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Covering the bases with a new QA program.

Creating a quality assurance section from scratch in their high-volume independent laboratory, the authors developed comprehensive initiatives and built in plenty of teamwork.

Our referral laboratory processes millions of blood and urine specimens for the insurance industry every year. The test menu and volume have expanded tremendously since 1984. Before then, the main offerings were a blood chemistry profile; assays for high-density lipoprotein (HDL) levels, hemoglobin |A.sub.1c~, and glucose; and complete blood counts. We also offered an extensive urinalysis package that included microscopic, protein, and glucose quantitation, nicotine level, specific gravity, therapeutic drug testing, and full drug screening, including cocaine.

* Business boom. As our clients' needs grew, so did our testing package. In 1986 we began testing for antibodies to the human immunodeficiency virus, which increased business tenfold within eight months. We now offer tests for |Beta~-2 microglobulin, prostate specific antigen, apolipoproteins, T-cells, and a complete urine adulterant panel.

With testing being done on such a large scale, our president felt the company should expand its quality assurance responsibilities. Running instrument calibration checks each day was no longer enough. He decided that one group should implement more extensive quality control and quality assurance measures.

We were supervisors heavily involved in quality control activities when the company president created our quality assurance section and appointed us manager and assistant manager. Another technologist became our one-person full-time support staff. At that time our group reported directly to the president; we now report to the chief pathologist. Among our responsibilities were coordinating Federal and state inspections and monitoring the lab's proficiency testing. Looking at the procedures of all sections of the lab was a priority.

* Laying the groundwork. At the time our department was created, only a few blind control urine specimens were being tested each day. The blood lab wasn't being challenged at all. We agreed that sending daily blood and urine control specimens through our system would be the best way to test for accuracy.

Before implementing such a program, we met with supervisors and managers on several occasions to discuss the kinds of samples to run. Whole blood, for example, would not be valid because of known degradation. We talked about how to create the controls and the kinds of results to expect. We reviewed lyophilized serum controls and analyzed their range values and stability. For urinalyses our team prepared an aqueous control with a shelf life of six months.

Our QA section developed two blind control programs that have proved highly effective. One identifies possible problems that develop during testing; the other monitors various aspects of our operations.

* John Doe program. Our QA section prepares samples that we send through the system with actual client specimens. About 600 John Doe samples are tested every week. While the number may seem extreme, it is only a small percentage of our total volume.

In our blood lab, we use two levels of a purchased lyophilized serum for blind controls. To evaluate urinalysis, we make negative, low, and high concentrations of urine controls in-house. After assaying controls to determine acceptable ranges for the analytes being tested, we define the ranges in our computer system.

These samples are logged in by personnel in the setup section and placed randomly throughout the daily run. Bench supervisors monitor them throughout the day, looking for mechanical and human errors. If a blind control falls outside an acceptable range, the lab's computer system generates a failure report, which comes to us. We communicate with the supervisor in charge, who has identified, corrected, and documented the problem. No worksheet is released until everyone involved is satisfied that results are accurate.

Every morning we receive two additional computer reports. One indicates the worksheets that were released for the previous day and by whom. The other lists all test results for the previous day's blind controls.

Preparing these blind control samples is a full-time job for our QC technologist, but the program has proved well worth the effort. John Doe controls have helped us to detect problems with our reagents, pipetting, and pouring of samples. After receiving a report indicating that all 13 chemistries on a control were inaccurate, for example, the bench supervisor discovered a plug inside the chemistry analyzer, impeding the flow. The equipment was fixed, the old results were thrown out, and the tests were done again.

* Super samples. Our Super Blind Control program follows controlled samples from the time they arrive at the lab to the time results are released. Only QA personnel know which samples are being tracked. The point is to mimic services and results that our clients actually receive.

Each of our four fictitious companies submits about 15 blood and urine specimen kits per week. Some are obtained from volunteers; we also use previously assayed specimens. Other specimens are derived from purchased or in-house controls.

We challenge employees by intentionally switching and mislabeling tubes, leaving patient ID forms incomplete, and submitting broken or empty vials. We include specimens that are meant to show bizarre results or that are known to be positive for drugs of abuse. Occasionally, we send controls to the labs that do some out-of-house testing for us. Before any specimen kit leaves our hands, we record its contents, the tests requested, and the results expected.

To keep track of all control samples, setup personnel assign the same control number to all items from one specimen kit and give production numbers to specimens according to their category. Urine specimens, for example, receive consecutive production numbers as they are placed in the tray being sent to the lab. Serums and whole blood are treated in a similar fashion. Setup staff also records any problems associated with the kits.

* Double proof. A duplicate of each sample is sent through the system. When testing is done, the quantitative results of the two samples must be no more than 10% apart. If the difference is greater, tests are repeated and documentation of corrective action is forwarded to our QA section, if necessary.

Abnormal and sensitive reports, such as positive tests for drugs of abuse or HIV, are held for retesting and verification in the laboratory's control analysis section, created shortly after we began to organize the company's QA efforts. Our lab director had previously run the control analysis section alone until it became clear that a full staff was needed. Our QA section receives all computer-generated final reports on samples to compare test results with our expectations.

When follow-up testing has gone through, we review test reports to verify completeness and accuracy. We also check to see how quickly tests were done. Each month, the accounting department TABULAR DATA OMITTED sends our QA section an itemized bill for all tests that were performed for our fictitious companies, which we scrutinize for accuracy as well. If we spot a problem, we make the appropriate employees aware of the problem and ask to be sent follow-up paperwork explaining how the situation was cleared up.

