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Reading the future: the increased relevance of laboratory medicine in the next century.

With the countdown to the next millennium running out, it's only natural to look for deeper meaning in this chronological changeover. Using experience rather than tarot cards, these authors examine recent and developing technology to project what the future holds for the clinical lab industry.

As the end of the millennium approaches, predictions for the next century abound. Although only retrospect will determine the accuracy of these predictions, some of them may become realities, especially those foretelling the continued growth and applications of technology. Futurists are placing great promise in the use of technology to reduce the costs of providing healthcare. In fact, healthcare technologies and healthcare-related internet services are two sectors that undoubtedly will see continued growth.

In an effort to look to the future, the Food and Drug Administration's Center for Devices and Radiologic Health convened a panel of experts in the fall of 1997 to predict trends likely to be important for the development of new medical products and technologies of the next century.(1) This group of visionaries decided that the most significant future technological trends include: (1) computer-related technologies, (2) molecular medicine, (3) home- and self-care, (4) minimally invasive procedures, (5) device/drug hybrid products, and (6) organ replacement/assist devices.

In general agreement with these trends for medical devices ranked by the FDA panel experts, the Medical Automation Research Center (MARC), at The University of Virginia, Charlottesville, VA, selected 4 growth areas that will have a technological impact on the future of laboratories: (1) point-of-care testing, (2) computer-aided process control, (3) medical robotic systems, and (4) molecular automation. Similar to the healthcare market, the laboratory, market will see a growth in technologies that will emphasize the emerging trends toward patient-focused care and patient self-diagnosis and will provide the tools necessary for laboratories to provide the high-quality diagnostic information and efficient service necessary to remain competitive in the next century.

While predicting the future is arguably guesswork, there are clear technological trends toward the development of laboratory automation systems, miniaturization, and the commercialization of recent discoveries in biology.

The future of three technological trends

Laboratory automation. Given the current negative economic outlook for medicine - and for laboratories in the United States in particular it is easy to predict that there is a bright future in technology designed to save time, resources, and therefore money. Because of the Balanced Budget Act of 1997, healthcare providers are facing severe reductions in Medicare funding. Thus, hospitals and clinics are not able to meet their expenses without a concomitant decrease in labor costs. In fact, the greatest savings in laboratory costs during the next several decades will come from technology that enables labor reductions.

Laboratory automation has the potential to be the most successful, medical cost-savings measure of our time because automated systems can help laboratories streamline and improve their processes to become more financially efficient and survive in the next century. To an outside observer, current U.S. laboratories appear expensive and relatively inefficient when compared with those in Japan. The Japanese have automated most of their government-funded laboratories and have demonstrated that they can employ 5 to 10 times fewer full-time equivalents (FTEs) than European and North American laboratories do while still achieving similar levels of productivity.[2] Automation has been responsible for this dramatic labor reduction in Japan, which has more than 170 installed automated systems currently in existence.[2]

Should our laboratory efficiency goals for the future be similar to those of Japan? Probably not. Early in the next century, point-of-care and home testing will redefine the location and delivery, model for clinical laboratory medicine; this will probably become the preferred model for North America.

As with the advent of any business automation, changes in jobs, production methods, and costs are inevitable. Certain elements of the future lab have arrived on the market and are helping some labs become significantly more efficient (in terms of the number of lab tests per FTE); while in other labs, managers are struggling to understand how to best implement this technology. Medical technologists are predicting that: there will be less need for their services in the next century.

Predictions for automation. The role of the centralized laboratory, will inevitably evolve to the point where automated systems will perform all but esoteric tests. Many tests will be done using definitive methods such as tandem mass spectrometry, which by the year 2002, will be able to pick out individual proteins and small molecules at the femtogram level from complex mixtures.[3] Consolidation of analyzer functions will allow most routine testing, including chemistry, toxicology, and immunoassay, to be performed in a single automated analyzer. It is likely that specimens will arrive in the laboratory completely processed in standardized, fully labeled containers that are ready for immediate analysis. Specimen preparation will take place in the blood container using specialized processing devices or materials directly incorporated into the container. A high-density coded label [ILLUSTRATION FOR FIGURE 1 OMITTED] on each specimen will contain full demographics and a recent medical history of the patient as well as the physiologic status at the time of sampling. In some instances, radio information chips will be attached to the tube to allow wireless encoding and reading of specimen information.[4] Because each specimen will be completely processed when it arrives in the laboratory,[5] it seems probable that the central receiving and triaging area will focus on customer service and providing medical information.

