Evolutions in Laboratory Technology

Vol. 18 • Issue 1 • Page 24

For nearly two decades automation has served to improve laboratory productivity and patient care by delivering workflow efficiency and quality results unachievable in a manual lab. But competing industry pressures-an ongoing labor shortage, tighter reimbursement policies and a graying population-require that automation perform at a higher level.

Responding to Pressure

These pressures are not new, but they are intensifying. In response, labs have been adopting various levels of automation, from pre-analytical through post-analytical phases. This has reduced the risks of errors and enabled laboratories to absorb higher testing volumes without adding staff. However, advances in data management software for the clinical laboratory, also known as middleware, can optimize automation further and achieve meaningful workflow efficiencies without the high costs associated with large capital expenditures.

Middleware configured with the user in mind (e.g., features icon-driven applications and proactively pushes information to the user) can take the guess work out of complex processes. Laboratorians can track samples, autovalidate results, monitor multiple analyzers and even improve quality control by tracking patient moving averages.

While automation improves the testing process itself, middleware improves the way that information flows throughout the laboratory. Together, they create a “hands-free” lab that enables laboratorians to focus on other strategic activities that improve patient care.

Challenges Drive Technology Evolution

Several factors are influencing a push to optimize automation. Chief among them is the shortage of qualified laboratory workers.

“The labor shortage has grown progressively worse over the years,” says Michael Astion, MD, PhD, director of Reference Laboratory Services, Department of Laboratory Medicine, University of Washington. “There simply aren’t enough graduates to fill the vacancies that will be created by retirements.”

Since 1970, the number of education programs for laboratory technologists and technicians has declined by more than 50 percent, with technologist programs accounting for the most dramatic decline; 70 percent of these programs closed between 1970 and 2007. Also, with a mean age of technologist approaching that of retirement, we can expect that labs will soon miss their most seasoned personnel.

To close the gap, laboratories have begun to initiate several staffing strategies. They may hire less-skilled workers or hire technologists who have been trained in other regions of the world. They may use more generalists in place of specialists. And some will likely offer part-time work to laboratorians who would otherwise retire.

Add to this escalating medical cost and payer policy revisions intended to encourage quality results (pay-for-performance, rather than quantity care). The clinical laboratory plays an integral role in meeting quality measures because while diagnostic tests account for only two percent of all Medicare expenditures, they influence 70 percent of all medical decisions.

Finally, the population is graying and this impacts the lab on two fronts. In the lab, as mentioned above, seasoned lab technologists are approaching retirement age. On the patient side, older people are living longer and spurring growth in clinical diagnostic industry. “There’s been a massive increase in the number of diagnostic tests available today,” says Dr. Astion. In fact, more than 4,000 laboratory tests have been developed for clinical use.

Automation has evolved to meet these needs, giving laboratories the means to conduct routine tests quickly and efficiently. Time-consuming manual steps are virtually eliminated, leading to far better turnaround time. For example, a manual centrifuge process that takes a mean of 50 minutes to complete can be cut to just 22 minutes with automation.

Automation also significantly reduces errors and improves quality. “You are eliminating the risk of human error-particularly with specimen processing-and that is a powerful benefit,” says Dr. Astion.

As critical as automation has been, however, it is not a silver bullet. “Automation has definitely helped laboratories take on more work and reduce errors,” says Dr. Astion. “But medical advances will continue to produce new, complicated tests that can’t be automated right away.”

Evolving to the Next Level of Productivity

Middleware is a powerful addition to automation because like automation, it can eliminate tedious, time-consuming manual steps in the laboratory. The two technologies can be seamlessly integrated to create a hands-free workflow in the lab.

With middleware, labs can view a dashboard display of patient samples in analysis on one screen. Stat samples are automatically displayed, minimizing processing delays and speeding delivery of critical sample results to clinicians. Technologists can locate a tube at any time with minimal keystrokes. And if a physician adds a test during the analysis period, middleware can track down the sample and initiate the added test.

Through the dashboard interface information is “pushed” proactively to technologists, providing visual alerts as to the status of patient sample. This is particularly important in the case of critical or life-threatening results. Additionally, pop-up notices can include instructions on next steps, to ensure process consistency across work shifts.

Additionally, middleware allows laboratories to program validation rules that are far more specific than what is possible on most current laboratory information system (LIS) software. For instance, decision rules can be written for specific doctors or sub-groups of patients.

Middleware uses decision rules to validate normal results, which are then sent to the LIS for release to the physician and the electronic medical record. Middleware allows for abnormal results to be called out for manual review. For most labs, nearly 80 percent of results can be autovalidated by middleware, directing the staff to the 20 percent of results that truly need attention.

Other Middleware Dimensions

But tracking and autovalidating samples is just one dimension of middleware. Laboratories also can monitor the performance of multiple analyzers, all from the same console. Reagent levels, calibration status, maintenance reminders and more are updated in real time and reported in a simple interface. For laboratories that are divided among different

locations, this technology adds tremendous value.

Yet a third dimension of middleware allows labs to continuously monitor the quality of test results. The software uses normal patient test results as an additional monitor of system stability between quality control runs. It achieves this through two statistical methods-the moving average of normal results and exponentially weighted moving average. Instead of checking quality controls once a day, technologists have access to real-time informatics, and they can be alerted to potential unstable system performance. In the event of unstable performance, the software automatically stops validating test results, saving the lab from generating inaccurate patient results. Technologists also can evaluate data across instruments, across control levels and during a defined time interval-all on a single chart.

Essential Investments

Middleware is evolving to new levels of sophistication. Icon-driven interfaces, pop-up screens, detailed instructions and color-coded alerts create an intuitive experience for operators. But as is the case with most new technologies, front-end investment is essential to ensure success. In the case of middleware, training and customer service are essential components in the application of a new system. Before deciding which middleware solution to apply, the lab director should compare and rate training programs and customer care policies associated with the product. A small, upfront investment in training pays off in stronger adoption and use of the software. A committed customer care program will keep the lab running and quality results in place under the most trying periods.

Technology, Lab Evolution

Looking forward, we can expect new, Web-based middleware to provide lab directors with greater day-to-day autonomy. We can also expect to see refinements in “push” technology that place the right information into the right hands at the right time.

In the meantime, middleware continues to offer a new level of efficiency by improving the way that information flows in the laboratory. Decisions, follow-up activities and sample tracking are all standardized, expediting quality results. With manual labor minimized, highly skilled workers can focus on more meaningful work in the lab.

By eliminating tedious manual work and expediting information using decision rules available only through middleware, labs can create a working environment that attracts new talent and entices potential retirees to stay longer.

“After using any level of automation for a while, technologists often say they can’t imagine being without it,” says Dr. Astion. “They realize it eliminates the work that they greatly dislike.”

Automation will continue to play a role in improving processes, but laboratories now have an option that optimizes automation and expounds on the concept of a “hands free” operation. The combination of middleware and automation will best equip laboratories to deliver high-quality patient care and adapt to the challenges ahead.

Ronald N. Berman is Beckman Coulter vice president, Clinical Automation and Clinical IT Business Centers, and an ADVANCE vendor advisory board member.