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 LIMS Streamlines Diagnostic Testing
Information
Technology Helps Streamline Business Process
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. This
article outlines the experiences of one company, Altrix Heathcare
plc as they implemented their laboratory information management
system.
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 1980’s. 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.
Figure
SEQ Figure \* ARABIC 1:
Intercept™ sampling kit
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.
 The laboratory information
management system (LIMS)
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.
Figure 2
: Frank Whitfield (Laboratory Manager) in the Altrix laboratory
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, 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 (see Fig. 3 - the sample being queried is
highlighted in blue).
Figure 3
: Micro plate module
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.
Conclusion
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.
This article was
printed in ELab, December 2004 |
