Policy and Procedure for the Reporting and Management of Serious

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					   Policy and procedure for the reporting and management of Serious Untoward Incidents (SUIs)




                              CDDFT Policy

Reference Number              POL/N&G/0022
Title
                              Policy and procedure for the reporting and management
                              of Serious Untoward Incidents (SUIs)
Version number                1.1
Document Type                 Policy
Original Policy Date          February 2011
Date approved                 February 2011
Effective date                February 2011
Approving body                Safety Committee
Originating Directorate       Directorate of Nursing and Service Transformation
Scope                         Trust-wide
Last review date              Na
Next review date              February 2014
Reviewing body                Safety Committee
Document Owner                Patient Safety and Clinical Risk Manager
Date superseded               New policy
Status                        Approved
Confidentiality               Management in Confidence / Staff in Confidence /
                              Commercial in confidence / Unrestricted
Keywords                      Incident, SUI, Risk




Approval


Signature of Chairman of Approving Body


Name / job tile of Chairman of approving
Body:
Signed paper copy held at (location):




POL/N&Q/0022                             Version 1.1                               Page 1 of 45
Policy and procedure for the reporting and management of Serious Untoward Incidents (SUIs)

Contents

                                                                                     Page
     1         Introduction                                                            4
     2         Purpose                                                                 4
     3         Duties                                                                  5
     4         Reporting and Management of SUIs                                        10
     5         Key Performance indicators                                              14
     6         References                                                              16
     7         Associated Documentation                                                17


Appendices
                 Procedure for the reporting, management and
                                                                                       18
Appendix A       investigation of Serious Untoward Incidents (SUI‟s) –
                 Community Health Services Only

Appendix B       Protocol for Investigation and Review of Serious
                 Untoward Incidents (SUI‟) – Acute Services only                       27

Appendix C       Procedure for setting up a hot line/help line (both Acute
                 and Community Health Services)                                        31

Appendix D      Escalation to the Strategic Health Authority (SHA)                     32


Appendix E      Staff support letter                                                   34


Appendix F      Guidance on developing and writing statements                          35


Appendix G      Definition of a RIDDOR reportable incident                             37


Appendix H      NPSA‟s List of Never Events                                            39


Appendix I      Rationale to support the provision of Complaints, Litigation,
                Incidents and PALs Reports                                             41

Appendix J      Being Open Letter/Letter of Apology                                     45


Appendix K      Telephone enquiry record (major incident)                              46




POL/N&Q/0022                           Version 1.1                              Page 2 of 45
Policy and procedure for the reporting and management of Serious Untoward Incidents (SUIs)

Document Control Information

Version control table
Date of issue   Version number       Status
February 2001 1.1                    Approved




Table of revisions
Date          Section     Revision                                   Author




POL/N&Q/0022                          Version 1.1                             Page 3 of 45
1     Introduction

      The NHS is accountable to the public for delivery of health care services and
      in this context, County Durham and Darlington Foundation Trust (CDDFT)
      need to monitor all safety issues and incidents to ensure that learning is
      shared across the organisation and partner organisations as appropriate.
      It is important to stress that CDDFT is committed to a policy of „fair blame‟.
      Fair blame means that the organisation:

         Operates its incident reporting policy in a culture of openness and
          transparency, which fulfils the requirements for integrated governance.
         Maintains a focus on continuing, demonstrable improvements in the quality
          of the patient‟s care experience.
         Adopts a systematic approach to an incident when it is reported and does
          not rush to judge or „blame‟ without understanding the facts surrounding it.
         Encourages incident reporting in the spirit of wanting to learn from things
          that go wrong and improve services as a result.


2     Purpose

      The purpose of this policy is to provide guidance, information and procedures,
      which if followed, will ensure that CDDFT complies with legislation, and the
      requirements of the National Patient Safety Agency (NPSA) with regard to
      incident reporting generally, but in particular the reporting, notification and
      investigation of „Serious Untoward Incidents‟ (SUIs).
      The document sets out CDDFT‟s approach to the identification, reporting and
      management of serious untoward incidents. The scope of this document is
      specific to „Serious‟ Untoward Incidents including „Near Misses‟. This policy
      relates to the Policy and Procedure for Managing Untoward Incidents and
      Near Misses.
      A number of principles underpin this policy:

              The accountability for development and approval of this policy rests
               with the Board of CDDFT.

              The Board of CDDFT are committed to an open and accountable
               incident reporting culture which includes the implementation of the
               principles of „Fair Blame‟.

              CDDFT accepts its responsibility for providing safe and secure
               environments for patients, staff and visitors. In order to achieve and
               maintain high standards, it is necessary to have early warning of actual
               and potential deficiencies in the systems set up to manage the many
               categories of risk to which healthcare organisations are exposed.
               CDDFT will encourage comprehensive reporting of all situations,
               events, acts, errors or omissions (including hazards and near misses),


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               which have (or might have) caused avoidable harm, loss or damage to
               any person or property.

           Formal disciplinary hearings will only be invoked following an incident
            where there are repeat occurrences involving the same person where
            their actions are considered to contribute towards the incident; where
            there has been a failure to report an incident in which a member of staff
            was either involved or about which they were aware (failure to comply
            with CDDFT Policy and Procedure); the action causing the incident is
            removed from acceptable practice or standards in view of CDDFT
            and/or professional regulatory body; there is proven malice or intent.

           Staff will be encouraged to use support mechanisms such as
            counselling and/or training.
      CDDFT will ensure that SUIs are identified, openly investigated, lessons
      learned and promptly applied. These lessons will be applied across CDDFT
      and may form the basis for inclusion in subsequent Clinical Audit and Clinical
      Training programmes.
      This Policy is intended to complement CDDFT Policy for Reporting and
      Management of Incidents and Near Misses, NHS County Durham and
      Darlington PCT‟s Policy and Procedure Guidance for Reporting and
      Management of Serious Untoward Incidents (SUIs) CG001, and National
      Patient Safety Agency‟s (NPSA‟s) National Framework for Reporting and
      Learning from Serious Incidents Requiring Investigation 2009.

3     Duties

      This policy should be used by all staff in CDDFT including students, voluntary
      staff, those on honorary contracts or trainees on temporary placements.
      3.1 All Staff responsibilities
      All staff, including temporary and agency staff, are responsible for complying
      with organisational policies and procedures. Failure to comply may result in
      disciplinary action being taken.
      3.1.1 Basis of allocation of responsibility
            The Health & Safety at Work Act 1974 places a Duty of Care on every
            employee, a responsibility to maintain safe systems of work, to take
            care of their own safety and that of colleagues and all other persons
            who may be affected by their acts or omissions.

               This means every individual employee is responsible for reporting
               incidents in which they are involved, or of which they have
               knowledge, and any situation they think is potentially dangerous
               or harmful to a patient or member of staff.
               Reporting SUIs does not absolve individuals of their responsibility to
               identify actions to prevent reoccurrence.


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               i)    When an incident occurs, it is the responsibility of the employee
                     to take immediate action to ensure the situation is made safe
                     and to preserve the scene if a crime is suspected. The employee
                     should also, depending upon the nature of the incident, consider
                     involving the local police (only after consultation with PSM).

               ii)   Employees have a duty to report all SUIs both verbally in the first
                     instance and then as per the relevant procedure. After the
                     incident employees reporting the incident or those involved in it
                     are required to discuss the matter with the person leading the
                     investigation, support improvements to working practices
                     highlighted by incident investigations, bring any training needs to
                     the attention of their line manager and attend any necessary
                     training.


3.2   Individual / Nominated Responsibilities
      3.2.1 Chief Executive
      The Chief Executive, as the accountable officer, has overall responsibility for
      ensuring that effective arrangements are in place for the reporting,
      management and learning from incidents.
      3.2.2 Trust Board
      The Board has overall responsibility for setting the strategic context in which
      organisational policies and procedures are developed, and for establishing a
      scheme of governance for the formal review and approval of policies.
      3.2.3 Director of Nursing and Service Transformation
      The Director of Nursing and Service Transformation is the Lead Officer for the
      management of all SUIs in line with the National Patient Safety Agency‟s
      (NPSA) National Framework for Reporting and Learning from Serious
      Incidents Requiring Investigation 2009. This officer ensures that mechanisms
      are in place to report all SUIs to the Strategic Health Authority (SHA).
      3.2.4 Assistant Director of Clinical Assurance
      The Assistant Director of Clinical Assurance will deputise in the absence of
      the Director of Nursing and Service Transformation.
      3.2.5 Patient Safety and Clinical Risk Manager
      The Patient Safety and Clinical Risk Manager will deputise in the absence of
      the Assistant Director of Clinical Assurance.




