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Voluntary proficiency testing: a step toward excellence.

Enrollment in voluntary proficiency testing (PT) allows clinical laboratorians to troubleshoot problems in unregulated areas while preparing for the mandatory PT that CLIA '88 inevitably will bring. Voluntary participation permits freedom to experiment, make mistakes, and take corrective action without fear of retribution from regulatory agencies. This article provides a guide to selecting a voluntary PT program and getting the most out of it.

The Wisconsin State Laboratory of Hygiene provides more than 25 clinical proficiency testing programs on a statewide, national, and international basis. Part of the University of Wisconsin-Madison, we have been a PT provider and participant for over 40 years and are in a unique position to offer advice on the benefits of voluntary PT for all laboratories, from physicians' office laboratories (POLs) to large metropolitan hospital facilities.

As chief of PT programs at our facility, I have had the opportunity to work directly with participating labs. In my experience, laboratorians who began voluntary PT years ago have consistently shown improvement. I have seen laboratories that were performing poorly do a U-turn to become some of the highest scorers.

* Commitment to quality. While the Health Care Financing Administration (HCFA) and many state governments have set up specific regulations governing proficiency testing, these rules rarely apply to all tests offered by an individual clinical laboratory. Nevertheless, physicians and patients have the right to know that all lab results are accurate. Voluntary PT is one way to assure that accuracy.

* Get a jump on regs. Under CLIA '88, laboratories will be required to subscribe to proficiency testing. Getting involved in PT while it's still voluntary helps laboratorians become familiar with the registration and report forms and gain confidence in the ability to meet reporting deadlines. Laboratory managers will learn the legal requirements for certification. Many new participants go through a lag phase before they understand the unique nature of PT. Those who reach that understanding will not be thus afflicted--and perhaps penalized--for having failed to fill out the official forms properly.

POLs reap special benefits from participating voluntarily in PT. Their small staffs prevent them from enjoying the technical advantage of consulting with colleagues on site. Low budgets and limited staff restrict educational opportunities for personnel. Although skimping on the laboratory's budget may seem like a logical cost saver to the physician, a malpractice suit sparked by delayed or incorrect diagnosis costs a serious amount of time and money and tarnishes a laboratory's reputation.

For POLs as for other laboratories, quality assurance activities should be viewed as a necessity, not an option. Small labs are not in a position to evaluate the accuracy of a test kit but must rely on the results obtained. The best way for them to assess the reliability of their testing methods is through a PT plan.

* Limited enrollment. As more regulations are implemented, laboratories will find it harder to locate openings in PT programs. The difficulty of obtaining PT samples that adequately mimic true patient specimens may cause PT providers to limit the number of participants. Some parasite specimens, for example, must be obtained through missionaries in Central and South America. In other cases, infected persons are too weak to donate material. One malaria victim can supply enough blood for 200 slides, but 2,000 laboratories may have signed up for malaria PT.

Each year our lab contracts for a year's worth of hard-to-obtain specimens. It then becomes nearly impossible to add participants after the registration deadline. While we have always tried to accommodate all laboratories that want to join, the anticipated crush caused by implementation of CLIA '88 regulations may require limitations. Other PT providers may be similarly constricted. Getting involved early will insure a place.

A checklist to use in selecting a PT program is provided in Figure I. A list of HCFA-approved proficiency testers, ever-changing but complete at press time, appears in Figure II.

* Procedures to use. PT samples are handled in the same way as any patient specimen. One unequivocal result is expected. A laboratory in one of our programs sent us a urinalysis result labeled as follows: "Ten of us say positive, three say negative, and one is undecided." That kind of analysis by committee is frowned upon.

Technologists often find something interesting and call over a colleague to confer. A laboratorian doing a test for PT, however, should not extend beyond the collaboration typical to that lab. Erros in the usual procedure will not be discovered if the procedure used for PT is performed differently.

We proficiency testers want one answer, the first answer, unless the test requires confirmation or it is that laboratory's normal procedure to confirm all positive findings.

For certification purposes, the technologist performing the test must sign a statement attesting that the analyses were done with procedures normally followed at that laboratory. Testing may not be saved for a particularly skillful technologist on another shift. Nevertheless, PT professionals realize that most of the results we receive reflect the lab's best work. We have found that if several labs report the same problem, the difficulty they cite is often even more widespread.

While PT providers don't try to make testing outrageously tricky for participants, passing is no cake-walk. We challenge them, just as they are challenged every day in actual patient testing.

* When problems arise. A laboratory that is unhappy with its score will be heard. If it can be demonstrated that the procedures that were followed exemplify good laboratory practice, we will alter the score, barring legal conflicts.

Some PT problems can be resolved with the supplier's assistance. Some distributors like to unload old or outdated material on POLs. Their feeling is, "POLs have no QC experience or anyone to talk to; they'll never know."

One POL new to our program failed to get a positive result with a "new" batch of antiserum on our PT specimen. They asked for a repeat specimen, but still failed to obtain a positive result. While troubleshooting the problem on the phone, I asked for the lot number of the antiserum. It was "5"--a single digit. Current lot numbers contain six digits.

* Lethal water. Another problem common to POLs stems from the lyophilization of PT specimens. Since patient specimens are not freeze dried, the technique for a PT specimen departs from the ideal normal procedure in that the specimen must be reconstituted. Sterile water is purchased for this step. It works well with Escherichia coli, but a fastidious organism such as Neisseria gonorrhoeae will not grow in that environment. Some of the commercial sterile water on the market contains bacteriostatic agents that kill only the less-hardy species.

* Color recognition. Laboratorians who are using a kit for the first time often interpret subtle color changes incorrectly. They may read the color change as signifying a negative result when the opposite is true. Frequently the blame is placed on the manufacturer. We talk to the participant to find out whether that is indeed the case; if so, we recommend that the manufacturer be contacted for technical assistance.

Proficiency testing is a reciprocal process. Both provider and participant benefit from the interaction. Analyzing specimens, accepting results, and filing them away is just the beginning. Laboratories that gain the most from their PT programs remain actively involved with their PT providers and continue to discuss any problems that arise.

* Mutual outreach. Education is the top priority. PT providers want to help laboratorians understand why they obtained a wrong result and to help them improve. It is not our goal to punish anyone for doing a bad job. Our facility has an outreach program with phone consultation, courses, workshops, and bench training.

By discovering and solving problems through voluntary PT, laboratorians help not only their patients and their departments but also other laboratory workers with similar problems. Consistent trouble with a particular analyzer or test kit may betray a reagent problem, for instance. In such cases it is important to let the manufacturer know that the equipment is unsatisfactory and to ask about in-service training or other options.

* Vendors' contribution. Unsatisfactory performance or lack of consensus among participants in a voluntary PT program serves a purpose when it highlights a weak link. Labs participating in our Lyme disease project, finding wide variability between varius manufacturers' test kits, went directly to the vendors for redress. In one case the manufacturer withdrew its kit. In another, the kits were improved. Manufacturers want their products to have a good reputation and will work with PT providers and participants to improve them.

Voluntary subscribers to proficiency testing programs generally represent the higher-quality labs--the ones that try hard to do good work. By adopting this attitude for your laboratory, you will be taking an important step toward providing the best possible patient care.

The author is chief a proficiency testing programs, Wisconsin State Laboratory of Hygiene, University of Wisconsin-Madison.
COPYRIGHT 1992 Nelson Publishing
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 1992 Gale, Cengage Learning. All rights reserved.

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Author:Bourdeau, Napoleon J.
Publication:Medical Laboratory Observer
Date:Mar 1, 1992
Words:1473
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