College of American Pathologists
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  Point-of-care testing through the lens of Lean


CAP Today




April 2010
Feature Story

Anne Paxton

Stephanie Mitchell, RN, MBA, first heard about Lean management about five years ago when her laboratory’s medical director, Mark Pool, MD, handed her a brochure and suggested she look into it. As administrative director of laboratory services at Riverside Medical Center in Kankakee, Ill., a 332-bed hospital that does nearly 700,000 billable tests per year, Mitchell had just been asked to make yet another round of cost cuts but had run out of ideas.

She had little hope that new management techniques would help. “I can remember thinking, you’re talking about improving quality and we’re drowning here!” she says. But she went to the seminar and was impressed by the case studies of laboratories just like hers. They had achieved dazzling efficiencies and cost savings not by cutting staff but by employing Lean. “They were doing things we had never thought of before, so I came back very excited to put something in place.”

It led to something like a full-scale reinvention of her laboratory—an outcome that many labs have experienced after adopting the strategies of Lean and its model of continuous improvement. With point-of-care testing specifically, Lean frequently allows laboratory managers to make gains in efficiency by extending Lean practices to nurses and others who use POC devices, and by shifting more testing to the main lab to pare down and even eliminate some kinds of point-of-care testing.

Lean has been a mainstay at Avera McKennan Hospital in Sioux Falls, SD, for at least six years, since administrative director Leo Serrano arrived. At his previous job at West Tennessee Healthcare, Lean had come along at the perfect time. “We were in the middle of trying to design a new lab, and West Tennessee became the second Lean project of Ortho Diagnostics’ ValuMetrix program. Using Lean, we wound up being able to design our new lab one-third smaller than what we had predicted, and we gained an enormous amount of efficiency and productivity.”

When he came to Avera McKennan, which recently earned CAP 15189 accreditation, “We took Lean to the next level and we haven’t stopped since.” The primary impact of Lean on point of care: keeping such a rapid turnaround time in the main lab that point of care is necessary only in certain areas of the hospital.

Value-stream mapping, a means of visualizing the processes that go on in the lab, was a core component of the leaning of Avera McKennan. “We value-stream map virtually everything. Once you visualize the entire value stream and flow chart all the processes and times and communication efforts you use, when you look at it, the bottlenecks and opportunities for improvement jump right out at you.”

With point of care, which RNs, respiratory therapists, and some physicians do, “we were fortunate that the hospital has embraced Lean in a number of areas, so in the ER, and in nursing units, Lean concepts were not lost on them. We were able to give them standard work on how POC work should be done, whether it was bedside glucose or i-Stat or whatever other few tests we’ve allowed them to do.”

The key impact of Lean, however, has been the sharp reductions in turnaround time in the main lab—largely achieved through constant tracking. “I’m a Lean purist. I’ll admit that I’m a Lean snob, and I was trained in the true tradition that if you don’t measure it, you can’t improve it. So we measure everything we do. That includes turnaround time by the hour,” Serrano says. Every morning he pulls up the TATs for the previous day as an average and for individual tests. “We can tell when something is slower and then we can go back and do root-cause analysis on why it’s slower.”

For example, the average TAT for CBCs is about 22 to 23 minutes, with results returned sometimes as quickly as eight to 10 minutes, he says, noting that even though the lab is a quarter mile from the hospital proper, the high-speed pneumatic tube system makes the distance seem negligible. “For our basic or comprehensive metabolic panel we average about 35 minutes from collection to availability on the EMR, and our troponins are right at 34 minutes.”

“This has made us able to fend off pressure for some kinds of POC testing,” Serrano says. The lab supports POC testing as appropriate under certain clinical conditions in certain areas, “and we actually go out of our way to make sure it works well.” However, use of i-Stats and other such units is tightly controlled because TAT from the main lab is good and the cost is lower. “That’s been drilled into clinicians and nursing staff very, very heavily.”