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      3.2.6 Executive Directors
      All Executive Directors are responsible for:
               i)     Ensuring the implementation of this policy and procedure within
                      their area of responsibility.

               ii)    Ensuring that necessary training or education needs are
                      identified and resourced in order to implement the policy.

               iii)   Ensuring that the above are built into the delivery planning
                      process.

               iv)    Ensuring that mechanisms are in place for the regular evaluation
                      of the implementation, effectiveness and management of this
                      policy within their directorate.


3.3   Assistant Directors/Clinical Divisional Managers/Service Managers (or
      equivalent)
      Are responsible for:

              Ensuring that staff are supported and encouraged to report SUIs.

              Reviewing all incidents within their services to ensure that all serious
               incidents have been identified as such.

              Ensuring the investigation procedure is followed within their service
               areas and within agreed timescales.

              Ensuring their staff have access to and comply with all relevant
               guidance and advice within the policy.

              Implementing agreed training or education methods or programmes in
               respect of this policy.

              Establishing mechanisms for regular evaluation of the implementation
               and effectiveness of this policy within service(s).

              Ensuring corrective action is taken to prevent the incident occurring
               again and that staff are advised of corrective actions taken and why
               this was necessary. This may involve liaison with other senior
               managers and specialist staff.

              Notifying the policy co-ordinator should any aspect of this policy be
               considered to be in need of revision.

              Disseminating learning from incidents to staff and also ensuring an
               audit trail is available should it be required.


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              Ensuring they collate and preserve evidence to show how
               implementation of action plans has been achieved.

              Providing specialist advice and support to investigation leads with the
               investigation of SUIs and subsequent reports and action plans.

              Ensuring that the Risk Registers are amended where necessary to
               include identified risks.


3.4   Patient Safety and Clinical Risk Officers (PSCROs)
      PSCROs have a key role in the management of SUIs. They will:
      i)       Take advice from the Director of Nursing and Service Transformation
               about the classification of all SUIs and report those which meet full
               SHA reporting criteria on to the STEIS database.

      ii)      Notify other relevant teams that an SUI has occurred, if notified verbally
               before the incident is reported on Safeguard.

      iii)     Forward relevant investigation reports and action plans to SHA.

      iv)      Provide specialist advice and support to investigation leads on
               investigation of SUIs and subsequent action plans.

      v)       Provide information for the Safety Committee (SC) about SUIs, the
               organisational response and an update on implementation of each SUI
               action plan by the services.

      vi)      Produce analytical reports in partnership with colleagues from the
               Patient Advice and Liaison Service (PALS) and Complaints which will
               be presented to Clinical Quality Committee, the CDDFT Board and
               relevant managers when necessary.

      vii)     Ensure that the SUI is reported to other key people in the organisation
               e.g. legal services.

      viii)    Oversee and coordinate the implementation of this policy and
               associated training.

      ix)      Produce and ensure the dissemination of patient safety alerts
               generated by lessons learnt from SUIs.




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3.5   Health and Safety/Non Clinical Risk Team
      Specific Responsibilities include:
      i)       Contributing to the achievement of policy by assisting managers with
               health and safety incident management where appropriate, lead the
               investigation on H&S related SUIs and produce reports and action
               plans.
      ii)      Ensure that SUI reports and action plans are submitted to H&S
               Committee.

      iii)     Review of all health and safety incidents to ensure that all serious
               health and safety incidents have been identified as such and the
               relevant processes actioned.

      iv)      Advise Patient Safety and Clinical Risk Manager and Patient Safety
               and Clinical Risk Officers of any H&S SUIs which fulfil STEIS reporting
               criteria.

      v)       Inform relevant external agencies of SUIs, where appropriate.

      vi)      Ensure lessons learned from H&S SUIs are disseminated.


3.6   Information Governance Manager/Pharmacy/Medicines Management
      Team/Medical Devices Lead
      Specific responsibilities include:
       i) Assisting managers with investigations and action plans in response to
          incidents related to their speciality.

      ii) Advise PSMs of any SUIs which fulfil STEIS reporting criteria.

      iii) Informing other relevant agencies e.g. Information Commissioner‟s Office/
           CD Officer/ MHRA of any incidents which fulfil criteria, and liaising with
           them on any investigations and ensuring any subsequent required actions
           are fulfilled.

      iv) Initiating production of any necessary analytical reports.


3.7   Safety Committee (SC) Members
      Nominated members of the SC have specific responsibilities which include:
      i)     Presenting new SUI reports and action plans on behalf of their
             represented services.

      ii) Presenting completed action plans on behalf of their represented services
          for „sign off‟ by the committee

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      iii) Reading, reviewing and commenting upon SUI reports and action plans
           presented to the PSC.

      iv) Disseminating outcome lessons and themes from across the range of
          services to their represented services.


4     Reporting and Management of SUIs
      Please see Appendices A and B
      4.1 Definitions
      “Incident”
      An incident is an unexpected, unplanned and/or uncontrolled event.
      “Serious Untoward Incident” (SUI)
      An incident occurring on NHS premises or non NHS premises but always
      related to the provision of health care wherever it is delivered and which
      involves one or more than one of the following:

              Death, serious injury or harm to patients, staff or the public
              Significant loss or damage to property or the environment
              Likelihood of significant public concern
              A „near miss‟, or even a low impact incident but one which has the
               potential to contribute to serious harm.
      Important note If there is any doubt about the definition of the incident,
      individuals are encouraged to discuss the matter with their line manager and
      Patient Safety and Clinical Risk Manager (PSCRM) without delay.
      “Near Miss”
      A Near Miss is an incident which is prevented by an intervention but had the
      potential to progress to serious harm.
      “Root Cause Analysis” (RCA)

      Root Cause Analysis is a method for investigating patient safety incidents and
      can help to identify what, how, and why patient safety incidents have
      happened. It is then possible to use analysis to identify areas for change,
      develop recommendations and look for new solutions. For further explanation,
      please see the RCA Resource Pack.

      “Contributory Factors”

      Contributory Factors are factors that either influenced or caused a single
      event or chain of events that contributed to an incident. The factors may have
      had either a negative or a positive effect, e.g. some may have mitigated or
      minimised the outcome of the incident.


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      “Safeguard System”

      Safeguard is a risk management system, used by community health
      services, which incorporates the incident reporting function.
      “Trigger Notification” (Safeguard)
      An e-mail communication regarding an incident sent via the Safeguard
      system.
      “Datix”
      Datix is a risk management system, used by acute services, which
      incorporates the incident reporting function.


   4.2 Escalation to the Strategic Health Authority (SHA)
      The Director of Nursing and Service Transformation as lead officer for
      managing all SUIs, will determine whether the SUI is reported to the Patient
      Safety Team at the SHA via the Strategic Executive Information System
      known as ‟STEIS‟
      Please see Appendix D


    4.3 Investigation of SUIs
      Once an incident has been identified as being serious (SUI, see 6.0) and has
      been reported as such, the Clinical Divisional Manager must identify a
      suitable member of staff to carry out an investigation using RCA, to find out
      why the incident occurred to prevent a similar incident occurring again, and to
      enable shared learning.
      Please see Appendices A and B


   4.4 Additional Requirements
      CDDFT is committed to creating a culture and environment which encourages
      workers to feel able to raise concerns sensibly and responsibly without fear of
      victimisation. The Trust operates a systematic method for staff to raise
      concerns in a way that is consistent with the Public Interest Disclosure Act
      (PIDA). This process is described in HR Policy „Raising Concerns (Whistle
      blowing) policy‟.

      4.4.1 Assistant Directors, Senior Managers and Heads of Service need to
            consider the following:

              If the incident has implications for an individual/patient being cared for,
               that individual/patient should be informed about what has happened
               and appropriate support should be offered to them.


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              Where appropriate the individual/patient‟s family, with the patient‟s
               permission, should also be informed about the incident.

              CDDFT has adopted the National Patient Safety Association (NPSA)
               „Being Open‟ guidance. This guidance encourages staff to be open,
               honest and apologise to patients and families when mistakes are made
               and is reflected in CDDFT‟s policy on „Being Open‟.
              The appropriateness of writing a letter of apology to the patient. A
               template letter is provided (Appendix J).

