It tops the agenda at reference and specialty labs, hospital labs, and physician’s office labs (POLs). It is the driving force behind mandates drawn by governments, the health care industry, and practitioners. References to it are found in seemingly every new-employee manual and every marketing campaign. It is quality, and today, lab professionals talk more about improving it than they ever have before. Here are four views to consider.

Planning QC Based on the Quality Required
The voice and views of James Westgard, PhD, rank among the most recognized in the clinical lab industry when it comes to issues of quality. A longtime author, lecturer, and researcher, Westgard has spent nearly 4 decades at the University of Wisconsin (UW) at Madison. He is a professor of Pathology and Laboratory Medicine at the UW Medical School, where he began his career as a clinical chemist before becoming director of Clinical Chemistry and associate director for Lab Administration. In addition to teaching, he was faculty director of Quality Management Services for the clinical laboratories at the school and clinic. Focused on lab-quality issues for nearly 30 years, he is a cofounder and principal of Westgard QC Inc. The company provides tools, technology, and training for laboratory-quality managers.

Westgard believes today’s labs too often perform arbitrary control instead of quality control (QC). “My point here is that laboratories seldom define the quality they need to achieve; therefore, they cannot evaluate the QC that is needed to ensure the desired quality is achieved,” he says.

He says there are guidelines that describe how to plan QC on the basis of the quality required for the test, and the precision and accuracy available from each method. They are provided by the Clinical and Laboratory Standards Institute (CLSI) document C24A2, which is currently being updated to C24A3.

“Unless QC is properly planned, laboratories may end up just running controls, not controlling quality,” Westgard says.

According to Westgard, many people, laboratory scientists among them, believe the analytical quality of laboratory testing is better than needed for health care applications. As a result, labs pay more attention to other areas, particularly preanalytic and postanalytic factors.

“It follows from this belief that statistical QC is no longer important, or at least that statistical QC can be reduced,” Westgard says. Evidence of that thinking can be found in the government’s recommendations for equivalent QC procedures. “Those recommendations provide a stamp of approval for laboratories to reduce QC and pay less attention to analytical quality,” Westgard says.

Quality isn’t the only priority for today’s labs, says Cathy J. Kenny, MT (ASCP), of Clinical Laboratory Consulting. “Money is major. If we can’t make money, we won’t be in business. I’ve seen staffing shortages in the Pittsburgh area so severe that some physician’s office labs have had to discontinue testing.”

Kenny also thinks laboratorians should become more involved with laboratory regulations and reimbursements. The cost of running lab tests can easily exceed reimbursement, and most labs don’t get involved in negotiating insurance contracts or lobbying the federal government regarding Medicare reimbursement, she says. – NB

Zoe Brooks of Harmonized Quality offers a short quality quiz on her Web site ( for lab professionals on all levels. The typical score on the quiz today is 38% — the same as when she gave the quiz in writing in 1994. – NB

He believes laboratories need to continue to perform statistical QC with the right rules and number of measurements. “Right now, we seem to be searching for ways to eliminate statistical QC because people no longer understand how to do it properly,” he says. However, statistical QC, he says, is still the best tool available and is widely applicable to today’s measurement technologies. “What is needed today is to completely automate the statistical QC process, which is possible with current computer capabilities.”

Westgard advises labs that even though the government says it’s OK, they should not adopt Centers for Medicare and Medicaid Services’ equivalent QC procedures. Clinical Laboratories Improvement Act (CLIA) regulations, he points out, “represent the minimum standards of performance to stay out of jail. Compliance equates to minimum or, at best, average, while excellence aims to do better than the minimum or the average.”

So how good does a lab have to be? “That gets back to the quality needed for each test,” Westgard says. “It is interesting that the CLIA regulations define quality criteria for acceptable performance in proficiency-testing events. Therefore, minimum quality requirements have been defined for some 70 to 80 tests. Those quality requirements should be used to plan QC procedures to guarantee that level of quality is achieved in daily testing.”

Patients today are very concerned about the accuracy of their laboratory tests, but have no way to evaluate whether or not results are correct, Westgard says. “Even physicians have trouble with that, which is why laboratories must take responsibility for producing correct test results. No one else can do this or compensate for the lack of responsibility in the laboratory,” Westgard says.

Quantifying Quality
C. Anne Pontius, MBA, CMPE, MT (ASCP), is founder and president of the Raleigh, NC-based Laboratory Compliance Consultants Inc, which specializes in POL operations, regulations, and financial feasibility. During her career, she has worked as a hospital laboratory supervisor, a hematology/oncology practice laboratory manager, and a Commission on Office Laboratory Accreditation surveyor. Pontius also serves as treasurer/secretary of the Clinical Laboratory Management Association.

“Quality is really in the eye of the beholder, and depends on someone’s expectations of quality,” Pontius says. “If you don’t quantify it, quality doesn’t have a value. The CLIA requirements are a minimum set of quality standards that must be implemented, but laboratories can add additional quality measures to achieve high accuracy and reliability rates.”

