In the past 20 years, laboratory information

Transcription

1 feature Information Technology in the Laboratory J. Mark Tuthill, MD, and Edward C. Klatt, MD, FASCP In the past 20 years, laboratory information technology (IT) has evolved from paperpushing to electronic data packaging. The traditional paper copy method for test result reporting used to involve

2 a great deal of time, not only in generating reports, but also in distributing and archiving reports for retrieval. Access to patient laboratory test results required the physical presence of a paper copy that had to accompany the patient or that required a health care worker to travel to a specific location to view it. An exponential increase in the use of health care resources in the past 3 decades has produced an expansion in laboratory testing, which in turn has generated ever greater amounts of data that threaten to overwhelm paper-based systems. These challenges call for alternative methods. The rise of personal computing in the early 1980s fueled a rapid expansion in the use of computers in businesses and at home, which drove down prices for both software and hardware. Systems for data handling and storage that developed in response to government and industry needs began to be applied to health care institutions. Anatomic and clinical pathology laboratories were particularly well-suited to adopt the new technologies, given that they generate and distribute large amounts of numeric data for use by a variety of health care providers. Therefore, health care systems developed electronic systems for data handling designed specifically to collect, collate, store, and supply laboratory test results in a timely fashion. The growth of these systems required personnel to develop, organize, and maintain them. Such key personnel began to form IT service teams in pathology laboratories. In the late 1980s the importance of managing laboratory data began to be formally recognized, and the term pathology informatics was coined to describe the use of IT in the laboratory. 1 The Rise of Laboratory IT Virtually every laboratory now uses some form of IT. The information generated by the clinical laboratory lends itself to electronic data processing, particularly in the area of clinical chemistry, where numeric tests results are often generated in great quantity. Most instruments used in testing patient blood specimens now electronically receive, produce, and store data that can easily be passed to a laboratory information system (LIS) through an interface. This eliminates the need for human transcription of results and, thus, eliminates a common form of laboratory error. Additionally, the task of specimen processing is undergoing transformation; specimen tubes that were formerly hand-labeled now have bar-coded labels that verify and transfer patient demographics directly into the LIS, further reducing errors. In anatomic pathology, reports are now typically generated by word processing (either by desktop computer or through the LIS). Secretarial transcription is being replaced by dictation to voice recognition systems, often with standardized templates that lend themselves to synoptic reporting. With synoptic recording, specific gross and microscopic findings are listed as separate data elements with defined ranges (eg, nuclear pleomorphism 1, 2, or 3 ) rather than as a narrative description of variable style and content. Dictation to voice recognition systems has the added benefit of optimizing the archiving and retrieval of information within the reports. Many anatomic laboratories now enhance their reports with specimen images obtained via digital cameras at the time of processing; the images are captured as the work is performed. The cameras are interfaced directly to computers that in turn are interfaced to LIS color laser printers with good quality output; these print reports with images enhance the understanding of the diagnosis for both clinicians and their patients. Computers can also collate anatomic and clinical laboratory results with data from other sources such as radiology to produce an electronic chart. Such electronic charts can be part of a larger proprietary institutional information system Systems are currently being developed that allow laboratories to order tests and report results nearly independent of time and place the "holy grail" of laboratory customer service. with standard admission-discharge-transfer and accessioning functions. Much of the data in such charts are derived from laboratory testing. Both desktop computers and an LIS can simplify laboratory administration and cost accounting by storing and analyzing laboratory workloads, expenditures, and revenues. Similarly, quality control and quality assurance functions are enhanced through use of LIS or stand-alone computer applications that record and analyze data points. A function increasingly touted in LIS software is that it can be programmed to assess compliance with regulatory requirements at the time of test ordering or accessioning. Such software can positively impact a laboratory s bottom line while improving customer service and physician ordering practices. Scheduling software is available to help allocate human resources, a task even the most seasoned laboratory managers sometimes find daunting. More recently, Internet technology has allowed laboratories to place their test catalogs and procedure manuals online, which means they can be quickly edited and made available to customers. Internet technology promises to be increasingly important to the future of laboratory medicine. Systems are currently being developed that allow laboratories to order tests and report results nearly independent of time and place the holy grail of laboratory customer service. Typically, new laboratory information systems are layered onto existing information systems, thereby extending the existing 357