      4.4.2 It is the responsibility of the line manager in conjunction with the Head
      of Service to involve HR as soon as there is any indication that the
      Disciplinary Procedure maybe invoked (Appendices A and B).
      4.4.3 All „Never Events‟ (Appendix H) must be reported immediately to the
      Director of Nursing and Service transformation.
      4.4.4 If a SUI occurs as a result of a failure of plant, machinery, medical
      equipment or other equipment, the AD of Clinical Assurance and Health and
      Safety/Non-Clinical Risk Manager must be notified. Likewise, these members
      of staff will also need to know if the incident has led to an adverse reaction
      relating to supplies or food; or as a result of a breach of the Health and Safety
      at Work act 1974 and associated regulations.

      4.4.5 The Head of Communications should be notified if it is considered that
      the incident may attract media interest.

      4.4.6 The Senior Manager in the service where the incident has occurred
      has a key responsibility to carry out a de-briefing meeting with the staff
      involved as soon as possible after the incident. The senior manager or line
      managers should then de-brief other staff and associated team members
      about what has occurred in their service. This should then be recorded on the
      „RCA report and action plan‟ form.

      4.4.7 The Senior Manager may also wish to consider whether a chaplaincy
      service should be provided to offer staff or relatives support if this is
      appropriate.
      4.4.8 Standing Financial Instructions must also be followed in all cases.


   4.5 Commissioning PCT

              CDDFT is required to report serious incidents to the Commissioning
               PCT and provide assurance that „best practice‟ incident management
               and investigation arrangements are in place. In order to fulfil this
               requirement, assurance that SUI reports and action plans have been
               fully implemented will be provided to the Commissioning PCT through
               the Clinical Quality Review Group.



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              CDDFT will provide SUI 24/72hr update reports on request from the
               commissioning PCT.

              All „Never Events‟ (Appendix H) must be reported immediately to the
               Commissioning PCT by the Director of Nursing and Service
               Transformation.

              Details of SUIs should be shared with the National Patient Safety
               Agency rapidly via the National Reporting and Learning System
               (NRLS).

              Consideration should be given to informing other relevant external
               stakeholders.


4.6   Media and Public Interest Protocol
      All media enquiries will be handled from the Chief Executive‟s office.
      Press statements will be coordinated, when appropriate, with the Head of
      Corporate Affairs. In the event of a serious criminal incident where the police
      are informed, any press statement will be prepared with the police press
      officer. Any statement relating to a prisoner will be handled by the Prison
      Authority
      The media will not be given any information with regard to personal injury or
      information until the patient; their relatives or staff injured have been informed.
      No information will be given without prior agreement of the individuals
      involved. There will be due regard for patient confidentiality when drafting
      press statements. In cases where there is potential for a claim to be brought
      against the Trust, the NHS Litigation Authority will need to be involved in the
      preparation of any press statements.
      Information given to the media will concentrate on the fact of the incident and
      where possible its potential consequences, but personal speculation about the
      cause of the incident will be avoided.
      Important note: Any member of staff, who takes a call from the media should
      ask the caller to contact the Chief Executive‟s Office.
      In the event of large numbers of patients being involved, a help line may be
      required.
      „Out of hours‟ media enquiries
      In the evenings and at weekends, a Senior Manager and Executive Director of
      the Trust are on call. If the on call Senior Manager or Executive Director need
      advice on handling a difficult media enquiry they can request advice from the
      Strategic Health Authority Communications Department, via (0191) 2106464.




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4.7     Help line/Hot line
        If the incident warrants setting up a hot line/help line for members of the public
        to contact, the agreed procedure should be implemented (Appendix C).


4.8     Implementation and Training
      4.8.1 Responsibilities
      Specific training has been identified as relevant for this policy. This training is
      provided by the Patient Safety Team and includes Risk Management, Incident
      reporting, Being Open and RCA training.
       4.8.2 Training
       So that all staff can understand the importance of the Incident reporting system
       the Trust will ensure that staff are trained to the appropriate level.
       Trust Board members and senior managers attend training appropriate to their
       identified needs on a yearly basis.
       All managers or staff involved in investigating incidents must undergo training
       on root cause analysis incident investigation techniques and risk grading. This
       training consists of a 1 day programme based on the NPSA Root Cause
       Analysis methodology. The objectives of the course are to:

               Increase the understanding of the theory underpinning RCA
               Provide candidates with an overview of the RCA process
               Provide skills in some RCA Tools
               Demonstrate the advantages of using a systems-based approach to
                patient safety incidents.
       Safety teams will receive appropriate specialist training as identified in personal
       development plans.
       All other staff groups will receive information on the risk management
       processes and how to report incidents on the Trust induction day.
       Additional training can be provided to departments / divisions by contacting the
       relevant safety/risk manager (Clinical or Non-Clinical)


5     Key Performance Indicators
It is essential that organisations put in place effective controls to ensure employees
have read, understood and work to agreed policies. Within community services,
policies are distributed through the „Safeguard‟ system.
This policy will be reviewed on a 3 yearly basis unless national, regional or
professional bodies require an earlier update.

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The effectiveness of this policy will be reviewed by the following:

      Discussion and identification of potential actions of issues raised at the
       appropriate risk related group (i.e. Health & Safety, Security, Patient Safety
       Committee)
      Number of incidents reported via the IR1 system
      Number of claims following an incident
      Number of complaints
      Number of incidents benchmarked against other Trusts using the ERIC
       statistics.
A report outlining the above will be forwarded to the Trust Board via the Risk
Management Committee on a quarterly basis and subsequent action plans
developed and monitored.
Learning

The following mechanisms and processes will be adopted within CDDFT to
maximise learning opportunities from incidents.

Learning at individual and service level

All staff should use incidents as the basis for reviewing their own professional
practice on an individual or collective basis.

Once an immediate remedial action has been implemented, the team or department
should meet to review current practice in the light of experience.

The review must consider practice or procedural issues and staff development
issues, patient, public or carer issues and the humanitarian impact of the incident,
policy issues, the use of the „risk assessment‟ process.

Members of the PSC, Health and Safety Committee and Information Governance
Committee have a specific responsibility disseminate outcome lessons and themes
from across CDDFT to their represented services.

Organisation wide learning

The Safety Committee will be made aware of SUI incidents that have previously
been subject to the SUI management procedure, and have subsequently re-
occurred. In addition to learning at local level, CDDFT will share learning as follows:

Integrated Complaints, Litigation Incidents & PALS reports will be forwarded to the
Safety Committee for observation and scrutiny.

Depending upon the nature of the SUIs, internal Safety Alerts will be developed by
the relevant team and disseminated across the organisation.

In order to strengthen learning and minimise future risks, a regular lessons learned
bulletin will be produced and circulated to all CDDFT staff.


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6      References
    1. NHSLA „Risk Management Standards for Acute Trusts” April 2007. Available
       at www.nhsla.com
    2. Department of Health 2001 “Building a Safer NHS for Patients” HMSO
       London. Available at
       www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAn
       dGuidance/DH_4006525
    3. ALARM/UCL 1999 “A Protocol for the Investigation and Analysis of Clinical
       Incidents” ALARM, London.
    4. Health and Safety Executive (HSE) The Reporting of Injuries, Diseases and
       Dangerous Occurrences Regulations 1995 (RIDDOR), HSE Books. Available
       at http://www.hse.gov.uk/pubns/hsis1.pdf
    5. Connecting for Health, Information Governance Toolkit
    6. National Patient Safety Agency‟s
    7. Health & Safety at Work Act 1974
        General duties of Employers and Employees. Requirement that employers
        assess and manage risks to health and safety.
    8. Human Rights Act 1998
        Rights and freedoms protected under the European Convention on Human
        Rights. It is unlawful for public authorities to act in a way that is incompatible
        with a Convention Right.
    9. Freedom of Information Act 2001
        All information held by public authorities is subject to disclosure under the
        Freedom of Information Act 2000 (FOI). From January 2005 the Act allows
        anyone, anywhere to ask for information held by organisations, although
        some information, such as patient identifiable information, is exempt.
    10. Data Protection Act 1998
        The Data Protection Act 1998 became law in March 2000. It expands
        on the 1984 Act to include manual as well as electronically held
        records. It also encompasses the Access to Records Act 1990 where it
        applies to living people. There are eight principles put in place by the
        Data Protection Act 1998 to make sure that information is handled
        properly.
    11. Equality Act 2006
        Provisions relating to Human Rights and discrimination on grounds of race,
        religion or belief sexual orientation; sex; amends the Disability Discrimination
        Act 1995.




