (where there is a loss or damage)                Crime No.         (if known provided by police for thefts, vandalism, suspected
                                                                                                                                                                                                                                                     fraud or arson)
          TO BE COMPLETED BY PERSON IN CHARGE - PLEASE COMPLETE CLEARLY IN BLACK INK                                                                                   £                                                  p                          No.
                     A.       TYPE OF EVENT                                                                                                                                F.            ACTION DETAILS

                                                                                                                                                                       Medical/First Aid Intervention                     Yes                 No      Name of Dr/First Aider:
                       Accident/Incident          Near Miss                             Fire                             Other
                                                  Near Miss reporting optional for                                                                                     Next of Kin (not) Informed                         Yes                 No
                                                  completing Section B & I
                                                                                                                                                                       Staff Reported to Occupational Health                      Yes                Sickness Absence 3+ days likely                        Yes           No
                       Security                   Damage to Property                    Theft of Property
                                                                                                                                                                       Only Actioned by:                                                             Copy sent                                         Date
                     B.       DETAILS OF PATIENT / PERSON INVOLVED
                                                                                                                                                                           G.            REMEDIAL ACTION
                   Title           First Name                                        Surname
Women’s Services
 Contractors &
  Independant




                                                                                                                                                                       Risk assessment reviewed                           Yes                 No
   Optional for




                   Home Address
                   Ethnic Origin                                                                                                                                       Describe what action has been taken to improve safety/prevent reccurance
                                                                                                                                                                       IMMEDIATE
                   D.O.B.              Age           Male                 Female                Home Tel No.
                   Ward/Dept                     Patient No.                              Job Title (staff only)
                   Is Person:        Staff       In pt.            Out pt.             Community pt.               Other (specify)
                                                                                                                                                                       PLANNED
                     C.       EVENT DETAILS
                   Location                                                          Ward/Dept/Exact Location
                                                                                                                                                                           H.            WITNESS DETAILS
                   Date                              Time                                              (24 hour clock)
                                                                                                                                                                       Please attach statement(s) to this report
                     D.       EVENT DESCRIPTION                                                                                                                        Name:                                                                         Name:
                                                                                                                                                                       Address:                                                                      Address:
                       CLINICAL EVENT                                                   NON CLINICAL EVENT
                   Use this space below to describe the FACTS relating to the event. Include names of all involved. Explain what
                   happened and how. Describe any injuries or losses sustained. GIVE DETAIL. BE PRECISE.                                                               Tel:                                                                          Tel:
                                                                                                                                                                           I.            REPORT COMPLETED BY
                                                                                                                                                                       (Print clearly)




                                                                                                                                                            Optional
                                                                                                                                                                       Name                                                                        Job Title
                                                                                                                                                                       Signed                                                     Tel. No.                                                   Date
                                                                                                                                                                           J.            MANAGER’S ACTION
                                                                                                                                                                       Name (print)                                             Base                                                  Tel:

                                                                                                                                                                       RISK PROFILE - LEVEL                               Catastophic                 Major                 Moderate                Low             Minimal
                                                                                                                                                                       Investigation/Remedial action comments
                                                                                                                                                                       Notification to external agencies e.g MHRA, please specify
                                                                                                                                                                       Signed                                                                      Date
                                                                                                                                                                       Health & Safety Representative informed                          Yes        No Name of Representative

                                                                                                                                                                           K.            FOR HEALTH & SAFETY DEPARTMENT USE ONLY

                                                                                                                                                                       RIDDOR                Yes          No         Date of notification
                                                                                                                                                                           L.            REPORT DISTRIBUTION
                                                                                                                                                                       Copy 1             To Incident information Co-ordinator
                                                                                                                                                                       Copy 2             To Be Retained Securely By Manager
                                                                                 Appendix 2


                         BIRKENHEAD AND WALLASEY PCT

             ACCIDENT/INCIDENT REPORT - WITNESS STATEMENT

Please complete in BLACK INK, write clearly.
Please submit this report at the same time as the accident/incident report.

