‘We wanted to be the best we could possibly be’: CAP ISO 15189-accredited labs on the difference it makes

To those intimidated by the 15189 accreditation process, Dr. Zarbo says, “This is hard work. But eventually, when it becomes the only way you work, it’s no longer hard; it just becomes the manner in which you work.” And to those who don’t see why such a lengthy and rigorous accreditation is worth it, he quotes the late quality management expert W. Edwards Deming: “Learning is not compulsory, and neither is survival.”

“This is really a survival mode,” he argues. “There’s going to be a lot of change going forward in health care, and not everybody’s going to be on the playing field. There’s going to be a lot of consolidation going forward, so this [15189 accreditation] is also a survival strategy, frankly. This is a competitive business strategy.”

When the Joint Pathology Center in Silver Spring, Md., earned 15189 accreditation last year, it became the first federal laboratory to do so. It was the culmination of a journey that began when director Clayton D. Simon, MD, was in a meeting with his boss. “The topic came up that we at the Joint Pathology Center say we produce a quality product,” he recalls. “And my boss was like: How do you know?”

Taken aback as he was by the question, Dr. Simon admitted it was a valid one. In response, he decided, “Fine. The best way to know is to get an outside organization to come in, you open your doors and your books, and you ask them, ‘How are we doing?’ So that’s what we did.”

How did he get buy-in from staff? “We’re the military—we can order people to do stuff,” he says tongue-in-cheek. “No, really, we explained to our personnel what we’re trying to do and why. If we’re going to tell people we’re a premier lab, we have to act like it. We represent ourselves to be the consultants to pathologists across the entire Department of Defense and Veterans Administration, and all of those hospitals are required by law to be CAP certified. If we’re going to be a step above, then we probably should take the next step.”

Quality assurance manager Grace M.B. Deneke, MA, MT(ASCP), was on the front lines of that step and all the steps that followed it. “To get buy-in, I think that was a delicate balance,” she says. “We created a quality manual that engaged all aspects of our organization. We had to create policies and procedures for the quality systems so they could gradually understand the value of addressing nonconformities. Just slowly entrenching the organization with quality provided us a buy-in. And then they could develop their quality indicators or performance indicators, which they would share during our monthly meetings and take pride in their accomplishment.”

The process of converting document control from a manual to an electronic system also helped achieve buy-in among staff. “It was very ambitious, it took lots of hours, but we got it down,” she says. “The beauty now is that everybody has access to the same document and they can quickly update it and see who’s in compliance, so they saw the benefit of having a system. It became, ‘OK, we can do this.’”

Early in the process, Deneke brought in an outside ISO consultant to lead the team through a value stream mapping process, “so everybody could see the flow of work and how much waste there was,” she says. “They were like, ‘Oh, we definitely need to stop doing that.’ Everybody’s process now is visible, so everybody’s paying attention to their section and how they contribute to the overall turnaround time.”

Dr. Simon’s favorite part of the accreditation process has been watching the gradual decrease in that turnaround time. Before 15189, an average of slightly more than seven days elapsed between the time the laboratory received a case to the time its customer received the diagnosis. Post-15189, that has gone to an average of slightly more than three days. That has helped keep the Joint Pathology Center competitive.

Dr. Simon explains: “See, if the JPC is taking too long, in a pathologist’s opinion, they’ll send it to somebody on the outside. If they send it to us, we do it for free, because that’s our job in the military. If they send it to someone else, like Mayo Clinic, they pay for it. Some of our customers were thinking, ‘Hmm, free in seven days or $300 in three days.’ Sometimes when you’re trying to get a patient diagnosed and treated, it’s worth the money spent. I needed to make the JPC competitive with other organizations that were charging for it. Now, 10 percent of our cases get signed out the same day we receive them. And they get them for free. You can’t put a price on that.”