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7    Associated Documentation
     Cross References (internal):
     Risk Management Strategy
     Risk Management Operational Policy
     Health and Safety Policy
     Violence and Abuse Policy
     Complaints Policy
     Medical Devices Policy
     Infection Control Manual and Policies
     Security Policy
     Major Incident Plan
     Claims Policy
     Whistleblowing Policy
     Being Open Policy
     Supporting staff involved in potentially traumatic or stressful work related
     incidents guidelines
     Falls Policy
     Security Incident Management Policy (POL/HIG/0010)




POL/N&Q/0022                        Version 1.1                      Page 17 of 45
                                                                           APPENDIX A


         PROCEDURE FOR THE REPORTING, MANAGEMENT &
                      INVESTIGATION OF
              SERIOUS UNTOWARD INCIDENTS (SUIs)
              (COMMUNITY HEALTH SERVICES ONLY)
Reporting and Management
   1. The first priority when a SUI occurs is to ensure the needs of individuals
      affected by the incident are attended to, including urgent clinical care. A safe
      environment should be re-established, all equipment or medication retained
      and isolated, and relevant documentation copied and secured to preserve
      evidence and facilitate investigation and learning. If a crime is suspected, the
      scene/environment should be preserved.

   2. An employee must report a SUI immediately or as soon as it is discovered to
      the relevant line manager and a Patient Safety & Clinical Risk Officer
      Manager (PSCRO). The PSCRO will be responsible for notifying the Clinical
      Director of Community Services and a HR Manager. The line manager will be
      responsible for notifying the Clinical Divisional Manager/Head of Service
      (where the incident has occurred). The Clinical Divisional Manager/Head of
      service must notify their appropriate service director depending upon the
      nature of the incident.

   3. Depending upon the features of the SUI, it may be necessary to involve the
      local police. It may be difficult to decide about police involvement and it should
      always be discussed with a PSCRO in any case.

      Police involvement should be considered when it is known there is one or
      more than one of the following:

              deliberate harm caused to patient or employee
              theft
              loss of identifiable data
              violence or the threat of violence
      NB – this is not an exhaustive list and there may be other instances where
      police involvement is recommended.
   4. If the incident is potentially a child or adult safeguarding concern, the relevant
      documents should be referred to and a safeguarding alert raised (CO 033
      NHS Safeguarding Children policy, CL 063 Safeguarding Adults at Risk of
      Abuse policy, Clinical Governance and Adult Safeguarding flowchart (NPSA
      „National framework for reporting and learning from serious incidents requiring
      investigation‟)).

      Please see flowcharts for both „in‟ and „out of normal‟ working hour‟s
      procedure.


POL/N&Q/0022                         Version 1.1                           Page 18 of 45
   5. Once the employee has reported the incident verbally, an on-line incident
      reporting form should be completed through the Safeguard system within
      24hrs of the incident being discovered.


   6. Once the reporter has completed and submitted the on-line incident form, a
      „trigger notification‟ will be automatically sent to the:

           Reporter‟s line manager and other managers depending upon the
            nature of the incident as described below:

Contractor /Visitor Accident                 Health & Safety/Non Clinical Risk Team
Environmental Management
Fire
Infrastructure/Estates/Facilities
Staff Accident /Incident
Staff Car Accident
Staff Ill Health
Violence and Aggression
Security
Medical Devices/Equipment
Unexpected Death                             Patient Safety Team
Security
Medical Devices/Equipment
Information Management & Technology          Records Manager/Information
Information Governance                       Governance
Documentation and record keeping             Patient Safety Team
Consent, communication & confidentiality
Medication general                           Medicines Management Team
Medication controlled drugs                  Patient Safety Team
Medical devices/equipment                    Medical Devices Lead
                                             Patient Safety Team
Pressure sores                               Patient Safety Team
Safeguarding adults
Clinical Care (implementation/monitoring)



   7. On receiving a trigger notification, the line manager should complete and
      submit their section of the incident form within 48hrs. Other relevant service
      managers on receiving a trigger notification should follow their agreed
      procedure.

   8. The Director of Nursing and Service Transformation as Lead Officer for
      managing all SUIs, will decide whether the SUI is reported to the SHA Patient
      Safety Team via the Strategic Executive Information System known as
      ‟STEIS‟.
      Please see Appendix D.




POL/N&Q/0022                        Version 1.1                          Page 19 of 45
Investigation
   9. An investigation should be carried out and the following adhered to:

          i)   A lead investigator should be appointed by Clinical Divisional Manager.

          ii) The RCA resource pack (Appendix ) should be consulted and an RCA
               undertaken. The RCA must be carried out within 20 working days of
               the incident being discovered and should involve the lead investigator,
               Staff members involved, any other relevant persons, and can be
               facilitated by a PSGM.

          iii) The „RCA investigation report and action plan‟ template (Appendix )
               should be completed by the lead investigator and timescale for action
               plan completion agreed.

          iv) The completed report and action plan should be submitted to the
               Patient Safety Team for initial quality check.

          v) A review meeting must take place within 10 working days of the RCA
               investigation to assess the quality and validity of the report and action
               plan and to decide whether any further action is required e.g. additional
               training or further investigation under NHS Darlington‟s Discipline
               policy. Review meeting attendees should include lead investigator,
               PSCRO and HR representative (if necessary). Attendees may change
               according to the nature of the incident.
      NB Unless there are extenuating circumstances the internal investigation
      process for a SUI will be completed within 60 working days.
      Once the RCA report and action plan are finalised, they should be:
          vi) „Signed off‟ by Clinical Divisional Manager/Service Manager as they
               receive the reports and decide on any further action to ensure that the
               content is appropriate, clear, concise and timely.

          vii) Submitted to the Patient Safety Team (PST) 14 days before the date of
               the next SC meeting for final quality check and necessary
               amendments.

          viii) Submitted to the Safety Committee (PSC) for review.

               PSC takes place once a month. Reports and action plans should be
               submitted to the next SC meeting following the RCA investigation.
               Any delays must be accounted for to the SC.




POL/N&Q/0022                          Version 1.1                          Page 20 of 45
               Escalation Process
               If the report and action plan are not received by the PST 14 days
               before the next SC meeting, escalation will occur as follows:
                  -   Delay of 4 weeks – Clinical Divisional Manager will be contacted
                  -   Delay of 8 weeks – Letter from Clinical Director of Community
                      Services to Clinical Divisional Manager advising report and
                      action plan to be submitted to following SC meeting.
Action Plan Implementation and Monitoring
          ix) The action plan should be implemented according to the agreed
               timescale. An update on the progress of the action plan will be
               presented by a PSCRO to the SC on a monthly basis to ensure
               implementation timescales are met. This also provides the opportunity
               for advice/guidance to be sought on possible implementation
               barriers/difficulties.
               A similar escalation process to above will be adopted if the action plan
               is not completed within the agreed timescale.
          x) Completed action plans should be signed by Clinical Divisional
               Manager and re-submitted with supporting evidence showing how the
               action plan was implemented, to the PST 14 days before the next SC
               meeting final checks. The action plan will be re-submitted to the SC
               and should be presented by the relevant SC member for final „sign off‟
               by the committee. The SC will decide whether or not enough action
               has been carried out to prevent the incident recurring or reduce any
               residual risk as far as possible.

          xi) Managers must ensure they collate evidence to support how action
               plan implementation has been achieved.

          xii) Lessons learned from the incident investigation will be disseminated
               throughout CDDFT, the wider organisation and with external
               organisations including the SHA and NPSA.




POL/N&Q/0022                          Version 1.1                          Page 21 of 45
                      REPORTING, MANAGEMENT AND INVESTIGATION OF SUIs
                                    „IN WORKING HOURS‟


                                                SUI occurs (definition 2.0)




                                               Reporter makes the situation „safe‟ and

                                         preserves equipment, medication and documentation


                                                                                                PSCRO        informs       Clinical
       Reporter completes on-line                   Reporter informs line manager               Director of Community Services
       incident report form via                      and PSCRO immediately                      and HR Manager and if relevant
       Safeguard (within 24 hrs)                               (verbally)                       other service managers (e.g.
                                                                                                Health & Safety). Information
                                                                                                gathering      to      begin     in
                                                                                                conjunction       with     service
                                                Line manager informs Clinical Divisional        manager        using       probing
                                               Manager/Head of Service and AD from the          questions
       Line     manager      receives             service where the incident occurred
       Safeguard incident report
       trigger and completes the
       incident report form (within
       48hrs).       Other   relevant
       services also receive the                Clinical    Divisional   Manager     informs
       trigger notification.                    appropriate service Director depending upon
                                                nature of incident.