A.       EVENT DETAILS

         Accident/Incident Report Form No.__________________________________________
         Location________________________________________________________________
         Date_________________                Time__________am/pm


B.       WITNESS DETAILS
         Name_____________________________ Telephone No_______________________
         Address___________________________ Job Title (staff only)__________________
         __________________________________ Base_______________________________
         __________________________________


C.       WITNESS STATEMENT
         Please describe what you saw - please give facts only.
         ___________________________________________________________________________
         ___________________________________________________________________________
         ___________________________________________________________________________
         ___________________________________________________________________________
         ___________________________________________________________________________
         ___________________________________________________________________________
         ___________________________________________________________________________
         ___________________________________________________________________________


D.       SIGNED                                                           DATE

E.     For incident Information Co-ordinator only:

       Received_____________________

       Signed_______________________
                                                                                                        Appendix 3


                                Birkenhead & Wallasey PCT

                Accident Incident Management Protocol
        Supplementary Accident/Incident Investigation Report Form
                 (to be attached to main accident/incident form for all risk profile level 1 reports)

This form should be completed to record details of investigation into accidents which result in injury to
any person working on Birkenhead and Wallasey PCT Premises, any Trust employee on duty but not on
Trust premises, and all patients or visitors affected by the Trust’s operations. It must be completed by
the injured persons manager or person in charge of the area where the accident took place.

The purpose of the form is to prevent similar incidents or accidents occurring again and to improve
safety standards. The questions on this form incorporate guidance to help managers to carry out effective
accident investigations.

Remember: you cannot investigate an accident effectively without visiting the scene and talking to the people
involved

Accident/Incident form number            (from main report form).           Date of accident
                                                                            Time of Accident

Name of injured person                             Work base address

Date of birth                     Age

Occupation

Address where accident occurred if different from above             Dept. telephone no
                                                                    Home telephone no..

    1. Describe what happened (Guidance: This should contain a description of the accident based on your
       enquiries. It should be factual and avoid comment. Use sketches and photographs fit helps. Any
       equipment involved should be clearly identified by name. Where a defect is identified the equipment
       should be retained for examination).

        …………………………………………………………………………………………………………………………
        …………………………………………………………………………………………………………………………
        …………………………………………………………………………………………………………………………
        …………………………………………………………………………………………………………………………
        …………………………………………………………………………………………………………………………

2 What were the causes of the accident? (Guidance you should concentrate on the cause of the accident rather
than the cause of the injuty. The distinction can be seen in the following example. A needle stick injury occurs
when a nurse is clearing away clinical waste. The syringe had been put down on a tray temporarily. The nurse
was distracted and later when clearing away clinical waste her finger was penetrated by the needle. The injury
was caused by careless disposal and handling of the syringe. The cause could be lack of training, lack of
supervision, disregard for sharps handling procedures or a combination of any of them. Try to be as factual as
possible and avoid speculation).
…………………………………………………………………………………………………………………………………………………..
…………………………………………………………………………………………………………………………………………………..
…………………………………………………………………………………………………………………………………………………..
…………………………………………………………………………………………………………………………………………………..
…………………………………………………………………………………………………………………………………………………..

3 Give reference to any instruction covering the work and activities involved. e.g. safety policy, protocols, risk assessment,
instructions or procedures.
…………………………………………………………………………………………………………………………………………………..
…………………………………………………………………………………………………………………………………………………..
…………………………………………………………………………………………………………………………………………………..
…………………………………………………………………………………………………………………………………………………..

4. Was the instruction or correct procedure followed, if not state what aspect was not being complied with.
…………………………………………………………………………………………………………………………………………………..
…………………………………………………………………………………………………………………………………………………..
…………………………………………………………………………………………………………………………………………………..
…………………………………………………………………………………………………………………………………………………..

