If you bring a roast to grandma’s house and it’s too big for her pan, you have a problem. John Siira, of Caliper Life Sciences Inc, Hopkinton, Mass, uses the quaint quandary to illustrate the mind-set of clinical lab directors who choose to avoid innovation. If you solve the problem by cutting off the edges of the roast, you are stuck in the past. In contrast, those who buy a bigger pan are acknowledging the new reality and making the necessary adjustments.
By all accounts, the figurative roast gets bigger every year as daily testing requirements for clinical labs continue to grow amid a nationwide shortage of laboratory technicians. The solution often boils down to biting the bullet and investing in new technology—a move that can admittedly be scary.
“In the sample prep arena, there is a reluctance and/or fear to move to an automated platform, because it would require revalidations of many processes,” says Siira, who serves as global product manager for extraction and evaporation at Caliper. “Instead of trying to be innovative, a lot of folks continue to do things manually, and that means you need a lot of labor and technicians to manage those sample-preparation processes. When you have multiple individuals, you may have multiple techniques, and that leaves a lot of room for variability in samples and data quality.”
Reliability and Reproducibility
On the other hand, a properly programmed robot is likely to get the same results time after time, which all leads to reproducible data quality. This quest for consistency is the focus of Beckman Coulter’s Agencourt DNAdvance System, an extraction kit for DNA isolation and purification from mammalian tissue samples. Specifically, the system incorporates solid phase reversible immobilization paramagnetic bead-based nucleic acid purification technology, which company officials say improves the overall efficiency of PCR-based testing in high-complexity research labs.
According to Todd Lombardo, senior product manager for Agencourt Bioscience Corp, a company owned by Orange County, Calif-based Beckman Coulter Inc, automation ultimately makes life easier for scientists and clinical lab researchers. “They don’t have to worry about pipetting and doing their own sample prep work,” Lombardo says. “A robot can take care of it for them so they can use their training for something a little more interesting.”
Engineers designed Agencourt DNAdvance to be a rapid sample prep system. To make this a reality, Agencourt incorporates Beckman Coulter’s Biomek liquid handling system robotics to automate processes and create efficiencies, with both flexibility and scalability in mind. Lombardo believes lab directors should look for systems that incorporate comprehensive solutions that include automation, chemistry, and even the software to help interpret results. “The whole test can be done on a platform from sample to answer, and I think that is what you are going to see,” Lombardo says.
Not more than a decade ago, most labs favored large multipurpose robots that performed a wide variety of tasks. Siira says that many of the lab directors who call him these days are looking for workstation-type devices that are easy to use and can be operated by baseline technicians—as opposed to robotics engineers or automation experts. These new robots have a smaller footprint and are usually focused on one or two applications instead of multiple functions.
Now that many labs have mass spectrometry, Siira says it is more important than ever to maximize value. “Mass spectrometry technology has come down in price significantly and increased in sensitivity,” Siira explains. “As labs buy more, there is a need for dedicated sample prep to make sure that these fairly expensive analytical instruments are always up and running. If you are not prepping samples fast enough, a bottleneck develops. You want those samples to be lined up in front of that mass spectrometry, or that LCMS or GCMS, so that your data is constantly pouring out the back end.”
More Data, Fewer Hands on Deck
Keeping the data waterfall flowing depends on high test volume, accurate documentation, and fewer people to deal with all of it. When it comes to the question of labor, Ralph Taylor, vice president of marketing and medical affairs for Sysmex America Inc, Mundelein, Ill, believes part of the blame for the shortage can be attributed to much of the current workforce nearing retirement. Taylor cites Bureau of Labor Statistics showing that the United States graduates fewer than half the personnel needed to staff the country’s clinical laboratories.
“It is estimated that US laboratories will need approximately 12,400 professionals annually between 2002 and 2010,” Taylor says. “The average number of clinical laboratory personnel expected to enter the job market is approximately 4,200 people per year.”
