College of American Pathologists
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Lean, mean—the evergreen hunt for efficiency

August 2004
Karen Lusky

Call this a tale of two very different laboratories that have scored similar gains in productivity, safety, and cost savings by applying Lean manufacturing and other process-improvement models. The central and common focus in their quests: the specimen.

West Tennessee Healthcare’s core lab in Jackson, Tenn., and the Cleveland Clinic Health System’s surgical pathology lab followed the flow of specimens from collection to reporting of results to identify and drive out the bottlenecks. As a result, West Tennessee has shaved its mean turnaround time from specimen collection to test results in its central lab from 71 minutes to 33 minutes, says the lab’s former executive director Leo Serrano, FACHE, CLSup(NCA), now director of laboratories at Avera McKennan Health System, Sioux Falls, SD.

The Cleveland Clinic’s surgical pathology laboratory last year handled 87,000 surgical specimens, up from 57,000 five years ago, with the same number of technical staff and only eight additional pathologists hired to "increase the depth" of its new subspecialty practice approach, says David Hicks, MD, director of surgical pathology. And the histology laboratory reduced its turnaround time, with the most dramatic gains in immunohistochemistry. The lab is now able to offer same-day IHC results (ordered before noon).

Serrano and Dr. Hicks chronicled their labs’ success stories in separate presentations at the recent Executive War College in New Orleans presented by The Dark Report.

In 2003, West Tennessee Healthcare, a six-hospital system anchored by Jackson-Madison County General Hospital, began implementing Lean manufacturing principles, which focus on producing single-piece flow wherever possible and eliminating wasted time, space, and materials.

To start out, a West Tennessee Healthcare dedicated Lean team videotaped and mapped every movement of specimens and employees. This way, the team could spot where things were happening to the specimen that didn’t contribute to a quickly reported and accurate test result.

Using the video, the Lean team identified what’s known in Lean speak as "inventory time," whereby a specimen sits around waiting for something to happen to it, which is a waste of time, literally, and slows the process.

West Tennessee’s core lab had dabbled in workflow analysis using Japanese manufacturing concepts years ago when an equipment vendor offered it as a value-added service. "But we weren’t smart enough to know what the vendor’s consultants were trying to do," Serrano quipped in his War College presentation, "Confessions of a Sinner: I Automated Bad Processes in My Lab." Serrano recounted how, in 1996, when an automation line was added to West Tennessee’s core lab, the demands of the automation dictated placement of equipment and workflow. "Automating bad processes will only make them worse," Serrano says.

That was a mistake that Serrano, who says he "doesn’t like to be bitten by the same dog more than once," definitely wanted to avoid when West Tennessee decided to build a new laboratory, expected to open this fall. So the health care system contracted with Johnson & Johnson’s Ortho-Clinical Diagnostics to help it design the most efficient and productive laboratory possible by using Ortho’s Performance Excellence program, a combination of Lean, Six Sigma, and Design Excellence. "The lab has been designed for a Lean, Six Sigma lab environment," to the extent that West Tennessee was able to reduce its projected 60,000 square footage requirements to 40,000 square feet. And given that construction and equipment costs run about $200 per square foot, the health care system saved $4 million, Serrano told CAP TODAY.

Performance Excellence required the West Tennessee Healthcare lab staff to start "leaning out" all of its work processes from the front-end collections to processing and testing.

The Lean team started by tackling phlebotomy. Phlebotomists now pick up test request labels at a standard place on each floor of the main hospital, which houses the core lab. "The phlebotomist picks up requests one at a time, follows the procedure for identifying the patient, collects the specimen, and tubes it to the lab," Serrano says. Then the phlebotomist takes the second request and follows the same process, and so on. The lab processes the specimens in the order in which they are received, thus creating a single-piece flow production line with a first-in, first-out approach to collecting and testing specimens and reporting results.

Where does Six Sigma fit in the picture? Once Lean eliminates the waste, Six Sigma tackles the remaining areas of variability or defect through root-cause analysis, says Maria Foster, national director for ValuMetrix Services at Ortho-Clinical Diagnostics. "If you try to implement Six Sigma before Lean, you end up chasing your tail," she says.

For example, once the phlebotomists were following the new single-piece flow routine, then a Six Sigma project was able to identify which phlebotomists were beating the benchmark time, which is an average of the best and average performers. By analyzing how these top performers did their jobs, Serrano says, "we identified the best practices to teach to phlebotomists who aren’t measuring up." Management continually identifies the phlebotomists who don’t hit the benchmark time to help them fine-tune their performance.