5. If the activity being carried out required the use of special equipment e.g. protective clothing, state if it was being used
correctly, or at all. (Guidance; You should specify the exact type of equipment and where relevant include serial numbers
and date of most recent inspection).
…………………………………………………………………………………………………………………………………………………..
…………………………………………………………………………………………………………………………………………………..
…………………………………………………………………………………………………………………………………………………..
…………………………………………………………………………………………………………………………………………………..

6. What action have you taken to prevent a recurrence? (Guidance; This should include such things as local instructions
issued, team briefing, training, and discipline etc. Telling someone to “take more caret’ is not an acceptable answer).
…………………………………………………………………………………………………………………………………………………..
…………………………………………………………………………………………………………………………………………………..
…………………………………………………………………………………………………………………………………………………..
…………………………………………………………………………………………………………………………………………………..

7. What other action has been taken? (Guidance: This should feature any action resulting from the investigation which is
likely to affect a wider audience. This may include contacting the Health and Safety department to request the issue of a
Safety Bulletin. on the subject).
…………………………………………………………………………………………………………………………………………………..
…………………………………………………………………………………………………………………………………………………..
…………………………………………………………………………………………………………………………………………………..
…………………………………………………………………………………………………………………………………………………..



Signature (by investigating manager or person in charge)         Date of investigation……………………………………….

Signed…………………………………………………….                                      Name……………………………………………………….

Dept……………………………………………………….                                       Telephone …………………………………………………

Address…………………………………………………………………………………………………………………………
                                           Reporting of Incidents to Relevant External Bodies                                                 Appendix 4


Risk Register                              Reports to Trust Board
                                           Corporate & Clinical Governance Committee & Risk Management Sub Committee
                                           Other Associated Committees Including Serious Untoward Incident & Complaints Review Group


                     Clinical Governance/Risk Manager
                                                                            Information to Estates Department

                                           Health & Safety Advisor                                    Reports to Health &
                                                                                                      Safety Executive
                                                                                                      RIDDOR

                                                                                    Medical Device
                                Fire Safety Officer                                 Incidents Reported
                                                                                    to:
                                                                                    MHRA and Health &Safety Advisors
                                Fire Incidents reported to:                                            Drug Incidents
                                NHS Estates                      Food Incidents                        Reported to:
                                Fire Authority                   Reported to:                          Pharmacy Department
                                                                 Infection Control Advisor
                                                                                                       Medicines Control Agency
          Medical Records Manager                                Local Authority
          (Claims) Reports to:                                   Consultant in Communicable Disease Control

          NHS Litigation Authority

                                Reviewed by Manager at Directorate/Head of Service Level

                                Finance Agency
                                                                                                      Violent Incidents
                                                       Incident Report, via Ward/Department           Counter Fraud and Security Management
                                                                                                      Services Guidelines
                                                                                   Appendix 5

              Birkenhead and Wallasey Primary Care Trust

           Approval Mechanisms for Press Release and Media
              Interviews when acting on the Trust’s behalf

1.     Introduction

This policy is designed to ensure that staff are protected and supported and that accurate and
appropriate comments are made when staff act on the Trust’s behalf.

2.     Background

The PCT has a dedicated Head of Communications (HOC) who has overall responsibility for
internal and external communications.

The PCT is also supported by M&M Associates Health PR Consultants, who are available to
provide a range of public relations activities including liaising with the media, facilitating
media interviews and handling enquiries. M&M also operates a 24-hour on-call pager system
for emergencies (07626 102810)

3.     Media Policy

This policy sets out an approvals system in place for reactive press releases and arrangements
for providing guidance to staff about the procedures to follow regarding media interviews.

It is worth noting that advance warning of possible media interest in a particular issue can
help all those involved to deal more efficiently and proactively with any enquiries. It is also
important to say that whilst the media often presents an opportunity for positive coverage,
there are times when an apparently harmless enquiry can result in extremely damaging
coverage. The importance of establishing the context in which the enquiry is to be set cannot
be over emphasised.

