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A quality assurance manual for the office laboratory.

The quality of testing is important regardless of a laboratory's size. Congress recognized that principle when it passed legislation last November requiring physicians' office laboratories to comply with the same regulations other labs are subject to.

As a client services technologist for several satellite clinic laboratories, I similarly sought to insure that they produced work as good as that of our main clinic laboratory, which serves 250 physicians. One of my job responsibilities was to create and monitor the progress of a quality assurance program for these labs.

Located throughout the greater Seattle metropolitan area, seven of the satellite clinics are primary care facilities, performing Stat and other limited laboratory testing on-site, while three others are clinics run for companies, performing only urine dipsticks. The medical staffs range from two to 25 physicians plus a few specialty physicians who rotate periodically from the main clinic. At the largest satellite clinic, laboratory work is ordered for 120 to 130 patients per day.

A satellite lab typically has one or more certified medical laboratory technicians or technologists as well as medical assistants to do the blood drawing, but in the smallest lab, a part-time technologist and nurses share testing duties. Laboratory technicians, depending on the size of their clinic, may also handle x-rays, ECGs, and pulmonary function tests. Specialization increases with clinic size. The larger satellite clinics maintain separately staffed radiology departments.

The manager of the main clinic laboratory and I agreed that we must create a quality assurrance manual for the satellite labs. Their busy staffs wanted to provide accurate test results but were not always sure where to start. Although all of the labs performed some degree of quality control, results were sometimes recorded haphazardly, and instrument maintenance tended to be lax. Even under the best of circumstances, they had a difficult time keeping pace with paperwork and maintenance duties.

At some sites, nurses were doing much of the laboratory work and, unfortunately, did not always see the necessity for quality control.

In response to the special needs of the various satellite labs, I developed a quality assurance manual that specifies minimum standards of performance for all aspects of laboratory testing. The biggest question I had to answer was "How often do I have to do quality control on any given instrument?"

To supplement information gathered from seminars, I spent a lot of time in our medical library reading journals and collecting ideas on QC for off-site labs. I also consulted the supervisors of the main clinic's hematology, urinalysis, and chemistry sections for advice.

Most literature recommended controls with each run. In a small office laboratory, however, tests are usually performed individualIy, and running a control every time would increase costs dramatically.

I compromised after considering the goals of quasity controlassurance that the reagents, system, and operator are all capable of producing an accurate result. Those goals could clearly be met by requiring that a control be tested at least once each day that a patient result was reported.

It took a couple of months to gather information and create appropriate quality control and maintenance forms for the various instruments in our satellite labs. The resulting manual, made up of 30 pages of procedure lists, quality control logs, and maintenance forms, was reviewed and approved by the manager of the main laboratory. Our hematology cell counters are covered by a manufacturer's QC program with specific forms, so they were excluded from the manual.

I made a three-hour presentation to the satellite laboratory staffs, stressing quality and patient care as the two most important aspects of their jobs. The presentation explained what a quality assurance program is and how to fill out forms for all daily, weekly, and monthly QA procedures. I also summarized the main clinic's laboratory policies.

Using an outline overview of the manual as a checklist (see Figure 1) , I monitored progress as the satellite staff members developed an understanding of the importance of laboratory quality assurance. The outline's headingsclerical activities, internal quality control, preventive maintenance, external quality control or proficiency testing, and personnel requirements-corresponded to a separate section of the manual with appropriate charts for documentation.

Among other things, the manual's clerical section tells how to complete the central laboratory and blood bank requisition forms. It also contains a copy of the laboratory's specimen labeling policy.

The internal quality control section of the manual provides information on the frequency of quality control testing (see Figure 11) and includes documentation charts for results on all instruments.

Technicians may perform control tests more frequently than the minimums listed in the manual. For high-volume tests, they usually run control specimens each morning as part of their dally start-up routine. Controls on infrequent tests, such as heterophile and pregnancy tests, are done with the first patient specimen of that day.

All control results are recorded on the specific charts in the quality assurance manual; including the forms in the manual encouraged documentation. Other entries include reagent and control lot numbers, expected values, and corrective actions taken. There 'is a step-by-step procedure detailing the actions to be taken when a control is out of the expected range.

Due to the satellite labs' low volume of testing and control values , I chose not to use the Westgard rules for quality control, which help climinate random error in large-volume test runs. Instead, I required control values to be within two standard deviations of the mean value for controls, even though this may lead to occasional retesting because of random error in a test run.

The maintenance section of the manual details frequency of cleaning and other steps (Figure III). It contains forms to document refrigerator and incubator temperatures, and centrifuge, microscope, and dilutor maintenance. Reports of repairs performed by a manufacturer's technical representative or our own biomedical engineer are also kept in this section.

The external quality control program-proficiency testinghas been in place for several years. Once a month, patient specimens that have been tested in our central laboratory are sent to the satellite laboratories as unknowns. Specimens are chosen from hematology, urinalysis, microbiology, chemistry, and serology to coincide with the scope of testing in the satellite clinics.

Each satellite lab performs the tests requested and receives the central laboratory's results the next week for comparison. The satellite lab then sends back a form with its proficiency test results for review by the client services technologist.

The client services technologist compares all of the satellite labs with one another and with the central laboratory and takes corrective action if necessary. This aspect of the quality assurance program has been valuable because it provide the medical laboratory technicians with additional practice and interesting cases (not all unknowns are in the normal range), and it alerts the main lab to any technical problems. Of course, it is important for all of our laboratory results to correlate so our patients can move easily among the satellite clinics and into the hospital affiliated with our main clinic without repeat testing.

The final section of the manual is devoted to personnel record keeping. Here the satellites' laboratory staff lists information about their continuing education, training, and certification.

The client services technologist visits each of the satellite laboratories at least once a month to review and sign off on their quality assurance manuals. These visits are also documented on a form that notes the level of compliance and any problems associated with specific aspects of the quality assurance program.

During a monthly visit to a satellite lab, I might write, "Three times you had values on your urine control that were out of range, and there's no corrective action noted. What happened?" Or I might note, "You haven't completed an optimum packing time on the microhematocrit centrifuge . It's overdue."

On my next inspection, I would check to be sure the problems had been corrected.

I also tried to deliver positive comments along with criticism. I would write, for instance, "The unknowns checked very well with the main laboratory and other satellites."

One copy of the monthly visit form is left in the satellite laboratory, and one is left with the satellite clinic manager. The client services technologist keeps the original to follow up on problems and to monitor trends among the laboratories.

The quality assurance manual has improved the quality of results in our satellite clinic laboratories. At the same time, laboratory personnet-knowing they are following standards for quality control-have gained more confidence in their results. Work on unknown specimens sent from the main laboratory for external quality control has improved considerably; results from all the laboratories now fall in a much narrower range than before the manual was developed. Similarly, control data are no longer spread all over the chart.

When national regulation of physicians' office laboratories takes effect, our satellite clinics will be well on their way to meeting the requirements-thanks to their quality assurance manuals.
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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Author:Hallquist, Carol M.
Publication:Medical Laboratory Observer
Date:Aug 1, 1989
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