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Procurement

Procurement

Procurement is an essential part to implementing the intra-operative 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 technology.
  • NHS Service Specification - provides a succinct overview of what service changes are required in order to ensure the successful embracement of the procurement process.
  • Department of Health guidance for PCT's - gives an overview of procurement guidance for PCTs that has recently been issued by the Department of Health.

Procurement Options

Procurement of the intra-operative technology 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 implementation and mentor sites. This highlights a (typical) indicative procurement process and approximate time scales for completion.

Two technologies exist for intra-operative sentinel node testing: one is available as a single commercial package, whilst the other combines multiple reagents which require some internal (procurement and clinical) expertise.

  • OPTION ONE: Whilst it is not NTAC's role to recommend specific manufacturers, this technology is currently only commercially available from Sysmex UK Limited. Sysmex UK Limited is able to offer a number of flexible financial options (including capital purchase, reagent rental and operating lease) for the acquisition of the CE-marked and IVDD compliant Click here, ancillary hardware, reagents and consumables (see current price list). Product information regarding the Sysmex UK Limited RD-100i analytical system and dedicated One Step Nucleic Acid Amplification (OSNA) reagents and consumables can be found via the Sysmex UK Limited.
  • OPTION TWO: Last year, a competitor product which was supplied from Veridex (a Johnson & Johnson company), withdrew its product from the marketplace for commercial reasons. This was on the basis of under-adoption of the technology in the United Kingdom and was not due to scientific or technical reasons. In response to the withdrawal of the Veridex system from the marketplace, Princess Alexandra NHS Hospital Trust, one of NTACs implementation sites, have established a similar intra-operative molecular test for sentinel lymph node assessment. Further details, including financial options for this test are available by clicking here.

The Office of Goverment 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, a single supplier technology is currently only commercially available from Sysmex UK Limited.

Click here an information sheet on the Sysmex UK Limited RD-100i analytical system.

In response to the withdrawal of the Veridex system from the marketplace, The Princess Alexandra Hospital NHS Trust, one of NTACs implementation sites, have established an intra-operative molecular test for sentinel lymph node assessment (metasin), equivalent to the Sysmex UK Limited system. Whilst the technology is not yet commercially available, the Trust is currently seeking to engage with other hospitals within the UK and the EEC who wish to establish this 'in-house' technology in clinical practice. This development will be closely monitored by NTAC and this How to Why to Guide will be updated as progress continues to be made.

For details visit www.metasin.com. Contact details for further information:

Dr Jolanta McKenzie jolanta.mckenzie@pah.nhs.uk, Dr. Vasi Sundaresan vasi.sundaresan@pah.nhs.uk

Contact telephone number for the above 01279 827094.

Training Programme

Training of clinical and scientific staff is essential in order to provide this service. Both options discussed above have the following training requirements:

OPTION ONE: Full training for laboratory staff operating the RD-100i analytical system is provided by Sysmex on site at your hospital for up to four people at no additional cost following purchase. Typically the training course is conducted over 2 days by trained Sysmex staff. Additional on-site support is available following the initial training period to ensure the system is fully integrated in the hospital patient care pathway. Please contact Sysmex for further details: http://www.sysmex-lifescience.com/Contacts-163-2.html

OPTION TWO: Training can be arranged for the use of the alternative intra-operative molecular test (metasin) system, which has been developed by the Princess Alexandra NHS Hospital Trust. For contact details for the team in Harlow and to find out how to organise this training, please click here.

However, before a formal training programme takes place, it is recommended that Trusts register with the UK National External Quality Assessment Scheme (NEQAS), if they have not done so already. The object of quality assurance is to ensure that the right result is provided on the right specimen at the right time, and interpreted according to the right reference data. This process requires a combination of Internal Quality Control (IQC) of the everyday analytical process and participation in External Quality Assessment (EQA) programmes, where overall accuracy and comparability of results between centres may be determined.

NTAC project and implementation sites are all registered with NEQAS.

NHS Service Specification

An operational service specification has been developed to complement the NTAC Project Implementation process, which guides Trusts through all of the service requirements that must be met in order to ensure that the benefits of procurement can be realised. This document clearly maps out how to measure the impact of following each requirement and gives a description of what a Trust needs to do in order to reach a successful output. Operational requirements surrounding the quality and level of service, clinical governance, implementation, financial demand and procurement requirements are all touched upon.

It is important to recognise that a structured approach to adopting this technology is critical to ensure the implementation of a successful model of care. Trusts should also note that it is likely that they will be required to develop a local business case for the implementation of this technology into their organisation, which will compliment the procurement exercise. This will need to include evidence of agreed funding for this technology, either from commissioners or from the Trusts own budget. NTAC project implementation and mentor sites have developed a business case and costing model, which can assist NHS organisations with planning for the implementation of this technology locally.

Department of Health Guidance for PCTs

The Department of Health has recently published a Click here, 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 Department of Health procurement guide for PCTs.

NOTE: It should be noted that each Trust is responsible for its own contractual arrangements and must procure this technology in the correct way; ensuring appropriate advice is sought through its local procurement department.

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