Instrument checklist for a group practice lab.
Our small laboratory, for example, had to reorganize itself around a discrete chemistry analyzer purchased in 1983. To aid other labs, we have condensed our experience into a 10-point checklist for setting up a new instrument. It can pinpoint many potential stumbling blocks.
The group practice we serve consists of 10 internists and a dialysis unit. The laboratory has four full-time technologists including the manager, one part-time technologist, and one part-time technician. They work in a number of areas--chemistry, hematology, serology, urinalysis, strep screens, and coagulation.
Our chemistry system used to consist of a colorimeter with kits for only four tests: glucose, BUN, cholesterol, and triglycerides. Introduction of the benchtop discrete analyzer enabled us to perform not only those tests but any of 16 other on patients prior to their doctor's appointment. Staff size was sufficient to handle this extra testing, thanks to the automation, but our duties changed somewhat.
Like many small labs, we do not have separate departments for chemistry and the other disciplines, or a quality control coordinator, or an instrumentation specialist. With our increased chemistry workload and responsibilities, we had to establish an extensive set of routines that may already be in place in larger organizations. We did this through research, trial and error, and discussion, often drawing upon our staff's varied lab backgrounds and the advice of the manufacturer's technical representative.
Here's a distillation of that effort--the checklist summary of what a small group practice laboratory should do when implementing a major new instrument:
1. Specimen collection and handling. Check the instrument manual for the requirements of individual tests. The laboratory may need to purchase a centrifuge and rearrange the benchtop area to handle increased volume. Additional supplies and reagents may be needed. We now use heparin whenever possible to speed processing time. Twenty-four hour urine chemistries may need special preservatives. Be sure to check this and have containers and preservatives on hand.
2. Calibration. Every insrument has its own requirements for calibration, which should be adhered to closely. Read the manual carefully and follow the suggested procedures. We have tried to schedule our calibrations on the lightest workload days. Our detailed records include a log of when a reagent pack lot is received, calibrated, and put into use (Figure I).
With our discrete analyzer, a lot number must be recalibrated every three months if the supply is not finished. Therefore, the log also reminds us of the next date for recalibration as well as the lot's expiration date.
3. Quality control. The new instrument greatly increased our quality control sophistication--and the amount of technologist time spent on QC. We wanted to develop an orderly process for daily QC runs and record keeping. Following our instrument's specifications, we decided to run one control, alternately normal and abnormal, every day on every test we expected to perform. If some other test is ordered during the day, we run a control first. On Fridays, we run a control on any test that was not requested during the week, in order to maintain current data on infrequent tests.
QC data for each test are plotted immediately on Levey-Jennings charts, and means and standard deviations are updated every time we have amassed 20 values. Changes in reagent lot numbers are also noted on these charts. We used to log the QC values first and later transfer them to Levey-Jennings charts. That was a wasteful duplication of effort, and we also fell behind on our charts.
Since we had already been using an assayed chemistry control, we opted to stay with it after checking that it was assayed for all of the tests we wanted to perform. We calculated our expected annual volume and asked our control supplier to provide a sequestered lot number for an entire year so we wouldn't have to keep adjusting QC for new lot numbers.
Our therapeutic drug assays and urine chemistries require special controls. From several possibilities suggested by the instrument manufacturer's technical representative, we made final choices based on a comparison of cost versus shelf life. Prolonged stability is essential because we don't run the controls every day.
A small laboratory should certainly look into QC programs offered by control manufacturers. Often free, they let you compare your QC data with the data of others using the same controls on the same instrument.
Accreditation is not a requirement for our physicians' lab, but we voluntarily participate in a university-sponsored proficiency program. Testing unknown samples four times a year is a valuable further check on instrument performance as well as overall laboratory performance.
4. Maintenance schedules. Since we don't have a night shift to ready the instrument for the morning workload, seven daily maintenance tasks are performed in the p.m. shutdown routine, and four tasks are performed in the early a.m. setup (Figure II). Weekly and monthly maintenance schedules are necessary, too, for maximum efficiency. The manufacturer's maintenance log forms list all the necessary tasks.
