Automating the microbiology laboratory is the last frontier
By Gary Tufel
Over the years, automation in clinical labs has made sizeable gains toward improving efficiency and productivity, and delivering timely and accurate results to improve patient outcomes. But automating the many processes used in microbiology departments has been laboratories’ “last frontier,” according to Brad Banks, worldwide marketing manager for lab automation at BD Diagnostics–Diagnostic Systems, Sparks, Md.
Because of the nation’s aging population, the volume of assays performed by US labs is continuing to increase. Yet, at the same time, the number of available techs is decreasing, says Nilam Patel, senior product manager for automation solutions at Sysmex America Inc, Lincolnshire, Ill. Coupled with an increased emphasis on quality and patient outcome initiatives, these trends are leading clinical laboratories to seek automation that provides quality clinical information, maximizes operational efficiency, and minimizes “sample touch points.”
MINIMIZING SAMPLE TOUCH POINTS
Automated diabetes testing is available to clinical laboratories via the Sysmex XN-9000 Lavender Top Management (LTM) system. LTM is a comprehensive automation solution that maximizes operational efficiencies, reduces sample volume and tube draws, provides quality clinical information, and minimizes “sample touch points” throughout the entire testing process. The system also offers a unique integration of both hematology and diabetes (HbA1c) testing onto a single “island” of automation. Lavender Top Management enables laboratories to realize virtually hands-free analysis of more than 90% of high-volume EDTA tests, and management of virtually 100% of EDTA tubes through sample sorting, rerouting, and archiving.
Lavender Top Management is driven by Sysmex WAM decision support software for the clinical laboratory. This library of simple and complex rules is customized to a laboratory’s best practices and unique workflow; it standardizes processes and positions the laboratory for future growth. With a reduction in draw volumes and more clinical information, laboratories and hospitals can provide a higher level of service and efficiency to their patients with the Lavender Top Management solution, Patel says.
Banks notes that BD Diagnostics, a segment of leading global medical technology company BD (Becton, Dickinson and Co), has been a key driver in the increase of automation in the clinical lab, particularly in microbiology, where activity has increased. “Microbiology testing is different from chemistry or hematology because of the wide variety of sample types and containers that are used,” says Banks. “Many of the same techniques have been used for 100 years.”
The seeming conservatism of microbiology labs is largely due to the wide variety of sample types involved and the preponderance of non-liquid samples—including stool, various swabs, sputum, and tissues—which can be difficult to automate. Processing microbiology samples in general is a very manual and error-prone process that requires a lot of manual sorting, labeling, and streaking of plates—steps that can slow down the testing process due to the potential for errors and the need for subculturing. And with the samples still being manually transported around the lab—coupled with the fact that each lab processes hundreds or thousands of samples—the need to automate microbiology testing has become increasingly apparent.
Other pressures are also driving the push for automation in the microbiology lab, including the unavailability of skilled labor, changes in the healthcare environment, the consolidation of hospitals and labs, and, of course, growing economic pressures. Ultimately, the combined weight of such pressures is compelling labs to seek out the increases in efficiency, accuracy, and improved time to result that automation can offer.
Microbiology automation is just coming into its own in North America, but it’s been in use in Europe for the past 7 years or so. Taking advantage of the European lead in the field, BD acquired the Netherlands-based Kiestra Lab Automation BV in 2012, and now offers the BD Kiestra suite of automated laboratory platforms. The group features three different-sized solutions that are modular in nature.
Over the past decade, Kiestra has developed technology to automate the plate streaking process, and combined it with automated plate transportation systems, integrated ergonomic work benches for inline workup, and automated incubation and digital imaging systems. According to Banks, the resulting platforms automate and streamline almost all the tasks once performed manually by lab techs, thereby significantly reducing error rates and the need for repeat testing, while also providing traceability throughout the process.
BD is now offering its second generation of Kiestra automated solutions. The new generation includes the ReadA compact automated incubator, which boasts a small footprint and enhanced workflow. Also new is the BD InoqulA, which can automate the processing of both liquid and non-liquid samples. According to Banks, it is the only automated specimen processor that streaks plates utilizing a unique magnetic rolling bead technology.
