Laboratory

automation and
information
management
ELSEVIER Laboratory Automation and Information Management 33 ( 1998) 163- 168

LIMS: An automating or informating technology?

J.E.H. Stafford *
Motherwell Information Systems, Sension House, Denton Drive, Northwich, Cheshire CW9 7LlJ, UK

Abstract

The hypothesis that automation of laboratory processes through LIMS implementation is not itself sufficient to greatly
benefit or provide strategic advantage to an organisation is discussed. Traditionally automation has been implemented in
order to increase management control over the means of production. As a result the introduction of automation into much of
the manufacturing industry has led to increased job dissatisfaction, worker alienation and industrial unrest. This is the case
irrespective of the automating technology, e.g. steam-powered machines or computer controlled systems. The specifiers and
implementors of LIMS have happily trodden down this well-worn path, without digesting the experiences of other industrial
sectors. However, the use of Information Technology to automate business processes provides a unique, additional
dimension. IT can provide information about the automated process itself. In this respect IT is an informating technology.
The use of computers within an informating strategy focuses on opportunities for continual learning as new data, events and
contexts characterising the automated process create chances for additional insights, improvements and innovation. LIMS
must informate as well as automate in order to achieve a successful implementation. 0 1998 Elsevier Science B.V. All rights
reserved.

Keywords: Laboratory automation; Informating strategy; User satisfaction; Data-centric: LIMS; Process-centric

1. Introduction vendors in addition to their implementation partners

in Europe and USA alone.
Computers have found widespread use within lab-
Nevertheless, in spite of the rapid adoption of
oratories. Initially used to facilitate management of
LIMS, particularly within regulated industries, there
data from increasingly more automated analytical
is much anecdotal and some published information
equipment, computers were subsequently employed
that suggests the user satisfaction level for installed
to automate the potentially error-prone clerical activ-
systems is around 50% [I]. The considered response
ities associated with the collation of sample and test
to this observation was to increase the perception of
data and subsequent reporting to the client. The
LIMS ownership by involving the user earlier in the
various software applications developed to meet these
decision making stages and to increase the project
automated clerical requirements were classified un-
and management skills to the level necessary for
der the category of laboratory information manage-
successful project completion. Whilst these initia-
ment systems, LIMS. Commercialization was rapid
tives may well facilitate the selection, specification
and the LIMS business now supports at least 80
and successful implementation of a standard LIMS
there is no a priori evidence to suggest that user
* Tel.: +44-l-606330010: e-mail: jstafford@mother.co.uk. satisfaction rate will increase as a result.