Another routine: “We track errors like you wouldn’t believe.” In the laboratory, this Lean practice has resulted in a 5.4 “Sigma rating” or better for almost five years‚ meaning it has reduced its error rate for patient identification to less than 80 errors per million opportunities. “It’s one of the things we’re most proud of,” Serrano says. However, POC identification errors are much higher—often because, as a tertiary care center, Avera McKennan receives many patients with wristbands from another institution, and these bands are sometimes left on by mistake.

Serrano believes the lab needs to remember it has a fiduciary responsibility as well as patient care responsibility. “If you have really good turnaround times, in effect you’re reducing the demand for expensive POC testing. The more your physicians and caregivers can rely on rapid TAT, the less likely they are to demand rapid POC. And it’s worked extremely well for us.”

At Riverside Medical Center, the Lean team consisted of five members who were dedicated to the three-month project, Stephanie Mitchell says. Initially the team followed laboratory processes, starting with a videotape of the phlebotomist and how blood was coming into the lab. “That was an instant success,” she says, “because the videotape showed clearly how batching the specimens meant they sat on the cart for long periods as other draws were done. We would look at the draw at this time, and watch it sit there, then write down how long it sat in the cart.”

Following Lean’s emphasis on first-in-first-out processing, “We immediately went to single-piece flow as best we could. After every one to three patients, we had them take the specimens to the pneumatic tube system and send them down. That step, eliminating waste in the system, dramatically reduced our turnaround time right off the bat.”

“With Lean principles, you try to eliminate batch processes,” she says. “On some instruments, it’s more cost-effective to run a batch, like some molecular tests. But we try to look at everything and not batch what we do.”

Her laboratory is in its fourth year of measuring and posting turnaround times on specific tests every day, and it has paid off in point-of-care cost savings. “In the ER, nurses were doing troponins at point of care, and for their department it was a hassle because they were under the same pressure we were to reduce costs,” Mitchell says.

The laboratory’s TATs were so good, the ER ultimately eliminated its point-of-care troponin testing and now all troponin tests are done in the lab. “Even though they had their own point-of-care instrument, they just found it was much easier and faster to send it to us. They were considering performing blood gases themselves as well, but that was another test we decided not to do at point of care because we could get them results faster.”

Audits and metrics are key in keeping changes in process on track. “We have a big-screen monitor that visually allows us to track turnaround times—patient names in yellow is a warning, and red means they’ve exceeded the designated turnaround time. Similarly, TATs are posted daily for troponin, potassium, CBCs, and other tests, both for inpatients and for the ER. “If the TAT for that day exceeded the goal, they’re red.”

The principle of standard work is central to Lean, Mitchell notes. “The staff throughout the project figure out the best processes. And once they figure out the single best way, everybody has to do it that way.” For example, phlebotomy carts were standardized so any phlebotomist could grab any cart and go. “We took a picture and laminated it so we can visually see if the carts are stacked per standard work—how many gold tubes, just how many purple tubes, should be stocked.”

A surprising drain on efficiency can be the amount of time people take to look for something, Mitchell says. “We actually taped off certain areas on the tables, so when a lab assistant has a rack of tubes and takes it back to drop it off, there’s blue tape around the spot, so she knows exactly where to take it. There’s tape to show where the stapler should go, books are in order, that supplies are in the right place. Because only those supplies needed in that core are there. Everything not needed was removed.”

Similarly, the Lean two-bin replenishing and kanban-cards system ensures that supplies don’t run out when they’re needed. “When one bin is empty, they have a specific place labeled that they put it. Then they use the bin underneath so they don’t have to stop and get supplies. At a certain time of day, somebody’s scheduled to replenish that bin, so no one ever has to go hunting for supplies.”

To facilitate the inventory control, kanban cards are used to determine par levels of supplies. The laboratory uses these cards to determine what supplies are needed, when, and how many. The team also emptied cupboards, cleaning out extra “stashes” of supplies, and preventing more stashes by removing the cupboard doors.

