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Selecting laboratory instrumentation.

Analyses of technology and workflow can help a lab determine whether it needs a new instrument or other changes to improve operations.

Dr. De Cresce is a pathologist at Michael Reese Hospital, Chicago, and ecturer at the University of Chicago School of Medicine Dr. Lifshtz is director of outpatient laboratories, New York University Medical Center, and clinical assistant professor of pathology, NYU School of Medicine They are coeditors of The Instrument Report, a monthly newsletter.

Selection of laboratory analyzers is very difficult in today's cost-conscious environment. Prices have grown rapidly to the point where most instruments cost more than $100,000 and many hit the $200,000 mark. Concurrently, hospitals have become much more demanding in the justification of instruments because capital funds are limited and subject to continued downward pressure.

The purchasing decision has a financial impact beyond capital spending. Reagents are the major source of revenue for manufacturers, and instrument ownership often creates a long-term commitment to a single vendor who may be able to charge monopolistic prices if proprietary reagents are used. Similarly, service agreements and consumables often cost more over the lifetime of an instrument than the instrument itself. All of these items must be put together to define the product's full -life-cycle cost.

Instruments are ultimately run by people, who represent the largest cost in most operations. Since a new analyzer can radically alter workflow and laboratory efficiency, its effect on how work is performed must be considered before it is purchased.

Instrument selection requires a detailed understanding of your own laboratory's operation and a vision of where technology is headed. Decisions made today will be with you till the mid1990s, so tunnel vision can be costly. On the other hand, dramatic new technologies do not necessarily change laboratories overnight. Understanding what technology can and cannot do for you is a crucial first step in evaluating analyzers.

This article will focus on understanding technology, assessing the lab's need for a new instrument, and workflow analysis. Part II, which will appear in next month's issue, will deal with instrument selection caveats and successful implementation of new instruments.

*Understanding technology. New technology is defined by what is currently available to do a given task. A major breakthrough 10 years ago may now be an instrument or concept to be avoided for the future. The reason is that instruments do not operate in a vacuum but, rather, are part of an ever-changing system of providing service in the laboratory.

Service, not technology, is the key here. Successful low-technology solutions to a problem are frequently far better than contrived high-tech processes that only add to cost. A few points should be obvious:

The 1989 crop of laboratory instruments is based on 1984 technology at best. This is because a very long lead time is required to bring an instrument to market. For example, many state-of-the-art devices available today use Intel 8088 or 8086 microprocessor chips as central processing units even though these units powered the first IBM personal computers and have been supplanted numerous times. In fact, many new lab instruments-designed before or at the time of the PC revolution-do not even incorporate 8088 chips but instead use older 8-bit processors.

The useful lifetime of an instrument rarely exceeds five years. By that time, technology makes better choices available, and many of the instrument's advantages are eliminated. One exception overriding this cycle is the 20-year-old Du Pont ACA, still a state-of-the art analyzer.

Most instruments can actually run 10 years or more, though sometime sooner their capabilities may no longer meet the demands of the laboratory. A Technicon SMA 12/60 that is nearly 20 years old will work splendidly in certain environments. Most labs, however, have changed how they operate in response to client needs and can no longer use this technology. That is why an ACA may still be considered modern while a 12/60 is called old-fashioned.

As the supply of medical technologists falls, instruments that are easier to use and more reliable will be at a premium. This will gain importance with the increasing technological complexity of instruments.

Changing laboratory boundaries are a fact of life. The traditional differentiations between sections have become mere paper walls established by lab management rather than barriers imposed by technology. As more and more tests become technology-based, the need for separate laboratories disappears and opportunities for savings appear.

Breakthrough technology. Everyone hopes to purchase an instrument based upon breakthrough technology. Such an analyzer is rare but has enormous impact on the average laboratory. It is quickly recognized by most laboratorians because it is a concept that has been lacking or one that solves a vexing problem.

Rapid acceptance in the marketplace is another hallmark of the breakthrough instrument. Devices such as the Beckman Astra or the Abbott TDx were sold as fast as they could be produced. The reasons were quite simple. They revolutionized the way a segment of the market performed its testing and replaced a group of inefficient analyzers.

