Michael Noble, Ph.D., professor in the Department of Pathology and Laboratory Medicine at the University of British Columbia and chair of the Program Office for Laboratory Quality Management, emphasizes that while increased awareness, education and standardization of information and protocols have helped improve laboratory quality, people still need to be reminded that the pursuit of quality is a commitment that needs constant time, effort and money. Hence, he advises lab managers to start small, stay committed and keep an eye on the “cost” of having poor quality as opposed to focusing on just the costs incurred for quality improvements.

Q: Having been in this field for more than a couple of decades, do you think we have gotten better, gotten worse or stayed the same in terms of lab quality?

A: I think we are doing better. In the 1940s, when we started looking at the notion of proficiency and competency for laboratories, studies done in Philadelphia labs found that there was absolutely no correlation between the lab results. Since 2000, we have started to recognize that we would do better if we emphasized the importance of standardization and there has been a huge amount of work in that direction. Accreditation, proficiency and monitoring have all gotten better, and it’s largely because the public is increasingly demanding it. If we stay along the track where we recognize improvements through standardization and monitoring, then we will continue to get better. If we choose to go back to the notion of using invalidated and unverified testing methods, then we would be right back in the mess we were in 25 years ago. One of the biggest problems we have right now is in the area of molecular diagnostics where very little of the work is truly validated for its use.

Q: Besides standardization, what else do you think has impacted lab quality?

A: Associated with standardization has been increased awareness and education. People who are coming into laboratories today are more aware than we were back in the mid-1970s. Back then, if Dr. Smith said it was so, then it was so, and that’s the way it was. But that’s not the way it works anymore. Now we have requirements and expectations for operating procedures. We have quality indicators that are requirements. We have a whole series of steps along the way and we take caution to ensure that the information we’re providing is what we expected.

Q: Improvements in quality involve costs. How can lab managers justify those costs and the return on investment?

A: The cost of quality is the part everybody sees. Managers see the cost of accreditation, of proficiency, and everybody sees the cost of quality control. What they don’t see, because it’s buried deep in their numbers, is the cost of poor quality.

Let me give you an example. One of the studies we did looked at how much time people spend correcting errors. In a small laboratory, with 10 technologists or less, even if they have only one error a day (and that would be extremely unusual), they can be consuming up to 35 percent of their employee time correcting those errors. So a third of their workforce is spent doing work that has no revenue associated with it. In very large laboratories, with greater than 250 full-time employees, nearly 12 percent of their personnel are involved in the correction of errors. Well, if you were to reduce those errors by 10-15 percent, the amount of money that you would save in productivity starts to get into the range of a couple hundred thousand dollars a year. I know that it’s really easy to look at the cost of quality, but I think that laboratory managers who understand and are committed to the notion of quality need to express to their top management how much they can benefit through the quality process by reducing their costs of poor quality.

Q: What are some of the biggest challenges preventing quality measures from taking place?

A: When it comes to quality, we hop around a lot depending on the flavor of the month. For a time, Lean was seen to be the godsend, and now you see a lot of literature talking about all the problems with Lean. You see the same thing with Six Sigma and with ISO 9000. The reality is that all of these programs are sound; if they are implemented, they will actually reduce team costs and improve the quality of the laboratory. The problem is that we tend not to implement them with commitment. We kind of expect the “magic bullet” and when that doesn’t occur, we drop it and go to the next one. We get more engaged in the tool than we do in the concept of quality.

The reality is that, with quality, the notion is one of continual improvement. It’s not a matter of doing it right the first time. It’s picking up the error, learning from it and always going forward a step at a time. And that’s where we tend not to be particularly good in our quality implementation. We always make this assumption that we have to get it right the first time. We don’t. Quality takes a long-term commitment. But it’s worth it in the end because costs are guaranteed to go down, the amount of energy people have will go up, the amount of enthusiasm will remain, we will stop losing personnel and we will make laboratories better.

Q: Besides Lean and Six Sigma, what other standards have impacted lab quality?

A: It seems to me that across Europe, increasingly in Canada, and to some degree in the United States, for the medical laboratory, ISO—and particularly ISO 15189—is becoming a very useful medical quality standard. I think there’s a good chance that this document, which keeps being revised and will be out with a new version in 2012 or 2013, has the sustainability of being a long-term standard. The ISO 15189 document is called “Medical Laboratories - Particular Requirements for Quality and Competence,” and it is very specific in identifying elements that are critical for quality management, in terms of the documents, the processes and the positions that are required. For example, ISO 15189 is very clear and specific and says that every laboratory “shall have” a laboratory quality manager. The point is that quality is a full-time job and if you think that your supervisor can do it on the side, you’re wrong. When ISO 15189 was first drafted, it was not written as an accreditation document. It was written as a document that laboratories would be able to read and implement, as a way of improving their own awareness and their own quality improvement program. I think that’s still the case, and it’s a good document for laboratory personnel to read.

Q: Do you have any advice as to how lab managers can make little, incremental changes that will eventually build up the right culture and expectations in their lab?

A: Yes, here’s the number one thing that they can do. They can make a commitment that every week or every two weeks they are going to do some form of a mini-audit within their laboratory. Today, we’re going to look inside the refrigerator to see if there are any outdated reagents. Next week, we’re going to review the standard operating procedures that are on the culture bench. None of these audits should take longer than 45 minutes to perform and maybe a day to analyze the results. Then you plan to study the results and act to fix the problem. By doing one mini-audit every week, at the end of a year you’ve done 52 mini-audits. Currently, what many laboratories tend to do, if they do them at all, is one big audit at the end of the year. And they never have the chance to actually look at any of the information and the time to analyze the results. So at the end of five years, they’re no further ahead than they were before. If they did one mini-audit every two weeks, at the end of four years, they’d have over a hundred. And the consequence of that is there are a hundred things that they’ve been able to put some sort of continual improvement on. So the message is: commit to get started, get started small, stay small but stay continuous, and over time accumulate a massive amount of information and help your laboratory.

Dr. Michael Noble, Ph.D., has held a broad variety of quality-oriented positions that focus on medical laboratory quality within the private, public, academic, research and planning environments, both national and international. He is a medical microbiologist and internal medicine specialist by training and has been an infectious diseases physician, an infection control physician, a laboratory specialist and a researcher at various times throughout his career. He is currently a professor in the Department of Pathology and Laboratory Medicine at the University of British Columbia and is also a medical microbiologist with LifeLabs Medical Laboratory Services. Dr. Noble has been actively involved in medical laboratory quality management issues for almost 25 years. In 2001, he developed the Program Office for Laboratory Quality Management (POLQM), to function as a companion program to the University of British Columbia Clinical Microbiology Proficiency Testing (CMPT) program, to broaden the scope in terms of both research and education opportunities. The Program Office has been successfully engaged in national and international research in laboratory quality management.