AUTOMATING THE HISTOLOGY LAB
Roche’s Ventana division changed the landscape of automation in the histology lab with the launch of its BenchMark Ultra platform, an automated immunohistochemistry/in situ hybridization (IHC/ISH) slide staining system. According to Megan Bailey, group marketing manager for tissue diagnostics platforms at Roche Diagnostics Corp, Indianapolis, the platform is the first IHC/ISH instrument that has 30 individual drawers to improve slide throughput.
“The BenchMark Ultra platform is designed for the premier pathology professional who values improved productivity,” says Bailey. “It is a fully integrated staining solution that delivers superior workflow efficiency and medical value through continuous and random processing of patient samples.” The platform processes up to 90 slides in 8 hours, or 120 slides with an overnight run, and offers simultaneous IHC, ISH, multiplexing, and fluorescein isothiocyanate (FITC) slide processing and titration.
In addition, the emerging area of digital pathology is transforming anatomic pathology labs in many ways. According to Christine Blinco, group marketing manager for tissue diagnostics assays at Roche, the Ventana portfolio in this area is designed to provide a comprehensive solution to help labs optimize their operations. “Our digital pathology suite is designed to be fully integrated and completely scalable—integrating workflow, scanners, and software—to empower labs from scanning to case sign-out,” she says. The result, according to Blinco, is improved operational efficiency, seamless connectivity and integration, and enhanced medical value to support excellent patient care.
On the software side, Ventana’s all-encompassing approach to companion algorithm image analysis includes assays, reagents, automated staining platforms, and digital pathology tools. The solution is designed to consistently provide validated, objective results through the Ventana portfolio of key breast cancer biomarkers, including HER2, PR, Ki-67, and p53. The system provides consistent, objective interpretations—verified by a pathologist—for each patient, as well as semiquantitative scoring and reduced inter- and intraobserver variability in IHC stain interpretation. The company’s Virtuoso software is designed to help optimize workflow, enabling real-time case consultation and anytime, anywhere access to slide images, for greater efficiency and flexibility and enhanced workload distribution to help clinical labs improve resource allocation.
Roche’s Ventana digital pathology product offering includes two cutting-edge digital pathology scanners for anatomic pathology labs. The iScan Coreo scanner offers user-friendly walk-away automation and flexible slide scanning, with a 160-slide capacity. For research applications, the Ventana iScan HT scanner offers continuous random access and stat processing, with 80 slides per hour at 20× and an approximate time to view of 45 seconds per slide.
According to Blinco, digital pathology solutions such as these can help labs gain time to focus on top priorities. Workflow can be improved with random access that decouples slide loading and slide handling without interrupting in-process scans, and remote consultation and access to subspecialist expertise can be managed with integrated software.
For the serum work area, Roche announced in July 2013 that it is developing the Cobas 8100 automated workflow series, an advanced system designed to automate many routine tasks to help diagnostic laboratories increase efficiency, reduce expenses, and maximize patient safety.
“This total lab automation solution can make a significant contribution to effective medical decision-making and higher efficiency in the medical laboratory,” says Jack Phillips, president and CEO of Roche Diagnostics. “In addition to helping labs lower costs and minimize the risk of sample mix-ups, it offers short and predictable turnaround times to help physicians make fast and reliable treatment decisions for patients.”
Using intelligent robotics, the Cobas 8100 series automatically prepares blood samples for immediate testing and postanalytical processing, providing high-speed processing of up to 1,100 samples per hour. The system offers dynamic and efficient sample transport options and great flexibility, enabling labs to automate both routine and stat tests. Healthcare professionals benefit from on-time, high-quality diagnostic results for both routine and emergency tests, even at laboratory workload peaks.
The Cobas 8100 series can easily be added onto Roche’s existing Cobas analyzers, and its flexible, modular design allows labs to grow over time as demand increases. Market availability in the US is expected in 2015.