According to Pontius, quality in the pre-CLIA era was driven largely by competition within the clinical testing environment. “You had to perform, you had to provide more consistent testing and more accurate results or your lab would lose out to better labs,” she says.

“The industry’s new buzzwords are ‘patient safety,’ ” Pontius says. “The focus on quality should have an outcome that can be related to improving patient safety.”

Like other labs, POLs are becoming invested in the quality movement. “You would be surprised at the level of testing done at POLs. Blood banking may be the one area where they don’t test, but large practices of 10 to 25 doctors or more are doing sophisticated testing of every kind, and quality is at the core,” Pontius says.

The high cost of improving quality, including investments in automation and lab information systems, Pontius says, can end up paying for itself. “Without quality controls at a certain frequency, you end up having to repeat large batches of patient tests. Remember, there are substantial gains when you pay for quality improvements in efficiency and patient safety,” she says.

Making Quality an Integral Part of Lab Management
Cathy J. Kenny, MT (ASCP), has worked with clinical laboratories since 1992. Her Wintersville, Ohio-based Clinical Laboratory Consulting offers expertise in areas of laboratory management, technical consulting, regulatory issues, continuing education, and financial studies.

Discussions about quality prompt an assortment of misconceptions, according to Kenny. Some lab professionals view quality as one more chore to complete; others view it as not especially pertinent to daily operations. Still others perceive quality to be an intangible that is important only to surveyors. It is clear that not everyone is on the same page regarding quality issues.

“Terminology gets in the way,” Kenny says. “Today, there are so many different ways of looking at quality: Six Sigma, TQM, CQI, and others. To make matters worse, CLIA now refers to quality assurance as quality assessment. This all adds to the confusion, making it easy for lab techs to throw up their arms and throw in the towel.”

Another change is that instead of QA being viewed as a separate entity, it is being incorporated as an integral part of the process of running a lab. “I think everyone is more aware of QA issues, with legal matters in the forefront and the 1999 Institute of Medicine study,” she says. “That seems to have us all looking into what quality process will best fit our unique laboratory.“

Advancing technology is helping labs better deal with the variety of technical issues related to quality and the accuracy and precision of lab results. But that’s only part of the picture. “I find that most lab errors don’t occur in the analytical phase of testing, but rather in preanalytical and postanalytical,” she says. “In other words, specimen collection, labeling, handling, and storage have much more room for error before that sample hits the analyzer. The same can be said for the reporting process.”

So are advances in laboratory-testing quality and accuracy contingent on spending more money? “Absolutely not,” Kenny says. “This is a common misconception. Actually, it’s been my experience that a good QA program will boost profits by increasing efficiency. To be successful, we must tie operational efficiency into our quality programs.” She cautions that overall lab operation is not advanced by reducing funding for continuing education and career development. Moreover, litigation and fear of litigation are driving efforts to improve lab quality, she says.

“One of my favorite responses to doctors who ask me whether something is a federal requirement is: ‘CLIA sets minimum standards for quality; do you wish to advertise that your practice reflects the bare minimum regarding quality?’ Again, I try to stress to my clients that a good QA program will increase profits by catching those little things that may be falling through the cracks.”

She points out that most people have no idea what a medical technologist is or does because no one ever sees them at work. “The irony is that if you have cancer and are undergoing chemo, the person who cuts your hair must have a state license, but the person who runs your CBC does not [except in a few states],” Kenny says. The Information Age has made patients more aware of quality than ever before, but, “I believe that they really have no idea where their lab results come from or what is involved in obtaining them, “ Kenny says.

Understanding Quality Concepts
Canadian-born Zoe Brooks, founder of the firm Harmonized Quality, is an author, lecturer, and professor. She has dealt exclusively with issues of laboratory quality for more than 20 years.

“There is an appalling gap between what is being done in quality control and what should be done,” Brooks says. “Today’s clinical labs reflect a shocking lack of understanding of the fundamental concepts of quality, and I don’t believe it’s a lack of money. It’s a lack of a process for getting information on valid quality concepts from the ivory tower to the masses, hard-working people in the lab.” She points to the CLIA requirements that mandate the establishment of performance standards for each test. “It is simply not being done,” Brooks says.

Too often, lab’s quality benchmark remains the +/- 2 standard deviation (SD)—a standard that served the industry well when it surfaced 6 decades ago. “Everything else has changed in recent years in testing, but not +/- 2 SD,” Brooks says.

She agrees with Westgard and others who believe lab errors occur only if shortcomings exist in both the analytical system and the quality-control system. “We spend millions, actually billions, verifying analytical systems, but never check to see if quality control is performed properly,” Brooks says.

She urges labs to take steps toward improvement, including setting test-performance standards, putting a structured process into quality-control systems, and making sure QC accurately mirrors patients.

“The problem is not with the frontline workers. They have not been given the education and tools they need,” Brooks says.

Nicholas Borgert is a contributing writer for Clinical Lab Products.