College of American Pathologists
Printable Version

  With Lean’s help, 14 inspections soon to be one


CAP Today




October 2008
Feature Story

Anne Ford

When Hans Froehling, PhD, joined Fort Lauderdale, Fla.-based Integrated Regional Laboratories three years ago as deployment leader of IRL’s Lean Six Sigma quality assurance initiative, he knew it would take a little while to get himself up to speed on the QA needs of the system, which consists of 13 hospital laboratories and one core laboratory, all of them in Florida. “It was a learning curve for me to truly understand what CAP is, what its requirements are, what the HIPAA rules say, what you can and cannot do,” he says. He knew, too, that in a situation such as this one, “you’re dealing with very experienced, highly educated personnel who have been in the field for a very long period of time,” he says. “When you come in as the Lean Six Sigma leader, they look at you like you have no idea what blood is.”

Dr. Froehling, who is now a senior consultant for Chi Solutions, Ann Arbor, Mich., holds a doctorate in business administration and is a certified Lean Six Sigma master black belt. (And yes, he knows what blood is.) His mission at IRL: to introduce Lean and Six Sigma waste- and defect-reduction methods to the laboratory network via several projects, one of which turned out to be the systemwide standardization of laboratory policies and procedures so that the network could be inspected by the CAP as one lab rather than 14.

“You can imagine what it costs to have 14 different CAP inspections—keeping track of the inspections, keeping track of the renewal of licenses,” he says. “IRL really wanted to have one integrated inspection rather than 14, which logistically is a nightmare.”

At CAP TODAY press time, the 18-month project was just about to conclude, in plenty of time for IRL’s first integrated CAP inspection, which is expected to take place between January and March of next year. The aim of the project, in addition to smoothing the inspection process, was to rein in laboratory costs and errors. In the end, it also generated intralaboratory communication that hadn’t previously existed. Before the integration project began, “a blood banker in the south [of IRL’s service area] did not know what a blood banker did in the north,” Dr. Froehling says. “After they got to know each other, it was actually a lot of fun. People knew each other, they called each other, asked questions of each other—something that had never happened before.”

One thing Dr. Froehling knew from the start was that he wanted the laboratories’ staff to feel that he was doing Lean Six Sigma with them, not to them. “You have to get the employees on board,” he says. So for the first few months, all he did was listen: “I visited each of the sites and I had discussions with the directors. They introduced me to their supervisors, who then introduced me to their bench people, and I spent some time on the benches with them and tried to understand what the specific problems of these individual hospital systems were.”

“It’s generally a lot of fun to engage employees in the process,” says Fred Patton, Dr. Froehling’s successor. Patton is IRL’s director of quality assurance and a Six Sigma master black belt. “They know the process better than you do. They know where the errors occur. They had an idea for how to avoid those errors two years ago but did not have a formal forum to share ideas and bring forward recommendations.”

Once Dr. Froehling had gathered enough employee input, he compiled a report listing IRL’s strengths, weaknesses, opportunities, and threats, and shared it with management. One opportunity that could benefit from Lean and Six Sigma principles, he successfully argued, was the CAP inspection project, which had been on IRL’s to-do list for some time without much progress having been made. Teams for microbiology, chemistry, hematology, and other disciplines were created, with each one consisting of representatives from each of IRL’s facilities. After each meeting, team members conferred with their laboratories’ pathologists and included their feedback in the next meeting so that, as Dr. Froehling says, “the pathologists never got blindsided” by the changes that were made.

To laboratories considering similar projects, Dr. Froehling stresses the importance of building relationships. He took time to “mingle and be seen”—that’s one of the recommendations he would make for anyone who wants to do this. “You cannot just communicate via e-mail. You have to be physically present,” he says. That’s because if you’re perceived as an outsider, the project will suffer: “It has to be an insider who does it, somebody who understands the organization, who understands the culture, who understands the people.” The ability to quickly size up personalities and identify strong project and team leaders is another must. Otherwise, as Dr. Froehling puts it, “you lose the game.”

Gay Prillaman, BS, MT(ASCP), Six Sigma black belt and the integration project’s team leader for hematology, makes it all sound a lot like spring cleaning on a vast scale: “We standardized instrumentation. We all have nice new instruments. We’ve all gone to the same kits. We’ve looked at best practices. We’ve removed processes that weren’t as productive. We’ve standardized all of our critical calls and all the reference ranges, the same INR, the same ISI. We’re all using the same lots of reagents. We’ve created a Lean principle throughout the entire system.” In addition, CAP standards now govern two laboratories that had previously been inspected by the Joint Commission.