NB: All this
happens within        Incident discussed with Clinical Director of Community Services, CEO or Deputy, and Service
24 hours except       Director.
where        stated
otherwise




                                               Decision made as to whether the
                                               incident is reportable to the SHA via
                                               STEIS

           YES - SUI IS reportable to
           SHA and Service Director/AD                                         NO – SUI does NOT fulfil SHA
           informed                                                            reporting   criteria and Service
                                                                               Director/AD informed




       PSCRO places the SUI
       incident description on
       the SHA STEIS database                        Consideration given to:

                                                          Police involvement
                                                          Media protocol
                                                          Involvement of Commissioners
                                                          Informing the patient/family/relatives
                                                          Safeguarding
                                                          Any disciplinary issues and HR involvement




                                                                                             Continued overleaf…..
    POL/N&Q/0022                                   Version 1.1                                   Page 22 of 45
                                             Clinical Divisional Manager appoints Lead
                                                             Investigator




    SUIs reportable to SHA
    are updated on STEIS
    database by PSCROs as                 RCA conducted within 20 working days. High
    appropriate.       Lead               level risks are rapidly identified to PSCROs/H&S
    Investigator and PSGM
    discuss/develop    rapid
    response         reports
    required by SHA
                                       RCA report and action plan drafted and timescale
                                       for completion of action plan agreed



                                                                                                  Consideration given to
                                       Completed report and action plan submitted to              producing Patient
                                       Patient Safety/H&S Team for initial quality check.         Safety/H&S Alert with
                                                                                                  key learning from SUI.




                               Review meeting takes place within 10 working days of the RCA
                               investigation to assess quality and validity of report and action plan and
                               decide whether further action required


 NB Reports and action
 plans should be submitted
 to the next SC meeting                     Report and action plan signed off by Clinical
 following     the      RCA                 Divisional Manager
 investigation. Any delays
 must be accounted for to the
 SC


                                            Report and action plan Submitted to the             Escalation Process
                                                                                    nd
                                            Patient Safety Team (PST)/H&S team by 2
                                            Wednesday of the month                              If the report and action plan are
                                                                                                not received by the PST by the
Report and action plan                                                                            nd
                                                                                                2 Wednesday of the month,
forwarded to SHA (within                                                                        escalation will occur as per
45 or 60 working days                                                                           procedure (Appendix A)
dependent upon incident
                                            Report and action plan Submitted to the PSC
grading). For independent                   for review.
investigations within 26
weeks.


Update on the progress of the               Action plan implemented according to agreed
action plan will be presented by            timescale.
a PSCRO to the SC on a
monthly    basis     to   ensure
implementation timescales are                                                                          Continued overleaf…
met
                                                                                             Continued overleaf…..

 POL/N&Q/0022                                    Version 1.1                                    Page 23 of 45
                          Once completed, action plan signed off and re-
                                                                  nd
                          submitted with evidence to the PST on 2
                          Wednesday of the month for final checks.




                           Action plan re-submitted to SC and presented
                           by relevant PSC member for final „sign off‟.




                        Lessons learned from the incident investigation disseminated
                        internally and externally




                                                                           Key:

Abbreviations
AD              Assistant Director                                           Text in rectangle = reporting action
CEO             Chief Executive Officer
CDCS            Clinical Director of Community Services
FSM             Functional Service Meetings
H&S             Health and Safety
SC              Safety Committee                                                  Text in oval = point of
PSCRO           Patient Safety & Clinical Risk Officer                            consideration
RCA             Root Cause Analysis
SHA             Strategic Health Authority
SMT             Senior Management Team
STEIS           Strategic Executive Information System
SUI             Serious Untoward Incident




POL/N&Q/0022                               Version 1.1                                    Page 24 of 45
                            REPORTING AND MANAGEMENT OF SUIs
                                 „OUT OF WORKING HOURS‟


                                        SUI occurs (definition 2.0)




                                      Reporter makes the situation „safe‟ and
                                      preserves equipment, medication and
                                                 documentation



                                         Senior Manager On-call is notified


                                      Executive Director On-Call informed by
                                             Senior Manager On-Call




                             Consideration given to the features of the incident and
                             decision made about the status of the SUI based on
                             SHA criteria (in on-call pack)



                                                                                NO – SUI does NOT fulfil
    YES - SUI IS reportable to
                                                                                SHA reporting criteria
    SHA STEIS database


                                           Consideration also given to:
Upload SUI details to SHA                         Police involvement
STEIS       using       operating                 Media protocol
procedure in on-call pack                         Involvement of
                                                   Commissioners
                                                  Informing the
                                                   patient/family/relatives
Report incident to Director of                    Safeguarding
                                                      cc
Nursing        and       Service                  Any disciplinary issues
transformation and AD of Clinical                  and HR involvement
Assurance next working day.




                               Follow    SUI    reporting  procedure                              Key:
                               (Appendix A) 9.00am next working day
                               and alert correct service manager and               Text in rectangular box =
                               PSCRO to escalate incident.                         reporting action


                                                                                       Text     in    oval
                                                                                       boundary = point of
                                                                                       consideration



  POL/N&Q/0022                                 Version 1.1                             Page 25 of 45
      SUIs PROGRESSING TO FURTHER INVESTIGATION UNDER DISCIPLINARY
                               PROCEDURE

                                Investigating officer appointed by                                 Within 0 + 33 working
                                  HofS within 3 working days of                                     days of the incident
                                    the RCA review meeting                                               occurring



                                                                                                   Within 0 + 53 working
                    Further investigation involving staff member using                              days of the incident
                        principles of disciplinary/capabilities policy                                   occurring



 Action                  Investigation report and recommendations to                               Within 0 + 58 working
  plan                        manager/HR within 5 working days                                      days of the incident
                                                                                                         occurring



                                                           Where possible,
                                                             operational                           Within 0 + 63 working
                                                       recommendations from                        days of the incident
                                                         report implemented                        occurring



                       No Hearing                                Disciplinary                      Within 0 + 78 working
                                                                  Hearing                           days of the incident
                                                                                                         occurring


             Individual              Systems                 Individual            Systems
             action     plan*        issues                    action               issues
             monitored               identified not             plan            identified not
             through PDP             picked up in            monitored           picked up in
             and E-KSF               RCA                      through                RCA
                                                             PDP & E-
 Patient                                                        KSF
 Safety
Committe
   e                                                            Action
                                                                 plan
   All actions
 signed off and
   shared via
    Lessons                                                  Patient Safety
Learned Bulletin                                              Committee



      1. Letter of decision to be copied to relevant manager and Head of Service for monitoring
         purposes.
      2. Patient Safety Committee monitors all systems related action plans to ensure organisation
         wide learning.
      3. Clinical Director of Community Services and Clinical Quality to receive outcome of all
         hearings in relation to clinical staff (registered and non-registered).
      4. Timescales may need to be extended to address



  POL/N&Q/0022                                 Version 1.1                                       Page 26 of 45
                                                                         Appendix B

     Protocol for Investigation and Review of Serious Untoward
                                Incidents
                       (ACUTE SERVICES ONLY)
Introduction
This protocol is a framework to facilitate in-depth analysis of and learning from
events where there has been significant harm to or death of a patient.

Aim / Purpose
 To ensure in-depth analysis of the incident, claim or complaint
 To ensure appropriate experience and expertise is fully applied to the review
   process
 To ensure that (in addition to the immediately obvious cause) all the events
   leading up to the adverse outcome are considered
 To ensure a structured and systematic approach is applied to the review aiding
   mapping of the events, a comprehensive investigation and production of a formal
   report
 To ensure a consistent (and documented) approach is used to all incidents,
   therefore, increasing openness for staff, reducing fear of unknown and creating a
   less threatening approach
 To facilitate a climate of openness and a blame free approach
 To ensure that learning takes place, reducing subsequent / similar risks
 To ensure that the findings are applied at all relevant levels



Scope
Any incident, claim or complaint which has been categorised as red during the
investigation should be reviewed using this protocol. The protocol may also be used
for other incidents, claims or complaints where the executive team feel that there
may be significant lessons for the organisation.
Initiation
The Chief Executive or any member of the executive team can request a review of
an incident, claim or complaint.