Staff are reminded of the agreed process for reporting serious and untoward incidents.

Flowcharts are attached which reflect the procedures outlined below.

4.     Procedures
Proposed procedures in place for approving press releases and for carrying out media
interview are as follows:

       4.1 Press Releases/Statements for Provider and Commissioned
          Services
       •   Approval for the content will be by contacting Head of Communications (HOC)
           and an Executive Director. Final approval will be sought wherever possible from
           Chief Executive.
       •   In all cases copies of press releases should be forwarded to Head of
           Communications (HOC). HOC will also be available to advise where appropriate.
                                                                                             1
       4.2 Media Interviews –Print, Radio and Television –
       Provider and Commissioned Services
       •   Staff who are approached by the media or who plan to contact the media, must
           contact their Manager and HOC.
       •   If required, a detailed list of questions the media may ask and informal media
           training will be provided
       •   HOC may call upon M&M’s involvement where appropriate
       •   Approval for conducting an interview will be sought from the Manager and final
           approval by relevant Director and Chief Executive
       •   In the event of a controversial issue, it may be necessary for the interview to be
           carried out by an Executive Director or the Chief Executive.
       4.3 Wirral Wide Services
       In the case of Wirral Wide Services it has been agreed that the PCT hosting the
       service will take the lead, and will liaise with the neighbouring PCT.

5.     Out of Hours (OOH)
Executive Directors, other than Director of Public Health, who participates in a Directors of
Public Health on-call-rota, and the General Manager for the PCT will be included in an on-
call-rota. The OOH list is made available at the switchboard of main hospitals i.e. Arrowe
Park Hospital, Clatterbridge Hospital and St Catherine’s Hospital. M & M Associates
provide OOH cover and will make first contact through the main switchboard at which time
on-call officers will be contacted.

.6.    Serious Media Incidents
HOC will report serious media incidents to the Strategic Health Authority linking with the
Serious and Untoward Incident reporting mechanisms.

7.         Contacts
Linda Danher, Head of Corporate Services & Communications
Sylvia Reynolds, Complaints Managers and Assistant Head of Corporate Services and
Communications
Telephone:    Lin Danher - 0151 651 0011 Ext 414 /651 3964
              Sylvia Reynolds 0151 651 0011 Ext 293 /
Fax: 0151 652 2668
lin.danher@bkwpct.nhs.uk

M&M Associates
Lynn May
Telephone: 01829 752751
Fax: 01829 752626
lynn@nhspr.co.uk
Out of hours pager: 07626 102810


MediapolsDec03/LD

                                                                                           2
Case 1

                       Media makes contact with
            M & M Associates, NHS Public Relations Consultants


                              Media contact M & M




                M & M contact HOC and Service Head/Manager




 M & M to proceed                    OR                 Deal with In-house




 M & M forward draft response/PR                       Draft response
 to HOC and relevant Director                          prepared




 HOC forward to Director                            HOC forward to Director
 and CE for approval                                and CE for approval




 Final approval to M & M
                                                     Response provided to media
 Response provided to media
Case 2.

      Media enquiries – Media makes direct contact with member of staff



                        Media contact member of Staff/Manager




            Staff contacts Manager and Head of Communications (HOC)




          HOC will obtain all necessary information to prepare response and will
              liase with Manager/Director and M & M where appropriate




          Support will be provided i.e. live media interviews and/or in preparation of
                                    press release/response




                         HOC seeks approval from Director/CE
                                 From CE/Director




                  Response provided to media and/or interview proceeds
Case 3.

