Kaiser Permanente NW Incorporates ISO-9000 In Regional Lab Design

First-Ever U.S. Use of ISO-9000 in Total Lab Design!

CEO SUMMARY: After achieving its ISO-9000 certification, Kaiser Permanente Northwest’s laboratory division accomplished another distinction. It became the first lab in the nation to use the principles of ISO-9000 to design, build and operate a new, state-of-the-art, automated laboratory facility. The unique workflow designed into this laboratory startles visitors. Not only is this the first laboratory designed, from the ground up, by an ISO-certified lab management team, but it provides a fascinating peek at how the next generation of clinical laboratories may be designed and operated.

Part One of Two Parts

RECENTLY THE LABORATORY DIVISION of Kaiser Permanente Northwest (KP-NW), based in Portland, Oregon, designed, built, and brought into operation a new, state-of-the-art, automated regional laboratory.

This laboratory facility is unique. To the knowledge of THE DARK REPORT, this is the first laboratory facility in the United States that incorporates the management principles of ISO-9000 in the laboratory’s design, construction, and subsequent daily operation.

Alone, that fact makes this laboratory noteworthy. But being first is not the most important part of this story. Prior to constructing their new automated regional laboratory, the KP Northwest lab team used ISO-9000 principles to re-engineer almost every aspect of laboratory operations. The new lab facility was then designed to support the re-engineered work processes.

Lab Gained Multiple Benefits

THE DARK REPORT believes this is the most important management insight. KP-NW’s lab team used ISO-9000 to create a break-through laboratory design—one that impresses senior laboratory administrators who tour the facility. As a result, when the new core laboratory became operational, its re-engineered work flow generated multiple benefits. Lab quality increased, as did productivity. Costs were reduced significantly. Morale and enthusiasm among lab employees soared. More importantly, the new automated regional laboratory provides a foundation to sustain ongoing operational improvements for years to come.

And it is these outcomes which impress knowledgeable visitors. Kaiser Permanente Northwest’s new automated laboratory facility is actually a prototype for how clinical labs will be designed and operated in the future—at least those which incorporate the management principles of ISO-9000, Lean, Six Sigma, and similar quality systems.

The lab management lessons from this groundbreaking project will be explained in two parts. In this installment, THE DARK REPORT assesses how laboratory administration at KP-NW engaged its entire lab staff to help: 1) identify work process improvement opportunities; 2) apply such opportunities to the design of the new lab facility; and 3) participate in reorganizing job responsibilities necessary to implement the work flow redesign suggestions.

In the next installment, THE DARK REPORT will evaluate the actual operation of the new laboratory. There were set-backs along with the successes. But the performance numbers tell a compelling tale. For KP Northwest’s lab division, effective deployment of ISO-9000 management principles generated substantial clinical and financial benefits. And the performance of the new lab to date indicates that additional benefits will continue to flow for years into the future.

New Lab Facilities’ Genesis

The effort to build this new laboratory facility started almost ten years ago, in 1995. “At that time, our laboratory team recognized the need to be proactive on two fronts to support our parent organization,” stated Dixie McFadden, KP-NW’s Administrative Director of Laboratories. “We believed a new lab facility would allow us to advance on both fronts.

“First, we considered laboratory automation to be a tool which could help us stay competitive in our marketplace and better perform for our clinicians and members,” she explained. “Second, we thought that a well-designed new lab facility would fundamentally change our cost structure for the better. It would allow us to make the same labor pool more productive.

“It would also add capacity, support the modest lab outreach program we have, and position us to service higher testing volume as Kaiser’s membership continues growing,” she noted.”

“We were told ‘no’ by administration several times,” recalled McFadden. “But we believed a new lab facility was the way to go. So we would rework our proposal and try again. Eventually we received authorization to proceed with the design and construction of the new lab facility.

“Meanwhile, during this same time, our lab management team had been looking at the organization and the processes in our 15 laboratory locations,” she said. “We realized that each lab site had similar equipment, did similar tests, and often times shared some of the same staff. Moreover, they were serving the same members, who were often served at different Kaiser locations.

“Despite these operational similarities, there were large variations in how they operated. We didn’t have consistent lab system processes and practices across all of our regional sites,” observed McFadden.

Eliminating Variation

“Strategically, it became a goal to rectify this situation,” she noted. “Knowing that Quest Nichols Institute had achieved this outcome as part of its ISO-9000 certification, we invited George Pounds to visit our lab. Another individual we brought in was David Navilanen. Among other insights, they helped us understand how GLP (good laboratory practices) could help eliminate variation in the way our regional lab sites operated.”

Exposure to the management principles of ISO-9000 had an unexpected impact on the thinking of KP-NW’s lab administration. “We learned that establishing system-level documentation of work processes was just one slice of overall work flow through the laboratory,” said McFadden. “It evolved rather naturally that we should analyze and address improvement opportunities across the entire spectrum of lab operations.

“To accomplish this, during 1998 and 1999, we underwent a ‘gap analysis’ with the help of consultants familiar with ISO principles,” explained McFadden. “We found that, in some areas, GLP had pushed us far along. But other operational areas of our labs needed lots of work. The decision was made to pursue ISO certification.