3 The Future of IT in the Laboratory: Laboratory Professionals Speak Out (excerpted from telephone interviews conducted by the authors in April 2001) Lab Med: What is the most significant change you expect to see in pathology practice as a result of IT? I expect that the amount of time laboratories spend on specimen analysis will decrease, whereas the time spent on information analysis will increase. Rather than separate reports generated by different sections of the laboratory, we will produce a combined report with data [synthesized into] more useful information. Michael J. Becich, MD, PhD Chairman of Pathology, Director of the Center for Pathology Informatics, and Associate Professor of Pathology Department of Pathology University of Pittsburgh Medical Center Shadyside Hospital Pittsburgh, PA There will be an increased emphasis on efficiency, and pathologists will need to embrace technologic tools to help them do their work. There will be a trend away from imagebased pattern recognition to numerical specimen analysis at the genomic level. Edward Shultz, MS, MD Director of Information Technology Integration, Associate Professor of Biomedical Informatics, and Associate Professor of Pathology Vanderbilt University Medical Center Nashville, TN Lab Med: What revolutionary new IT is on the horizon for pathology and laboratory medicine? Virtual slides with advanced imaging technology will change the way we practice pathology specimens will be examined digitally. Tissue microarrays will provide standards for FISH [fluorescence in situ hybridization] and immunohistochemistry. Electronic chip microarrays will provide many tests [that can be run simultaneously] on many patients to help identify many disease conditions. Dr Becich More of what we do will be hands-off, but we will be developing expert rule-based IT systems. Laboratory data incorporated into data warehouses will allow data mining for information regarding predictions about medical outcomes. Voice and template technology will allow categorization of information with standardization of data, greatly increasing its value. Dr Shultz Lab Med: What are some barriers to successful IT implementation in pathology practice? Administrators [tend to] view pathology as a service, not as a strategic diagnostic resource. Dr Becich A major barrier is the innate conservatism of the pathologist and resistance to providing technologic solutions. Anatomic pathologists savor their prose, though little evidence suggests that much of the detail we provide is valuable. Clinical pathologists [can be] suspicious about quality outside their own laboratory but must [learn to] integrate and mix information across laboratories; the mobile nature of clients demands use of results from disparate sources in a convenient way. Dr Shultz 358 systems functionality but not changing their underlying architecture. Some institutions enhance their clinical information systems with Web-based systems that incorporate data into hypertext markup language (HTML) documents that can be viewed by a Web browser from a desktop computer. Such Web-based systems can distribute data locally or globally via existing Internet or Intranet connections, without the need for a separate local area network (LAN). Who Works in IT? For many laboratories, the approach to developing an IT staff has been to approach existing personnel with motivation and willingness to learn, regardless of prior training, and ask them to develop their IT knowledge and skills as the IT system itself is implemented. Medical technologists and pathologists are typically already some of the most computer-savvy persons in medicine because of the interest in technology that attracted them to laboratory medicine. Many IT personnel have learned on the job, increasing their skills in tandem with the development of the LIS and its human and electronic interfaces. Training on LIS technology typically is provided by the vendor and occurs within the laboratory at the time of hardware and software installation. Customarily, additional inservice training then occurs after every hardware or software update and for new employees. Many vendors also sponsor workshops. Formal informatics fellowships and informatics training in pathology residency programs are also beginning to appear. In fact, the Accreditation Council on Graduate Medical Education requirements for pathology residency training currently include some informatics training or experience. 2 Many medical technology curricula are also now incorporating elements of IT. 3