This decision is taken after considering the incident report, claim or complaint file,
the advice of the appropriate Risk Manager, Complaints or Legal Services Manager,
initial discussion with lead consultants and / or nursing and Para-medical staff.

Who should investigate?

There needs to be a degree of objectivity and independence in the review and for
this reason, in the case of a clinical event, the lead consultant and clinical staff
actively involved in the case may not be involved in conducting the investigation.



POL/N&Q/0022                        Version 1.1                          Page 27 of 45
The appropriate Risk Manager, Complaints Manager or Legal Services Manager will
be actively involved in the review process with the support of either the divisional
manager, matron for the ward or the Clinical Director or appropriate staff in the case
of a non-clinical incident.
The appropriate Director will advise who will be the lead reviewer and who will assist.

Roles and responsibilities (Duties)
The lead reviewer conducts all interviews and prepares a report for the appropriate
Director.
The second reviewer supports the lead at reviewer interviews taking notes and
clarifying points made where necessary.
The lead reviewer is responsible for ensuring that the relevant external agencies
have been notified and where appropriate either consulted or involved in the
investigation process.

Disciplinary Issues
The purpose of the review is to learn lessons and, rather than seek to blame
individuals, consider the wider general organisational issues.
The occurrence of an event is not in itself evidence of neglect, carelessness or
dereliction of duty. Only if evidence of repeated poor performance emerges despite
adequate training / retraining will disciplinary action be considered.
If this becomes evident then advice should be sought from the Personnel
Department. The Trust‟s policy on discipline gives more detail on this point.

Interviews
     Clinical Incidents, complaints and claims
The interview questions will need to be tailored to meet the requirements of the
situation. However, an outline checklist to aid the reviewer in formulating the
questions is given at the end of this procedure.

      Non-clinical incidents, complaints and claims
The interview questions will need to be tailored to meet the requirements of the
situation. The Director will ensure that the lead reviewer has sufficient expertise to
ask pertinent questions.

Report
A report of the investigation and findings will be produced by the review team. The
report will describe the chronology of events, map the events and put them into
context i.e. (environmental factor, statutory requirements, care management
problems, clinical context and factors, specific and general contributory factors).
The report should include the following:

      Statement of what happened

POL/N&Q/0022                         Version 1.1                          Page 28 of 45
      The review team
      The nature of the investigation
      The findings
      The root causes
      Recommendations (with timescales)
      Lessons learned
      Any audit findings


Follow Up
Once completed the report should be presented to the appropriate director and
reviewed according to the Trust process. The original incident form will be re-graded
as appropriate by the appropriate Manager. Lessons learned will be shared at the
Safety Committee, Health Care Governance Committee and appropriate divisions.
Training
Root Cause Analysis training is available and should be offered to all staff who may
undertake an investigative role.
Further information is available from Clinical Risk Management or the Life Long
Learning directory.


http://cddah-
spweb/sites/personnel/learning/Life%20Long%20Learning%20Directory/Forms/AllIte
ms.aspx


All staff may access this training to gain a greater understanding of Root Cause
Analysis, Incident and Staff Accident Investigation.




POL/N&Q/0022                        Version 1.1                         Page 29 of 45
      Flow Chart showing the Communication Procedure following an Incident
                                (Acute services)


                          Person                              Patient and/or Relatives/
                                                              Next of kin
                          witnessing event




Consultant                Ward Manager/
                          Site coordinator
(or GP)




Clinical Director         Senior      Nurse               Risk Manager/ Legal
                          Directorate                     Services Manager
                          Manager/

                          Manager on call


Medical Director
                          Director of Nursing
                          or executive on
                          call
                                                           Other staff




Media               Chief             Chairman
                    Executive




                    Stakeholders


                                                    Key

                                                             Direct communication

                                                             Ensures communication
                                                             has taken place



  POL/N&Q/0022                        Version 1.1                           Page 30 of 45
                     Incident Investigation- Checklist of Contributory Factors

   Please consider each question in turn, in the light of the incident and tick all questions you
   agree with

 Framework                              Contributory Factors                             Tick   Tick
   Factor                                                                                 for    for
                                                                                          No    Yes
Org & Man         Do you feel that management generally showed appropriate care
                  and concern?
Work              Did the working environment (e.g. heat, noise, etc) affect you?
Environment       Was there adequate and reliable information from all equipment?
                  Did all the equipment you used work adequately and effectively?
                  Did you have enough medical and nursing supplies?
                  Did you have to rely on a new (locum) doctor or (agency)
                  nurse/midwife whom you had not worked with before?
                  Do you feel your orientation period to the hospital/speciality/ward
                  prepared you for this case?
                  Was your training in using equipment/protocols sufficient for this
                  case?
                  Did you have to spend time on non-clinical duties?
                  Did you have an unexpected or sudden increase in workload?
                  Did you have to prioritise more than one case simultaneously?
                  Were there delays in carrying out clinical procedures?
Team              Was communication between yourself and other members of staff
                  effective?
                  Was there any language or                  cultural problems      or
                  misunderstandings between staff, the patient and the relatives?
                  Were the case notes available, legible, attributable and complete?
                  Were the case notes adequately flagged to alert you to risk
                  factors?
                  Did you have adequate supervision or support?
                  Was help/advice from another member of staff available at all
                  times?
                  Did staff agree about who was in charge either of the patient or the
                  ward?
Individual        Do you feel you had enough knowledge and experience to deal
                  with the problem/complication?
                  Did you feel tired, hungry or unwell?
                  Did you feel appreciated and was your morale high?
                  Do you feel your opinions and competence were accepted,
                  appreciated and unquestioned?
Task              Was there agreement regarding the interpretation of test results?
                  Were routine tests carried out and the results documented in the
                  notes?
                  Were test results quickly and easily available?
                  Was the appropriate person consulted when necessary about the
                  management of care?
                  Did you have enough time to spend with the patient explaining
                  procedures, possible complications and outcomes?
Patient           Was the patient/visitor helpful and co-operative?




   POL/N&Q/0022                             Version 1.1                             Page 31 of 45
Please use the following space to expand on any questions




POL/N&Q/0022                    Version 1.1                 Page 32 of 45
                                                                                      Appendix C

                  Procedure for setting up a Hotline/Helpline
                    (Acute & Community Health Services)

In some incidents, such as problems with screening results, it can be anticipated that there
will be multiple enquiries from the public or other stakeholders.

In the event that a large number of patients or relatives are likely to make telephone
enquiries the Trust will consider establishing a “help line”. The Chief Executive or nominated
executive director will authorise the establishment of a help line under the leadership of a
nominated coordinator. The relevant senior managers and clinicians will agree the
information to be given and the number of staff required. Usually senior nursing staff will be
required to staff the phone lines, although this may need to be revised according to the
nature of the incident. All staff answering calls to the helpline will receive a full briefing on the
incident, Trust response and information required to be documented prior to taking any calls.
Consideration will be given to use of an external body such as NHS Direct who have
expertise in this area. In some cases elements of the major incident policy may be
implemented.

A press release stating the help line number will be drafted and issued via the usual
channels. Help lines will be based at University Hospital North Durham, in the old Trust
headquarters or in the post graduate centre. At Darlington Memorial Hospital the help line
will be established in the Executive Boardroom where multiple telephone lines are available.
A written record of the calls received will be made including a summary of the advice given.
A proforma for this purpose is included at Appendix C, but this may be altered to suit the
requirements of the incident. In agreeing what information is to be divulged by help line staff,
due attention will be paid to data protection. For this reason although e-mail may be used to
communicate internally with staff, external correspondence will be by letter or telephone.

If it is necessary to contact a large number of patients by post, a team led by the
coordinating Executive Director must agree:

       The content of the letter to be sent
       To whom the letter should be sent
       Who should sign the letter
       The timing of the letter, including who will liaise with the post room about the volume
        and timing of the mail
       The timing of any media release
       The timing of the opening of a telephone “hot line”

The coordinator will review the number of calls made to the help line and based on the
information the Chief Executive and appropriate directors will declare “stand down” at an
appropriate time. Before stand down is declared arrangements will be made for the receipt of
any further calls relating to the incident and switchboard will be informed of these
arrangements.