Of course, success often has a flip side, though in this case it’s one Dr. Simon gladly accepts. “We track how many customers call us with a question, such as asking where their case is,” he says. “We have more and more people calling us asking us where their case is, and we’ve had it less than five days. That tells me they’re so used to cases coming out faster that they’re already missing their case at four or five days. When our average was seven days, they’d wait till 10 days, 12 days, two weeks. Now they’re calling us three days in. That, to me, is a success story. Yes, we’re fielding more questions, but in my view that is a positive thing because we’re meeting their expectations.”

To laboratories that are considering undergoing the 15189 process, he says, “I think they need to go into it with their eyes open, knowing this is not going to be easy. It’s like turning a very large ship with a very small rudder. The better your processes already are, the easier it will be to go through it. If your processes are less than good, it requires larger changes, and people are resistant to that.

“Now, people are resilient,” he continues. “Once you demonstrate why those changes need to happen, it becomes a whole lot easier for people to buy into it. It’s like watching your child grow. You don’t see the changes day to day, but if you take a picture when they’re two years old, and then a picture when they’re three years old, you see a huge difference.”

When the JPC received its 15189 accreditation, it held a ceremony so all of the employees could share in the moment. Dr. Simon asked his boss—a major general—to give a speech. “He started looking at what ISO 15189 actually is, and he was stunned,” Dr. Simon recalls. “He goes, ‘You people are underplaying this. This is a huge accomplishment.’ Well, to us working in a laboratory, it didn’t seem that huge. It was just the next logical step.”

After nearly 10 years as a member of the CAP 15189 Committee, Frank Schneider, MD, assistant professor in the Department of Pathology and Laboratory Medicine at Emory University School of Medicine, now chairs the committee. What has he witnessed during that time? “What we have seen and learned is that a small laboratory can do this just as well as a big laboratory can do it,” he says.

Small or big, even after 10 years one of the most common questions the committee gets about the CAP 15189 program is: Where’s the checklist?

“Most people are used to the Laboratory Accreditation Program, which is very checklist based,” he explains. “But the ISO program doesn’t have a checklist. It’s based on this international standard 15189. The first advice I always give people is, go online and buy yourself the standard. There is no checklist; it’s a collection of requirements that a laboratory should meet. The goal of ISO is not to develop or publish accreditation documents. They publish standards, and it is up to you how you want to meet the requirements. So it is not prescriptive, like certain CLSI documents that tell you exactly how to do things.”

The other common question he hears: Why would we do this? One answer he often gives: “We have learned over the years that many laboratories benefit from it in terms of constant inspection readiness and deficiency reduction. When you look at the outcomes of LAP inspections, a lot of problems laboratories have are document control, and ISO labs perform pretty well in those inspections.”

In the end, what drives people into the program, in his view, is the vision of “not stomping out fires when they run into problems”—that is, “not struggling anymore with these recurrent issues.”

Juan C. Millan, MD, whose laboratory system recently achieved 15189 accreditation, agrees. “The important thing is that you have to look at everything that really is not coming out right. You cannot just simply say, ‘Well, it’s a random error.’ You need to look and do root cause analysis where you see what is required, and then you change the processes.” Dr. Millan is clinical vice president of diagnostics, director of chemistry services, and medical director of Legacy Laboratory Services, Portland, Ore.

Dr. Schneider elaborates: “ISO is a wonderful complement to a very technical driven Laboratory Accreditation Program in that it provides this overarching process-oriented look at the laboratory from beginning to the end. It’s designed in a way that it improves the operation of the whole laboratory. For that, you need the right culture in the laboratory. I think laboratories do better if they want it. I recommend that labs don’t look at this as something that they have to do, and it usually doesn’t work as well if it gets handed down from the top as, ‘Someone should do this.’”

“What laboratories should know is that this is easier than you think,” he concludes. “And there’s no reason to shy away from it.”

Anne Ford is a writer in Evanston, Ill.

Laboratories interested in ISO 15189 accreditation, or those that are already ISO 15189 accredited but wish to exchange information with peers, can request a tour of Henry Ford Health System laboratories, which are an ISO 15189 Center of Excellence and Learning. To request a tour, contact Caroline Maurer, director of CAP 15189 Laboratory Improvement Programs, at cmaurer@cap.org or 847-832-7451.