4 The use of IT in the laboratory has not reduced the workforce. But it has allowed laboratories to cope with increasing workloads and demands for information and regulatory oversight without having to expand the workforce. Former laboratory tasks such as filing, copying, and transcription of paper reports have been replaced by hardware installation, software programming, data management, and maintenance of electronic information systems. What Is the Role of the IT Manager? IT management can occur at multiple levels. An individual pathologist may be the administrative head of an IT department in a larger laboratory or devote part of his or her time to IT functions in smaller laboratories. The administrative head of an IT department is responsible for system design, development, and interfaces to other departments and works with other administrators to oversee the general development of electronic data systems. An IT manager within the laboratory is often a medical technologist with the full-time job of overseeing day-today system maintenance, troubleshooting problems that arise, and training other laboratory workers in the use of the LIS. Such IT managers are often recruited from existing ranks at the time of LIS planning and learn the job as the LIS is installed and developed. A background in medical technology helps the IT manager oversee equipment and human interfaces with the LIS. The time and skills devoted to managing human interaction with the LIS are as important as those devoted to working with the LIS equipment itself. The IT manager often attends vendor-sponsored workshops and informatics meetings to keep abreast of new developments. What Is the State of the Art in IT? The sky currently seems to be the limit in IT. The meager size of yesterday s hard drive has given way to high capacity, high-speed equipment that demands good design, careful deployment, and efficient management. Telecommunications lines such as asynchronous digital subscriber lines or cable modems now deliver speeds of 300 kilobits per second to 10 megabits per second to home or office computers. Although these high-speed telecommunication connections have not penetrated all US markets and are often fraught with technical frustrations, successful installations are becoming more commonplace. Decreasing telecommunications costs and increasing bandwidth enable the physician s office to have the high-quality IT services that only a university or academic Former laboratory tasks such as filing, copying, and transcription of paper reports have been replaced by hardware installation, software programming, data management, and maintenance of electronic information systems. medical center could afford just 5 years ago. The corporate telecommunications infrastructure is even more robust, with fiberoptic cabling between buildings and transcontinental networks with bandwidths measured in gigabits per second (1 gigabit = bits). The expanding infrastructure also supports wireless and satellite telecommunications systems in applications that are becoming increasingly common, such as accessing laboratory data through a handheld electronic device. Similarly, data storage systems have increased multifold in their capacity, as have computer processors. Today s servers typically have multiple processors, gigabytes of random access memory, and storage systems with terabyte capacity. However, in some ways these improvements have barely kept pace with increased user demands and software requirements. As studies in genomics (the study of all the genes in human cells and tissues), proteomics (the study of all proteins in human cells and tissues), DNA microchip analysis, and tissue microarrays become more commonplace in medical practice, the need to store and analyze large data sets will be a requirement for all laboratories. These activities will continue to drive the need for high-speed, sophisticated computer processing in the laboratory. However, the cornerstone of day-to-day laboratory work will remain the desktop computer, interfaced to the LIS, with robust Internet access. The rise of telepathology has played a pivotal part in the advancement of IT use in the laboratory. Fueled by advances in digital imaging technology and computing power, pathology reports are being enhanced with images, and slides can be examined at remote sites, using robotic microscopes in real time. An increasing number of vendors provide virtual microscope systems that digitize a slide for remote access, for incorporation of images into reports, or both. These systems will soon allow complete digitization of a glass slide in minutes. Gross and microscopic images could then be electronically annotated for more effective communication. Pathology images could then be displayed on lightweight flat screen liquid crystal display (LCD) panels that could be placed on a wall like an x-ray light box. Such systems promise to transport the practice of pathology anywhere. However, in many ways the fundamental architecture of the LIS has changed little in the face of technologic innovations. Vendors of present systems have been slow to change their systems from proprietary Massachusetts General Hospital Utility Multiprogramming System (MUMPS) based databases to more modern relational or object relational 359

