College of American Pathologists
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Push for patient safety is nudge for automation
Laboratory automation systems & workcells

May 2003
Robin A. Felder, PhD

In a 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.

Once specimens 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.

Intelligent 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.

Getting 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.

Today, there 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.

The majority 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.

The diagnostic 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.

Giving 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.

Many vendors 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 capabilities.

Tecan recently 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.

Keeping 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.

Considering the circumstances
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’ needs.

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 output.

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.

Laboratory automation 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 without carryover.

Undoubtedly, 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.