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The clinical lab of the future.

The clinical lab of the future

Here is how the clinical lab of the 1990s may operate:

Computer entry of a DRG code will generate a number of test orders.

Specimens will be positively identified and labeled by bar code at the bedside.

An electronic bar-code reader in the laboratory will sort arriving test tubes according to workstation and send them on their way by robot.

Hurry-up computer messages will go from a workstation to the specimen receipt area when testing is about to begin.

Single instruments will offer wide test menus for multiple lab disciplines.

Electronic reports will travel to a central database where sophisticated computers will analyze the information.

Laboratorians will have a new role monitoring this highly automated process.

What forces will drive today's laboratory into such a future? Much of the impetus will come from limitations on reimbursement, which will continue to compel labs to cut costs, shorten turnaround, and maximize efficiency. Major advances in technology and instrumentation will provide the tools needed to make these improvements.

For example, molecular biology will usher in an entirely new approach to identifying disease; through the use of DNA probes, infectious organisms will be identified in minutes instead of days or weeks. Sophisticated computers will coordinate data handling and interpretation through artificial intelligence. Instruments will be able to perform a wide range of tests crossing many disciplines.

These developments will ultimately reshape the laboratory field. The traditional hospital laboratory will take on a new role as a central database, coordinating the testing done at satellite locations and at specialty reference facilities. In fact, this "central coordinating facility' may not even be located on the premises of the hospital.

Reference laboratories will move away from their traditional role of providing an abundance of data at a lower cost and concentrate more on unique services, such as esoteric testing. These tests will be developed in close collaboration with academic institutions.

Further development of compact, easy-to-use instrumentation will shift more routine tests to the patient's bedside, the operating room, the emergency room, and other decentralized sites. Sophisticated computers will develop diagnostic algorithms for physicians. Both economic and regulatory forces will lead to a de-emphasis of routine profiles in an effort to contain costs.

New technologies, such as recombinant DNA methods, will have a major impact on laboratory medicine. Diseases will be reclassified on the basis of abnormalities at the level of the gene rather than just through abnormal traits or biochemical data. For instance, sickle cell disease would be identified by its abnormal molecular structure, not by the abnormal hemoglobin that is formed.

Lastly, reimbursement limitations may slow the introduction of other, expensive new technologies in all but a few major medical centers.

Let's take a closer look at key aspects of the future:

Testing strategies. Clinical laboratories can expect to see physicians employ different testing strategies in the 1990s. There will be more emphasis on real-time testing or on-line monitoring of various chemicals. This may take the form of intravenous biosensors, implanted in certain critically ill patients.

The advantage of this testing mode would be that it provides continuous rather than discrete data about an analyte. It might also yield useful information about the fluctuations of various analytes during an illness--data that might otherwise be missed with only periodic testing.

Testing will be more selective, with fewer full profiles ordered: Only those tests specific to a patient's illness will be requested. Thus physicians will order more specialized profiles. Some of these--cardiac, kidney, and liver profiles, for example--are already widely used. The future will probably bring new test groups, for cancer, opportunistic infections, and genetic abnormalities.

Though some of these profiles might be ordered to screen individuals at high risk for an illness, it is likely that much of the test ordering for inpatients and outpatients alike will be determined by computer-generated diagnostic algorithms based on patients' Diagnosis Related Groups.

Tomorrow's clinical laboratory will play a vital role in an increasingly complex health care system. No longer functioning as a stand-alone testing facility, the laboratory will be linked to other medical databases, such as a hospital information system, physician office system, or another reference lab. This will facilitate test ordering, interpretation, and reporting.

Doctors in many hospitals can now order tests from computer terminals on the floors; in the future, they should also be able to order from their office or home. The request would be transmitted via modem to the testing facility, where if need be the patient could have a specimen collected.

Remote entry of this kind avoids laboratory request forms and the clerical transcription errors associated with them. It also provides a way for the physician to enter clinical information that could then be used to interpret test results, trigger additional testing, or satisfy third-party reimbursement requirements. Alternatively, one might automatically order a specific test battery by merely entering a DRG code.

Clinical laboratories will also alter their test ordering practices for reference work. They will have communication links to reference labs and automatically transmit test requests and specimen identification. In the other direction, test reports will automatically be sent to the requesting lab's computer system. This will save countless hours of relabeling and ordering reference work.

Specimen collection. In some instances, such as testing prior to transfusion, improper specimen identification can pose a threat to the patient's life. Bar-code systems can help insure positive patient identification and also assist in tracking the whereabouts of a specimen at any given time.

In a hospital, a phlebotomist collecting blood would verify a patient's identity by running an optical reader over the patient's unique bar-coded wristband. The phlebotomist would also use a portable bar-code printer to print labels containing the patient ID and a record of tests ordered. These orders would be downloaded to the protable printer by a real-time infrared communication link to a laboratory or hospital computer system.

