The design and procurement process

The wide range of professionals who may be involved in the planning, construction and commissioning of a radiotherapy treatment facility is shown in table 1.2. The actual number involved will depend on the magnitude of the project and the contractual arrangements.

For a minor capital scheme, the main activities are most likely to be the selection of the equipment and the adaptation of an existing room to take the new equipment. A small design team is sufficient and can be usually drawn from hospital staff. The team should include:

• •  
  a representative of the Planning Department (who may also be the project leader),
• •  
  a radiotherapy physicist,
• •  
  a radiographer,
• •  
  a medical physics technical officer and
• •  
  a member of the Works Department.

The selection of the equipment may be undertaken by a wider group of radiotherapy physicists, radiographers and technical officers, including the radiotherapy physicist and radiographer on the project team.

When the new equipment has been chosen and the installation and adaptation requirements are clear, the project team should also include:

• •  
  selected representatives of the hospital's approved contractors, e.g. for building and electrical work,
• •  
  the supplier's representative and
• •  
  the RPA.

For a major capital scheme, e.g. involving the installation of linear accelerator(s) in a new or modified building, there will be more complex issues around the design, construction or alteration of the building and its integration into existing facilities and services. This will require additional expertise from outside the hospital and will usually include an architect, a structural engineer, an electrical engineer and a quantity surveyor. These may all come from the same organisation, depending on the contract arrangements. The project may well be managed at two levels: a smaller project team and a larger design and execution team. The effects of the works and the introduction of new equipment on the maintenance of clinical services will also have to be assessed and any adverse effects minimised. The project team might comprise the following:

• •  
  a senior member of the Finance Department (who may be the project officer),
• •  
  a radiation oncologist,
• •  
  a senior radiotherapy physicist (MPE),
• •  
  the radiotherapy patient services manager,
• •  
  a representative of the Planning Department,
• •  
  a member of the Estates Department and
• •  
  the selected architect.

The larger design team will report to the project team at regular intervals through one of its members who serves on both teams. The design team will include:

• •  
  the selected architect (who may be the project manager) and his/her supporting staff,
• •  
  the representative of the Planning Department,
• •  
  the senior medical physicist,
• •  
  relevant radiotherapy physicists,
• •  
  radiotherapy patient services manager,
• •  
  relevant senior radiographers,
• •  
  a medical physics technical officer,
• •  
  a member of the Estates Department,
• •  
  the RPA,
• •  
  IT specialist(s) and
• •  
  patient and public voice (PPV) partners.

When the building design and the selection of the equipment has been finalised and construction is underway, progress meetings of the design team should also include:

• •  
  representatives of the construction company,
• •  
  the structural engineer,
• •  
  the electrical engineer,
• •  
  the mechanical engineer and
• •  
  the equipment supplier's representative.

All project and planning team meetings should be minuted and any changes in the design (variation orders) carefully costed and agreed, as these are often the source of additional expenditure and budget overruns.

The role of the IT specialist(s) is important with modern complex radiotherapy management systems and the sharing of images and large amounts of data between treatment planning and treatment systems. He/she may come from medical physics or the hospital's IT Department, or preferably one from both. The requirements of the equipment vendor's management software should be clearly understood so that it is not compromised by the hospital's general IT requirements. Common practice is to confine the heavy radiotherapy data flows to a separate network (linking the treatment units, planning systems and CT simulators) with a firewall to the hospital network for the import/export of patient administrative information and the import of images from hospital imaging facilities.