Miniaturization. Parallel to the development of highly automated core laboratories, developments in technology are making it possible to predict with a high degree of certainty that miniature analyzers and point-of-care testing will play a principal role in the diagnosis of disease. For several years, handheld analyzers that can analyze many common clinical chemistry tests, including electrolytes, glucose, hemoglobin, creatinine, pH, blood gases, coagulation factors, cholesterol, bone markers, and pregnancy testing have existed [ILLUSTRATION FOR FIGURE 2 OMITTED].[6] Even the polymerase chain reaction (PCR) now exists in a handheld format.[7]

When we at MARC ranked all the tests in our laboratory by frequency of ordering, we discovered that 50% of our tests could be provided at the point of care with existing technology. In the past, we have suggested that 80% of total laboratory testing will be available at the patient's bedside within the next 5 years at a fraction of the cost of central laboratory testing.[2] The price of point-of-care testing is less compared with the central laboratory because of the labor costs associated with specimen packing, transportation, and unpackaging before analysis. However, compelling studies exist that suggest that not all point-of-care testing decreases turnaround time of the entire diagnostic process[8] or saves a sufficient amount of money to justify the expense. This apparent paradox has stifled the growth in point-of-care testing and has redirected the focus of diagnostic technology toward preanalytical and analytical consolidation in the central laboratory. These earlier studies were based on relatively early point-of-care systems that were not under laboratory supervision.

Other studies show convincing evidence that point-of-care testing can be performed for less than half the cost of centralized testing.[9] It therefore seems more likely that point-of-care testing will predominate in the lab of the future. If the uncalculated additional cost savings for improved patient conditions and reduced laboratory overhead are added in as well, then even more dramatic savings can be recovered. The lab of the future will clearly require innovative technologies to provide timely information to the increasingly busy physician.

Predictions for miniaturization. New technologies portend the multifunctional bedside analyzer with minimally invasive specimen collection techniques. Burns et al. have created the first complete PCR analytical device equipped with a specimen preparatory area, an amplification area, and a capillary liquid chromatograph that fits into the space of a fie tack.[10] SpectRx has developed a laser-based skin perforator that allows a few microliters of interstitial fluid to leak into a small analytical device for minimally invasive glucose measurements.[9] Infrared sensors are being used in conjunction with Fourier transformation to noninvasively measure glucose and additional analytes (e.g., bilirubin) directly through the skin.[9] Multianalyte, spectroscopy-based, noninvasive sensors will provide a wide range of analytical tests at the bedside in the near future. One can even imagine the advent of the wireless invasive analyzer that would reside in a device that could be injected or implanted under the skin or elsewhere in the body.

Biotechnology. Novel molecular tools have also been developing at a rapid pace. The projected sequencing of the human genome within the next 3 years has captured the attention of many pharmaceutical companies that stand to profit from the discovery of a host of new therapeutic targets. Other, less widely recognized technologies have emerged that also may have broad implications in the next 10 years. For example, synthetic antibody-like molecules with high affinity and specificity have been developed from DNA and RNA. Synthetic DNA and RNA "aptamers" may replace the antibody in molecular diagnostics and serve as novel designer drugs for infections, cancer, and other diseases. Diagnostic tools using aptamers could achieve new levels of analytical sensitivity by employing innovative, single-molecular detection methods that use laser excitation.

Early in the next century, approaches to drug design will evolve from a fundamental understanding of human biochemistry and physiology, possibly as a result of the sequencing of the human genome. When selected targets are identified, rapid drug discovery will result from combinatorial synthesis (the parallel synthesis of many different compounds at the same time) and robotic screening.

