They speak a different language, sometimes with a faraway look in their eyes.
They have black belts and green belts, though most don't practice martial arts. They follow prophets and evangelizers who spread the gospel of quality; true believers disseminating their faith not only within their hospitals and healthcare organizations but throughout the country and indeed the world via Web sites, publications and conferences.
These quality cultists follow denominational dogmas with strange-sounding, obscure names like Six Sigma, Lean Manufacturing, ISO 9000 (no, it's not a camera setting), Toyota Way and even one named after a deceased former U.S. commerce secretary. Hospitals are spending millions of dollars on consulting firms to help integrate the new processes, a business opportunity unseen since the Y2K and compliance initiatives of the past decade.
Kenneth Kizer -- the president and chief executive officer of the Washington-based National Quality Forum who has worked on quality issues for more than 20 years -- says true believers exude an element of almost religious passion.
"They really do give you the feeling that they're evangelizing, that for them quality is a higher calling, a kind of a mission," says Kizer, whose organization sets quality standards in healthcare.
And they're changing healthcare, infusing it with processes rooted in industrial engineering, bringing the language, discipline and accountability of manufacturing into hospital emergency departments, delivery rooms and operating suites while introducing strange new terms and uniform standards into the hospital lexicon.
Richard Wade, a spokesman for the American Hospital Association, says the AHA doesn't track total hospital spending on quality processes and systems, partly because quality touches on so many different hospital relationships. But he's sure it's not a small figure.
"I can't imagine that it doesn't exceed $1 billion," he says.
An ancient religion
While the drumbeat for improved healthcare quality may have grown increasingly louder in recent years -- thanks in large part to the first Institute of Medicine report on medical errors -- the quest for quality is nothing new. Kizer says quality accountability has been discussed in healthcare for nearly three millenniums. He says healthcare quality tenets were encrypted in the Code of Hammurabi in ancient Babylonia on black stone tablets now displayed in Paris' Louvre.
While hospitals didn't exist then, Babylonian officials, concerned about a series of physician-related patient deaths, created laws explicitly to reward healthcare quality -- or punish its absence.
"If the doctors did it right, they were to be paid for their work," Kizer says. "If they didn't, the doctors' hands would be cut off. Talk about the ultimate alignment of incentives."
After World War II, quality guru W. Edwards Deming, an American sent to Japan to speed its rebuilding and transformation to an industrial democracy, applied his teachings in statistical analysis in ways that are influencing U.S. hospitals 60 years later. Deming taught Japanese companies to measure, focus on continuous quality improvements and reduce errors by doing things right the first time.
The Japanese modified Deming's ideas to turn their country into a global manufacturing powerhouse. Years later when Japanese companies such as Toyota and Sony began conquering the U.S. market with their products, a new generation of Americans learned from the Japanese the lessons they had already mastered thanks to Deming.
In the 1970s and 1980s, Kizer says, some of those quality processes made the transition from industry to healthcare. Programs like total quality management, or TQM (a management approach that grew out of Japanese manufacturing in the 1950s); continuous quality improvement, or CQI; and quality circles were first championed by Westinghouse, Ford Motor Co. and Philips Semiconductors, and later moved into hospitals.
Those systems waned in popularity, Kizer says, partly because of limited application and partly because of the technological transformation of American healthcare, the switch to prospective payment systems by Medicare and the rising cost of delivery -- all of which made hospitals focus attention more on cutting costs and less on implementing team-based quality processes as a means to achieve those savings.
But the old faiths didn't die out. Just as animism and paganism surrendered to Judaism, Christianity and Islam, new quality processes emerged from the earlier doctrines of TQM, CQI and quality circles.
While most of the new processes can claim an American lineage tracing back to the concepts of Deming, some also included Japanese bloodlines. More recent books include The Toyota Way: 14 Management Principles from the World's Greatest Manufacturer by Jeffrey Liker and The Machine that Changed the World: The Story of Lean Production by James Womack, Daniel Jones and Daniel Roos, which continue to disseminate the ideas that data-driven quality processes could be applied not only to manufacturers but to service industries like healthcare as well.
Kizer, who helped transform the Department of Veterans Affairs healthcare system, says that until recently many in healthcare argued whether quality could even be measured. "I remember 10 years ago having this argument that healthcare was too complicated, with too many nuances and unlike manufacturing, where you could parse out the components and define quality. Today we look back on that with historical interest. Now it's clear, of course, that you can measure the quality of healthcare."