ISO-9000 Certification

“By October 2000, GS (International Certification Services) successfully conducted an audit of our regional laboratory, which led to that lab’s ISO-9000 certification. Although not ISO-certified, our other regional lab sites operate under ISO principles and share standardized work instructions.”

Even as work on ISO certification was occurring, there was progress on the request to build a new regional lab facility. “In the fall of 1999, KP administration issued conditional approval for us to proceed with the design and construction of a new automated laboratory,” stated McFadden. “Final approval was issued in February 2000, right in the midst of our efforts to gain ISO- 9000 certification.”

With that approval, formal planning to design the new lab began in April 2000. “Because we were now trained in the principles of ISO, we wanted to design our new laboratory facility to reflect those techniques. We knew we wanted three things: automation, a lab without walls, and a layout that would support ongoing, systematic redesign of workflow through the lab,” summarized McFadden.

“Twelve people made up the conceptual design group, including pathologists, Ph.D.’s, managers, a national facilities representative, and our consultant,” she noted.” In June, following two months of conceptual work, 15 design teams were initiated, consisting of lab staff members.

“Each design team had a project leader,” continued McFadden. “Some were managers and some were staff members. Kris Bailey (AICon consultant) was the project director who coordinated this effort. Carol Vogt, KP-NW clinical service manager, was the project manager throughout the two-year process.

“There were 15 design teams. Each team was trained in ISO system documentation and workflow design techniques,” noted McFadden. “This training meant that our teams now looked at laboratory operations through a ‘new’ lens—one that emphasized systems and processes. Each team performed workflow mapping, did physical design of their area for the proposed lab, and specified necessary equipment.”

“Whereas most people design a new laboratory by department, we did not!” declared McFadden. “Using insights from ISO, our 15 teams designed our new regional lab by process and by volume.”

McFadden says the “aha moment” came early in the design process. “We mapped our existing work processes, then laid them out on the floor plan of the proposed new lab facility,” she noted. “We recognized that the same work process occurred in five separate places around the lab. Logically, all this work could be put in one place in the lab. The new work area that was created is called ‘shared preparation.’ This includes specimens for histology, cytology, microbiology, special chemistry, and anatomic pathology.”

This design breakthrough represented a fundamental difference in how the new KP-NW lab facility was designed. “Whereas most people design a new laboratory by department, we did not!” declared McFadden. “Using insights from ISO, our 15 teams designed our new regional lab by process and by volume.”

Such design innovations quickly led to the dismantling of traditional laboratory departments, since the goal was to design around process and function. “Another key innovation came from a staff member,” recalled McFadden. “She said, ‘since we are not departments anymore, maybe we are neighborhoods?’ That term caught on. Now we have neighborhoods for Medical Offices, Hospital Lab, Core Lab, Prep and Read, SAM/TOX, Client Services, and Support.”

In creating the radical changes found in the new lab facility, the design teams started with existing laboratory work flows. “It was as simple as starting with a map of the existing work area in our existing lab departments,” said McFadden. “Once this was done, design teams then applied ISO tools to create smoother, more efficient workflows in the new lab. It was at this stage that a cascade of innovations occurred.

“It was remarkable to see the creativity and clever solutions which emerged from the design teams,” she added. “Because people from all parts of the lab were part of the design process and were designing their future work environment, they had a high level of commitment and recognized how specific changes would benefit the lab and allow them to make a greater contribution. Their design recommendations were so comprehensive that we saved a considerable amount on architectural fees—and got a better-designed lab facility!”

Notable Achievement

The innovative new regional laboratory at KP Northwest is a significant event for the laboratory industry. It is the first sizeable laboratory designed, built, and operated by an ISO-9000- certified laboratory organization.

It means this laboratory is the first real-world demonstration of the quality management systems in use throughout commerce and industry, but still relatively untried in healthcare. For that reason, its successes and its failures merit closer study. The second installment in this two-part series will address these topics.

One noteworthy lesson about the design phase of this pace-setting laboratory facility should be obvious: Once laboratorians are trained in the principles of quality management, they gain a new set of useful tools. It helps them understand lab operations and out- comes in new ways. Not only do they have a deeper understanding about the systemic cause of problems, but they have a new set of tools with which to identify and fix those problems.

In designing the KP-NW regional lab facility, it was the lab staff themselves who recognized that five separate departments currently performed the same accessioning function—and that this function could be consolidated and handled in just one area of the laboratory. This same concept of combining similar work processes, even across traditional department lines, led to the concept of “neighborhoods.”

In many lab environments, concepts such as these would certainly represent radical changes. Lab staff with decades invested in defending their department from various types of re-engineering efforts, would vigorously oppose the creation of neighborhoods organized around lab function, not test menu.

Yet, within the labs at KP Northwest, virtually the entire lab staff contributed to creating new neighborhoods, then participated in the process required to staff these neighborhoods. That unusual support for a radical reorganization hints at the positive downstream benefits that accrue from using quality management principles to re-engineer an existing laboratory.

Perceptive lab directors and pathologists will pick up on this. For these individuals, a site visit to the KP-NW regional lab facility can offer valuable insights about how to successfully deploy quality management systems in their own lab organization.

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