* Big picture. Our Super Blind Control program helps us to strengthen any weak links in our lab's chain of operations. When we discovered that specimens were being delayed by the heavy workload of bench personnel, for example, we asked the lab director to step in. He reallocated work by moving staff members into different positions to fill in for employees away for vacations, maternity leave, or illness. Monitoring any recurring incidence of error in a given lab section helps us determine which staff groups may need more training.

Initially, lab personnel were not happy about the new programs, which they felt questioned their professional ability. They resented being given more work on top of their already demanding schedules. Soon their attitude turned around completely. They began to realize that our programs were not created to point blame at anyone, but to enhance quality. In the long run, they now understand, improving the quality of testing saves time, effort, and money.

Our programs help us avoid the embarrassment of having to call a client to explain why inaccurate results were released. Not told which samples are being used as controls, employees must strive for accuracy on every test, every day. We are pleased at the small number of errors identified over the past eight years.

* Black and white. Documentation is integral to our QA initiatives. As soon as we discover a problem, we write it down and pass the information to those who need to know. Accurate records keep communication lines open between lab sections and between the lab and other departments.

Most problems and their potential impact are documented on our corrective action request form. We submit our observations to the appropriate manager, who fills in the reason the problem occurred and what action was taken to correct it.

If we identify a situation that may have an immediate deleterious effect on a patient or client, we record its potential impact on our critical quality problem form, which tells a manager that the situation demands prompt attention. Corrective action taken and follow-up comments are filled in by that manager after the problem has been resolved. An error in accounting would fall into this category, for example, if a client was about to be sent an inaccurate bill.

Both forms are filed in our QA section according to the type of problem identified. During periodic meetings with management, we use the forms to track the kinds of errors that have evolved over a specific period of time and to measure improvement.

* Multifaceted goals. Our QA duties do not end with our two programs. We promote quality in everything we do. For example:

Inspections. Our QA section coordinates all lab inspections, working closely with managers and supervisors to prepare their areas for successful on-site visits. Having a central coordinator has proved to be extremely efficient. Someone from our team accompanies inspectors around the lab. We also oversee all procedures and write or review all correspondence related to the inspection.

QA meetings. Once a week the QA section holds a meeting at which management has a chance to air grievances and share important data. Each supervisor, who is proficient in one area of the lab, shares helpful information about his or her specialty, such as a new test procedure being performed at the bench. Also discussed are CLIA '88 regulations and proficiency testing results.

We work hard to make our meetings educational. Our consulting pathologist has given slide presentations on abnormal cells. We have shown a number of informative product videos provided by vendors.

Employees from other in-house departments, such as marketing, computer operations, and research and development, are invited to teach us about their areas and to discuss newly implemented procedures. Staff members who have attended professional seminars off site update our group on changes in the field.

Proficiency testing. While Federal regulations require laboratories to enroll in only one survey per year for every test performed, we order up to 80 from various qualifying agencies. A notebook available to the staff at all times contains pertinent survey results and details of any corrective actions taken.

Section evaluations. We make two visits to each bench throughout the month, checking to make sure that procedures and maintenance manuals are up to date and that supervisors and technologists are wearing gloves and coats and keeping their work areas clean. The laboratory should always be "inspection-ready."

After noting any deficiencies on our section evaluation form, the bench supervisor reviews our comments and corrects any problems. We then forward a report to our chief pathologist.

Safety inspections. We make a copy of the safety manual available at each bench. To comply with OSHA's requirement that employees receive in-service safety training, our company employs a full-time manager of safety and continuing education, who conducts periodic staff training that consists of lectures, videotapes, and handouts. At the end of each scheduled session, the manager administers a short test, making sure participants have absorbed the material.

Each month our safety manager performs an overall inspection of the lab to verify that safety procedures are being followed and that equipment is working properly. Any violations are documented on our safety inspection form and reported to the person in charge of that area. If we identify a mechanical problem with an eyewash station, for example, the facilities manager will need to see that the equipment is repaired. For a blood spill, a supervisor will take charge.

We encourage those who work with body fluids to participate in our institution's hepatitis vaccination program. To insure that employees receive the necessary injections at the correct intervals, a representative from a local clinic comes to the laboratory to administer the vaccines, which are underwritten by the company. Our safety manager documents who takes part in the program.

Graphic reminders. Posters on quality from a communications company arrive several times a month. Hung on the lab walls, they serve as a reminder to employees that quality is our ultimate goal. The staff looks forward to reading new ideas on the posters regularly.

Zeroing in. Every year we study three or four areas of the lab with an eye to making general and specific improvements. We may examine such potential problem areas as costs, equipment, accidents, or turnaround time. If we find a problem, we plan a meeting with the people involved to work out a solution.

* Quest continues. We have met the primary goal of our quality assurance section: to identify and correct any problems in our lab operations long before potentially flawed results are released to clients. As business continues to grow, finding possible gaps in the system early will be more important than ever.

Searching for ways to improve laboratory service is a never-ending process. We hope to expand our team so that more blind testing can be done. In the meantime, we continue to pursue quality assurance measures with the full support of our lab staff and management, whose participation is integral to our success.

Bjerkan is manager of quality assurance and McKelvy is assistant manager of quality assurance at Home Office Reference Laboratory in Lenexa, Kan. The authors wish to thank Lisa A. Herron, MT(ASCP), for her contributions to this article. Herron, who was quality control technologist at the authors' lab when this article was written, is now a medical technologist at Providence St. Margaret Hospital, Kansas City, Kan.
COPYRIGHT 1991 Nelson Publishing
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 1991 Gale, Cengage Learning. All rights reserved.

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Title Annotation:quality assurance in clinical laboratories
Author:Bjerkan, Deborah; McKelvy, Bridget W.
Publication:Medical Laboratory Observer
Date:Sep 1, 1991
Previous Article:Measuring performance and promotability of middle managers.
Next Article:Laboratory quality and economic necessity: values in collision.

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