Immunoassay Systems Usher in a New Order

CAP Today, December 1995, pp. 38

There was a time when laboratory Help Wanted ads specified the analyzer the medical technologist needed to be skilled at operating. But for more and more laboratory tests, push-button automation is becoming the norm. The new immunoassay systems are drastically reducing the labor required to conduct an expanding menu of tests, and they are hastening a perhaps equally significant trend toward workstation consolidation. Says Robert DeCresce, MD, director of laboratories at Rush Presbyterian - St. Luke's Medical Center in Chicago: "The same revolution that occurred in the 1980s in the chemistry lab with the introduction of the random access analyzer is happening in the 1990s with immunoassay."

Reducing in the Number of Immunoassay Analyzers

A typical laboratory that purchases a random access immunoassay system may have multiple batch analyzers, some for routine testing and some for stats, and may send out certain tests to reference labs. By acquiring a new immunoassay analyzer, it can often phase out several instruments, free technologists so they can perform tests that were formerly sent out, reduce staffing, make a full test menu available at all times, and improve turnaround time.

In one hospital laboratory on Long Island, the numbers tell the story. Denise Uetwiller-Geiger, clinical chemist and administrative director of the laboratory at John T. Mather Memorial Hospital, conducted an integrated systems efficiency analysis to assess the impact of the lab's acquisition of a high-volume, continuous random access immunoassay analyzer.

We were looking for an analyzer with a broad test menu and one that would help us achieve workstation integration and eliminate manual stations which were labor-intensive, Uetwiller Geiger says. The new analyzer, with assay capabilities including therapeutic drug monitoring, metabolic, fertility, thyroid, and tumor markers, completed an average of 80 tests per hour, allowed workflow integration that eliminated extra analyzes, and made it possible for intensive manual stations to be eliminated. As a result, the laboratory projects annual savings of $18,892 on labor, about $10,000 in reagents, calibration, and controls, and $3,000 on parts - a total of $31,892.

"Reduction of analyzers decreases service costs, simplifies reagent purchasing, decreases quality control costs, and increases lab space," Uetwiller-Geiger said in reporting her findings at the Clinical Laboratory Management Association annual conference in August. "Random access improves efficiency, increases productivity, decreases turnaround time, and enhances service levels while reducing labor costs."

Personnel represents 60 to 80 percent of operating costs in the laboratory, where the need to contain costs is more urgent than ever. Thus, laboratories all over the country are replacing analyzers with new capital equipment that, because personnel expenses drop precipitously, brings savings right away. There is intense pressure on laboratories to reduce operating costs, says Robert Bauer, a consultant with CaseBauer & Associates in Dallas, Tex., "and a lot it directed toward the reduction of head count." But along with the pressure, Bauer adds, lab management has clout it didn't have before. As a result, more labs are overcoming the political and institutional constraints that may have prevented them from reorganizing or consolidating workstations in the past. More and more walls are being broken down between main labs and point-of-care and between subdepartments—but in his view the real driver is not simply the availability of instrumentation but the financial mandates of managed care's capitated contracts.

Increasing Immunoassay Automation

The primary thrust of instrument purchases right now, Bauer believes, is increased automation. "There is generally a continuum in the revolution that Bob DeCresce speaks of," he says, "when you look at the market as a whole. In the first phase, labs reduce costs—first by bringing tests internally that you're spending a lot of money for outside. In the second, labs take a manual or semiautomated state to a production state—in other words, front to back automation. In a third phase, labs reduce the number of automated platforms through consolidation." For better characterized technologies, like clinical chemistry, labs are farther along the continuum, he adds. In immunoassay they are just now reaching a phase 2 higher state of automation.

With 25 manufacturers' systems competing, it is a buyer's market. Moreover, vendors have lowered barriers to acquiring new instruments by offering them through fairly aggressive rental programs. "With the higher cost per test for immunoassays, much higher than that of chemistry, reagent rental programs market instrument costs reasonably transparent to the purchaser," Bauer notes He compares the market to leasing programs for luxury cars: "Everyone can suddenly afford a BMW." In the lab, even though there is severe cost pressure, there is still much duplication of immunoassay systems.

In a sense, he says, the manufacturers are "flooding" the market because they are all jockeying for position. "What happens is you have multiple instruments in a facility and the manufacturers competing against each other for how heavily used they are. It puts labs in a good position." In fact, Bauer adds, "I don't know if labs have ever been in a position where they could leverage this level of automation."

He sees another effect of the kind of automation immunoassay systems are offering: progressive shifting of test location. First, reference labs are losing some business because fewer tests need to be referred. Second, as affiliated laboratory systems look across testing sites, they are setting up centralized testing locations and drawing additional tests from reference labs along with some low-medium volume tests currently dispersed across their network.

Reducing Immunoassay Costs

Aside from that, though, Bauer does not think managed care's greatest impact is getting labs to improve efficiency; rather, it is mediating the utilization of these tests. "Particularly for those with capitated contracts, they'll try to adjust utilization so physicians are using fewer tests. A good example is streamlined thyroid testing protocols. There is much more to be gained this way," he maintains.

