College of American Pathologists
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  Blood centers set sights on full automation


cap today



October 2006
Feature Story

Anne Paxton

If there were road signs on the highway to blood center automation, they might read "Steep Grade Ahead," "Detour," or maybe even "Prepare to Stop."

At the very least, they’d say "Bump."

But most blood service laboratories are pretty convinced they won’t encounter a "Wrong Way" sign. For while blood centers have made a halting transition to automation, with some setbacks along the way, fully automated testing for infectious diseases and for types and screens is gradually becoming the norm.

"We’re in the process of completely revamping our laboratories and putting in all the automation we can find out there," says Michael J. Fuller, chief executive officer of BloodSource, Sacramento, Calif. BloodSource, which has two Abbott Diagnostics Prisms and performs ABO/Rh, syphilis, and CMV on the Olympus PK7200, conducts 3 million different tests on the 225,000 units it collects each year.

When Camden-Clark Memorial Hospital’s Ortho ProVue system went live in 2004, automating the hospital’s typing and screening, no other blood centers in the surrounding area had automation, says Tena Roush, MT(AMT), MLT (ASCP), NCA, blood bank supervisor at the Parkersburg, WVa., hospital. But since then, "I know of two other facilities that have adopted it as well." Her staff is enthusiastic about the system’s automation, efficiency, reduced sample volume, less-subjective results interpretation, and greater patient safety because every sample is bar-coded. "They’re appreciative of the fact that the ProVue is a walkaway system," Roush says, because they can prepare blood components, issue blood products, and do other tasks. "And it’s very easy to operate" and needs minimal monthly maintenance. "For the blood bank to become automated was a joy—and a significant change from tube testing." On the rare occasion when the system may be down, she says, the staff is "really disappointed."

The pace of automation appears to have quickened as a few obstacles were removed in the past two years. Two of the six assays for the Prism—assays under review at the Food and Drug Administration for many years—have been approved, and there are strong signals that others will follow this year and next year. Olympus’ Tango, a type-and-screen instrument that was also only available outside the U.S., won FDA approval as well, and it joins the Olympus PK7200.

Along with Immucor (which offers Galileo and Rosys for types and screens) and Ortho-Clinical Diagnostics (which makes the Ortho Summit Processor for infectious disease testing and ProVue for types and screens), that makes four vendors competing in the U.S. blood center automation market. Although it’s a hugely popular instrument world-wide, Abbott’s Prism has been in a certain sense a rebuke to the early adopters of automated viral testing in the blood center. Many U.S. blood centers have their automated systems in a partial holding pattern, as they wait for the FDA to liberate into duty the Prisms they acquired in 1998.

For example, the Community Blood Center of Greater Kansas City is still using its Abbott Commanders from the mid-1980s for several assays. "The Commander is a semiautomated system," says Gary E. Tegtmeier, PhD, scientific director of the blood center. "We’ve been using it a long time—much longer than we would have wished because the Prism test licensure in this country has been held up by Abbott’s regulatory problems with the FDA. Something we were slated to have in 1998 or 1999 slipped to 2006." That was the year the blood center implemented its first Prism assay (anti-HBc), with good results, and it will add the second one (HBsAg) this fall.

But most blood centers with Prisms, he says, have not yet cranked up their instruments. "It’s not economical, if you sit down and do the dollars and cents, to run one assay on it. The assays are more expensive than the ones of the previous generation that Abbott has offered, so you only begin to realize savings in terms of FTEs [full-time equivalents] when you get three or more assays."

From the European data, Prism purchasers know the anti-HBc assay, which uses chemiluminescence for detection and has a low rate of false-positives, was a big improvement. "We knew we’d realize savings of donors and units if we implemented the new core assay right away, and we have seen a dramatic drop in reactivity rate," Dr. Tegtmeier says. "That’s maybe 15 or 20 units a week that we’re not trashing." The blood center was tired of deferring donors, "and we wanted to get the instrument up and running simply because we had been waiting so long for it."

Has it been worth it? "We were given analyses by Abbott suggesting there would be savings on labor that would outweigh the increased reagent cost over time, and salvaging of units that would otherwise not be available for release for transfusion. But I don’t want to be a fabulist. At present we can’t state how much we’re going to save or how much more we’re going to pay to have the Prism onboard."

"If the cost-benefit analyses that Abbott has done play out," he adds, "it should be more than a zero-sum game. The reagents are definitely more expensive, but we should potentially save money based on labor savings."

The good news, he says, is that performance of the core test has been as advertised—and maybe even better than advertised. "But sadly, it’s very difficult to sit here in the U.S. and know an instrument developed here and good enough to be used in Europe for 10 years" did not become available here until 2005. "There’s something radically wrong with that."

