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

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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.’”

‘Everybody’s process now
is visible, so everybody’s
paying attention to their
section and how they
contribute to the overall
turnaround time.’ — Grace Deneke, MA, MT(ASCP)

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.”


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