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					             ALL IRELAND RADIOTHERAPY PHYSICS
                       AUDIT SCHEME


                         PROJECT INITIATION DOCUMENT



                                                   Sponsors:


    Northern Ireland Regional Medical Physics Agency, Belfast

       Medical Physics Department, St Luke’s Hospital Dublin



                                       Other interested parties:



                               Belfast City Hospital Trust, Belfast

                               Cork Regional Hospital, Cork City

                           Galway Regional Hospital, Galway City

                             St Vincent’s Private Hospital, Dublin

                                  Mater Private Hospital, Dublin

                         Radiological Protection Institute of Ireland




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                                                CONTENTS

EXECUTIVE SUMMARY

1.        Strategic Context

2.        Background to Project

3.        Terms of Reference

          3.1       Project Sponsor

          3.2       Project Scope

          3.3       Project Objectives

4.        Organisational Arrangements

          4.1       Project Directors

          4.2       Project Board

                    4.2.1      Membership

                    4.2.2      Responsibility of Board

                    4.2.3      Meetings of Board

5.        Project Issues

          5.1       Project Justification

          5.2       Project Constraints

          5.3       Project Risks

          5.4       Indemnity

          5.5       Private Radiotherapy Centre

6.        Project Plan

          6.1       Deliverables

          6.2       Resources and Funding

          6.3       Timetable

          6.4       Project Control


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          6.5       Project Sign Off

          6.7       Project Closure

7.        Financial

8.        Summary

9.        References




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                       All-Ireland Radiotherapy Physics Audit Scheme
          1.        Strategic Context
          Cancer is second only to heart disease as a cause of death and both Departments of
          Health (Northern Ireland and Republic of Ireland) have placed a high priority on
          improvements in the treatment of persons with cancer.


          Radiotherapy is received by up to half of all cancer patients, either as part of their
          primary treatment or in connection with recurrence or palliation.

          The effect of radiotherapy depends on the dose applied, whilst the limiting factor is
          tolerance (avoiding radiation induced morbidity) of the normal tissues surrounding the
          tumour.

          Medical Physics has an integral and key role in the treatment of cancer patients by
          radiotherapy. The most fundamental responsibility is to ensure that the radiation dose
          prescribed by the Clinical Oncologist is converted into an optimised treatment plan
          and received by the patient.

          The diagram on the opposite page shows the patient flows and the various processes
          and the involvement of various groups at different stages. Whilst there are minor
          variations between centres, the medical physics input scans the entire process and is
          critical to the quality of the service.

          There have been a number of reports on Quality Assurance in Radiotherapy which
          emphasise the impact of Quality Assurance on radiotherapy results and its importance
          in avoidance of errors (ref 1-3).

          Accurate calibration, quality assurance of radiotherapy treatment machines and
          computer planning systems is critical to ensure that patients receive the correct level
          of radiation to control their disease. Failure in the calibration or quality assurance can
          lead to failure in treatment, possibly affecting a number of patients over a period of
          time.

          An independent audit of these processes is an essential part of the quality assurance
          programme. All the radiotherapy centres in Ireland have been audited by either the
          UK National Dosimetry group or by the EC Network of the Europe against Cancer
          programme. However, these audits are limited in frequency and scope and so there is
          a need to further develop the auditing methodology, protocols and best practice. This
          can best be achieved with the co-operation of all the radiotherapy centres.

          The aim of this project is for all the public radiotherapy centres in the island of Ireland
          to collaborate in mutual auditing of the calibration of radiotherapy equipment and the
          treatment planning process, together with the development of the audit process. After
          establishing an audit programme similar to the UK and EU schemes, but without
          divorcing participants from these schemes, the project will extend the range of audit
          undertaken. An investigation and assistance service will be made available to Centres
          where anomalies may be discovered.


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          It is expected that in the longer term the project will act as a catalyst for initiating a
          broader audit programme to include multidisciplinary (medical and radiographer)
          groups who will examine other potential sources of error in the treatment process.

          The NCI All Ireland Cancer Conference in Belfast in October 1999 marked the
          beginning of a longer term initiative between the National Cancer Institute of the
          United States and the Department of Health in Northern Ireland and the Republic of
          Ireland to enhance cancer research in Ireland. The project will explore extending the
          project to the audit across the Atlantic. This would be necessary for the proposed
          radiotherapy clinical trials.