The laboratory system

In the future, a systems approach to medical care delivery will replace the department-centric systems that are currently in place. The laboratory may expand its influence on the diagnostic process by participating in the management of all aspects of medicine. For example, the laboratory may provide and maintain new technologies that will enable physicians to decide more easily which treatment options to offer. More than 80% of the diagnostic information produced in a typical hospital is generated by the laboratory. Thus, the department of laboratory medicine could gain significant influence over the practice of medical care by properly leveraging information technologies.

Timely delivery of goods will become an ever-increasing issue as hospitals become more efficient. Mobile robots will visit each patient's room on a scheduled basis to deliver medical supplies and dietary and pharmacy orders and to pick up medical specimens.[11] After it arrives in the laboratory, the mobile robot will place specimens directly into the analyzer [ILLUSTRATION FOR FIGURE 3 OMITTED].[12] When the analysis is complete, a computer will review the results and send them to the attending physician's handheld information device [ILLUSTRATION FOR FIGURE 4 OMITTED]. The laboratory will be connected to the physician through a real-time link to provide test interpretation and consultation for follow-up testing. In the future, physicians will be grateful for the collaborative help of the laboratory in the diagnostic process.

Providing in-depth follow-up consultation is the key to laboratory survival in the next century. Through the strategic implementation of information technologies, clinical pathologists can become active participants in the diagnosis of disease as well as invaluable consultants for the physician. For instance, Masahide Sasaki, MD, Red Cross of Japan, Yamaguchi Prefecture, Japan, has developed a data-reporting method that allows easy interpretation of the many clinical laboratory tests that have become invaluable to his practicing physicians (abstract submitted to Worldlab, Florence, Italy, 1999).[13]

Process control. The success of laboratory automation systems in the future rests on the creation of machine intelligence with the capabilities to manage the many complex events that will occur in an automated laboratory. Process control software and expert systems will be required to maintain a minute-to-minute database of specimen status (where it is and what has been done to it) as well as the analytical results. Process control software will also monitor for exceptions to the normal operational process, such as insufficient quantity, unreadable bar codes, poor quality sample, improper container, improper phlebotomy site or time, and specimen damage, and then follow rules regarding how exceptions should be treated. The more intelligent systems will learn from experience and use this information to optimize throughput and the utilization of resources. Most importantly, the expert system will have to keep the operators informed of all important events and analytical results so that timely decisions can be made. Process control will evolve into the information repository for the laboratory that can be mined for information from many disparate databases to provide real-time decisionmaking support tools for the physician.

Scheduling phlebotomists, technologists, and instrument operations will be a job for scheduling software modules. Furthermore, many administrative tasks, such as planning and implementing training, ordering supplies, and monitoring quality control, may be programmed into the process controller. As in many industries, the computer assistant will free technologists from many of the mundane chores associated with running a complex laboratory.

Biometrics

Biometrics is the use of sensors to measure natural body features for positive identification. For example, fingerprint identification chips, combined with a fingerprint database, can ensure that individuals are positively identified. Banks are now installing automated teller machines that read the customer's iris patterns to provide error-free identification.

Biometrics can be quite useful in assuring that patients and their body fluids are positively identified throughout the diagnostic process. This technology may also provide a gateway to patient medical history and diagnostic information: A patient's complete medical history may be made available through the Web when he or she simply places a finger (or other body part) into the sensor mechanism.

Nonlaboratory systems

Technology has already begun to proliferate to other areas of the medical center for more efficient patient care with the increased use of automated pharmacy robots, mobile transportation robots, and surgical robotics. At MARC, we have demonstrated in simulation studies that the use of a fleet of mobile robots to deliver medical specimens and pharmacy supplies to hospital wards will save a significant amount of money as well as improve service in our institution. The installation of 6 robots in an 8-floor hospital with 550 beds may be projected to result in more than $250,000 in savings every year as well as reduce overall turnaround time by 30%. (Other data, R.A.F., A. Kumar, and M.D. Rosetti, unpublished data, 1999.) Surgery robots already are being developed that can perform complex procedures through only a few small incisions.[14] Robotics can access remote surgical sites and perform with superhuman speed and precision.