“You get everything out of the area that you don’t need, then tape areas to show where things are supposed to go,” Mitchell sums up. “Not running out of supplies means staff can keep on working, not be distracted, and concentrate on what they need to, which is working on the instruments.” Through this more efficient stocking system, the laboratory was able to decrease inventory by more than $20,000.

Wasted steps were uncovered in the value-stream mapping process. “Techs were walking all over the place, trying to find supplies, or standing and waiting over an instrument while it runs when they could be doing something else—and that’s waste. But when you eliminate steps, you eliminate errors.”

After removing all the walls in the laboratory to reduce the number of steps, all manual testing was moved to a different area—“blood gases, urines, anything not on our core instruments—so the person working with instrumentation could continually flow,” Mitchell says.

“We are trying to really look at the ‘Why’ in improving processes, and it’s not always what’s on the surface; you have to dig deep into the root cause of the problem. In Lean, you refer to the ‘Five Whys’—based on the philosophy that it takes asking the question ‘Why?’ five times to get at the real issue.”

Breaking down a process by looking at it from start to finish, the Lean team then looked at which steps were value-added, non-value-added, and pure waste. “We used pie charts throughout the lab to post each process, showing, for example, the 26 ways a specimen came into the lab, and looking at the steps they did and what part was value-added versus not-value-added. And we tried to decrease not-value-added.”

Post-Lean, laboratory inspection visits are much easier. “We had our first unannounced CAP visit in the middle of adopting Lean,” Mitchell says, and that was somewhat stressful. “But now we have things in place; it’s very systematic, very organized, so anytime somebody wants to come in, we’re always ready.”

In 2001, when Virginia Mason Medical Center in Seattle began its Lean journey, it was pretty much unheard of, says Ka­therine A. Galagan, MD, director of clinical laboratories. As then-chief of pathology, she organized the first impromptu workshop at the medical center as an experiment of sorts. The experiment, which looked at histology workflow, was surprisingly successful, even though her understanding of Lean at that point was limited. The entire executive leadership team went to Japan the next summer to study Lean in depth. “We all then became certified leaders, and now we have our own institute, and people come here from all over the world to study and do projects with us,” Dr. Galagan says.

Understanding the Lean concept of standard work wasn’t that hard for laboratorians, who are used to following procedures, she says. But it was a bit more of a stretch to convey the concept to others around the medical center. In fact, “It was a real struggle. I think at first it was very much seen as a negative, that trying to control processes and waste meant people would be losing their jobs, despite our assurances that nobody would lose their job.”

Not everything went smoothly, Dr. Galagan recalls. “For our first project in the clinical laboratory, we tried to have phlebotomists drawing patients whenever and wherever they wanted. And they were not successful because the medical center is just too big and our staff was limited.” It was the equivalent of trying to take on world hunger, she says. “We learned we needed to focus the projects and that scale was really, really important. And once we started doing that, we got very good traction.”

The starting point was value-stream mapping. “You observe processes, write down every step, then measure. And as you measure, the thing you see most is waste.”

In the course of value-stream mapping, the team leader or process owner develops a “spaghetti map,” a way to physically represent the area and its processes with lines and arrows showing where people or things, or both, are moving.Virginia Mason Laboratory “So the value-stream map, the time observation form, and the standard worksheet or spaghetti map are tools the team can use during the week of the Rapid Process Improvement Workshop [RPIW].” During the RPIW, the team members come up with five or six different ways to solve the various waste problems, Dr. Galagan explains. “The fact is they already have ideas, because they’ve been doing the process and know where the waste is. The team leader and workshop leader will push them to think of even more ideas. Then these ideas are tested during the RPIW week.”

Another useful tool is the kaizen event. “You might choose to do a kaizen event instead of an RPIW, which is basically a smaller RPIW that is used to bring about a more focused improvement or change,” Dr. Galagan says.

Sometimes improvement in the laboratory involves reaching out to partner with clinical areas in the hospital or outpatient clinics. Specimen transportation is a good example of an area the laboratory has been able to improve through an RPIW in conjunction with its clinical colleagues. “We had already done a lot of work in the anatomic pathology area to improve specimen flow, and we noticed we were getting specimens from the day before or two days before, so we asked ‘How come?’”

