By Carolyn Hoke, PhD

 From left to right are team members Carolyn Hoke, PhD, Nellie Cunanan, Gene Pawlick, MD, and Maggie Lin.

Kaiser Permanente’s Richmond Marina Way South Regional Laboratory complex is a football field-sized facility located in San Francisco’s East Bay region. The 50,000-square-foot laboratory processes more than 1 million automated chemistries per month, making it one of the largest privately owned laboratory facilities in the country. It continues to grow due to membership growth and expanded screenings to support Kaiser’s clinical practice guidelines.

In 2002, as a move from the prior facility in Berkeley to the new one in Richmond was being planned, laboratory executives knew that making the switch was not going to be easy. Because we perform more than 35,000 chemistries per day—every one of which must be executed under stringent quality guidelines—there could be no lag between the closing of the older facility and the opening of the new one. Administrators needed to purchase equipment and install it in the new laboratory facility 6 miles away, and they needed to train their entire staff on the new instruments by the time the doors opened. Furthermore, the analyzers they wanted to evaluate before making their decisions were very large in scale, yet they had to be installed, tested, calibrated, and serviced without limiting or interfering with operations in Berkeley. Finally, it all had to be done with existing staff, budgets, and space limitations in both locations—and all without compromising quality.

 Mila Osoteo (foreground) and Randall Chang and Jane Ma (background).

At the time, Kaiser Berkeley was using decade-old Hitachi instruments for general chemistry testing, and that equipment needed replacing. Therefore, 18 months before the scheduled Richmond opening, Kaiser Permanente entrusted three primary individuals in Berkeley to lead the evaluation that would help them decide which new automated chemistry analyzers would be installed in the new complex. The primary analyzer selection, recommendation, and implementation team included me, as regional services manager of the chemistry department, and two of my colleagues: John Anderson, chemistry supervisor, and Maggie Lin, clinical research and development scientist. In addition, staff members were invited to review the evaluation process at key points during the project.

The Search
We looked at how our chemistries were being handled in Berkeley, and decided that the move created a perfect opportunity to revise our operations to handle our rapid growth,” says Anderson. “We sought a system to handle our heavy volumes expediently and accurately. We also wanted some new options not available on older equipment, like clot detection, better reagent utilization, open channels, and a willingness to support the widest variety of applications, even if the company did not itself offer branded products to meet every individual test need.

“Finally, maintenance was also very important to us,” Anderson says. “We wanted an instrument that was constructed so we could easily access all the parts necessary for regular service and maintenance.”

The search process began in earnest in October 2002. It started with identifying the companies that might be able to meet our demanding volume and quality requirements. The team reviewed instruments and reagents offered by the leading companies to determine whether there were any that did not meet Kaiser’s specific quality specifications, and researched how the major suppliers handled such situations. We conducted on-site visits to evaluate operations where various companies’ instruments were already installed. We collected information and spoke with customers all over the United States.

 Randall Chang (foreground) and Maggie Lin (background).

When we’d done all our homework, our decision came down to Olympus and one other company. The team was familiar with the other company, and not as familiar with Olympus. We also considered Olympus’ experience handling chemistries for other large reference laboratories across the United States as a positive influence on our final decision. In addition, we spoke with our own toxicology laboratory professionals in Berkeley, since they were already using two smaller Olympus AU640 analyzers to handle drugs-of-abuse screens and other toxicology assays. They told us they had very good experiences with the Olympus units, and the units had excellent uptime and reliability records. That was very encouraging.

Within a few weeks, we were ready to install an Olympus AU5431 chemistry analyzer for evaluation. The modular AU5431 is a high-volume analyzer that automates and consolidates chemistry-immuno testing with the potential of up to 147 onboard chemistries and a throughput of up to 6,600 tests per hour. It offers a 122-test menu—one of the largest in the industry—that includes chemistries and a broad menu of specialty tests. With a fully integrated track system to intelligently route samples to high-speed processing modules for simultaneous test processing, it is Olympus’ highest-volume analyzer. We knew the AU5431 was a contender, and we wanted to run it and test it ourselves.