          Preparing pro-active press releases/statements for provider and
                              commissioned services



              Source of communications e.g. Manager/Service Head




               Contact Head of Communications (HOC) and Director




                                     HOC
                                                                            Deal with
                                                                            in-house




                                                   Approved by CE/Director/Partner
   sends to M & M                                  and where appropriate Bebington &
                                                   West Wirral PCT HOC ie. Wirral wide
                                                   services




   Draft PR to HOC                                   Sent direct to media contacts




   HOC seeks final approval from CE and
   Bebington & West Wirral PCT HOC (where appropriate i.e. Wirral-wide
   services




   M & M send to media contacts
                                                                                            Appendix 6



                       BIRKENHEAD AND WALLASEY PCT

     SUMMARY OF THE REPORTING OF INJURIES, DISEASES AND DANGEROUS
               OCCURRENCES REGULATIONS 1995 (RIDDOR).

              (Which will be undertaken by Maria Robinson H&S Dept St Catherines)

RIDDOR requires the reporting on FOUR broad categories of incident arising from workplace
activities to the Health and Safety Executive on a prescribed form.

1.    Specified Types of Physical Injury and Death

       e.g.      Fracture of: skull, spine or pelvis; any bone in the arm or wrist but not a bone in the
                 hand; any bone in the leg or ankle but not a bone in the foot.

                 Amputation of a hand or foot; or a finger, thumb or toe or any part thereof, if the
                 joint or bone is completely severed.

                 The loss of sight of an eye or penetrating injury to an eye.

                 Any injury requiring immediate medical treatment (including burns).


2.    Accidents which incapacitate employees for more than three days

      This excludes the day of the accident but includes both a Saturday and Sunday.

      Injuries to Non employees arising from workplace activities who require hospital treatment


3.    Dangerous Occurrences

       e.g.      The collapse of a hoist
                 The overturn of an excavator
                 The bursting of a boiler
                 An electrical short-circuit or overload attended by fire.

      Any incident related to the above or detention in hospital for more than 24 hours must be
      reported to the Health and Safety Executive as quickly as possible by telephone. This
      contact must be followed within 10 days by a written report on Form F 2508. Records of
      the details of these notifiable accidents must be kept by the employer and retained for at
      least THREE years

4.    Diseases

      Occupationally related diseases e.g. asbestosis, hepatitis, asthma.
      Cases of disease must be reported when a written diagnosis is received from a Doctor. All
      reports under this heading are sent to the HSE on Form 2508A.
RISK MANAGEMENT                                                    Education & Training
PROCESS
                                                            Patient & Public Involvement                       Issues raised from
                                                                   Use of Information                          these areas may be
                                                                                                                fed through other
                                                              Staffing & Staff Management                     Clinical Governance
                                                                                                                   Committees
                                                               Research and Development

                                                                     Clinical Audit


                                                                    There is a requirement
   Place on                                                          For complaints info         Reactive Drivers
 Risk Register
                                     PCT Board                       To be monitored and
                                                                      Reported to Board              Complaint
                                                                           Directly             (Complaints Procedure)


                            Corporate and Clinical Governance
         Monitoring of                  Committee                                                     Claim
                                                                                 Collated       (Claims Procedure)
         Risk Register
                                                                               information
                               Risk Sub Committee & Other                     on Complaints
                                     Risk Committees                            On Claims             Incident
                                                                                                (Incident Reporting
                             Health Safety and Welfare Committee                                    Procedure)
  Request for
                Out
  Root Cause Comes           Serious & Untoward Incidents and
  Analysis to From            Complaints Review Committee                                              PALS
      be       Root
  undertaken   Cause
                              Weekly Risk Management Meeting
 (Root Cause Analysis
              Reported
   Analysis                                                   If incident is serious             Incident Reporting
  Procedure)                                               (category A/red Incident)              Form Completed            All category B, C, D
                                                       Reporting Procedure – Reported                                          & E incidents
                         Collated trend                to Strategic Health Authority via                                         managed at
                                                                                              Information from forms
                          Information                              Sties System               input onto data base and
                                                                                                                             operational level
                           Reported                                                            collated to show trends
                                                     Appendix 8




       Procedure for the Root Cause Analysis

Of Serious Untoward Incidents, Complaints and Claims


     Lead Person: Clinical Governance/Risk Manager




                            Date Printed: November 2003
                            Review Date: July 2005
Introduction

This procedure aims to assist nominated lead investigators (see Appendix 2)
to successfully investigate and resolve serious incidents, complaints and
claims, as defined by the incident management matrix (Incident Policy). It
allows the investigator to identify the direct, contributory and root causes
associated with the incident.

