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. 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
organizations 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.
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). 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. Personalized 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. 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.
by Dana H
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