          2.        Background to the Project
          The proposals for this project were collaboratively developed by both the radiotherapy
          physics services at St Luke’s Hospital, Dublin and at the Northern Ireland Cancer
          Centre, Belvoir Park Hospital, Belfast. The proposals were approved by both the
          Northern Ireland Regional Medical Physics Agency and St Luke’s Hospital and
          submitted to them to their respective Departments of Health (Department of Health
          and Social Services, as then, and the Department of Health and Children) in 2000.

          The proposals were considered by and supported by the North/South Joint Health
          Technology Group in 2001 and subsequently agreed by the two Health Ministers at a
          North-South Ministerial meeting. The two Departments agreed to jointly provide the
          funding requested.

          3.        Terms of Reference
          3.1       Project Sponsors

          Mr L Birthistle Chief Executive, St Luke’s Hospital
          Prof P Jarritt  Chief Executive, Northern Ireland Regional Medical Physics Agency

          3.2       Project Scope

          The aim is to establish an All-Ireland audit scheme, involving all public sector
          radiotherapy centres, covering the calibration of radiotherapy equipment and the
          treatment planning process and to offer an investigation and assistance service to
          centres where anomalies are discovered.

          3.3       Project Objectives

                   To establish a mutual audit scheme equivalent in scope to that of the UK
                    National Dosimetry Scheme and determine the optimum frequency of audit.
                   To establish an investigation and assistance service to centres
                   To extend the scheme to areas not covered by the UK National service such as:
                    -
                        Multi-leaf collimator
                        In-vivo dosimetry
                        Orthvoltage/deep x-ray units and procedures


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                         Brachytherapy units and procedures
                         Intensity modulated radiotherapy techniques (IMRT)
                   Explore and prepare proposals for extending audit to areas involving other
                    professional groups (medical and radiography)
                   Explore and, if feasible, initiate international audits, particularly in the context
                    of the links with the National Cancer Institute in the USA and the possibility of
                    Joint Irish NCI radiotherapy clinical trials

          4.        Organisational Arrangements
          4.1       Project Directors

                    Dr A Hounsell, Consultant Clinical Scientist, NIRMPA
                    Mr P McCavana, Medical Physicist, St Luke’s Hospital

          4.2       Project Board

          4.2.1     Membership
                    Project Sponsors (Joint Chair)
                    Dr McClean, Head of Medical Physics, St Luke’s Hospital
                    Mr T Leslie Frew, Head of Radiotherapy Physics, NIRMPA
                    Project Directors
                    Representative of DHSSPS or of Belfast City Hospital Trust
                    Representative of Dept of Health and Children - Mr Wilf Higgins


          4.2.2     Responsibilities
                    The Project Board will: -

                         Approve appointment and Approve expenditure
                         Approve Project Initiation Document
                         Receive minutes of the meetings of the Project Team
                         Receive copies of key reports
                         Receive and approve final reports and sign off project
                         Appraise Radiological Protection Institute of Ireland and Health & Safety
                          Executive for Northern Ireland of results and developments

                    The Board may issue instructions and guidance to the Project Team.

          4.2.3     Meeting of Board
                    It is expected that the Board will normally carry out its role by correspondence.

                    However, there should be regular meetings along the following guidelines:
                     Meet at the beginning of the project to approve appointments and finalise
                      remit.
                     Meet and end of 1st Year.
                     Meet at end of 2nd Year.
                     In addition, there should be 2 meetings per year; one in Northern Ireland
                      and one in Dublin, chaired by the respective Project Sponsors



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                    The Board will meet at the end of the project to receive final report and sign
                    off the project.

          4.3       Project Team

          4.3.1     Membership
                    Project Directors (Joint Chair) and Project Manager
                    Representatives from other Participating Centres
                            Cork               Dr T Conere
                            Galway             Prof W Van der Putten
                               One nomination from Private Centres:
                               Mater Private         Ms M Houston
                               St. Vincent’s Private Mr M Sheridan

                    The project team will have power to co-opt up to two members.

          4.3.2     Meetings
                    It is expected that the Project Team will meet as required and at least twice per
                    year.