As stated earlier, a major development may entail a PPP to design, construct and operate the facility through a PFI. This requires comprehensive and substantial teams such as those outlined above for a major capital scheme in both the hospital and the construction components of the partnership. The role of the hospital team is to specify the objectives of the new facility, particularly with regard to the range of services to be provided, their volume and expected growth, and check that the completed scheme meets these objectives. The role of the construction company together with its appointed architect will be to design and construct the facility to meet the hospital's objectives for the cost agreed. Whilst construction companies are familiar with mechanical, electrical and structural matters, they are much less familiar with the requirements of radiotherapy and radiation protection legislation and should have a radiotherapy expert and an RPA available to their design and construction teams. It is beneficial to the project if the contractual arrangements allow a dialogue between the hospital's radiotherapy team and RPA and the contactor's expert and RPA so that details of the design, e.g. the planned radiation workload for individual linear accelerators, and radiation protection policy are available to the design team from the earliest possible stage. It is essential that the final design of any radiation facilities, together with the radiation protection calculations to meet the hospital's radiation protection policy, are approved by the hospital's RPA before construction starts. At the conclusion of the project, there must be agreement with the hospital's RPA on the performance of the radiation survey of the new facility and the wide availability of survey results to ensure that the design criteria have been met and the facility is safe for clinical use. The hospital's RPA may also need to notify the Health and Safety Executive if it is a new radiation facility. The maintenance company in the PPP will be familiar with building maintenance but usually less familiar with the technical support usually provided in radiotherapy by medical physics technical officers to ensure high levels of equipment availability for treatment. This issue needs to be discussed long before clinical services commence and a sub-contract with the hospital team may be necessary due to the very specialised nature of the work.

For a minor capital scheme, the starting point will be a specification for the new equipment. This will be drawn up by radiotherapy physicists and radiographers, in conjunction with the radiation oncologists, to meet the clinical need. Prior to finalising the specification it is advisable to have preliminary discussions with manufacturers to ensure that the proposed specification reflects current possibilities. The specification may be in the form of an output based specification which describes what the equipment has to achieve or a detailed specification of the equipment and its performance, or a combination of the two. Specifications must not be written so that only one manufacturer can comply. After approval by the hospital, the specification can be sent to potential suppliers and must be advertised with a clear closing date for offers in the Official Journal of the European Union (OJEU) if it is expected to cost more than a prescribed limit. Current thresholds valid from 1 January 2016 to 3 December 2017 are £106 047 for NHS Trusts and £164 170 for NHS Foundation Trusts. Although these thresholds are based on thresholds in euros, they remain unchanged during this period independent of currency fluctuations. Alternatively, the hospital can use the radiotherapy equipment framework agreement negotiated by the NHS Supply Chain. Using the framework it is possible to set up a mini-competition between suppliers without advertising in the OJEU. Additions to the baseline specification can be agreed between the suppliers and the purchaser. In some circumstances it is possible that a new model of equipment may not be available in the framework.

To evaluate the offers in a uniform and objective manner, the users should develop an option appraisal pro-forma in which each of the identified performance parameters is given a weight according to its relative importance. Each performance parameter can then be scored over a set range for each supplier's equipment on the basis of how closely it matches the desired performance and a weighted total score calculated to indicate which supplier's equipment most closely approaches the ideal solution. It will also be necessary to look at other issues, such as operator and physicist training, maintenance arrangements and costs, reliability (as determined from other users), compatibility with existing equipment, installation requirements and cost, and to include these in the decision on the first choice. Visits to other users of the proposed equipment can be valuable for assessing ease of use, reliability and the standard of service support. A purchase order can then be issued for the equipment. At this stage, the installation issues should be clear and a specification for the building and electrical works can be drawn up by the Estates Department. This can be issued to contractors approved by the hospital and quotations invited by a given date. Site visits by potential equipment suppliers and contractors are important to ensure the quality of quotations. These can be evaluated by the project team, contracts issued to the successful contractors and the first meeting of the larger team convened to draw up a timetable for the development, taking account of delivery dates and the possible need to modify the clinical service. The progress of the project should be monitored at regular intervals through project team meetings with reports to the responsible hospital officer. Contact persons must be available to the supplier and contractors to respond to technical issues and to minimise any interference with ongoing clinical services.