In Uetwiller-Geiger's facility, which supports Long Island IVF and where fertility testing is 40 percent of the total test volume, one goal achieved by the new immunoassay analyzer was the creation of a central laboratory with an automated area and a non automated area. 'We wanted to have testing divided by technology," she says, rather than into traditional compartments such as hematology and chemistry. But in looking at analyzers on the market, she says, an important element in the selection process was the ability to go from radioisotopic testing to nonradioisotopic.

Many labs would like to get rid of radio immunoassay testing, agrees Mark S. Lifshitz, MD, director of clinical laboratories at New York University Medical Center. "I would, too." But there are some tests that can't be done using nonradioisotopic techniques, he notes. For example, the CA125 tumor marker test in the United States is still available only by RIA. His lab will have to decide eventually whether to continue doing a couple of RIA tests or to discontinue RIA testing and send the tests to a reference lab until they are available on automated immunoassay analyzers.

Dr. DeCresce points out that radioimmunoassay testing until about 10 years ago tended to be labor-intensive and was usually conducted in batches in separate areas, or in separate labs or often even nuclear medicine departments. 'If you ordered an RIA test in the morning, the run started at 10 and the sample got there at 11", it would have to wait. Because there were lots of standards and controls with RLA, he says, the laboratory might process a batch of tests only every other day.

When newer, nonradioisotopic systems came along, they were followed by stand-alone machines that were able to do tests automatically, more like a Xerox machine, he says. These automated batch analyzers worked most efficiently with batches but could also work for a small number of tests or single tests. Batches of varying size could be run frequently because there was much less overhead from calibrators and controls.

Because these small instruments were relatively inexpensive—though the reagents were not, they tended to proliferate, says Dr. DeCresce. "Someone would buy one analyzer for one test, and another for three other tests", he notes. "People had the luxury of finding instruments that did one or two tests well."

With the cost containment drive of the 1990s, however, labs have been motivated to take advantage of the new immunoassay systems that allow them to move almost all the tests done on dedicated systems to random access systems. "It's allowed us to revolutionize the way we run the lab," says Dr. DeCresce. By consolidating tests and machines, the lab can use one person for the work of three or four, obtain supplies from one vendor, and obtain far better pricing.

In most cases, laboratories buying the new instruments are nearing the end of their current analyzers' useful lives, so they are making capital outlays that would have been necessary anyway. But there are so many machines on the market now that an industry shakeout is inevitable, Dr. DeCresce believes, and the competitive advantage will go to the manufacturer that delivers more tests. "The real thing that drives the industry is the size of the menu," he said. "The bigger the menu, the more popular the machine, and menu is a function of the popularity of the machine," because the manufacturer can invest more in research and development.

Since his lab started acquiring new immunoassay technology, he says, "we've been able to move essentially all of our immunoassay testing into our chemistry lab with a couple of exceptions, and we've been able to consolidate virtually all our work onto two instruments." This has dramatically changed the physical space the laboratory occupies, too. He compares the old setup to the days when televisions and videocassette players were separate, with wires and pipes all over the place. "Now it's cheaper to buy one unit together."

Some laboratories succeed in justifying the purchase of an immunoassay analyzer by marketing to physician offices, smaller hospitals, and corporations. At John T. Mather Memorial Hospital, improved turnaround is important to the patient population it serves. "As fertility specialists," says Uetwiller Geiger, "we are continuing to pick up testing from other specialists in the area and other assisted reproductive technology programs. They have very tight windows for turnaround times," she adds, since results of tests sent in the morning from up to 40 miles away may be used to adjust medication later in the afternoon. But not every lab can count on outreach, Bauer notes. "There's not enough outreach testing to go around," he points out.

Reducing the Number of Laboratory Personnel

An obvious implication for laboratory personnel is that there is much less talk today of personnel shortages. "In our hospital," says Dr. DeCresce, "it's meant clearly a drop in the number of people doing this work. Luckily, we've done it by and large by attrition. A number of people have been retrained and are doing other jobs." The impact on patient care, he adds, has been dramatically positive.

What about quality? The new immunoassay technology has raised concerns about the sensitivity and precision of the tests. "Every lab has to assess the performance characteristics and limitations of the analyzer to determine whether it meets the needs of the institution and the patient population," Uetwiller Geiger says. Dr. DeCresce views quality in terms of clinical utility. "In today's environment, these analyzers give us the opportunity to provide the full range of services with in the constraints imposed by lower reimbursement," he says. "To do that we have to make some compromises—not on quality when it affects patient care. But sometimes we spend a lot of extra money for very little benefit. That's why the pathologist has to make sure if they spend extra money they really get a benefit for the patient.

Down the road there will be even more consolidation, he predicts. Dr. Lifshitz cautions that labs need to be ready for dramatic budget measures. "Labs need to be proactive about understanding this environment and taking steps now to become as efficient as possible—before they're put in a position where it has to be done rapidly and with such drastic measures that the service level of the lab collapses."

Many laboratories are looking to change the way they work by using more technology. That should not mean leaping blindly into capital costs, Dr. Lifshitz says. "My feeling is that too many people have jumped into automation without asking what is our mission in the future." He stresses that all labs need to carefully consider issues of staffing, equipment, and test volume in asking themselves, ''What can we gain from re-engineering the lab another way?"

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