In an era of increased competitiveness, economic uncertainty, ever-increasing regulation and global turmoil, companies are striving to continually improve operational efficiency. Many are looking to information technology to provide reductions in operating costs and increased efficiency by automating and streamlining existing business processes. Elian Winstanley reports.
Altrix Healthcare plc has established the largest specialist oral fluid testing laboratory in Europe. They provide a full screening and confirmation testing service for drugs of abuse, and a screening service for disease markers.
This is achieved through the collection of an oral sample, based on technology originally developed for HIV screening in the USA in the late 1980s. Samples can be collected almost anywhere by a trained member of staff or an external collector in a procedure that takes under two minutes, eliminating the inconvenience of collecting a blood or urine sample. The sample collected is known as oral mucosal transudate (OMT); an ultra-filtrate of blood that is ideal not only to detect drugs and their metabolites but also to screen for blood borne viruses and other disease markers.
From a single donor sample taken for drugs of abuse testing, it is possible to screen for a wide range of substances and their metabolites, such as opiates and morphine specific compounds (including heroin), cocaine (including crack cocaine), benzodiazepines (such as valium), amphetamines (including speed), methamphetamines (including ecstasy), cannabinoids, methadone, buprenorphine, barbiturates, PCP and propoxyphene.
With regard to disease marker screening, a sample taken using similar technology can be used to provide initial screening for Hepatitis B,
Hepatitis C and HIV. This means that wider screening of high-risk groups can be undertaken without unnecessarily exposing health care workers to risk.
Based on this collection technology, Altrix offer tailored services to a range of organisations in the health, clinical justice and corporate sectors. OMT testing is widely used by both criminal justice and drug treatment providers as these services have identified the many benefits it offers, such as a quick, easy collection that is almost impossible to cheat, a morphine specific screen that identifies likely heroin use, not just broader use of opiates and GC/MS confirmation testing that helps distinguish between cocaine and crack and will identify the use of heroin.
One of the most important aspects of this type of testing is that of defensibility. There are two central meanings for defensibility in this context. The first questions whether the testing technique, and all its associated processes, will withstand critical courtroom scrutiny and so form a successful basis for court, tribunal, or disciplinary proceedings.
The second questions whether the use of the technique is consistent with good employment practices. A full treatment of these issues is beyond the scope of this article; however one aspect of defensibility must be the reliability of the result obtained by the testing laboratory. This opens up issues such as chain of custody, sample size, sample identity, quality assurance, method validation and accreditation and result traceability. It is in these areas, as well as those pertaining to general operational efficiency, that the laboratory information management system comes into its own.
When the company first started, Altrix installed separate systems for Customer Services and Laboratory Management that were developed in house. Although these systems worked well in the early days, as the company became more successful, their limitations started to seriously impede the company's growth.
For instance, because the two systems were separate, situations could arise in which samples were logged into the laboratory system but customer services were unaware of their existence. The system could not support parallel processing of sample batches, resulting in increased costs for the business owing to the payment of overtime for laboratory staff.
Some specialist activities, such as the quality assurance of completed microplates, could not be performed by the laboratory system, requiring additional third party software and introducing data transcription issues. Instrument interfacing was very limited, again resulting in costs for re-typing data with the consequent risk of transcription errors.
In November 2002, Altrix's Board of Directors, faced with increasing sample volumes, decided to investigate the replacement of their existing IT applications with a single, integrated COTS (Commercial Off the Shelf) solution.
After demonstrations and discussions with various potential suppliers, they chose the Starlims product from the Starlims Corporation. Although there were several reasons for this particular choice, two in particular stood out. The first was that Starlims already offered an integral customer relationship management module with support for customer management, quotations, invoicing etc. The second was the sheer flexibility of the product, allowing it to be readily configured to meet the company's requirements. The product could also provide solutions to meet remote access requirements to allow customers to submit samples and query results, and to permit full instrument interfacing.
The implementation project started in July 2003. Personnel from the chosen supplier met with Altrix personnel in order to review the whole business process, and to decide how to configure the solution to best meet Altrix's needs. As well as the basic requirements of an integrated customer services/ laboratory system permitting parallel batch processing, highly specific requirements such as the provision of QC trend analysis and data processing were also discussed.
Benefits of the new system
The result was the creation of a system based on a standard product, but configured so as to fully reflect the business processes. For example, a special module was added to facilitate viewing the completed EIA micro plates and applying the quality control rules, a task previously performed using external software.
In Altrix Healthcare's legacy system, the raw optical density values produced by the instrument had to be manually transcribed into Microsoft Excel for further processing With the introduction of Starlims, laboratory staff can see a visual representation of the plate and can perform the necessary processing of the raw result on screen. The user can also trigger retests for selected samples as necessary, as the module is fully integrated within the laboratory system. Frank Whitfield (Fig. 1), the Laboratory Manager commented: "Starlims now holds all of the required information in one place, facilitating accurate result interpretation.“
This module was also designed to facilitate the retrieval of individual plate data following a result query, previously a tedious and time consuming task. With the introduction of the new module in Starlims, the operator can enter the number of the sample in question and view the appropriate plate (Fig. 2.) The sample being queried is highlighted in blue.
Altrix were also able to take advantage of standard product features, such as the proactive messaging system. This ensures that laboratory tasks are not inadvertently missed.
For example, using the old system it was difficult to keep track of samples that required special attention, such as those submitted with parameters that could not be matched within the system or those that failed chain of custody checks.
The introduction of the Starlims dynamic console allows such samples to be readily brought to the attention of customer services staff. This, together with many other similar examples, has led to a solution where the outstanding tasks are now driven by the LIMS, rather than the user having to repeatedly query the system to determine what needed to be done.
Frank Whitfield also maintains that the implementation of the new system has greatly improved traceability. He, or more importantly an auditor, can see at a glance exactly how a particular sample was processed in terms of who did what (with access to the appropriate training records to show that they are in fact qualified to perform the task), which equipment was used and the appropriate calibration and maintenance records and which batches of reagent were utilised.
Electronic signatures and reasons are required at key stages in order to proceed, and the system automatically maintains full audit trails and event logs.
The final report is stored securely in the LIMS database in an encrypted form, and copies of it can be viewed on demand. Change control for final reports is also provided.
Personalised testing certificates and related reports can be automatically issued to multiple client contacts via a variety of mechanisms including email, fax, post (with automated address label production) or by the publishing of results as encrypted files for forwarding via FTP.
Results can be reviewed and released within the system, with electronic signatures applied automatically.
Again, these initiatives have greatly streamlined the operation and delivered significant benefits in terms of time saved and consequent reduction in operating cost.
The implementation of a LIMS that is configured to meet the precise requirements of the end user can deliver significant benefits. Operational excellence can be leveraged by increasing efficiency, automating existing business processes and reducing operating costs.
As Frank Whitfield commented: "As well as hugely improving information management, implementation of Starlims has allowed better use of staff resources leading to improved turnaround times, a benefit that is passed on to the customer.“
In the words of Chris Snelson, Altrix's Operations Director, the Starlims project "has delivered all of our expectations to date“. Chris also commented that the supplier members of the implementation team were extremely helpful and happy to work with Altrix personnel to determine best practice solutions for the business, via detailed discussion.
At the time of writing, Altrix and Starlims personnel are together planning the addition of further functionality to the core Starlims system, with the aim of providing enhanced customer access and replacing remaining legacy applications with fully integrated modules.
Elian Winstanley is managing director of StarlIms UK, Bolton, Lancashire, UK. www.starlims.com