For a major capital scheme, a more complex procedure employing external expertise is necessary. The project team will need to draw up a design brief with an outline of the scheme including the building, equipment and siting requirements, together with an overall indication of cost. Expressions of interest to design and manage the project will be invited from suitably experienced organisations through an advertisement in OJEU. These expressions of interest are evaluated by the project team and a shortlist (usually three organisations) is invited to make presentations to the project team with more details of their design, proposed management of the project, professional expertise available and fee structure. The hospital will then enter into a contract with the successful organisation and in all probability their architect will become the project manager and lead the design team. The design will begin with general layouts which will be evaluated for their workability, relationship to existing facilities and appearance. Having selected an optimal layout, the design details will be developed into plans and room data sheets by the design team. These will be supported by structural, mechanical and electrical plans developed by the architect's team and consulting engineers. Once the plans and data sheets are finalised, expressions of interest can be invited from construction companies to construct the facility though an OJEU announcement. Again these expressions of interest are evaluated by the project team together with the architect, and a tender to build the facility can be issued to a shortlist (usually three) of companies with a closing date. Presentations by the shortlisted companies are very helpful in assessing previous experience in this specialised area, quality and commitment. The tenders returned will be evaluated by the larger project team for quality and price, and the construction contract issued to the successful bidder.

A specification for the equipment can be developed in parallel with the building design. This must clearly state the key features of the desired equipment and any accessories required. Expressions of interest and tenders can again be invited from equipment suppliers through an OJEU announcement or by using the framework agreement negotiated by the NHS Supply Chain. Presentations by the suppliers are helpful to learn more about the equipment and options available and for the supplier to inspect the proposed site. The tenders returned by the closing date will be evaluated by the radiotherapy and medical physics members of the larger project team for compliance with the specification. Again, the users should develop an option appraisal pro-forma in which each of the identified performance parameters is given a weight according to their relative importance. Each performance parameter can then be scored over a given range for each equipment supplier on the basis of how closely it matches the desired performance and a weighted total score calculated to indicate which supplier's equipment most closely approaches the ideal solution. It will also be necessary to look at other issues such as operator training, maintenance training, reliability (as determined from other users), compatibility with existing equipment, installation requirements and cost, and to include these in the decision on the first choice. Again, visits to other users of the proposed equipment can be valuable for assessing ease of use, reliability and the standard of service support. A purchase order can then be issued for the equipment. In some instances, the equipment will be supplied as part of a wider national initiative. There is usually some flexibility within these arrangements to ensure that the recipient receives equipment which meets the local requirements and is compatible with existing equipment. In these circumstances, a pro-forma should be used for an option appraisal of the alternatives from different suppliers in order to reach an objective conclusion. This can be a helpful summary of the reasons for the first choice if unsuccessful suppliers ask for the reasons why they were unsuccessful. In general, it is desirable to complete the selection of the equipment before the design and room data sheets are finalised, so that any detailed requirements relating to specific equipment, e.g. the position of primary shielding in relation to the treatment isocentre, may be incorporated into the latter before tenders are issued.

For a PFI, the Trust project team will need to draw up a comprehensive brief for the services to be provided by the new facility. This will require estimates of future growth to ensure that the facility remains clinically sufficient over the long period of the contract, but should be as accurate as possible to minimise costs and future charges. Similarly equipment requirements should be realistic and not excessive. Expressions of interest to design, construct and manage the project will be invited from suitably experienced consortia through an advertisement in the OJEU. These expressions of interest are evaluated by the project team and a shortlist (usually three consortia) is invited to make presentations to the project team with more details of their design, proposed management of the project, professional expertise available and costs. The hospital will then enter into negotiation with the preferred consortium to finalise all aspects of the project. If this is successful, a contract will be awarded to the successful bidder and in all probability their architectural practice will become project manager and lead the design work. The design will need to be evaluated for its ability to meet the specification now and in the future, its relationship to existing facilities and compliance with a wide range of regulations. Having selected an optimal layout, the design details will be developed into plans and room data sheets by the design team. These will be supported by structural, mechanical and electrical plans developed by the architect's team and consulting engineers. The equipment supplier will in all probability be a sub-contractor to the construction element of the consortium and it is important to ensure that the equipment requirements are clearly understood by the supplier and not altered in the supply chain.

For a major capital scheme, acceptance of the building and services will be undertaken by a hospital team including senior staff who will be working in the new facility. 'As built' plans of the facility must be handed to the hospital. A detailed inspection of the facility should take place and be compared with the plans and room data sheets. A snagging list of all defects should be drawn up and a timetable to remedy them agreed with the construction company.