POL/N&Q/0022                               Version 1.1                                Page 33 of 45
                                                                             Appendix D

  ESCALATION TO THE STRATEGIC HEALTH AUTHORITY (SHA)


 1. If the Director of Nursing and Service Transformation decides that the SUI is to
    be reported to the SHA, this must occur within 24 hours of the incident being
    discovered and placed on the electronic STEIS database. On a normal working
    day (9am-5pm Monday to Friday), this will be done by a PSM; outside of normal
    working hours, by the Executive Director on call.
    It is important to note that only those SUIs with features matching the
    SHA‟s „reportable‟ criteria will be placed on the SHA STEIS database.
    There will be occasions when serious untoward incidents occurring in
    CDDFT do not need to be reported to the SHA because the incident does
    not meet the STEIS reporting criteria.
 2. Once an incident has been reported to the SHA, the „incident grade‟ should be
    identified by a PSCRO and agreed in conjunction with the SHA for purposes of
    determining the investigation and monitoring approach as follows:

    Grade 0 – Notification only. The provider organisation must update the
    PCT/SHA with further information within 3 working days of a grade 0 incident
    being notified. If within 3 working days it is found not to be a serious incident, it
    can be downgraded with the agreement of the accountable SHA/PCT.

    Grade 1 – RCA required within 45 working days from the date the incident is
    notified to the PCT/SHA.

    Grade 2 - RCA required within 60 working days from the date the incident is
    notified to the PCT/SHA.

    For further information on incident grading please see:
    NPSA National Framework for reporting and learning from serious incidents
    requiring investigation, winter 2010 - www.nrls.npsa.nhs.uk/patientsafetydirect

 3. The PSCRO should notify by e-mail the following members of staff that an
    incident has been reported via STEIS - the Chairman, Chief Executive, relevant
    Clinical Director and AD of Clinical Assurance.

 4. If the Director of Nursing and Service Transformation decides that the SUI is not
    reportable to the SHA STEIS, it will continue to be managed by CDDFT and
    investigated in exactly the same way as STEIS reportable incidents. The only
    difference being that this type of SUI does not meet the STEIS criteria and is
    therefore not externally reportable.

 5. Where SUIs are STEIS reportable, PSCROs should ensure regular contact is
    made with the SHA regarding the updated position and should have updates
    available upon request for 24/72hr reports. It is therefore important that the
    relevant line manager, lead investigator and PSCRO remain in close contact so
    that new information can be shared and reported on.

POL/N&Q/0022                          Version 1.1                            Page 34 of 45
 6. Out of normal working hours, the Senior Manager on call is responsible for
    ensuring that the Executive Director (ED) on call is made aware of the incident.
    The ED will inform the Chief Executive. The ED will then consider the features of
    the incident and decide about the status of the SUI based on SHA criteria (in on-
    call pack). If the ED decides the incident should be reported to the SHA, then the
    SUI details should be uploaded to the SHAs STEIS using the operating
    procedure in on-call pack. The Senior Manager for the service where the
    incident has occurred should discuss the incident with a PSM at 9.00 am the
    following working day, who will in turn report the matter to the Director of Nursing
    and Service Transformation. It is also important that the service manager
    discusses the incident with their Director by 9.00 am the next working day. The
    „In Normal Working Hours‟ reporting procedure must then be followed.

 7. The Director of Nursing and Service Transformation as lead officer, where
    appropriate, will convene an Incident Co-ordination Group in line with the
    „Memorandum of Understanding‟ (described in NHS County Durham and
    Darlington‟s CG001 Policy and Procedure Guidance for Reporting and
    Management of Serious Untoward Incidents, January 2010).




POL/N&Q/0022                         Version 1.1                           Page 35 of 45
                                                                          Appendix E

                               Staff support letter



Dear ……………………………..


As you are probably aware a patient with whom you have had recent
contact/provided care, died unexpectedly/was subject to an adverse event on
……………………………………….
I have enclosed a staff guidance sheet for your information which I hope you will find
helpful.
I appreciate that this is never easy for those concerned. However support is
available to you from your colleagues and managers, and I wanted to take this
opportunity to offer you my support and that of the risk management team.
The Trust promotes an open culture which allows us to work together to make this
process as open and uncomplicated as possible and to learn from what happened
and to help others who might find themselves in the same situation.
If you have any concerns or questions feel free to contact me and I will do my best to
explain what may happen next and any parts of the process you do not understand,
including confirming what is expected from you in terms any further investigations
that may be required.
I hope the information is helpful. If you have any questions, suggestions or
comments, please give me a call on the above number.
Yours sincerely




Assistant Director of Clinical Assurance




POL/N&Q/0022                         Version 1.1                         Page 36 of 45
                                                                          Appendix F

         Guidance on the Development and Writing of Statements

1.       Introduction
Staff are often requested to provide statements in response to complaints,
untoward incidents and claims against the Trust etc. The person providing the
statement may have been directly involved in, or witnessed, a specific event. On
occasion a statement is requested to clarify/confirm normal working practices in a
given situation. When developing a statement it is important to cover all of the
events in question.

Whatever the reason for providing a statement it is important that the Trust has a
standard proforma to assist staff with such a task.
2.       Purpose
The following standards should be applied whenever possible:

      Use Trust headed paper.
      Have the statement typed whenever possible. If this is not possible
       legibility should be ensured by printing the statement in black ink.
      Leave double spacing between each line of text.
      Number each page (bottom right of each sheet).
      Number each paragraph (left hand margin at first line of each paragraph).
      Statement should be single sided.


3.       Content of Statements

A statement must be in the words of the witness though assistance can be given
by a third party e.g. Head of Department, Divisional Manager.
The following guidelines should be applied:
    The statement should be in narrative form in the first person.
    Events should be complete and stated in chronological order.
      Events should be timed.
      Must provide all of the necessary factual detail and where specific issues
       are identified, i.e. via a complaint, respond to each of those issues.
      Must sufficiently reference any documents referred to (attach if
       appropriate).
         The first paragraph should include your full name and contact address e.g.
     
         I, Joe Smith c/o The University Hospital of North Durham, Durham City will
         state as follows:-


POL/N&Q/0022                          Version 1.1                         Page 37 of 45
      The second paragraph should include details of your professional
       qualifications and employment details e.g. `I am employed by County
       Durham and Darlington NHS Foundation Trust and I am a Registered
       Qualified Nurse. My qualifications are R.G.N. and I have a Diploma in
       Nursing Science. I have worked on surgical Wards for the Trust since
       1993 and I am currently employed on a full time basis on Care Ward‟.
      Subsequent paragraphs should contain detailed relevant information (in
       chronological order) relating to the issue in hand, including the
       background to the incident. It is important that you record all timings in
       your statement.
      The final paragraph should read, `I believe that the facts in this statement
       are true`.
      The statement should then be clearly signed and dated (print and sign
       name).

4.      Statements Provided in Response to Claims against the Trust

A statement developed as a direct result of a litigation claim is a privileged
document i.e. it cannot be disclosed without agreement of the Legal Services
Manager and/or the Trust Solicitors/NHS Litigation Authority.

The Legal Services Manager and/or the Trust Solicitors to ensure compliance
with the format determined within the Pre Action Protocol must facilitate
development of these statements.

The Front sheet must detail the name of the maker of the statement, version
number, date and number of exhibits e.g. articles, publication and accompanying
reports etc.

5.      Further Considerations

If you have been asked to provide a statement on issues that are outside your
expertise/knowledge then you should discuss this with the Legal Services
Manager.

Statements must omit hearsay, rumour, similar fact and opinion. You should
simply state the facts.
It should be remembered that statements provided for one purpose may be used
for another e.g. statements used for follow up of untoward incidents may be
provided to assist the Complaints Department respond to a formal complaint.
Statements provided during a complaint investigation are can be disclosed in the
event that a claim is made.

Legal Services
County Durham and Darlington NHS Foundation Trust
May 2007

POL/N&Q/0022                          Version 1.1                          Page 38 of 45
Appendix G


                Definition of a RIDDOR reportable incident


Under the reporting of injuries, Diseases and Dangerous Occurrences regulations
1995 (RIDDOR,) CDDCHS has a legal duty to formally notify the Health and Safety
Executive (HSE) of details of certain incidents that occur in the course or work
activities.
The Health & Safety Manager and Health & Safety Advisors are responsible for
ensuring that CDDCHS complies with the requirements of the regulations within the
time limits for reporting:

      Immediately for serious and dangerous occurrences.
      10 days for an „over three day‟ absence from work for staff injured in a work
       related incident.
It is therefore important to give as much detail on the Incident report, so that the
Trust can fulfil its legal requirements under RIDDOR.




