A practical approach

The role of the TF is to produce, first, a well balanced, technically sound and comprehensive project proposal document (PD), and then, if approval is granted from the national health authorities, a full feasibility study (FS). In all these actions the TF is called upon to play a decisive role in identifying strengths and weaknesses and to introduce corrective measures when necessary. Indeed, with initial modest resources at hand, the first practical objective is to prepare documentation and material to demonstrate the value of PET in the context of the national health care policies.

The following is a ‘two step’ approach that has proved to be effective in situations where there was only an embryonic idea to set up a PET centre.

may be faced during implementation and the strategies for solving them, the need for more advanced clinical diagnostic tools, an estimate of the total cost of the project and the time for its implementation, identification of potential financial sources, guidelines for project implementation, and identification of interested stakeholders.

The PD is addressed principally to decision makers in the government and seeks the official endorsement of the relevant government authorities to proceed to a more advanced phase of the project, namely, the preparation of a comprehensive feasibility study (FS). It can also be utilized for the preparation of a comprehensive project proposal (PP) to the IAEA and/or other potential financing sources within as well as outside the country.

It is not always necessary to follow this suggested two step approach, depending on the circumstances. If there is already a well informed understanding and the authorities have already decided that the PET technology is to be established, a feasibility study alone may be sufficient.

2.3.2. Step 2: The feasibility study

Essentially, the FS should be designed to provide a clear, comprehensive, and quantitative picture of what exactly is required for a cyclotron/PET centre in terms of financial resources and otherwise. This document should elucidate the

‘whys and hows’ of the project, in the framework of national health policies. It should give the relevant authorities a well informed understanding of the project, to help them consider its short and long term political, and financial implications.

It should contain a clear set of concrete recommendations so that they can make the necessary decisions.

The FS expands the conceptual and policy aspects of the PD and should provide: documented and quantitative evidence to justify the investment;

definitions of the technological components needed  including the site, staff and training requirements  approximate estimates of the financial requirements; and legal, regulatory, and environmental issues. The FS will define the scope, phases and priorities of the utilization programme, and propose a management and operational structure as well as a realistic business plan. The short and long term financial implications of the project, from the initial investment to the routine operation of the facility, are a critical part of the FS, and should include the identification of potential financial sources and schemes, and propose strategies to secure the funding.

The advantage of this two-step approach is that it avoids entanglement in an involved, time consuming, and in many cases costly feasibility study process, sometimes without any assurance from the national authorities that a

cyclotron/PET project proposal will be supported. Such assurances are best obtained in writing.

2.3.3. Project schedule

Managing a project to implement a clinical PET centre is a demanding task that is long and time consuming. Figure 2.1 depicts a Gantt chart of a typical project when the centre must be built from the scratch.

REFERENCES TO SECTION 2

[2.1] FACEY, K., BRADBURY, I., LAKING, G., PAYNE, E., Overview of the clinical effectiveness of positron emission tomography imaging in selected cancers, Health Technol. Assess. 44 Oct. 11 (2007) iii–iv, xi–267.

[2.2] PODOLOFF, D.A., et al., NCCN Task Force Report: Positron emission tomography (PET)/computed tomography (CT) scanning in cancer, J. Natl Compr. Cancer Network 5 (2007) Suppl 1:S1–S22.

[2.3] HILLNER, B.E., et al., Impact of positron emission tomography/computed tomography and positron emission tomography (PET) alone on expected management of patients with cancer: Initial results from the National Oncologic PET Registry, J. Clin. Oncol. 26 13 (2008) 2155–2161.

1-Apr Start date1-JanMonths to completion ---> ActivityResponsible Team

Constitution of the project groupNational / Local Health authorities Individuation of the needs; general criteria for the technology Project group Preparation of the feasibility studyProject group Initial layout of the PET centreProject group / Engineers, designers Initial evaluation of radiation protection

Project group / Physicists,N.M. doctors Definition of the designProject group Decison on the modality of purchaseProject group Preventive evaluation of running costsProject group Initial definition of staffing levelProject group Advanced layoutProject group / Engineers, designers Paperwork and application for building license Project group / Engineers, designers Tenders for equipment and building construction

Project group / Local Health authorities Completion of the tendersLocal Health authorities Selection of equipment and constructorLocal Health authorities Trainig activitiesProject group / local staff Final design of building and layoutProject group Predisposition of the radiation protection plan Project group / Physicists,N.M. doctors application for licensing Project group / Physicists,N.M. doctors Opening of the building court; start of the construction

Project group / Engineers, designers Procuerement of equipmentLocal Health authorities / Physicists,N.M. doctors Monitoring of the building constructionProject group Installation of equipmentProject group / Physicists,N.M. doctors Acceptance testing Project group / Physicists,N.M. doctors Qualification of radiopharmaceutical production Radiopharmacists, radiochemists, physicists Possible start of clinical activity

FIG. 2.1. Gantt chart of a PET project from inception (N.M.: nuclear medicine).