Similar arrangements apply for a PFI scheme. However, whereas in a major capital scheme the maintenance of the new facility will be by the hospital's Estates Department, in a PFI scheme the responsibilities will be borne by an external maintenance contractor. Details such as the warranties on service equipment, e.g. air conditioning plant, need to be passed to the appropriate organisation.

The acceptance of radiotherapy treatment facilities will be undertaken by the RPA, checking the adequacy of the radiation protection for staff and members of the public, and an MPE radiotherapy physicist, with the assistance from other members of the radiotherapy physics team, checking the performance of the equipment against its specification.

Acceptance should begin with a basic radiation protection survey by the RPA of the shielding provided by the facility when the installation engineer states that the installation can produce radiation. At this stage, although installation is complete and the equipment operational, its radiation performance will not be optimised to match the specification. This survey should ensure that external dose rates are acceptable over a range of equipment orientations and that the facility is safe to operate for an extended series of tests. Engineering controls and warning signs should also be checked for correct operation. Electrical safety tests should also be performed at this stage to ensure that the equipment does not present an electrical hazard to the acceptance team. The latter testing may be done by the clinical engineering section of the medical physics department or by the hospital's electromedical equipment maintenance department.

A more detailed radiation protection survey should be performed following the acceptance procedure, when it is confirmed that the equipment performance, in particular beam energies and dose rates, matches the specification. External dose rates should be measured over a range of equipment orientations with and without scatter material in the radiation beam at the isocentre. Measured dose rates can then be compared to those in the radiation protection calculations to assess compliance with the calculations and any assumptions. More details on performing a radiation survey are given in chapter 12.

During the acceptance, a critical examination as required by the Ionising Radiation Regulations (IRR 1999) should be carried out by the supplier to confirm that the intended radiation protection and safety features incorporated into the equipment and its operation are satisfactory in the current installation. The examination may be performed by a representative of the equipment supplier or by the RPA at the request of the supplier.

In PFI projects, the radiation protection surveys may be undertaken by the construction company's RPA as part of their contract with the company. Alternatively, they can be done by the hospital's RPA to a protocol agreed with the constructor's RPA and with the constructor's approval. The latter is often more convenient if surveys are done at short notice. In either situation, the results of surveys should be approved by both RPAs and be generally available to show that the facility complies with national regulations and the hospital's policy on radiation protection.

Following acceptable outcomes for the basic radiation protection survey and electrical safety testing, acceptance testing of the mechanical and radiation performance of the equipment can then commence safely. Joint acceptance testing with the equipment supplier's installation engineer using the supplier's test pro-forma is commonplace. This will cover a wide range of parameters and the acceptable tolerances will be given in the pro-forma. As each test is passed within tolerance, it should be signed off by the supplier's engineer and the radiotherapy physicist. This is better than gathering a large amount of data for subsequent analysis and approval. If the equipment fails a test, further adjustment will be necessary, which may impact on tests already performed and render them invalid. Ideally all tests should be done as a complete set with no intervening adjustments to settings. At the conclusion of testing, the equipment may be accepted as meeting the specification, accepted subject to a small list of remedial actions, or not accepted because of non-compliance with a performance parameter of major importance or a long list of faults requiring remedial action. In the second case, time scales should be agreed for correcting the defects. In the third case, a new joint acceptance procedure is necessary after the installation engineer has corrected the problem(s). The final section of the joint acceptance pro-forma should reflect this situation and must be signed by both the installation engineer and responsible physicist. Following successful acceptance, this section will be the basis for further payment to the supplier for the equipment.

Following handover of the facility, reconfiguration of clinical services may be necessary. This should be done by the senior oncology staff involved taking into account all the relevant factors and a clear timetable developed to make all staff aware of the changes and their role in them.

Following acceptance of the equipment, further commissioning will be necessary before it enters clinical use. This includes the gathering of detailed information on equipment characteristics and radiation beams for treatment planning systems, absolute calibrations of radiation output, establishment of quality assurance protocols, establishment of clinical treatment protocols and operator training. It should be understood that in the interests of patient safety, commissioning cannot be shortened to make up for any earlier delays in construction, etc.