Analyzer Installation
We installed one AU5431 unit in a building adjacent to the Berkeley laboratory. The staff then worked extensively with Olympus Regional Manager Bob Gurney, Olympus Technical Support Representatives Joan Turner and Diane Henning, and local Olympus Service Engineer Ken Conser to make sure the evaluation instrument was fully operational and the staff was trained.

“Olympus worked with us to adapt several reagents, trained us to run the instruments, and gave us the opportunity to run it ourselves to see what the instrument could really do,” says Lin. “It went very smoothly. We simultaneously worked with Data Innovations Inc and our local (Cerner) laboratory computer system coordinators to help us manage instrument data to meet our quality needs. Olympus support staff made every effort to coordinate these relationships and worked cooperatively to make sure our needs were being met.”

The system was initially set up to run 30 tests. “We were able to establish workflow in the testing phase, and since implementing it, we have appreciated the instrument’s flexibility because we work in such a dynamic environment,” says Anderson. “There are 48 channels on each of the three analytical modules, so there is room for growth.”

Part of the testing phase included conducting throughput studies to determine how many instruments Kaiser Permanente would need. We wanted capacity for additional growth, and since we were designing the lab from the ground up, we knew we had to plan for a configuration we could live with and grow with for a decade or more. By the middle of 2003, we decided to purchase four units.

Installation began in January 2004. The evaluation unit was destined to become one of the new purchases, and three more instruments were shipped directly to Richmond. The new AU5431 instruments were all installed within 2 weeks, and then they were tested to ensure that their values matched exactly. One of the biggest challenges we faced was training, as all 26 staff members had to become experts on the new equipment.

“We were fortunate to have the Olympus team patiently work with our staff, just a couple of people at a time,” says Lin, who set up the procedures by which the switchover took place. “They were able to accommodate our work and duty schedules and get everyone up to speed in time.”

Every staff member received 4 full days of Olympus-provided training on-site, and then Lin provided a fifth day. The instruments went live in March 2004, and Olympus staff stayed on-site 24/7 for the first week. Once the equipment was up and running without a hitch, our entire Richmond operation was converted to a production laboratory, and the Berkeley automated chemistry section was shut down.

Current Operations
Today, in the giant Richmond facility, the automated chemistry area is near the center of the facility, where samples arrive already bar-coded and centrifuged. Blood tubes are placed in racks and automatically sorted to various targets—immunochemistry, special chemistry, automated chemistry, and so on. Some racks go to aliquotters, and tubes are decapped if appropriate. In the expedite area, high-priority samples—such as those from transplant patients—are handled. Automated equipment puts the samples into the correct racks for processing, and the racks are loaded on the instruments. In addition, the expedite area is used for troubleshooting or routing samples that need further testing. After testing is completed, specimens are taken to an archive sorter and are placed in refrigerated vertical storage systems.

As a special service, we offer physicians the ability to add tests easily by dialing an 800 number or logging a request online. For instance, if an enzyme proves to be elevated, the physician can log in and request that the lab pull the specimen and run additional tests. This is also a great service to patients, who now do not need to provide blood as often for follow-up tests. Most results are electronically provided to physicians by the time they come in after morning rounds. Oncology and preoperative patient results come in even earlier, around 6 am, to make them available for early review in the operating room or other specialty areas. Results appear in the physician’s computer laboratory in-box, with flagged results first.

“One of the interesting parts of using this equipment is that we can track exactly what each unit is doing all the time,” says Anderson. “If we want to evaluate something, our Olympus engineer can go in and monitor what is happening with each part of each unit, making diagnostics much simpler. In addition, we have been extremely pleased with the uptime on the Olympus systems. In fact, our staff has had absolutely no complaints.”

A Real Triumph
The management at Kaiser Permanente continues to look at assays and work flow to assess performance. We have very positive feelings about the support we’ve received from Olympus. We also appreciate their management tools, which look at utilization and efficiencies. This helps us rebalance our reagents for maximum efficiency on every instrument. With Olympus’ help, the switchover was a real triumph for our staff.

Carolyn Hoke, PhD, is director of technical strategy and development at Kaiser Permanente regional laboratories in Berkeley and Richmond, Calif.