By Sarah Schmelling

Sonora Quest Laboratories, Tempe, Ariz.

Six Sigma. It sounds like it could be the speed of a spaceship in your average science fiction novel. Add to it that it involves people who work up to earning Green and Black Belts, and it seems even more fantastic. But Six Sigma, as many organizations inside and outside of health care are finding out, is a quality-management system that has the very real goal of making work processes as perfect as possible. It is not a specific company’s product but a nonbranded program that can be applied to any organization.

Without the system, Sonora Quest Laboratories (SQL), based in Tempe, Ariz, could not be close to where it is today, says Joyce Santis, MBA, HCM, the company’s COO. And where it is is impressive: SQL received the 2003 Arizona Pioneer Award for Quality, the first health care organization to win it. Also, SQL has found a great deal of additional recognition since implementing the system close to 5 years ago. “It’s about reducing error, and it’s about improving processes. In doing so, we have learned that we can also bring cost savings, which allow us to do the things that we need to do,” she says. “It’s made such a difference in our laboratory.”

Still, the system is complicated, has a learning curve, and requires investment in time and money. It’s equivalent to changing one’s entire philosophy on how business processes should be done. And it doesn’t happen overnight.

Joining Pieces Together
Even before Six Sigma, SQL was not a run-of-the-mill laboratory operation. It’s a joint venture between Banner Health, the largest health care system in Arizona, and Quest Diagnostics Inc, the nation’s largest clinical testing provider.

“We represent Quest Diagnostics on the commercial reference side; we have our for-profit commercial operation, which is Sonora Quest Laboratories; and we also manage and staff the laboratories at all the Banner Hospitals,” Santis explains.

SQL is part of a laboratory network called Laboratory Sciences of Arizona LLC (LSA), which manages the six hospital laboratories for Banner Health, and all employees of these various pieces—currently numbering about 1,900—are officially employed by LSA. Under this umbrella, some employees “are assigned to the commercial reference lab Sonora Quest, others are assigned to the hospital labs, and still others have system responsibilities that extend to both sides of the business,” Santis says. She adds that the organization also manages Health Diagnostics Laboratory in Phoenix, a lab owned by Cigna Insurance. Overall, the three main laboratories process an average of 17,000 requisitions per day.

Santis is the first to admit it’s a complicated model. “It’s very unusual,” she says. “There have been a lot of attempts at integrated laboratory systems through the years; some have been somewhat successful, and many have not. I think we’re probably one of the best examples of how an integrated laboratory system can and should work, and we’re able to get all sorts of benefits from it.”

But these benefits have mostly come after the implementation of Six Sigma. When the joint venture was first formed in 1997, the outlook did not seem so positive, Santis says. “Basically, you had two laboratories: the original Sonora lab, and Quest Diagnostics,” she explains, adding that they were not only competitors, they were fierce ones. “It was the local guy versus the big national guy. And when the joint venture was agreed upon, they continued to operate in their separate locations, with their separate systems and instrumentation, doing things the way they had already been doing them.”

It was a joint venture primarily in name only, she says. Even after a facility was built to house both labs, they remained separate within the building. “There were many issues, not the least of which were different types of methodologies and instrumentation and different types of standard operating procedures,” she says. “It was not a good marriage; there wasn’t even a honeymoon.”

Santis joined the company about 3 months after the cohabitation began. “It was not a good situation,” she says. “Nobody had bought into the fact that they were supposed to be one big happy family.”

Then, about a year after she joined the company, the two boards of directors agreed that these issues would have to be addressed. They brought in a new CEO, David Dexter, who came from Quest Diagnostics, and he made additional changes to the management team.

By the end of 1999, the organization had made the conscious decision to adopt a quality-management system, “to get everybody on board and focused in the same direction, so that we could get the business under control,” Santis says.

The system they all could agree upon was Six Sigma.

Going Six Sigma
First developed in the late 1970s, Six Sigma originated at the telecommunications giant, Motorola, as a way to prevent problems by building quality analysis into work processes. Santis says it differs from other quality initiatives, because “It incorporates the voice of the customer.”

Companies often think they know what their customers are looking for, “but we don’t ask them,” she says. “We assume that we know what’s best for them and what they need, but we’re not always right about that.”

Six Sigma, she says, requires “facts and data, not anecdotes,” meaning that through multiple tools, they actually get feedback from a customer that is incorporated into the system.

Its overall purpose, she explains, is to reduce defects. The Six Sigma ideal is 3.4 defects for every one million opportunities, or 99.9997% accuracy. “So if we perform a million laboratory tests, we only make mistakes on 3.4 of them,” Santis says. “It’s pretty close to being perfect.”

And while defects in the manufacturing world, like with Motorola, mean a product doesn’t work correctly, defects in health care mean medical errors. “And we have too many opportunities for error in the laboratory—in health care in general, and in the laboratory in particular—because it’s a very complicated business with many parts,” she says.

Reducing defects through Six Sigma starts with project managers—the Green Belts and Black Belts—who receive formal training to become Six Sigma experts. These managers then survey customers and gather data statistically, “to find out what your defects are and what your baseline is,” Santis says. “Then, you look for innovative ways to improve the processes that you have in place.”

