College of American Pathologists
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  Integrated analyzers: proof is in the throughputting


CAP Today




November 2008
Feature Story

Anne Paxton

The laboratory at Huntsville Hospital was faced a few years ago with a “human-factor” challenge. To maximize the impact of its new integrated chemistry-immunoassay systems, the hospital lab had to take on the testing from two stat labs, closing them in the process. The first stat lab, located at a sister hospital three blocks away, was low volume and costly to operate, so closing it was fairly straightforward. The tricky part was closing the stat lab in Huntsville Hospital’s emergency department, the largest ED in Alabama.

“The ED lab was extremely busy and was staffed with a specimen processor and a medical technologist, and the ED staff had the perception that having a stat lab there was crucial to their operation,” says Sharon Preston, MBA, MT(ASCP) SC, automated lab manager. So Preston initiated a strategy that marketers call “forced trial.”

“Without first consulting with the ED staff, we performed a trial run for three days. The processor and medical technologist remained in the stat lab but did not perform any of the testing. As the ED staff dropped off samples in the stat lab, our staff tubed the samples three floors up to the main lab where the testing was performed.”

The main lab’s turnaround time during this trial was actually better than that of the stat lab, so the laboratory had persuasive data to bring to the table when it met with the ED staff. “We showed them our efficient automation line in the main lab, and used the turnaround time data to convince them we could handle their stat testing in the main lab,” Preston says. The outcome: “The ED stat lab was officially closed that day, and our hospital saved over $500,000 annually by closing both stat labs.”

For several years, the consolidation of testing on as few platforms as possible has been a nationwide trend. But increasing numbers of labs are finding, as Huntsville Hospital’s did, that they can reap even greater returns by combining chemistry and immunoassays into one workstation.

When Huntsville’s main lab consolidated using Roche Modular Systems, its instrument count for chemistry-immunoassay testing dropped from eight to two.

“We wanted systems that would integrate high volumes of chemistry and immunoassay testing into one workstation and would also provide the broad menu we offered, with the ability to add to our menu. We also wanted a vendor that could provide high-volume systems for the main lab and low-volume systems for the stat labs, but with standardized reagents,” Preston says.

The original configuration was a DPE (a high-volume D module connected to a mid-volume P module for chemistry testing and an E-170 module for immunoassay testing) and a PE (another P module connected to a second E-170). Now it consists of a DPP (chemistry line) and an EE (immunoassay line), with both lines connected to the Roche Modular Pre-analytic automation.

“Consolidation and integration had an immediate effect on our efficiency,” Preston notes. The workflow was smooth, turnaround times improved dramatically, and the four technologists needed for the former setup were pared to two—one for each “line.” But there was an unexpected problem: The technologists were “literally sitting back waiting for more work to be brought to them.”

Specimen processing had become a chokepoint, Preston says. The 4,000 samples arriving each day had to be manually scanned, centrifuged, sorted, and delivered. In addition, “approximately 50 percent of the outreach samples were received without a bar-code label or proper requisition. The processing area could not keep up with the constant influx of samples, and there were always baskets full of samples in biohazard bags waiting to be processed.”

“It didn’t take long to realize we were not going to achieve total efficiency until we tackled the specimen processing area,” Preston says. The solution was the Modular Preanalytic system.

Now, despite the closure of the stat labs, which means some samples must travel three blocks by pneumatic tube to the lab, Huntsville’s TAT is better than before. “We are performing more than twice the work we did 10 years ago with only two techs instead of the four techs we used previously, and we have our early-morning workload easily finished by 7 AM, and our outreach workload done by 11 PM.”

“The closing of the stat labs more than made up for the cost of the systems,” Preston says—adding that the technologists “can’t wait” for the coagulation module that is scheduled to be added at the end of the year.

