Photodynamic Diagnosis of Bladder Cancer
Procurement
Procurement is an essential part to implementing the in-vitro test into routine clinical practice. The purchasing of this technology however can be complex and time consuming - but it doesn't need to be. In this section, we have provided information on what procurement means, what the various options are for purchasing the technology (and any associated consumables), who provides this technology and other factors that Trusts need to think about before, during and after implementation.
To explore this section please click on the headings below:
- Procurement Options - provides an overview of the options that are now available to the NHS for purchasing this technology.
- Supplier Details - lists the current technology suppliers and provides individual information sheets on the technology that is currently available.
- Training Programme - details the training options that are available to clinical staff surrounding the technique.
- Department of Health guidance for PCTs - gives an overview of procurement guidance for PCTs that has recently been issued by the Department of Health.
Procurement Options
It is important to recognise that a structured approach to adopting the technique is critical to ensure its successful implementation. It is probable that Trusts will be required to develop a local business case that will complement the procurement exercise. Procurement of the PDD technique must comply with Trusts "Standing Financial Instructions" (SFIs) and current Public Procurement Legislation. Trusts should always ensure they engage with their local procurement (supplies) department when considering the development of services in this way.
A formal "tender" process will be required in order to purchase this technology and an example procurement project plan which Trusts may find useful has been developed by the NTAC project sites. This highlights a (typical) indicative procurement process and approximate time scales for completion.
Whilst it is not NTAC's role to recommend specific manufacturers, the current suppliers of the blue light technology are Karl Storz, R Woolf and Olympus. The capital equipment can be purchased through NHS Supply Chain via a National Framework. The framework can be used to procure the equipment and consumables required for the PDD technique, which removes the requirement to complete a formal procurement process. To find out more about this framework and how you can access contact the NHS Supply Chain lead for this area on: yun.hwang@supplychain.nhs.uk
At the time of publication, the only chemical licensed for bladder instillation in the use of photodynamic diagnosis of bladder cancer is hexaminolevulinate, which is marketed by GE Healthcare Limited under the brand name Hexvix®. It is available in a pack of one 10ml glass vial containing 85mg of hexaminolevulinate as 100mg hexaminolevulinate hydrochloride as a powder and one 50ml polypropylene or glass vial containing solvent. Reconstitution in the solvent is required.
The Office of Government Commerce has produced a procurement summary paper which highlights the details of procuring within the public sector which Trusts may find useful.
NOTE: Each Trust is responsible for its own contractual arrangements and must choose one or other of the above routes ensuring appropriate advice is sought through its local procurement or supplies department.
Supplier Details
Whilst it is not NTAC's role to recommend specific manufacturers, this technology and associated agents is currently only commercially available from GE Healthcare, Karl Storz, R Wolf and Olympus.
Training Programme
NTAC Project Implementation Trusts adopted a "train the trainer" approach when they implemented the PDD technology. Training was acquired from existing PDD users alongside industry support. The 'master trainer' was then able to cascade the knowledge gained through the appropriate staff groups according to a defined training schedule. A training plan is required when planning for implementation of this technique. If a dedicated clinical lead / clinical champion does not already have the skills required to use PDD proficiently, then he/she should observe the technology in use by an existing expert user. This could be at one of the NTAC Implementation Project Trusts, at another existing user site, or at a reference centre site as advised by the supplier of Hexvix®. Additionally, guidance from supplier company representatives on technical issues is available during initial use. Once suitably trained, the nominated clinical lead should then demonstrate the skills to the remaining surgeons and theatre staff and supervise them until fully proficient.
The additional skills required and their acquisition is outlined below:
Consultant Urologists, SpRs and Theatre staff who will be participating in PDD-assisted TURBT. Additional skills required:
Understanding of the blue light technology and its applications.
Ward Nurses:
Ward nurses must be able to explain to the patients the instillation of photo-sensitising chemicals and its implications. They must be proficient in the Instillation of the photo-sensitising chemical. Written information must be available for the patient.
Medical secretaries and admissions administrative staff:
These members of staff must be aware that there is a 1 hour pre-operative instillation requirement for the photo sensitising chemical to be taken up by the bladder, and that the procedure of TURBT must be carried out within 6 hours.
Department of Health Guidance for PCTs
The Department of Health has recently published a procurement guide for PCTs, which provides a framework for decisions regarding this essential component of service delivery. Its aim is to "support PCT boards, their delegated authorities and providers (where applicable) in making appropriate and effective decisions about procurement, and ensuring consistency with the overarching principles for public services procurements. These principles include transparency, proportionality, non-discrimination and equality of treatment" - Source: Department of Health: PCT procurement guide for health services.
The purpose of the guide is to enable PCTs to:
- Decide when to use procurement for a clinical service.
- Determine what procurement approach to use if they are running a procurement exercise.
- Outline some key aspects of procurement including the scope of a service specification, financial and risk issues.
Click here to access the report.
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