The information obtained from the investigation can then be analysed and the
common causes and trends highlighted to the organisation via the risk
management process. By analysing such occurrences we can ensure
lessons are learnt and practice is changed appropriately, the investigation will
help address areas of poor performance, systems failures, violations of
procedures, and the need for changes in both clinical and non clinical
practice.

This procedure should be read in conjunction with:

   •   The Risk Management Strategy/Policy
   •   The Claims Policy
   •   The Complaints Policy/Procedure

Definitions

       Serious Adverse Incident

An accident or incident when a patient, member of staff or member of the
public suffers injury or unexpected death, or the risk of death or injury, or
when actions of staff are likely to cause significant public concern or attract
media interest.

       Root Causes

Failures in processes that if eliminated, would prevent an adverse Incident
from reoccurring.

       Root Cause Analysis

A structured investigation that aims to identify the true cause of a problem,
and the actions that are necessary to either eliminate or significantly reduce
the risk.

The simple approach to root cause analysis is very simple, the investigator
asks the question ‘Why?’ about each significant event and condition in the
emergent picture in the accident sequence and keeps asking ‘Why?’ until its
usefulness is exhausted.
        Immediate causes / Active failures

Apparent reasons why the event occurred, that need to be analysed to
determine underlying Influences


        Underlying causes ‘ Latent Failures:

Underlying factors or influences that need to be analysed to determine the
root causes.


When does a Root Cause Analysis need to be conducted?

An investigation will commence using the Risk Matix an incident can be
graded in severity. If the incident is deemed serious in nature and therefore
scores red on the matrix, an investigation procedure needs to be initiated.


Likelihood of                        Risk Level/Consequence and Weighting
Reocurrence
                      Catastrophic        Major        Moderate         Low        Minimal
                          (5)              (4)           (3)             (2)         (1)
Almost certain (5)   25              20              15            10          5
Likely (4)           20              16              12            8           4
Possible (3)         15              12              9             6           3
Unlikely (2)         10              8               6             4           2
Rare (1)             5               4               3             2           1

Risk Profile Grading Level/Management of Risk

In terms of grading the risks the following categories are then applied.

□ Green Low Risk                                  Managed by Service Area

□ Amber High Risk                                 Managed by Senior Managers

□ Red Extreme Risk                                Managed by Director Level
                                                  Immediate Action required (see Incident
                                                  Management Matrix)

    •   In the event of a Serious Untoward Incident the designated individuals
        within the PCT will confirm the severity status and appoint a lead
        investigator.

    •   An investigation will commence immediately, by Senior Managers,
        depending on seriousness/nature of incident. If unable to commence
        investigation immediately, it is to commence as soon as reasonably
        practical.
        For serious/untoward incidents the investigative team should include
        members of staff trained in route cause analysis.

   •    If the incident is to be reported through StEIS, a post incident review
        team will be convened.

   •    In the event of a complaint/claim, the Executive Director with
        responsibility for Complaints/Claims and the Complaint/Claims
        Manager will allocate a support manager to conduct the root cause
        analysis.


Undertaking the Investigation

It is not proposed in this procedure to undertake a detailed explanation of root
cause analysis. However investigations need to consider the following key
points in order to be considered successful.


