September 2012
Feature Story

Anne Ford

Like so many labs these days, Sonora Quest Laboratories in Phoenix uses Lean principles to keep its productivity up and its error rates down. But at least in histology, there remain pressures—big, fat, heavy pressures—that Lean can do only so much to lighten.

“Years ago, you received a specimen in the lab, you had several days to complete the technical portion and get that report out,” says William DeSalvo, HTL(ASCP), Sonora Quest’s system production manager for anatomic pathology. “Now, in most instances, a lot of the specimens received are minute diagnostic material, and they want it out in 24 hours or less. They don’t just want a standard hematoxylin and eosin stain; they want an H and E stain plus IHC, molecular probes, a consultation with specialists, and maybe additional information for an integrated pathology report.

“And when you start moving into digital pathology, which will probably hit the histology lab hard in the next couple of years, you’re going to have even more pressure,” he continues, “because you’re not going to have pathologists available to manipulate and scan the slides. You’re going to have histologists doing that so pathologists can spend their time reviewing and trying to be more efficient.” All that to say: “We have to find ways to be more streamlined in histology.”

Histology laboratories from New Hampshire to Texas agree. They’re implementing all the Lean and Six Sigma possible, bringing in new instrumentation, and even taking a critical look at histology training programs, all in an attempt to boost productivity and efficiency in the face of present and future pressures.

Tammy Biggs, laboratory manager at the Medical City Hospital, Dallas, sums up the biggest benefit of her lab’s new automated special-staining platform in five blunt words: “It frees up the techs.”

That is, Ventana Medical Systems’ BenchMark Special Stains platform eliminates the need for a technologist to spend all day performing special stains by hand. In fact, it requires less than an hour a day of hands-on time, Biggs says. “It deparaffinizes online,” she says. “It used to be that we had to put a specimen in the oven and dry it and put it in xylene and hydrate it, and then put it on the stainer. But now, all we have to do is put it in the oven and dry it.” Moreover, the platform’s individual heated slide platforms make it possible to run, say, a Steiner stain and an acid-fast bacilli at the same time: “It can adjust the heat for each slide, so all programs are compatible with each other.”

“We do a lot of bone marrow biopsies here,” she continues, “and so we have bone marrow smears, and we’ve even figured out how to run those. Before we had the stainer, we were hand-staining all of those, and we may have 30, 40 bone marrow smears a day.”

Another advantage of automating special stains, Biggs points out, is that it yields staining that’s more uniform—a plus for pathologists. With manual staining, “some techs are heavier-handed,” she says. “Sometimes their counter-stains are lighter or darker, and the pathologists have to adjust to whoever’s staining. The techs are following the procedure; it’s just not going to be completely consistent like an automatic stainer would be.” Too, the automatic stainer automatically records all lot numbers and expiration dates, another thing a technologist would otherwise have to do manually.

In the histology lab at Catholic Medical Center, Manchester, NH, bringing in new histology instrumentation was a given: The entire anatomic pathology laboratory was recently designed from scratch, opening in 2010. Efficiency and productivity were bywords from the beginning, says pathology supervisor Stephen A. Feher, MS, SCT(ASCP). “The whole thing, from start to finish, was based on eliminating unnecessary steps, buying state-of-the-art equipment that was good value for the money, and putting together a lab that was able to put out a quality product with excellent turnaround time and without excessive staff,” he says.

When determining which tissue processor to purchase for histology, Feher and his team first took a long, hard look at the traditional histology process and considered where it could be Leaned. “We looked at the conventional histology model, where all the tissue comes in throughout the day, gets a gross examination, gets put into racks, and gets put into the processor at the end of the day. At 2 or 3 AM, an army of histotechs shows up, and they have till 7 or 7:30 to get all that work out for the pathologists. When the pathologists come in, they have 15 or 20 folders of slides they have to get through in that day’s time. We thought there was a better way to do that.

“According to Lean principles, that process has so much dead time,” he explains. “People are busy for five hours of an eight-hour shift, while the pathologists are pulling their hair out trying to get through that workload.” Distributing slides to the pathologists throughout the day in smaller batches was the way to go, they decided. “And in order to do that, we needed a smart processor that would give us the option of having a number of different processing times run simultaneously.”

After looking at a number of instruments, they settled on the Leica Peloris. “We considered microwave processors,” he says, “but the people using them were telling us that while they worked great and processed the tissue quickly, every now and then they would overprocess the tissue and dry or burn it, and we didn’t want to have that.” As for special staining, he initially tried to program a Leica Multistainer to do it. “That didn’t work very well for us,” he says. “Special stains are really hard if you’re going to do them manually in histology, and it requires as much intuition as it does technical knowledge to know when to take those stains out.” They changed to the Dako Artisan special stainer, which Feher says simplified things. Like Medical City Hospital, “we were having one person take all day long to do nothing but special stains when we were trying to do them manually. Now we have one person who takes 15 minutes a couple times a day to do special stains.”

Regarding staffing, Feher and his team elected to create an extended first shift rather than have two shifts. The first of the laboratory’s three histotechnicians shows up at 5 AM; the last leaves at 7 PM. This approach is possible because two pathology technicians have been trained to take care of more basic tasks such as overseeing quality control functions, temperature checks, and stain changes, “so that we can use those histology technicians for what makes them valuable—their microtomy and IHC skills,” Feher says. “Some places have their histotechs doing all kinds of stuff, and it’s kind of wasted value in our eyes to have them do that. We want to keep them cutting and staining.”

