Introduction

As the clinical diagnostic laboratory has entered the 21st century, it is interesting to reflect on past scientific and social events that have influenced the status of the laboratory and to anticipate future problems and opportunities. It would be a mistake to suggest that all of the significant medical and social events that had an impact on the present laboratory function can be discussed or evaluated in a short introductory chapter. It is also possible to mistakenly attribute more influence to some events than they deserve simply because they are being interpreted with a 21st century bias. However, some threads of commonality have influenced the evolution of diagnostic laboratories from earliest times. It is the objective of this chapter to highlight events that, in my opinion, have shaped how and/or why clinical laboratories have arrived at their present position in the practice of medicine.

A history of diagnostic testing can be started by reviewing the evolution of diagnostic tests from isolated procedures to organized diagnostic laboratory testing. Originally, laboratory tests were performed at the side of the patient with small, simple equipment, rapid evaluation of the result, and a diagnostic opinion rendered. Test choice, performance, and interpretation were all left to the individual practitioner. There was no professional support staff to assist at any point in the process. Little exchange took place between practitioners because the individual's success was directly related to which procedures were done and the manner in which they were done. A premium was paid for showmanship as well as successful treatments.

The modern laboratory is a physical place, either standing alone or as a component of a health care institution, with numerous pieces of complicated capital equipment, where hundreds and sometimes thousands of specimens per day are processed for dozens of tests. Usually, the laboratory accepts a teaching and a research responsibility to accompany this patient service obligation. Today's laboratories are staffed by professionals trained in several subspecialties, who are available for consultation in all aspects of diagnostic testing. This structure underlines the current complexity and sophistication of the modern laboratory operation. There are a myriad of professional organizations, meetings, and publications that have developed to make information exchange convenient and efficient. This exchange is also necessary to ensure a single level of care. The system that supported showmanship and theatrics has been replaced by one that only tolerates scientifically based medical practices.

Today's laboratory is in a state of flux—faced with issues of near-patient testing, outreach programs, utilization, extensive regulation, and stringent fiscal controls. The first three of these issues are reminiscent of the early beginnings of diagnostic testing. The laboratory organization has replaced the individual practitioner, but testing is moving back toward the patient in the form of near-patient testing or outreach programs. In the past, a few individuals spoke about appropriate use of diagnostic testing, whereas, today, committees and organizations are dedicated to the control of laboratory utilization—an ontogeny recapitulating phylogeny phenomenon. A review of history gives some insight into relationships and similarities of past activity with current practice. What are perceived as new problems and opportunities can be traced to antiquity.

The development of the modern laboratory required several conditions to be met at appropriate times in history. Obviously, technology was and is the primary force behind advances in medicine. This has been both a blessing and a curse. It is a blessing because the understanding and treatment of disease requires sophisticated tools that only technological advances can produce. It can be a curse because there is a direct relationship between sophistication and health care cost. Other social issues dealing with availability and ethics assume a much greater importance than in the past. Angiography, computer-aided tomography (CAT) scans, organ transplantation, and DNA analysis are just a few of the expensive but valuable technologies available to the modern physician. Such questions as when are they used, to whom are they available, and what is done with the result are dilemmas of the 21st-century laboratory.

Another result of current technology is that it removes a large number of tests and procedures from the primary physician. The expertise required to perform these and other

From: Molecular Diagnostics: For the Clinical Laboratorian, Second Edition Edited by: W. B. Coleman and G. J. Tsongalis © Humana Press Inc., Totowa, NJ

procedures combined with the significant cost of the equipment precludes the primary physician from being the laboratorian.

A second condition that had to be met was logistics. Laboratory testing had to be convenient. All the concerns of collection, preservation, testing, and reporting had to be easy and fast for both patient and physician. A practical consequence of this was the proliferation of laboratories with increased resources to deliver the service. In the beginning, these resources were human and consisted of having specimens transported to the primary laboratory site. This later became multiple collection sites, courier services, mechanical processing, and electronic reporting.

These logistical issues led directly to a third condition for laboratory development: economics. There are two components to economic considerations. First, the laboratory service has to be an economically viable option for the ordering physician. The service must be delivered in a way so the physician does not experience any cost or significant loss of income from referring tests to a diagnostic laboratory. Second, there must be a mechanism to support the cost of laboratory testing. The latter problem was solved, for a short time, by the third-party reimbursement system. As one of the social reform programs of the 20th century, the widespread availability of insurance made the cost of health services invisible to the patient. Without proper controls, the effect of this reimbursement system was to encourage the proliferation of technology and make services accessible to large segments of the population. The incentive was for every testing center to have all the best technology and make it available to everyone.

This chapter will highlight some historical events and practices that demonstrate how this evolution took place. The events outlined here are not absolute in defining the practice of laboratory medicine, but they suggest how concepts could evolve and develop into the practice of diagnostic laboratory testing as it is today, including some events that could be precursors of molecular diagnostics.

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