        Assign a team, which ideally should be between 2 – 5 individuals. The
        team should have an appointed lead investigator / chairman.
        Utilise other individuals skills and knowledge i.e. use multidisciplinary
        teams.
        Outline the sequence of pertinent events – may need to physically
        chart sequence.
        Avoid early judgements, any blame or attribution
        Concentrate on the facts only and avoid subjectivity.
        Identify the causal factors leading up to each pertinent event. In most
        cases the incident does not result from one single event, but is more
        likely to have evolved cumulative triggers, which in isolation may have
        had no effect, but when they occur in the event chain may be serious
        or catastrophic in nature.
        Methodology may need to include a variety of approaches: Interviews,
        statement writing, review of documentation and direct observation.
        Analyse the causal factors
        Complete the root cause matrix
        Provide recommendations to the Trust, which may prevent the
        reoccurrence of the incident.


External Agencies


It may be necessary, on occasion, to include external agencies in the root
cause analysis procedure. Other external agencies may include:


    •   Health & Safety Executive
    •   NHS Litigation Authority
    •   Ombudsman
                  •      Environmental Health
                  •      Police/Other Emergency Services
                  •      Strategic Health Authority
                  •      Social Services
                  •      CHAI
                  •      Wirral County Council
                  •      Environmental Health
                  •      Independent carers associations
                  •      Independent advocacy services




                  Birkenhead and Wallasey PCT will endeavour to work with any external
                  agencies that could assist in the effectiveness of root cause analysis, and
                  ensure lessons are learnt and recommendations implemented.




              Root Cause Analysis


    Collect the facts               Analyse the facts        Integrate evidence      Make
                                                             and establish           recommendations
                                                             causes.


•    What happened?           •   How did it happen?        Draw Conclusions         Validate
•    Witnesses                •   Causal factors                                     Conclusions
•    Physical evidence        •   What happened
•    Sketches or                  throughout the chain of
     photographs                  events?
•    Records and              •   Focus on problem-
     Documentation                solving not on blame.        •   Why did it        •   Recommendations,
•    Medical                  •   System and process               happen?               if accepted, are
     Evidence                     based – don’t                •   Findings              appointed a lead
     Etc.                         concentrate on the           •   Probable causes       implementer.
                                  individual.                  •   Judgements of
                                                                   need.
          Immediate & Underlying Causes
               Patient, Individual,Team
                 Task, Environment                    Immediate Causes(s)
                         Factors




               Organisational                         Underlying Causes(s)
               Management
                  Factors


                                                       Root Cause(s)




                                                               Doing Less Harm




Root Cause Matrix

   Material and                 Organisational           People                    External
    Equipment
Design                   Staffing                Training                    Weather/
                                                                             environment
Layout and               Procedure/policy        Time pressure               Building
housekeeping
Quality                  Risk assessment         Communication               Visitor / 3rd
                                                                             party
Lack of                  Medicine / drugs        Supervision


Installation                                     Patient behaviour

Maintenance



Major cause
                                                                  Lead Investigators should
                                                                  refer to appendix 1 for more
Moderate Cause                                                    guidance on root causes.


Minor Cause
Learning from Incidents

It is essential that at the conclusion of a root cause analysis that lessons are
learnt and that changes are recommended which will ultimately enable
Birkenhead and Wallasey PCT to improve patient care, to be a safe place of
work for it’s staff, and to be a safe environment for it’s patients, visitors and
contractors. Recommendations will be addressed by feeding information
through the Governance Strucuture.

Lead investigators are required to complete a Root Cause Matrix on
completion of an investigation (see above). This will highlight risks, within the
organisation. These identified risks may have to be added to either the Risk
Register for management action.


Example of a Completed Root Cause Matrix

                                          Probability   Severity   Overall
         N
                                            of re-       if re-    risk
         o     Identified Root Cause      occurrence    occurs     rating
         .
                                             (1-5)       (1-5)

                 Training needs re
         1                                    5            4         20
                     evaluation

              Communication issues
         2                                    3            3          9
              between departments




Lead investigators will find that in about 80% of all the incidents that they
investigate, they are due to 20% of probable causes, and these causes are
listed in appendix 1. However investigators will have to be aware that the
generic list of root causes are not exhaustive, and may need to be added to.