The ability of the integrated systems offered by Beckman Coulter to address entire disease states in a single patient report and from a single point of sample entry was what convinced Max Wells, CLS, MT(ASCP), laboratory technical supervisor at Lodi (Calif.) Memorial Hospital, to install a Beckman integrated system in his laboratory. “We had analyzers in place that were acquired 10 years ago, and for an analyzer operating constantly, that’s pretty old, so we knew the time was coming that something needed to be done.

“When we saw the combined platforms, I realized immediately that with a single entry and exit point, they would greatly simplify things,” Wells says. Lodi now has the DxC 800 chemistry platform, the Dxl 800 immunoassay platform, and the DxC 600i chemistry-immunoassay platform. The latter consists of a DxC 600 chemistry analyzer connected by a closed tube aliquoter to an Access 2 immunoassay analyzer. With this system of analyzers in place, Lodi has been able to double its throughput.

Before the integration, the laboratory at the 180-bed Lodi Memorial performed stat chemistries with two people, sometimes three. “Now we have one in all of chemistry for each shift—3.25 FTE,” Wells says. Sometimes they need help maintaining the analyzers, but only one is needed to operate them. The laboratory now feels equipped to handle the increased workload it faces at the end of 2009, Wells says, when the hospital plans to add another 100 beds.

The combined platform has significantly improved turnaround time, he adds. “It seems like the No. 1 thing the ER and others are concerned with are our cardiac panel, total CK, and troponin. We used to run two tubes—one on one instrument, one on the other. The Beckman system lets us run everything on one tube and sends the data all at once. Before, if there was a problem with one of the specs and the technologist was not right on top if it, things could be delayed quite a bit. Now it’s much easier to keep track of all the information needed.”

Division of testing responsibilities has brought much smoother throughput. “Our combined platform does all the stat testing and much of the inpatient testing, and a separate platform does clinics and outpatients. They are redundant systems and back each other up, so when one is down, the other one can carry the workload,” Wells says.

Beckman’s new integrated system, the UniCel DxC 880i, only recently became available in the United States. It was on the market in Europe and in use in the laboratory at Westküstenklinikum in Heide, Germany. “Our staff decreased in the last year and our volume went up, so we were looking for a system with a large test menu,” says Anna Maria Schweiger, MD, chief pathologist for the laboratory at Westküstenklinikum, which acquired the DxC 880i in May. “We felt the DxC 880i would be the system of the future.” Its menu consists of more than 150 tests, with up to 120 onboard at once, and it has a throughput of 1,440 chemistries or 400 immunoassays per hour.

Shifting from serial processing of tubes to a single-tube system has greatly improved staff efficiency and turnaround time, she says. “In 2006, some of our testing was taking the lab two to four hours, a very long time. Now we take 30 minutes, and this is what the physicians need.”

There were early glitches during the attempt to connect the system to the laboratory information system, but communications experts from Beckman were able to fix that in a few weeks, and the interface works smoothly now.

Overall, Dr. Schweiger’s laboratory, which pays for the system on a per-test basis, has realized substantial savings from the integrated platform. “In clinical chemistry our costs are about equal, but in immunological testing we have about 20 percent lower costs.”

With 690 licensed beds, St. Joseph’s Hospital and Medical Center in Phoenix is the largest hospital in Arizona, and an integrated chemistry-immunoassay platform was an important part of the clinical laboratory’s quest for greater efficiency and productivity, says chemistry supervisor Susan McMillan, MT (ASCP).

In April 2007, St. Joseph’s laboratory acquired two Abbott Architect ci8200 systems that have required less operator hands-on time and reduced rerun testing and turnaround times. “Between routine hospital inpatient testing and our outreach lab, we are doing 3.6 million tests a year in chemistry and immunoassay. With the analyzers we had, the throughput could no longer accommodate our volume.”