The Six Sigma project reduced the time it takes to get the specimens to the lab to an average of 5.2 minutes, as of May 2004, Serrano told CAP TODAY. "That’s an enormous accomplishment when you consider that we started out in excess of 20 minutes," he adds.

In the West Tennessee central laboratory, the Lean team reorganized the work cells around similar automation rather than segregated departments. Says Foster, "By combining similar instrumentation processes in a single cell, you increase flow...and generalists can handle the high volume in the work cell where the focus is on the majority of the testing the lab does," which in most central labs is chemistry, immunoassay, hematology, and coagulation. "Those tests go to the generalist and the rest go to the specialist—you take the latter offline to prevent it from slowing down the flow," Foster says.

The Lean team also established standard workflow patterns within each work cell. Says Serrano: "If a work cell has one to three instruments and we determined there was a cycle time of five minutes from the time when the specimen is received to completion of the tests, we know that every five minutes the operators would be doing a loop in that work cell by hitting each item as it came through." That approach standardizes and levels the workload. Staff in Lean environments are encouraged to work at a calm, quiet, even pace, which means holding off on the social interactions until break times.

Next they had to figure out how to ease the bottleneck of large batches of outreach test specimens delivered by its couriers each day from more than 1,100 clients in 27 counties, most of them rural. The lab decided to break up the batches by adding short-distance runners to meet the couriers midway through their routes to bring back the specimens. "Yes, the specimens still arrive in batches," Serrano says, "but we process them using single-piece flow with a first-in-and-first-out approach with enough processors so they are constantly being fed into the system."

They also reallocated work to material handlers who load specimens directly onto the analyzers (but don’t actually push the button, which Tennessee regulations prohibit). This approach speeds delivery and loading of specimens, and it frees the technologists and technicians to do what they do best: test specimens. Says Foster, "The med techs become like the chef who can focus on the meal without chasing the lettuce and tomato and meat slicer, or the surgeons where other people provide them the materials required to perform what they have been trained and are paid to do."

What kind of measurable outcomes have the Lean and Six Sigma projects at West Tennessee produced to date? As of Serrano’s War College presentation in April, the lab had gone for 11 months without one documented patient identification error by a lab employee. "We don’t want to say they’ve actually gone away because we have a Six Sigma project looking at labeling errors by nursing and medical staff in the emergency room," Serrano says.

Even though the volume of testing in the central lab has increased by 1 million tests in the past two years, the lab staff has been able to do the testing at an even pace with four fewer medical technologists on the day shift than required in the pre-Lean days. The lab reassigned the four staff members to meet other organizational goals, such as clinical teaching and continuous performance improvement, says central lab manager Debbie Robinson, BS, MT (ASCP) SC.

This staffing efficiency has also freed up personnel to expand molecular diagnostic testing. The lab was able to begin offering fluorescence in situ hybridization technology for breast cancer testing in the anatomic pathology lab without adding new FTEs.

While Serrano doesn’t have data to show how the improved turnaround times have affected patient care, his "best proof is that the emergency department docs used to clamor and scream for a lab in the ER but now realize there is no need," he says. Another study in progress at West Tennessee has shown that the quicker TAT on test results has reduced the length of stay in the ICU by a third of a day—not as much as Serrano had hoped, but the savings do add up.

The West Tennessee central laboratory continues to make improvements, most recently in acquiring automation that fits its Lean scheme. The lab chose the ThermoElectron automation that Ortho sells in the United States. "It’s a whole different concept of automation and it is very much attuned to the single-piece flow," Serrano says. For example, centrifugation is the only time a deviation occurs in single-piece flow, but the new EnGen, a robotic track system, uses two arms per centrifuge that operate independently, he adds. "So one robotic arm can be loading while the other unloads, which is faster and more efficient."

The EnGen also processes the blood and sends the tubes to one of the lab’s Vitros 950s to be automatically sampled, Robinson says. "If the sample isn’t supposed to be directly sampled on the 950, it gets routed to a specific drawer . . . which enables the tech to simply take the samples out of the assigned drawer for the instrument that will perform the test," she says. Both spun and unspun samples can be placed on the EnGen. The drawers in which the samples are placed determine whether the robot will take them to one of the two centrifuges or simply route them to the 950 or a drawer.

Though the automation is impressive, Serrano is quick to point out that it’s not a panacea. "The solution lies in your processes," he says.

