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The future of automation in clinical laboratories

Jack Zakowski and Diane Powell

With economic forces creating ever more intense competition, clinical labs see automation as a key to survival.

Clinical laboratories today are facing many challenges in order to remain competitive. These challenges are a result of a combination of market forces, including the continued reduction of government reimbursement rates for laboratory tests, cost-restraint measures from the managed care industry, and an overall move toward containment of national healthcare costs.

As pressures increase for clinical labs to become more productive and cost-efficient, they are forced to look more closely at their internal processes for ways to increase productivity with smaller budgets. In order to survive in the future, it will be necessary for labs to adopt as many of the following strategies as possible:

• Run more tests.

• Test in fewer sites.

• Operate with fewer instruments.

• Retain lower operating costs.

• Employ relatively less skilled labor.

• Use more automation in a paperless environment.

Automation Is the Answer

Automation will increasingly become a crucial mechanism for clinical laboratories to achieve higher productivity and cost efficiency. Automation helps streamline the workflow and results in a more reproducible process with less hands-on interaction, which can significantly reduce costs and decrease the need for skilled labor. In the future, regardless of their size, more laboratories will be using more automation. If they don't, they will not survive the current downsizing and consolidation that is affecting clinical laboratories across the nation.

One key goal for automation in clinical diagnostics is to minimize non-value-added steps in the lab—processes like sorting tubes, decapping, centrifugation, loading analyzers, and sorting for storage. Non-value-added steps can all be handled by automation components, which free up the technologist's time. Because labor accounts for approximately 65% of the cost of producing test results, automation and better information management can reduce the manual, hands-on steps in a lab while improving labor efficiency.

A second key goal is to increase available time for value-added steps—the tasks that technologists perform that help make a difference in the quality of the test results and, ultimately, the diagnosis. Value-added steps include such activities as reviewing critical results and deciding whether to rerun or perform reflex testing based on a specific result.

Lab automation covers a broad spectrum of processes that occur in the lab—from the receipt of the sample to the reporting of the validated results (see Figure 1). Any or all of these processes can be automated, whether the lab's goal is to have system-based, modular work cells or total laboratory automation (TLA).

Figure 1. Cycle of events affecting total turnaround time and laboratory efficiency for a typical clinical laboratory test.

TLA Isn't for Everyone

When the trend toward clinical laboratory automation first began, in the early to mid 1990s, much of the talk about automation centered around TLA. Targeted to the largest, highest-volume laboratories, TLA is a multimillion dollar investment that requires a lot of space to implement. Because of the high cost and space requirements, there are fewer than 20 laboratories in the United States currently using TLA.

TLA—together with sophisticated laboratory information systems (LIS) and computerized data management software programs—automates everything done in a lab except the most esoteric testing. From the time that bar coded samples are placed on a conveyor or track, they are automatically centrifuged; decapped; sorted to workstations; tested on clinical chemistry, immunoassay, hematology, coagulation, or urinalysis workstations; and routed for postanalytical processes, storage, and retrieval.

For the high-end laboratories that have adopted TLA, the benefits seem to have paid off. For example, Mt. Sinai Medical Center (New York City), working with Beckman Coulter Inc. (Fullerton, CA), recently implemented one of the largest and most comprehensive fully automated laboratories in the world, with one of the most advanced LIS systems available. The lab currently processes 4000 tests per day, and has the capability to expand to more than 25,000 tests per day.

Mt. Sinai's TLA system uses robotics for sample preparation, which is connected to the automated analyzers (see Figure 2). Once the bar coded specimens are placed on the tracks, all processes and procedures are entirely automated until the final review of results by lab personnel. In its first months of operation, the lab has greatly improved the speed of testing and reporting results to physicians, as well as increasing testing accuracy and worker safety, while reducing costs.

Figure 2. The TLA system at Mt. Sinai Medical Center (New York City) uses robotics for sample preparation.

Modular Automation

TLA, however, is not an affordable or practical solution for the majority of small to mid-sized hospital and reference laboratories. The trend for most clinical labs (and for automation manufacturers) is toward modular automation, consisting of consolidated and integrated analyzers, independent work cells, and automation for pre- and postanalytical processes.