The lab had an automation track connected to its analyzers for many years and planned to upgrade it, but found the integration of the Architect ci8200s to be more efficient than the track automation, she says. “We planned to take a stepwise approach by bringing the ci8200s in first, and later bring in the Abbott automation line to attach on the instruments. We quickly realized our integrated analyzers were more efficient than our previous track automation. With automation, once a specimen gets on line, you can’t hurry it up or take it off. You are unable to prioritize stat or critical care testing. Within a couple of months of getting the ci8200s, every tech said, ‘We don’t want to put the instruments on line because we like having specimen management under our control again,’” McMillan says.

The lab now plans to bring in the Abbott automation as a standalone front-end processor. “This way,” she says, “we feel we will have the most efficient benefit of automation, integrating chemistry and immunoassay into one tube and on one platform, but without the complexity and cost of full automation.”

People think automation is going to be more efficient, and it’s true, McMillan adds. “But it’s like having another analyzer. You have to run the automation line and troubleshoot problems and errors on the line. With the instruments not on line, all of a sudden you’re in charge of your work again; it is a less complicated solution.” With St. Joseph’s 220 critical care beds, its 50-bed emergency department, same-day surgeries, clinics, and “patient-waiting” testing, she says, “the Architect’s combination of throughput and stat priority really works for us.”

A study conducted by Abbott at St. Joseph’s, and presented at this year’s AACC meeting, found that the Architects brought an overall 26 percent improvement in mean TAT from the previous automation system. The improvement consisted, in part, of a 36 percent decrease in the mean TAT for immunoassay-only samples, and a 39 percent decrease in mean TAT for samples with both chemistry and IA ordered. “We changed our instruments and processing, and grew by nearly 20 percent all around the same time. The integrated ci8200s have made a dramatic difference,” McMillan says.

Before integrating systems, St. Joseph’s was meeting basic turnaround time needs for patient care. “But nobody orders only a CMP anymore. It’s a CMP along with a B12, a TSH, a cortisol, and a prealbumin,” she says. “What the physicians need is for all the results to be available when they walk in the room to evaluate the patient.” A consolidated analyzer with a large menu makes it possible for the lab to meet that need.

Her only challenge so far relates to the usual problem area: IT. “We are delayed in bringing in the front-end automation because IT has to allow Abbott onto our network, and that has taken us longer than anticipated,” McMillan says. “Every vendor wants to sell or give you Internet connectivity to monitor and provide trouble­shooting assistance for analyzers, but there is resistance by hospitals and laboratories to allow vendors onto highly secure computer networks that contain sensitive information.”

When the integrated platform was launched, McMillan was worried because of the large menu. “You’ve got one technologist performing 70 assays all at the same time, and that might make the learning curve a little bigger for integrated platforms. But with the blended software and integrated platform, it is easier than learning to operate two analyzers.”

McMillan’s ideal would be to acquire a third 8200 and move more of the laboratory’s esoteric testing onto it.

Moving up to integration with Siemens Healthcare Diagnostics’ Dimension RxL Max has brought economies of scale, lower operating costs, and greater efficiency to the laboratory at Upper Chesapeake Medical Center (UCMC), in Bel Air, Md., says Audrey M. McClaine, MHA, MT (ASCP)DLM, director of laboratory services.

A single-station, multitasking work­station, the RxL Max has a built-in HM immu­no­assay module and offers users higher throughput with expanded reagent capacity for large workloads. McClaine’s laboratory at UCMC uses one RxL Max predominantly for stat testing and another for tests that take a little longer, such as cardiac markers and thyroids.

Before coming to UCMC, McClaine was lab director at another hospital where integration was planned. “When Siemens came out with immunoassays for their RxLs, we were right there and we became the second hospital to acquire the system in Delaware. I’ve had a lot of experience with Siemens’ platforms and the benefits of consolidation.”

“Whenever you can consolidate and bring things onto one instrument, you have less maintenance, less calibration, and less downtime, particularly on the evening and night shifts,” she says. “The techs don’t have to run around to so many little boxes. Instead of having to split samples or moving samples, you have one tube; you put it on the instrument and there is no lag time, no worry about batching, so routines are done much more quickly and released much faster.”

