for success. As technology moves toward microcomputerization, microchemistry, chip technology, and enhanced test menus, the use of POCT will require ongoing scrutiny (69, 70).
Although the push for decentralized testing may be coming from a variety of sources, it is generally thought that the central laboratory has become more involved in managing the new testing technologies and trying to circumvent anticipated problems with testing quality and patient care.
There are real, continued concerns about test accuracy, precision, training, and QC issues; personnel training and experience; and proficiency testing by those actually performing the testing. To date, there is little scientific evidence for cost reduction and/or reduction in length of stay. There appears to be mounting evidence that in some settings, the cost is higher than that of central laboratory testing.
Large, integrated testing laboratories may become “the laboratory of the future,” particularly considering the issue of economy of scale; i.e., the more we perform large numbers of the same test, theoretically the lower the cost. Although this approach is more applicable to some areas of the laboratory (chemistry), it is being carefully evaluated even in labor-intensive areas with less automation (microbiology). As technology continues to change, the departmental limits within any laboratory (chemistry, hematology, microbiology, or blood bank) continue to become less well defined. Many laboratory operations are now structured around automated and manual methods rather than specific clinical disciplines. This approach will continue and will also affect personnel training and utilization. Review of in-house versus send-out tests will continue, particularly regarding cost containment parameters.
With continued development and implementation of computerized history algorithms, clinical pathways, and case management, more structured support for clinical decision making will also dramatically affect the laboratory. Inappropriate test-ordering patterns and overutilization will become less and less significant. The use of algorithms may also become much more common within the laboratory itself. All of these changes will be developed through the use of multidisciplinary teams, including all members of the health care delivery system (ancillary departments, nursing staff, and physicians).
New technology will continue to be evaluated for a number of parameters, including type of data, technical characteristics, diagnostic characteristics, clinical utility, and cost-benefit analysis. Laboratory design will be another key issue and will be influenced by a number of factors, including consolidation of health care facilities; continued shift to outpatient care and POCT and alternative-site testing; development and use of clinical paths; and development and evaluation of new technologies. Physical plant design should consider a number of factors, such as analysis of institution mission, scope of the project, and specific objectives; written statements of needs; mechanisms for keeping people informed; careful analysis of operational needs (work flow, traffic patterns, etc.); detailed review of current and future space requirements (consolidation of instrumentation, workstations, storage capacity, and equipment location); flexibility of design (modular furniture and utilities); and safety issues.
Currently, hospitals and clinics are not able to meet their expenses without continued decreases in labor costs. During the next few years, the greatest savings in laboratory costs will come from technology that leads to labor reductions. Laboratory automation has the potential to be a highly successful, cost-saving measure and has been implemented in Japan, where many laboratories employ 5 to 10 times fewer full-time equivalents than European and North American laboratories while still achieving similar productivity results. Future expectations include the performance of all but a few esoteric tests by automated systems, the use of mass spectrometry, and performance of most routine testing on a single automated analyzer. It is very likely that specimens will arrive in the laboratory ready for testing, with all processing having been done prior to receipt by the laboratory. The specimen may contain information chips carrying patient medical history and physiologic data at the time of sampling. These chips may also allow wireless encoding and reading of specimen information. Thus, the old specimen-processing area can concentrate on customer service, provision of medical information, and client education.
As an adjunct to the highly automated core laboratory, miniature analyzers and POCT will play a major role in testing. Multianalyte, spectroscopy-based, noninvasive sensors will provide a wide range of tests at the bedside; there is even the possibility of a wireless invasive analyzer that would reside in a device that could be injected or implanted under the skin or elsewhere in the body.
New molecular tools have been developed rapidly, especially with the excitement over the completion of the human genome project. Synthetic antibody-like molecules with high affinity and specificity have been developed from both DNA and RNA. These molecules may replace antibodies in molecular diagnostics, achieving tremendous levels of sensitivity.
Biometrics is the use of sensors to measure natural body features for positive identification. In the future, biometrics will be extremely helpful in confirming that patients and their body fluids or other specimens are correctly identified. A patient’s complete medical history may be available on the Web when the patient simply places a finger into the sensor mechanism.
Nonlaboratory systems, such as robots, will be used much more commonly for delivery functions, saving a significant amount of money as well as improving service. Surgery robots that can perform complex procedures through very small incisions are currently under development, and some have been implemented.
An area of research and laboratory practice that will be critically impacted by complex and interrelated legislative, regulatory, and administrative developments is stem cell research and the application of cloning technology to medical practice in tissue and organ transplantation and reproductive technology. The cloning research issue is closely linked to the highly emotional controversy over abortion and genetic manipulation and has elicited strong and conflicting opinions from various constituencies, including the research and medical community, religious groups, and organizations committed to research and treatment of specific diseases.
A number of approaches are being developed and used to serve as “practice guidelines”—more structured approaches for both information gathering and clinical decision making related to the patient. A clinical pathway is defined as a set of interventions or actions that is used to help a patient move progressively through a clinical experience to an expected, positive outcome. One of the main reasons for developing clinical pathways is to provide a tool to evaluate clinical patient management and outcomes. Once defined sets of expectations are developed, data can be used to monitor variances. The cost of care and utilization of resources can then be monitored more closely.
By using clinical pathways for predictable clinical outcomes (conditions, diseases, and procedures selected are generally very well established and patient outcomes are consistent), many also believe that patient care is more consistent. These clinical pathways can also be used as a teaching tool for all health care personnel. The development of clinical paths must be a multidisciplinary effort, with input from all relevant members of the health care team. Many institutions are also using the process of clinical path development to foster team building and continuous quality improvement initiatives.
Regardless of names or titles, the following are becoming more widely used and accepted. They are listed from the most well-defined and predictable medical situations (clinical pathway) to very complex cases with many underlying factors and complications (case management).