If getting 14 laboratories to agree on new or modified institutionwide policies and practices sounds like herding cats, it was. Prillaman says: “We have hospitals that are quite rural, we have hospitals that are very metropolitan, we have hospitals that are primarily women and child­ren. You have pathologists who are more oriented to the pediatric market, and some to the geriatric market. It’s resulted in quite a few phone calls to CAP. We’ve been using CAP as our referee in a lot of the processes.”

Still, “we have nobody bloody and bleeding,” Prillaman says. “Everybody is still really excited” about the project’s benefits. For one thing, “if we run out of a kit, we can call one of our sister facilities and borrow something from the same lot, which is always nice. We also know who does what test.” In addition, they were able to centralize some things. “With us needing a control plasma to do mixing studies, it meant that a lot more of the mixing studies come to the core lab because we have the -70° freezer to store it in,” she says.

Another big plus: being able to have laboratorians from one site substitute for or supplement staff at another site in case of emergency. “I don’t know if you’re familiar with south Florida. We have these things called hurricanes,” Prillaman says. “We’ve had instances where one facility had individuals who couldn’t make it into work because they had trees through their roofs.” Now that the laboratory processes are standardized across the network, workers will be able to fill in more easily at sites they don’t normally cover.

Surprisingly, what would seem to be a simple, straightforward project step turned out to be one of the most difficult: getting pathologists to sign off on the new procedures. That’s because, as Dr. Froehling puts it, “Pathologists like to do pathology.” As opposed to? Paperwork. Specifically, paperwork about new policies. The kind of paperwork that physicians often just don’t have time to deal with in the course of the day. The kind that, left unchecked, could circulate between laboratories in a massive system such as IRL’s for years. The kind that makes the lower lips of even the most hard-edged project managers start to tremble as they realize that the sign-off sheets they so laboriously circulated are slowly, inexorably turning into desk mulch in a building two towns away. In short, “you cannot just assume that you give out an order and 14 pathologists will sign off [on it],” Dr. Froehling says. “It’s just not going to happen.”

“Physicians get busy and it sits on their desk,” Patton says. “It was literally taking months for one set of policies and procedures” to circulate among the laboratories and return with all the necessary signatures. The answer turned out to be a better process, one brilliant in its simplicity: Instead of circulating one piece of paper among 14 pathologists, send each pathologist his or her own copy. “We didn’t need 14 signatures on one piece of paper. All we needed was 14 signatures. It was more work on our end, but it turned out to be a much more efficient process. Sign it, get it back to us,” he says. Now “we’re getting them out there and back in about two weeks.” In the future, similar sign-off processes will become even easier with the use of SharePoint, which will make it possible to manage and distribute policies and procedures electronically. (“I’m really looking forward to that,” Patton says fervently.)

Its CAP inspection project may be nearly complete, but that doesn’t mean IRL is finished with Lean Six Sigma methods. Patton and Prillaman continue to lead Lean and Six Sigma projects for laboratory quality and process improvement. Patton, for example, just initiated error-proofing for two of the departments. “There’s a whole variety of simple things that can be applied to avert errors,” he says. And error-proofing is a more effective strategy than double-checking or re-training employees who make mistakes, he adds. “Here’s one example: We were getting some errors in our specimen processing area, and partly the cause was that the specimens that the couriers would pick up in the physicians’ offices came in mixed from different sources. Maria Garcia, who is supervisor of specimen processing, created separate bins for certain types of work, particularly new accounts we were concerned about. Sometimes the approach is quite simple.”

Another concept from Lean Six Sigma that Patton has found success with at IRL is the 5S program (“sort, set in order, shine, standardize, and sustain”). “The function of 5S is to simply clean and organize the work environment before you try to enter a Lean project,” he explains. “It reveals the work process more clearly to you. It’s a matter of cleaning up, straightening the environment, getting rid of things you don’t need, making things you do need readily available to the worker.” A departmental award program was created. “It’s not a lot of money, but people got very competitive about it. For example, boxes on the floor are considered fire hazards and may be damaged if the sprinkler system goes off. So any boxes in the area have to be on pallets. People went out and bought pallets and organized their environments. They got very invested in it, and it’s made a big difference. The change in cleanliness in the lab was dramatic,” Patton says.

IRL will only find more Lean Six Sigma applications from here. “Last year we had five projects. This year we’ve got 12, and more in the pipeline,” Patton says. “Our ability to do more is growing. The more we can strengthen that, the more thoroughly we’ll be compliant with CAP.”

Anne Ford is a writer in Chicago.