Laboratory Informatics and the Laboratory Information System
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1 Laboratory Informatics and the Laboratory Information System DANIEL F. COWAN The primary objective of clinical laboratorians is to provide the highest possible quality of service to patients and those who care for patients. High-quality ser- vice encompasses accurate and precise analysis, timely, clear, and concise report- ing, and delivery of the service to a location in a format most valuable to the user of the service. Quality has also come to include elements of efficiency, effective- ness, analysis of diagnostic utility, and decision support.1,2 Delivery of the ser- vice has come to mean that integration into a comprehensive electronic medical record (EMR) is to be expected.3,4 Although it is widely accepted that about 70% of the information used in the management of patients comes from the clinical and anatomical pathology laboratories,5 in one large medical center in which information flow is tracked, about 94% of requests to the EMR are for laboratory results.4 In addition, a critical quality feature is the transformation of laboratory data into information.2,5,6–8 Drives for improved quality, integration, and efficiency have resulted in the incorporation of information technology and the personnel, policy, and proce- dural changes needed to exploit the technology into the clinical service labora- tory.9–11 This applies equally well to anatomic and clinical pathology. It seems clear enough that the managers of laboratory operations must understand infor- mation, the purpose of information, and the proper management of information in order to survive and prosper in an environment that demands an orientation to service and a full appreciation for the inter-relationship between processes and events. This is especially so when more information is being produced than can be assimilated, far beyond the limitations of memory-based learning, and the future is uncertain. The ability to respond and adapt to change requires recogni- tion of changes in an early stage and understanding of the changes in qualitative and quantitative terms. This means that decision makers must have full and ready access to high-quality, accurate information. The flow and management of information is made possible by the technol- ogy of computers and other information devices. Although the technology is fascinating, the important issues for the laboratorian are the purpose and 2 D.F. Cowan management of information. The laboratorian must understand that the labo- ratory is a knowledge- and service-based enterprise. Information manage- ment is an essential task of leadership, and like other aspects of management, if it is not done well in the laboratory, either it will be taken away by a higher level of administration or by an institutional information services organiza- tion or it will be outsourced. The pathology laboratory must be run as a business, and usually it is a compo- nent of a larger business: a hospital, medical center, or some other enterprise.12 This perception should not be much of a surprise, but for the laboratorian whose orientation is technical, academic, or altruistic, it requires a drastic reorientation of thinking. Laboratory leadership is responsible not only for technical and sci- entific matters but also for the jobs of people employed by the laboratory. Skill in business matters may be the critical factor in the viability of the laboratory and hence in the livelihood of those who work in it. Business tends to be a very competitive affair. Some businesses succeed and some fail. The struggle of busi- ness is and will always be a struggle for advantage. Those who build and sustain competitive advantage will win; those who do not will lose. Competition is all about advantage.13 Advantages over business competitors seldom are quantum jumps. They are much more likely to be the accumulation of small incremental gains realized over time resulting from careful management. Every human enter- prise, even if not competitive in a direct way, must be run in a businesslike fashion; otherwise its resources, always limited, will not be used in a way that enhances the purposes of the organization. This principle applies as much to churches as to commercial establishments. The purpose of information technology, or as it is sometimes called, infor- mation movement and management, is competitiveness. It allows an organi- zation to build and sustain a competitive advantage. All other activities, such as increasing efficiency, developing a better product, and decision support, are contributors to that objective, not the objective itself.13 After all, if the business fails, the laboratory closes or is sold and whatever high-minded or altruistic motives that might have driven it cannot be realized. The successful leader balances his or her attention between the present and the future; under- stands that today’s success is temporary; while enjoying today’s success is preparing for tomorrow’s greater success; and cultivates the ability to see the world as it is, not as it ought to be. The effective use of information services in any enterprise requires an understanding of the environment, structure, function, and politics of the organization, as well as the role of management and management decision making in it. Six types of information systems or subsystems are used in various organizational levels. Executive support systems (ESSs) are used at the strategic decision level of an organization; they are designed to address unstructured decision making us- ing advanced graphics and communication representing vast amounts of struc- tured and processed information. 1. Laboratory Informatics 3 Management information systems (MISs) provide current and historical per- formance data to middle managers who use it in planning, controlling, and decision making. Decision support systems (DSSs) are similar to MISs but tend to be more analytical; they deal with semistructured problems using data from both internal and external sources. Knowledge work systems (KWSs) are used by knowledge workers (scien- tists, engineers, and so on) to help create and distribute new knowledge. Office automation systems (OASs) are used to increase the productivity of data workers (secretaries, bookkeepers, and so on) but may also be used by knowledge workers. Transaction processing systems (TPSs) are basic business systems used at the operations level of an organization to keep track of daily transactions in the course of business. TPS might include databases and spread sheets. Business of Pathology Because it primarily involves the acquisition, creation, evaluation, and dissemi- nation of information, the practice of pathology can be characterized as a com- plex information system designed to produce useful information for individual or groups of patients. An information system can be formally defined as interre- lated components working together to collect, process, store, and disseminate information to support decision making, coordination, control analysis, and vi- sualization within an organization.14 This information function of the service department complements pathology’s traditional role as a method for systematic study of disease as seen in a patient, living or dead. In addition to its basis in laboratory testing, pathology also includes collection, processing, and dispens- ing of blood and blood products and consultation in their appropriate use. Each step in these processes requires the accumulation, organization, validation, stor- age, and transmission of information. Therefore, it is apparent that the laborato- rian is continually involved in information processing and communication tasks. Indeed, as actual analytical processes are done more and more by automated machines, the laboratorian is becoming primarily an information manager.10 The choice is not whether to be an information manager; it is to be a competent or an incompetent one. Information Product of the Laboratory The business product of the laboratory, aside from the exception of blood and blood products, is information.2,9,15–17 As with any business enterprise, the product offered by the laboratory, information, must be delivered to the user in a timely manner, in a comprehensible precise form and format, and at a location satisfactory to the user. One hopes to make a profit by so doing, or if 4 D.F. Cowan in a capitated or other cost-limiting system, do it in the way that uses the smallest possible amount of money. As a practical matter, information generated in the laboratory can be clas- sified as product information, information intended to be used outside the laboratory, such as patient results, and process information, information pro- duced in the course of receiving, processing, and testing specimens, organiz- ing of reports, and all the financial, scheduling and other operational matters necessary to run the laboratory. Thus, in the generation of information, the laboratory has both product goals and process goals. The product goals of the laboratory are service related, including promptness, clarity in communica- tion, accuracy, and error reduction. The process goals of the laboratory are efficiency in the use of resources and documentation for management and for accreditation. The overall goal of laboratory information management is to obtain, create, manage, and use information to improve patient services and individual and laboratory performance in contributing to patient care, busi- ness management, and support processes. Pathologist as Information Manager This approach to the specialty