Without accurately identifying the root cause of the serious untoward incident /
complaint or claim, the organisation will fail to identify systems weaknesses
and therefore will be unable to facilitate change, thus preventing the PCT
becoming an Organisation with a Memory. Training in Root Cause Analysis
will be undertaken by Executive Directors, and Senior Managers who will be
responsible for undertaking root cause analysis.
                                                                                               Appendix 1


Risk Factors


   1.   Natural disaster or criminal activity

   2.   Equipment failure

        •   Expected failure

            Design specifications

                 •       Specifications have potential for improvement
                 •       Design not to specification
                 •       Work / equipment interface not considered

            Design Suitability

                 •       New equipment not up to standard
                 •       Hazard analysis


        •   Equipment / Part Defective

                     •   Purchasing
                     •   Handling
                     •   Storage
                     •   Quality Assessment
                     •   Manufacturing defect

        •   Planned preventative maintenance

                     • PPM
                     • No PPM

        •   Repeated failures

                     • Management system
                     • Corrective Active



   3.   Performance Difficulties

        •   Individual performance

                     •   Excessive tiredness, unwell, upset, bored, distracted, overwhelmed.
                     •   No written procedures
                     •   Written procedure not followed
                     •   Made a mistake using procedure
                     •   Equipment alarms turned down or off
                     •   Not trained to carry out the task or understand the equipment
                     •   Work environment not conducive to safe practice e.g. dark, hot, humid etc.

            o    Did task involve repetitive motion, uncomfortable positions, vibration, or manual handling?



        •      Team performance

                     •   Was there a problem with verbal communication or shift change over
                     •   Were there language difficulties between parties.
                     •   Was time available to explain procedures / risk to family / patient
                     •   Did a failure in the case notes contribute?
•    Management Systems

         • Was there pressure to perform the task in a hurry or to use shortcuts
         • Had management been warned of the problem before
         • Were policies, procedures or administrative controls not used, missing or in need of
           improvements.
         • Was there a failure in the provision of tests and results
         • Would an independent audit have highlighted the problem earlier?

•   Procedures

         • Procedures not used, or procedures not followed
         • Wrong procedures
         • Followed incorrectly


•   Training

         • No training


•   Communication
         • Non existent or untimely
         • Misunderstood verbal communications


•   Work Direction

         • Preparation
         • Selection of worker
         • Supervision during work


•   Quality Control

         • No inspection
         • Assessment tool


•   Management Systems

         •   Supervision
         •   Remedial action
         •   Policies
         •   Policies not used


•   Human Engineering

         •   Man / Machine interface
         •   Work environment
         •   Complex systems
         •   Error identification
                                                                  Appendix 2

Investigation Team


Medical Director – Wallasey Local Health Directorate
Medical Director – Birkenhead Local Health Directorate
Medical Director – Community Services and Director of Infection Control
Executive Director of Nursing & Quality
Non Executive Director (Complaints Convenor)
Director of Public Health
Associate Director of Medicines Management
Clinical Governance/Risk Manager
Professional Nurse Adviser
CPD & Effective Practice Co-ordinator
Joint Mental Health Commissioner
Business Manager Community Services
Pals Co-ordinator
Complaints & Claims Manager
Fraud Officer
                                                           Appendix 9


                                    Useful Contacts


Director of Nursing & Quality                         0151 651 3926

Clinical Governance/Risk Manager                      0151 651 3892

Director of Public Health                             0151 651 3971

Director of Finance & Performance                     0151 651 3929

Health & Safety Advisor                               0151 678 7272 ext 3415

Incident Information Co-ordinator                     0151 604 7254

Fire Safety                                           0151 678 5111 ext 3627

Infection Control Advisor                             0151 643 5401

Medicines and Healthcare Regulatory Agency            020 7972 8277/8056
Hannibal House
Elephant & Castle
London
SE1 6TQ

				
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