Few immediate competitors will appear after the breakthrough analyzer comes out on the market, either because the analyzer has patent protection or because the concept is truly revolutionary and has not been thought of before.

Premium pricing usually accompanies the breakthrough analyzer. Potential purchasers must decide if the benefits are worth the extra cost of operation and amortization.

Here are the principal effects of the breakthrough analyzer:

1. Changes in the basic workflow of the laboratory.

2. Workstation consolidation, which leads to the elimination of extra instruments. With elimination of instruments, service costs are lowered, reagent purchasing is simplified or eliminated, quality control costs are often decreased, and additional lab space is created at no cost.

3. Labor savings. These usually result, especially if workstations are eliminated. Replacement of batch or dedicated analyzers also saves labor by smoothing the processing of specimens.

4. Improved service levels. These often follow from new technology since work can be turned around in a more expeditious manner.

5. New standards of performance. When the breakthrough analyzer sets higher performance standards, older technology starts selling at a discount. Whether the discount compensates for what the new technology offers must be evaluated.

Current technology. Here we are talking about instruments that operate on technology readily available in the marketplace. Laboratory management can easily identify these instruments. Similar concepts abound. Many analyzers incorporate identical principles and operate the same way.

Key features differentiate "me too" players. Although instruments may appear similar, differences can make one more valuable than another.

The best price deals are found in current technology. Competition is stiff, and prices fall when a number of analyzers are available for purchase in one segment of the market.

At the same time, smart implementation of current technology can yield many of the breakthrough instrument's advantages: One obtains an instrument at lower cost and achieves premium results.

Recognizing the breakthrough potential of current technology requires that you understand your current workflow and know what changes are necessary and which will yield the greatest improvement in your laboratory; clearly define your objectives so you know what has to be improved and how you want to do it; design new systems to improve workflow with a new instrument; and know the instrument features that yield the greatest benefits.

Future directions. Traditional boundaries within laboratories are rapidly disappearing as lab sections gain the ability to process tests in a common manner. Immunoassay is an excellent example. Radiologists or endocrinologists often performed thyroid testing, while gynecologists may have performed certain androgen and estrogen procedures, and microbiologists performed certain serologic tests. New technology makes these testing differentiations among lab sections foolish.

For example, enzyme immunoassay methods can perform a wide range of procedures, such as hepatitis assays, rubella serology, pregnancy tests, ferritin tests, and drug assays. One instrument such as the Hitachi 717 may be capable of performing many of the assays.

Tests should be consolidated whenever possible. The choice of instrument, however, must follow the decision to bring tests together. Otherwise, the choice may never be fully utilized.

Clinical chemistry will expand into other areas as automation grows. This is bound to create frictions, which are best handled from a technical rather than political standpoint.

The optimum approach is to do away with artificial, historical limits that have been established for reasons not germane to the present situation. Test locations should be chosen according to such factors as technology, ideal workflow demands, and patient care needs.

* Do I need a new instrument?

A positive answer to this question seems so obvious to potential buyers of new technology that they often don't feel the need to investigate the matter. However, new instruments are not always the optimal solution to a lab problem.

Many laboratories purchase new instruments on the basis of old specifications. These specifications, which may be related to workflow or how the previous analyzer operated, are often not designed to achieve optimal productivity but rather to recreate the status quo. In such situations, the laboratory may not even require a new instrument, but if it does, chances are the wrong instrument will be purchased.

Therefore the reasons for purchasing the new instrument, and the changes that are to be implemented with its arrival, must be clearly outlined. "My analyzer is too old" is rarely a good reason by itself.

A new analyzer should change the way the lab operates. It should improve workflow, for one thing. Workflow is frequently ignored because it is not glamorous to investigate. Many laboratory directors and supervisors have no clear idea how specimens are processed from start to finish. An entire lab operating system may have to be redesigned to accommodate a new instrument in the most optimal way. Changes should aim at:

1. Eliminating batch testing as much as possible. A slower analyzer operating continuously may be better than a rapid analyzer that operates only twice a day in huge runs. Obviously, certain types of tests lend themselves to batching, but most physicians want their results now, not when the instrument is ready to perform.

