Finding Efficiencies with Pre-Analytical Automation

Finding Efficiencies with Pre-Analytical Automation

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Finding Efficiencies with Pre-Analytical Automation

With 65 percent of the laboratory’s cost for labor lying in sample preparation, automating pre-analytical sample handling is a major cost-cutting step.

Laboratories are always looking for ways to cut costs. Automation is one way they can achieve cost reductions—it pays for itself over time by decreasing labor costs. Automating the pre-analytical sample processing area is a good way to experience a significant drop in labor expenditures.

Until recently, however, the only choice for labs wanting to automate the pre-analytical handling of specimens was total laboratory automation (TLA). While TLA is a viable option for large laboratories that process a large number of tests per day, it is not often an affordable choice for small and some medium-sized labs. These labs can choose a modular or sectional approach—automating one or two parts of the lab at a time and fitting those pieces together like a puzzle as more elements are added.

Recently, manufacturers have begun to make pre-analytical sampling processors to meet the needs of these small- to medium-sized labs looking to cut cost through automation.

Why Automate?
Why should a laboratory automate the pre-analytical handling of samples? Because it will save money, say experts at LabAutomation 2001, Palm Springs.

“From a laboratory cost breakdown point of view, pre-analytical handling of specimens is probably the largest cost for labor in the laboratory,” says Laurence M. Demers, PhD, DABCC, distinguished professor of Pathology and Medicine at Penn State M. S. Hershey (PA) Medical Center. “That’s because most laboratories have automated equipment that do the analytical piece. But, it’s really the pre-analytical piece that ends up being a very costly part of the laboratory operation.”

Pre-analytical sample processing units ideally perform any activity associated with preparing the sample for analysis. Dr. Demers explains that in terms of labor requirements for an automated clinical laboratory, the front-end pre-analytical piece consists of 65 percent of the total labor required to generate a laboratory test result. The analytical piece takes up 15 percent of the labor; instrument upkeep and maintenance consume 8 percent; sample storage and retrieval take up 10 percent; and transporting the sample from the processing area to the instrument consumes 2 percent. Therefore, automating the pre-analytical piece will lead to major cost savings.

“Labor equals money. So that’s where the laboratory cost-per-sample is influenced by the pre-analytical labor component,” explains Dr. Demers.

While this area of the laboratory has a high labor cost, it often has a high employee turnover rate. Many laboratories hire laboratory assistants at a low hourly rate to perform some of the more monotonous tasks of pre-analytical sample preparation, such as decapping, barcoding and centrifuging tubes.

“Because lab assistants are in the low-end of the pay scale, the minute another job becomes available that’s paying 25 cents more an hour, they’ll leave,” explains Dr. Demers. “It’s usually a very high turnover area of the laboratory because they have to work nights, weekends and holidays. The assistants often don’t have the same allegiance that a medical technologist has.”

“It’s also the most error prone area of the laboratory because lots of specimens are being handled that are labeled in a variety of creative ways by the phlebotomists, doctors, nurses and everyone else involved in the process,” adds Robin Felder, PhD, professor of Pathology and director of the Medical Automation Research Center, University of Virginia Health Sciences Center, Charlottesville. “You have to essentially clean up everyone else’s creativity and make it into a standardized product to go into the laboratory.”

A specimen-processing unit is valuable in eliminating these inconsistencies, the experts maintain.

“The automated piece gives you consistency in an extremely important area of the laboratory,” says Dr. Demers.

History of the Pre-Analytical Sample Processor
The pre-analytical sample processor is a relatively new phenomenon. In years passed, many manufacturers focused on developing automation devices for the analytical portion of the laboratory. However, they have only recently begun to address automating the pre-analytical piece in a modular aspect.

“It has been addressed for several years through the total automation approach,” says Dr. Demers. “Some of the bigger companies have the full nine yards, where they have the processing piece automated and integrated directly into the analytical piece. However, most laboratories cannot afford that total lab automation piece, so laboratories are looking toward sectional laboratory automation. They’d like to buy something that automates the specimen processing part separate from the analytical part.”