          4.3.3     Responsibilities of Team
                    The Team will:

                         Report to the Project Board
                         Agree the Project Initiation Document
                         Agree the detailed project plan and any subsequent changes
                         Advise the Project Directors and Project Manager
                         Receive regular reports from the Project Manager
                         Sign off each project product
                         Quality assure products of the project
                         Receive final reports and make appropriate recommendations to the project
                          board

          4.4       Project Manager

          A Principal Medical Physicist will be appointed as Project Manager.

          The job description is set out in Appendix 1.

          The Project Manager will be a Grade B (18-25) Clinical Scientist, employed by
          NIRMPA but appointed jointly by NIRMPA and St Luke’s.

          Appointment Panel:
          Head of Radiotherapy Physics, St Luke’s Hospital
          Head, Radiotherapy Physics, NIRMPA
          Project Directors
          One external assessor




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          5.        Project Issues
          5.1       Project Justification

          Clinical Governance requirements and national and internal recommendations
          (Reference 1-5).

          5.2       Project Constraints

          5.2.1     Resources
                    Funding for a Project Manager has been identified for a period of 36 months.
                    In addition all participating staff will need to make available staff on a part
                    time basis to support the project and this will be critical.

          5.2.2     Staffing
                    Appointment and retention of a suitable project manager is ‘project critical’.
                    There is a UK and Irish shortage of radiotherapy physicists with requisite
                    expertise and experience.

          5.2.3     Co-operation of Participating Centres
                    The co-operation of management and medical and radiographic staff at
                    participating centres.

          5.3       Project Risks

          5.3.1     Ability to Operate within Resources
                    Project manager will provide regular reports to the Project Team.

          5.3.2     Key Project Staff being Unavailable
                    Project resources will be planned and committed.

          5.4       Indemnity

                    All participating centres will sign an indemnity statement including that the
                    centres will accept full responsibility for the calibration of their own
                    equipment and their own policies, procedures and protocols.

                    The Centre will not seek any legal redress against any individual involved or
                    any other participating centre for any advice given or results produced as a
                    result of the project.

          5.5       Private Radiotherapy Centres

                    Heads of Radiotherapy physics of private radiotherapy centres will be invited
                    to nominate a representative to be a member of the project Team. The private
                    radiotherapy centres will be charged for all audits undertaken and services
                    provided at cost.




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          6.        Project Plan
          6.1       Deliverables

          6.1.1     Detailed project plan to be approved by the Project Team and Project Board
                    within 3 months of the Project Manager taking up post.

          6.1.2     Initial audit of each centre to level of current UK National Dosimetry Service.

          6.1.3     Policy and Procedure for mutual investigation and assistance service.

          6.1.4     All-Ireland Mutual Audit Scheme and Plan for all Radiotherapy units at all
                    energies available.

          6.1.5     Audit schemes for: -
                        Multi-leaf collimator
                        In-vivo dosimetry
                        Orthovoltage units and procedures
                        Brachytherapy units and procedures
                        IMRT
                        Other areas as determined by the Project Team. Priority for each of the
                           above to be agreed.

          6.1.6     Mutual Audit of areas in 6.1.5 between all centres.

          6.1.7     Report on potential expansion for mutual audit of areas involving other
                    disciplines:
                         Simulators and CT
                         Immobilisation
                         Standard Treatment Protocols
                         Treatment Planning

          6.1.8     Report and proposals for international co-operation and mutual audit.

          6.1.9     Develop a Standard Operating Procedure for audit

          Due to the record and development nature of the aspects of the project – the Project
          Team will have the freedom to interpret and adapt the above to meet changing
          circumstances and developments. Any major changes are to be approved by the
          Project Board.




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          6.2       Project Control

          Regular and formal monitoring of actual progress against planned will be used to
          ensure timeliness, budgetary control and quality of project products.

          Checkpoint meetings will be held six monthly, or more frequently, by the Project
          Team and minutes of the meetings of the team will be sent to the Project Board.


          6.2.1     Project Managers Reports
                    The Project Manager will prepare reports for each meeting of the Project
                    Team.
          6.2.2     Product Sign Off
                    The Project Team will sign-off each product. Its purpose is to record that the
                    Team are satisfied that the product has been delivered to the agreed level of
                    quality.

          6.2.3     Project Closure
                    A formal final report will be prepared by the Project Team and signed off by
                    the Project Board.

          7.        Financial
          Financial control and audit will be exercised through the normal financial
          arrangements of the Medical Physics Agency and St Luke’s Hospital.

          The Medical Physics Agency will monitor expenditure and provide financial reports.