Mix and match
While there are purists among the foot soldiers for quality, many are pragmatists who mix and match elements of competing processes to suit their organizations' needs. Physician/researchers and quality gurus such as Donald Berwick of the Institute for Healthcare Improvement, as well as groups such as the NQF and the Leapfrog Group; coalitions of large employers and unions; and federal agencies such as the CMS and the Agency for Healthcare Research and Quality all gathered momentum in their quest to persuade hospitals to measure and improve quality.
Kizer says the older programs such as TQM and CQI lack the cachet of the newer programs, although he says that in some cases an older process morphed into a newer one, as in the case of St. Louis-based SSM Health Care, which practiced CQI for years before pursuing and becoming the first healthcare organization to win the prestigious Malcolm Baldrige National Quality Award.
Carolyn Clancy, director of
the federal Agency for Healthcare Research and Quality under HHS, says she sees common themes
in religious devotion and the quality movement.
"There's a growing cadre of people working in quality who define this as their life's work. I know one who even has the term "change agent" as his title on his business card," she says. "They are highly motivated by this."
Clancy likened the U.S. healthcare system to the huge elephant that the blind men attempted to describe in fables with varying degrees of success.
"Each of these quality systems gets a handle on one part of it," she says. "I think it (the quality process movement) is unlikely to go away soon. The 'trust me' method of providing care doesn't work anymore and purchasers are demanding more from the healthcare services they're paying increasingly more for."
Gail Warden, former longtime president and CEO of Detroit-based Henry Ford Health System and chairman of the NQF, credits much of the quality movement to work performed by Berwick at the Harvard Community Health Plan in Boston, out of which grew the Institute for Healthcare Improvement.
Last year, the IHI and Berwick launched the 100K Lives Campaign, a movement to enlist 2,000 hospitals to reduce unintended deaths by 100,000 in the next 18 months
by using evidence-based system improvements and best practices and reporting their progress.
That campaign does not endorse any specific quality program. So far, more than 1,800 hospitals have volunteered.
Warden says the difference between the early quality process programs and those in vogue today is continuous training.
"There is much more emphasis on the training you have to have," he says. "And the concept of eliminating waste to improve quality has intensified. They've developed more on an industrial model, much more so than CQI and TQM."
The quality programs vary by focus, though their goals of higher quality may be similar. He says, for example, that the focus on improving customer satisfaction is a key element of the Toyota Way espoused by former U.S. Treasury Secretary Paul O'Neill, who championed the Toyota model at Alcoa, the aluminum company he formerly led and turned around thanks to his preoccupation with quality improvement.
The Lean Manufacturing/ Toyota Way systems employ techniques taught by the Toyota Institute along with many consulting and training firms.
The most difficult
While Warden says consulting groups can assist hospitals in applying for the prestigious Baldrige Award, he cautions that it is also the most difficult to achieve. "It's a big order for any organization to meet all those requirements and it's a long, arduous process to qualify." Only four hospitals and health systems have received the Baldrige honor.
Warden says one weakness in sustaining CQI has been that the hospital chief executives who have championed them eventually leave, often without a plan for succession and continuation of the program. When the pastor leaves, what happens to the flock?
"Once you start it, you have to keep it going," Warden says, noting that some organizations that championed quality processes slipped after their leaders left. West Paces Medical Center in Atlanta had earned high marks for its successful TQM program, but closed in 1999, six years after its CEO left and his successor ended the TQM program there.
Warden conceded that it's difficult to evaluate the cost-effectiveness of the quality processes.
"There are certainly some great success stories," he says. "And probably others not as successful. They have to judge whether they're getting their investment back, because it's sizable, in some cases involving millions of dollars, not just hundreds of thousands."
Eunice Halverson, corporate vice president at SSM's Quality Resource Center, says that system's "quality journey" began in 1990 with the introduction of a CQI program. Halverson says that worked well for nearly a decade, but by the late '90s the system's CEO, Sister Mary Jean Ryan, sought to move quality efforts into a new era.
Halverson says SSM had hit a plateau: "Our senior leadership looked for something that would get us to the next level of performance."