Dr. Felder agrees that modular automation is a better approach for small and medium laboratories, while TLA remains a great opportunity for large laboratories.

“TLA is certainly a viable option for large laboratories,” he says. “Many people claim that TLA is dead, but it’s still a very useful solution to a complex automation problem.”

To decide which kind of system fits the needs of the laboratory, it’s important to use simulation models—computer tools that take laboratory demographics, including sample number, hour of the day, test selection and the current labor force—and decide what is the best way to optimize the laboratory.

“Those are commercially available pieces of software, but it takes a professional to manage to run that software correctly,” warns Dr. Felder. “There are consulting groups that do simulation models for laboratories. Additionally, most of the clinical vendors have simulation modelers that provide these services to clients.”

“In the United States, I think the total lab automation momentum is slowing,” comments Dr. Demers. “Five years ago everybody was excited that labs were going to become totally automated. It turns out that that has not met people’s expectations because there’s underutilized capacity of these systems, and they cost several million dollars. There are interface complexities with the system, so it removes flexibility from the laboratory. When a new instrument comes out, they have a difficult time getting it hooked up to what is already connected in a TLA laboratory.”

However, a few years ago, there were no modular pre-analytic instruments on the market, as much of the focus was on TLA. In addition, because the perception was that pre-analytical specimen preparation is a low-cost area of the laboratory, it was one of the last areas to be automated, he says.

“All of the research and development went in to automating the analytical piece because that was the piece that was extremely expensive since expensive med techs are running the tests,” says Dr. Demers. “In the last 15 years, we’ve come a long way in terms of improved automation that brings a lot of tests together on the same platform, consolidates workstations and more. We’re just about maxed for that automation piece. Now people are looking to save even more.”

Dr. Felder agrees that pre-analytical automation came forward only when the manufacturers began to focus on areas outside of analytical automation.

“It’s been on everybody’s mind, but the actual solutions that have been available for purchase haven’t arrived until just recently,” he comments. “It took a while for the companies to realize that there was a significant market for the small- and medium-sized laboratory. And, it took a while for the market to understand that automation can really pay for itself. The vendors had to realize it was worth doing and the purchasers had to realize it was worth purchasing.”

Dr. Felder notes that these two groups—the manufacturers and buyers—have now come together. Laboratories, he says, are interested in pre-analytical automation because it’s an acceptable automation solution. Once that happens, these devices will begin to connect directly to the analytic instruments.

“When everybody understands that pre-analytics works and they start purchasing and using them, then vendors will address the next logical step, namely coupling to analytical devices and eventually to storage and retrieval,” he says. “The obvious first choice is to couple pre-analytics into chemistry, resulting in the creation of a work cell. When you start combining these automated workstations, you end up with work cells.”

The New Systems
More manufacturers are deciding to produce pre-analytical sample handling instruments. According to Dr. Felder, laboratories have a range of choices when it comes to pre-analytical sample processing units. Units include the Roche Modular, Beckman Coulter Power Processor, Abbott/Tecan GENESIS FE 500, Bayer Advia LabCell, Ai Scientific Pathfinder and versatile systems from LabInterlink and A&P Clinlog.

“Most of the major vendors have some sort of device or group of devices that can serve as a pre-analytical processor,” says Dr. Felder. “These represent a wide variety of throughputs, sizes and capabilities. They are all quite different, so it takes a bit of careful study of the problem to match the needs with the proper pre-analytical processor.”

Dr. Demers’ laboratory chose the Tecan system.

“The Tecan is a sort of the first-of-its-kind instrument designed specifically to be an independent unit that resides within the specimen processing area of the laboratory,” he says.

Instruments like the Tecan are smaller and come at a much lower cost than TLA. They perform the major tasks of specimen processing, including specimen receipt and sorting, centrifugation, decapping, secondary tube labeling, volume detection and clot detection and aliquotting into analyzer racks.

“It automates all of the essential steps in specimen processing and brings it into one little front-end work cell,” states Dr. Demers. “The specimens come into the laboratory and are loaded onto this specimen processing unit. The technologist just has to walk over to the unit, remove the rack and put that rack right into the analytical system.

