Six Sigma: Does quality process make error-free care truly achievable?

Is new model flavor of the month,’ or the Holy Grail of quality?

Of all the quality tools that have been imported from the business world to the health care setting, perhaps none has achieved the notoriety or the cult status of Six Sigma. In fact, some supporters claim that Six Sigma is succeeding where total quality failed. Coined by Motorola in the mid-1980s, Six Sigma, in simplest terms, refers to a quality measure that seeks to approach perfection — a data-driven technique for eliminating defects, or in medical terms, errors. To a manufacturing engineer, for example, that means producing fewer than 3.4 defects per million opportunities. 

With an industrywide emphasis on reducing errors, particularly in the wake of the landmark Institute of Medicine report, it’s no wonder Six Sigma has caught the attention of quality managers. But is such an approach realistic in a profession some argue is more art than science? Is it even realistic to strive for perfection in health care? Many quality professionals respond with a resounding "yes."

"Our participation in Six Sigma is a recognition that we really want to support the idea of zero-defect care," says Traci Atherton, RN, BSN, vice president of clinical support at Baylor Grapevine hospital in Grapevine, TX. She explains that the Six Sigma approach "preaches that quality is not optional. It’s big, big picture stuff for facilities that are trying to get the fewest possible errors. If we want to talk about an error-free environment, we must explore how we would actually work toward perfection, to be a zero-error facility. What will our programs look like, and what do we need to do to achieve success?"

To Atherton, Six Sigma really is a change in focus to some of the key areas of process management. "The goal is to implement a care delivery system that avoids reliance on memory — that sets up processes that eliminate every opportunity for error," she explains.

"It’s a myth that there’s so much variation in medicine it becomes an art," says Walter H. Ettinger, MD, MBA, executive vice president of Virtua Health System in Marlton, NJ. "The fact is, there are evidence-based therapies and diagnostic tools where there should be very little variation in use. One of the things quality professionals in health care have tended to focus on is the individual; what Six Sigma does is it allows you to focus on the process. Six Sigma really lends self to health care, particularly in the area of safety," he says.

Cutting out the waste

"There’s a lot of waste in health care," adds Carol P. Mullin, RN, MSN, a Six Sigma "black belt" at Virtua. (See box, below.) "We’ve had a lot of eye-opening experiences when we looked at process. Take transport, for example. On any given day, we had six transporters who were sent two to six times a day to pick up a patient.


What is a black belt?

Like many facets of Six Sigma, the term "black belt" appears shrouded in mystery to the uninitiated. Author Thomas Pyzdek defines a Six Sigma black belt as follows:

"Candidates for technical leader [black belt] status are technically oriented individuals held in high regard by their peers. They should be actively involved in the organizational change and development process. . . . Because they are expected to master a variety of technical tools in a relatively short period of time, technical leader candidates will probably possess a background in college-level mathematics, the basic tool of quantitative analysis.

"College-level course work in statistical methods should be a prerequisite. . . . Successful candidates should understand one or more operating systems, spreadsheets, database managers, presentation programs, and word processors. As part of their training, they will be required to become proficient in the use of one or more advanced statistical analysis software packages."

Source: Pyzdek T. "What is a black belt?" Web: Go to February 2000 issue.

"When they got there, their patient had either been moved, had died, or had been discharged. But the way our information systems were set up, that information didn’t get around," she adds.

"That’s up to 24 or 36 times in a day we could re-deploy transporters. Six Sigma enables you to quantify these processes; we’re all used to looking at temperature or blood pressure, but we aren’t used to counting the things we do."

"Six Sigma helps you focus on root causes," adds Mullin. "You do a statistical equation to help you figure out what percentage contribution a particular X,’ or factor, has on Y.’ If you only have the resources to put in three of six changes, you want to go with the ones with the highest percentile effect. This approach works very well with physicians because they are scientists. It’s most gratifying; we’ve not gotten any arguments from physicians."

Getting your feet wet

There are a number of reasons for health care facilities to become involved with Six Sigma, just as there are many ways to do it. "We were intrigued by the issue of Six Sigma primarily because our culture has been to look at models outside of health care," notes Randall Linton, MD, incoming president and CEO of Luther Midelfort-Mayo Health System in Eau Claire, WI. "That led us to look at the Motorolas, the GEs, and the Allied Signals, particularly as they have ventured into Six Sigma in service industries," Linton explains.

After initial research, including some discussions with the Boston-based Institute for Healthcare Improvement (IHI), Linton and his colleagues looked for opportunities to learn more about Six Sigma training. "The Carlson School of Business at the University of Minnesota, which is right in our backyard, had found a way for companies to come together, to look at Six Sigma, and to work on a specific project," he notes. "They, in turn, teamed up with Blue Fire Partners for faculty support."

About 18 months ago, formal training began, as a team from Luther Midelfort, including Linton, selected a specific project to work on, billing, and began to learn and to work together with the other companies, many of whom were not health care organizations. "We benefited from that collaboration and interaction," he notes.