Home health. The quality and outcome of healthcare are of utmost importance to the patient. Therefore, future technologies will focus on enabling the patient to take a more active role in his or her own care. Patients will be able to view, interpret, and add important information to their medical records through Web-based tools. Patients will be able to use diagnostic products purchased from a grocery store or pharmacy and automatically upload the results to their medical records in the privacy of their homes. For the elderly or the technologically challenged, automated companions may provide conversation and medical information and even take vital signs.

Summary and conclusion

Through intelligent process control and data management, the laboratory may become the most frequently used - and the most important - source of diagnostic information in medicine. The central laboratory of the future is destined to become an esoteric testing center, whereas routine testing - administered at the patient bedside or at home - will become more economical. Point-of-care testing will soon become the most profitable way to provide laboratory services. Novel phlebotomy techniques and noninvasive tests may allow some diagnostic testing to be done through automated robotic companions that serve homebound patients or the elderly.

References

1. Herman WA, Marlowe DE, Rudolph H. Future trends in medical device technology: Results of an expert survey [abstract]. [Center for Devices and Radiological Health Web site.] April 8, 1998. Available at: http://www.fda.gov/cdrh/ost/trends/TOC.html. Accessed June 22, 1999.

2. Felder RA. Cost-justifying laboratory automation. Clin Lab News. 1996;22(4): 10-13.

3. Arnott D, Shabanowitz J, Hunt DF. Mass spectrometry of proteins and peptides: Sensitive and accurate mass measurement and sequence analysis. Clin Chem. 1993;39(9):2005-2010.

4. Freiherr G. Wireless technologies find niche in patient care. Medical Device & Diagnostic Industry. August 1998: 83-93.

5. Estey C, Felder RA. A novel specimen centrifugation technique: Axial separation. Clin Chem. 1996;42(3):402-409.

6. Erickson KE, Wilding P. Evaluation of a novel point-of-care system, the i-STAT portable clinical analyzer. Clin Chem. 1993;39(2):283-287.

7. Timoney CF, Felder RA. Cepheid: Expanding the boundaries for practical applications of microinstrumentation and microfluidics. J Assoc Lab Automation. 1998;3(6):22-26.

8. Van Heyningen C, Watson ID, Morrice AE. Point-of-care testing outcomes in an emergency department. Clin Chem. 1999;45:437-438.

9. Felder RA. The distributed laboratory: Point of care services with core laboratory management. In: Price CP, Hicks J, eds. Point-of-Care Testing. Washington, DC: American Assoc Clin Chem Publishing. In Press.

10. Burns MA, Johnson BN, Brahmasandra SN, et al. An integrated nanoliter DNA analysis device. Science. 1998;282:484-487.

11. Felder RA. Transporting with mobile robots. Lab Automation News. 1996;1(4):6-12.

12. Graves S, Felder RA. Robotic automation of coagulation analysis. Clin Chem Acta. 1998; 278(2):269-279.

13. Sasaki M, Takeda K. Next-generation laboratory automation systems in Japan: New heights of throughput and automation. Clinical Chemistry and Laboratory Medicine. 1999;37;S55:ISSN 1437-8523.

14. Wang YF, Uecker DR, Wang Y. A new framework for vision-enabled and robotically assisted minimally invasive surgery. Comput Med Imaging Graph. November-December 1998; 22(6):429-437.

Robin A. Felder is professor of pathology, director of the Medical Automation Research Center (MARC), and CEO of the Association for Laboratory Automation; Sean Graves is assistant professor of pathology and division director of robotics and automation at MARC; and Theodore Mifflin is associate professor of pathology and division director of molecular automation at MARC, The University of Virginia, Charlottesville, VA.
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Author:Felder, Robin A.; Graves, Seam; Mifflin, Theodore
Publication:Medical Laboratory Observer
Article Type:Industry Overview
Date:Jul 1, 1999
Words:2994
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