Modular equipment can either operate as stand-alone instruments independent of other devices, or it can be grouped together to form work cells. Common modular automation devices incorporate centrifuges, decappers, aliquoters, specimen loaders, and unloaders. The idea is to automate in customized, incremental steps, based on a lab's individual needs and budget.

System-based automation includes consolidated clusters of instruments that work together to improve overall workflow efficiency. As productivity improves, labs can add advanced data management capabilities for additional automation through information flow. Then, as a budget allows, other systems can be added, including everything from table-based, robotic workstations all the way to linear automation systems that use a conveyor track to move individual sample tubes through the lab. Several large automation vendors currently offer incremental modular automation solutions.

As laboratory automation moves toward system-based, modular automation, smaller labs, with throughputs that will never require TLA, will now be able to afford to automate. Small to mid-sized labs that have recently implemented system-based automation systems have experienced positive results in a short period of time.

In 1998, the Loyola University Medical Center Laboratories, near Chicago, needed to combat ongoing budgetary restraints and declining reimbursements. The lab first consolidated its departmental-based labs into a more efficient core lab system and cross trained lab personnel to handle a wider variety of laboratory procedures.

Next, the Loyola lab implemented a computerized bar code labeling system and added an Accelnet, a modular lab automation system with robotics (Beckman Coulter). The Accelnet system reads the bar codes, sorts samples for the correct testing, loads and unloads samples from a centrifuge, decaps the tubes, and delivers them to the appropriate analyzers (see Figure 4).

Loyola's core lab currently processes 2500–3000 tests per day. Since it implemented automation with robotics, the lab has increased test volume by 20%, reduced sample turnaround times by 11%, and saved $100,000 in staff salaries.

Front-End First

Because manual sample processing is the most labor-intensive area of a lab, it is a logical place to begin the automating process.

Surveys have shown that the majority of automation for small to mid-sized hospitals and reference labs will be at the preanalytical front end, with the key goals being to increase productivity and achieve faster testing turnaround times that will allow them to remain competitive. Automating tasks like sorting samples (using bar code technology), loading and unloading the centrifuge, decapping tubes, and sorting samples to the appropriate analyzers can quickly improve turnaround times, decrease human error, and reduce labor costs (see Figure 3).

Figure 3. Core lab design emphasizes automation in the most labor-intensive areas of clinical laboratory testing.

In October 1998, the lab at St. Mary's Hospital Center (Montreal), implemented front-end automation along with a sophisticated LIS system (see Figure 6). Prior to installing automated equipment, the lab was reconfigured from a traditional noncomputerized department-based facility to a fully computerized core lab. St. Mary's took these steps as a result of budget cuts and an increase in its volume of tests when several nearby hospitals closed down. St. Mary's now has an automated system that utilizes bar code technology to sort tubes by workstation requirements; load samples into the centrifuge; start and unload the centrifuge; decap tubes and sort samples to specific analyzer racks.

Figure 4. At Loyola University Medical Center Laboratories, an Accelnet modular lab automation system uses robotics to free technicians from the most labor-intensive tasks in a lab, such as sorting samples and loading and unloading the centrifuge.

St. Mary's began to see significant results in just a matter of months. While testing volume was increased by 25%, the lab never increased its staff, and costs per test decreased. Also, while test volumes increased, turnaround times improved, and there has been a significant reduction of standard deviation with the front-end automation system. In stat chemistry tests alone, the turnaround time at St. Mary's lab went from 35 minutes to 25 minutes, and standard deviation went from 81 to 37 minutes.

Automation Is a Process

While more laboratories are looking to automation to respond to cost-containment and productivity pressures, they will increasingly look at the whole process before purchasing automated equipment. When the bottom-line goal is a more efficient and productive lab, each step must be broken down and analyzed to pinpoint areas of potential improvement (see Figure 5).

Figure 5. Improved efficiency for clinical laboratories will increasingly mean reviewing the entire testing process with a view toward identifying areas of potential improvement.

This multistep approach toward automation should begin with an in-depth laboratory process analysis. This involves a third party (usually a representative from an automation vendor) going on-site to review a lab's current setup. The result should be a detailed report that identifies preanalytical labor-saving opportunities, as well as how automated equipment can help the lab enhance efficiency and reduce costs in the future.