She explains that the system works on the “DMAIIC” principle: define, measure, analyze, innovative improvement, and control. “These are the phases of a Six Sigma project,” she says. “You start by defining the problem and getting the voice of the customer, getting the data you know of.”

The next step is to analyze this data through “a variety of mathematical and statistical tools,” with a Black or Green Belt leading the project’s team. Then, based on this analysis, the team puts together recommendations for innovative improvements that are modeled into the process they are overseeing, “and they keep testing and implementing these improvements until they have achieved the defect reduction that was their goal,” Santis explains.

Once the goal is achieved, the project goes into the control phase. After a given amount of time, the project is handed over to the people who work specifically in that area, and they continuously monitor it to make sure that the goal is maintained. “That’s the biggest difference to me that Six Sigma made—that you continually monitor, and you continually work at keeping it in control,” she says. “It’s just a never-ending process, and that’s something we all had to get used to.”

For a real-life example of how this works, Santis points to SQL’s first Six Sigma project, which was to reduce wait time in its patient-service centers. She says patients had complained that the wait time was too high, and the administration originally thought the way to solve this problem was to add more staff. Then, while putting it through the Six Sigma system, they found that the amount of time patients were willing to wait differed from what SQL thought it was. “So we changed our processes, we measured and fine-tuned, and we made our goal, which was to have 5% or fewer of our patients wait 20 minutes or more to be seen,” she says. “And 4 years later, we’re still measuring every month, we’re still holding people accountable for it.”

Santis says that at times the wait time has increased, and they’ve been forced to look at why this would happen. “It was because we introduced new procedures, or various payors decided to implement co-pays for laboratories, or something else brand-new that we hadn’t had to deal with before,” she says. “And whenever we introduce new things into the procedure, we have to go back and fine-tune our processes so we can get back to our goal.”

As of last fall, SQL had successfully used Six Sigma to reduce order to specimen collection cycle time for STAT emergency department tests by 61%, reduce specimen-misidentification errors by 59%, reduce needle-sticks by 70%, and reduce specimen management data-entry error rates by 90%, among other achievements.

And while the organization has invested a great deal financially into Six Sigma, primarily through Black and Green Belt training—and because Black Belts concentrate solely on the system for their jobs—they’ve also been able to save money, Santis says. She explains that most of the savings come from making processes more efficient, instead of adding staff members to solve a problem. “The biggest expenses you have in almost any business is your staffing: salary, wages, and benefits,” she says. “So you have to invest that money wisely.”

She says that in their first patient-service-center project, they learned they would not have to add a staff member to reach their goal. “And we did that by getting rid of the nonvalue-added activities, by improving training, by streamlining paperwork and processes, or just finding ways to do things better.”

A New Way of Thinking
Santis believes Six Sigma could be useful for a laboratory of any size, because “basically, it’s just a commitment to quality using the tools of the system,” she says. “It doesn’t matter if you’re doing 17 or 17,000 tests per day; you still don’t want to make mistakes.”

She says you can start by identifying employees who either have the desire to learn the system or already have training. Quest Diagnostics had Black Belts who trained five Black Belts within SQL, and now they are in turn training 40 Green Belts at the company. Both levels have certain numbers of projects they must complete each year, as set by SQL management.

It is important to note, however, that there is a big learning curve with Six Sigma, Santis says. “You don’t say on a Friday, ‘Let’s start this on Monday.’” She adds that employees should understand that it is a big commitment, requiring at least 15% of their time on the job for Green Belts and 100% for Black Belts.

There was resistance at first, she says. “We all work hard in the laboratory business. Everybody’s busy. And there’s never an overabundance of people to do any job, so people were naturally resistant and even a little resentful of the amount of time that was required.”

But when they could see the results of the system, “It made believers out of all of us,” Santis says. “We have dozens of examples of where Six Sigma has helped us improve. And we won’t stop. We may never be Six Sigma perfection, but we’re going to continue to push as hard as we can to get there.”

The company is very proud of its success and awards. Santis says they’ve entered competitions for both the Arizona Governor’s Award and the national Malcolm Baldrige Award for quality, and that they’re “foolishly optimistic.” She says it would be a tremendous validation for SQL’s employees. “It’s not about us in administration, it’s about the whole organization.”

She says Six Sigma makes the work less complicated for employees. “It’s a way of thinking, of deciding that you are not going to settle for 99%.” She explains that because the majority of medical decisions are made based on laboratory results, they have to be as close to perfect as possible. “We owe that to our patients, and to our physician clients.”

And while Santis says she would love to say they never make mistakes, they do. “But Six Sigma helps us identify those mistakes and deal with them more efficiently so we won’t make them again,” she says. “We keep making our processes better and better, so we reduce that opportunity to make an error.”

“Can we be perfect?” she adds. “Well, we’re all human beings. But that certainly doesn’t mean we can’t try.”

Sarah Schmelling is a contributing writer for Clinical Lab Products.