5 360 "A continual challenge faced by most laboratorians is [the] timely delivery of information to clinicians. IT has significantly improved our ability to do this. Sending reports electronically to distant printers is one example. The promise of the Internet, however, is to push this information to desktop PCs, cellular phones, and PDAs [personal data assistants]. Although we possess the technology to do so, widespread [lack of] acceptance of the Internet by the majority of today's practicing physicians for applications other than personal use slows the evolution of this approach. Physician workflow, in the hospital and in the office, demands seamless integration of information-sharing technologies, including hospital information systems, laboratory information systems, practice management systems, and electronic medical records (both inpatient and outpatient). When this occurs, I believe that we will see the paradigm of information delivery shift to the Internet." Ronald M. Weiss, MD, MPH Director, Associated Regional University Pathologists Laboratories (ARUP) Salt Lake City, UT databases. This has created an operational bottleneck at the LIS as laboratory managers struggle to adapt traditional systems to the demands of new applications and technology. However, as new vendors enter the market, and as old vendors learn new tricks, the overall functionality of LIS software appears to be improving. More and more systems offer image management, compliance checking, and custom designs that allow users to deploy them for applications that more closely mirror the needs their clinical practice. One significant advance in software technology is the advent of data mining, a process that allows a pathologist to extract meaningful information from mountains of stored data. Such operations, which have typically been poorly supported in prior LIS versions, are being increasingly recognized as a critical part of the LIS. Information technology has evolved from mere data storage to data analysis. New data analysis tools, the generation of higher-resolution digital images with faster manipulation, and advanced application of microelectronics will continue to emerge. Voice recognition software called free text software that can take dictation like a human secretary but has no need for breaks or sick days is currently available and can be interfaced with the LIS for automated report generation. Although the use of current voice-operated systems requires patience, planning, and perseverance, the increasing use of such systems in fields like the airline industry has focused technological development on this area. Clearly, the goal of hands-free instrument operation is no longer a distant dream. The Future of IT IT will be crucial in future health care initiatives. Patient information must be standardized so that it can easily be shared across IT systems before outcomes data can be added and analyzed and, thus, before major studies of the efficacy of clinical care can be performed to optimize health care usage and funding. Such standardized, shared data will also allow consumers to make informed choices about health care plans and providers, and will help physicians and regulators monitor fraud abuse, determine patterns of morbidity and mortality, and research the causes, prevention, and treatment of disease. 4 But this type of data mining is only possible when systems are interconnected and methods of data entry and retrieval become standardized. The use of IT in developing neural networks and expert systems, in which the application of programmed rules and logic help find solutions to situations (eg, by narrowing down a list of differential diagnoses from laboratory data), will provide medicine with a means of enhancing accuracy of diagnosis and utilization of resources and reducing errors. 5,6 The increasing use of webbased systems will give both physicians and their patients swift access to crucial information. 1. Friedman BA. Informatics as a separate section within a department of pathology. Am J Clin Pathol. 1990;94(4 suppl 1):S2-S6. 2. Goldberg-Kahn B, Healy JC. Medical informatics training in pathology residency programs. Am J Clin Pathol. 1997;107: Ryman DG, Leach DL. Determining clinical laboratory science curriculum for the 21st century. Clin Lab Sci. 2000;13: Gawande AA, Bates DW. The use of information technology in improving medical performance, I: information systems for medical transactions. MedGenMed. February 7, 2000:E Gawande AA, Bates DW. The use of information technology in improving medical performance, II: physician-support tools. MedGenMed. February 14, 2000:E Laposata M, Van Cott EM. How to work up hypercoagulability. CAP Today Jan;14: J. Mark Tuthill, MD, is assistant professor at the Department of Pathology, University of Vermont College of Medicine, Fletcher Allen Health Care, in Burlington, VT Edward C. Klatt, MD, FASCP, is professor of pathology at the University of Utah, Salt Lake City, UT