As an example of how automation can be used to ease the labor shortage, Sysmex combined the HST-N hematology platform with the Bio-Rad Laboratories Inc Variant II Turbo Link to enable on-demand, automated diabetes testing in a random-access setting. “This integrated hematology and A1c automation solution, which uses decision logic rules software (Sysmex Wam), maximizes efficiencies in the area of data and sample management, and labor utilization,” Taylor says.
In addition to keeping an eye on efficiency in hematology, the company’s newer products address clinically relevant measures such as the reticulocyte hemoglobin equivalent (RET-He) parameter. Taylor points out that the RET-He parameter, which directly measures the mean hemoglobin content of red blood cell precursors (reticulocytes), assists with early recognition of functional iron deficiency, which is critical in patients with end-stage renal disease. This new parameter, on an automation platform, expedites relevant information to the physician for patient diagnosis and treatment.
Christoph Menzel, PhD, senior global product manager, automation, for Germany-based Qiagen, agrees that cost cutting is a must, and better automation is a good way to get there. In the competitive molecular biology/DNA realms, Qiagen’s bid to boost efficiency comes in the form of its QIAgility PCR setup robot; the Rotor-Gene Q real-time PCR cycler; and the QIAsymphony for flexible preparation of DNA, RNA, and protein samples.
Menzel describes the QIAgility as a compact benchtop instrument that enables automated PCR setup in a wide range of formats. “Fully automated PCR setup is rapid and reliable, and eliminates all error-prone manual pipetting steps,” Menzel says. “Besides removing the burden on lab staff for these highly repetitive but critical tasks, it also increases the precision and standardization of the analytical results. The hardware and software are particularly optimized to set up PCR reactions for consecutive analysis on the Rotor-Gene Q real-time cycler.”
The QIAsymphony, the company’s sample-preparation flagship, addresses the link between efficiency and flexibility in lab automation. Features include in-process sample loading and queuing for starting materials and sample volumes. Particularly during tough economic times, a certain amount of flexibility is crucial.
“We have seen situations where huge, expensive, specialized robotics have become ineffective as soon as the focus or requirements of the lab change,” Menzel says. “Hospitals cannot stop performing necessary patient tests just because the economy is struggling. In fact, this makes an even stronger case as to why it’s more important to now invest in automated solutions that improve efficiency for a broad menu of potential applications.”
Increasing Integration Among Systems
Reducing complexity and increasing flexibility are the main areas of focus for Pete Van Overwalle of Roche Diagnostics Corp. Van Overwalle, group marketing manager, lab automation, believes that automation systems will increasingly be called on to accommodate different types of sample tubes and caps.
“There is an increasing trend for labs to link additional types of instruments, such as coagulation or hematology analyzers, to their automated platforms,” Van Overwalle says. “We’ll see increased integration between instrument systems, middleware, and the lab information system, with enhanced functionality to cover gaps with information flow from bar coded primary samples to multiple aliquots tubes.”
Later this year, Indianapolis-based Roche plans to launch the cobas p 501 and cobas p 701 postanalytic storage units. According to Van Overwalle, the cobas units are high-capacity systems (up to 15,000 or 30,000 tubes) with a relatively small footprint to automatically store and retrieve bar-coded sample tubes to and from environmentally controlled, refrigerated storage spaces.
“They can be customized to automatically dispose of samples after a predetermined period of time, and they’re fully integrated into the LIS, which means they deliver a sample automatically when a rerun or retest is ordered,” Van Overwalle says.
“They’re designed to connect directly to Roche preanalytics and analytics, giving the lab comprehensive automation for the entire sample-management process, from receipt of the patient sample to automated disposal. This helps eliminate manual labor tasks and can reduce the time it takes for sample retrieval, which in the average lab could be 20 minutes or more. It has the potential to also help prevent quality degradation of the sample by sending tubes into storage within minutes of being aliquoted.”
How is the economy affecting the financial viability of clinical labs? It depends on who you ask, but the consensus among the experts so far is “not much.” Van Overwalle acknowledges that testing volumes are down slightly, and he says the reason appears to be that some patients and their prescribing physicians are deferring some elective treatment options—and the diagnostic testing that accompanies them.
