Abstract
LABORATORY AUTOMATION -WHAT'S THE RIGHT CHOICE FOR YOUR LAB?
With so many options being offered by diagnostic vendors and automation manufacturers, it can be difficult to determine what the best solution might be for each lab's unique requirements. To assist in this process, laboratories should remember to insure that their automation decision allows for true flexibility. Flexible Automation decisions can provide labs with the opportunity to take advantage of today's rapidly changing healthcare environment. But before making any decisions, laboratories must first have an overall automation strategy in place.
As an alternative strategy for laboratory automation, the Stepwise Approach is gaining momentum. This approach involves the evaluation of process improvements (reengineering), data management enhancements, and finally lab automation components (front-end, workcells, back-end, etc.). The focus of this strategy is to explore and implement lab automation in a step by step process. Potential automation customers need to first evaluate current processes and then determine if current data management can handle any application desired by the lab. Only when process improvements have been made, and the optimal data management system is in place, should the laboratory explore the options that exist for lab automation.
To start, labs must evaluate current processes. How do samples get to the lab? What routes do drivers take to get to the lab? Once in the lab, what is the workflow of samples? What bar-coding system is used? What size tubes are used? What happens with aliquots? What about staffing issues? The list goes on.
Often, a third-party evaluation of process improvement alternatives can lead to nonbiased recommendations. Labs have the flexibility as to the degree of change that they can adopt. Careful evaluation of options can achieve maximum productivity gains with minimal investment.
Process reengineering can enable the laboratory to become significantly more efficient. For example, labs can realize significant efficiency gains by implementing bar code labeling of samples and the use of primary tubes for analysis in conjunction with the consolidation of workstations. Argent Consulting, an Oklahoma City based consulting company that has extensively researched laboratory workflow throughout the world, found that if a laboratory processing 150,000 immunoassay samples annually moves from no barcodes, the use of aliquot tubes, and multiple immunoassay workstations to the use of bar-coded primary tubes on one or two analytical systems, they can save an estimated $300,000.00 annually. These savings result from a reduction in aliquots (reduced labor costs, material costs) and through consolidation of instruments (labor, maintenance, Cals/QC, reductions).
The scenario is as follows: Prior to making any changes, the laboratory in question runs its immunoassay tests on five (5) different instruments. With so many workstations, all primary tubes, upon arrival to the lab, are accessioned and aliquoted. This process is manual, takes a lot of time, and is prone to error. These aliquots are then taken to the various instruments for analysis. By reengineering these steps as shown in figure 1, a laboratory can realize significant savings with very little investment. The improved scenario has the bar-coded primary tube being accessioned and taken straight to one consolidated analyzer. The up-front aliquotting is minimized, thus saving tremendous amounts of labor and materials. Though this may sound trivial, it is important that laboratories make these types of process improvements before they consider any kind of laboratory automation. It is suprising the number of laboratories mat are evaluating automation and have not even implemented an effective bar code labeling system.
With reengineering, a laboratory can realize significant savings with very little investment.
ANALYTICAL PHASE
The analytic phase plays a very important, and sometimes overlooked, role in process improvements. As indicated above, the use of bar-coded primary tubes on instruments allows labs to become more efficient in the pre-analytical phase. Workstation consolidation is a key area to focus on to help reduce the number of aliquots. By doing so, the laboratory saves valuable labor resources, making them available for other tasks — i.e. labor becomes more productive — labs can do more with the same amount of people. In addition, the cost of implementing process improvements is minimal while the associated savings are very significant.
After the identification and implementation of process improvements, laboratories should next consider data management enhancements. This area of focus impacts all areas (pre-analytical, analytical, and post analytical) of the lab. Good data management will enhance a laboratory's capabilities in each of these areas. Keep in mind that laboratories are in the “information business” and it is their Laboratory Information System that provides the vehicle to deliver that information.
It is the LIS and its capabilities that will either enhance or burden any form of automation. Ninety percent of the effectiveness of automation is software related. Labs must evaluate if their information system has the capabilities they need today, tomorrow, and into the future, especially in an automated setting.
As an example, the LIS should have true networking capabilities via an “open architecture” design. In today's environment of mergers, core labs, etc., it is almost inevitable that the LIS will require linkage to another system at some point. It is better to insure that the system can do this now. This is especially true as it relates to laboratory automation. Lab Automation Systems have computer controllers that need to communicate directly with the LIS. Capable data management systems must be in place before one should consider the capabilities of an automation system.
Once processes and LIS systems have been optimized, laboratories can consider automation. Dollars spent to automate non-optimal equipment and LIS's can actually create more problems then they solve. When considering lab automation alternatives, laboratories should again employ a stepwise approach. They should evaluate the impact of front-end automation, workcells, combining the two, and total laboratory automation. Every lab has unique needs, and automation alternatives should be explored with this in mind. To begin with, laboratories should examine the areas of the lab that have the greatest impact in terms of efficiencies.
Research by Argent Consulting indicates that 65% of laboratories' “hands-on” time is associated with front- end sample handling, (sorting of samples, centrifugation, decapping, aliquorting, bar-code labeling, etc.) prior to any processing of test results (see figure 2). With the remaining 35% of hands-on time divided between actual sample analysis, data manipulation, and sample storage/retrieval, one can see that the greatest impact on labor and efficiencies can be realized by initially focusing on front-end, pre-analytical activities of sample sorting, centrifugation, sample inspection, decapping, aliquotting, bar-code labeling, and racking of samples.