“From the time the tube enters the laboratory until it is in that analytical rack, the system more or less guarantees that that is the right sample,” he continues. “It’s constantly reading the bar code and it does barcode the daughter tubes, so you have good sample identity and integrity throughout the specimen-processing unit.”

Choosing a System
Before choosing a pre-analytical sample processor, laboratories need to assess their testing load to determine which kind of instrument is best for them.

“The first thing they need to do is a careful assessment of the number of tubes they’re processing every hour of the day and what tests are requested on those tubes,” Dr. Felder advises. “Once you know your needs, you can match a system that has enough capacity to deal with those needs. It’s also very important to try to standardize as much as possible the input tubes that come into your laboratory. The greater the variety of specimen containers, the greater the problem of dealing with automation.”

But, no matter how many benefits the pre-analytical system offers, there’s no point in getting one if it’s not going to work consistently and connect to the laboratory information system.

“It’s important for laboratories to assess all of the aspects of a pre-analytical processor,” advises Dr. Felder. “Does the pre-analytical processor handle a range of sample types? Does that range match with what your laboratory is using? What are the failure rates on some of the more delicate parts of the pre-analytical processor? Is the system going to perform successfully week after week, month after month without excessive maintenance? And, will this pre-analytical system plug easily into your LIS so the data can be exchanged properly? Without that, a pre-analytical processor is virtually worthless.”

“The system is only as good as the connection to the laboratory information system,” agrees Dr. Demers. “If you cannot connect to your LIS, it’s really not going to help you.”

Benefits of Pre-Analytical Automation
Cost savings. Sample integrity. Reduction of processing errors. These are all benefits that come from automating pre-analytical sample processing.

“The major benefits that I see with respect to the laboratory is providing consistency in processing from the time the sample enters the laboratory until it’s ready to be analyzed,” says Dr. Demers. “And, reduction in staffing is probably the single most important improvement we’ve experienced. Other laboratories should be able to reduce the number of people they have handling the samples.”

“Labs will also see decreased turnaround time because the one thing about a pre-analytical processor is that it can consistently and somewhat rapidly process the tubes,” adds Dr. Felder. “The most important thing is consistency–you know exactly how long it’s going to take for the tubes to be processed.”

Dr. Demers says that his laboratory has experienced a reduction in processing errors. Errors can come from inappropriate sorting, routing of the specimen to the wrong analyzer rack, inappropriate measurement of the sample into aliquot tubes and mislabeling. When a reliable instrument does the processing, these errors are eliminated.

Another benefit is the reduction of the laboratory assistants’ exposure to sample handling. Because they only have to place the samples on the instrument, they are not handling the sample nearly as much as they were when they were processing them manually.

“Previously, someone would be decapping a tube. The cap might be hard to get off and they could splash. Blood gets splashed all over the place,” says Demers. “Using the analyzer, biohazard exposure is minimized.”

Finally, automating pre-analytical sample processing adds stability to the staffing. Using this equipment reducing stress to the lab when people call in sick or can’t make it in to work. The analyzer does the job virtually by itself.

Not all systems are perfect, however. Dr. Felder notes that he would like to see improvements in the throughput of the pre-analytical specimen processing systems. He would also like to see the addition of an automated sample inspection station.

“None of them on the market yet have a pre-analytical inspector that will tell you if the right tube has been selected for the right test, whether there’s enough volume or whether there’s an issue in terms of broken tubes or sample quality,” he says. “That all needs to be done with a pre-inspection station or automatic quality assessor.”

However, the benefits of pre-analytical specimen processors make them worthwhile investments for laboratories looking to cut costs, Drs. Demers and Felder say.

“Labor savings, reduction in processing errors, improved integrity of the sample processing activity and consistency in the sample processing integrity, reduced biohazard exposure and stability to staffing are the major benefits,” says Dr. Demers.

When it comes down to it, pre-analytical sample preparation units save valuable time and money for the laboratory while eliminating exposure to biohazards and processing errors.

After all, “the test results are only as good as how well that specimen has been processed,” says Dr. Demers.

Rebecca Thimm is an editorial assistant.

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