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The fundamentals of a sound maintenance program.

Laboratory maintenance is a two-edged sword. Its first purpose is to insure that instruments function at a specified level of performance; its second is to minimize downtime. The two aspects can be characterized as instrument quality assurance and preventive maintenance. Together they are the foundation for a comprehensive program to evaluate, monitor, and troubleshoot instruments.

The difference between maintenance and quality control is commonly misunderstood. Essentially, maintenance is concerned with the adequacy of instrument performance, whereas quality control confirms the validity of test results. In general, laboratory maintenance is prospective in nature and quality control is retrospective. We perform maintenance in preparation for testing and examine QC results after testing is completed.

Maintenance and QC sometimes overlap. For instance, quality control monitoring might detect an instrument dysfunction and prompt a visit by the repair person. On the other hand, if QC measures uncover aberrant patient values resulting from faulty reagents--and unrelated to instrument dysfunction--the situation would fall outside the realm of maintenance.

Maintenance is an ethical imperative as well as an economic necessity. From a medical standpoint, reliable instrumentation is a prerequisite for providing the physician with valid, highly reproducible test results on which to base sound clinical decisions. Financially, a reduction in downtime increases technologists' efficiency and ultimately shortens patient stay.

To design a maintenance program, one must know the level of performance expected from each instrument. The laboratorian, not the manufacturer, should specify this acceptable level. We cannot safely assume that all the manufacturer's specifications are suitable or even correct. Some factory specifications can be consistently exceeded in the lab, while others cannot be reproduced routinely.

Thorough evaluation is the best way to define an instrument's performance limits. Ideally, an instrument should be evaluated before purchase to find out whether it meets all the laboratory's needs. If the lab receives a different instrument of the same make and model, the substitute should also undergo at least an abbreviated evaluation.

After setting performance standards, the laboratory must map out two schedules: one for measuring various performance parameters and another for cleaning, repairs, and parts replacement. Design these schedules carefully and use input from a variety of sources, including hands-on experience, suggestions from the manufacturer and technical representative, evaluations, tips from other users, and common sense.

Begin the actual evaluation with a review of the literature to see whether the instrument can do the tasks you want it to perform. If so, determine the instrument's essential components--spectrophotometer, temperature regulation, and so forth--and test the performance range of each. Laboratory journals abound with such component performance tests as spectrophotometric linearity, temperature regulation, and pipettor accuracy.

Some components cannot be tested directly, but you can measure the instrument's overall performance by use of primary standards--in which the analyte is weighed out into solution--or, less preferably, by secondary standards in which the level of analyte to be measured is determined by another instrument. If components are in unreachable compartments or perform hard-to-measure functions, you may have to seek confirmation by the manufacturer's maintenance experts. In this case, have a laboratory representative present to make sure that verification is completed, documented, and signed. Once you find an acceptable, reproducible level of functioning, it can be specified as the instrument's standard of performance.

Often, the same evaluative tests can be used to monitor an instrument or its components. How often should performance standards be monitored? That depends on the instrument's or component's liability to change, the practicality of verification, and its relative importance to accurate patient data.

All the monitoring and evaluation in the world doesn't count for much unless it is on the record in a clear, consistent, and usable form. Prepare a maintenance chart for each instrument, showing its schedule for performance monitoring and routine cleaning and repair. Post it near the instrument or keep it in a nearby manual.

The chart should be designed with room to keep track of daily, weekly, and monthly maintenance chores, and space for the signatures of all who carry them out. The examples in Figures I and II have worked well in the laboratory of our 675-bed hospital.

Review all maintenance charts periodically, consider improving them at least annually, and keep the charts for at least one year. Chart review is best carried out by one person, usually the chief technologist or quality control supervisor. File all records of repairs, additions, and manufacturer verification in the maintenance book.

The technologist running tests on an instrument is the most likely candidate to carry out daily and perhaps weekly maintenance. More complicated or unusual tasks may be best assigned to the section supervisor, laboratory biomedical engineer, or to a particular technologist in charge of the instrument.

The person most familiar with an instrument should troubleshoot all but its most superficial problems. You might assign certain technologists to the care and feeding of each instrument and send them all to appropriate manufacturers' workshops. Some laboratories employ biomedical engineers. This arrangement allows the lab to solve many problems quickly on its own and to call promptly for outside help when needed.

Try to perform as many repairs as possible in-house. Encourage technologists to attempt repairs. As they become more familiar with their assigned instruments, you will grow more independent of the manufacturer and eventually shave the length of downtime periods. When you must call on the manufacturer for repairs, have technologists observe the process.

Modular instruments and do-it-yourself repair packages can help increase self-reliance. If your institution has a biomedical engineer, he or she may benefit from special repair courses beyond those normally offered to technologists. Finally, make contingency plans to have back-up instrumentation or alternate laboratory service ready in case of instrument failure.

For most complex analyzers, a maintenance contract is a necessity. The average yearly outlay for such a contract is some 10 per cent of the instrument's cost. When making instrument purchases, give prime consideration to whether the manufacturer can provide quick repairs, especially if the instrument will be used for Stat testing and daily or round-the-clock use.

How well will your prospective instrument be serviced? For clues, observe how promptly the company has attended to any other instruments it has sold your laboratory, and find out how other users have fared. Every manufacturer should be willing to provide a nonscreened users' list to help you contact others who can answer your questions.

Determine where repair help will come from. The farther away a service person is stationed, the longer you must wait for assistance. Also check on the background and experience of service personnel. Should the primary service person be unavailable when needed, know whom to contact in your area as a stand-in.

To cover many of these points, demand the following stipulations in the maintenance contract: For essential instruments, a repair specialist will be in your laboratory within 24 hours, and telephone hot-line assistance will be available at any hour, day or night.

Laboratories have lost countless hours waiting for one tiny part to arrive. Cut downtime and jangled nerves through judicious preordering of component parts. Don't be afraid to order a large excess inventory of parts that are rapidly consumed or frequently replaced. These parts are usually cheap, unlikely to be wasted, and tragic to run out of. Consider the sturdiness, durability, and cost of parts when determining how many to stock. It's a good rule to keep on hand at least one of any part that can be replaced by in-house staff.

To sum up: Your lab's maintenance program should consist of instrument performance monitoring coupled with routine repair and upkeep. Good maintenance starts before purchase, through evaluation of an instrument's capabilities and establishment of expected performance limits. It is enhanced by making a specific technologist responsible for an instrument. For long-term benefits, closely scrutinize maintenance contracts and ordering practices.

This is just the general outline for a maintenance program, of course. Once it is adapted to your specific needs, it should enable the lab to achieve more efficient testing with more valid results.
COPYRIGHT 1985 Nelson Publishing
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Copyright 1985 Gale, Cengage Learning. All rights reserved.

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Title Annotation:maintenance and repair of laboratory instruments
Author:Smith, Darryl R.
Publication:Medical Laboratory Observer
Date:Jul 1, 1985
Previous Article:Effective management training for supervisors.
Next Article:Are we outdating reagents too soon? Here are ways to extend the shelf life of many lab products without jeopardizing test results.

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