Bar codes could also be used to identify outpatients. Each patient would be given a unique bar-coded card containing demographic data and billing information.

Work flow. Perhaps the most significant and noticeable change will occur in the heart of the laboratory, where specimens are processed. The concept of autoflow --our abbreviated term for automated work flow--is central to this change. Upon entering the lab, the bar-coded specimens will be fed into a reader that will automatically verify their receipt, sort tubes according to workstation, and route them to the appropriate location. Robots or conveyors may handle the transportation.

The laboratory computer will help technologists by providing real-time work flow analysis. For instance, it might tell the specimen receipt area to deliver a specimen quickly to a workstation that is about to begin batch testing for a particular analyte. Computerized work flow analysis can also be used to modify staff schedules in line with unexpected workload fluctuations.

Workstations will be consolidated, since a single instrument will be able to perform a wide range of tests that previously required several devices and operators. Tests will be performed on a routine or Stat basis, and in a random access mode.

For instance, a single analyzer might run assays for hormones, drugs, specialized proteins, coagulation factors, serologies, and, of course, routine chemistries. The analyzer would also sample directly from the closed collection tube, automatically rerun specimens with abnormal results, and reflexively order further testing based on initial results.

It is likely that instruments will perform tests according to technology, not specialty. A biochemical analyzer would thus perform tests for drugs, hormones, infectious disease serologies, and immunoassays, while an image analyzer would examine the cellular constituents of semen, cerebrospinal fluid, and urine.

This integration of tests across traditional laboratory disciplines will ultimately eliminate the various lab sections as we know them. It will give rise to an "open' lab with fewer physically and operationally distinct areas. Instead of such sections as special chemistry, routine chemistry, and serology, we might find a single workstation for routine testing.

Reporting. Traditionally, the laboratory's end product has consisted of a paper report. Test data are printed either in the lab or at distant sites, such as a patient floor or a physician's office, via a telecommunication link.

The entire process will change dramatically in the future. Laboratory computers will transmit data to the terminals or computers of end-users, and electronic reports will replace hard-copy reports. The information will automatically merge into the patient's computerized health record. This will eliminate the tedious task of filing reports with patient charts and also give physicians immediate access to lab data.

By integrating lab data with a patient's other medical findings, computers can aid in diagnosis and treatment. Furthermore, physicians will be able to manipulate the computer-stored data and spot trends. There are other advantages to electronic reports. They can incorporate images (e.g., electrophoresis tracings or cell morphology) and voice data such as a personalized message or interpretation from the pathologist.

When reporting results, laboratories will probably include statistical data relating to a test's diagnostic utility, such as sensitivity, specificity, and predictive value. And besides going to the requesting physician, results may also be transmitted to a private patient database center that consolidates all health records for a given patient. The center would provide instant access to a patient's entire medical record.

New instruments. Biosensors, nuclear magnetic resonance analyzers, and robots, to name a few types of new instruments, will have an impact on laboratory medicine. A biosensor is a microelectronic device that uses a biological molecule, such as an antibody or enzyme, as a sensing element. A reagent-free method of analysis, it will be particularly suited to emergency rooms, patient floors, physician offices, and other decentralized testing sites.

A biosensor implanted in a patient could provide real-time continuous biochemical monitoring; as a portable hand-held device, it could produce simultaneous measurements of several analytes, all from a single whole blood microspecimen.

Nuclear magnetic resonance, which measures the spin of protons in a magnetic field after a radiofrequency current has been applied, has become an increasingly popular method of diagnostic imaging. Since it can rapidly identify a multitude of compounds, it will find a niche in reference laboratories.

Robots will play an increasingly important role in carrying out such mundane tasks as specimen sorting, receipt verification, and centrifugation. They also will be ideal for handling biohazardous materials. Sophisticated robots might even be able to operate instruments in satellite labs, with the central laboratory's computer system monitoring their activities.

With this metamorphosis of the clinical lab, the laboratorian's role is likely to change from actually performing the lab work to monitoring the tests performed, perhaps in a robotically controlled satellite facility. Though this degree of automation will require fewer workers, it will also create more interesting tasks and enhance each laboratorian's productivity.

In summary, we are heading toward a greater dependence on computers and advanced technology. They will reshape duties, instruments, and work flow in the laboratory of tomorrow.
COPYRIGHT 1988 Nelson Publishing
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 1988 Gale, Cengage Learning. All rights reserved.

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Author:Lifshitz, Mark S.; De Cresce, Robert P.
Publication:Medical Laboratory Observer
Date:Jan 1, 1988
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