Virtua also had the help of corporate partners. "Our system was formed in 1998 as the result of a merger," recalls Ettinger. "During 1999, we spent a lot of time consolidating corporate departments and putting together an integrated management team and a single board. In early 2000, we decided we wanted to distinguish ourselves by creating an outstanding patient experience."

This led to the creation of the "Star Initiative," whose goals included becoming a nationally recognized health system; having patient satisfaction in the 90th percentile; and winning the Governor’s Award for Excellence, which is New Jersey’s equivalent of the Malcolm Baldrige Award. (Incorporating Six Sigma into a larger initiative may be a prerequisite for success. See "Six Sigma 'not the way to learn how to walk.'"in this issue.)

"So now we had our goals, but how would we achieve them?" asks Ettinger. "We created a partnership with GE to have them teach us their Six Sigma methodology. We wanted a set of tools to really help us drive the five aspects of the outstanding patient experience: resource stewardship, a caring culture, clinical quality, excellent service, and the best people." The partnership was a natural, as GE was a large medical equipment vendor for the system and had a well-known reputation in Six Sigma circles.

"[Mullin] and the five other black belts have gone through rigorous training and were certified just like they would be at GE," explains Ettinger. "They took three days of CAP [Change Acceleration Process] and three of GE Workout coaching training, then 13 days of Six Sigma. Then came a six-month process to lead their teams through the program."

The black-belt candidates were chosen from among the system’s best managers, says Ettinger. "Our goal is to have all six return to management positions in the organization and take their skills with them," he explains. "We didn’t add any positions; we took them out of their positions and compensated by not adding FTEs [full-time equivalents]." In addition, 60 people were trained as Star coaches, who are capable of leading both CAP and Workout. (For more on the GE Workout, see QI/TQM, March 2001, p. 30.) Senior management also received five days of training to help ensure their support.

Baylor Grapevine is in the early stages of its Six Sigma experience, but Atherton has a pretty clear idea of where she’d like to go. "We’re going to look at checklists, protocols, reminders, standardized equipment, forms, times, and locations, so that you avoid that reliance on memory," she says. "Right now, you could walk onto floor 2, 3, or 4 as a nurse, and no two floors would look the same or would have the same equipment. If you want to avoid the chance for human error, those things have to all be similar," she adds.

Atherton says her facility will be looking at products and devices that could fail, such as IV connections. "We’ll also be taking a look at processes — how many steps are required — and seeing that patient care processes are designed with built-in opportunities to recover from error. All of this is being budgeted for this year."

The proof of the pudding

How have the Six Sigma experiments been going? "We have really started to see significant results," says Linton. "What we’ve been looking at is making sure the right party is billed for a service. It sounds like a very simple goal, but it can be complicated, especially as insurances change."

Linton says he’s found that Six Sigma tends to be best applicable for the "untouchables" — those large projects no one seems to want to tackle, or knows how to tackle. "Billing fit the requirements laid out in the book The Six Sigma Way. There was a significant gap between current and desired performance; the cause was not clearly understood; and an optimal solution was not apparent," he notes. (Cavanagh R, Neuman R, Pande P. The Six Sigma Way: How GE, Motorola, and Other Top Companies Are Honing Their Performance. New York City: McGraw-Hill; 2000.)

Through Six Sigma’s strong emphasis on identifying and prioritizing customers, Linton’s team discovered that not only were patients the key customers, but customer service reps also were key customers of the process. "We found we had created a process that made it very difficult for them to do a good job," Linton notes. The team developed a job description within which it was possible for the customer service reps to be successful, and many of the leading indicators in terms of backlogs and days in accounts receivable are showing very positive trends, Linton reports. "It think we’ll find that the investment in our project will be recouped many times over," he predicts, adding that "Six Sigma gives us the advantage of prospectively looking at potential solutions and determining the predictability of their success. I’m not sure we would have come up with the same solution without it."

A total of six projects are ongoing at Virtua. "In all of them, we’ve been able to define what the goals are and what measures will be used, processes for follow-up, and improvement plans," reports Erich Florentine, vice president for operations improvement. "Two projects were focused on: recruitment and retention. In recruitment, we identified processes that were tied up for five to 10 days and cut that down to zero to one day," notes Florentine, who worked for GE before joining Virtua. "On a project in the emergency department, we looked at patient satisfaction and time to the treatment area. Based on two months’ data, there actually was improvement, but of course, we’re looking for long-term, sustained improvement."

"Our pilot starts on June 19," Mullin reports. "We’re looking at length of stay for congestive heart failure patients. We had heavy data collection in February and March, after which the average dropped from 6 to 4.3; our goal is 4.2. I wonder if the data collection had a halo effect’; naturally, I want to have the whole summer to look at."

Linton is so high on Six Sigma that two more teams have completed their training, and two more projects are in process. "One continues to look at issues in billing; the other is hospital patient flow," he says. "We are convinced that the applicability of Six Sigma into other clinical areas has promise, and we want to continue to pursue it."