65% of laboratories' “hands-on” time is associated with front-end sample handling, prior to any processing of test results.
FRONT END PROCESSING SYSTEM EXAMPLES
There are several excellent examples of automated front-end processing systems including systems by TECAN, Labotix, and IDS. They provide automated sample sorting, centrifugation, decapping, aliquotting, and bar-coding. Customers can choose from various configurations to include all components or any combination. After a laboratory improves its front-end processing, the next area that deserves focus is the actual analysis of samples, including instrumentation and their configuration within the lab. It is clear that consolidation of workstations within the lab is a major priority. For most labs, doing more work with fewer pieces of equipment is critical. How can a lab decrease the number of instruments, while increasing test volume and efficiencies in a more automated format? The answer lies in the workcell.
A workcell is an island of automation. Examples include Abbott's ARCHITECT™ system, The Roche MODULAR™ system, and the Sysmex HST™ system. Workcells should be modular building blocks that allow expansion of instrument capabilities as testing needs change, while maintaining a single user interface with the analyzer.
The characteristics of a workcell should include the ability to seamlessly integrate multiple modules into a single system. As multiple modules are integrated, a single system control center drives the workcell. Workcells should allow for the combining of multiple technologies, such as clinical chemistry and immunoassays. This helps to minimize sample splitting and consolidate labor resources. The workcell concept allows customers complete flexibility to expand or contract capabilities as needed in a very short period of time, with little or no down time. Not only is the implementation of workcells a process improvement, as described above, but it is also most certainly laboratory automation.
Another important consideration when evaluating potential automation alternatives is cost. The key questions are “how much is it going to cost”, “what is the return on investment” and “how long will it take to realize this return.” It is proving to be very difficult to quantify the returns on some automation alternatives.
With Total Laboratory Automaton as an example, concrete data will not be available for several years, due to the 5-to 10-year payback period forecasted for these multi-million dollar systems. Of the laboratories in the United States that have fully integrated a TLA solution, few have been able to document a return on their investment. In fact, many of these TLA labs have indicated that they have not realized the overall labor savings that they had initially forecasted. However, with automated front-end workcells and analytical workcells, the initial investment is relatively small with a much faster return (12 to 24 months in many cases).
KEY CONCEPTS
Lets explore further potential impacts of lab automaton for the “typical” hospital laboratory and small to medium-sized reference lab. Four key concepts/conclusions regarding the laboratory industry must be considered.
Change is certain. The changes experienced in the laboratory industry over the last several years represent only the beginning. Much more change awaits us. We'll continue to see staff reductions, vendor consolidation, and lab concept changes, including how automation is viewed.
Predicting outcomes is difficult. Due to the ever changing healthcare environment, predicting what the laboratory will look like tomorrow is extremely difficult. There are so many variables that will influence how each lab will be operating next week, next month, next year.
There is a need for cost effective alternatives to the way labs produce results. Labs must explore—and vendors need to supply— cost effective means of providing goods and services. This includes components for automation. In fact, market research indicates that more than half of the laboratories looking to purchase automation equipment want to do so from their diagnostics instrument vendor to potentially realize cost savings through bundling of products (see fig. 3).
More than half of the laboratories looking to purchase automation equipment want to do so from their diagnostics instrument vendor to potentially realize cost savings through bundling of products.
Flexibility is the KEY to SUCCESS. This is the single most important component of any lab automation strategy. When the environment changes, and it will, labs need to be able to react quickly.
Market share shifts take place so rapidly that overnight the “fixed platform lab” is left behind while the lab that employs flexible-automation” will survive and thrive. This is the idea of the flexible approach to lab automation — automated front end sample handling coupled with workcell sample analysis.
WHERE DO LABORATORIES TURN FOR FRONT-END AND ANALYTICAL WORKCELL SOLUTIONS?
Over the next several months, you will see diagnostic manufacturers supporting this concept with systems that directly address the points made in this article. In fact, at recent trade shows, starting with the AACC in Chicago, several major diagnostic manufacturers unveiled pre-analytical automation equipment and/or analytical workcells. The providers of laboratory instrumentation must provide solutions for customers that include both front-end systems and workcell analyzers. Customers will turn to those who can offer these solutions together.
“Flexible automation” allows for automated front-end sample handling with manual sample transfer to analytical workcells. (see figure 4) More complex automation systems often rely on the use of a track system bolted to the floor to move samples from accessioning, through processing, and out to storage/retrieval areas. Is this complexity necessary? For some very high volume laboratories, yes. But for the typical hospital lab and most reference labs, maybe not.
“Flexible automation” allows for automated front-end sample handling with manual sample transfer to analytical workcells.
With “flexible automation” all of the high-impact efficiencies are realized through the front-end system, along with the true automation of sample analysis found at the analytical workcell. All of this with minimal risk for decision makers due to a small up front investment, a very fast (within 12 – 24 months) return on investment, and all of the major benefits of more complex Total Lab Automation solutions.
Total lab automation is here, and definitely has it's place, but for the vast majority of labs, a more flexible solution is the key to long term viability. For the hospital lab or the small to medium-sized reference lab, TLA is generally cost prohibitive and takes away flexibility. These labs must be able to change very quickly. The appropriate solution for most labs will likely be a “flexible automation” solution.