POL/N&Q/0022                          Version 1.1                           Page 39 of 45
                                                                              Appendix H
                       NPSA‟s list of „Never Events‟ 2011 February

Initially in 2010 there was 8 Never Events but this has been increased if a Never Event was
 to occur they would be treated as a Serious Untoward Incident and Board need informing
                                        immediately.



1. Wrong site surgery (existing)
2. Wrong implant/prosthesis (new)
3. Retained foreign object post-operation (existing)
4. Wrongly prepared high-risk injectable medication (new)
5. Maladministration of potassium-containing solutions (modified)
6. Wrong route administration of chemotherapy (existing)
7. Wrong route administration of oral/enteral treatment (new)
8. Intravenous administration of epidural medication (new)
9. Maladministration of Insulin (new)
10. Overdose of midazolam during conscious sedation (new)
11. Opioid overdose of an opioid-naïve patient (new)
12. Inappropriate administration of daily oral methotrexate (new)
13. Suicide using non-collapsible rails (existing)
14. Escape of a transferred prisoner (existing)
15. Falls from unrestricted windows (new)
16. Entrapment in bedrails (new)
17. Transfusion of ABO-incompatible blood components (new)
18. Transplantation of ABO or HLA-incompatible Organs (new)
19. Misplaced naso- or oro-gastric tubes (modified)
20. Wrong gas administered (new)
21. Failure to monitor and respond to oxygen saturation (new)
22. Air embolism (new)
23. Misidentification of patients (new)
24. Severe scalding of patients (new)
25. Maternal death due to post partum haemorrhage after elective Caesarean
    section (modified)



Further information at DOH website Never Events.




POL/N&Q/0022                          Version 1.1                             Page 40 of 45
                                                                            Appendix I

               Rationale to Support the Provision of
          Complaints, Litigation, Incidents and PALs Reports

This document outlines the content and process for providing integrated quarterly
Complaints, Litigation, Incidents and Pals reports to the Quality & Innovation
Committee.
The purpose of the integrated report is to facilitate the analysis of Complaints,
Incidents, Claims and PALs information and allow trend analysis and correlations
between individual collections of data. The report will be future referred to as the
“CLIP” report.


Roles and Responsibilities
The Associate Director of Clinical Assurance is responsible for the initiation of the
report.
The Patient Experience Manager, Legal Services Manager, and Patient Safety and
Clinical Risk Manager will be responsible for validating their data and providing the
appropriate narrative for the report.
The Quality & Innovation Committee will receive and acts on the CLIP report and
ensures themes arising are checked against more detailed data in order to identify
future actions.
The Quality & Innovation Committee has a responsibility to ensure commitment of
Clinicians is central to effective complaints handling, particularly in terms of
embedding the learning from complaints with the Trust.
Frequency of reporting
The CLIP reports will be compiled on a quarterly basis to take account of the
following time periods:

      April/May/June
      July/August/September
      October/November/December
      January/February/March
In addition the above quarterly reports will be supported by an annual report.
Reports will go to the Quality & Innovation Committee. Representatives attending
the Committee act as the conduit for ensuring the conclusions drawn from the CLIP
Report are communicated within the Divisions.
This process will be monitored and reviewed on an annual basis to assess the added
value it provides to the Healthcare Governance Committee.




POL/N&Q/0022                          Version 1.1                          Page 41 of 45
Content of CLIP Report
The CLIP report will cover:

      Complaints, highlighting all Divisional complaints, type of complaint, actions
       taken, to identify trends and themes or any shortfalls in the service in a
       particular area in order for improvement to take place
      Litigation, highlighting all new cases within the trust, covering employer‟s
       liability, public liability and clinical negligence cases, once again any themes
       or trends will be identified with the directorates involved to allow the
       directorate to improve /change systems.
      Incidents, highlighting incidents in all areas within the Trust, top ten incidents,
       common themes, red and amber incidents, also to highlight open and closed
       cases and where possible contributory factors to patient safety incidents.
      PALs, highlighting all enquiries via PALs, specifically looking at how the
       enquiry came into PALs, common themes, trends and outcomes.
The report will cover Site specific data, directorate specific data and if required
location exact data.
Identification of Risks
The risk matrix is used where risks are derived from the CLIP Report and
subsequently this initiates population as appropriate of Risk Register, Corporate and
Operational.
Sharing information from lessons learned
       Learning at individual and service level
          All staff should use incidents as the basis for reviewing their own
           professional practice on an individual or collective basis.

              Once an immediate remedial action has been implemented, the team or
               department should meet to review current practice in the light of
               experience.

              The review must consider practice or procedural issues and staff
               development issues, patient, public or carer issues and the humanitarian
               impact of the incident, policy issues, the use of the „risk assessment‟
               process.

              Members of the Safety Committee, Health and Safety Committee and
               Information Governance Committee have a specific responsibility
               disseminate outcome lessons and themes from across CDDCHS to their
               represented services.


   Organisation wide learning

              Depending upon the nature of the SUIs, internal Safety Alerts will be
               developed by the relevant team and disseminated appropriately.



POL/N&Q/0022                           Version 1.1                           Page 42 of 45
              Where there are lessons to be learned emerging from the CLIP Report,
               either local or organisational, direct communication in writing is to be
               made with the appropriate Directorate.
              In the event of organisation-wide lessons a Trust-wide communication
               will be distributed. In addition the lessons learned will feature (where
               appropriate) in „Delivering Excellence” (Clinical Governance Newsletter).

              A further internal transmission avenue for learning lessons exists via the
               directorate Clinical Governance half day events.


Sharing information externally to the Trust
The Trust participates in SHA Networks to ensure cross organisational learning. In
addition there are representatives of whole health economy as members of Clinical
Governance Committee i.e.; PCT reps.




POL/N&Q/0022                            Version 1.1                          Page 43 of 45
                                                                            Appendix J

Date
Private and Confidential
Dear ………………….
It is with great regret that I write to you about the service you recently received from
the ………. (team/service) here at County Durham and Darlington Foundation Trust.
It was never our intention to cause harm to you and your family and we are deeply
sorry for the error, and the harm it has caused.
We always investigate incidents and errors of this type and have a national
procedure to follow which is set by the NHS. I think the investigation will take around
…….days and I am hoping to have the completed investigation report by (date).
The exact cause of the incident will emerge as we go through this investigation
process but the fact that we made certain key errors is already evident. It is clear
that…..
(Insert a very short factual explanation of what happened using:

      short sentences
      no abbreviations or complex terms

Since some of the errors leading up to this incident are already clear, we will act on
these immediately to make sure that they do not happen again. The investigation
may highlight other errors as we go through the process. County Durham and
Darlington Foundation Trust will draw up an „action plan‟ to show the work we will do
to rectify these errors. I would like you to be involved in helping us to draw up this
action plan if you are willing to do so. I will be in touch with you again about this.
It is natural that you may wish to think about talking to the NHS Patient Advice and
Liaison Service PALS), the NHS complaints service or an Independent Complaints
Advocacy Service (ICAS). If you would like to know how to contact these services,
please do let me know. I would be happy to forward any information to you.
In closing, please accept my sincere apologies for the harm our service has caused.
Yours sincerely


Words in this template letter are either extracted from or based upon NPSA
Policy „Being Open when Patients are Harmed: Safer practice notice 10‟.




POL/N&Q/0022                         Version 1.1                           Page 44 of 45
                                                                                     Appendix K

       Record of telephone enquiry in the event of a Major Incident or
       Major Adverse Clinical Incident
Nature of
Incident

Date            Time           Call taken by
                               (print name)


Name of Caller (Status of Caller e.g. friend, family member or general public etc)




Details of Conversation (Remember this record will be kept, capture the main issues,
questions, concerns raised by the caller AND your responses. Continue overleaf rather than
using a separate sheet.)




Details of the Caller i.e. Address, Telephone No; If Caller is happy to provide




Is follow up contact

Planned  Yes  No 

Requested         Yes    No 

If yes detail who will follow up and within what time frame


End of Call time              Signature




       POL/N&Q/0022                            Version 1.1                           Page 45 of 45

				
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