THE UDI RULE
Banks notes that BD has been voluntarily assigning global trade item numbers (GTINs) and production data (lot, expiry, serial numbers, etc) in human readable and bar code format to its products for well over a decade. Now that FDA has finalized its rule on unique device identifiers (UDIs), BD is assessing and modifying its voluntary GTIN implementation to ensure that it is compliant with UDI requirements. “The BD Kiestra platform can already scan bar codes. As more lab products are marked with UDI-compliant bar codes, BD Kiestra will evolve to further leverage the speed, accuracy, and process improvements that bar codes enable,” he says.
In 2012, Sysmex launched the Sysmex XN-Series of automated hematology analyzers. To aid in the diagnosis and management of disease, these configurable, scalable hematology analyzers enable clinical laboratories to automatically provide reportable clinical information to the physician on immature cell population characteristics that can reflect the state of leukopoiesis, erythropoiesis, and thrombopoiesis.
For example, reticulocyte hemoglobin content (RET-He) can be useful to physicians in the diagnosis of iron deficiency and iron deficiency anemia (ID/IDA) because the parameter is a direct measure that reflects the iron available for hemoglobin synthesis. The immature platelet fraction (IPF) can be useful to physicians because it provides the physician with an assessment of bone marrow thrombopoiesis from a peripheral blood sample in a way that is similar to the assessment of erythropoiesis using reticulocyte counts. IPF helps physicians in the differential diagnosis of thrombocytopenia as a result of platelet destruction versus compromised production. These parameters meet key test criteria of clinical relevance, speed, and affordability, says Sysmex’s Patel.
MAXIMIZING OPERATIONAL EFFICIENCY
Lean principles of operation are driving clinical laboratories to look at more efficient ways of managing data. Rules-based autovalidation and automated sample management are both being explored to help improve turnaround times as well as staff productivity. In fact, hematology laboratories and laboratories that use integrated HbA1c testing solutions employing Sysmex WAM
decision support software are able to achieve autovalidation rates as high as 85%, says Patel.
Sysmex WAM has an extensive, complex rule set for both hematology and Bio-Rad HbA1c testing based on International Society for Laboratory Hematology (ISLH) consensus and WAM-user best practices. The set includes rules for critical results, linearity, flagging, delta and previous check rules against flags, operator alerts and coded comments, and finally, patient-specific and sample aging rules. Laboratories are able to edit the rule set to meet their patient-specific and operational workflow needs. This comprehensive rules library can help laboratories maximize efficiency by minimizing sample handling, eliminating processing steps, and increasing capacity.
THE NEXT STEP IN LAB AUTOMATION?
Banks says the future of BD’s lab automation efforts will include continuing development of microbiology lab automation with physical integration of analytical instruments onto the BD Kiestra systems, and the continuing innovation of informatics platforms. The reasons for these emphases include the federal push to implement electronic medical records as well as the need for labs to consolidate large amounts of data—and for clinicians to be able to access that information easily, from anywhere.
Although the trend toward automating microbiology labs is growing in North America, the prevalence of automation remains higher in Europe due to various economic and geographical differences between the two regions, says Banks. Resistance to change is also a factor, so an effort to educate labs about the benefits of automation, and to demonstrate how microbiology lab automation can help make a difference, has been an ongoing process. Within the past 2 or 3 years, however, the efficiency and improved outcomes demonstrated by automation in Europe is helping the number of automated labs to grow quickly in Canada and the US, he says.
Banks also cites lab and hospital consolidation as other factors that could be playing into the growth of automation, but there’s no stopping its continued implementation. One major selling point: “Approximately 70% of clinical decisions are made on the basis of diagnostic testing—so lab input is key,” he says. “If we can help to improve the speed and accuracy of results and facilitate delivering that information faster to the correct clinical decision-makers, it will help save money, increase efficiency, expedite the correct treatment therapies, support improved patient outcomes, and increase customer satisfaction.
“To achieve these gains, hospitals and labs may have to look at changing their processes, and making larger investments in new automation equipment up front. I’m confident exciting things will come out of implementing these solutions for everyone.”
Gary Tufel is a contributing writer for CLP. For more information, contact CLP chief editor Steve Halasey via [email protected]