2. Avoiding queuing where possible. This can be a contradiction since queuing becomes a fact of life if continuous workflow is desired. A reasonable maximum queue time should be determined, however, in an effort to avoid buying an instrument that provides much more or much less throughput than the laboratory needs.

3. Permitting random processing. This lets the lab operate the way the specimens arrive-in no particular preordained order. Instruments that require order should be carefully evaluated to see what redeeming features they have. In general, random processing is preferable to ordered worklisting.

Increased throughput should be sought on new analyzers if the additional capability can be used. Outpatient testing, lab consolidations, and new ventures all require increased throughput.

Stat as well as routine testing capability is frequently required on new analyzers because the alternative, separate workstations, adds costs to a laboratory's operations . On the other hand, combined functions may well interfere with each other and consequently prevent smooth operation of the laboratory.

A desire to decrease costs is often cited as the reason for purchasing an analyzer. Although a new instrument frequently increases direct costs because of depreciation and reagent expense, overall costs should be cut by any analyzer if its acquisition is to make sense. Reagent type, consumables, labor, and service costs must be carefully analyzed before purchase.

Improved methods are an advantage in some cases, especially if quality control and calibration costs can be decreased. Methods themselves, however, do not *Improve the operation of the laboratory and should not be the deciding factor in the purchase of an analyzer.

Finally, among reasons for buying an analyzer, broader test menus are important because they can help consolidate instrumentation. For example, many of the new analyzers perform immunoassays in addition to routine chemistries. Hematology instruments can now do five-part differentials combining the manual differential workstation with the traditional automated eight-part hemogram.

Many of the benefits cited above can be attained without a new instrument. For example, workflow improvements can optimize specimen processing and raise the throughput of a current analyzer. In a similar manner, careful investigation may yield ways to add methods to existing instruments that were not originally designed with such applications in mind.

Used instruments are often an overlooked possibility. Many independent laboratories purchase aging analyzers from hospitals and put them to work for specific applications. This saves on, depreciation costs and may allow a lab to defer a major purchase until the optimal instrument is available.

A new instrument is like a new car: It has many new bells and whistles, it is a status symbol, and it costs a lot more than what it replaces. Increased miles per gallon rarely recover the capital cost of a new car. In the same way, a new instrument rarely pays for itself through reagent savings. The savings must come from another source, and that source in most cases is improved workflow.

*Workflow analysis. The first step in determining whether a new analyzer is necessary is to plot actual workflow in the laboratory. This is a time-consuming but invaluable process. It provides a snapshot of how testing is performed and helps laboratory management find opportunities for improvement.

Workflow analysis can reveal if a new instrument will help. Once the analysis is done, workflow can be redesigned to best take advantage of a new instrument's features. The analysis begins with detailed specimen mapping of the laboratory.

Specimen mapping. Specimen mapping requires a careful analysis of how specimens arrive in the laboratory and how they flow through the system, with an eye to pinpointing bottlenecks.

Orders should be plotted on a chart by time of their arrival in the lab at half-hour increments. Detailed counts of specimens and tests per specimen should be made. In general, this should be done for a representative week.

Once mapping is performed, trends based on the data can be plotted. Since the average laboratory has hundreds of specimens arriving each day, the laws of statistics are on your side: Small variations will certainly occur from day to day, but there will not be any gross deviation from average figures. Figure I shows data extracted from specimen mapping on the primary chemistry analyzer used at a 700-bed hospital.

Inpatient and outpatient orders should be segregated because the two markets behave quite differently. Specific nursing stations should be analyzed if possible since the rhythm of the hospital or laboratory must be carefully charted.

Stat versus routine specimens should be studied. Often an inordinate number of Stats may come from a single site. Improvement may be possible if those responsible for excess Stats are persuaded that decreases in total Stat load will result in better service for all customers. This is difficult, but often the facts can be convincing.

Tests per specimen density will enable the laboratory to understand specimen splitting requirements. Although it is frequently desirable to draw as little blood as possible, in many cases an extra tube of blood can lead to considerable labor savings in the specimen handling areas of the laboratory.

