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Date: Friday 30th of July 2010

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Who Buys IVD's?

Who Buys IVD's?

The in vitro diagnostics (IVD's) sold in this country fall into a range of areas which include clinical use by the NHS, consumer tests, research and forensic testing. The procurement landscape for most of these is quite straightforward but becomes more complex as the NHS procurement system comes into play.

CONSUMER testing is an increasingly complex and controversial area. The range of self-tests available to buy over the counter, or particularly via the internet is growing and the number of self-testing services are increasing. These are usually more complex tests which cannot be performed at home so a sampling kit (which should be CE marked) is purchased and the consumer sends the sample to a laboratory and receives a report back.

Procurement by the NHS includes laboratory tests and equipment as well as point of care testing and products for patients to use for self-management of long term conditions. For self-management the products are provided to patients by prescription in the same way as drugs.

Individual NHS acute Trusts, PCT's on occasions, collaborative procurement organisations (CPO or 'Hubs'), NHS Supply Chain all buy for the NHS market. There is no single supply route. They probably each use different organisations to facilitate electronic tendering and invoicing as well as operating on different terms and conditions.

If you still consider the N in NHS means National you may be surprised at the extent of the diversity. Better think of N = numerous! Asides from division of the UK into the 'devolved administrations', England splits into 10 Strategic Health Authorities (SHA), and each of these is made up of its constituent Trusts. These are relatively independent local organisations with little direct control from Whitehall. Each SHA has an associated 'hub'. In the nature of things these are all different, with varying levels of buy-in from local Trusts, geographic coverage (with some apparently operating sans frontiers), products/contracts coverage etc. They do often have clinical procurement specialists, and may be perceived to have a role in linking the procurement process with clinical requirements, as well as the wider local economy.

Formerly the NHS Logistics Authority took care of the supply of many consumables to the NHS via its own warehousing and transport. This has been privatised as NHS Supply Chain with a greatly expanded scope, and a remit to save on the NHS spend. It works with framework contracts, runs a massive catalogue operation mainly for consumable items, which it may or may not stock as well as developing contracts for the supply of capital items - imaging being recently added.

NHS Supply Chain's pathology programme has sights set on framework contracts for the major analytical platforms next year. It launched an MRSA tests contract in May, cataloguing the products, and plans to add Chlamydia/Gonorrhoea and Clostridium difficile, as well as blood gas analyser contracts shortly. Its tender for POC Drugs of Abuse tests closes at the end of July.

Managed Equipment Service has become a favoured vehicle for Trusts - with a lead supplier providing all the requirements to operate the pathology service for a period, for a fee, to an agreed service level. These complex contracts are worked to transfer risk from the Trust to the supplier and to allow the Trust to reclaim VAT, under the provisions for 'contracted out services'.

NHS Procurement has become more complex, with the drive to a more decentralised and locally based service, along with constant pressure to reduce costs - which seem to end up at the supplier's door. A core element of BIVDA's role is to represent the IVD sector to these purchasing organisations, monitor activity and keep its member companies informed.

Authors: Doris-Ann Williams & Colin Andrews, BIVDA

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