The anti-HBc assay also provided a key incentive for the Oklahoma Blood Institute to switch vendors, says Ronald Gilcher, MD, president and chief executive officer of the OBI, located in Oklahoma City.

"We had been looking at the Prism device for many, many years, but its reagents were not licensed until just the last year and a half." The Oklahoma Blood Institute now does the anti-HBc, and both the HBV surface antigen screening and confirmatory tests, approved last July.

The OBI plans to get the HTLV-I/II, HIV 1/2, and HCV assays up and running on Prism as soon as they are licensed, but for now it performs those tests on Abbott’s Commander system.

While the Commander requires a lot of technologist time, the Prism is a "true walkaway," says Sherry Pattee, MT(ASCP), OBI’s testing laboratory manager. "You put the calibrators and samples on, set the controls, and then walk away from the instrument to let it perform its job." Adding more tests does not seem to increase the processing time, she notes.

While the OBI doesn’t plan layoffs, automation has altered the blood center’s training needs. "More and more technologists are getting out of the field, and it’s harder to find them," says Pattee, whose own alma mater in Oklahoma City closed recently along with several other schools. "So we are going toward B.S. and chemistry-degreed people and training them on the instrumentation. It does help that instruments like Prism don’t require so much training."

Automation essentially "shrinks" the blood center laboratory—and that’s a good thing, Dr. Gilcher says. "These automated testing devices are basically laboratories in a box, and one thing I love about them is they shrink the size of the laboratory. Space is a cost, a very important cost." It’s not only square footage that’s important but also the movability of the instruments.

"This came home for us about a year ago," Dr. Gilcher says, "when we had a heavy rain. The roof leaked severely in one area and it poured water into the NAT [nucleic acid testing] laboratory. The laboratory was shut down for a number of days until we had cleaned and decontaminated it. That’s really unlikely to happen with these automated devices, which are movable."

Preventing false-positive test results for donors is a significant benefit of Prism, says Fuller of BloodSource. "We completely understood the quality of the anti-HBc test was going to be superior, but the cost-benefit actually very specifically came from the lower [number of] false-positives." Though the cost of the system and the reagents add up to more than the cost of the Commander, BloodSource was able to justify the larger expense "by the number of donors we were going to keep donating," Fuller says.

In addition, says Michele DeRee, MT(ASCP) CLS, director of BloodSource’s processing laboratory, "You have a lot more GMPs [good manufacturing practices] covered by being on Prism versus the Commander. There is a lot of information captured by the instrument itself, and it will not allow you to run if everything has not met the requirements."

On Nov. 30 of last year, Puget Sound Blood Center in Seattle became the first blood center in the country to go live with the newly approved anti-HBc test and launch an Abbott Prism, says Mark Destree, MT(ASCP), MBA, MS, director of blood processing laboratories. But so far that is the only test Puget Sound performs on the Prism; the blood center is in the middle of a bar-coding revamp, so it plans to add the HBsAg test next year.

Puget Sound performs testing not only for its own 205,000 collections per year but also for four other blood centers—Hawaii, Alaska, Eugene, Ore., and San Bernardino, Calif.—giving it a collective annual volume of 415,000. It continues to do the rest of its viral testing on the Commander, as it has for nearly two decades.

"Moving only one test over, we probably added labor, but down the road we estimate our labor will be cut at least 50 percent by converting to Prism." In fact, for each test switched to the Prism, the blood center expects to save one FTE and reduce the footprint of its testing equipment by 50 percent. "In a perfect world," Destree says, "we’ll go from 10 people to three, through attrition rather than layoffs." The labor savings will be matched with increases in reagent costs, they know, but they’re hoping it will be a "wash."

After the other tests are approved, the Prism will perform five tests and have one channel functioning as a backup, or potentially performing a test for Chagas disease, when that becomes available. In the meantime, he estimates the blood center is saving 457 donations per year from the 40 percent drop in HBV false-positives. "That’s the better part of a day’s work," he says, and probably worth $91,000 a year. Blood Systems Laboratories tests 2.6 million donor samples a year at its Bedford, Tex., and Tempe, Ariz., laboratories—the two largest-volume blood donor testing labs in the country. It made the commitment to go with Ortho-Clinical Diagnostics’ Ortho Summit Processors for its viral testing a little more than five years ago, and it now has eight OSP testing stations.

"The basis for our move to automation was the higher level of current GMP documentation," says Morris Dixon, MT(ASCP) SBB, MM, who is BSL’s director of operations in Bedford.

From his point of view, that’s "the strength of the system."