0925-5281/98/$ - see front matter 0 1998 Elsevier Science B.V. All rights reserved.
PII: S1381-141X(97)00017-8
164 J.E.H. Stafford/Laboratory Automation and Information Management
Is it possible that the user’s and industry’s percep-
tion of LIMS requirements has become fixed in the
past and prevents the development and implementa-
tion of more user-acceptable LIMS software applica-
tions? If so, what has been overlooked and how can
we exploit this insight to improve the effectiveness
of LIMS applications and implementation?
Computers are unique in their capacity to auto-
mate in that they are also capable of providing
additional information about the underlying auto-
mated process. This property of computer systems
was recognized by Zuboff [2], who coined the word
‘informate’ to describe it. Users can exploit the
informating properties of computer-based systems to
facilitate their understanding of the automated pro-
cess e.g. analytical process, sample collection and
preparation systems, data management. Data charac-
terizing these automated processes e.g. system suit-
ability, QC results, analyte recoveries, sample back-
log and turnaround times are readily generated, but
need to be turned into information to be of practical
use to aid decision making. The resulting increased
potential for control over the automated processes
will lead to improved job satisfaction since the user
will no longer feel that they are at the mercy of, or
threatened by, the computer. They will become mas-
ter of the computer, not continue as its perceived
slave. Consequently, more emphasis must be placed
on laboratory processes and applications that create
information from procedural data acquired and man-
aged by a LIMS in order to empower the LIMS user.
New LIMS should redress the imbalance between
data and processes and become more process-centric.
2. Why is automation not sufficient?
There are a number of ways of defining automa-
tion [3] with computers providing a mechanism by
which a process can be made automatic. In defining
an automation strategy for the laboratory, LIMS was
classified under information management together
with, for example, databases and spectral libraries.
This is consistent with the widespread perception
that the sole purpose of LIMS is to automate labora-
tory clerical activities. However, only the status quo
[2] is maintained when computer based systems are
used in this manner to facilitate improvements in
33 (1998) 163-168
(laboratory) business practices at the expense of
increased user dissatisfaction.
The increased use of computers and mechanical
devices to automate portions or all of routine analyti-
cal procedures resulted in an explosion of paper-work
because the analysis of the instrumental response
was no longer the rate limiting step for data collation
[4]. The rate limiting step became the effort required
to manually transfer data from document to docu-
ment as it passed through subsequent data collation,
manipulation and approval processes prior to genera-
tion of the final report or certificate and filing.
Transcription errors were common and required
careful review processes to detect them.
There was also an increased awareness of the
importance of quality issues and quality assurance
programs were implemented not only to comply with
regulatory guidelines e.g. GLP and GMP, but also
for commercial reasons. These programs also added
to the laboratory workload and need for improved
documentation management procedures.
Given this background it is perhaps not surprising
that laboratory managers sanctioned the rapid take
up of a technology, LIMS, that provided a means of
reducing the need for data transcription and automat-
ing the reviewing and reporting of data.
A laboratory can be viewed as a high level pro-
cess wherein samples and their accompanying paper-
work are inputs and the outputs are analytical data in
the form of reports [5]. A measure of laboratory
performance is productivity in terms of the number
of samples analyzed and error-free reports issued in
a given accounting period. Thus business reasons
alone were sufficient to justify using computers to
automate the data collation, manipulation and report-
ing processes, thereby increasing productivity. How-
ever, experience in other sectors suggested that this
approach to automation leads to general worker dis-
satisfaction for those who must interact with the
computerized process [2]. The driving force for au-
tomation in this scenario is the laboratory business
manager’s need to control the means of production
rather than facilitating the analyst’s work.
2.1. Impact of automation
In an analysis of the application of computers to
automate non-laboratory activities in other industrial
sectors Zuboff [2] came to number of pertinent con-
 J.E.H. Stafford/Laboratory Automation and Information Management
elusions. Firstly the desire to automate was driven by
the manager’s need to exert more control over the
means of production. In doing so the manager
usurped any element of control that the worker had
over their own work activities, thus demotivating the
workforce. Secondly, worker motivation was not
affected when automation was introduced that facili-
tated participation of the workforce in the decision
making necessary to maintain the automated process.
Thirdly, automation maintains the status quo.
There is an uncanny parallel between the first
observation described by Zuboff and experiences
described by laboratory users of LIMS.
Managers of laboratories within larger organiza-
tions are also affected. There are many good Corpo-
rate reasons for wanting to make analytical data
readily available to groups outside the laboratory for
further manipulation or to support decision making.
However, the ‘fire and forget’ reporting model for
laboratory automation does not fit into this new
vision where external user groups require a filtered
view of the analytical database [Sl. If external users
are able to interrogate the database on demand,
bypassing laboratory generated reports, the manager
may resent this loss of control over a perceived
product of the laboratory process. This could lead to
local resistance to the use of computer systems to
implement a Corporate wide data-sharing system.
The third observation has an interesting implica-
tion for LIMS applications and their implementation.
All published advice for those intending to imple-
ment a LIMS advocates modeling and understanding
the current laboratory practices and then modeling
the desired state. In principle this should reflect an
optimized model, but in practice will reflect the
perceived capabilities of the yet to be chosen system,
particularly in the case of the first implementation
[6]. The advice is valid in that a laboratory does not
want to encapsulate inefficient practices. However,
the corollary is that it is very difficult, if not practi-