As for histology workflow, Feher and his team knew what they didn’t want—a disjointed, rambling path reminiscent of the one Jeffy takes to dinner in “Family Circus” cartoons. “In our workflow, everything flows in a linear fashion, so you’re never coming back on yourself,” he says. “Every step is straight ahead or just a little bit to the right. For example, our grossing stations are located on one side of our grossing room, and six feet away from the stations are our processors. So when the grossing technicians finish the gross exams, they can turn around, put their specimens into the processor, and begin the processing cycle.” When the processing is completed, as they come out of the grossing room, the next stop is the embedding stations, and directly behind that is where the technicians will cut their sections. Directly to the right of that is the immunohistochemistry station. “It works that way all the way to the microscope we have for them to check out their work before they distribute the slides to the pathologists.”

Further, “we had some sliding pass-through windows put in for cytology and histology,” Feher says. “Just beyond where they do the microscopic checkout, we have file trays that are marked with each pathologist’s name, and the techs place the slides into the trays through the pass-through window. That way the techs don’t have to go from a dirty area of the lab to a clean area, meaning they don’t have to de-glove and take their lab coats off. It probably saves three to five minutes at a time. Over the course of a year, that adds up to a couple of people’s paychecks.”

As chair of the National Society for Histotechnology’s Quality Control Committee, Sonora Quest’s DeSalvo takes a broader view of the potential obstacles histologists face when trying to maximize efficiency and productivity. As he puts it, “I’m a big-picture sort of guy.”

While good workflow and efficient instruments are key—Sonora Quest, says DeSalvo, was an early and enthusiastic adopter of rapid tissue processors, and relies heavily on Lean and Six Sigma principles—he disagrees with the notion that “if we just reorganize our workflow and bring in new instruments, everything will be better.” Rather than focusing solely on “how to reduce opportunities for error and defect,” he says, “there needs to be a reexamination of how we train and turn out our histotechnicians and histotechnologists.”

Why? Because, in his opinion, a lack of standardization in histology processes is hampering the ability of laboratories to hire good histologists and get them oriented as quickly as possible. “There are many good schools, but a lot of those programs just are not that similar,” DeSalvo says. “The majority of them do not have a clinical training program that allows us to take a student and have them be functional in the lab [right away]. If you take a student from one of those programs, you still have to invest several weeks to several months of training before they become functional in all the technical tasks that have to be done.” And with little standardization across all histology laboratories, he says, “you have to train students in your particular techniques, unlike cytology or medical technology.”

“Standardization is a real issue in histology,” agrees independent laboratory consultant Randy Stephens, HT(ASCP), who specializes in histology process improvement. “If the goal is to eliminate waste, then it is essential that this variation we see in histology be minimized.”

Standardization isn’t just a training issue; in DeSalvo’s view, it’s also an obstacle to implementing Lean and Six Sigma. “People get frustrated, because they try to implement something in their laboratory that they saw in a presentation on Lean and Six Sigma, but what they saw was developed for a particular place,” he says. “The concept will transfer, but the practical application of that process is going to be completely different from laboratory to laboratory. That’s a problem. If you produce a slide here in Phoenix and send it to somebody in Chicago, they may very well ask for the block, because they want to redo all that testing. And that’s not cost-effective for health care. We have to get to standardization across the basic procedures in histology, so we can get to the level of what the clinical lab has done with Six Sigma and Lean.”

On a related note, DeSalvo doesn’t think that enough histology laboratories are collecting the daily metrics that would allow them to monitor their defects and errors. “Most people in histology don’t do that, because it’s a cumbersome manual process to collect workload metrics every day. But that’s really necessary if you want to effect change.”

In addition, the ongoing shortage of histotechnologists has, to his mind, created a workforce of “well-trained technicians who can do exactly what we tell them to do and produce a reliable result, but who have less understanding of how everything fits together,” he says. “As we move into more personalized medicine, there’s going to be a need to have a better understanding of what we do other than just creating the correct result. As we move up the ladder of precision and specificity, small mistakes create big errors.”

Standardization, personnel, and metrics issues aside, DeSalvo would like to see more automation in histology. “The problem is that in the histology lab, the best we have is semi-automation,” he says. “We have some immunohistochemistry instruments, histochemical special stain instruments, and hematoxylin and eosin stain instruments, but they’re not fully automated because there is manual manipulation on both ends.” That said, “These are big advances for us, and without them, it’s very hard to gain efficiency.”

What he’d like to see next, automation-wise: a rapid tissue processor connected to an automated embedder. “If you could put a cassette in one end of your tissue processor, and it came out embedded in paraffin block at the other end, that would be a great process improvement in the lab,” he says. “All that time spent on the tedious, repetitious task of embedding could be moved to cutting and staining.” This could be a reality within the next five years, he predicts, adding, “That will be a game-changer.”

“You’ve got to look at the whole picture,” DeSalvo says. “As we move to personalized medicine, the AP department is going to require precision tissue processing. Probably flow cytometry will be brought back in. Maybe sequencing. Already DNA techniques are being done. What we hear a lot from the client is that they want all of this information pulled together in a single surgical pathology report, and they want the pathologists involved because they’re the physicians best trained to take all of this seemingly unrelated information and pull it into a differential diagnosis and add prognostic information.

“There’s nobody else, I think, who’s prepared to do that. And for the pathologist to do that, we need to have a very efficient and standardized process with well-trained histotechnologists,” he says. “That’s how I look at it.”