"The level of detail on processing time, time to pipette, moving plates from incubator to washer—the data we’re capturing today could never have been captured in the past. And if we had to hand-document all the incubation times and lot numbers that would be required by less-automated systems, we could not provide clients with the turnaround time they expect."

A large donor testing service in the U.S. recently sent staff to visit BSL, Dixon says, and the visitors liked what they saw. "They were using a semiautomated microplate testing service, and they were considering automation. After they came to our laboratory, they made the decision to move to OSPs based on GMP management," he says.

The Bedford facility has increased its staff since it automated, but over that five-year period its testing volume quadrupled, from 250,000 to 1 million. "We average seven people in my department, and they are testing on average about 3,500 samples a night, so we get 17,500 test results per night out of seven people."

With greater volume, the turnaround time has also gone up slightly, but on numerous other measures, automation has brought a rich return on investment. "It’s hard to quantify in dollars," says Chris Nare, MT(AMT), BSL’s technical director for viral marker testing. "But the reduction in human error—making an error while testing and having to retest samples—I think would be unachievable if we were running any other system."

BSL has emerged from both FDA inspections in the last four years with no 483s (FDA forms citing noncompliance with GMPs), Nare says. "I think you can say that’s priceless. Prior to having automation, we were having FDA findings related to viral testing. No matter how hard we tried, with the level of documentation it was almost humanly impossible to do it with manual processing."

The one thing Nare would make better is the level of reagent management. "We’d like to have tools to allow better tracking and less scanning so that we could almost fully eliminate the use of a wrong reagent."

Ortho has told BSL that the successor to OSP, Paradigm, will be a modular, completely hands-off system that will make use of RFID (radio frequency identification) to spin, decap, sort, pipette, test, and obtain results. "Any time you can reduce the touch points between humans and the test system you will reduce the chance for human error," Nare says, "and that’s one way automation allows us to provide a better quality of service." The blood bank and transfusion service at the University of Michigan Hospitals and Health Centers, Ann Arbor, switched from running the majority of its types and screens manually to using an automated system three years ago when it acquired two Ortho ProVues, says laboratory supervisor Terry Downs, MT(ASCP) SBB.

It has actually slightly increased the turnaround time for testing patients, but that hasn’t been a bad thing, in her view. "No machine can do the types and screens as fast as they can be done manually. But what the machine does do is allow the technologist to determine the workflow and optimize the order that patient samples are tested, placing urgent requests before routine and outpatient."

A type and screen can be done manually in 45 minutes from the time it reaches the blood bank, and it takes about 55 minutes on the machine, she says. "But the ProVue frees up people to work on the emergency tasks, because once the specimens are on the ProVue, that technologist can perform other duties"—and a 10-minute difference is probably not that important, she says. For the true emergency, the technologist has the option to run the test manually. The turnaround time for routine outpatient samples dropped from an average of three hours 21 minutes to an average of one hour 48 minutes.

Though both ProVues are usually operating at the same time, "we try to stagger them so if a stat comes in, the technologist has the opportunity to add an urgent sample and not compromise the testing onboard." The technologists have less aggravation because the machine processes samples more efficiently. "They usually come in large dumps every few hours. The most efficient batch on the ProVue is larger than we would test manually by tube," Downs says. "We’re able to get them on the machine and have a continuous flow of non-stat tests. When the next shift comes in there’s no backlog."

Based on her experience, Downs has advice for blood centers considering automation: Have samples come already labeled with their accession numbers to avoid relabeling. "When we started, we were not interfaced with our laboratory computer system, so although we had accession labels, we’d still have to specify the tests to be run and we had to manually enter the results into our LIS."

The ProVue, she notes, does not require use of accession labels, but having it automatically download the test orders and upload the test results is far preferable. "We have already interfaced, and that has been wonderful. We don’t have to assign a technologist to enter results; we can upload them to the laboratory computer system, have them verified and available for viewing."

The ProVues’ greater specificity has been a boon. "The ProVue is excellent for antibody screens because the technology is very specific for finding clinically significant antibodies. Even though the ProVue’s gel technology can be more sensitive to warm autoantibodies, it is "great for cold autoantibodies because it doesn’t tend to pick them up, causing unnecessary additional work," she says.

Downs also points to the increased safety for the technologists. "There is minimal specimen handling; you just pop the top and place it on the machine with no pipettes and tubes and the possibility of broken glass." The technologists at Montefiore Medical Center’s blood bank, Bronx, NY, had to be convinced that automation with Immucor’s Galileo was the most desirable way to conduct types and screens. But Leana Rahman, MPH, MT(ASCP), CQA(ASQ), blood bank manager, now believes her blood bank, which started with Immucor’s semiautomated Rosys instrument and progressed to one Galileo, one Rosys, and two ABS2000 instruments, may be more invested in automation than other small blood banks, which are often reluctant to purchase a first-generation instrument.