“Some physicians are taking more of a phased approach to testing,” Van Overwalle says. “Instead of ordering a comprehensive panel of tests right up front, they will order one or two preliminary diagnostic tests as a first step and then evaluate whether to add others based on those results.”
George Rodrigues, PhD, senior scientific manager at Artel, Westbrook, Me, says it’s also likely that physicians will continue to practice defensive medicine, thanks in part to a litigious American society. When you factor in the labor shortage, that could mean more daily tests per person, despite the economic downturn.
“Doctors are doing more defensive medicine and ordering more tests,” Rodrigues says. “Laboratories are crunched because they have fixed reimbursement rates for most of those tests. They have to manage expenses. They have a shortage of technicians, and they are trying to figure out ways to get all this work out.”
No one ever wants lab results later, so the inevitable trend toward quicker turnarounds has made technician training more important than ever. In an effort to improve skills in liquid handling, Artel offers training and certification for pipetting proficiency. Those who successfully complete the level one, 1-day seminar receive certification in this discipline. The 2-day level two seminars explore low-volume liquid delivery measurement/quality assurance in a more in-depth manner. Trainees who successfully pass the written and practical exams receive a certificate of competency.
Rodrigues points out that even people coming in with biology degrees or general science backgrounds do not have basic laboratory skills, and the need for additional training is often great. “Lab accreditation has made this important and motivates people to take a serious look at training,” Rodrigues says. “People buy equipment that ends up sitting for a few years because of all the resources it takes to get it online, validate the method, troubleshoot, and develop standard operating procedures.”
“There is an underappreciation for the cost and effort involved in transitioning to new automated processes,” adds Wendy Vaccaro, technical services manager at Artel. “From our perspective, training and standardization is vital to save time and money.”
When it comes to federal reimbursement, a report from Ron Berman, vice president of clinical automation and clinical information business centers, Beckman Coulter, reports that while clinical diagnostic tests account for only 2% of Medicare expenditures, they influence a whopping 70% of all medical decisions. One key to boosting lab efficiency, Sherman reports, could be pay for performance (also known as value-based purchasing), which rewards physicians, hospitals, medical groups, and other health care providers for meeting certain performance measures for quality and efficiency.
“The prediction is the new policy will lead to improved chronic disease management and disease-screening programs, which will lead to increased volume in clinical diagnostic labs,” Berman writes. “It is also expected that P4P will expand policies that deny payment for errors, an effort to achieve health care quality over quantity. In the clinical diagnostic lab, where 70% of all medical decisions are influenced, the strongest intervention against errors is total lab automation.”
More with Less: Sound Familiar?
With insurance payors looking to pay less and less per test, experts agree that both science and economics are driving the automation evolution. Factor in an undeniable shortage of lab technicians, and labor-saving equipment becomes more important than ever.
“People cost money, and there is no way to get around that,” Agencourt’s Lombardo says. “If there is a way to automate a process, it decreases labor costs and usually increases reliability. One person is not going to be able to do the same test the right way a thousand times, but a machine is likely to do that—especially when you are talking about clinical labs.”
Among his customers, John Siira sees plenty of anecdotal evidence that the labor shortage is real and the right equipment is vital. “One of my customers can’t hire people fast enough, and when they do they have to pay much higher prices to get even baseline-type technicians,” says Siira, product manager at Caliper. “There are a lot of jobs here [in New England] even in a recession, so you have to pay for the talent.”
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If the automated equipment is intuitive enough, Siira says some labs could conceivably save on labor costs. “We try to design Caliper automation to be Burger King tech friendly, to basically make it not so complex—so you may not need to hire an expensive individual to run the automation,” says Siira with tongue partially in cheek. “Companies want scientists to be doing science and researchers to be doing research—not worrying about automation processes.”
Siira says that equipment developed over the last 3 to 5 years—including Caliper’s RapidTrace product for tube-based solid-phase extraction—has essentially changed the game when it comes to overall sample throughput, speed, efficiency, and data quality. Now more than ever, he says, is the time for change. “Don’t be concerned with how you have always been doing it,” Siira enthuses. “Be innovative and look for new approaches.”
Greg Thompson is a contributing writer for CLP.