The Analyser Monitoring Programme (AMP) has been running for four years and has provided UK laboratories with free, up-to-date and objective information about the reliability of laboratory instruments and about company responsiveness. Laboratories have used the information not only in the procurement of new general biochemistry and immunoassay analysers but also in quality management. The scheme has also benefited the suppliers of laboratory instruments by providing them with comprehensive data on faults encountered in busy working laboratories.
Currently, AMP is funded by the Centre for Evidence-based Purchasing (CEP), which provides independent and objective evidence-based information on medical equipment to underpin purchasing decisions and drive the uptake of innovative medical technologies in the NHS. The CEP website (www.pasa.nhs.uk/cep) includes further information about the work undertaken for the NHS. The AMP is managed by the Guildford Medical device Evaluation Centre (GMEC), led by consultant biochemist Stephen Halloran.
How the programme works
The information gathered by participating laboratories is very similar to that required by Good Laboratory Practice and Clinical Pathology Accreditation (CPA) standards. Participating laboratories are provided with analyser-specific log sheets on which they record information about any event that causes one or more analytes to become unavailable for 15 minutes or more. The incidents include instrument or reagent problems, preventative maintenance visits and system upgrades. Details of engineer visits are also recorded on the log sheets. The information is returned to GMEC at monthly intervals to be processed and collated.
Annual reports are produced that contain comparative average downtime and engineer visit data, and model-specific graphs that show the mean downtime for each registered analyser. A detailed breakdown of fault types for each analyser model is also presented.
The latest AMP annual reports were published in January 2009 for general biochemistry analysers (CEP09006) and May 2009 for immunoassay analysers (CEP09011) and can be downloaded from the NHS Purchasing and Supply Agency website (www.pasa.nhs.uk/cep). Shorter quarterly web updates are published on the GMEC website (www.surrey.ac.uk/gmec). Figures 1 and 2 show examples of the data presented in the reports.
Participants
The AMP receives information from NHS laboratories around the UK and includes sites that operate the most commonly used mid- to high-throughput general biochemistry and immunoassay analysers. Table 1 shows the number of sites that returned data during 2009.
Benefits of AMP
A recent review of the benefits of AMP showed that participants are very supportive of the work of the scheme.
When procuring a new instrument the traditional methods of reviewing manufacturers’ performance data and peer-reviewed published data, and a visit to a ‘show’ laboratory, often provide a limited and somewhat subjective picture of performance and supplier support. The AMP improves this process by providing objective, up-to-date data from a wide range of sources.
As laboratories have become busier, local support groups have waned and so has the opportunity to compare notes on the reliability of systems and on commonly seen faults. Likewise, most supplier user group meetings are no longer held annually. However, AMP provides the laboratories with the data with which to approach companies with their concerns, and also supplies manufacturers with the information they require to be able to target problem areas.
Many faults are not reported to the company hotline but are handled ‘in house’. Often quick fixes are performed in a laboratory’s haste to get the analyser working and the results flowing. While this seems to solve the problem it may not treat an underlying fault, which may return to cause further intermittent downtime or serious damage to the system.
Companies have been surprised at the level of under-reporting to their hotlines and have asked GMEC to emphasise that laboratories should always contact the company helpdesk, even in retrospect, so that faults may be monitored and the appropriate help provided to reduce further downtime.
Several companies, suppliers of analysers that perform both well and poorly, would like all their users to sign up to AMP in order to provide a more complete picture. Laboratories have used the data in AMP reports to work with companies to resolve difficulties, either by highlighting commonly seen faults that need to be addressed or by showing that there are overwhelming problems with a particular analyser that ultimately needs to be replaced.
As we all know, having a reliable analyser has many benefits including reduction in sample turnaround time, releasing laboratory workers to perform other tasks, and a reduction in the stress levels experienced by the whole laboratory. All these factors add up to a financial saving for the NHS, which it can spend on other areas of patient care.
What of the future?
The future of this invaluable scheme is now in the balance. The Centre for Evidence-based Purchasing has supported and encouraged the development of AMP over the past five years. It has seen evidence that the industry has improved the quality of product support, and the objective data provided through AMP have been influential in securing procurement of reliable instruments suitable for local clinical need. However, the remit of CEP is evolving and there is now greater emphasis on innovative devices and procedures, and less on the ongoing monitoring of devices in routine use. Consequently, CEP can no longer provide financial support for AMP. So, for this valuable scheme to continue, a new sponsor must be found. If AMP does not continue then the clinical laboratory community will lose a valuable source of objective, reliability data and the chance to:
* augment subjective methods of choosing a new analyser
* question multidisciplinary procurements from a single supplier that may not be the best option for all
* improve company support provided to existing customers by targeting commonly occurring faults.
In addition to the data presented in the AMP annual reports, this unique scheme offers potential for further data to be collated, for example to:
* examine the effect of managed contracts on downtime
* include other analyser models and types, primarily supporting haematology.
Annual reports
The AMP reports can be downloaded from www.pasa.nhs.uk/cep. The next annual reports for both general biochemistry and immunoassay will be published in March 2010.
The CEP and GMEC would like to take this opportunity to thank all UK laboratory staff who support and provide data for AMP. Particular thanks go to the diagnostics industry that has consistently supported the programme and utilised the data to help enhance further the quality of support it gives to its clinical customers.