The Cleveland Clinic Health System includes nine community hospitals, two affiliate hospitals, and a downtown campus or the "mother ship" in Cleveland. It embarked on its process improvements in 2002 at the request of the new anatomic pathology department chair, John R. Goldblum, MD, and with the aid of a strong team that consisted of many, including Carol Farver, MD, and Jennifer Brainard, MD.

"The new chair had a vision of moving toward more molecular pathology," Dr. Hicks said in his War College presentation. The AP department, which had a longtime reputation for excellence, was also starting to heave at the seams with increasing volumes and the demand for immunohistochemical testing (a 50 percent increase in the past three years and still climbing) at a time when resources were declining.

Dr. Hicks and his colleagues traced how specimens moved from their point of origin in the operating room or clinics through the reporting of test results. They found the bottlenecks to be "mind-boggling," Dr. Hicks says. "Looking at the whole complex process, we decided we needed gains in every area to make it work better."

Take the histology laboratory, which sections its own tissue blocks for IHC and chromogenic in situ hybridization, or CISH, and other molecular procedures, including clinical and research assays. In tracing the specimen flow, Dr. Hicks observed 200 to 300 blocks coming off the tissue processor at a time; each block had to be embedded in wax, which the staff couldn’t begin to keep up with all at once.

To resolve the bottleneck in embedding, the lab staggered the stop and start times for the tissue processors so the blocks would come out at different times. Dr. Hicks then rearranged the histology staff and added an evening and night shift to handle the workflow. As a result, the staff was able to produce close to a continuous throughput. "It wasn’t perfect," he says, "but we realized several hours’ gain in terms of when the slides came out" for pathologists to sign out.

Cleveland Clinic’s surgical pathology laboratory worked with Ventana Medical Systems to achieve its goals of using automation to improve productivity and efficiency. In June 2002, the IHC lab converted to a fully automated instrument for routine diagnostics and research IHC and CISH testing. Once the tissue blocks are embedded and cut, they are loaded onto the BenchMark, "a fully automated staining platform that offers walkaway automation by performing the baking, dewaxing, cell conditioning [for antigen unmasking], and staining steps all online," says Jack Phillips, director of marketing for Tucson, Ariz.-based Ventana Medical Systems.

The instrument uses standardized protocols, which can be customized, along with standardized reagents. The computer on the stainer reads a bar code placed on the slide which tells the computer which agents need to be dispensed on the slide for the particular staining protocol.

Using the previous semiautomated system, pathologists were ordering the stain to be redone (at no cost to the patient) 25 percent of the time because of a problem with the staining or with other processes that went awry. "In the first five months after implementing fully automated staining systems, the number of no-charge repeats fell to 14 percent . . . and is currently at three percent," Dr. Hicks reports.

The new automated system also makes it possible for the lab to work up and validate new antibodies and probes for IHC and CISH testing at a clip of three to six a month. "With the system we use now, working up new antibodies is easier because everything is online—the computer controls, the times, the temperatures, the enzymatic digestions," he says. "So you dial in your conditions and do a run and the computer can provide different conditions for each slide so you can test a bunch of different conditions."

The Benchmark system also eliminated an occupational safety hazard: Histology technicians no longer have to put the slides in a dish with a buffer, microwave them, and then remove the slides from the micro and hot buffer before placing them in the staining machines, as they used to do when using the semiautomated system. "Some staff had been burned performing the manual steps before the laboratory implemented the fully automated system," Dr. Hicks says.

To boost the efficiency of its pathologists, the AP department moved from a generalist pathology model to a subspecialist model, a change that clinicians had been clamoring for. "Cleveland Clinic has a group of specialized surgeons who just do breast cancer or colon cancer or we have prostate surgeons or kidney surgeons," Dr. Hicks says. But under the generalist model, the pathologist in the signout room would be responsible for handling whatever came his or her way. "So sometimes the pathologist would seek consultation from pathologists with the most expertise in certain areas," which interrupted everyone’s workflow.

The subspecialty signout has advantages. Pathologists can develop their subspecialty skills in areas in which they have the most interest, thereby promoting scholarly productivity and academic activity. And residents can learn from the most experienced expert on each case.

Under the subspecialist model, cases are assigned at the time of accessioning. The accessioning desk puts cases into color-coded cassettes using a 14-color scheme with some colors that have exotic names. "The histotechs then sort by cassette color at a triage table placed just beyond embedding, which also helps prioritize the cases as to which ones should be cut into blocks first," Dr. Hicks says.