cally impossible, to readily change a LIMS configu-
ration once implemented and inefficient, old or re-
dundant practices become embedded in the auto-
mated system. The ability to quickly respond to
change is a feature of successful business practice
and a LIMS that cannot readily meet these new
requirements must always fall short of expectation
and a candidate for replacement [6].
33 (1998) 163-168 165
Changes in requirements that reflect new reports
or data entities for management are readily managed
by modem LIMS with data base configuration and
reporting tools. However, changes in business rules
or processes cannot, because they are almost always
embedded deep within the LIMS executable or
database management system. Consequently data
base driven, data-centric LIMS will always tend to
maintain the status quo.
3. Informating properties are not exploited in
LIMS
Successful use of computers to automate business
practices must exploit the informating properties of
computerized systems. Standard LIMS do not exploit
informating properties very well. A good example is
the mandatory audit function for LIMS in regulatory
environments.
The use of computer systems to automate labora-
tory clerical activities created an additional challenge
in that there was an urgent need to be able to
demonstrate the accuracy and integrity of electroni-
cally stored data. Regulatory guidelines required that
corrected data in paper systems remain legible, but
standard computer systems over-wrote the data item
when edited.
Data management systems in multi-user environ-
ments automatically record the time and date and
nature of access to a record and the user ID. How-
ever, the data is transient in that only the most recent
access is recorded. Where there is need to demon-
strate data integrity all write and delete access must
be recorded. Consequently an audit application was
specified that would track and record all changes to
critical data items and store the data in a readily
retrievable form. Note that the resulting audit appli-
cation could not have been developed were it not for
the appropriate specification of the underlying data
or file management systems.
However, although the audit function informs the
user of changes to the data it does not fully exploit
the informating properties of computer systems. Ulti-
mately it is necessary to run a report to extract the
audit data for an object of interest. There is no
mechanism for assessing the data in order to make a
166 J.E.H. Stafford/Laboratory Automation and Information Management
decision concerning what the audit data illustrates
about the data entry and manipulation processes.
Similar considerations apply to object histories
e.g. chain of custody for a sample. If the LIMS just
tracks the date, current location of the sample and its
current owner then it is a data reporting function i.e.
data-centric. The system records what has happened,
not what should happen.
This type of LIMS limitation was recognized and
discussed some years ago in reference to the backlog
report [7]. This is standard report in all LIMS, but it
is just a report. In order to make the reported data
useful it must be turned into information vide infra.
4. LIMS as an informating technology
An informating strategy for the implementation of
data management automation will help to redress the
imbalance apparent in the laboratory by focusing
more on the processes than on the crude laboratory
inputs and outputs. Laboratory processes are owned
by the laboratory personnel who have direct impact
upon the quality of ‘their’ processes and conse-
quently on the quality of the process products (out-
puts) e.g. analytical data, reports. An informating
strategy will help to identify the software applica-
tions necessary to facilitate decisions concerning how
the automated process is behaving, leading to in-
formed corrective actions to maintain or improve
process quality. A process-centric approach will also
influence LIMS architecture, which as a result will
become more amenable to changes in business prac-
tices. Indeed the impact may be as fundamental as
influencing properties of the objects used to build
LIMS of the future.
The historical emphasis placed on the visible
product of laboratory activities viz. analytical data
and reports has naturally led to the development of
data-centric LIMS applications, where more empha-
sis is placed on data management automation than on
management of the automated processes that produce
the data. Traditional measures of laboratory produc-
tivity based on data reported are no longer viable in
a Corporate vision of data accessible to all with
appropriate authority. The laboratory is just another
service function amongst many others. One way for
the laboratory to regain its identity is to refocus on
33 (1998) 163-168
those procedural aspects that comprise the total labo-
ratory activity. Laboratory personnel from the most
junior technician up to the laboratory director own
these processes. They will have a vested interest in
ensuring that the work they do, viz. the process they
are involved with, is of the highest quality. However,
in order to maintain the processes they need to
measure the performance of the process and charac-
terize the parameters that impact on process perfor-
mance. Employing LIMS to facilitate these processes
will be of little value unless implemented with a
view to exploiting the informating properties of com-
puter systems.
Consider for a moment chromatography systems
as part of data management automation. In order to
monitor instrument performance a system suitability
test is performed prior to injecting the calibration
standards, samples and quality control samples. From
a purely data model perspective the system suitabil-
ity test will not have the same characteristics as the
calibration standards or samples. Consequently a
standard LIMS that generates test worksheets will
not be able to record system suitability unless there
is a mechanism for associating the suitability test and
results with that particular instance of the instrument
run or test worksheet. The test results may thus not
be recorded with the appropriate data set or in the
LIMS and will not readily be available for query
should there be an issue with regard to the analytical
results. Likewise it is common practice to only record
the calculated result in the LIMS. This practice
results in a loss of information because the chro-
matographic data, retention times and peak area or
height are not stored in a readily retrievable manner.
These data yield valuable information about the ana-
lytical process itself, in addition to the QC results.
An informating strategy requires not only storage of
all the chromatographic data, but also statistical qual-
ity and process control applications to analyze the
data. These applications should be seamlessly acces-
sible from within the test worksheet to facilitate
