Push for patient safety is nudge for automation
Laboratory automation systems & workcells
A. Felder, PhD
marketplace rocked by lab consolidation and a med tech labor
crisis, automation is establishing a firm footing, thanks in part
to the push to improve patient safety.
are routed to the laboratory, automation technology can ensure that
they are delivered swiftly, arrive safely, and are rapidly sorted
for analysis. Specimens should be inspected for flaws that will
compromise analysis as soon as possible in the analytical process.
sorting, transportation, routing, and analysis are the goals of
automation systems. Providing solutions to the complex process of
sample dilution, repeat and reflex analysis, and queuing for medical
urgency contributes to patient safety. Once specimens have been
analyzed, storing and retrieving them efficiently will permit automated
reanalysis and other forms of intelligent retesting.
a bang for your buck
After nearly a decade of interest in laboratory automation systems,
it is ironic that the need to reduce errors, not the anticipated
return on investment from labor cuts, seems to be the catalyst for
increasing the use of robotics. ROI, however, is obviously still
a driving force, as evidenced by some early installations, which
failed to generate the necessary ROI and thus posed a challenge
to the lab automation industry.
are many examples of significant investment returns in automated
laboratories of all sizes thanks to careful planning and well-orchestrated
installations. The generally held opinion is that the largest laboratories
are interested in completely integrated automation platforms, or
total laboratory automation systems, such as those from A&T
Corp., Beckman Coulter, Lab-InterLink (also sold via Ortho-Clinical),
MDS Laboratory Services, and Roche Diagnostics.
of medium-sized to small labs are interested in consolidating their
analytical workstations with task-targeted automation to create
a less expensive alternative to TLA. These labs typically seek integrated
workstations, such as those sold by Beckman Coulter, Dade Behring,
Lab-InterLink (also sold via Ortho-Clinical), PVT LabSystems, Roche
Diagnostics, Sysmex Corp. of America, and Thermo Electron.
automation industry is also rising to the challenge of providing
solutions to the smaller laboratory by selling workstations that
target specific tasks. Among the companies offering products to
fill this need are AI Scientific, Olympus America, PVT LabSystems,
Roche Diagnostics, Tecan (also sold via Abbott Laboratories), and
Thermo Electron. In addition to the new products on the market,
some mature systems have been outfitted with a range of features
that focus on enhancing throughput, reliability, and versatility.
specimen storage its due
Specimen storage and retrieval, or post-analytical automation, is
an often overlooked area of the laboratory. Specimen reflex and
repeat testing consumes an unappreciated amount of labor and accounts
for some diagnostic errors. Proper specimen storage can reduce sample
degradation from long-term exposure to room temperatures, decrease
the chance of specimen mix-ups, and reduce the time necessary to
find the specimen and put it back in the analytical queue.
have been quite innovative in automating the sample storage area
of the laboratory. Tecan, for example, has continuously improved
the performance of its pre- and post-analytical processor, which,
in part, accounts for its continued popularity. In response to laboratory
requests, the Tecan-designed Genesis FE 500 workcell provides sample-archiving
introduced a new tube inspection unit for its FE 500 that can determine
common sample problems, such as insufficient volume, even through
sample labels. Therefore, samples of poor quality can be eliminated
from the queue before they slow the analytical process.
errors to a minimum
Several major commercial laboratories have implemented six sigma
quality management systems. Six sigma dictates that laboratories
should achieve an error rate of no more than 3.4 errors per million
laboratory operations. Achieving a six sigma quality level will
require widespread use of automation technology since it has proven
difficult to avoid errors when manually performing the complex tasks
found in clinical laboratories. For example, 60 percent of the labor
in a clinical laboratory is focused on the pre-analytical phase
of laboratory testing, and this phase accounts for a significant
proportion of errors. Examples of pre-analytical errors include
failure to place stat specimens in stat queues, excessive waiting
time for specimens following centrifugation, improper aliquotting,
and lost and mislabeled specimens. Automated pre-analytical processors
have already demonstrated their utility in reducing labor and errors,
but they will also improve the documentation of errors, for which
each laboratory will become accountable in the future.
Patient safety is also getting a boost from intelligent software,
or process control. Autonomous robotic systems are needed to increase
laboratory efficiency, eliminate dependence on labor, and allow
the laboratory to provide data for patient diagnosis more rapidly.
The automation vendors listed in the accompanying survey have created
some level of intelligent process management in order to perform
the targeted laboratory tasks, but they also provide the flexibility
needed in a changing laboratory environment. Laboratory automation
systems should be able to endure changing circumstances over extended
operation, such as changing test menus, modifications to reference
ranges, and shifts in laboratory staffing and physicians’
In the future,
autonomous system software should be able to make effective management
decisions through adjustable autonomy (changing their level of independent
decisionmaking based on the circumstances) and by prioritizing new
goals, learning from past experience, and providing user-friendly
Preparing for tomorrow
As the post-genome era unfolds, increasing numbers of specimens
will arrive in the laboratory for analysis of single nucleotide
polymorphisms and proteins. SNP panels have proven their utility
in the diagnosis of cystic fibrosis, cancer, and hypertension.
will need to evolve to maintain closed-tube sampling for DNA analysis
because of the increased possibility of cross-contamination. Furthermore,
the laboratory will require devices for DNA extraction from whole
blood, either in the form of a dedicated workstation or as part
of the SNP analyzer. Novel diagnostic plasma proteins will also
require special handling since many of these proteins are expected
to be present in low concentrations and to be susceptible to oxidation
and temperature-induced degradation. The distinguishing features
for successful automation platforms, therefore, eventually will
include higher throughput, onboard refrigeration, and sample aspiration
the next generation of automation systems will be faster, less costly,
accommodate all tube sizes, including pediatric tubes, and be equipped
to deal with the genome/proteome era.
In the meantime,
CAP TODAY offers a
listing of 20 clinical laboratory automation systems from 15
vendors that are serving today’s lab market. The 2003 listing
highlights vendors’ system features and functionality and
identifies their level of market penetration. The information provided
is based on vendors’ responses to a questionnaire.
Karen Titus is CAP TODAY contributing editor and co-managing editor.