“We found that some of the biggest problem areas were in GI, dermatology, and our general internal medicine clinic, and there were all sorts of reasons these samples were sitting there. In dermatology, specimens were sitting in the doctors’ pockets until they had time to fill out the requisitions. In GI, they were sitting in a box waiting until lunch time or the end of the day before being sent down.”

The team developed solutions to address this problem three or four years ago, and the solutions helped, Dr. Galagan says. “But now we are back to having the specimens sitting again in a few areas. So if people don’t keep to their standard work, or new people come and don’t get taught, things can slide back. You have to make sure Lean is an institutionalized process that goes on continually.”

Coincidentally, she turned her attention to improving point-of-care testing at about the same time the hospital was adopting Lean. “When I became laboratory director in the early 2000s, I was very interested in getting a handle on the POC testing, which was all predominantly manual, not well documented, not well billed, with few training and competency checks. So the first thing we did is put in connectivity for our glucose meters, which allows for automatic download of the testing into the laboratory information system, allowing us to chart results, bill, track errors, and use lockouts if QC isn’t being done or if operator training isn’t up to date. Connectivity is being used in many medical centers now, but if you think of this solution in Lean parlance, you’d say you were eliminating waste and defects and creating standard work.”

Connectivity and Lean both stem from a drive for efficiency and error prevention. “The good thing has been that since the entire medical center understands Lean, we don’t have to convince people anymore that it’s all a good thing. When they get locked out, which doesn’t happen very often, they understand why it’s important.”

Changes in nursing workstations due to Lean management have also had an impact on point of care. “Under Lean, you make sure everything is where you need it. So when you come back to the nursing station, they set it up so you can download the meter right there instead of having, say, to walk into a utility room.”

However, the nursing department made a decision recently that has caused concern. “We have a little glitch, because they decided to cut down on all the things that were required for training, and they removed our POC module.” Predictably, that showed up in the numbers, she says.

“We monitor them, and all of a sudden we noticed more people being locked out, so we started investigating and it became clear that POC had been removed from their training program. The nursing educators looked at all the things nurses have to do and decided that one wasn’t important. So we actually are planning a kaizen event to make sure people get the training they need in a timely manner, and don’t get locked out.”

The patient identification and labeling arena is a perfect one for Lean tools, Dr. Galagan says. “We’ve actually been collecting data for many years and using it to drive improvement efforts. We’ve found it best to go to the high-error areas and work directly with their managers.” As a result, “we’ve seen a continual decline in the nurse-collected specimen labeling error rate.” In the laboratory, the mistake-proofing process that is part of Lean has brought the phlebotomists’ patient identification errors down to one or none per month. “In fact, over the past year, there were only two labeling errors in more than 165,000 blood draws.”

Making sure that “value-added” steps are retained in processes is another Lean practice that has helped improve POC testing, Dr. Galagan says, though it was done via connectivity. “When we first instituted POC connectivity for glucose, the results were being charted sporadically, and in parts of the medical record where they were not easy to find or compare to laboratory-drawn glucose tests. We also were billing only hundreds of tests per month. In the first month of connectivity, the charting and billing went up into the tens of thousands.”

Virginia Mason laboratory administrative director Lee Darrow, MT(ASCP), SBB, says mistake-proofing is the primary part of Lean that affects POC testing.

“In Lean, one of the things you do is look at how you can mistake-proof processes. So as we made decisions about which glucose meters to buy, for example, we checked out how they could enable us to limit the possibility of a nurse doing a sugar on the wrong patient or running the instrument without being completely oriented to it.”

The more you improve processes, the more you uncover ways to improve, Darrow says. “We call it ‘lowering the water level that exposes the rocks.’ You’re constantly finding more and more processes, motions, and actions that are done that are wasteful. At the same time, you’re much more alert to safety and to picking up issues that could be potential hazards either to staff or to patients.”

Anne Paxton is a writer in Seattle.