Some of the questions asked are: How do the samples get to the lab? Once in the lab, what is the workflow of samples? What are the peak testing hours? Is bar coding used and, if so, how? How are aliquots and stat testing handled? What are the staffing issues? What are the test volume needs in the future? After a lab's specific test volume needs, cost-reduction goals, and budgets are taken into account, then the automation process can begin.

Workstation Consolidation

Figure 6. Front-end automation using a Power Processor (Beckman Coulter) at St. Mary's Hospital Center (Montreal).

Consolidation to fewer workstations with broader menus is a crucial first step to a more efficient laboratory. This step often works best in a core or centralized laboratory layout, which improves the workflow in a lab by moving the routine analyzers closer in a central sample processing area.

Because the physical process of loading today's more sophisticated analyzers for chemistry, immunochemistry, hematology, and coagulation are similar, it makes sense to group them together in a common area close to specimen processing. In this way, it is easier to load the analyzer racks, communicate with the LIS for test menus and results, and then unload the racks.

Consolidating broader testing menus on a minimum number of analyzers also reduces aliquoting and relabeling steps. Automation vendors are responding to this need by producing new-generation analyzers that have much broader testing menus.

Information Management

LIS integration will become increasingly important in the future. Without adequate LIS and integrated data management programs that allow instruments to communicate with one another, automated equipment, no matter how sophisticated, will never reach its potential.

When specimens are delivered to a core or central receiving area, each sample should already be identified and labeled by bar code technology. This allows labs to immediately begin routing for individual tests, while still tracking each sample anywhere in the testing process and allowing for rerun or reflex testing when necessary.

LIS systems are becoming increasingly sophisticated and will eventually result in a paperless work environment. Current systems offer bidirectional communication, making it possible to electronically communicate sample identification and test orders to the lab's analyzers, which then electronically transfer results back to the LIS. This function eliminates the need for hard-copy work lists and loading orders.

In addition, data management software allows for the linkage of testing orders with electronically logged-in samples, automatic programming of instruments, automatic receipt and verification of results, and the electronic transfers of test results.

The goal of all laboratories is to get the test results back to the physician as quickly and accurately as possible. Today's electronic communication systems make it possible to gather data from multiple workstations, transmit the test results to a patient's file or a doctor's office, or to automatically generate a fax report.

Other Trends in Automation

As the home-care and outpatient healthcare markets grow—some industry experts say by 70% in the next year alone—automation will move more often to a patient's bedside. Physicians who are adopting point-of-care (also called near-patient) testing now have access to small, handheld analyzers for tests that include glucose, electrolytes, and some hematology testing. Some of these analyzers can be hooked into a hospital or core lab's LIS system. Although the trend toward near-patient testing seems destined to grow, the current high costs and issues related to standardization may inhibit the proliferation of these analyzers.

Another issue that will become increasingly important is worker safety in the lab. In California and several other states, government has enacted bloodborne pathogen and sharps-injury legislation that is pushing hospitals to implement strict guidelines to better protect healthcare workers. The language in these bills includes protecting lab workers from biological and biohazard exposures.

These laws will affect the design and sales of automated equipment as labs look for key features such as automated decapping and recapping, which can protect lab technicians from being splashed by test samples. As worker safety is increasingly legislated throughout the United States, closed-tube systems will also become more important. These systems access the sample by automatically piercing through the caps rather than using a decapping method.

As more labs move toward automation, there will also be more demand for standardized interfaces that will allow different manufacturer's instruments to be connected and work together. This will particularly be an issue with the growth of modular automation. When a lab's needs grow, requiring further automation, it will be important that individual pieces of equipment can be upgraded or connected to customize laboratory growth.

Conclusion

As economic factors continue to drive the healthcare industry, clinical laboratories of all sizes will be competing for their share of the diagnostics market. There will be more consolidation and downsizing. Community hospital labs will no longer be able to survive just by doing their own inpatient testing. Labs of all sizes will attempt to develop outreach programs to draw outpatient, home health, and private-practice tests to their facilities. Even as testing volumes increase, budget restraints will require staffing to either stay the same or be reduced. As labs take a number of measures to deal with this environment, automation will be a key factor in their survival.

Photos courtesy of Beckman Coulter

Jack Zakowski, PhD, is manager of systems development applications, and Diane Powell is a principal applications scientist at Beckman Coulter Inc. (Fullerton, CA).