          8.        Summary
          The project will establish a sustainable All-Ireland radiotherapy scheme which will
          extend the scope and frequency of the current UK and European schemes.


          9.        References
          9.1       Quality Assurance in Radiotherapy. ESTRO Report.          D. Thwaites et al.
                    Radiotherapy and Oncology 35 (1995) 61-71

          9.2       Quality Assurance in Radiotherapy. Report of the Working Party. Chairman.
                    Prof N M Balcken. UK Department of Health 1991

          9.3       Manual of Cancer Services Assessment Standards. Consultation Document.
                    UK Department of Health. June 2000




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                    All Ireland Radiotherapy Audit Project

               Joint Post between N.I.R.M.P.A (Belfast) and
                            St. Luke’s (Dublin)

                                 Principal Radiotherapy Physicist
Project duration – initially for three years with the opportunity for permanent appointment.

Employer:           Northern Ireland Regional Medical Physics Agency

Post:               Clinical Scientist Grade B18-25

Base:               Belvoir Park Hospital, Belfast but substantial time will be spent at St
                    Luke’s Hospital Dublin and visits made to other radiotherapy centres
                    in Ireland on a regular basis.

Accountable to:                Project Directors

Line Manager:                  Dr A Hounsell, Consultant Clinical Scientist, NIRMPA

Responsible to:                Mr P McCavana, St Luke’s Hospital for all activities
                               undertaken at St Luke’s Hospital

Liaises with:                  Project Team

Job role:
        The appointee will establish and oversee the development of an all-Ireland
        radiotherapy physics audit process. He or she will operate in both Belfast and
        Dublin from which they will co-ordinate visits to all participating radiotherapy
        centres in Ireland. The audit process, whilst initially focussed on dosimetry, is
        expected to evolve to cover all other relevant aspects of procedure in the
        radiotherapy process.

Condition of appointment:

          The appointee will be appointed jointly by NIRMPA and St. Luke’s. The post
          will become the responsibility of NIRMPA over a two year period after which
          time the post role may be re defined.

Specific responsibilities of post:

     1. To develop a dosimetry audit process for externally applied radiations of
        photon and electron.

     2. To create the necessary organisational structure to support such an audit on
        an all-Ireland basis.




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     3. To liaise with the appropriate Radiotherapy Physics departments to
        facilitate the application of the audit process.

     4. To assist in the diagnosis and rectification of any aberrations that become
        apparent through the audit process.

     5. To produce a planned development route for the audit process to involve other
        aspects of radiotherapy.

     6. To take responsibility for the management of equipment involved in the
        application of the audit process.

     7. To produce appropriate reports of audits for individual radiotherapy centres
        and the project management team.

     8. To ensure that the audit process becomes integrated into the annual
        routine of all centres participating.


General radiotherapy:

     9. To develop and maintain skills.

Research & development:

     10. To initiate and participate in appropriate research and development as funding
         and resources permit.

General:

     11. To participate in appropriate training courses and meetings as required.

     12. To participate in teaching and training of physics or other staffs as required.

     13. To contribute to existing services including routine, emergency and other work
         outside normal working hours as and when required.

     14. To comply with the relevant Health & Safety at Work Legislation.

     15. To comply with the Data Protection Act and equivalent in the Republic of
         Ireland, respecting our clients’ rights to confidentiality.

     16. To comply with the requirements of The Ionising Radiation (Medical
         Exposure ) Regulations (Northern Ireland) 2000 and Ionising Radiations
         Regulations (Northern Ireland) 2000 and equivalent legislation when in the
         Republic of Ireland.

     17. To participate in Staff Review.

     18. To possess and maintain a valid driving licence and have transport to enable
         duties of the post to be undertaken.


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NOTE 1

Joint advertisement to be issued with appropriate logos (St. Luke’s and NIRMPA,
Depts of Health?)

NOTE 2

To ensure a balance one representative from either DHSSPS or BCH Trust should be
nominated

NOTE 3

Project Sponsors will write to the Private Hospital CEO’s to request one nominated
Physics representative from the Private Hospitals following the first meeting of the
Board.

NOTE 4

1 External assessor. Suggestion: David Thwaites. To be agreed

NOTE 5

Is the person appointed for an 36 month fixed term contract?

NOTE 6

Draft Timetable - needs to be revised to begin January 200_?




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