In 1999, the system -- which is spread over four states -- applied for and won state quality recognition awards. That same year the Malcolm Baldrige awards expanded to include healthcare organizations. Halverson says SSM applied for the state awards to obtain the vital feedback reports that offer tips on how to get even better.
In a study of persistence, SSM applied for the Baldrige for three years running before becoming the first hospital or health system to win the coveted award in 2002. The award, presented by the U.S. president, was created in 1987 by Congress to recognize quality in American manufacturing and honor Baldrige, who died in a rodeo accident in 1987.
"Baldrige touches everything within your organization, from finance to patient care," Halverson says. "Everybody within the organization talks to each other. There's always an opportunity for improvement. That's why we continue the process."
Creating a climate of quality improvement and making it last motivated Greg Stock, president and CEO of Thibodaux (La.) Regional Medical Center, to adopt Six Sigma techniques. Stock says Thibodaux has employed other quality processes, including Clinical Pathways, CQI and TQM on projects over the years.
"The problem with TQM and CQI is that people got infatuated with process and didn't necessarily get results," Stock says. "We don't see them (Six Sigma and Lean Manufacturing) as the only means of achieving excellence in healthcare," he says. "But they do represent some of the better tools out there. It depends on how you deploy them."
In 2000, Thibodaux began implementing the Six Sigma and Lean techniques to improve quality by streamlining processes and reducing systemic variation and waste. Stock says Thibodaux's patient satisfaction levels continued to grow, which also translated into better financial performance. The hospital has enjoyed double-digit operating margins for the past four years, two years ago achieving a 17% operating margin at a time when the average hospital operating margin was about one-third of that.
He emphasized that infidels and other nonbelievers need to accept the new quality faith, or hunt for other jobs. "People who don't buy into these things must work somewhere else," Stock says. "They have to lead and enforce or go. We need alignment. And we discipline with deployment."
While CEOs call the shots on which quality-process programs to implement, those directing the programs and leading the training enforce the creed. Susan McGann is a Master Black Belt -- as a senior quality leader in Six Sigma is called -- at four-hospital Virtua Health in Marlton, N.J. McGann, a registered nurse and vice president of enterprise development, serves as a keeper of the faith at Virtua, which adopted Six Sigma in 2000 after a presentation from GE Healthcare.
McGann says that after a 1998 merger, Virtua's four hospitals needed to meld into a single cohesive organization and viewed a team approach to quality as the best way to achieve that goal.
"We were the Noah's ark of healthcare: We had two of everything," she says. "We thought we needed to get everyone back on the same platform and needed a common language for that. We needed to execute on the same vision of outstanding patient experience."
By 2001, the system had taken six managers perceived to be high performers out of their current jobs -- McGann included -- and made them the future of Six Sigma at Virtua.
She likens Six Sigma to attending church services. "You have some people who come every week and worship devoutly, some who come but don't put their hearts and souls into it, like dabblers, and some who are lapsed and rarely come," she says. "It's not just tools and data and geekism. It transforms the way you think. At Virtua we're true believers. We walk and live and breathe it. It's one of those things you evangelize about. If you dabble you're not really getting the benefits or the opportunity to make a difference in your system."
Driving new standards
As Six Sigma was moving from shop floors to hospital corridors, in Detroit the Big Three automakers were grappling with ways to expand a successful standardization methodology from the automobile industry to healthcare, its largest and fastest growing cost. Dan Reid, purchasing manager for General Motors Corp.'s powertrain unit, says the latest entry into the quality-process competition in the U.S. -- ISO 9000 -- is also foreign-born. He says the program and its focus on uniform standards trace their roots to the Industrial Revolution.
"If you had a bad product then, you'd take it up with the producer," Reid explains. "With the Industrial Revolution the supply chain grew further away from the customer, who could no longer deal directly with the provider."
So customers developed specifications, and companies and nations became involved in the specifications, or standards, business, one of the earliest of which was the British Standards Institute. As suppliers became more multinational, the International Organization for Standardization was established in 1946 to create common specifications.
He says U.S. automakers each had separate specifications for parts and supplies, which raised supplier costs and ultimately manufacturer costs -- which were then passed on to consumers. In the late 1980s, the automakers came together for the first time to agree on a set of uniform standards, eventually incorporating the ISO system into their work in 1994.
"For us (the automakers) that was pretty revolutionary," Reid says.
