By Doug Graham
Terms such as Lean, Kaizen, Kanban, and Six Sigma are latecomers in the vernacular of healthcare. Nevertheless, Lean processes have made a deep impact in life sciences, particularly in the area of histology where, until recently, workflow could sometimes chug slowly along. Thanks to both technological and methodological enhancements, processes once entailing days now require mere hours to complete. Here’s a look at Lean from the histological perspective, where the need for speed and absolute accuracy is pushing past old barriers en route to greater operational efficiency.
An Organizing Principle
Crucial surgical decisions are made in the histological laboratory, where a board-certified pathologist and their team work behind the scenes to identify a disease latent in tissue samples and determine its magnitude. Because of the high stakes involved (life and death), a histology lab is an environment of controlled chaos permeated by an attitude of extraordinary urgency. Functionally, a lab is rather like the busy kitchen of a top Manhattan restaurant, except that the frenzied universe of histology allows no room for error. Given that, Lean and histology make for a match as natural as bread and butter.
“Think of Lean as an organizing principle,” advises Martha Foley, Ph.D., global segment marketing manager of research at Leica Biosystems Newcastle, Ltd. (www.leica-microsystems.com), a complete histology solutions provider focused on the spectrum of consumables, reagents, and instruments needed from patient to pathologist. “Applied to histology, the Lean concept focuses on all process elements: workflow for one, sample origin for another, and the speed at which examination results must be turned around.”
There are also mitigating factors in histology that must be taken into account, Foley adds. Breast tissue, for example, is pretty much all fat and must be worked accordingly. AIDS mitigates histological processing as well, as AIDS-infected tissues require much in the way of special handling. These kinds of factors add complication, and for this reason, Lean must embrace an entire histological system and organize it so that work transpires with maximum efficacy and the lowest risk of mishap possible.
Reduce “Wasteful” Activities
Simply put, Lean processes enhance value via the reduction of waste. In fact, strict adherents of this manufacturing/management philosophy cite as wasteful any activity or resource allocation not specifically value-skewed to the end customer. Developed by the Toyota Corporation, Lean principles are also fixed on workflow, or more precisely, on smoothing away ripples from a process stream in the service of efficiency. This has particular relevance in a histology lab where samples transition from station to station, each of which is a time and efficiency roadblock on the highway to examination results.
“Lean methodologies can definitely be applied to histology laboratories,” explains Johnathon Deniz, automation product manager at Leica. “Through the application of such strategies, a lab can achieve all benefits to be had via the Lean concept, including waste time cutback, greater productivity, and reduced turnaround. One of Lean’s most attractive attributes to histology is its propensity to bring departments together, simply because it’s the one tool that puts everyone involved on the same page. People can actually see how their actions affect one another and contribute to turnover and/or throughput overall.”
Pinpointing Improvement Opportunities
Value stream mapping (VSM) is a Lean building block that is directly connected to histology. Like all Lean processes, its principal emphasis is on waste eradication. But VSM goes further by carrying waste erasure to the next level by pinpointing improvement opportunities.
So how does this apply to histology? “Walk a biopsy or tissue sample through the histology process, and you’ll capture a snapshot of how the laboratory works in real time,” Deniz suggests. “You might find, for example, that your lab overproduces bar code labels, a very wasteful practice. Another possible discovery is that samples are left waiting for someone to collect them or be put through a machine. Wasteful again. Your walk-through may also uncover delays created by massive sample batches awaiting processing. Taken individually, these are little things. Collectively, however, they amount to a gluttonous consumption of efficiency.”
Histological processes can be time-stamped and lead-timed in the form of a value stream map, Deniz continues. When all data is collected and graphed, major hurdles to operational efficiency will be glaringly spotlighted. Delays will nearly always be related to waiting time — waiting for a machine to finish processing, waiting for a staff member to become available, waiting for a pathologist to come forth with a diagnosis. Waiting. Waiting. Waiting.
“We recently conducted a VSM workshop at Addenbrooke’s, one of the largest National Health Service teaching hospitals in Britain,” Deniz says. “We started by querying Acting Histology Manager Ian Sturdgess on how many people he employed, how many machines were at work in the lab, and the average number of slides the machines processed on a daily basis. Upon workshop launch, we asked the histology team to map out the workflow of a typical day using Post-it notes. Then, all personnel were cut loose to commence with business as usual.” Leica Microsystems spent the entirety of the following day monitoring workflow. Five Leica employees joined the teams as the teams went about their tasks, and at day’s end got back together to create an Addenbrooke-appropriate VSM. “The process pinpointed areas of the operation in which future improvements could be made,” Deniz recalls. “The implementation of an LIS [lab information system], for example, would easily shave as much as an hour from the daily routine of the lab’s immunology section, where a good deal of time is spent entering slides. Significant efficiency improvement can be realized via cell-building, and we proposed floor plans in critical areas with that goal in mind.”
More Than Just Time, Efficiency Improvements
Lean histology is also seeing increased acceptance in the United States, as operating costs spike and competition travels in the same direction. Adoption of this model has been facilitated by the creation of technologies designed for bursting through laboratory bottlenecks.
“We recently installed an instrument that allows us to insert glass slides for the examination of special antibody stains during the work day,” says Dr. Bruce Horten, medical director, Genzyme Genetics (www.genzymegenetics.com), a Manhattan-based reference laboratory focused on pathology regarding cancer and prenatal and reproductive testing. “This was not possible with the machines we used previously, as they did not permit the interruption of a cycle in progress. With the new technology, cycle interruption is not an issue, and this allows us to compare new slides with slides already processed in order to come up with a rapid diagnosis. We can now do in a single day what used to take several.”
Lean has penetrated Genzyme’s laboratory processes well beyond histology, Horten adds. In the flow cytometry lab, for example, an assembly line approach was instituted to piecemeal work to a number of individuals rather than to stick one person with the whole project, as was status quo in years past. Genzyme has also Leanified scheduling within its accessioning department in order to fast-forward the receipt of material in the histology lab. Batching, the practice of accumulating cases until they are stacked to the point where they justify processing, is also history. Nowadays, cases are managed instead on a first-come, first-serve basis.
“It goes without saying that the time and efficiency savings provided by Lean are tremendously beneficial to patients,” Horten comments. “But Lean pays a lab big dividends as well. The quality and efficiency enhancements achieved via Lean practice help make a facility much more competitive, and that’s a leg up any enterprise can use.”