The AP department decided that each pathologist could cover no more than three subspecialties. And pathologists selecting high-volume subspecialties may handle only one. "For example, someone could do gastrointestinal or genitourinary alone and be very busy," Dr. Hicks notes. The department maintained a generalist approach in handling intraoperative consultations. The assigned pathologist consults with the subspecialist pathologist if he or she has a question about a frozen section.

To expedite paperwork, the surgical pathology laboratory began using Kurzweil Voice, a voice-recognition system in which simple biopsy reports are dictated into a microphone and then automatically typed. The lab outsourced its larger reports to an overnight transcription service where transcriptionists are paid by the word and docked for late reports. "Thus, the paperwork is available much earlier and more closely matches the time when the slides are available," Dr. Hicks says.

He began making daily rounds in the lab at 6:30 am and 4:30 pm to identify problems earlier and to assess workflow and make appropriate adjustments. What he saw was histotechnologists doing a lot of non-histo activities. "So we hired aides to provide clerical, technical, sort and distribution of cases and do the final quality control" before the slides went to the pathologists. The lab also made more use of physician extenders and pathology assistants in the grossing area.

Collectively, the changes have revamped turnaround times in the histology lab. Before implementation, the histology laboratory was averaging 900 to 1,500 tissue blocks per day, "and there were never slides available in the evening for residents to review before the pathologists signed them out," Dr. Hicks says. "The biopsy results dribbled out of the lab during the day, with the last ones coming out between 3 and 5 PM."

Now the histology laboratory is handling the same number of blocks, but the slides come out throughout the day at a steady pace and the work is completed, with results reported, between noon and 1 PM on most days. "And 15 to 20 percent of the cases are previewed by residents in the evenings and then signed out by the pathologists in the morning," he says.

The Cleveland Clinic also wanted to improve the biological quality of the pathology archives, which is vitally important given the role of molecular pathology in tumor diagnosis, prognostication, and predicting a patient’s response to therapy. "The critical role specimen integrity plays in producing accurate information [for these purposes] demands an active lab quality control program and standardization that extends back to the grossing room," Dr. Hicks says. His department tried to find ways to minimize the time between biopsy and fixation. For now the lab is using neutral-buffered formalin as the fixative, which Dr. Hicks has found doesn’t alter the DNA in the specimens, as does a copper-based fixative the lab had used previously.

Over- or under-fixed tissue can impair the results of molecular testing, and he and his colleagues have therefore tried to standardize tissue fixation, fixation times, and processing. "We try to place appropriately trimmed tissue into the fixative as soon as possible, with fixation times of several hours, and then put it on the processor. Grossing of tissue is very precise," he says. "Our pathology assistants have gotten used to [the standardized method] and we no longer see cassettes with fat oozing between the cracks."

To help AP labs work even smarter, the Cleveland Clinic is one of several institutions doing a beta trial of a lab information system connectivity project with Ventana. "The initiative interfaces the LIS to the Ventana staining instruments, which is the first time that has happened in the AP lab," says Ventana’s Craig Carter, marketing manager for LIS conductivity.

This project is streamlining the way data are entered, simplifying labeling, and enhancing reporting. "A major bottleneck in AP workflow today occurs because a lot of critical data has to be entered a couple of different times," Carter says. For example, as it stands now, the histotechnologist enters accession and test information into the LIS and then again at the staining instrument. "We are going to streamline that process, allowing the LIS to generate the data to produce bar-coded labels automatically," Carter says. Once the labeled slide is placed on the instrument, the stainer will automatically read the bar code and know what test to run.

West Tennessee Healthcare and the Cleveland Clinic surgical pathology lab continue to look for ways to work smarter, but they also recognize the limits of doing ever more with dwindling resources, which has become something of a mantra akin to magical thinking in health care these days. "Through automation and Lean principles, the lab has become more efficient, sort of like the General Motors assembly line in a sense," Dr. Hicks says. "But if the work becomes overwhelming and people can’t get it out without rushing too fast, then there can be errors."

Ortho’s Foster leans in here with a key Lean principle: If the lab staff has standardized its work and fully understands its operations, then it knows when the demand increases and can predict the new operational requirements. "You can clearly articulate and justify with data what you need and where you need it . . . you’re not just operating on a gut feeling," she says.

Karen Lusky is a writer in Brentwood, Tenn.