Reid says surveys from the suppliers revealed a 3-to-1 return on investment for all costs relating to the ISO process. The suppliers say that more than half experienced a 50% decrease in errors. And tracking its supplier base, GM has seen an 85% quality improvement over five years. "It's pretty dramatic savings and pretty impressive quality improvement."
Several years later, GM's former vice president of purchasing and current CEO Rick Wagoner suggested that the company also needed to examine the potential application of ISO to healthcare as those costs encroached on the company's bottom line. It took a few years, but the group developed a handbook of voluntary standards that can be adopted by hospitals and healthcare organizations incorporating ISO 9000.
Jane DeHart, vice president of Dearborn, Mich.-based Midwest Health Systems, was administrative director for the Henry Ford Health System's department of occupational health when GM sought a request for a proposal from the hospital in 1999.
"They asked if we were certified to ISO 9000 and we had no idea what they were talking about," she says. But recognizing the automaker's clout, DeHart contacted GM's Reid, who told her that no international uniform standards for healthcare quality then existed for ISO.
"Healthcare costs are killing auto companies and we wanted to work together to deal with this crisis," says DeHart, whose system owns which owns five ambulatory surgery centers and an occupational health plan.
Reid and DeHart subsequently joined a work group co-sponsored by the American Society for Quality, a professional association, and the Automotive Industry Action Group, a not-for-profit trade association of 1,600 U.S. auto manufacturers and suppliers, to develop ISO guidelines for healthcare. Those groups collectively authored ISO guidelines for healthcare.
About 150 U.S. hospitals have become ISO-certified so far.
Those who have ventured into the quality-process movement say it can be a daunting experience.
"It is not for the timid," says Lee Adler, medical director of Florida Hospital in Orlando. Adler says of implementing quality process-improvement programs, "I wouldn't dabble unless your organization is totally committed" to transforming itself.
"Our organization aspired to achieve pre-eminence in healthcare, to become a global pacesetter developing (Adventist) faith-based healthcare nationally and in the world," he says. "It's a lofty position to put yourself into."
He says Florida Hospital executives explored a variety of tools to reach those goals before deciding on a GE Healthcare-driven approach that blended two quality processes: Lean Manufacturing and Six Sigma.
"I've never thought of it like a religion. But there are folks who are totally convinced that it's their passion," Adler says. "It's energizing when you're able to improve a process and see the outcomes."
But he cautioned that there is a 30% to 40% failure rate. "It's not universally successful."
That's why he says he's a pragmatist when it comes to competing quality-process programs. "My passion for performance process improvement should not be confused with the tools I'm using. My passion is not Six Sigma or Lean or TQM. You use the right tool for the right process."
For Robert Caplan, medical director of quality for Seattle-based Virginia Mason Medical Center, the answer was found thousands of miles across the Pacific. Caplan says Virginia Mason is so committed to continuous improvement in patient care that since 2002 it has sponsored nine trips to Japan to have its staff and executives trained in the Toyota Production System.
"We are passionate about quality," Caplan says, adding that the hospital has patterned its Virginia Mason Production System after the much-praised auto manufacturer's program made famous in recent business best-sellers.
"We saw this as a way in which we would get unwavering commitment to our patients, get our work force totally engaged and empowered and create a culture of improvement in which all of our staff act quickly on suggestions to improve," says Caplan, who peppers his conversation with Japanese terms such as muda (waste) and kaizen (continuous improvement).
Virginia Mason contracted with a training branch of Toyota called Shingijutsu Co., or New Workplace Technology, to train its staff.
"When we started, we found it had not yet been adopted by any healthcare organizations but saw many other diverse industries had adopted it with astounding results," Caplan says.
Virginia Mason's Kaizen Promotion Office, which is budgeted at more than $1 million annually and employs eight staff members, leads a hospitalwide training and education effort to integrate the Toyota Way to all of its 5,000 employees.
"We are on the road to integrating into the culture all members of our work force," Caplan says. To date more than 100 Virginia Mason board members, managers and employees have gone to Japan for training.
"Our investment comes back to us in many ways," Caplan says. "We've achieved enormous savings by getting rid of waste, using space more efficiently and increasing the quality time our staff can spend with patients. Some projects have saved more than $1 million or more and greatly exceeded what we've spent."
What do you think?
Write us with your comments. Via e-mail, it's [email protected]; by fax, 312-280-3183.