analysis of the analytical process.
The requirement to store raw analytical data in an
easily retrievable form is a feature of the LASF
process model for laboratory automation [8] and is
consistent with the implications of adopting an infor-
mating strategy.
The limitation of using LIMS to generate labora-
 J.E.H. Stafford/Laboratory Automation and Information Management
tory performance data i.e. sample backlog report was
discussed above. An informating approach implies a
requirement to transform sample backlog data into
information by comparing the backlog against a set
of limits viz. a specification is set for a measure of
the sample backlog. Bespoke software is required to
implement this concept in standard LIMS as a back-
log management system, because the LIMS model
for specification checking is limited to comparing
analytical results against product specifications.
A characteristic of the data-centric LIMS model is
use of the ‘status’ attribute e.g. available, in testing,
rejected, to describe the state of laboratory entities
e.g. sample, test, result, project. This feature of
LIMS is sold by virtue of offering the user the
possibility of monitoring the workflow. By itself this
feature is not very useful since the user can only
generate reports summarizing laboratory objects of a
certain status i.e. the current state of the laboratory.
What is potentially of more use is to determine what
will happen.
LIMS use many of these object statuses to apply
laboratory business rules e.g. a rejected result cannot
be approved. However, since the rules are usually
deeply embedded within the architecture of the LIMS
it is impossible to implement new a business rule
that states, for example, ‘in certain circumstances a
rejected result can be approved’ without extensive
customization. An informating strategy expressed in
LIMS design would focus on processes and provide
a tool set that would enable the implementor to
model the laboratory processes on the screen and
define the business rules that determine how the
processes link together and transform input into out-
puts. LIMS would become a workflow application
and thus able to meet changing business require-
ments more readily.
As a workflow application there are many possi-
bilities for managing and understanding laboratory
processes by analysis of data associated with the
workflow. For example, if due dates are included
after each task in the workflow the LIMS could
automatically record actual times to complete the
task. Actual times could be used to refine task timing
or predict availability of approved results or flow
bottlenecks. Limits set against critical tasks in the
workflow would provide early warning of a break-
down in the workflow.
33 (1998) 163-168 167
An interest possibility arising from the workflow
paradigm is the potential capability for the system to
learn. If it were possible to build the workflow on
the fly for an ad hoc sample as the analyst was
determining the best analytical approach, the suc-
cessful route could be subsequently stored. The next
time a similar sample was presented the system
could select or suggest the appropriate workflow. If
in addition the system captured the reasoning behind
the analyst’s route i.e. the business rules, elements of
an expert system would be in place.
A further implication of exploiting informating
properties of computer systems relates to the con-
struction of the LIMS software application itself. The
increasing use of object oriented technology in the
construction of new LIMS applications provides for
the opportunity to specify that the objects and their
methods should be self-testing. The recording and
storage of the outcomes from the self-testing pro-
cesses will provide the evidence required to support
the premise that the systems are operating or con-
tinue to operate in a valid manner i.e. as specified.
The software driven processes that enable com-
puter systems to function and communicate are taken
very much for granted. Yet the stochastic nature of
the underlying electronic processes dictates that there
will be a significant amount of self-verification built
into the system. For example, when data is packaged
for transfer between computers across a network a
check sum is automatically calculated based on the
data content and included in the frame for transmis-
sion [9]. The receiving computer unpacks the frame,
recalculates the check sum and accepts the transmis-
sion if the check sums agree. This model would
readily translate to a scenario familiar to users carry-
ing out Black Box validation of their LIMS. How-
ever, instead of the users constructing a test protocol
to demonstrate that data entered at a screen prompt
was stored in a correct manner, the software would
carry out the check automatically. The software
‘methods’ to capture and process screen input and
store the data in the database management system
would be automatically encoded and compared with
the value previously calculated for a known success-
ful execution of the function (unit or module test). If
the values agree the data is stored, if not the system
tries again or reports an error. In this scenario the
emphasis is on processes not the data. Data integrity
168 J.E.H. Stafford/Laboratory Automation and Information Management
and validation is managed by the database manage-
ment system since the charac-teristics of the data
elements comprising the screen prompts are inherited
from the database meta-data definitions.
References
[II R.D. McDowall, A Model for a Comprehensive LIMS in
Advanced LIMS Technology, Case Studies and Business Op-
portunities. J. E. H. Stafford @d.l, Publ. Blackie Academic
and Professional, London, 1995.
El S. Zuboff, In the Age of the Smart Machine: The Future of
Work and Power, Publ. Heinemann Professional Publishing,
Oxford, UK, 1988.
[31 R.D. McDowall, Strategic approaches to laboratory automa-
33 (1998) 163-168
tion, Chem. Intell. Lab. Syst. Lab. Inf. Manage. 17 (1992)
265-282.
[4] D.J. Betteridge, Towards intelligent automation, Anal. Proc.
24 (1987) 106-108.
[5] J.E.H. Stafford, LIMS: An Automating or Informating Tech-
nology in Advanced LIMS Technology - Case Studies and
Business Opportunities, J.E.H. Stafford (Ed.), Publ. Blackie
Academic and Professional, London, 1995.
161 T.V. Iorns, Replacement LIMS: Moving Forward or Maintain-
ing the status quo. in Advanced LIMS Technology - Case
Studies and Business Opportunities, J.E.H. Stafford (Ed.),
Publ. Blackie Academic and Professional, London, 1995.
[7] R.R. Mahaffey, Laboratory Automation in LIMS - Applied
Information Technology for the Laboratory, R.R. Mahaffey
(Ed.), Publ. Van Nostrand Reinhold, NY, 1990.
181 J. Liscouski, Laboratory and Scientific Computing A Strategic
Approach, Publ. John Wiley and Sons, NY, 1995.
[9] S.P. Maj, Networking Concepts for Chemists, Chem. Intell.
Lab. Syst. Lab. Inf. Manage. 13 (1992) 203-210.