Montefiore’s approximately 5,000 types and screens per month (a total of 8,000 at both campuses) are now, as a result of automation, done 85 percent by machine, 15 percent by hand. "But I had to reassure my staff that it was to alleviate their workload, so they would no longer have to perform types and screens but could do more complicated work the machine can’t perform."

"Our whole thing is detecting antibodies so we can get compatible blood for patients, but no technologist is perfect. Although it was never my intention to replace technologists, when the Galileo could run 300 specimens a day with comparable results to the manual tube method, my staff had to come to the realization that the Galileo was as accurate as manual screening or better."

Since installing the Galileo, the blood bank has managed to keep operating with the same FTEs while its volume has risen by 30 percent. "And we don’t ever have racks of specimens sitting there waiting to be processed," Rahman says. "Once something is on the Galileo and batch analyzer, it takes 30 to 45 minutes to turn around, permitting a technologist to type and screen a stat test and have it out the door in 20 minutes."

Automation is becoming practical for mid-size and small blood centers, says Jodi Minneman, chief operating officer of Community Blood Center, Dayton, Ohio. "The vendors are making technology that is as usable by a medium-sized center as by a big testing laboratory. We have a lot of options available."

Community Blood Center, which collects 85,000 red cells a year and 5,000 apheresis platelets, is fully automated and, pending FDA licensing, is halfway to doing all its own infectious disease testing in-house using its Abbott Prism and Gen-Probe’s Tigris (for nucleic acid testing). The blood center just finished validating and went live with the Prism HBV test, and it expects to start performing a triplex test called the Procleix Ultrio (including HIV, HCV, and HBV assays) on the Tigris in 2007.

However, Minneman says, "We only have one of each instrument, whereas larger centers have more than one because they want a backup. We’re trying to do it without that because we do not have the money for it." So far it’s worked: Each instrument has gone down only once, and the delays did not affect operations significantly, she says. Dr. Tegtmeier at the Community Blood Center of Kansas City maintains that if they are making money, "even small blood centers can afford to put in automation like Prism. I know Abbott has established some lower boundary, maybe 50,000 units a year, below which they say it makes no sense, but I think [whether automation is implemented] has more to do with the financial health of the blood center." As for the future, possible FDA additions to the required-test list could take automation in unexpected directions, Dr. Tegtmeier says. "The joker in the deck is probably Chagas disease, which the FDA is on record as saying we need to test for. Ortho has a test for it and is winding up trials on it. Sometime in 2007, we may be looking at the need to add yet another test to the menu that won’t be going on the Prism straightaway. If Ortho is the only licensee, we may be compelled to get into microplate format, which we haven’t worked with since the introduction of the second-generation HCV test in 1992."

"So that will throw a monkey wrench in the works," he says, "in terms of trying to stay with one platform. It’s great to have two technologies in-house, but for smaller operations like ours, that becomes problematic. That’s why we elected to stay with Abbott." If the FDA mandates testing for Chagas, "we’ll either have to send out the test or get instruments we don’t have room for."

The FDA is usually reluctant to give anyone a monopoly on a certain screening test, he notes. But in the case of the p24 antigen "when it was mandated, Ortho was there with a test and Abbott was behind, but the FDA said you had to start testing. So those of us who were using Abbott assays had to send samples out. The same could happen with Chagas, although the FDA could also license the one test and say we must be using a test, say, six months down the line. But that’s going to confound the issue and will take up the sixth channel on the Prism, which doesn’t allow you an additional channel to work with if you’ve got problems."

In addition to Chagas, other unknowns are in the automation picture, Destree of Puget Sound notes. "If you look at the industry 10 years ago, with the semiautomated systems it was all reagent rentals. Only one company actually forced you to buy an instrument, but even they loosened up and had leasing arrangements later on." In 1998, that changed when many blood centers bought Prisms, expecting that the Prism would be the standard of care for a number of years—but they had to wait until 2005 for the assays.

Figuring out which technologies will change rapidly and which will be relatively stable is a challenge, Destree says. With typing, for example, people knew the basic technology would stay the same, so a major purchase could be depreciated over 10 years. But he predicts some of the fastest advances will be in nucleic acid testing. "We really advise people to rent that equipment," because in two years they will most likely want to switch to new instruments.

Whatever lies ahead, there are indisputable facts that are making automation a must-have for blood centers. "There is a critical shortage of professionals in transfusion medicine," BloodSource’s Fuller says. "We just have not educated and graduated enough medical technologists and nurses for what we need today, and without the automation, I think we’d be in a very precarious situation. Automation will help us bridge the gap."

Anne Paxton is a writer in Seattle.