Turnaround time variations should be observed. Periods of peak demand may require temporary use of an additional analyzer. It is pointless, however, to staff extra instruments when their throughput is not required.

Identify actual laboratory capacity needs during the study. In most cases the required capacity is far lower than imagined by all parties. The simple solution is always to buy more instruments than the lab needs. This may be too simple-the cost often far exceeds the benefits that extra throughput promises the user.

Look for nontechnology solutions in the lab. Improving workflow can produce much greater return per dollar expended than technology-dependent solutions.

Formulate ideal workflow patterns for your laboratory based on the specimen mapping study results; this should be done before the purchase, not as an afterthought, Any new instrument should complement the ideal workflow rather than complicate it. Poor planning results in poor decisions!

Workstation analysis. The next step is to look where the work is performed in the laboratory. If individual tests have multiple workstations, it should be for sound reasons, not because of a manager's preference or historical usage. Following are the elements of workstation analysis:

1. The tests that each location performs should be determined. The amount of redundant testing may well be startling, the reasons hard to understand. A new instrument would have to rationalize testing at different locations.

2. Volume by time of day for each workstation should then be determined. The use of a workstation should match the results of the previously performed specimen mapping. If it does not, something is wrong.

3. Productivity (specimenbased) of each workstation should be analyzed. Although this may seem simplistic, many times there are very wide variations. Technologists will rarely volunteer that they are underworked; it is the manager's responsibility to properly allocate time and effort.

4. Test scheduling should make sense compared to the clinical needs of the hospital. Isoenzyme testing twice a day, for example, may be difficult to furnish but necessary. Different methods may make it more feasible. Batching makes sense if clinical decision making and length of stay are not thereby prolonged.

5. Identify opportunities for improvement. All alternatives should be identified before considering a new instrument. The savings may be just as large as those obtained with a new instrument at only a fraction of the instrument cost.

6. Consolidate, consolidate, consolidate. This should be the number one priority of any laboratory management interested in increasing the productivity of its operation.

Specimen workflow. Specimen workflow is the next logical step in achieving maximum productivity. Each time a specimen is split, a transaction cost is incurred. College of American Pathologists workload values recognize that work on a specimen encompasses much more than the test effort.

For example, if a specimen requires two therapeutic drug assays and they are performed on different analyzers, the work is nearly doubled as compared with performing both tests on the same instrument. Even if there are reagent savings in using separate instruments (because the analyzer that can process both assays has higher reagent costs), the handling costs are apt to be greater. Handling means Labor and the possibility of error.

Thus consolidation is more important than the technology employed to perform individual tests. It yields much greater savings than first apparent.

Specimen workflow is usually completely ignored since the analysis is not glamorous and may point out that a new instrument is not required at all. The workflow must be tailored to any new technology planned for the laboratory. Specimen handling should be simplified rather than complicated or kept the same.

Split specimens prior to entry to the lab if at all possible. This eliminates needless walking around by technologists making upward of $10 per hour. Once split, specimens can be delivered to the appropriate lab areas for immediate processing. Computergenerated aliquot labels are an excellent idea that can usually be done by any capable lab system.

Splitting specimens organizes the work for the lab in a rational manner. It also has the effect of eliminating worklists for many workstations. Worklists are often a carryover from previous manual procedures and a means of double-checking made necessary by inadequacies in the specimen processing area. The inadequacies should be corrected and the lists dropped.

Maintaining the randomness of specimens is vital to an efficient operation. Random arrival permits near-continuous processing where applicable. It is the laboratory equivalent of "just in time" inventory systems.

Japanese auto plants in the U.S. far outshine American-run plants with the same workers. Why'? They use better workflow, not more expensive technological solutions such as robots. Again, a good low-tech solution can make all the difference.

In our concluding article next month, we will discuss the specifics of instrument shopping and placement in the lab.
COPYRIGHT 1989 Nelson Publishing
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 1989 Gale, Cengage Learning. All rights reserved.

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Title Annotation:part 1
Author:De Cresce, Robert P.; Lifshitz, Mark S.
Publication:Medical Laboratory Observer
Date:Feb 1, 1989
Previous Article:How we marketed drug abuse testing.
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