A service contract is important, but it is no substitute for a solid inhouse maintenance routine. A smll laboratory may well lack a backup system, so it's imperative to keep an analyzer in tip-top shape and to know basic trouble-shooting techniques. Keeping some spare parts on hand also helps reduce downtime.
5. Ordering system. Set up an inventory and ordering system that keeps close track of supplies on hand and frequency of use. Running out before a new shipment arrives and overordering of perishable materials are two kinds of costly mistakes.
On supplies that do not pose an outdating problem, we receive special discounts for bulk ordering; there are also specific deadlines to meet for free shipping. Such incentives drive down reagent costs.
6. Designating forms. All of the above items have one thing in common: paperwork. To streamline record keeping, we created our own calibration checklist, reagent pack log, daily workload recording sheet, and inventory forms.
As in most small laboratories, every member of our staff does everything. The forms are designed to enable anyone to pick them up and see at a glance what has been done. We also use maintenance and calibration forms supplied by the manufacturer. All of the sheets are kept on clipboards within easy reach of anyone who needs them.
7. Staff training. Our technologist laboratory manager and another full-time technologist attended the instrument manufacturer's training course. They then trained the rest of the staff to operate the analyzer and perform basic troubleshooting. Again, everyone must be a jack-of-all-trades in our lab. It also boosts morale to include the entire staff in the fun of handling a new instrument.
8. Instrument log. We use a steno notebook to record anything unusual pertaining to the instrument, particularly troubleshooting incidents. When we phone for advice on a problem, we record the date, the name of the person we talked to, the advice given, and action taken. This documents service contracts, details a history of instrument repair, and saves us the trouble of making a future call when the same problem recurs. If a service representative visits the lab, we have him write down what was done and how long it took.
9. Instrument evaluation. A 90-day instrument trial period gave us enough time to analyze actual performance versus prior expectations. Our expected volume was based partly on the sum of previous in-house tests and send-outs.
A small laboratory is apt to rely somewhat on manufacturer projections of the new instrument's workload impact. The manufacturer's representative will tell you that when physicians learn the lab has added a particular test, ordering tends to go up. This may happen; then again, it may not.
For example, the chemistry analyzer permitted total protein testing, a procedure our physicians had long expressed interest in. We dropped if after the trial period, however, because requests were few and far between. The reagents were becoming outdated, and standard and control costs per test ran too high. On the other hand, we have added T.sub.3 and T.sub.4 to our test menu, based on fairly strong demand.
Our cost per test evaluation analyzed only the direct expenses of the instrument--reagents, calibration, quality control, and maintenance. We did not figure in general laboratory overhead, such as utilities and salaries, reasoning that it was the same under the old instrumentation and the new. If calibration and QC were not spread over a sufficient volume to hold costs within a reasonable test charge, the test was dropped, as in the case of total protein. New tests are added by the same criteria. We update cost per test data on a regular basis--every six months thus far.
10. Office communication. Inform the medical staff about the expanded test menu, faster turnaround times, and new reference values. Posting a memo on the bulletin board and using the interoffice mail boxes are good ways to introduce new tests (Figure III). We also held meetings with the business office staff to evaluate test charges and with the receptionists to make sure they built in enough time for lab tests when scheduling patients. No new instrument, regardless of how sophisticated it is, will pay off without good communication between the laboratory and the rest of the organizatoin to utilize it to its maximum capacity.
The final step in our 90-day evaluation was a lab conference to assess how staff members liked the instrument, whether we had enough staff to cover the increased workload, and any other concerns. We concluded that more time was being spent on calibration, quality control, and maintenance. But technologist time per test had decreased markedly.
In fact, we now run five times as many tests in-house as we used to before acquiring the analyzer, and no one feels any "busier." We are also more confident about the quality of our results.
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|Publication:||Medical Laboratory Observer|
|Date:||Jan 1, 1985|
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