New instrument makes transplant safer, cheaperby Michael BakerPublic Relations At MUSC, the delicate recovery process from organ transplantation just became more precise. A new instrument, the liquid chromatography-tandem mass spectrometer, has helped the Department of Pathology and Laboratory Medicine increase the safety of transplant patients while decreasing the cost of their care. According to Christine Papadea, Ph.D., director of clinical chemistry, the human immune system generally rejects any foreign entities within the body. Unfortunately for transplant recipients, foreign entities include donated organs. Immunosuppressants, as their name entails, are drugs that protect newly donated organs from rejection by the immune system. At the same time, these drugs can have risky side effects. Papadea explained that when physicians administer the drugs, dosage accuracy is extremely important to achieve the best possible outcome. “An incorrect dosage can be very dangerous to transplant patients,” she said. “If the dosage is too small, the immune system will reject a new organ. On the other hand, an improperly high dosage can be toxic.” Janice Lage, M.D., chair of pathology and laboratory medicine, echoed Papadea’s assertion of the importance of proper dosing. “We want to maintain a proper balance with the patient’s immune system,” Lage said. “Obviously, you want the drugs to suppress the immune system enough to prevent the body from rejecting the transplanted organ. But you don’t want the immune system to cease its functions completely.” After administering a standard dose of immuno-suppressants to a transplant patient, physicians order a blood test to determine if the dosage is too high, too low, or optimal. For years the method of choice, an immunoassay, held a favored position in many laboratories because of the ease and simplicity of the corresponding instrumentation. “Honestly, I could teach you to do the test in about 10 minutes,” Papadea said, “but the immunoassay results aren’t as accurate as we’d like them to be.” The immunoassay method also detects many inactive metabolites of the active drug, adding the inactive and active drug metabolites to compute the drug level. The end result is an overestimate of the true drug level. Now, the spectrometer should remedy any uncertainty in the testing process. The instrument greatly increases the accuracy of transplant patients’ blood tests by measuring only the active metabolites in the blood, excluding any extraneous measurements. “The spectrometer is so important because it fine-tunes the physicians’ abilities to regulate the dose for each patient,” Papadea said. “It’s more accurate than the immunoassay method, and it’s very efficient as well.” Specifically, the spectrometer decreases the time it takes for physicians to receive test results. While previous testing methods forced physicians to run separate blood tests for each type of immunosuppressant—and sometimes to send tests to an out-of-state reference lab—the spectrometer eliminates testing delays caused by such exercises. Instead, the instrument detects all the immunosuppressants at once, right inside the laboratory. Lage added that the spectrometer’s simultaneous testing method virtually eliminates human error. “If physicians order a blood test for the incorrect drug, it’s not a catastrophe,” she said. “Rather than running the tests all over again—which takes more of the patients’ blood, time, and money—the physicians simply ask the lab to check the readouts from the drugs that were tested simultaneously.” Speed and efficiency are two major benefits of the spectrometer, but like everything in life, the new equipment came at a noteworthy, albeit frontloaded, price. Personnel training and validation studies took several months. “Initially, the cost was very, very high,” Papadea explained. “This was not an easy undertaking. The technical know-how to use the new instrument is demanding.” Still, after looking at the advantages and disadvantages of the situation, the Department of Pathology and Laboratory Medicine converted to the new spectrometer method of blood testing. “There was overwhelming evidence that we couldn’t ignore,” Papadea said. “We realized that recouping the cost of the spectrometer would be fairly simple.” In fact, the financial windfall induced by the spectrometer’s purchase should have long-term effects. Joyce Foster, manager of specialized testing services, said that the spectrometer saves MUSC between $20,000 and $30,000 in reagent costs each month and reduces annual costs by nearly 85 percent. The Department of Pathology and Laboratory Medicine also knew that new equipment—regardless of its ability to save time, money, and lives—requires a period of adjustment for everyone involved. “The new instrument gives different numerical results than our clinicians were accustomed to,” Lage explained. “Like physicians at other universities, they encountered problems because national protocols for handling the results were based on the older, less accurate methods, not the new one.” For that reason, the department met with various transplant groups within MUSC to present a scenario for the transition between immunoassay and spectrometer testings. Although the university purchased the spectrometer in June, normal clinical use didn’t begin until January of this year. “Establishing something like this doesn’t happen overnight,” Papadea said, “and a drastic procedural change isn’t something you just spring on physicians.” Further showing its commitment to a smooth integration, the department hosted a symposium in mid-March, inviting scientists from nationally recognized medical centers that either had purchased the instrument or were considering such a move. The symposium yielded many new ideas, including a helpful nugget of wisdom from a clinical chemist at the University of Michigan, who shared a new method of handling the blood test samples. The chemist’s method provided a faster, less labor-intensive boost to the already efficient spectrometer. Soon, Lage said, the department plans to publish the results and recommendations drawn from the symposium in a pathology journal. The validation trials and symposium represent parts of the learning process that comes with new equipment, but the extended period of integration hasn’t moved MUSC from the front line of research. Nearly a year passed between purchase approval and the spectrometer’s clinical induction, but Papadea said that to her knowledge, MUSC remains one of a handful of institutions in the southeast that uses the new blood testing method. Now that the growing pains appear to be over, the department can reap the benefits of a new system that makes transplant patients’ aftercare much safer and more efficient and also saves the university a substantial amount of money during a time of statewide budget cuts. “The department’s role in all of this,” Lage said, “was to provide professional support to the lab by determining which instrument would be most beneficial to patients while cutting the cost of laboratory testing.” Both Lage and Papadea give immense credit for the spectrometer’s acquisition to Prabhakar Baliga, M.D., head of transplant surgery. “The entire endeavor started with Dr. Baliga’s knowledge,” the two women agreed. “He initiated the department’s interest in acquiring the instrument, and he continues to support our work.” By combining the purchase of a single instrument, the hard work of people
like Baliga, Lage, and Papadea, and a commitment to interdisciplinary cooperation,
MUSC proved that improving patient care and cutting costs don’t have to
be mutually exclusive.
Friday, March 26, 2004
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