In acquiring the system, McClaine wanted to be cost-neutral, and that goal was accomplished. “We felt we got the best bang for the buck with these RxL Maxes.” When the Siemens Advia Centaur CP system is released, her laboratory will probably acquire one to improve turnaround time and expand its test menu.

One weakness of combining chemistry with immunoassay is that immunoassay tests take longer to perform, so the overall throughput time may be impaired. “Throughput has been our only problem, but you can learn to work around this situation, particularly if you’re a large enough hospital to have two instruments or your laboratory can batch immunoassays.”

The latest addition to the spectrum of integrated chemistry-immunoassay analyzers is from Ortho-Clinical Diagnostics. In late October, Ortho received FDA 510(k) clearance for its Vitros 5600 integrated system, which was introduced in July. It integrates clinical chemistry and immunoassays and is able to perform more than 100 different chemistry, immunoassay, and infectious disease assays on a single platform, with user-defined applications available.

“This is Ortho’s first entry into an analyzer that can do all types of their testing on one platform,” says John Chapman, DrPH, DABCC, professor of pathology and laboratory medicine at the University of North Carolina and associate director of the core/clinical chemistry laboratory, UNC Hospitals.

As a paid consultant to Ortho, Dr. Chapman had pilot tested several 5600 assays in advance of the FDA clearance. He says his hospital system is “absolutely” interested in acquiring the system. “It’s a large-menu analyzer that incorporates the immunoassay tests and all of the clinical chemistry tests that a lab, even a large lab, would need to run—everything but the very low-volume esoteric type of tests.”

Ortho describes the analyzer’s chief innovations as its “sample-centered” processing approach, intelligent sample handling, and small footprint. To optimize throughput, Dr. Chapman says, the Ortho system looks ahead at about 50 samples to determine the most efficient pathway for performing the assays.

“Ortho built on all the features that worked well in its previous instrument offerings and incorporated them into this new combined system.” With a workload of 3 million chemistries a year, his laboratory, which now has six instruments, plans to consolidate it all into three boxes when it moves to the 5600.

“If we acquired this tomorrow, we could perform the same test menu it now takes us two different analyzer systems to perform. What does that buy you? All sorts of advantages. The technologists now only have to learn to operate one system. You don’t have to move samples around.” And the system’s sample-centered processing “actually takes the sample and delivers it to each internal module, as necessary, without spending time on a track—again, saving time and saving the amount of sample you have to have.”

An added feature not available on some other systems, Dr. Chapman says, is the Ortho system’s sample indices function, previously introduced in the company’s Vitros 5,1 FS system. This feature allows the system to automatically look at every sample loaded and measure the degree of hemolysis, icterus (or bilirubin), and turbidity, comparing what it finds against tables entered into the instrument’s computer system and indicating whether the sample itself is acceptable for the specific assays ordered. “It does this without slowing throughput or using additional sample or reagent,” he says.

With the 5600 system, this sample indices feature has been extended to all of the immunoassays on the menu, as well as the chemistries. “That’s a tremendous labor savings because the technologists no longer have to worry about trying to visually determine acceptability. We know from years of experience that technologists’ assessments of these interferents in samples are often quite inaccurate, so quality improves with this feature.”

The system’s use of MicroSlide, MicroTip, and MicroWell technologies means that any washing required is minimal, and because waste is disposed of in a self-contained waste module, no access to a water supply or drain is needed. Finding those can be a chronic logistical issue in the lab, Dr. Chapman notes, because with increasing workloads and the introduction of new tests, “you need to be able to reconfigure the laboratory layout as efficiently as possible. With these instruments, all you have to do is move the power supply.”

While features among the systems differ, the impact of integrated chemistry-immunoassay technology on laboratory operations will continue to be substantial, Dr. Chapman says. When any analytical system is replaced, there’s always a certain amount of upheaval, but now, he says, “the menus with these systems are so broad, no matter what you do, it’s going to be a very serious move for the laboratory.”

Anne Paxton is a writer in Seattle.